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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
one)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
file number 001-15771
ABEONA
THERAPEUTICS INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
83-0221517 |
(State or other jurisdiction
of incorporation or organization) |
|
(I.R.S. Employer I.D. No.) |
6555
Carnegie Avenue, 4thFloor
Cleveland,
OH 44103
(Address
of principal executive offices, zip code)
(646)
813-4701
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common Stock, $0.01 par
value |
|
ABEO |
|
Nasdaq Capital Market |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ |
Accelerated filer ☐ |
Non-accelerated filer ☒ |
Smaller reporting company ☒ |
Emerging growth company ☐ |
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares outstanding of the registrant’s common stock as of August 2, 2024 was 43,314,397 shares.
ABEONA
THERAPEUTICS INC.
Form
10-Q
For
the Quarter Ended June 30, 2024
INDEX
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (including information incorporated by reference) contains statements that express management’s opinions,
expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or
may be deemed to be, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “expects,” “anticipates,” “intends,”
“plans,” “believes,” “could,” “would,” “seeks,” “estimates,”
and variations of such words and similar expressions, and the negatives thereof, are intended to identify such forward-looking statements.
Such “forward-looking statements” speak only as of the date made and are not guarantees of future performance and involve
certain risks, uncertainties, estimates, and assumptions by management that are difficult to predict. Various factors, some of which
are beyond the Company’s control, could cause actual results to differ materially from those expressed in, or implied by, such
forward-looking statements. In addition, we disclaim any obligation to update any forward-looking statements to reflect events or circumstances
after the date of this report, except as may otherwise be required by the federal securities laws.
Forward-looking
statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in forward-looking
statements due to a number of factors. These statements include statements about, among other things: our ability to address the items
raised in the FDA’s complete response letter related to our Biologics License Application for pz-cel; the timing and outcome of
our resubmission of a Biologics License Application for pz-cel; our plans to continue development of AAV-based gene therapies designed
to treat ophthalmic diseases; the achievement of or expected timing, progress and results of clinical development, clinical trials and
potential regulatory approvals; our pipeline of product candidates; our belief that pz-cel could potentially benefit patients with RDEB;
our belief in the adequacy of the clinical trial data from our VIITAL™ clinical trial, together with the data generated in the
program to date, to support regulatory approvals; our dependence upon our third-party customers and vendors and their compliance with
regulatory bodies; our estimates regarding expenses, future revenues, capital requirements, and needs for additional financing; our intellectual
property position and our ability to obtain, maintain and enforce intellectual property protection and exclusivity for our proprietary
assets; our estimates regarding the size of the potential markets for our product candidates, the strength of our commercialization strategies
and our ability to serve and supply those markets; and future economic conditions or performance.
Important
factors that could affect performance and cause results to differ materially from management’s expectations are described in the
sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as updated from time
to time in the Company’s SEC filings, including this Quarterly Report on Form 10-Q. These factors include: the timing and outcome
of our resubmission of the Biologics License Application for pz-cel; our ability to access our existing at-the-market sale agreement;
our ability to access additional financial resources and/or our financial flexibility to reduce operating expenses if required; our ability
to obtain additional equity funding from current or new stockholders; the potential impacts of global healthcare emergencies, such as
pandemics, on our business, operations, and financial condition; our ability to out-license technology and/or other assets, deferring
and/or eliminating planned expenditures, restructuring operations and/or reducing headcount, and sales of assets; the dilutive effect
that raising additional funds by selling additional equity securities would have on the relative equity ownership of our existing investors,
including under our existing at-the-market sale agreement; the outcome of any interactions with the U.S. Food and Drug Administration
(“FDA”) or other regulatory agencies relating to any of our products or product candidates; our ability to continue to secure
and maintain regulatory designations for our product candidates; our ability to develop manufacturing capabilities compliant with current
good manufacturing practices for our product candidates; our ability to manufacture cell and gene therapy products and produce an adequate
product supply to support clinical trials and potential future commercialization; the rate and degree of market acceptance of our product
candidates for any indication once approved; and our ability to meet our obligations contained in license agreements to which we are
party.
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
($
in thousands, except share and per share amounts)
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 34,426 | | |
$ | 14,473 | |
Short-term investments | |
| 88,282 | | |
| 37,753 | |
Restricted cash | |
| 338 | | |
| 338 | |
Other receivables | |
| 1,640 | | |
| 2,444 | |
Prepaid expenses and other current assets | |
| 1,218 | | |
| 729 | |
Total current assets | |
| 125,904 | | |
| 55,737 | |
Property and equipment, net | |
| 3,975 | | |
| 3,533 | |
Operating lease right-of-use assets | |
| 4,024 | | |
| 4,455 | |
Other assets | |
| 100 | | |
| 277 | |
Total assets | |
$ | 134,003 | | |
$ | 64,002 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 3,099 | | |
$ | 1,858 | |
Accrued expenses | |
| 4,924 | | |
| 5,985 | |
Current portion of long-term debt | |
| 2,222 | | |
| — | |
Current portion of operating lease liability | |
| 1,792 | | |
| 998 | |
Current portion payable to licensor | |
| 4,805 | | |
| 4,580 | |
Other current liabilities | |
| 1 | | |
| 1 | |
Total current liabilities | |
| 16,843 | | |
| 13,422 | |
Long-term operating lease liabilities | |
| 3,018 | | |
| 4,402 | |
Long-term debt | |
| 16,133 | | |
| — | |
Derivative liabilities | |
| 668 | | |
| — | |
Warrant liabilities | |
| 24,100 | | |
| 31,352 | |
Total liabilities | |
| 60,762 | | |
| 49,176 | |
Commitments and contingencies | |
| - | | |
| - | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| — | | |
| — | |
Common stock - $0.01 par value; authorized 200,000,000 shares; 41,661,993 and 26,523,878 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 417 | | |
| 265 | |
Additional paid-in capital | |
| 846,654 | | |
| 764,151 | |
Accumulated deficit | |
| (773,696 | ) | |
| (749,524 | ) |
Accumulated other comprehensive loss | |
| (134 | ) | |
| (66 | ) |
Total stockholders’ equity | |
| 73,241 | | |
| 14,826 | |
Total liabilities and stockholders’ equity | |
$ | 134,003 | | |
$ | 64,002 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations and Comprehensive Income (Loss)
($
in thousands, except share and per share amounts)
(Unaudited)
| |
| | |
| | |
| | |
| |
| |
For the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | — | | |
$ | 3,500 | | |
$ | — | | |
$ | 3,500 | |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| — | | |
| 1,575 | | |
| — | | |
| 1,575 | |
Research and development | |
| 9,218 | | |
| 8,523 | | |
| 16,425 | | |
| 16,564 | |
General and administrative | |
| 8,646 | | |
| 5,021 | | |
| 15,769 | | |
| 9,018 | |
Gain on operating lease right-of-use assets | |
| — | | |
| (1,065 | ) | |
| — | | |
| (1,065 | ) |
Total expenses | |
| 17,864 | | |
| 14,054 | | |
| 32,194 | | |
| 26,092 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (17,864 | ) | |
| (10,554 | ) | |
| (32,194 | ) | |
| (22,592 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 1,191 | | |
| 417 | | |
| 2,034 | | |
| 781 | |
Interest expense | |
| (1,072 | ) | |
| (103 | ) | |
| (2,024 | ) | |
| (204 | ) |
Change in fair value of warrant and derivative liabilities | |
| 24,927 | | |
| (8,629 | ) | |
| 7,626 | | |
| (6,364 | ) |
Other income | |
| 224 | | |
| 2,215 | | |
| 386 | | |
| 2,618 | |
Net Income (loss) | |
$ | 7,406 | | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic income (loss) per common share | |
$ | 0.19 | | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
Dilutive loss per common share | |
$ | (0.26 | ) | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 40,010,481 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
Dilutive | |
| 51,226,715 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Change in unrealized gains (losses) related to available-for-sale debt securities | |
| 50 | | |
| (30 | ) | |
| (68 | ) | |
| 34 | |
Comprehensive income (loss) | |
$ | 7,456 | | |
$ | (16,684 | ) | |
$ | (24,240 | ) | |
$ | (25,727 | ) |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit)
($
in thousands, except share amounts)
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
(Deficit) Equity | |
Three months ended June 30, 2024 |
| |
| | |
| | |
| | |
| | |
Accumulated | | |
| |
| |
| | |
| | |
Additional | | |
| | |
Other | | |
Total | |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
(Deficit) Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance at March 31, 2024 | |
| 27,550,693 | | |
$ | 276 | | |
$ | 772,129 | | |
$ | (781,102 | ) | |
$ | (184 | ) | |
$ | (8,881 | ) |
Stock-based compensation expense | |
| — | | |
| — | | |
| 1,323 | | |
| — | | |
| — | | |
| 1,323 | |
Cancellation of common stock in connection with restricted share awards, net of issuances and shares settled for tax withholding settlement | |
| (186,796 | ) | |
| (2 | ) | |
| (313 | ) | |
| — | | |
| — | | |
| (315 | ) |
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | |
| 1,013,061 | | |
| 10 | | |
| 3,495 | | |
| — | | |
| — | | |
| 3,505 | |
Issuance of common stock in connection with underwritten offering, net of offering costs | |
| 12,285,056 | | |
| 123 | | |
| 70,030 | | |
| — | | |
| — | | |
| 70,153 | |
Issuance of common stock upon exercise of pre-funded warrants, net of shares settled | |
| 999,979 | | |
| 10 | | |
| (10 | ) | |
| — | | |
| — | | |
| — | |
Net income | |
| — | | |
| — | | |
| — | | |
| 7,406 | | |
| — | | |
| 7,406 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| 50 | | |
| 50 | |
Balance at June 30, 2024 | |
| 41,661,993 | | |
$ | 417 | | |
$ | 846,654 | | |
$ | (773,696 | ) | |
$ | (134 | ) | |
$ | 73,241 | |
Six months ended June 30, 2024 |
| |
| | |
| | |
| | |
| | |
Accumulated | | |
| |
| |
| | |
| | |
Additional | | |
| | |
Other | | |
Total | |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2023 | |
| 26,523,878 | | |
$ | 265 | | |
$ | 764,151 | | |
$ | (749,524 | ) | |
$ | (66 | ) | |
$ | 14,826 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 2,869 | | |
| — | | |
| — | | |
| 2,869 | |
Cancellations of common stock in connection with restricted share awards, net of issuances and shares settled for tax withholding settlement | |
| (49,296 | ) | |
| — | | |
| (329 | ) | |
| — | | |
| — | | |
| (329 | ) |
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | |
| 1,902,376 | | |
| 19 | | |
| 9,943 | | |
| — | | |
| — | | |
| 9,962 | |
Issuance of common stock in connection with underwritten offering, net of offering costs | |
| 12,285,056 | | |
| 123 | | |
| 70,030 | | |
| — | | |
| — | | |
| 70,153 | |
Issuance of common stock upon exercise of pre-funded warrants, net of shares settled | |
| 999,979 | | |
| 10 | | |
| (10 | ) | |
| — | | |
| — | | |
| — | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (24,172 | ) | |
| — | | |
| (24,172 | ) |
Other comprehensive loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (68 | ) | |
| (68 | ) |
Balance at June 30, 2024 | |
| 41,661,993 | | |
$ | 417 | | |
$ | 846,654 | | |
$ | (773,696 | ) | |
$ | (134 | ) | |
$ | 73,241 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit), Continued
($
in thousands, except share amounts)
(Unaudited)
Three months ended June 30, 2023 |
| |
| | |
| | |
| | |
| | |
Accumulated | | |
| |
| |
| | |
| | |
Additional | | |
| | |
Other | | |
Total | |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance at March 31, 2023 | |
| 17,929,344 | | |
$ | 179 | | |
$ | 723,069 | | |
$ | (704,443 | ) | |
$ | (65 | ) | |
$ | 18,740 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 927 | | |
| — | | |
| — | | |
| 927 | |
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement | |
| 1,657,052 | | |
| 17 | | |
| (22 | ) | |
| — | | |
| — | | |
| (5 | ) |
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | |
| 1,891,761 | | |
| 19 | | |
| 6,348 | | |
| — | | |
| — | | |
| 6,367 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (16,654 | ) | |
| — | | |
| (16,654 | ) |
Other comprehensive loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (30 | ) | |
| (30 | ) |
Balance at June 30, 2023 | |
| 21,478,157 | | |
$ | 215 | | |
$ | 730,322 | | |
$ | (721,097 | ) | |
$ | (95 | ) | |
$ | 9,345 | |
Six months ended June 30, 2023 |
| |
| | |
| | |
| | |
| | |
Accumulated | | |
| |
| |
| | |
| | |
Additional | | |
| | |
Other | | |
Total | |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2022 | |
| 17,719,720 | | |
$ | 177 | | |
$ | 722,049 | | |
$ | (695,336 | ) | |
$ | (129 | ) | |
$ | 26,761 | |
Balance | |
| 17,719,720 | | |
$ | 177 | | |
$ | 722,049 | | |
$ | (695,336 | ) | |
$ | (129 | ) | |
$ | 26,761 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| 1,697 | | |
| — | | |
| — | | |
| 1,697 | |
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement | |
| 1,768,116 | | |
| 18 | | |
| (27 | ) | |
| — | | |
| — | | |
| (9 | ) |
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | |
| 1,990,321 | | |
| 20 | | |
| 6,603 | | |
| — | | |
| — | | |
| 6,623 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (25,761 | ) | |
| — | | |
| (25,761 | ) |
Net income (loss) | |
| — | | |
| — | | |
| — | | |
| (25,761 | ) | |
| — | | |
| (25,761 | ) |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| 34 | | |
| 34 | |
Balance at June 30, 2023 | |
| 21,478,157 | | |
$ | 215 | | |
$ | 730,322 | | |
$ | (721,097 | ) | |
$ | (95 | ) | |
$ | 9,345 | |
Balance | |
| 21,478,157 | | |
$ | 215 | | |
$ | 730,322 | | |
$ | (721,097 | ) | |
$ | (95 | ) | |
$ | 9,345 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
($
in thousands)
(Unaudited)
| |
| | |
| |
| |
For the six months ended June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 978 | | |
| 1,276 | |
Stock-based compensation expense | |
| 2,869 | | |
| 1,697 | |
Change in fair value of warrant and derivative liabilities | |
| (7,626 | ) | |
| 6,364 | |
Non-cash gain of right-of-use lease assets | |
| — | | |
| (1,065 | ) |
Accretion and interest on short-term investments | |
| (66 | ) | |
| (74 | ) |
Amortization of right-of-use lease assets | |
| 431 | | |
| 450 | |
Non-cash interest | |
| 735 | | |
| 204 | |
(Gain) loss on disposal of property and equipment | |
| (2 | ) | |
| 47 | |
Change in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| — | | |
| (3,500 | ) |
Other receivables | |
| 804 | | |
| (2,039 | ) |
Prepaid expenses and other current assets | |
| (639 | ) | |
| (777 | ) |
Other assets | |
| 177 | | |
| (65 | ) |
Accounts payable and accrued expenses | |
| (121 | ) | |
| 1,836 | |
Lease liabilities | |
| (590 | ) | |
| (622 | ) |
Other current liabilities | |
| — | | |
| 1 | |
Net cash used in operating activities | |
| (27,222 | ) | |
| (22,028 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Capital expenditures | |
| (1,436 | ) | |
| (250 | ) |
Proceeds from disposal of property and equipment | |
| 18 | | |
| 179 | |
Purchases of short-term investments | |
| (89,890 | ) | |
| (14,156 | ) |
Proceeds from maturities of short-term investments | |
| 39,359 | | |
| 21,649 | |
Net cash (used in) provided by investing activities | |
| (51,949 | ) | |
| 7,422 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from ATM sales of common stock, net of issuance costs | |
| 9,962 | | |
| 6,623 | |
Payments related to net settlement of restricted share awards | |
| (28 | ) | |
| (9 | ) |
Proceeds from underwritten sales of common stock, net of issuance costs | |
| 70,153 | | |
| — | |
Proceeds from issuance of long-term debt | |
| 20,000 | | |
| — | |
Payment of debt issuance costs | |
| (963 | ) | |
| — | |
Net cash provided by financing activities | |
| 99,124 | | |
| 6,614 | |
| |
| | | |
| | |
Net increase (decrease) in cash, cash equivalents and restricted cash | |
| 19,953 | | |
| (7,992 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 14,811 | | |
| 14,555 | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 34,764 | | |
$ | 6,563 | |
| |
| | | |
| | |
Supplemental cash flow information: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 34,426 | | |
$ | 6,225 | |
Restricted cash | |
| 338 | | |
| 338 | |
Total cash, cash equivalents and restricted cash | |
$ | 34,764 | | |
$ | 6,563 | |
| |
| | | |
| | |
Supplemental non-cash flow information: | |
| | | |
| | |
Right-of-use asset obtained in exchange for new operating lease liabilities | |
$ | — | | |
$ | 419 | |
Derivative and warrant additions associated with loan and security agreement | |
$ | 1,042 | | |
$ | — | |
Cash paid for interest | |
$ | 1,290 | | |
$ | — | |
Cash paid for taxes | |
$ | 7 | | |
$ | 6 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
ABEONA
THERAPEUTICS INC. AND SUBSIDIARIES
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
1 – NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES
Background
Abeona
Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation,
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead
clinical program is for pz-cel, an autologous, cell-based gene therapy currently in development for recessive dystrophic epidermolysis
bullosa (“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based
gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM™ capsids that the Company has exclusively
licensed from the University of North Carolina at Chapel Hill and developed internally through its AAV vector research programs.
Basis
of Presentation
The
Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting
principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions
have been eliminated in consolidation. In the opinion of management, all adjustments, consisting only of normal recurring
adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations,
and changes in financial position for such periods, have been made. These unaudited interim condensed consolidated financial
statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Certain
information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the
U.S. Securities and Exchange Commission (“SEC”). The December 31, 2023 condensed consolidated balance sheet was derived
from the audited statements but does not include all disclosures required by U.S. GAAP.
Therefore,
these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the
SEC on March 18, 2024.
Liquidity
In
accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there
are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as
a going concern within one year after the date the accompanying unaudited interim condensed consolidated financial statements were issued.
As
a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development
activities for pz-cel and other product candidates, business planning, raising capital, establishing its intellectual property portfolio,
acquiring or discovering product candidates, and providing general and administrative support for these operations. As a result, the
Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses
and negative cash flows will continue for the foreseeable future.
Since
its inception, the Company has funded its operations primarily with proceeds from sales of shares of its stock. The Company has incurred
recurring losses since its inception, including net losses of $24.2 million and $25.8 million for the six months ended June 30, 2024
and 2023, respectively. As of June 30, 2024, the Company had an accumulated deficit of approximately $773.7 million. To date the Company
has not generated any significant revenues and expects to continue to generate operating losses for the foreseeable future. As of the
issuance date of these unaudited interim condensed consolidated financial statements, the Company expects that its existing cash, cash
equivalents, restricted cash and short-term investments of $123.0 million as of June 30, 2024, will be sufficient to fund its operating
expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these condensed consolidated
financial statements.
While
the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from
the issuance date of these unaudited condensed consolidated financial statements, the Company’s liquidity could be materially affected
over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party
funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory
events or unanticipated costs related to pz-cel; (4) any other unanticipated material negative events or costs. One or more of these
events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become
due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes
to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Use
of Estimates
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
Other
receivables
Other
receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As
of June 30, 2024 and December 31, 2023, the Company had ERC receivables of $1.6 million and $2.1 million, respectively.
Summary
of Significant Accounting Policies
There
have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023 that are of significance, or potential significance, to the Company.
Credit
Losses
The
Company reviews its available-for-sale investments for credit losses on a collective basis by major security type and in line with the
Company’s investment policy. As of June 30, 2024, the Company’s available-for-sale investments were in certificates of deposits
and securities that are issued by the U.S. treasury and U.S. federal agencies, are highly rated, and have a history of zero credit losses.
The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of
write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic
trends, supportable forecasts, and other relevant factors. The Company’s accounts receivable are with customers that do not have
a history of uncollectibility nor a history of significantly aged accounts receivables. As of June 30, 2024, the Company did not recognize
a credit loss allowance for its investments or accounts receivable.
Net
Income (Loss) Per Share
Basic
net income (loss) per share is computed by dividing net income (loss) attributable to common shareholders by the weighted-average
number of shares of common stock outstanding during the period. The weighted average number of shares of common stock includes the
weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining
unfunded exercise price is $0.0001
or less per share. Diluted net income (loss) per share is computed based on the weighted average number of shares of common stock
plus the effect of dilutive potential commons shares outstanding during the period using the treasury stock method and if-converted
method. Dilutive potential securities result from outstanding restricted stock, stock options, stock purchase warrants and
conversion features in the Company’s loan agreement. When the Company has a net loss during the period, the Company does not
include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive.
A reconciliation of the numerators and the denominators
of the basic and diluted net income (loss) per share computations is as follows (in thousands, except per share amounts):
SCHEDULE
OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net
income (loss) used for basic net income (loss) per share | |
$ | 7,406 | | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
Effect
of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Fair
value adjustments for warrant and derivative liabilities | |
| (20,854 | ) | |
| — | | |
| — | | |
| — | |
Numerator
for dilutive net income (loss) per share - net income available for common shareholders’ after the effect of dilutive securities | |
$ | (13,448 | ) | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted
average number of common shares outstanding - basic | |
| 40,010,481 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
Effect
of dilutive shares: | |
| | | |
| | | |
| | | |
| | |
Shares
of common stock issuable upon exercise of stock options | |
| 178,931 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock underlying restricted stock | |
| 2,293,570 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of warrants | |
| 8,165,236 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of conversion feature of loan agreement | |
| 578,497 | | |
| — | | |
| — | | |
| — | |
Dilutive
potential common shares | |
| 11,216,234 | | |
| — | | |
| — | | |
| — | |
Denominator
for dilutive net income (loss) per share - adjusted weighted average shares used in computing net income (loss) per share - dilutive | |
| 51,226,715 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
| |
| | | |
| | | |
| | | |
| | |
Earnings
per share: | |
| | | |
| | | |
| | | |
| | |
Basic
income (loss) per common share | |
$ | 0.19 | | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
Dilutive
income (loss) per common share | |
$ | (0.26 | ) | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
The
following table sets forth the potential securities that could potentially dilute basic loss per share in the future that were not included
in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Shares of common
stock issuable upon exercise of stock options | |
| — | | |
| 230,723 | | |
| 178,859 | | |
| 230,723 | |
Shares of common stock
underlying restricted stock | |
| — | | |
| 2,566,303 | | |
| 1,647,666 | | |
| 2,566,303 | |
Shares of common stock
issuable upon exercise of conversion feature of loan agreement | |
| — | | |
| — | | |
| 614,251 | | |
| — | |
Shares of common stock
issuable upon exercise of warrants | |
| 1,788,000 | | |
| 9,397,879 | | |
| 9,987,560 | | |
| 9,397,879 | |
Total | |
| 1,788,000 | | |
| 12,194,905 | | |
| 12,428,336 | | |
| 12,194,905 | |
In
January 2024 as part of the Loan and Security Agreement, see Note 8, the Company issued warrants to purchase $2,400,000 worth of shares
of the Company’s stock which have an exercise price equal to the lesser of (i) $4.75 and (ii) the price per share of the Company’s
net bona fide round of equity financing before September 30, 2024 (the “2024 Loan Agreement Warrants”). In connection with
the underwritten common stock offering consummated on May 7, 2024 pursuant to the terms of the 2024 Loan Agreement Warrants, the exercise
price of the 2024 Loan Agreement Warrants was reduced to the lesser of (i) $4.07 per share and (ii) the price per share of the Company’s
next bona fide round of equity financing before September 30, 2024 in which the Company sells or issues shares of its common stock, excluding
certain excluded issuances. Utilizing the exercise price of $4.07, which is the only known price at June 30, 2024, the Company included
589,681 of shares of common stock issuable upon exercise of the 2024 Loan Agreement Warrants for the six months ended June 30, 2024 and
no shares for the three and six months ended June 30, 2023 in the table above.
Recently
Adopted Accounting Pronouncements
The
Company did not adopt any new accounting pronouncements during the three and six months ended June 30, 2024.
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements
to Income Tax Disclosures. ASU 2023-09 is intended to enhance the transparency and decision usefulness of income tax information
through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The
standard is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The
requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of
operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its income tax disclosures.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which
expands disclosures about a public entity’s reportable segments and requires more enhanced information about a reportable segment’s
expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit
or loss information in assessing segment performance and allocating resources. The standard is effective for annual reporting periods
beginning after December 15, 2023, and interim periods within years beginning after December 15, 2024, with early adoption permitted.
The requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of
operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its reportable segment disclosures.
NOTE
2 – SHORT-TERM INVESTMENTS
The
following table provides a summary of the short-term investments (in thousands):
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS
| |
June 30, 2024 | |
| |
Amortized Cost | | |
Gross Unrealized Gain | | |
Gross Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
$ | 68,918 | | |
| — | | |
| (106 | ) | |
$ | 68,812 | |
U.S. federal agency securities | |
| 5,998 | | |
| — | | |
| (35 | ) | |
| 5,963 | |
Certificates of deposit | |
| 13,500 | | |
| — | | |
| 7 | | |
| 13,507 | |
Total available-for-sale, short-term investments | |
$ | 88,416 | | |
| — | | |
| (134 | ) | |
$ | 88,282 | |
| |
December 31, 2023 | |
| |
Amortized Cost | | |
Gross Unrealized Gain | | |
Gross Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
$ | 8,406 | | |
| — | | |
| (13 | ) | |
$ | 8,393 | |
U.S. federal agency securities | |
| 29,413 | | |
| — | | |
| (53 | ) | |
| 29,360 | |
Total available-for-sale, short-term investments | |
$ | 37,819 | | |
| — | | |
| (66 | ) | |
$ | 37,753 | |
As
of June 30, 2024, the available-for-sale securities classified as short-term investments mature in one year or less. The Company carries
its available-for-sale securities at fair value in the unaudited condensed consolidated balance sheets. Unrealized losses on available-for-sale
securities as of June 30, 2024, were not significant and were primarily due to changes in interest rates, including market credit spreads,
and not due to increased credit risks associated with specific securities. None of the short-term investments have been in a continuous
unrealized loss position for more than 12 months. Accordingly, no other-than-temporary impairment was recorded for the three and six
months ended June 30, 2024.
There
were no significant realized gains or losses recognized on the sale or maturity of available-for-sale investments for the three and six
months ended June 30, 2024 or 2023.
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
Useful lives (years) | |
June 30, 2024 | | |
December 31, 2023 | |
| |
| |
| | |
| |
Laboratory equipment | |
5 | |
$ | 8,140 | | |
$ | 6,935 | |
Furniture, software and office equipment | |
3 to 5 | |
| 1,057 | | |
| 986 | |
Leasehold improvements | |
Shorter of remaining lease term or useful life | |
| 8,744 | | |
| 8,603 | |
Subtotal | |
| |
| 17,941 | | |
| 16,524 | |
Less: accumulated depreciation | |
| |
| (13,966 | ) | |
| (12,991 | ) |
Total property and equipment, net | |
| |
$ | 3,975 | | |
$ | 3,533 | |
Depreciation
and amortization are reflected in research and development and general and administrative expenses in the consolidated statements of
operations and comprehensive income (loss), as determined by the underlying activities. Depreciation and amortization on property and equipment
was $0.5 million and $0.6 million for the three months ended June 30, 2024 and 2023, respectively and $1.0 million and $1.3 million for
the six months ended June 30, 2024 and 2023, respectively.
NOTE
4 – FAIR VALUE MEASUREMENTS
The
Company calculates the fair value of the Company’s assets and liabilities that qualify as financial instruments and includes additional
information in the notes to the consolidated financial statements when the fair value is different than the carrying value of these financial
instruments. The estimated fair value of other receivables, prepaid expenses and other current assets, other assets, accounts payable,
accrued expenses, and payables to licensor approximate their carrying amounts due to the relatively short maturity of these instruments.
U.S.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in
the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement
date. This guidance establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used
to measure fair value are as follows:
|
● |
Level
1 - Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
● |
Level
2 - Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active
markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable
or can be corroborated by observable market data. |
|
|
|
|
● |
Level
3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use
significant unobservable inputs. |
The
Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis (at least annually)
into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement
date in the table below.
The
following table provides a summary of financial assets measured at fair value on a recurring basis as of June 30, 2024
and December 31, 2023 (in thousands):
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS
Description | |
Fair Value at
June 30, 2024 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | |
| | |
| | |
| |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 33,380 | | |
$ | 33,380 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 68,812 | | |
| 68,812 | | |
| — | | |
| — | |
U.S. federal agency securities | |
| 5,963 | | |
| — | | |
| 5,963 | | |
| — | |
Certificates of deposit | |
| 13,507 | | |
| 13,507 | | |
| — | | |
| — | |
Total assets measured at fair value | |
$ | 121,662 | | |
$ | 115,699 | | |
$ | 5,963 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Payable to licensor | |
$ | 4,805 | | |
$ | — | | |
$ | — | | |
$ | 4,805 | |
Derivative liabilities | |
| 668 | | |
| — | | |
| — | | |
| 668 | |
Warrant liabilities | |
| 24,100 | | |
| — | | |
| — | | |
| 24,100 | |
Total liabilities measured at fair value | |
$ | 29,573 | | |
$ | — | | |
$ | — | | |
$ | 29,573 | |
Description | |
Fair Value at December 31, 2023 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 1,034 | | |
$ | 1,034 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 8,393 | | |
| 8,393 | | |
| — | | |
| — | |
U.S. federal agency securities | |
| 29,360 | | |
| — | | |
| 29,360 | | |
| — | |
Total assets measured at fair value | |
$ | 38,787 | | |
$ | 9,427 | | |
$ | 29,360 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Payable to licensor | |
$ | 4,580 | | |
$ | — | | |
$ | — | | |
$ | 4,580 | |
Warrant liabilities | |
| 31,352 | | |
| — | | |
| — | | |
| 31,352 | |
Total liabilities measured at fair value | |
$ | 35,932 | | |
$ | — | | |
$ | — | | |
$ | 35,932 | |
Warrant
Liabilities
As
of June 30, 2024 and December 31, 2023, the Company had the following outstanding warrant liabilities:
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES
|
|
June 30, 2024 | | |
December 31, 2023 | |
Warrants issued as part of the 2021 public offering, expiration date December 2026, exercise price of $9.75 per share |
|
| 1,788,000 | | |
| 1,788,000 | |
Warrants issued as part of the 2022 Private Placement Offering, expiration date November 2027, exercise price $4.75 per share |
|
| 7,609,879 | | |
| 7,609,879 | |
Warrants issued as part of the 2024 loan agreement, expiration date January 2029, exercise price equal to the lesser of (i) $4.07 and (ii) the price per share of the Company’s next bona fide round of equity financing before September 30, 2024 |
|
| 589,681 | | |
| — | |
Outstanding warrants |
|
| 589,681 | | |
| — | |
For
the warrants issued as part of the 2024 loan agreement, the Company utilized the exercise price of $4.07, which is the only known price
at June 30, 2024, to calculate the number of warrants in the table above.
The
common stock warrants related to the 2021 Public Offering and the 2022 Private Placement are not indexed to the Company’s own stock
and therefore have been classified as liabilities at their estimated fair value. The common stock warrants related to the Loan Agreement
were determined to be liability classified under ASC 815 as the common stock warrants do not include an explicit share limit and the
number of shares issuable under the warrant agreements are variable based on the exercise price. Changes in the estimated fair value
of the warrant liabilities is recorded as changes in fair value of warrant liabilities in the consolidated statement of operations and
comprehensive income (loss).
The
following table provides a summary of the activity on the warrant liabilities (in thousands):
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES
| |
| | |
Warrant liabilities as of December 31, 2023 | |
$ | 31,352 | |
Fair value of warrants issued in connection with Loan Agreement | |
| 220 | |
Gain recognized in earnings from change in fair value | |
| (7,472 | ) |
Warrant liabilities as of June 30, 2024 | |
$ | 24,100 | |
The
warrant liabilities are valued using significant inputs not observable in the market. Accordingly, the warrant liability is measured
at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair
value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value
and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the common stock
warrants utilized the Black-Scholes option-pricing model, which incorporated assumptions and estimates to value the common stock warrants.
The Company assessed these assumptions and estimates at the end of each reporting period.
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Common share price | |
| $4.24 | | |
| $5.01 | |
Expected term (years) | |
| 2.46 – 4.53 | | |
| 2.96 – 3.84 | |
Risk-free interest rate (%) | |
| 4.26% – 4.51% | | |
| 3.84% – 3.92% | |
Volatility (%) | |
| 100.00% - 101.03% | | |
| 100.00% | |
Expected dividend yield (%) | |
| 0% | | |
| 0% | |
Derivative
Liabilities
The
Conversion Right embedded within the Loan Agreement (see Note 8 below) required bifurcation as certain adjustments to the conversion
price were not indexed to the Company’s own stock and therefore the Conversion Right was recorded as a derivative liability. The
derivative liability is remeasured at each reporting period with the change in fair value recorded to changes in fair value of warrants
and derivative liabilities in the condensed consolidated statement of operations until the derivative is exercised, expired, reclassified,
or otherwise settled.
The
following table provides a summary of the activity on the derivative liabilities (in thousands):
SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES
| |
| | |
Derivative liabilities as of December 31, 2023 | |
$ | — | |
Fair value of derivatives issued in connection with Loan Agreement | |
| 822 | |
Gain recognized in earnings from change in fair value | |
| (154 | ) |
Derivative liabilities as of June 30, 2024 | |
$ | 668 | |
The
derivative liabilities are valued using significant inputs not observable in the market. Accordingly, the derivative liability is measured
at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair
value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value
and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the derivatives
utilized the Monte Carlo simulation model, which incorporated assumptions and estimates to value the derivatives. The Company assessed
these assumptions and estimates at the end of each reporting period.
SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Common share price | |
| $4.24 | | |
| — | |
Expected term (years) | |
| 3.00 | | |
| — | |
Risk-free interest rate (%) | |
| 4.40 | % | |
| — | |
Volatility (%) | |
| 97.78 | % | |
| — | |
NOTE
5 – SETTLEMENT LIABILITY
On
November 12, 2021, the Company entered into a settlement agreement (“Settlement Agreement”) with the Company’s prior
licensor REGENXBIO Inc. (“REGENXBIO”) to resolve all existing disputes between the parties. In accordance with the Settlement
Agreement, the Company agreed to pay REGENXBIO a total of $30.0 million, payable as follows: (1) $20.0 million paid in November 2021
after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement
(paid in November 2022), and (3) $5.0 million upon the earlier of (i) the third anniversary of the effective date of the Settlement Agreement
or (ii) the closing of a Strategic Transaction, as defined in the Settlement Agreement.
As
of June 30, 2024, the Company recorded the payable due to REGENXBIO in the condensed consolidated balance sheets based on the present
value of the remaining payments due to REGENXBIO under the Settlement Agreement using an effective interest rate of 9.6%. The present
value of the amount due in November 2024 was $4.8 million and $4.6 million as of June 30, 2024 and December 31, 2023, respectively.
NOTE
6 – ACCRUED EXPENSES
The
following table provides a summary of the components of accrued expenses (in thousands):
SCHEDULE OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Accrued employee compensation | |
$ | 3,423 | | |
$ | 3,688 | |
Accrued contracted services and other | |
| 1,501 | | |
| 2,297 | |
Total accrued expenses | |
$ | 4,924 | | |
$ | 5,985 | |
NOTE
7 – LEASES
The
Company leases space under operating leases for administrative, manufacturing and laboratory facilities in Cleveland, Ohio. The Company
also leases office space in New York, New York, that the Company sublets. The Company also leases certain office equipment under operating
leases, which have a non-cancelable lease term of less than one year and the Company has elected the practical expedient to exclude these
short-term leases from the Company’s right-of-use assets and lease liabilities.
The
Company has entered into two sublease agreements with unrelated third parties to occupy the Company’s administrative offices in
New York, New York. The Company expects to receive $0.8 million in future sublease income through September 2025 from the two subleases
noted above.
The
following table provides a summary of the Company’s operating lease liabilities (in thousands):
SUMMARY OF OPERATING LEASE LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Current operating lease liability | |
$ | 1,792 | | |
$ | 998 | |
Non-current operating lease liability | |
| 3,018 | | |
| 4,402 | |
Total operating lease liability | |
$ | 4,810 | | |
$ | 5,400 | |
Lease
costs and rent are reflected in general and administrative expenses and research and development expenses in the consolidated statements
of operations and comprehensive income (loss), as determined by the underlying activities. The following table provides a summary of the components
of lease costs and rent (in thousands):
SCHEDULE OF COMPONENTS OF LEASE COST
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Operating lease cost | |
$ | 328 | | |
$ | 353 | | |
$ | 662 | | |
$ | 708 | |
Variable lease cost | |
| 122 | | |
| 116 | | |
| 196 | | |
| 215 | |
Short-term lease cost | |
| 11 | | |
| 13 | | |
| 34 | | |
| 31 | |
Total operating lease costs | |
$ | 461 | | |
$ | 482 | | |
$ | 892 | | |
$ | 954 | |
Cash
paid for amounts included in the measurement of operating lease liabilities was $0.3 million for the three months ended June 30, 2024
and 2023 and $0.6 million for the six months ended June 30, 2024 and 2023.
Future
minimum lease payments and obligations, which do not include short-term leases, related to the Company’s operating lease liabilities
as of June 30, 2024 were as follows (in thousands):
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Future minimum lease payments and obligations | |
Operating Leases | |
| |
| |
2024, remainder | |
$ | 886 | |
2025 | |
| 853 | |
2026 | |
| 791 | |
2027 | |
| 807 | |
2028 | |
| 823 | |
Thereafter | |
| 1,693 | |
Total undiscounted operating lease payments | |
| 5,853 | |
Less: imputed interest | |
| 1,043 | |
Present value of operating lease liabilities | |
$ | 4,810 | |
The
weighted-average remaining term of the Company’s operating leases was 62 months and the weighted-average discount rate used to
measure the present value of the Company’s operating lease liabilities was 7.2% as of June 30, 2024.
The
Company received sublease income, which is recorded in other income on the condensed consolidated statement of operations and comprehensive
income (loss), of $0.1 million during the three months ended June 30, 2024 and 2023 and $0.3 million and $0.2 million during the six months ended
June 30, 2024 and 2023, respectively. Future cash receipts from the Company’s sublease agreements as of June 30, 2024 are as follows
(in thousands):
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE
| |
Operating | |
Future cash receipts | |
Subleases | |
| |
| |
2024, remainder | |
$ | 319 | |
2025 | |
| 485 | |
Total future cash receipts | |
$ | 804 | |
NOTE
8 – DEBT
The
following table provides a summary of the Company’s debt, net of debt issuance costs and discounts (in thousands):
SCHEDULE
OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Loan Agreement Principal | |
$ | 20,000 | | |
$ | — | |
Accreted final payment fee | |
| 162 | | |
| — | |
Unamortized debt issuance costs and discounts | |
| (1,807 | ) | |
| — | |
Total long-term debt | |
| 18,355 | | |
| — | |
Less: current maturities | |
| 2,222 | | |
| — | |
Long-term debt, net of current maturities | |
$ | 16,133 | | |
$ | — | |
Loan
and Security Agreement
On
January 8, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Agreement”)
with Avenue Venture Opportunities Fund, L.P., a Delaware limited partnership, as administrative agent and collateral agent (“Avenue”
and the “Agent”) and Avenue Venture Opportunities Fund II, L.P., a Delaware limited partnership (“Avenue 2”
and, together with Avenue, the “Lenders”). Also on January 8, 2024, the Company entered into a Supplement to the Agreement
(collectively with the Agreement, the “Loan Agreement”) with the Agent and the Lenders. The Loan Agreement provides for senior
secured term loans (the “Loans”) in an aggregate principal amount up to $50 million, with (i) a committed tranche of $20
million advanced on the Closing Date (“Tranche 1”), (ii) a committed tranche of up to $10 million which may be advanced upon
the request of the Company between June 30, 2024 and September 30, 2024, subject to the Company obtaining FDA approval of pz-cel in recessive
dystrophic epidermolysis bullosa, with the issuance of a Priority Review Voucher (“Tranche 2”), and (iii) a discretionary
tranche of up to $20 million which may be advanced between March 31, 2025 and March 31, 2026 (the “Discretionary Tranche”)
provided at the discretion of the Lenders. The Loans are due and payable on July 1, 2027 (the “Maturity Date”).
The
Loan principal is repayable in equal monthly installments beginning on April 8, 2025, with the possibility of deferring principal payments
an additional nine to fifteen months contingent upon (i) the Company obtaining FDA approval of pz-cel in recessive dystrophic epidermolysis
bullosa, with the issuance of a Priority Review Voucher and (ii) the Company raising $90 million of cumulative equity and/or non-dilutive
capital subsequent to the Closing Date. The Loans bear interest at a rate per annum (subject to increase during an event of default)
equal to the greater of (i) the prime rate, as published by the Wall Street Journal from time to time, plus 5.00% and (ii) 13.50%. The
interest rate as of June 30, 2024 was 13.50%.
The
Company may, subject to certain parameters, voluntarily prepay the Loans, in whole, at any time. If prepayment occurs on or before the
one-year anniversary of the Closing Date, the Company is required to pay a prepayment fee equal to 3.00% of the principal amount of the
Loans prepaid; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the
Closing Date, the Company is required to pay a fee equal to 2.00% of the principal amount of the Loans; if prepayment occurs after
the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 1.00% of the principal amount of the Loans.
A final payment fee of 5.00% of the principal amount of the funded Tranche 1, Tranche 2 Loans and Discretionary Tranche Loans is also
due upon the Maturity Date or any earlier date of prepayment.
The
Company’s obligations under the Loan Agreement are secured by a pledge of substantially all of the Company’s assets. Pursuant
to the Loan Agreement, the Company is subject to a financial covenant requiring the Company to maintain at all times $5 million in unrestricted
cash. The Loan Agreement also contains affirmative and negative covenants customary for financings of this type that, among other things,
limit the ability of the Company and its subsidiaries to (i) incur additional debt, guarantees or liens; (ii) pay dividends;
(iii) enter into certain change of control transactions; (iv) sell, transfer, lease, license, or otherwise dispose of certain assets;
(v) make certain investments or loans; and (vi) engage in certain transactions with related persons, in each case, subject to certain
exceptions. The Loan Agreement also includes events of default customary for financings of this type, in certain cases subject to customary
periods to cure, following which the Agent may accelerate all amounts outstanding under the Loans.
Pursuant
to the Supplement to the Loan and Security Agreement, Avenue also has the right to convert up to $3 million of the outstanding principal
of the Loans into shares of Company common stock (the “Conversion Right”) at a price per share equal to 120% of the exercise
price of the Warrants (further discussed below) at any time while the Loans are outstanding, subject to certain terms and conditions,
including ownership limitations. The Conversion Right required bifurcation as certain adjustments to the conversion price were not indexed
to the Company’s own stock and therefore the Conversion Right was recorded as a derivative liability. On January 8, 2024, the Conversion
Right was recorded at the closing date fair value of $0.8 million which was based on a Monte Carlo simulation model. The derivative liability
is remeasured at each reporting period with the change in fair value recorded to change in fair value of warrants and derivative liabilities
in the condensed consolidated statement of operations until the derivative is exercised, expired, reclassified, or otherwise settled.
In
addition, subject to applicable law and specified provisions set forth in the Supplement to the Loan and Security Agreement and solely
to the extent permitted under applicable stock exchange rules without requiring stockholder approval, the Lenders may participate in
certain equity financing transactions of the Company in an aggregate amount of up to $1 million on the same terms, conditions and pricing
offered by the Company to other investors participating in such financing transactions (such right, the “Participation Right”).
The Participation Right automatically terminates upon the earliest of (i) July 1, 2027, (ii) such time that the Lenders have purchased
$1 million of the Company’s equity securities in the aggregate pursuant to the Participation Right, and (iii) the repayment in
full of all of the obligations under the Loan Agreement.
On
the Closing Date and pursuant to the funding of Tranche 1 of the Loan Agreement, the Company issued to each of Avenue and Avenue 2 (collectively,
the “Warrantholders”) warrants to purchase up to $480,000 and $1,920,000 of Company common stock, respectively which is more
fully described in Note 9 below.
The
future payment obligations of the principal are as follows (in thousands):
SCHEDULE
OF FUTURE PAYMENT OBLIGATIONS
| |
|
| |
2024, remainder | |
$ |
— | |
2025 | |
| 6,667 | |
2026 | |
| 8,889 | |
2027 | |
| 4,444 | |
Total principal | |
$ | 20,000 | |
NOTE
9 – EQUITY
Public
Offerings
On
December 21, 2021, the Company closed an underwritten public offering of 1,788,000 shares of common stock at a public offering price
of $9.75 per share and stock purchase warrants to purchase 1,788,000 shares of common stock at an exercise price of $9.75. The net proceeds
to the Company were $16.0 million, after deducting $1.5 million of underwriting discounts and commissions and offering expenses payable
by the Company. The net proceeds were allocated to the warrant liability as noted below with the remainder of $7.0 million recorded in
common stock and additional paid-in capital. In the event of certain fundamental transactions involving the Company, the holders of the
stock purchase warrants may require the Company to make a payment based on a Black-Scholes valuation, using specific inputs that are
not considered indexed to the Company’s stock in accordance with ASC 815, Derivatives and Hedging (“ASC 815”).
Therefore, the Company accounted for the stock purchase warrants as liabilities, which were recorded at the closing date fair value of
$9.0 million which was based on a Black-Scholes option pricing model. The remainder of the proceeds were allocated to common stock issued
and recorded as a component of equity.
As
of June 30, 2024, there were 1,788,000 stock purchase warrants outstanding related to this public offering. These stock purchase warrants
expire on December 21, 2026. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in
any dividends or other distribution of assets to holders of shares of common stock. There was no warrant activity during the six months
ended June 30, 2024, other than the change in fair value of the warrants for the stock purchase warrants issued as part of this public
offering.
Open
Market Sale Agreement
On
August 17, 2018, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Jefferies
LLC (“Jefferies”) pursuant to which, the Company may sell from time to time, through Jefferies, shares of its common stock
for an aggregate sales price of up to $75.0 million. Any sales of shares pursuant to this agreement are made under the Company’s
effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC.
The
Company sold 1,013,061 and 1,891,761 shares of its common stock under the ATM Agreement during the three months ended June 30, 2024 and
2023, respectively, resulting in net proceeds of $3.5 million and $6.4 million during the three months ended June 30, 2024 and 2023,
respectively. The Company sold 1,902,376 and 1,990,321 shares of its common stock under the ATM Agreement during the six months ended
June 30, 2024 and 2023, respectively, resulting in net proceeds of $10.0 million and $6.6 million during the six months ended June 30,
2024 and 2023, respectively.
Private
Placement Offerings
On
November 3, 2022, the Company sold 7,065,946 shares of its common stock, and in lieu of shares of common stock, pre-funded warrants exercisable
for 543,933 shares of common stock and accompanying warrants to purchase 7,609,879 shares of its common stock to a group of new and existing
institutional investors in a private placement. The offering price for each share of common stock and accompanying warrant was $4.60,
and the offering price for each pre-funded warrant and accompanying warrant was $4.59, which equaled the offering price per share of
the common stock and accompanying warrant, less the $0.01 per share exercise price of each pre-funded warrant. Each accompanying warrant
represents the right to purchase one share of the Company’s common stock at an exercise price of $4.75 per share of common stock.
The pre-funded warrants were exercised in December 2022 and converted to 543,933 shares of commons stock. Total shares sold or converted
during the year ended December 31, 2022 were 7,609,879 for an aggregate purchase price of $35.0 million gross, or $32.6 million net of
related costs of $1.5 million which was expensed to general and administrative expenses and $0.9 million which was recorded as a reduction
to additional paid-in-capital. The net proceeds were allocated to the warrant liability as noted below with the remainder of $12.9 million
and $0.1 million recorded in additional paid-in capital and common stock, respectively.
In
the event of certain fundamental transactions involving the Company, the holders of the stock purchase warrants may require the Company
to make a payment based on a Black-Scholes valuation, using specific inputs that are not considered indexed to the Company’s stock
in accordance with ASC 815. Therefore, the Company is accounting for the stock purchase warrants as liabilities. On November 3, 2022,
the stock purchase warrants were recorded at the closing date fair value of $22.0 million which was based on a Black-Scholes option pricing
model. The remainder of the proceeds were allocated to common stock issued and recorded as a component of equity.
As
of June 30, 2024, there were 7,609,879 warrants outstanding related to this private placement offering. The warrants expire on November
3, 2027. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in any dividends or other
distribution of assets to holders of shares of common stock. There was no warrant activity during the six months ended June 30, 2024,
other than the change in fair value of the warrants related to warrants issued as part of this private placement offering.
Direct
Placement Offering
On
July 6, 2023, the Company sold 3,284,407
shares of its common stock, and in lieu of shares of common stock, pre-funded warrants exercisable for 2,919,140
shares of common stock (the “2023 Pre-Funded Warrants”), to a group of existing institutional investors for an aggregate
purchase price of $25.0
million gross, or $23.0
million net of related costs. The offering price for each share of common stock was $4.03,
and the offering price for the 2023 Pre-Funded Warrants was $4.0299,
which represents the per share offering price for the Company’s common stock less a $0.0001
per share exercise price for each such 2023 Pre-Funded Warrant. The 2023 Pre-Funded Warrants are immediately exercisable at a
nominal exercise price of $0.0001
per share, may be exercised at any time and do not have an expiration date. On May 9, 2024, 300,000
of the 2023 Pre-Funded Warrants were exercised, leaving 2,619,140
2023 Pre-Funded Warrants outstanding as of June 30, 2024. The 2023 Pre-Funded Warrants are classified as equity in accordance with
ASC 815, Derivatives and Hedging, given the 2023 Pre-Funded Warrants are indexed to the Company’s own shares of common
stock and meet the requirements to be classified in equity. The 2023 Pre-Funded Warrants were recorded at their relative fair value
at issuance in the stockholders’ equity (deficit) section of the consolidated balance sheet and the 2023 Pre-Funded Warrants
are considered outstanding shares in the basic and diluted earnings per share calculation for the three and six months ended June
30, 2024 given their nominal exercise price.
Underwritten
Offering
On
May 7, 2024, the Company sold 12,285,056
shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656
shares of its common stock (the “2024 Pre-Funded Warrants”), for an aggregate purchase price of $75.0
million gross, or $70.2
million net of related costs. The offering price for each share of common stock was $4.07,
and the offering price for the 2024 Pre-Funded Warrants was $4.0699,
which represents the per share offering price for the Company’s common stock less a $0.0001 per share exercise price for each
2024 Pre-Funded Warrant. The 2024 Pre-Funded Warrants are immediately exercisable at a nominal exercise price of $0.0001
per share and may be exercised at any time until the pre-funded warrants are exercised in full. On June 24, 2024, 700,000
of the 2024 Pre-Funded Warrants were exercised, leaving 5,442,656
2024 Pre-Funded Warrants outstanding as of June 30, 2024. The 2024 Pre-Funded Warrants are classified as equity in accordance with
ASC 815, Derivatives and Hedging, given the prefunded warrants are indexed to the Company’s own shares of common stock
and meet the requirements to be classified in equity. The 2024 Pre-Funded warrants were recorded at their relative fair value at
issuance in the stockholders’ equity (deficit) section of the consolidated balance sheet and the 2024 Pre-Funded Warrants are
considered outstanding shares in the basic and diluted earnings per share calculation for the three and six months ended June 30,
2024 given their nominal exercise price.
Common
Stock Warrants related to the Loan and Security Agreement
On
January 8, 2024, in connection with entering into the Loan and Security Agreement, the Company issued to each of Avenue and Avenue 2
(collectively, the “Warrantholders”) warrants to purchase up to $480,000 and $1,920,000 worth of shares, respectively, of
Company common stock (collectively, the “January Warrants”). The Warrants expire on January 8, 2029 (the “Expiration
Date”) and upon issuance, had an exercise price per share equal to the lesser of (i) $4.75 and (ii) the price per share of the
Company’s next bona fide round of equity financing before September 30, 2024 in which the Company sells or issues shares of its
common stock, excluding certain excluded issuances as defined in the Supplement. In connection with the underwritten common stock offering
consummated on May 7, 2024, and pursuant to the term of the January Warrants, the exercise price of the January Warrants was reduced
to the lesser of (i) $4.07 per share and (ii) the price per share of the Company’s next bona fide round of equity financing before
September 30, 2024 in which the Company sells or issues shares of its common stock, excluding certain excluded issuances. In addition,
upon a change of control where the per share price of the Company common stock is less than or equal to two times that of the exercise
price, the Warrantholders would be entitled to receive the shares of common stock underlying the January Warrants without payment of
the exercise price. Assuming an exercise price of $4.07 per share, 589,681 shares of common stock would be issued in connection with
the exercise in full of the January Warrants. The January Warrants do not include an explicit share limit and the number of shares issuable
under the warrant agreements are variable based on the exercise price and therefore the January Warrants were liability classified based
on a Black-Scholes valuation in accordance with ASC 815. On January 8, 2024, the January Warrants were recorded at the closing date fair
value of $0.2 million which was based on a Black-Scholes option pricing model.
The
Warrantholders may exercise the January Warrants at any time, or from time to time up to and including the Expiration Date, by making
a cash payment equal to the exercise price multiplied by the quantity of shares. The Warrantholders may also exercise the January Warrants
on a cashless basis by receiving a net number of shares calculated pursuant to the formula set forth in the January Warrants. The January
Warrants are subject to anti-dilution adjustments for stock dividends, stock splits, and reverse stock splits.
NOTE
10 – STOCK-BASED COMPENSATION
The
Company previously granted stock options under its 2005 Equity Incentive Plan (the “2005 Incentive Plan”), under which no
further grants can be made. In addition, prior to May 17, 2023, the Company had previously granted stock options and stock awards under
the Abeona Therapeutics Inc. 2015 Equity Incentive Plan (the “2015 Incentive Plan”). As of May 17, 2023, no further grants
can be made under the 2015 Incentive Plan. The Company now grants stock options and stock awards under the Amended and Restated Abeona
Therapeutics Inc. 2023 Equity Incentive Plan (the “2023 Incentive Plan”) which was initially approved by stockholders on
May 17, 2023 and amended and restated to increase the number of shares of Common Stock reserved for issuance thereunder, which amendment
and restatement was approved by stockholders on April 24, 2024. As of June 30, 2024, there were 1,783,571 shares available to be granted
under the 2023 Incentive Plan. In addition, in 2023, the Company’s board of directors approved various restricted stock awards
granted to certain new hires as inducement grants. On October 10, 2023, the Company’s board of directors approved the Abeona Therapeutics
Inc. 2023 Employment Inducement Equity Incentive Plan (the “Inducement Plan”). As of June 30, 2024, there were 719,700 shares
available to be granted under the Inducement Plan.
The
following table summarizes stock-based compensation expense for the three and six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF STOCK BASED COMPENSATION
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the three months ended June
30 | | |
For the six months ended June 30 | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 224 | | |
$ | 218 | | |
$ | 570 | | |
$ | 404 | |
General and administrative | |
| 1,099 | | |
| 709 | | |
| 2,299 | | |
| 1,293 | |
Total stock-based compensation expense | |
$ | 1,323 | | |
$ | 927 | | |
$ | 2,869 | | |
$ | 1,697 | |
Stock
Options
The
Company estimates the fair value of each option award on the date of grant using the Black-Scholes option-pricing model. The Company
then recognize the grant date fair value of each option as compensation expense ratably using the straight-line attribution method over
the service period (generally the vesting period). The Black-Scholes model incorporates the following assumptions:
|
● |
Expected
volatility – the Company estimates the volatility of the share price at the date of grant using a “look-back” period
which coincides with the expected term, defined below. The Company believes using a “look-back” period which coincides
with the expected term is the most appropriate measure for determining expected volatility. |
|
|
|
|
● |
Expected
term – the Company estimates the expected term using the “simplified” method, as outlined in SEC Staff Accounting
Bulletin No. 107, “Share-Based Payment.” |
|
|
|
|
● |
Risk-free
interest rate – the Company estimates the risk-free interest rate using the U.S. Treasury yield curve for periods equal to
the expected term of the options in effect at the time of grant. |
|
|
|
|
● |
Dividends
– the Company uses an expected dividend yield of zero because the Company has not declared nor paid a cash dividend, nor are
there any plans to declare a dividend. |
The
Company did not grant any stock options in the six months ended June 30, 2024 and 2023.
The
Company accounts for forfeitures as they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures
arise.
The
following table summarizes stock option activity during the six months ended June 30, 2024:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Number of
Options | | |
Weighted
Average
Exercise Price | | |
Weighted
Average
Remaining
Contractual
Term (years) | | |
Aggregate
Intrinsic Value (in thousands) | |
| |
| | |
| | |
| | |
| |
Outstanding at December 31, 2023 | |
| 179,001 | | |
$ | 38.58 | | |
| 6.83 | | |
$ | 3 | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Cancelled/forfeited | |
| (142 | ) | |
$ | 43.71 | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 178,859 | | |
$ | 38.58 | | |
| 6.29 | | |
$ | 1 | |
Exercisable | |
| 151,580 | | |
$ | 38.70 | | |
| 6.16 | | |
$ | 1 | |
Unvested | |
| 27,279 | | |
$ | 37.85 | | |
| 7.03 | | |
$ | — | |
The
aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair
value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s
common stock. As of June 30, 2024, the total compensation cost related to non-vested option awards not yet recognized was approximately
$0.7 million with a weighted average remaining vesting period of 0.9 years.
Restricted
Stock
The
following table summarizes restricted stock award activity during the six months ended June 30, 2024:
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY
| |
Number of
Awards | | |
Weighted Average
Grant Date Fair
Value Per Unit | |
| |
| | |
| |
Outstanding at December 31, 2023 | |
| 2,448,169 | | |
$ | 4.25 | |
Granted | |
| 180,200 | | |
$ | 5.17 | |
Cancelled/forfeited | |
| (161,835 | ) | |
$ | 3.67 | |
Vested | |
| (818,868 | ) | |
$ | 4.80 | |
Outstanding at June 30, 2024 | |
| 1,647,666 | | |
$ | 4.14 | |
As
of June 30, 2024, there was $6.0 million of total unrecognized compensation expense related to unvested restricted stock awards, which
is expected to be recognized over a weighted average vesting period of 2.1 years. The total fair value of restricted stock awards that
vested during the six months ended June 30, 2024 was $3.9 million.
NOTE
11 – LICENSE/SUPPLIER AGREEMENT
Sublicense
and Inventory Purchase Agreements Relating to CLN1 Disease
In
August 2020, the Company entered into sublicense and inventory purchase agreements with Taysha Gene Therapies (“Taysha”)
relating to a potential gene therapy for CLN1 disease. Under the sublicense agreement, Taysha received worldwide exclusive rights to
intellectual property and know-how relating to the research, development, and manufacture of the potential gene therapy, which the Company
had referred to as ABO-202. Under the inventory purchase agreement, the Company sold to Taysha certain inventory and other items related
to ABO-202. The Company assessed the nature of the promised license to determine whether the license has significant stand-alone functionality
and evaluated whether such functionality can be retained without ongoing activities by the Company and determined that the license has
significant stand-alone functionality. Furthermore, the Company has no ongoing activities associated with the license to support or maintain
the license’s utility. Based on this, the Company determined that the pattern of transfer of control of the license to Taysha was
at a point in time.
The
transaction price of the contract includes (i) $7.0 million of fixed consideration, (ii) up to $26.0 million of variable consideration
in the form of event-based milestone payments, (iii) up to $30.0 million of variable consideration in the form of sales-based milestone
payments, and (iv) other royalty-based payments based on net sales. The event-based milestone payments are based on certain development
and regulatory events occurring. At inception, the Company evaluated whether the milestone conditions had been achieved and if it was
probable that a significant cumulative revenue reversal would not occur before recognizing the associated revenue and determined that
these milestone payments were not within the Company’s control or the licensee’s control, such as regulatory approvals, and
were not considered probable of being achieved until those approvals were received. Accordingly, at inception, the Company fully constrained
the $26.0 million of event-based milestone payments until such time that it is probable that significant cumulative revenue reversal
would not occur. The sales-based milestone payments and other royalty-based payments are based on a level of sales for which the license
is deemed to be the predominant item to which the royalties relate. The Company will recognize revenue for these payments at the later
of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has
been satisfied or partially satisfied. To date, the Company has not recognized any sales-based or royalty revenue resulting from this
licensing arrangement.
Under
this arrangement, the Company recognized no revenue for the three and six months ended June 30, 2024 and 2023. As of June 30, 2024 and
December 31, 2023, the Company does not have any contract assets or contract liabilities as a result of this transaction.
Sublicense
Agreement Relating to Rett Syndrome
In
October 2020, the Company entered into a sublicense agreement with Taysha for a gene therapy for Rett syndrome, including intellectual
property related to MECP2 gene constructs and regulation of their expression. The agreement grants Taysha worldwide exclusive rights
to intellectual property developed by scientists at the University of North Carolina at Chapel Hill, the University of Edinburgh and
the Company, and the Company’s know-how relating to the research, development, and manufacture of the gene therapy for Rett syndrome
and MECP2 gene constructs and regulation of their expression.
The
Company assessed the nature of the promised license to determine whether the license has significant stand-alone functionality and evaluated
whether such functionality can be retained without ongoing activities by the Company and determined that the license has significant
stand-alone functionality. Furthermore, the Company has no ongoing activities associated with the license to support or maintain the
license’s utility. Based on this, the Company determined that the pattern of transfer of control of the license to Taysha was at
a point in time.
The
transaction price of the contract includes (i) $3.0 million of fixed consideration, (ii) up to $26.5 million of variable consideration
in the form of event-based milestone payments, (iii) up to $30.0 million of variable consideration in the form of sales-based milestone
payments, and (iv) other royalty-based payments based on net sales. The event-based milestone payments are based on certain development
and regulatory events occurring. The Company evaluated whether the milestone conditions have been achieved and if it is probable that
a significant cumulative revenue reversal would not occur before recognizing the associated revenue. The Company determined that these
milestone payments are not within the Company’s control or the licensee’s control, such as regulatory approvals, and are
not considered probable of being achieved until those approvals are received. Accordingly, the Company has fully constrained the $26.5
million in event-based milestone payments until such time that it is probable that a significant cumulative revenue reversal would not
occur. The sales-based milestone payments and other royalty-based payments are based on a level of sales for which the license is deemed
to be the predominant item to which the royalties relate. The Company will recognize revenue for these payments at the later of (i) when
the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied
or partially satisfied. To date, the Company has not recognized any sales-based or royalty revenue resulting from this licensing arrangement.
Under
this arrangement, the Company recognized nil and $3.5 million in revenue during the three and six months ended June 30, 2024 and 2023,
respectively based on event-based-milestone payments. The Company has no contract assets or contract liabilities as of June 30, 2024
and December 31, 2023 as a result of this transaction.
Ultragenyx
License Agreement
On
May 16, 2022, the Company and Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) entered into an exclusive license agreement (the
“License Agreement”) for AAV gene therapy, ABO-102, for the treatment of Sanfilippo syndrome type A (MPS IIIA). Under the
License Agreement, Ultragenyx assumed responsibility for the ABO-102 program from the Company, with the exclusive right to develop, manufacture,
and commercialize ABO-102 worldwide. Also pursuant to the License Agreement, following regulatory approval, the Company is eligible to
receive tiered royalties from mid-single-digit up to 10% on net sales and up to $30.0 million in commercial milestone payments. Both
forms of consideration comprise the transaction price to which the Company expects to be entitled in exchange for transferring the related
intellectual property and certain, contractually-specified, transition services to Ultragenyx. The sales-based royalty and milestone
payments are subject to the royalty recognition constraint. As such, these fees are not recognized as revenue until the later of: (a)
the occurrence of the subsequent sale, and (b) the performance obligation to which they relate has been satisfied.
Additionally,
pursuant to the License Agreement, Ultragenyx will reimburse the Company for certain development and transition costs actually incurred
by the Company. These costs are passed through to Ultragenyx without mark-up. The Company has determined that these costs are not incurred
for the purpose of satisfying any performance obligation under the License Agreement. Accordingly, the reimbursement of these costs is
recognized as a reduction of research and development costs. As of June 30, 2024 and December 31, 2023, the Company does not have any
contract assets or contract liabilities as a result of this transaction.
NOTE 12 – SUBSEQUENT EVENTS
In July of 2024, the compensation committee of the
board of directors granted various employees and directors restricted stock awards, under which the holders have the right to receive
an aggregate of 1,659,484 shares of the Company’s common stock. Total stock compensation estimated for these awards at the time
of grant was $8.0 million, with $7.3 million vesting in three equal annual installments and $0.7 million vesting in one annual installment.
Pursuant to the terms of the awards, the shares not vested are forfeited upon separation from the Company.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion and analysis together with our unaudited condensed consolidated financial statements and accompanying
notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”). This discussion and analysis contains forward-looking
statements, which involve risks and uncertainties. As a result of many factors, such as those described under “Forward-Looking
Statements,” “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report, our actual
results may differ materially from those anticipated in these forward-looking statements.
OVERVIEW
Abeona
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. Our lead clinical program
is pz-cel, investigational autologous, COL7A1 gene-corrected epidermal sheets, currently in development for recessive dystrophic epidermolysis
bullosa (“RDEB”). In 2022, we announced positive data from the VIITAL™ study evaluating the efficacy, safety and tolerability
of pz-cel. The VIITAL™ study met both its two co-primary efficacy endpoints demonstrating statistically significant, clinically
meaningful improvements in wound healing and pain reduction in large chronic RDEB wounds. On September 25, 2023, we submitted a Biologics
License Application (“BLA”) for pz-cel to the U.S. Food and Drug Administration (“FDA”).
In
November 2023, the FDA accepted and granted priority review for our BLA for pz-cel, and subsequently, under the Prescription Drug User
Fee Act (“PDUFA”), the FDA set a target action date of May 25, 2024. In April 2024, the FDA issued a Complete Response Letter
(“CRL”) in response to the BLA. The CRL noted that certain additional information needed to satisfy the Chemistry Manufacturing
and Controls (“CMC”) requirements of the pz-cel BLA must be satisfactorily resolved before the application can be approved.
The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request
any new clinical trials or clinical data to support the approval of pz-cel. On August 8, 2024 we completed a Type A Meeting with the
FDA to discuss our forthcoming resubmission of our BLA. We expect to receive the FDA’s meeting minutes within the next few weeks
and are on track to resubmit our BLA in the second half of 2024. Upon acceptance of the BLA, we expect the FDA to set a PDUFA date of
six months from the date of submission.
We
have continued to prepare our current Good Manufacturing Practices (“cGMP”) commercial facility in Cleveland, Ohio for manufacturing
pz-cel drug product to support our planned commercial launch of pz-cel, if approved. Pz-cel study drug product for all our VIITAL™
study participants has been manufactured at our Cleveland facility. As part of our commercial planning, we continue to engage with stakeholders
across the healthcare system, including public and private payors, and healthcare providers to better understand market access and potential
pricing for pz-cel. We have also begun discussions with high volume treatment centers of excellence to onboard them for pz-cel application
upon potential FDA approval.
Our
development portfolio also features adeno-associated virus (“AAV”) based gene therapies designed to treat ophthalmic diseases
using the novel AIM™ capsids that we have exclusively licensed from the University of North Carolina at Chapel Hill and developed
internally through our AAV vector research programs.
Preclinical
Pipeline
Our
preclinical programs are investigating the use of novel AAV capsids in AAV-based therapies for serious genetic eye diseases, including
ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (“XLRS”) and ABO-505 for autosomal dominant optic atrophy
(“ADOA”). We completed pre-Investigational New Drug Application (“pre-IND”) meetings with the FDA regarding the
preclinical development plans and regulatory requirements to support first-in-human trials.
Other
Recent Developments
On
May 7, 2024, we sold 12,285,056 shares of our common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares
of our common stock (the “2024 Pre-Funded Warrants”), for an aggregate purchase price of $75.0 million gross, or $70.2 million
net of related costs. The offering price for each share of common stock was $4.07, and the offering price for the 2024 Pre-Funded Warrants
was $4.0699, which represents the per share offering price for our common stock less a $0.0001 per share exercise price for each 2024
Pre-Funded Warrant. The 2024 Pre-Funded Warrants are immediately exercisable at a nominal exercise price of $0.0001 per share and may
be exercised at any time until the pre-funded warrants are exercised in full. On June 24, 2024, 700,000 of the 2024 Pre-Funded Warrants
were exercised, leaving 5,442,656 2024 Pre-Funded Warrants outstanding as of June 30, 2024.
RESULTS
OF OPERATIONS
Comparison
of Three Months Ended June 30, 2024 and June 30, 2023
| |
For the three months ended June 30, | | |
Change | |
($ in thousands) | |
2024 | | |
2023 | | |
$ | | |
% | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | — | | |
$ | 3,500 | | |
$ | (3,500 | ) | |
| (100 | )% |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| — | | |
| 1,575 | | |
| (1,575 | ) | |
| (100 | )% |
Research and development | |
| 9,218 | | |
| 8,523 | | |
| 695 | | |
| 8 | % |
General and administrative | |
| 8,646 | | |
| 5,021 | | |
| 3,625 | | |
| 72 | % |
Gain on right-of-use lease assets | |
| — | | |
| (1,065 | ) | |
| 1,065 | | |
| (100 | )% |
Total expenses | |
| 17,864 | | |
| 14,054 | | |
| 3,810 | | |
| 27 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (17,864 | ) | |
| (10,554 | ) | |
| (7,310 | ) | |
| 69 | % |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 1,191 | | |
| 417 | | |
| 774 | | |
| 186 | % |
Interest expense | |
| (1,072 | ) | |
| (103 | ) | |
| (969 | ) | |
| 941 | % |
Change in fair value of warrant liabilities | |
| 24,927 | | |
| (8,629 | ) | |
| 33,556 | | |
| (389 | )% |
Other income | |
| 224 | | |
| 2,215 | | |
| (1,991 | ) | |
| (90 | )% |
Net income (loss) | |
$ | 7,406 | | |
$ | (16,654 | ) | |
$ | 24,060 | | |
| (144 | )% |
License
and other revenues
License
and other revenues for the three months ended June 30, 2024 was nil as compared to $3.5 million for the same period of 2023. The revenue
in 2023 consists of revenue resulting from achieving clinical milestones under a sublicense agreement we entered into with Taysha in
October 2020 relating to an investigational AAV-based gene therapy for Rett syndrome.
Royalties
Total
royalty expenses for the three months ended June 30, 2024 was nil as compared to $1.6 million for the same period of 2023. The decrease in expense
was due to royalties owed to our licensors resulting from the milestones due from Taysha related to Rett.
Research
and development
Research
and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical and development costs,
clinical trial costs, manufacturing and manufacturing facility costs, costs associated with regulatory approvals, depreciation on lab
supplies and manufacturing facilities, and consultant-related expenses.
Total
research and development spending for the three months ended June 30, 2024 was $9.2 million, as compared to $8.5 million for the same
period of 2023, an increase of $0.7 million. The increase in expenses was primarily due to:
|
● |
increased
salary and related costs of $1.6 million; partially offset by: |
|
● |
decreased
clinical and development work for our cell and gene therapy product candidates of $0.6 million which was due to the finalization
of our clinical trials, excluding our long-term follow up trials, in 2023; and |
|
● |
decreased
other costs of $0.3 million. |
We
expect our research and development activities to continue as we work towards advancing our product candidates towards potential regulatory
approval, reflecting costs associated with the following:
|
● |
employee
and consultant-related expenses; |
|
● |
preclinical
and developmental costs; |
|
● |
clinical
trial costs; |
|
● |
the
cost of acquiring and manufacturing clinical trial materials; and |
|
● |
costs
associated with regulatory approvals. |
General
and administrative
General
and administrative expenses primarily consist of payroll and personnel costs, office facility costs, public reporting company related
costs, professional fees (e.g., legal expenses), pre-commercial launch activity costs and other general operating expenses not otherwise
included in research and development expenses.
Total
general and administrative expenses were $8.6 million for the three months ended June 30, 2024, as compared to $5.0 million for the same
period of 2023, an increase of $3.6 million. The increase in expenses was primarily due to:
|
● |
increased
salary and related costs of $1.1 million; |
|
● |
increased
pre-commercial preparation costs of $1.1 million; |
|
● |
increased
non-cash stock-based compensation of $0.4 million; and |
|
● |
increased
other costs such as professional fees and recruiting of $1.0 million. |
Gain
of right-of-use lease assets
The
gain on right-of-use lease assets was $1.1 million for the three months ended June 30, 2023. The gain on right-of-use assets for 2023
was related to the termination of our operating leases for office space that we no longer use, resulting in a gain from the difference
of the right-of-use lease assets and the lease liabilities. There was no such gain during the three months ended June 30, 2024.
Interest
income
Interest
income was $1.2 million for the three months ended June 30, 2024, as compared to $0.4 million in the same period of 2023. The increase
resulted from higher earnings on short-term investments driven by higher interest rates and increased average short-term investment balances.
Interest
expense
Interest
expense was $1.1 million for the three months ended June 30, 2024, as compared to $0.1 million in the same period of 2023. The increase
was primarily due to the credit facility entered into by the Company in January 2024, resulting in recognized interest expense of $1.0
million.
Change
in fair value of warrant and derivative liabilities
The
change in fair value of warrant and derivative liabilities was a gain of $24.9 million for the three months ended June 30, 2024, as compared
to a loss of $8.6 million for the same period in 2023.
We
issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period.
In addition, the conversion feature in our loan agreement is required to be classified as a liability and valued at fair market value
at each reporting period. The change in the fair value of warrant and derivative liabilities was primarily due to the decrease in our
stock price year over the year and a reduced term of each of the warrants and derivative liabilities.
Other
income
Other
income was $0.2 million for the three months ended June 30, 2024, as compared to $2.2 million in the same period of 2023. The change
was primarily a result of $2.1 million in other income related to the impact of the employee retentional credit that was recorded in
2023.
Comparison
of Six Months Ended June 30, 2024 and June 30, 2023
| |
For the six months ended June
30, | | |
Change | |
($ in thousands) | |
2024 | | |
2023 | | |
$ | | |
% | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | — | | |
$ | 3,500 | | |
$ | (3,500 | ) | |
| (100 | )% |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| — | | |
| 1,575 | | |
| (1,575 | ) | |
| (100 | )% |
Research and development | |
| 16,425 | | |
| 16,564 | | |
| (139 | ) | |
| (1 | )% |
General and administrative | |
| 15,769 | | |
| 9,018 | | |
| 6,751 | | |
| 75 | % |
Gain on right-of-use lease assets | |
| — | | |
| (1,065 | ) | |
| 1,065 | | |
| (100 | )% |
Total expenses | |
| 32,194 | | |
| 26,092 | | |
| 6,102 | | |
| 23 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (32,194 | ) | |
| (22,592 | ) | |
| (9,602 | ) | |
| 43 | % |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 2,034 | | |
| 781 | | |
| 1,253 | | |
| 160 | % |
Interest expense | |
| (2,024 | ) | |
| (204 | ) | |
| (1,820 | ) | |
| 892 | % |
Change in fair value of warrant liabilities | |
| 7,626 | | |
| (6,364 | ) | |
| 13,990 | | |
| (220 | )% |
Other income | |
| 386 | | |
| 2,618 | | |
| (2,232 | ) | |
| (85 | )% |
Net loss | |
$ | (24,172 | ) | |
$ | (25,761 | ) | |
$ | 1,589 | | |
| (6 | )% |
License
and other revenues
License
and other revenues for the six months ended June 30, 2024 was nil as compared to $3.5 million for the same period of 2023. The revenue
in 2023 consists of revenue resulting from achieving clinical milestones under a sublicense agreement we entered into with Taysha in
October 2020 relating to an investigational AAV-based gene therapy for Rett syndrome.
Royalties
Total
royalty expenses for the six months ended June 30, 2024 was nil as compared to $1.6 million for the same period of 2023. The increase in expense
was due to royalties owed to our licensors resulting from the milestones due from Taysha related to Rett.
Research
and development
Total
research and development spending for the six months ended June 30, 2024 was $16.4 million, as compared to $16.5 million for the same
period of 2023, a decrease of $0.1 million. The decrease in expenses was primarily due to:
|
● |
decreased
clinical and development work for our cell and gene therapy product candidates and other related costs of $2.6 million which was
due the finalization of our clinical trials, excluding our long-term follow up trials, in 2023; |
|
● |
decreased
other costs of $0.3 million, partially offset by: |
|
● |
increased
salary and related costs of $2.8 million. |
General
and administrative
Total
general and administrative expenses were $15.8 million for the six months ended June 30, 2024, as compared to $9.0 million for the same
period of 2023, an increase of $6.8 million. The increase in expenses was primarily due to:
|
● |
increased
salary and related costs of $2.0 million; |
|
● |
increased
pre-commercial preparation costs of $2.4 million; |
|
● |
increased
non-cash stock-based compensation of $1.0 million; and |
|
● |
increased
other costs such as professional fees and recruiting of $1.4 million. |
Gain
of right-of-use lease assets
The
gain on right-of-use lease assets was $1.1 million for the six months ended June 30, 2023. The gain on right-of-use assets for 2023 was
related to the termination of our operating leases for office space that we no longer use, resulting in a gain from the difference of
the right-of-use lease assets and the lease liabilities. There was no such gain during the six months ended June 30, 2024.
Interest
income
Interest
income was $2.0 million for the six months ended June 30, 2024, as compared to $0.8 million in the same period of 2023. The increase
resulted from higher earnings on short-term investments driven by higher interest rates and increased average short-term investment balances.
Interest
expense
Interest
expense was $2.0 million for the six months ended June 30, 2024, as compared to $0.2 million in the same period of 2023. The increase
was primarily due to the credit facility entered into by the Company in January 2024, resulting in recognized interest expense of $1.8
million.
Change
in fair value of warrant and derivative liabilities
The
change in fair value of warrant and derivative liabilities was a gain of $7.6 million for the six months ended June 30, 2024, as compared
to a loss of $6.4 million for the same period in 2023.
We
issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period.
In addition, the conversion feature in our loan agreement is required to be classified as a liability and valued at fair market value
at each reporting period. The change in the fair value of warrant and derivative liabilities was primarily due to the decrease in our
stock price year over the year and a reduced term of each of the warrants and derivative liabilities.
Other
income
Other
income was $0.4 million for the six months ended June 30, 2024, as compared to $2.6 million in the same period of 2023. The change was
primarily a result of $2.1 million in other income related to the impact of the employee retentional credit that was recorded in 2023.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
Flows for the Six Months Ended June 30, 2024 and 2023
| |
For the six months ended June 30, | |
($ in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Total cash, cash equivalents and restricted cash (used in) provided by: | |
| | | |
| | |
Operating activities | |
$ | (27,222 | ) | |
$ | (22,028 | ) |
Investing activities | |
| (51,949 | ) | |
| 7,422 | |
Financing activities | |
| 99,124 | | |
| 6,614 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | |
$ | 19,953 | | |
$ | (7,992 | ) |
Operating
activities
Net
cash used in operating activities was $27.2 million for the six months ended June 30, 2024, primarily comprised of our net loss of $24.2
million and decreases in operating assets and liabilities of $0.4 million and net non-cash charges of $2.6 million. Non-cash charges
consisted primarily of $(7.6) million of the change in fair value of warrant and derivative liabilities, $2.9 million of stock-based
compensation and $1.0 million of depreciation and amortization.
Net
cash used in operating activities was $22.0 million for the six months ended June 30, 2023, primarily comprised of our net loss of $25.8
million, increases in operating assets and liabilities of $5.1 million and net non-cash charges of $8.9 million.
Investing
activities
Net
cash used in investing activities was $51.9 million for the six months ended June 30, 2024, primarily comprised of proceeds from maturities
of short-term investments of $39.4 million, offset by purchases of short-term investments of $89.9 million and capital expenditures of
$1.4 million.
Net
cash provided by investing activities was $7.4 million for the six months ended June 30, 2023, primarily comprised of proceeds from maturities
of short-term investments of $21.6 million, partially offset by purchases of short-term investments of $14.2 million.
Financing
activities
Net
cash provided by financing activities was $99.1 million for the six months ended June 30, 2024, primarily comprised of $70.2 million
in net proceeds from sales of common stock, $10.0 million from open market sales of common stock pursuant to the ATM Agreement (as defined
below) and net proceeds of $19.0 million from our January 2024 Loan Agreement.
Net
cash provided by financing activities was $6.6 million for the six months ended June 30, 2023, primarily comprised of $6.6 million in
net proceeds from ATM sales of common stock.
We
have historically funded our operations primarily through sales of common stock.
Our
principal source of liquidity is cash, cash equivalents, restricted cash and short-term investments, collectively referred to as our
cash resources. As of June 30, 2024, our cash resources were $123.0 million. We believe that our current cash and cash equivalents, restricted
cash and short-term investments are sufficient to fund operations through at least the next 12 months from the date of this report on
Form 10-Q. We may need to secure additional funding to carry out all of our planned research and development and potential commercialization
activities. If we are unable to obtain additional financing or generate license or product revenue, the lack of liquidity and sufficient
capital resources could have a material adverse effect on our future prospects.
We
have an open market sale agreement with Jefferies LLC (as amended, the “ATM Agreement”) pursuant to which, we may sell from
time to time, through Jefferies LLC, shares of our common stock for an aggregate sales price of up to $75.0 million. Any sales of shares
pursuant to this agreement are made under our effective “shelf” registration statement on Form S-3 that is on file with and
has been declared effective by the SEC. We sold 1,902,376 shares of our common stock under the ATM Agreement and received $10.0 million
of net proceeds during the six months ended June 30, 2024.
Since
our inception, we have incurred negative cash flows from operations and have expended, and expect to continue to expend, substantial
funds to complete our planned product development and potential commercialization efforts. We have not been profitable since inception
and to date have received limited revenues from the sale of products or licenses. We expect to incur losses for the next several years
as we continue to invest in commercialization, product research and development, preclinical studies, clinical trials, and regulatory
compliance and cannot provide assurance that we will ever be able to generate sufficient product sales or royalty revenue to achieve
profitability on a sustained basis, or at all.
If
we raise additional funds by selling additional equity securities, the relative equity ownership of our existing investors will be diluted,
and the new investors could obtain terms more favorable than previous investors. If we raise additional funds through collaborations,
strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future
revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable
to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, or terminate our product
development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties
that we would otherwise prefer to develop and market ourselves.
Our
future capital requirements and adequacy of available funds depend on many factors, including:
|
● |
the
successful development, regulatory approval and commercialization of our cell and gene therapy and other product candidates; |
|
● |
the
ability to establish and maintain collaborative arrangements with corporate partners for the research, development, and commercialization
of products; |
|
● |
continued
scientific progress in our research and development programs; |
|
● |
the
magnitude, scope and results of preclinical testing and clinical trials; |
|
● |
the
costs involved in filing, prosecuting, and enforcing patent claims; |
|
● |
the
costs involved in conducting clinical trials; |
|
● |
competing
technological developments; |
|
● |
the
cost of manufacturing and scale-up; |
|
● |
the
ability to establish and maintain effective commercialization arrangements and activities; and |
|
● |
the
successful outcome of our regulatory filings. |
Due
to uncertainties and certain of the risks described above, our ability to successfully commercialize our product candidates, our ability
to obtain applicable regulatory approval to market our product candidates, our ability to obtain necessary additional capital to fund
operations in the future, our ability to successfully manufacture our products and our product candidates in clinical quantities or for
commercial purposes, government regulation to which we are subject, the uncertainty associated with preclinical and clinical testing,
intense competition that we face, the potential necessity of licensing technology from third parties and protection of our intellectual
property, it is not possible to reliably predict future spending or time to completion by project or product category or the period in
which material net cash inflows from significant projects are expected to commence. If we are unable to timely complete a particular
project, our research and development efforts could be delayed or reduced, our business could suffer depending on the significance of
the project and we might need to raise additional capital to fund operations, as discussed in the risks above.
We
plan to continue our policy of investing any available funds in suitable certificates of deposit, money market funds, government securities
and investment-grade, interest-bearing securities. We do not invest in derivative financial instruments.
Critical
Accounting Estimates
The
preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts and related disclosures in the financial statements. Management
considers an accounting estimate to be critical if:
|
● |
it
requires assumptions to be made that were uncertain at the time the estimate was made, and |
|
● |
changes
in the estimate or different estimates that could have been selected could have a material impact in our results of operations or
financial condition. |
While
we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances,
actual results could differ from those estimates and the differences could be material. For a discussion of the critical accounting estimates
that affect the unaudited condensed consolidated financial statements, see “Critical Accounting Estimates” included in Item
7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report as
well as the discussion below related to our derivative liability.
See
Note 1 to our unaudited condensed consolidated financial statements for a discussion of our significant accounting policies.
Derivative
Liability
We
account for the fair value of the conversion right embedded within the loan agreement in accordance with the guidance in ASC 815, which
requires us to bifurcate and separately account for the conversion feature as an embedded derivative contained in our loan agreement.
Accordingly, we account for the conversion feature as a derivative liability in our condensed consolidated balance sheet. Derivatives
are measured at their fair value on the balance sheet. In determining the appropriate fair value, we use a Monte Carlo simulation model,
which incorporated assumptions and estimates to value the derivatives. The derivative liability is remeasured at each reporting period
with the change in fair value recorded to change in fair value of warrant and derivative liabilities in the condensed consolidated statement
of operations until the derivative is exercised, expired, reclassified, or otherwise settled.
Recently
Issued Accounting Standards Not Yet Effective or Adopted
See
Note 1 to our unaudited condensed consolidated financial statements for a discussion of recently issued accounting standards not yet
effective or adopted.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management and consultants, including the Chief Executive Officer (our principal executive
officer) and Chief Financial Officer (our principal financial officer), we have conducted an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures (“Disclosure Controls and Procedures”), as of June 30, 2024, as such
term is defined in Rules 13a-15I and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Conclusion
of Evaluation — Based on this Disclosure Controls and Procedures evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that our Disclosure Controls and Procedures as of June 30, 2024 were effective.
Changes
in Internal Control Over Financial Reporting – There were no changes in our internal control over financial reporting that
occurred during the quarter ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
None.
ITEM
1A. RISK FACTORS
Our
business and financial results are subject to numerous risks and uncertainties. As a result, the risks and uncertainties discussed in
Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023 should be carefully considered.
The
Complete Response Letter related to our Biologics License Application for pz-cel for the treatment of patients with recessive dystrophic
epidermolysis bullosa may impair our ability to successfully commercialize pz-cel.
On
April 16, 2024 we received a Complete Response Letter (a “CRL”) related to our Biologics License Application (“BLA”) for pz-cel
for the treatment of patients with recessive dystrophic epidermolysis bullosa (“RDEB”). In the CRL, the FDA noted that certain additional
information needed to satisfy Chemistry Manufacturing and Controls (“CMC”) requirements must be satisfactorily resolved before
the application can be approved. On August 8, 2024 we completed a Type A Meeting with the FDA to discuss our forthcoming resubmission
of our BLA. We expect to receive the FDA’s meeting minutes within the next few weeks and are on track to resubmit our BLA in the
second half of 2024. Upon acceptance of the BLA, we expect the FDA to set a PDUFA date of six months from the date of submission. There
can be no assurance that we will be able to satisfy the requirements of the CRL or the timeline on which we will be able to do so. A
delay in receiving approval of the BLA could shorten any periods during which we may have the exclusive right to commercialize our pz-cel
or allow our competitors to bring products to market before we do. This may impair our ability to successfully commercialize pz-cel.
If any of the foregoing were to occur, our business, financial condition, results of operations, and prospects will be materially harmed.
Other
than as set forth above, there have been no material changes in the assessment of our risk factors from those set forth in our Annual
Report on Form 10-K for the year ended December 31, 2023.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(c)
The following table provides information about purchases of equity securities that are registered pursuant to Section 12 of the Exchange
Act for the quarter ended June 30, 2024:
| |
Total number of
shares (or units)
purchased (a) | | |
Average price
paid per share
(or unit) | |
Shares delivered or withheld pursuant to restricted stock awards | |
| | | |
| | |
April 1, 2024 - April 30, 2024 | |
| — | | |
$ | — | |
May 1, 2024 - May 31, 2024 | |
| — | | |
$ | — | |
June 1, 2024 - June 30, 2024 | |
| 66,683 | | |
$ | 4.52 | |
| |
| 66,683 | | |
$ | 4.52 | |
(a) |
Reflects
shares of common stock surrendered to the Company for payment of tax withholding obligations in connection with the vesting of restricted
stock. |
ITEM
5. OTHER INFORMATION
Securities
Trading Arrangements of Directors and Executive Officers
On
April 25, 2024, Vishwas Seshadri, the Company’s President and Chief Executive Officer and a member of the Company’s board
of directors, terminated a Rule 10b5-1 trading arrangement. On April 25, 2024, Joseph Vazzano, the Company’s Chief Financial Officer,
terminated two Rule 10b5-1 trading arrangements. Each of the terminated trading arrangements were intended to satisfy the affirmative
defense in Rule 10b5-1(c).
ITEM
6. EXHIBITS
See
Exhibit Index below, which is incorporated by reference herein.
Exhibit
Index
Exhibits: |
|
|
|
4.1 |
Form of Pre-Funded Warrant to Purchase Common Stock (incorporated by reference from our Form 8-K filed with the SEC on May 3, 2024). |
|
|
31.1 |
Principal Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934. |
|
|
31.2 |
Principal Financial Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934. |
|
|
32* |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
101 |
The
following materials from Abeona’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, formatted in Inline XBRL
(Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets at June 30, 2024 and December 31, 2023 (unaudited),
(ii) Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and six months ended June 30,
2024 and 2023 (unaudited), (iii) Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and six
months ended June 30, 2024 and 2023 (unaudited), (iv) Condensed Consolidated Statements of Cash Flows for the six months ended June
30, 2024 and 2023 (unaudited), and (v) Notes to Condensed Consolidated Financial Statements (unaudited). |
|
|
104 |
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
*
Pursuant to Item 601(b)(32)(ii) of Regulation S-K, this exhibit shall not be deemed “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference
in any filings under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof
and irrespective of any general incorporation language in any filing.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
|
ABEONA
THERAPEUTICS INC. |
|
|
|
|
Date: |
August
12, 2024 |
By: |
/s/
Vishwas Seshadri |
|
|
|
Vishwas
Seshadri |
|
|
|
President
and Chief Executive Officer |
|
|
|
(Principal
Executive Officer) |
|
|
|
|
Date: |
August
12, 2024 |
By: |
/s/
Joseph Vazzano |
|
|
|
Joseph
Vazzano |
|
|
|
Chief
Financial Officer |
|
|
|
(Principal
Financial Officer) |
EXHIBIT 31.1
PRINCIPAL EXECUTIVE OFFICER CERTIFICATION PURSUANT
TO 18 U.S.C.
SECTION 1350, AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Vishwas Seshadri, certify that:
1. |
I have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2024, of Abeona Therapeutics Inc.; |
|
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: |
August 12, 2024 |
By: |
/s/ Vishwas Seshadri |
|
|
|
Vishwas Seshadri |
|
|
|
President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
EXHIBIT 31.2
PRINCIPAL FINANCIAL OFFICER CERTIFICATION PURSUANT
TO 18 U.S.C.
SECTION 1350, AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Vazzano, certify that:
1. |
I have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2024, of Abeona Therapeutics Inc.; |
|
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: |
August 12, 2024 |
By: |
/s/ Joseph Vazzano |
|
|
|
Joseph Vazzano |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial Officer) |
EXHIBIT 32
CERTIFICATION PURSUANT TO 18 U.S.C.
SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Abeona
Therapeutics Inc. (the “Company”) on Form 10-Q for the quarterly period ended June 30, 2024 as filed with the Securities and
Exchange Commission on the date hereof (the “Report”), we, Vishwas Seshadri, President and Chief Executive Officer of the
Company, and Joseph Vazzano, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that:
|
(1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: |
August 12, 2024 |
By: |
/s/ Vishwas Seshadri |
|
|
|
Vishwas Seshadri |
|
|
|
President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: |
August 12, 2024 |
By: |
/s/ Joseph Vazzano |
|
|
|
Joseph Vazzano |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial Officer) |
v3.24.2.u1
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 02, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-15771
|
|
Entity Registrant Name |
ABEONA
THERAPEUTICS INC.
|
|
Entity Central Index Key |
0000318306
|
|
Entity Tax Identification Number |
83-0221517
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
6555
Carnegie Avenue
|
|
Entity Address, Address Line Two |
4thFloor
|
|
Entity Address, City or Town |
Cleveland
|
|
Entity Address, State or Province |
OH
|
|
Entity Address, Postal Zip Code |
44103
|
|
City Area Code |
(646)
|
|
Local Phone Number |
813-4701
|
|
Title of 12(b) Security |
Common Stock, $0.01 par
value
|
|
Trading Symbol |
ABEO
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
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Entity Common Stock, Shares Outstanding |
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43,314,397
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 34,426
|
$ 14,473
|
Short-term investments |
88,282
|
37,753
|
Restricted cash |
338
|
338
|
Other receivables |
1,640
|
2,444
|
Prepaid expenses and other current assets |
1,218
|
729
|
Total current assets |
125,904
|
55,737
|
Property and equipment, net |
3,975
|
3,533
|
Operating lease right-of-use assets |
4,024
|
4,455
|
Other assets |
100
|
277
|
Total assets |
134,003
|
64,002
|
Current liabilities: |
|
|
Accounts payable |
3,099
|
1,858
|
Accrued expenses |
4,924
|
5,985
|
Current portion of long-term debt |
2,222
|
|
Current portion of operating lease liability |
1,792
|
998
|
Current portion payable to licensor |
4,805
|
4,580
|
Other current liabilities |
1
|
1
|
Total current liabilities |
16,843
|
13,422
|
Long-term operating lease liabilities |
3,018
|
4,402
|
Long-term debt |
16,133
|
|
Derivative liabilities |
668
|
|
Warrant liabilities |
24,100
|
31,352
|
Total liabilities |
60,762
|
49,176
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
|
|
Common stock - $0.01 par value; authorized 200,000,000 shares; 41,661,993 and 26,523,878 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
417
|
265
|
Additional paid-in capital |
846,654
|
764,151
|
Accumulated deficit |
(773,696)
|
(749,524)
|
Accumulated other comprehensive loss |
(134)
|
(66)
|
Total stockholders’ equity |
73,241
|
14,826
|
Total liabilities and stockholders’ equity |
$ 134,003
|
$ 64,002
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
2,000,000
|
2,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
41,661,993
|
26,523,878
|
Common stock, shares outstanding |
41,661,993
|
26,523,878
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenues: |
|
|
|
|
License and other revenues |
|
$ 3,500
|
|
$ 3,500
|
Expenses: |
|
|
|
|
Royalties |
|
1,575
|
|
1,575
|
Research and development |
9,218
|
8,523
|
16,425
|
16,564
|
General and administrative |
8,646
|
5,021
|
15,769
|
9,018
|
Gain on operating lease right-of-use assets |
|
(1,065)
|
|
(1,065)
|
Total expenses |
17,864
|
14,054
|
32,194
|
26,092
|
Loss from operations |
(17,864)
|
(10,554)
|
(32,194)
|
(22,592)
|
Interest income |
1,191
|
417
|
2,034
|
781
|
Interest expense |
(1,072)
|
(103)
|
(2,024)
|
(204)
|
Change in fair value of warrant and derivative liabilities |
24,927
|
(8,629)
|
7,626
|
(6,364)
|
Other income |
224
|
2,215
|
386
|
2,618
|
Net Income (loss) |
$ 7,406
|
$ (16,654)
|
$ (24,172)
|
$ (25,761)
|
Basic income (loss) per common share |
$ 0.19
|
$ (0.92)
|
$ (0.72)
|
$ (1.48)
|
Dilutive loss per common share |
$ (0.26)
|
$ (0.92)
|
$ (0.72)
|
$ (1.48)
|
Weighted average number of common shares outstanding: |
|
|
|
|
Basic |
40,010,481
|
18,017,874
|
33,662,908
|
17,464,026
|
Dilutive |
51,226,715
|
18,017,874
|
33,662,908
|
17,464,026
|
Other comprehensive income (loss): |
|
|
|
|
Change in unrealized gains (losses) related to available-for-sale debt securities |
$ 50
|
$ (30)
|
$ (68)
|
$ 34
|
Comprehensive income (loss) |
$ 7,456
|
$ (16,684)
|
$ (24,240)
|
$ (25,727)
|
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v3.24.2.u1
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 177
|
$ 722,049
|
$ (695,336)
|
$ (129)
|
$ 26,761
|
Balance, shares at Dec. 31, 2022 |
17,719,720
|
|
|
|
|
Stock-based compensation expense |
|
1,697
|
|
|
1,697
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement |
$ 18
|
(27)
|
|
|
(9)
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement, shares |
1,768,116
|
|
|
|
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM) |
$ 20
|
6,603
|
|
|
6,623
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares |
1,990,321
|
|
|
|
|
Net income (loss) |
|
|
(25,761)
|
|
(25,761)
|
Other comprehensive income |
|
|
|
34
|
34
|
Balance at Jun. 30, 2023 |
$ 215
|
730,322
|
(721,097)
|
(95)
|
9,345
|
Balance, shares at Jun. 30, 2023 |
21,478,157
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 179
|
723,069
|
(704,443)
|
(65)
|
18,740
|
Balance, shares at Mar. 31, 2023 |
17,929,344
|
|
|
|
|
Stock-based compensation expense |
|
927
|
|
|
927
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement |
$ 17
|
(22)
|
|
|
(5)
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement, shares |
1,657,052
|
|
|
|
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM) |
$ 19
|
6,348
|
|
|
6,367
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares |
1,891,761
|
|
|
|
|
Net income (loss) |
|
|
(16,654)
|
|
(16,654)
|
Other comprehensive income |
|
|
|
(30)
|
(30)
|
Balance at Jun. 30, 2023 |
$ 215
|
730,322
|
(721,097)
|
(95)
|
9,345
|
Balance, shares at Jun. 30, 2023 |
21,478,157
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 265
|
764,151
|
(749,524)
|
(66)
|
14,826
|
Balance, shares at Dec. 31, 2023 |
26,523,878
|
|
|
|
|
Stock-based compensation expense |
|
2,869
|
|
|
2,869
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement |
|
(329)
|
|
|
(329)
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement, shares |
(49,296)
|
|
|
|
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM) |
$ 19
|
9,943
|
|
|
9,962
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares |
1,902,376
|
|
|
|
|
Issuance of common stock in connection with underwritten offering, net of offering costs |
$ 123
|
70,030
|
|
|
70,153
|
Issuance of common stock in connection with underwritten offering, net of offering costs, shares |
12,285,056
|
|
|
|
|
Issuance of common stock upon exercise of pre-funded warrants, net of shares settled |
$ 10
|
(10)
|
|
|
|
Issuance of common stock upon exercise of pre-funded warrants, net of shares settled, shares |
999,979
|
|
|
|
|
Net income (loss) |
|
|
(24,172)
|
|
(24,172)
|
Other comprehensive income |
|
|
|
(68)
|
(68)
|
Balance at Jun. 30, 2024 |
$ 417
|
846,654
|
(773,696)
|
(134)
|
73,241
|
Balance, shares at Jun. 30, 2024 |
41,661,993
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 276
|
772,129
|
(781,102)
|
(184)
|
(8,881)
|
Balance, shares at Mar. 31, 2024 |
27,550,693
|
|
|
|
|
Stock-based compensation expense |
|
1,323
|
|
|
1,323
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement |
$ (2)
|
(313)
|
|
|
(315)
|
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement, shares |
(186,796)
|
|
|
|
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM) |
$ 10
|
3,495
|
|
|
3,505
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares |
1,013,061
|
|
|
|
|
Issuance of common stock in connection with underwritten offering, net of offering costs |
$ 123
|
70,030
|
|
|
70,153
|
Issuance of common stock in connection with underwritten offering, net of offering costs, shares |
12,285,056
|
|
|
|
|
Issuance of common stock upon exercise of pre-funded warrants, net of shares settled |
$ 10
|
(10)
|
|
|
|
Issuance of common stock upon exercise of pre-funded warrants, net of shares settled, shares |
999,979
|
|
|
|
|
Net income (loss) |
|
|
7,406
|
|
7,406
|
Other comprehensive income |
|
|
|
50
|
50
|
Balance at Jun. 30, 2024 |
$ 417
|
$ 846,654
|
$ (773,696)
|
$ (134)
|
$ 73,241
|
Balance, shares at Jun. 30, 2024 |
41,661,993
|
|
|
|
|
X |
- DefinitionStock issued during period shares of common stock upon exercise of prefunded warrants net of shares settled.
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (24,172)
|
$ (25,761)
|
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
Depreciation and amortization |
978
|
1,276
|
Stock-based compensation expense |
2,869
|
1,697
|
Change in fair value of warrant and derivative liabilities |
(7,626)
|
6,364
|
Non-cash gain of right-of-use lease assets |
|
(1,065)
|
Accretion and interest on short-term investments |
(66)
|
(74)
|
Amortization of right-of-use lease assets |
431
|
450
|
Non-cash interest |
735
|
204
|
(Gain) loss on disposal of property and equipment |
(2)
|
47
|
Change in operating assets and liabilities: |
|
|
Accounts receivable |
|
(3,500)
|
Other receivables |
804
|
(2,039)
|
Prepaid expenses and other current assets |
(639)
|
(777)
|
Other assets |
177
|
(65)
|
Accounts payable and accrued expenses |
(121)
|
1,836
|
Lease liabilities |
(590)
|
(622)
|
Other current liabilities |
|
1
|
Net cash used in operating activities |
(27,222)
|
(22,028)
|
Cash flows from investing activities: |
|
|
Capital expenditures |
(1,436)
|
(250)
|
Proceeds from disposal of property and equipment |
18
|
179
|
Purchases of short-term investments |
(89,890)
|
(14,156)
|
Proceeds from maturities of short-term investments |
39,359
|
21,649
|
Net cash (used in) provided by investing activities |
(51,949)
|
7,422
|
Cash flows from financing activities: |
|
|
Proceeds from ATM sales of common stock, net of issuance costs |
9,962
|
6,623
|
Payments related to net settlement of restricted share awards |
(28)
|
(9)
|
Proceeds from underwritten sales of common stock, net of issuance costs |
70,153
|
|
Proceeds from issuance of long-term debt |
20,000
|
|
Payment of debt issuance costs |
(963)
|
|
Net cash provided by financing activities |
99,124
|
6,614
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
19,953
|
(7,992)
|
Cash, cash equivalents and restricted cash at beginning of period |
14,811
|
14,555
|
Cash, cash equivalents and restricted cash at end of period |
34,764
|
6,563
|
Supplemental cash flow information: |
|
|
Cash and cash equivalents |
34,426
|
6,225
|
Restricted cash |
338
|
338
|
Total cash, cash equivalents and restricted cash |
34,764
|
6,563
|
Supplemental non-cash flow information: |
|
|
Right-of-use asset obtained in exchange for new operating lease liabilities |
|
419
|
Derivative and warrant additions associated with loan and security agreement |
1,042
|
|
Cash paid for interest |
1,290
|
|
Cash paid for taxes |
$ 7
|
$ 6
|
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v3.24.2.u1
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES |
NOTE
1 – NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES
Background
Abeona
Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation,
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead
clinical program is for pz-cel, an autologous, cell-based gene therapy currently in development for recessive dystrophic epidermolysis
bullosa (“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based
gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM™ capsids that the Company has exclusively
licensed from the University of North Carolina at Chapel Hill and developed internally through its AAV vector research programs.
Basis
of Presentation
The
Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting
principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions
have been eliminated in consolidation. In the opinion of management, all adjustments, consisting only of normal recurring
adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations,
and changes in financial position for such periods, have been made. These unaudited interim condensed consolidated financial
statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Certain
information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the
U.S. Securities and Exchange Commission (“SEC”). The December 31, 2023 condensed consolidated balance sheet was derived
from the audited statements but does not include all disclosures required by U.S. GAAP.
Therefore,
these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the
SEC on March 18, 2024.
Liquidity
In
accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there
are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as
a going concern within one year after the date the accompanying unaudited interim condensed consolidated financial statements were issued.
As
a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development
activities for pz-cel and other product candidates, business planning, raising capital, establishing its intellectual property portfolio,
acquiring or discovering product candidates, and providing general and administrative support for these operations. As a result, the
Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses
and negative cash flows will continue for the foreseeable future.
Since
its inception, the Company has funded its operations primarily with proceeds from sales of shares of its stock. The Company has incurred
recurring losses since its inception, including net losses of $24.2 million and $25.8 million for the six months ended June 30, 2024
and 2023, respectively. As of June 30, 2024, the Company had an accumulated deficit of approximately $773.7 million. To date the Company
has not generated any significant revenues and expects to continue to generate operating losses for the foreseeable future. As of the
issuance date of these unaudited interim condensed consolidated financial statements, the Company expects that its existing cash, cash
equivalents, restricted cash and short-term investments of $123.0 million as of June 30, 2024, will be sufficient to fund its operating
expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these condensed consolidated
financial statements.
While
the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from
the issuance date of these unaudited condensed consolidated financial statements, the Company’s liquidity could be materially affected
over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party
funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory
events or unanticipated costs related to pz-cel; (4) any other unanticipated material negative events or costs. One or more of these
events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become
due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes
to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Use
of Estimates
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
Other
receivables
Other
receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As
of June 30, 2024 and December 31, 2023, the Company had ERC receivables of $1.6 million and $2.1 million, respectively.
Summary
of Significant Accounting Policies
There
have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023 that are of significance, or potential significance, to the Company.
Credit
Losses
The
Company reviews its available-for-sale investments for credit losses on a collective basis by major security type and in line with the
Company’s investment policy. As of June 30, 2024, the Company’s available-for-sale investments were in certificates of deposits
and securities that are issued by the U.S. treasury and U.S. federal agencies, are highly rated, and have a history of zero credit losses.
The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of
write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic
trends, supportable forecasts, and other relevant factors. The Company’s accounts receivable are with customers that do not have
a history of uncollectibility nor a history of significantly aged accounts receivables. As of June 30, 2024, the Company did not recognize
a credit loss allowance for its investments or accounts receivable.
Net
Income (Loss) Per Share
Basic
net income (loss) per share is computed by dividing net income (loss) attributable to common shareholders by the weighted-average
number of shares of common stock outstanding during the period. The weighted average number of shares of common stock includes the
weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining
unfunded exercise price is $0.0001
or less per share. Diluted net income (loss) per share is computed based on the weighted average number of shares of common stock
plus the effect of dilutive potential commons shares outstanding during the period using the treasury stock method and if-converted
method. Dilutive potential securities result from outstanding restricted stock, stock options, stock purchase warrants and
conversion features in the Company’s loan agreement. When the Company has a net loss during the period, the Company does not
include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive.
A reconciliation of the numerators and the denominators
of the basic and diluted net income (loss) per share computations is as follows (in thousands, except per share amounts):
SCHEDULE
OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net
income (loss) used for basic net income (loss) per share | |
$ | 7,406 | | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
Effect
of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Fair
value adjustments for warrant and derivative liabilities | |
| (20,854 | ) | |
| — | | |
| — | | |
| — | |
Numerator
for dilutive net income (loss) per share - net income available for common shareholders’ after the effect of dilutive securities | |
$ | (13,448 | ) | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted
average number of common shares outstanding - basic | |
| 40,010,481 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
Effect
of dilutive shares: | |
| | | |
| | | |
| | | |
| | |
Shares
of common stock issuable upon exercise of stock options | |
| 178,931 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock underlying restricted stock | |
| 2,293,570 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of warrants | |
| 8,165,236 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of conversion feature of loan agreement | |
| 578,497 | | |
| — | | |
| — | | |
| — | |
Dilutive
potential common shares | |
| 11,216,234 | | |
| — | | |
| — | | |
| — | |
Denominator
for dilutive net income (loss) per share - adjusted weighted average shares used in computing net income (loss) per share - dilutive | |
| 51,226,715 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
| |
| | | |
| | | |
| | | |
| | |
Earnings
per share: | |
| | | |
| | | |
| | | |
| | |
Basic
income (loss) per common share | |
$ | 0.19 | | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
Dilutive
income (loss) per common share | |
$ | (0.26 | ) | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
The
following table sets forth the potential securities that could potentially dilute basic loss per share in the future that were not included
in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Shares of common
stock issuable upon exercise of stock options | |
| — | | |
| 230,723 | | |
| 178,859 | | |
| 230,723 | |
Shares of common stock
underlying restricted stock | |
| — | | |
| 2,566,303 | | |
| 1,647,666 | | |
| 2,566,303 | |
Shares of common stock
issuable upon exercise of conversion feature of loan agreement | |
| — | | |
| — | | |
| 614,251 | | |
| — | |
Shares of common stock
issuable upon exercise of warrants | |
| 1,788,000 | | |
| 9,397,879 | | |
| 9,987,560 | | |
| 9,397,879 | |
Total | |
| 1,788,000 | | |
| 12,194,905 | | |
| 12,428,336 | | |
| 12,194,905 | |
In
January 2024 as part of the Loan and Security Agreement, see Note 8, the Company issued warrants to purchase $2,400,000 worth of shares
of the Company’s stock which have an exercise price equal to the lesser of (i) $4.75 and (ii) the price per share of the Company’s
net bona fide round of equity financing before September 30, 2024 (the “2024 Loan Agreement Warrants”). In connection with
the underwritten common stock offering consummated on May 7, 2024 pursuant to the terms of the 2024 Loan Agreement Warrants, the exercise
price of the 2024 Loan Agreement Warrants was reduced to the lesser of (i) $4.07 per share and (ii) the price per share of the Company’s
next bona fide round of equity financing before September 30, 2024 in which the Company sells or issues shares of its common stock, excluding
certain excluded issuances. Utilizing the exercise price of $4.07, which is the only known price at June 30, 2024, the Company included
589,681 of shares of common stock issuable upon exercise of the 2024 Loan Agreement Warrants for the six months ended June 30, 2024 and
no shares for the three and six months ended June 30, 2023 in the table above.
Recently
Adopted Accounting Pronouncements
The
Company did not adopt any new accounting pronouncements during the three and six months ended June 30, 2024.
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements
to Income Tax Disclosures. ASU 2023-09 is intended to enhance the transparency and decision usefulness of income tax information
through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The
standard is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The
requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of
operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its income tax disclosures.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which
expands disclosures about a public entity’s reportable segments and requires more enhanced information about a reportable segment’s
expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit
or loss information in assessing segment performance and allocating resources. The standard is effective for annual reporting periods
beginning after December 15, 2023, and interim periods within years beginning after December 15, 2024, with early adoption permitted.
The requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of
operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its reportable segment disclosures.
|
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- DefinitionThe entire disclosure for the organization, consolidation and basis of presentation of financial statements disclosure, and significant accounting policies of the reporting entity. May be provided in more than one note to the financial statements, as long as users are provided with an understanding of (1) the significant judgments and assumptions made by an enterprise in determining whether it must consolidate a VIE and/or disclose information about its involvement with a VIE, (2) the nature of restrictions on a consolidated VIE's assets reported by an enterprise in its statement of financial position, including the carrying amounts of such assets, (3) the nature of, and changes in, the risks associated with an enterprise's involvement with the VIE, and (4) how an enterprise's involvement with the VIE affects the enterprise's financial position, financial performance, and cash flows. Describes procedure if disclosures are provided in more than one note to the financial statements.
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v3.24.2.u1
SHORT-TERM INVESTMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
SHORT-TERM INVESTMENTS |
NOTE
2 – SHORT-TERM INVESTMENTS
The
following table provides a summary of the short-term investments (in thousands):
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS
| |
June 30, 2024 | |
| |
Amortized Cost | | |
Gross Unrealized Gain | | |
Gross Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
$ | 68,918 | | |
| — | | |
| (106 | ) | |
$ | 68,812 | |
U.S. federal agency securities | |
| 5,998 | | |
| — | | |
| (35 | ) | |
| 5,963 | |
Certificates of deposit | |
| 13,500 | | |
| — | | |
| 7 | | |
| 13,507 | |
Total available-for-sale, short-term investments | |
$ | 88,416 | | |
| — | | |
| (134 | ) | |
$ | 88,282 | |
| |
December 31, 2023 | |
| |
Amortized Cost | | |
Gross Unrealized Gain | | |
Gross Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
$ | 8,406 | | |
| — | | |
| (13 | ) | |
$ | 8,393 | |
U.S. federal agency securities | |
| 29,413 | | |
| — | | |
| (53 | ) | |
| 29,360 | |
Total available-for-sale, short-term investments | |
$ | 37,819 | | |
| — | | |
| (66 | ) | |
$ | 37,753 | |
As
of June 30, 2024, the available-for-sale securities classified as short-term investments mature in one year or less. The Company carries
its available-for-sale securities at fair value in the unaudited condensed consolidated balance sheets. Unrealized losses on available-for-sale
securities as of June 30, 2024, were not significant and were primarily due to changes in interest rates, including market credit spreads,
and not due to increased credit risks associated with specific securities. None of the short-term investments have been in a continuous
unrealized loss position for more than 12 months. Accordingly, no other-than-temporary impairment was recorded for the three and six
months ended June 30, 2024.
There
were no significant realized gains or losses recognized on the sale or maturity of available-for-sale investments for the three and six
months ended June 30, 2024 or 2023.
|
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- DefinitionThe entire disclosure for investments in certain debt and equity securities.
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v3.24.2.u1
PROPERTY AND EQUIPMENT, NET
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
Useful lives (years) | |
June 30, 2024 | | |
December 31, 2023 | |
| |
| |
| | |
| |
Laboratory equipment | |
5 | |
$ | 8,140 | | |
$ | 6,935 | |
Furniture, software and office equipment | |
3 to 5 | |
| 1,057 | | |
| 986 | |
Leasehold improvements | |
Shorter of remaining lease term or useful life | |
| 8,744 | | |
| 8,603 | |
Subtotal | |
| |
| 17,941 | | |
| 16,524 | |
Less: accumulated depreciation | |
| |
| (13,966 | ) | |
| (12,991 | ) |
Total property and equipment, net | |
| |
$ | 3,975 | | |
$ | 3,533 | |
Depreciation
and amortization are reflected in research and development and general and administrative expenses in the consolidated statements of
operations and comprehensive income (loss), as determined by the underlying activities. Depreciation and amortization on property and equipment
was $0.5 million and $0.6 million for the three months ended June 30, 2024 and 2023, respectively and $1.0 million and $1.3 million for
the six months ended June 30, 2024 and 2023, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.2.u1
FAIR VALUE MEASUREMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
NOTE
4 – FAIR VALUE MEASUREMENTS
The
Company calculates the fair value of the Company’s assets and liabilities that qualify as financial instruments and includes additional
information in the notes to the consolidated financial statements when the fair value is different than the carrying value of these financial
instruments. The estimated fair value of other receivables, prepaid expenses and other current assets, other assets, accounts payable,
accrued expenses, and payables to licensor approximate their carrying amounts due to the relatively short maturity of these instruments.
U.S.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in
the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement
date. This guidance establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used
to measure fair value are as follows:
|
● |
Level
1 - Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
● |
Level
2 - Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active
markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable
or can be corroborated by observable market data. |
|
|
|
|
● |
Level
3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use
significant unobservable inputs. |
The
Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis (at least annually)
into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement
date in the table below.
The
following table provides a summary of financial assets measured at fair value on a recurring basis as of June 30, 2024
and December 31, 2023 (in thousands):
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS
Description | |
Fair Value at
June 30, 2024 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | |
| | |
| | |
| |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 33,380 | | |
$ | 33,380 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 68,812 | | |
| 68,812 | | |
| — | | |
| — | |
U.S. federal agency securities | |
| 5,963 | | |
| — | | |
| 5,963 | | |
| — | |
Certificates of deposit | |
| 13,507 | | |
| 13,507 | | |
| — | | |
| — | |
Total assets measured at fair value | |
$ | 121,662 | | |
$ | 115,699 | | |
$ | 5,963 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Payable to licensor | |
$ | 4,805 | | |
$ | — | | |
$ | — | | |
$ | 4,805 | |
Derivative liabilities | |
| 668 | | |
| — | | |
| — | | |
| 668 | |
Warrant liabilities | |
| 24,100 | | |
| — | | |
| — | | |
| 24,100 | |
Total liabilities measured at fair value | |
$ | 29,573 | | |
$ | — | | |
$ | — | | |
$ | 29,573 | |
Description | |
Fair Value at December 31, 2023 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 1,034 | | |
$ | 1,034 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 8,393 | | |
| 8,393 | | |
| — | | |
| — | |
U.S. federal agency securities | |
| 29,360 | | |
| — | | |
| 29,360 | | |
| — | |
Total assets measured at fair value | |
$ | 38,787 | | |
$ | 9,427 | | |
$ | 29,360 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Payable to licensor | |
$ | 4,580 | | |
$ | — | | |
$ | — | | |
$ | 4,580 | |
Warrant liabilities | |
| 31,352 | | |
| — | | |
| — | | |
| 31,352 | |
Total liabilities measured at fair value | |
$ | 35,932 | | |
$ | — | | |
$ | — | | |
$ | 35,932 | |
Warrant
Liabilities
As
of June 30, 2024 and December 31, 2023, the Company had the following outstanding warrant liabilities:
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES
|
|
June 30, 2024 | | |
December 31, 2023 | |
Warrants issued as part of the 2021 public offering, expiration date December 2026, exercise price of $9.75 per share |
|
| 1,788,000 | | |
| 1,788,000 | |
Warrants issued as part of the 2022 Private Placement Offering, expiration date November 2027, exercise price $4.75 per share |
|
| 7,609,879 | | |
| 7,609,879 | |
Warrants issued as part of the 2024 loan agreement, expiration date January 2029, exercise price equal to the lesser of (i) $4.07 and (ii) the price per share of the Company’s next bona fide round of equity financing before September 30, 2024 |
|
| 589,681 | | |
| — | |
Outstanding warrants |
|
| 589,681 | | |
| — | |
For
the warrants issued as part of the 2024 loan agreement, the Company utilized the exercise price of $4.07, which is the only known price
at June 30, 2024, to calculate the number of warrants in the table above.
The
common stock warrants related to the 2021 Public Offering and the 2022 Private Placement are not indexed to the Company’s own stock
and therefore have been classified as liabilities at their estimated fair value. The common stock warrants related to the Loan Agreement
were determined to be liability classified under ASC 815 as the common stock warrants do not include an explicit share limit and the
number of shares issuable under the warrant agreements are variable based on the exercise price. Changes in the estimated fair value
of the warrant liabilities is recorded as changes in fair value of warrant liabilities in the consolidated statement of operations and
comprehensive income (loss).
The
following table provides a summary of the activity on the warrant liabilities (in thousands):
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES
| |
| | |
Warrant liabilities as of December 31, 2023 | |
$ | 31,352 | |
Fair value of warrants issued in connection with Loan Agreement | |
| 220 | |
Gain recognized in earnings from change in fair value | |
| (7,472 | ) |
Warrant liabilities as of June 30, 2024 | |
$ | 24,100 | |
The
warrant liabilities are valued using significant inputs not observable in the market. Accordingly, the warrant liability is measured
at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair
value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value
and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the common stock
warrants utilized the Black-Scholes option-pricing model, which incorporated assumptions and estimates to value the common stock warrants.
The Company assessed these assumptions and estimates at the end of each reporting period.
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Common share price | |
| $4.24 | | |
| $5.01 | |
Expected term (years) | |
| 2.46 – 4.53 | | |
| 2.96 – 3.84 | |
Risk-free interest rate (%) | |
| 4.26% – 4.51% | | |
| 3.84% – 3.92% | |
Volatility (%) | |
| 100.00% - 101.03% | | |
| 100.00% | |
Expected dividend yield (%) | |
| 0% | | |
| 0% | |
Derivative
Liabilities
The
Conversion Right embedded within the Loan Agreement (see Note 8 below) required bifurcation as certain adjustments to the conversion
price were not indexed to the Company’s own stock and therefore the Conversion Right was recorded as a derivative liability. The
derivative liability is remeasured at each reporting period with the change in fair value recorded to changes in fair value of warrants
and derivative liabilities in the condensed consolidated statement of operations until the derivative is exercised, expired, reclassified,
or otherwise settled.
The
following table provides a summary of the activity on the derivative liabilities (in thousands):
SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES
| |
| | |
Derivative liabilities as of December 31, 2023 | |
$ | — | |
Fair value of derivatives issued in connection with Loan Agreement | |
| 822 | |
Gain recognized in earnings from change in fair value | |
| (154 | ) |
Derivative liabilities as of June 30, 2024 | |
$ | 668 | |
The
derivative liabilities are valued using significant inputs not observable in the market. Accordingly, the derivative liability is measured
at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair
value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value
and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the derivatives
utilized the Monte Carlo simulation model, which incorporated assumptions and estimates to value the derivatives. The Company assessed
these assumptions and estimates at the end of each reporting period.
SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Common share price | |
| $4.24 | | |
| — | |
Expected term (years) | |
| 3.00 | | |
| — | |
Risk-free interest rate (%) | |
| 4.40 | % | |
| — | |
Volatility (%) | |
| 97.78 | % | |
| — | |
|
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v3.24.2.u1
SETTLEMENT LIABILITY
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
SETTLEMENT LIABILITY |
NOTE
5 – SETTLEMENT LIABILITY
On
November 12, 2021, the Company entered into a settlement agreement (“Settlement Agreement”) with the Company’s prior
licensor REGENXBIO Inc. (“REGENXBIO”) to resolve all existing disputes between the parties. In accordance with the Settlement
Agreement, the Company agreed to pay REGENXBIO a total of $30.0 million, payable as follows: (1) $20.0 million paid in November 2021
after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement
(paid in November 2022), and (3) $5.0 million upon the earlier of (i) the third anniversary of the effective date of the Settlement Agreement
or (ii) the closing of a Strategic Transaction, as defined in the Settlement Agreement.
As
of June 30, 2024, the Company recorded the payable due to REGENXBIO in the condensed consolidated balance sheets based on the present
value of the remaining payments due to REGENXBIO under the Settlement Agreement using an effective interest rate of 9.6%. The present
value of the amount due in November 2024 was $4.8 million and $4.6 million as of June 30, 2024 and December 31, 2023, respectively.
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v3.24.2.u1
ACCRUED EXPENSES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
NOTE
6 – ACCRUED EXPENSES
The
following table provides a summary of the components of accrued expenses (in thousands):
SCHEDULE OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Accrued employee compensation | |
$ | 3,423 | | |
$ | 3,688 | |
Accrued contracted services and other | |
| 1,501 | | |
| 2,297 | |
Total accrued expenses | |
$ | 4,924 | | |
$ | 5,985 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
LEASES |
NOTE
7 – LEASES
The
Company leases space under operating leases for administrative, manufacturing and laboratory facilities in Cleveland, Ohio. The Company
also leases office space in New York, New York, that the Company sublets. The Company also leases certain office equipment under operating
leases, which have a non-cancelable lease term of less than one year and the Company has elected the practical expedient to exclude these
short-term leases from the Company’s right-of-use assets and lease liabilities.
The
Company has entered into two sublease agreements with unrelated third parties to occupy the Company’s administrative offices in
New York, New York. The Company expects to receive $0.8 million in future sublease income through September 2025 from the two subleases
noted above.
The
following table provides a summary of the Company’s operating lease liabilities (in thousands):
SUMMARY OF OPERATING LEASE LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Current operating lease liability | |
$ | 1,792 | | |
$ | 998 | |
Non-current operating lease liability | |
| 3,018 | | |
| 4,402 | |
Total operating lease liability | |
$ | 4,810 | | |
$ | 5,400 | |
Lease
costs and rent are reflected in general and administrative expenses and research and development expenses in the consolidated statements
of operations and comprehensive income (loss), as determined by the underlying activities. The following table provides a summary of the components
of lease costs and rent (in thousands):
SCHEDULE OF COMPONENTS OF LEASE COST
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Operating lease cost | |
$ | 328 | | |
$ | 353 | | |
$ | 662 | | |
$ | 708 | |
Variable lease cost | |
| 122 | | |
| 116 | | |
| 196 | | |
| 215 | |
Short-term lease cost | |
| 11 | | |
| 13 | | |
| 34 | | |
| 31 | |
Total operating lease costs | |
$ | 461 | | |
$ | 482 | | |
$ | 892 | | |
$ | 954 | |
Cash
paid for amounts included in the measurement of operating lease liabilities was $0.3 million for the three months ended June 30, 2024
and 2023 and $0.6 million for the six months ended June 30, 2024 and 2023.
Future
minimum lease payments and obligations, which do not include short-term leases, related to the Company’s operating lease liabilities
as of June 30, 2024 were as follows (in thousands):
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Future minimum lease payments and obligations | |
Operating Leases | |
| |
| |
2024, remainder | |
$ | 886 | |
2025 | |
| 853 | |
2026 | |
| 791 | |
2027 | |
| 807 | |
2028 | |
| 823 | |
Thereafter | |
| 1,693 | |
Total undiscounted operating lease payments | |
| 5,853 | |
Less: imputed interest | |
| 1,043 | |
Present value of operating lease liabilities | |
$ | 4,810 | |
The
weighted-average remaining term of the Company’s operating leases was 62 months and the weighted-average discount rate used to
measure the present value of the Company’s operating lease liabilities was 7.2% as of June 30, 2024.
The
Company received sublease income, which is recorded in other income on the condensed consolidated statement of operations and comprehensive
income (loss), of $0.1 million during the three months ended June 30, 2024 and 2023 and $0.3 million and $0.2 million during the six months ended
June 30, 2024 and 2023, respectively. Future cash receipts from the Company’s sublease agreements as of June 30, 2024 are as follows
(in thousands):
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE
| |
Operating | |
Future cash receipts | |
Subleases | |
| |
| |
2024, remainder | |
$ | 319 | |
2025 | |
| 485 | |
Total future cash receipts | |
$ | 804 | |
|
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v3.24.2.u1
DEBT
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
DEBT |
NOTE
8 – DEBT
The
following table provides a summary of the Company’s debt, net of debt issuance costs and discounts (in thousands):
SCHEDULE
OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Loan Agreement Principal | |
$ | 20,000 | | |
$ | — | |
Accreted final payment fee | |
| 162 | | |
| — | |
Unamortized debt issuance costs and discounts | |
| (1,807 | ) | |
| — | |
Total long-term debt | |
| 18,355 | | |
| — | |
Less: current maturities | |
| 2,222 | | |
| — | |
Long-term debt, net of current maturities | |
$ | 16,133 | | |
$ | — | |
Loan
and Security Agreement
On
January 8, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Agreement”)
with Avenue Venture Opportunities Fund, L.P., a Delaware limited partnership, as administrative agent and collateral agent (“Avenue”
and the “Agent”) and Avenue Venture Opportunities Fund II, L.P., a Delaware limited partnership (“Avenue 2”
and, together with Avenue, the “Lenders”). Also on January 8, 2024, the Company entered into a Supplement to the Agreement
(collectively with the Agreement, the “Loan Agreement”) with the Agent and the Lenders. The Loan Agreement provides for senior
secured term loans (the “Loans”) in an aggregate principal amount up to $50 million, with (i) a committed tranche of $20
million advanced on the Closing Date (“Tranche 1”), (ii) a committed tranche of up to $10 million which may be advanced upon
the request of the Company between June 30, 2024 and September 30, 2024, subject to the Company obtaining FDA approval of pz-cel in recessive
dystrophic epidermolysis bullosa, with the issuance of a Priority Review Voucher (“Tranche 2”), and (iii) a discretionary
tranche of up to $20 million which may be advanced between March 31, 2025 and March 31, 2026 (the “Discretionary Tranche”)
provided at the discretion of the Lenders. The Loans are due and payable on July 1, 2027 (the “Maturity Date”).
The
Loan principal is repayable in equal monthly installments beginning on April 8, 2025, with the possibility of deferring principal payments
an additional nine to fifteen months contingent upon (i) the Company obtaining FDA approval of pz-cel in recessive dystrophic epidermolysis
bullosa, with the issuance of a Priority Review Voucher and (ii) the Company raising $90 million of cumulative equity and/or non-dilutive
capital subsequent to the Closing Date. The Loans bear interest at a rate per annum (subject to increase during an event of default)
equal to the greater of (i) the prime rate, as published by the Wall Street Journal from time to time, plus 5.00% and (ii) 13.50%. The
interest rate as of June 30, 2024 was 13.50%.
The
Company may, subject to certain parameters, voluntarily prepay the Loans, in whole, at any time. If prepayment occurs on or before the
one-year anniversary of the Closing Date, the Company is required to pay a prepayment fee equal to 3.00% of the principal amount of the
Loans prepaid; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the
Closing Date, the Company is required to pay a fee equal to 2.00% of the principal amount of the Loans; if prepayment occurs after
the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 1.00% of the principal amount of the Loans.
A final payment fee of 5.00% of the principal amount of the funded Tranche 1, Tranche 2 Loans and Discretionary Tranche Loans is also
due upon the Maturity Date or any earlier date of prepayment.
The
Company’s obligations under the Loan Agreement are secured by a pledge of substantially all of the Company’s assets. Pursuant
to the Loan Agreement, the Company is subject to a financial covenant requiring the Company to maintain at all times $5 million in unrestricted
cash. The Loan Agreement also contains affirmative and negative covenants customary for financings of this type that, among other things,
limit the ability of the Company and its subsidiaries to (i) incur additional debt, guarantees or liens; (ii) pay dividends;
(iii) enter into certain change of control transactions; (iv) sell, transfer, lease, license, or otherwise dispose of certain assets;
(v) make certain investments or loans; and (vi) engage in certain transactions with related persons, in each case, subject to certain
exceptions. The Loan Agreement also includes events of default customary for financings of this type, in certain cases subject to customary
periods to cure, following which the Agent may accelerate all amounts outstanding under the Loans.
Pursuant
to the Supplement to the Loan and Security Agreement, Avenue also has the right to convert up to $3 million of the outstanding principal
of the Loans into shares of Company common stock (the “Conversion Right”) at a price per share equal to 120% of the exercise
price of the Warrants (further discussed below) at any time while the Loans are outstanding, subject to certain terms and conditions,
including ownership limitations. The Conversion Right required bifurcation as certain adjustments to the conversion price were not indexed
to the Company’s own stock and therefore the Conversion Right was recorded as a derivative liability. On January 8, 2024, the Conversion
Right was recorded at the closing date fair value of $0.8 million which was based on a Monte Carlo simulation model. The derivative liability
is remeasured at each reporting period with the change in fair value recorded to change in fair value of warrants and derivative liabilities
in the condensed consolidated statement of operations until the derivative is exercised, expired, reclassified, or otherwise settled.
In
addition, subject to applicable law and specified provisions set forth in the Supplement to the Loan and Security Agreement and solely
to the extent permitted under applicable stock exchange rules without requiring stockholder approval, the Lenders may participate in
certain equity financing transactions of the Company in an aggregate amount of up to $1 million on the same terms, conditions and pricing
offered by the Company to other investors participating in such financing transactions (such right, the “Participation Right”).
The Participation Right automatically terminates upon the earliest of (i) July 1, 2027, (ii) such time that the Lenders have purchased
$1 million of the Company’s equity securities in the aggregate pursuant to the Participation Right, and (iii) the repayment in
full of all of the obligations under the Loan Agreement.
On
the Closing Date and pursuant to the funding of Tranche 1 of the Loan Agreement, the Company issued to each of Avenue and Avenue 2 (collectively,
the “Warrantholders”) warrants to purchase up to $480,000 and $1,920,000 of Company common stock, respectively which is more
fully described in Note 9 below.
The
future payment obligations of the principal are as follows (in thousands):
SCHEDULE
OF FUTURE PAYMENT OBLIGATIONS
| |
|
| |
2024, remainder | |
$ |
— | |
2025 | |
| 6,667 | |
2026 | |
| 8,889 | |
2027 | |
| 4,444 | |
Total principal | |
$ | 20,000 | |
|
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.2.u1
EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
EQUITY |
NOTE
9 – EQUITY
Public
Offerings
On
December 21, 2021, the Company closed an underwritten public offering of 1,788,000 shares of common stock at a public offering price
of $9.75 per share and stock purchase warrants to purchase 1,788,000 shares of common stock at an exercise price of $9.75. The net proceeds
to the Company were $16.0 million, after deducting $1.5 million of underwriting discounts and commissions and offering expenses payable
by the Company. The net proceeds were allocated to the warrant liability as noted below with the remainder of $7.0 million recorded in
common stock and additional paid-in capital. In the event of certain fundamental transactions involving the Company, the holders of the
stock purchase warrants may require the Company to make a payment based on a Black-Scholes valuation, using specific inputs that are
not considered indexed to the Company’s stock in accordance with ASC 815, Derivatives and Hedging (“ASC 815”).
Therefore, the Company accounted for the stock purchase warrants as liabilities, which were recorded at the closing date fair value of
$9.0 million which was based on a Black-Scholes option pricing model. The remainder of the proceeds were allocated to common stock issued
and recorded as a component of equity.
As
of June 30, 2024, there were 1,788,000 stock purchase warrants outstanding related to this public offering. These stock purchase warrants
expire on December 21, 2026. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in
any dividends or other distribution of assets to holders of shares of common stock. There was no warrant activity during the six months
ended June 30, 2024, other than the change in fair value of the warrants for the stock purchase warrants issued as part of this public
offering.
Open
Market Sale Agreement
On
August 17, 2018, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Jefferies
LLC (“Jefferies”) pursuant to which, the Company may sell from time to time, through Jefferies, shares of its common stock
for an aggregate sales price of up to $75.0 million. Any sales of shares pursuant to this agreement are made under the Company’s
effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC.
The
Company sold 1,013,061 and 1,891,761 shares of its common stock under the ATM Agreement during the three months ended June 30, 2024 and
2023, respectively, resulting in net proceeds of $3.5 million and $6.4 million during the three months ended June 30, 2024 and 2023,
respectively. The Company sold 1,902,376 and 1,990,321 shares of its common stock under the ATM Agreement during the six months ended
June 30, 2024 and 2023, respectively, resulting in net proceeds of $10.0 million and $6.6 million during the six months ended June 30,
2024 and 2023, respectively.
Private
Placement Offerings
On
November 3, 2022, the Company sold 7,065,946 shares of its common stock, and in lieu of shares of common stock, pre-funded warrants exercisable
for 543,933 shares of common stock and accompanying warrants to purchase 7,609,879 shares of its common stock to a group of new and existing
institutional investors in a private placement. The offering price for each share of common stock and accompanying warrant was $4.60,
and the offering price for each pre-funded warrant and accompanying warrant was $4.59, which equaled the offering price per share of
the common stock and accompanying warrant, less the $0.01 per share exercise price of each pre-funded warrant. Each accompanying warrant
represents the right to purchase one share of the Company’s common stock at an exercise price of $4.75 per share of common stock.
The pre-funded warrants were exercised in December 2022 and converted to 543,933 shares of commons stock. Total shares sold or converted
during the year ended December 31, 2022 were 7,609,879 for an aggregate purchase price of $35.0 million gross, or $32.6 million net of
related costs of $1.5 million which was expensed to general and administrative expenses and $0.9 million which was recorded as a reduction
to additional paid-in-capital. The net proceeds were allocated to the warrant liability as noted below with the remainder of $12.9 million
and $0.1 million recorded in additional paid-in capital and common stock, respectively.
In
the event of certain fundamental transactions involving the Company, the holders of the stock purchase warrants may require the Company
to make a payment based on a Black-Scholes valuation, using specific inputs that are not considered indexed to the Company’s stock
in accordance with ASC 815. Therefore, the Company is accounting for the stock purchase warrants as liabilities. On November 3, 2022,
the stock purchase warrants were recorded at the closing date fair value of $22.0 million which was based on a Black-Scholes option pricing
model. The remainder of the proceeds were allocated to common stock issued and recorded as a component of equity.
As
of June 30, 2024, there were 7,609,879 warrants outstanding related to this private placement offering. The warrants expire on November
3, 2027. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in any dividends or other
distribution of assets to holders of shares of common stock. There was no warrant activity during the six months ended June 30, 2024,
other than the change in fair value of the warrants related to warrants issued as part of this private placement offering.
Direct
Placement Offering
On
July 6, 2023, the Company sold 3,284,407
shares of its common stock, and in lieu of shares of common stock, pre-funded warrants exercisable for 2,919,140
shares of common stock (the “2023 Pre-Funded Warrants”), to a group of existing institutional investors for an aggregate
purchase price of $25.0
million gross, or $23.0
million net of related costs. The offering price for each share of common stock was $4.03,
and the offering price for the 2023 Pre-Funded Warrants was $4.0299,
which represents the per share offering price for the Company’s common stock less a $0.0001
per share exercise price for each such 2023 Pre-Funded Warrant. The 2023 Pre-Funded Warrants are immediately exercisable at a
nominal exercise price of $0.0001
per share, may be exercised at any time and do not have an expiration date. On May 9, 2024, 300,000
of the 2023 Pre-Funded Warrants were exercised, leaving 2,619,140
2023 Pre-Funded Warrants outstanding as of June 30, 2024. The 2023 Pre-Funded Warrants are classified as equity in accordance with
ASC 815, Derivatives and Hedging, given the 2023 Pre-Funded Warrants are indexed to the Company’s own shares of common
stock and meet the requirements to be classified in equity. The 2023 Pre-Funded Warrants were recorded at their relative fair value
at issuance in the stockholders’ equity (deficit) section of the consolidated balance sheet and the 2023 Pre-Funded Warrants
are considered outstanding shares in the basic and diluted earnings per share calculation for the three and six months ended June
30, 2024 given their nominal exercise price.
Underwritten
Offering
On
May 7, 2024, the Company sold 12,285,056
shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656
shares of its common stock (the “2024 Pre-Funded Warrants”), for an aggregate purchase price of $75.0
million gross, or $70.2
million net of related costs. The offering price for each share of common stock was $4.07,
and the offering price for the 2024 Pre-Funded Warrants was $4.0699,
which represents the per share offering price for the Company’s common stock less a $0.0001 per share exercise price for each
2024 Pre-Funded Warrant. The 2024 Pre-Funded Warrants are immediately exercisable at a nominal exercise price of $0.0001
per share and may be exercised at any time until the pre-funded warrants are exercised in full. On June 24, 2024, 700,000
of the 2024 Pre-Funded Warrants were exercised, leaving 5,442,656
2024 Pre-Funded Warrants outstanding as of June 30, 2024. The 2024 Pre-Funded Warrants are classified as equity in accordance with
ASC 815, Derivatives and Hedging, given the prefunded warrants are indexed to the Company’s own shares of common stock
and meet the requirements to be classified in equity. The 2024 Pre-Funded warrants were recorded at their relative fair value at
issuance in the stockholders’ equity (deficit) section of the consolidated balance sheet and the 2024 Pre-Funded Warrants are
considered outstanding shares in the basic and diluted earnings per share calculation for the three and six months ended June 30,
2024 given their nominal exercise price.
Common
Stock Warrants related to the Loan and Security Agreement
On
January 8, 2024, in connection with entering into the Loan and Security Agreement, the Company issued to each of Avenue and Avenue 2
(collectively, the “Warrantholders”) warrants to purchase up to $480,000 and $1,920,000 worth of shares, respectively, of
Company common stock (collectively, the “January Warrants”). The Warrants expire on January 8, 2029 (the “Expiration
Date”) and upon issuance, had an exercise price per share equal to the lesser of (i) $4.75 and (ii) the price per share of the
Company’s next bona fide round of equity financing before September 30, 2024 in which the Company sells or issues shares of its
common stock, excluding certain excluded issuances as defined in the Supplement. In connection with the underwritten common stock offering
consummated on May 7, 2024, and pursuant to the term of the January Warrants, the exercise price of the January Warrants was reduced
to the lesser of (i) $4.07 per share and (ii) the price per share of the Company’s next bona fide round of equity financing before
September 30, 2024 in which the Company sells or issues shares of its common stock, excluding certain excluded issuances. In addition,
upon a change of control where the per share price of the Company common stock is less than or equal to two times that of the exercise
price, the Warrantholders would be entitled to receive the shares of common stock underlying the January Warrants without payment of
the exercise price. Assuming an exercise price of $4.07 per share, 589,681 shares of common stock would be issued in connection with
the exercise in full of the January Warrants. The January Warrants do not include an explicit share limit and the number of shares issuable
under the warrant agreements are variable based on the exercise price and therefore the January Warrants were liability classified based
on a Black-Scholes valuation in accordance with ASC 815. On January 8, 2024, the January Warrants were recorded at the closing date fair
value of $0.2 million which was based on a Black-Scholes option pricing model.
The
Warrantholders may exercise the January Warrants at any time, or from time to time up to and including the Expiration Date, by making
a cash payment equal to the exercise price multiplied by the quantity of shares. The Warrantholders may also exercise the January Warrants
on a cashless basis by receiving a net number of shares calculated pursuant to the formula set forth in the January Warrants. The January
Warrants are subject to anti-dilution adjustments for stock dividends, stock splits, and reverse stock splits.
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v3.24.2.u1
STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
NOTE
10 – STOCK-BASED COMPENSATION
The
Company previously granted stock options under its 2005 Equity Incentive Plan (the “2005 Incentive Plan”), under which no
further grants can be made. In addition, prior to May 17, 2023, the Company had previously granted stock options and stock awards under
the Abeona Therapeutics Inc. 2015 Equity Incentive Plan (the “2015 Incentive Plan”). As of May 17, 2023, no further grants
can be made under the 2015 Incentive Plan. The Company now grants stock options and stock awards under the Amended and Restated Abeona
Therapeutics Inc. 2023 Equity Incentive Plan (the “2023 Incentive Plan”) which was initially approved by stockholders on
May 17, 2023 and amended and restated to increase the number of shares of Common Stock reserved for issuance thereunder, which amendment
and restatement was approved by stockholders on April 24, 2024. As of June 30, 2024, there were 1,783,571 shares available to be granted
under the 2023 Incentive Plan. In addition, in 2023, the Company’s board of directors approved various restricted stock awards
granted to certain new hires as inducement grants. On October 10, 2023, the Company’s board of directors approved the Abeona Therapeutics
Inc. 2023 Employment Inducement Equity Incentive Plan (the “Inducement Plan”). As of June 30, 2024, there were 719,700 shares
available to be granted under the Inducement Plan.
The
following table summarizes stock-based compensation expense for the three and six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF STOCK BASED COMPENSATION
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the three months ended June
30 | | |
For the six months ended June 30 | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 224 | | |
$ | 218 | | |
$ | 570 | | |
$ | 404 | |
General and administrative | |
| 1,099 | | |
| 709 | | |
| 2,299 | | |
| 1,293 | |
Total stock-based compensation expense | |
$ | 1,323 | | |
$ | 927 | | |
$ | 2,869 | | |
$ | 1,697 | |
Stock
Options
The
Company estimates the fair value of each option award on the date of grant using the Black-Scholes option-pricing model. The Company
then recognize the grant date fair value of each option as compensation expense ratably using the straight-line attribution method over
the service period (generally the vesting period). The Black-Scholes model incorporates the following assumptions:
|
● |
Expected
volatility – the Company estimates the volatility of the share price at the date of grant using a “look-back” period
which coincides with the expected term, defined below. The Company believes using a “look-back” period which coincides
with the expected term is the most appropriate measure for determining expected volatility. |
|
|
|
|
● |
Expected
term – the Company estimates the expected term using the “simplified” method, as outlined in SEC Staff Accounting
Bulletin No. 107, “Share-Based Payment.” |
|
|
|
|
● |
Risk-free
interest rate – the Company estimates the risk-free interest rate using the U.S. Treasury yield curve for periods equal to
the expected term of the options in effect at the time of grant. |
|
|
|
|
● |
Dividends
– the Company uses an expected dividend yield of zero because the Company has not declared nor paid a cash dividend, nor are
there any plans to declare a dividend. |
The
Company did not grant any stock options in the six months ended June 30, 2024 and 2023.
The
Company accounts for forfeitures as they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures
arise.
The
following table summarizes stock option activity during the six months ended June 30, 2024:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Number of
Options | | |
Weighted
Average
Exercise Price | | |
Weighted
Average
Remaining
Contractual
Term (years) | | |
Aggregate
Intrinsic Value (in thousands) | |
| |
| | |
| | |
| | |
| |
Outstanding at December 31, 2023 | |
| 179,001 | | |
$ | 38.58 | | |
| 6.83 | | |
$ | 3 | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Cancelled/forfeited | |
| (142 | ) | |
$ | 43.71 | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 178,859 | | |
$ | 38.58 | | |
| 6.29 | | |
$ | 1 | |
Exercisable | |
| 151,580 | | |
$ | 38.70 | | |
| 6.16 | | |
$ | 1 | |
Unvested | |
| 27,279 | | |
$ | 37.85 | | |
| 7.03 | | |
$ | — | |
The
aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair
value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s
common stock. As of June 30, 2024, the total compensation cost related to non-vested option awards not yet recognized was approximately
$0.7 million with a weighted average remaining vesting period of 0.9 years.
Restricted
Stock
The
following table summarizes restricted stock award activity during the six months ended June 30, 2024:
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY
| |
Number of
Awards | | |
Weighted Average
Grant Date Fair
Value Per Unit | |
| |
| | |
| |
Outstanding at December 31, 2023 | |
| 2,448,169 | | |
$ | 4.25 | |
Granted | |
| 180,200 | | |
$ | 5.17 | |
Cancelled/forfeited | |
| (161,835 | ) | |
$ | 3.67 | |
Vested | |
| (818,868 | ) | |
$ | 4.80 | |
Outstanding at June 30, 2024 | |
| 1,647,666 | | |
$ | 4.14 | |
As
of June 30, 2024, there was $6.0 million of total unrecognized compensation expense related to unvested restricted stock awards, which
is expected to be recognized over a weighted average vesting period of 2.1 years. The total fair value of restricted stock awards that
vested during the six months ended June 30, 2024 was $3.9 million.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
LICENSE/SUPPLIER AGREEMENT
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
LICENSE/SUPPLIER AGREEMENT |
NOTE
11 – LICENSE/SUPPLIER AGREEMENT
Sublicense
and Inventory Purchase Agreements Relating to CLN1 Disease
In
August 2020, the Company entered into sublicense and inventory purchase agreements with Taysha Gene Therapies (“Taysha”)
relating to a potential gene therapy for CLN1 disease. Under the sublicense agreement, Taysha received worldwide exclusive rights to
intellectual property and know-how relating to the research, development, and manufacture of the potential gene therapy, which the Company
had referred to as ABO-202. Under the inventory purchase agreement, the Company sold to Taysha certain inventory and other items related
to ABO-202. The Company assessed the nature of the promised license to determine whether the license has significant stand-alone functionality
and evaluated whether such functionality can be retained without ongoing activities by the Company and determined that the license has
significant stand-alone functionality. Furthermore, the Company has no ongoing activities associated with the license to support or maintain
the license’s utility. Based on this, the Company determined that the pattern of transfer of control of the license to Taysha was
at a point in time.
The
transaction price of the contract includes (i) $7.0 million of fixed consideration, (ii) up to $26.0 million of variable consideration
in the form of event-based milestone payments, (iii) up to $30.0 million of variable consideration in the form of sales-based milestone
payments, and (iv) other royalty-based payments based on net sales. The event-based milestone payments are based on certain development
and regulatory events occurring. At inception, the Company evaluated whether the milestone conditions had been achieved and if it was
probable that a significant cumulative revenue reversal would not occur before recognizing the associated revenue and determined that
these milestone payments were not within the Company’s control or the licensee’s control, such as regulatory approvals, and
were not considered probable of being achieved until those approvals were received. Accordingly, at inception, the Company fully constrained
the $26.0 million of event-based milestone payments until such time that it is probable that significant cumulative revenue reversal
would not occur. The sales-based milestone payments and other royalty-based payments are based on a level of sales for which the license
is deemed to be the predominant item to which the royalties relate. The Company will recognize revenue for these payments at the later
of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has
been satisfied or partially satisfied. To date, the Company has not recognized any sales-based or royalty revenue resulting from this
licensing arrangement.
Under
this arrangement, the Company recognized no revenue for the three and six months ended June 30, 2024 and 2023. As of June 30, 2024 and
December 31, 2023, the Company does not have any contract assets or contract liabilities as a result of this transaction.
Sublicense
Agreement Relating to Rett Syndrome
In
October 2020, the Company entered into a sublicense agreement with Taysha for a gene therapy for Rett syndrome, including intellectual
property related to MECP2 gene constructs and regulation of their expression. The agreement grants Taysha worldwide exclusive rights
to intellectual property developed by scientists at the University of North Carolina at Chapel Hill, the University of Edinburgh and
the Company, and the Company’s know-how relating to the research, development, and manufacture of the gene therapy for Rett syndrome
and MECP2 gene constructs and regulation of their expression.
The
Company assessed the nature of the promised license to determine whether the license has significant stand-alone functionality and evaluated
whether such functionality can be retained without ongoing activities by the Company and determined that the license has significant
stand-alone functionality. Furthermore, the Company has no ongoing activities associated with the license to support or maintain the
license’s utility. Based on this, the Company determined that the pattern of transfer of control of the license to Taysha was at
a point in time.
The
transaction price of the contract includes (i) $3.0 million of fixed consideration, (ii) up to $26.5 million of variable consideration
in the form of event-based milestone payments, (iii) up to $30.0 million of variable consideration in the form of sales-based milestone
payments, and (iv) other royalty-based payments based on net sales. The event-based milestone payments are based on certain development
and regulatory events occurring. The Company evaluated whether the milestone conditions have been achieved and if it is probable that
a significant cumulative revenue reversal would not occur before recognizing the associated revenue. The Company determined that these
milestone payments are not within the Company’s control or the licensee’s control, such as regulatory approvals, and are
not considered probable of being achieved until those approvals are received. Accordingly, the Company has fully constrained the $26.5
million in event-based milestone payments until such time that it is probable that a significant cumulative revenue reversal would not
occur. The sales-based milestone payments and other royalty-based payments are based on a level of sales for which the license is deemed
to be the predominant item to which the royalties relate. The Company will recognize revenue for these payments at the later of (i) when
the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied
or partially satisfied. To date, the Company has not recognized any sales-based or royalty revenue resulting from this licensing arrangement.
Under
this arrangement, the Company recognized nil and $3.5 million in revenue during the three and six months ended June 30, 2024 and 2023,
respectively based on event-based-milestone payments. The Company has no contract assets or contract liabilities as of June 30, 2024
and December 31, 2023 as a result of this transaction.
Ultragenyx
License Agreement
On
May 16, 2022, the Company and Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) entered into an exclusive license agreement (the
“License Agreement”) for AAV gene therapy, ABO-102, for the treatment of Sanfilippo syndrome type A (MPS IIIA). Under the
License Agreement, Ultragenyx assumed responsibility for the ABO-102 program from the Company, with the exclusive right to develop, manufacture,
and commercialize ABO-102 worldwide. Also pursuant to the License Agreement, following regulatory approval, the Company is eligible to
receive tiered royalties from mid-single-digit up to 10% on net sales and up to $30.0 million in commercial milestone payments. Both
forms of consideration comprise the transaction price to which the Company expects to be entitled in exchange for transferring the related
intellectual property and certain, contractually-specified, transition services to Ultragenyx. The sales-based royalty and milestone
payments are subject to the royalty recognition constraint. As such, these fees are not recognized as revenue until the later of: (a)
the occurrence of the subsequent sale, and (b) the performance obligation to which they relate has been satisfied.
Additionally,
pursuant to the License Agreement, Ultragenyx will reimburse the Company for certain development and transition costs actually incurred
by the Company. These costs are passed through to Ultragenyx without mark-up. The Company has determined that these costs are not incurred
for the purpose of satisfying any performance obligation under the License Agreement. Accordingly, the reimbursement of these costs is
recognized as a reduction of research and development costs. As of June 30, 2024 and December 31, 2023, the Company does not have any
contract assets or contract liabilities as a result of this transaction.
|
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v3.24.2.u1
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE 12 – SUBSEQUENT EVENTS
In July of 2024, the compensation committee of the
board of directors granted various employees and directors restricted stock awards, under which the holders have the right to receive
an aggregate of 1,659,484 shares of the Company’s common stock. Total stock compensation estimated for these awards at the time
of grant was $8.0 million, with $7.3 million vesting in three equal annual installments and $0.7 million vesting in one annual installment.
Pursuant to the terms of the awards, the shares not vested are forfeited upon separation from the Company.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.2.u1
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Background |
Background
Abeona
Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation,
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead
clinical program is for pz-cel, an autologous, cell-based gene therapy currently in development for recessive dystrophic epidermolysis
bullosa (“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based
gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM™ capsids that the Company has exclusively
licensed from the University of North Carolina at Chapel Hill and developed internally through its AAV vector research programs.
|
Basis of Presentation |
Basis
of Presentation
The
Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting
principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions
have been eliminated in consolidation. In the opinion of management, all adjustments, consisting only of normal recurring
adjustments, except as otherwise disclosed, necessary for the fair presentation of the financial position, results of operations,
and changes in financial position for such periods, have been made. These unaudited interim condensed consolidated financial
statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Certain
information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the
U.S. Securities and Exchange Commission (“SEC”). The December 31, 2023 condensed consolidated balance sheet was derived
from the audited statements but does not include all disclosures required by U.S. GAAP.
Therefore,
these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the
SEC on March 18, 2024.
|
Liquidity |
Liquidity
In
accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there
are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as
a going concern within one year after the date the accompanying unaudited interim condensed consolidated financial statements were issued.
As
a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development
activities for pz-cel and other product candidates, business planning, raising capital, establishing its intellectual property portfolio,
acquiring or discovering product candidates, and providing general and administrative support for these operations. As a result, the
Company has incurred significant operating losses and negative cash flows from operations since its inception and anticipates such losses
and negative cash flows will continue for the foreseeable future.
Since
its inception, the Company has funded its operations primarily with proceeds from sales of shares of its stock. The Company has incurred
recurring losses since its inception, including net losses of $24.2 million and $25.8 million for the six months ended June 30, 2024
and 2023, respectively. As of June 30, 2024, the Company had an accumulated deficit of approximately $773.7 million. To date the Company
has not generated any significant revenues and expects to continue to generate operating losses for the foreseeable future. As of the
issuance date of these unaudited interim condensed consolidated financial statements, the Company expects that its existing cash, cash
equivalents, restricted cash and short-term investments of $123.0 million as of June 30, 2024, will be sufficient to fund its operating
expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these condensed consolidated
financial statements.
While
the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from
the issuance date of these unaudited condensed consolidated financial statements, the Company’s liquidity could be materially affected
over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party
funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory
events or unanticipated costs related to pz-cel; (4) any other unanticipated material negative events or costs. One or more of these
events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become
due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes
to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
|
Use of Estimates |
Use
of Estimates
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
|
Other receivables |
Other
receivables
Other
receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As
of June 30, 2024 and December 31, 2023, the Company had ERC receivables of $1.6 million and $2.1 million, respectively.
|
Summary of Significant Accounting Policies |
Summary
of Significant Accounting Policies
There
have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023 that are of significance, or potential significance, to the Company.
|
Credit Losses |
Credit
Losses
The
Company reviews its available-for-sale investments for credit losses on a collective basis by major security type and in line with the
Company’s investment policy. As of June 30, 2024, the Company’s available-for-sale investments were in certificates of deposits
and securities that are issued by the U.S. treasury and U.S. federal agencies, are highly rated, and have a history of zero credit losses.
The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of
write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic
trends, supportable forecasts, and other relevant factors. The Company’s accounts receivable are with customers that do not have
a history of uncollectibility nor a history of significantly aged accounts receivables. As of June 30, 2024, the Company did not recognize
a credit loss allowance for its investments or accounts receivable.
|
Net Income (Loss) Per Share |
Net
Income (Loss) Per Share
Basic
net income (loss) per share is computed by dividing net income (loss) attributable to common shareholders by the weighted-average
number of shares of common stock outstanding during the period. The weighted average number of shares of common stock includes the
weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining
unfunded exercise price is $0.0001
or less per share. Diluted net income (loss) per share is computed based on the weighted average number of shares of common stock
plus the effect of dilutive potential commons shares outstanding during the period using the treasury stock method and if-converted
method. Dilutive potential securities result from outstanding restricted stock, stock options, stock purchase warrants and
conversion features in the Company’s loan agreement. When the Company has a net loss during the period, the Company does not
include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive.
A reconciliation of the numerators and the denominators
of the basic and diluted net income (loss) per share computations is as follows (in thousands, except per share amounts):
SCHEDULE
OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net
income (loss) used for basic net income (loss) per share | |
$ | 7,406 | | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
Effect
of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Fair
value adjustments for warrant and derivative liabilities | |
| (20,854 | ) | |
| — | | |
| — | | |
| — | |
Numerator
for dilutive net income (loss) per share - net income available for common shareholders’ after the effect of dilutive securities | |
$ | (13,448 | ) | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted
average number of common shares outstanding - basic | |
| 40,010,481 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
Effect
of dilutive shares: | |
| | | |
| | | |
| | | |
| | |
Shares
of common stock issuable upon exercise of stock options | |
| 178,931 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock underlying restricted stock | |
| 2,293,570 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of warrants | |
| 8,165,236 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of conversion feature of loan agreement | |
| 578,497 | | |
| — | | |
| — | | |
| — | |
Dilutive
potential common shares | |
| 11,216,234 | | |
| — | | |
| — | | |
| — | |
Denominator
for dilutive net income (loss) per share - adjusted weighted average shares used in computing net income (loss) per share - dilutive | |
| 51,226,715 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
| |
| | | |
| | | |
| | | |
| | |
Earnings
per share: | |
| | | |
| | | |
| | | |
| | |
Basic
income (loss) per common share | |
$ | 0.19 | | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
Dilutive
income (loss) per common share | |
$ | (0.26 | ) | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
The
following table sets forth the potential securities that could potentially dilute basic loss per share in the future that were not included
in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Shares of common
stock issuable upon exercise of stock options | |
| — | | |
| 230,723 | | |
| 178,859 | | |
| 230,723 | |
Shares of common stock
underlying restricted stock | |
| — | | |
| 2,566,303 | | |
| 1,647,666 | | |
| 2,566,303 | |
Shares of common stock
issuable upon exercise of conversion feature of loan agreement | |
| — | | |
| — | | |
| 614,251 | | |
| — | |
Shares of common stock
issuable upon exercise of warrants | |
| 1,788,000 | | |
| 9,397,879 | | |
| 9,987,560 | | |
| 9,397,879 | |
Total | |
| 1,788,000 | | |
| 12,194,905 | | |
| 12,428,336 | | |
| 12,194,905 | |
In
January 2024 as part of the Loan and Security Agreement, see Note 8, the Company issued warrants to purchase $2,400,000 worth of shares
of the Company’s stock which have an exercise price equal to the lesser of (i) $4.75 and (ii) the price per share of the Company’s
net bona fide round of equity financing before September 30, 2024 (the “2024 Loan Agreement Warrants”). In connection with
the underwritten common stock offering consummated on May 7, 2024 pursuant to the terms of the 2024 Loan Agreement Warrants, the exercise
price of the 2024 Loan Agreement Warrants was reduced to the lesser of (i) $4.07 per share and (ii) the price per share of the Company’s
next bona fide round of equity financing before September 30, 2024 in which the Company sells or issues shares of its common stock, excluding
certain excluded issuances. Utilizing the exercise price of $4.07, which is the only known price at June 30, 2024, the Company included
589,681 of shares of common stock issuable upon exercise of the 2024 Loan Agreement Warrants for the six months ended June 30, 2024 and
no shares for the three and six months ended June 30, 2023 in the table above.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
The
Company did not adopt any new accounting pronouncements during the three and six months ended June 30, 2024.
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements
to Income Tax Disclosures. ASU 2023-09 is intended to enhance the transparency and decision usefulness of income tax information
through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The
standard is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The
requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of
operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its income tax disclosures.
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which
expands disclosures about a public entity’s reportable segments and requires more enhanced information about a reportable segment’s
expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit
or loss information in assessing segment performance and allocating resources. The standard is effective for annual reporting periods
beginning after December 15, 2023, and interim periods within years beginning after December 15, 2024, with early adoption permitted.
The requirements of this ASU are disclosure related and will not have an impact on the Company’s financial condition, results of
operations, or cash flows. The Company is currently evaluating the impact of adopting this ASU on its reportable segment disclosures.
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v3.24.2.u1
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
SCHEDULE OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS |
A reconciliation of the numerators and the denominators
of the basic and diluted net income (loss) per share computations is as follows (in thousands, except per share amounts):
SCHEDULE
OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net
income (loss) used for basic net income (loss) per share | |
$ | 7,406 | | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
Effect
of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Fair
value adjustments for warrant and derivative liabilities | |
| (20,854 | ) | |
| — | | |
| — | | |
| — | |
Numerator
for dilutive net income (loss) per share - net income available for common shareholders’ after the effect of dilutive securities | |
$ | (13,448 | ) | |
$ | (16,654 | ) | |
$ | (24,172 | ) | |
$ | (25,761 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted
average number of common shares outstanding - basic | |
| 40,010,481 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
Effect
of dilutive shares: | |
| | | |
| | | |
| | | |
| | |
Shares
of common stock issuable upon exercise of stock options | |
| 178,931 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock underlying restricted stock | |
| 2,293,570 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of warrants | |
| 8,165,236 | | |
| — | | |
| — | | |
| — | |
Shares
of common stock issuable upon exercise of conversion feature of loan agreement | |
| 578,497 | | |
| — | | |
| — | | |
| — | |
Dilutive
potential common shares | |
| 11,216,234 | | |
| — | | |
| — | | |
| — | |
Denominator
for dilutive net income (loss) per share - adjusted weighted average shares used in computing net income (loss) per share - dilutive | |
| 51,226,715 | | |
| 18,017,874 | | |
| 33,662,908 | | |
| 17,464,026 | |
| |
| | | |
| | | |
| | | |
| | |
Earnings
per share: | |
| | | |
| | | |
| | | |
| | |
Basic
income (loss) per common share | |
$ | 0.19 | | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
Dilutive
income (loss) per common share | |
$ | (0.26 | ) | |
$ | (0.92 | ) | |
$ | (0.72 | ) | |
$ | (1.48 | ) |
|
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE |
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Shares of common
stock issuable upon exercise of stock options | |
| — | | |
| 230,723 | | |
| 178,859 | | |
| 230,723 | |
Shares of common stock
underlying restricted stock | |
| — | | |
| 2,566,303 | | |
| 1,647,666 | | |
| 2,566,303 | |
Shares of common stock
issuable upon exercise of conversion feature of loan agreement | |
| — | | |
| — | | |
| 614,251 | | |
| — | |
Shares of common stock
issuable upon exercise of warrants | |
| 1,788,000 | | |
| 9,397,879 | | |
| 9,987,560 | | |
| 9,397,879 | |
Total | |
| 1,788,000 | | |
| 12,194,905 | | |
| 12,428,336 | | |
| 12,194,905 | |
|
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v3.24.2.u1
SHORT-TERM INVESTMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS |
The
following table provides a summary of the short-term investments (in thousands):
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS
| |
June 30, 2024 | |
| |
Amortized Cost | | |
Gross Unrealized Gain | | |
Gross Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
$ | 68,918 | | |
| — | | |
| (106 | ) | |
$ | 68,812 | |
U.S. federal agency securities | |
| 5,998 | | |
| — | | |
| (35 | ) | |
| 5,963 | |
Certificates of deposit | |
| 13,500 | | |
| — | | |
| 7 | | |
| 13,507 | |
Total available-for-sale, short-term investments | |
$ | 88,416 | | |
| — | | |
| (134 | ) | |
$ | 88,282 | |
| |
December 31, 2023 | |
| |
Amortized Cost | | |
Gross Unrealized Gain | | |
Gross Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
$ | 8,406 | | |
| — | | |
| (13 | ) | |
$ | 8,393 | |
U.S. federal agency securities | |
| 29,413 | | |
| — | | |
| (53 | ) | |
| 29,360 | |
Total available-for-sale, short-term investments | |
$ | 37,819 | | |
| — | | |
| (66 | ) | |
$ | 37,753 | |
|
X |
- DefinitionTabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).
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v3.24.2.u1
PROPERTY AND EQUIPMENT, NET (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
Property
and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
Useful lives (years) | |
June 30, 2024 | | |
December 31, 2023 | |
| |
| |
| | |
| |
Laboratory equipment | |
5 | |
$ | 8,140 | | |
$ | 6,935 | |
Furniture, software and office equipment | |
3 to 5 | |
| 1,057 | | |
| 986 | |
Leasehold improvements | |
Shorter of remaining lease term or useful life | |
| 8,744 | | |
| 8,603 | |
Subtotal | |
| |
| 17,941 | | |
| 16,524 | |
Less: accumulated depreciation | |
| |
| (13,966 | ) | |
| (12,991 | ) |
Total property and equipment, net | |
| |
$ | 3,975 | | |
$ | 3,533 | |
|
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v3.24.2.u1
FAIR VALUE MEASUREMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS |
The
following table provides a summary of financial assets measured at fair value on a recurring basis as of June 30, 2024
and December 31, 2023 (in thousands):
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS
Description | |
Fair Value at
June 30, 2024 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | |
| | |
| | |
| |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 33,380 | | |
$ | 33,380 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 68,812 | | |
| 68,812 | | |
| — | | |
| — | |
U.S. federal agency securities | |
| 5,963 | | |
| — | | |
| 5,963 | | |
| — | |
Certificates of deposit | |
| 13,507 | | |
| 13,507 | | |
| — | | |
| — | |
Total assets measured at fair value | |
$ | 121,662 | | |
$ | 115,699 | | |
$ | 5,963 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Payable to licensor | |
$ | 4,805 | | |
$ | — | | |
$ | — | | |
$ | 4,805 | |
Derivative liabilities | |
| 668 | | |
| — | | |
| — | | |
| 668 | |
Warrant liabilities | |
| 24,100 | | |
| — | | |
| — | | |
| 24,100 | |
Total liabilities measured at fair value | |
$ | 29,573 | | |
$ | — | | |
$ | — | | |
$ | 29,573 | |
Description | |
Fair Value at December 31, 2023 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 1,034 | | |
$ | 1,034 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 8,393 | | |
| 8,393 | | |
| — | | |
| — | |
U.S. federal agency securities | |
| 29,360 | | |
| — | | |
| 29,360 | | |
| — | |
Total assets measured at fair value | |
$ | 38,787 | | |
$ | 9,427 | | |
$ | 29,360 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Payable to licensor | |
$ | 4,580 | | |
$ | — | | |
$ | — | | |
$ | 4,580 | |
Warrant liabilities | |
| 31,352 | | |
| — | | |
| — | | |
| 31,352 | |
Total liabilities measured at fair value | |
$ | 35,932 | | |
$ | — | | |
$ | — | | |
$ | 35,932 | |
|
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES |
As
of June 30, 2024 and December 31, 2023, the Company had the following outstanding warrant liabilities:
SCHEDULE OF OUTSTANDING WARRANT LIABILITIES
|
|
June 30, 2024 | | |
December 31, 2023 | |
Warrants issued as part of the 2021 public offering, expiration date December 2026, exercise price of $9.75 per share |
|
| 1,788,000 | | |
| 1,788,000 | |
Warrants issued as part of the 2022 Private Placement Offering, expiration date November 2027, exercise price $4.75 per share |
|
| 7,609,879 | | |
| 7,609,879 | |
Warrants issued as part of the 2024 loan agreement, expiration date January 2029, exercise price equal to the lesser of (i) $4.07 and (ii) the price per share of the Company’s next bona fide round of equity financing before September 30, 2024 |
|
| 589,681 | | |
| — | |
Outstanding warrants |
|
| 589,681 | | |
| — | |
|
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES |
The
following table provides a summary of the activity on the warrant liabilities (in thousands):
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES
| |
| | |
Warrant liabilities as of December 31, 2023 | |
$ | 31,352 | |
Fair value of warrants issued in connection with Loan Agreement | |
| 220 | |
Gain recognized in earnings from change in fair value | |
| (7,472 | ) |
Warrant liabilities as of June 30, 2024 | |
$ | 24,100 | |
|
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS |
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Common share price | |
| $4.24 | | |
| $5.01 | |
Expected term (years) | |
| 2.46 – 4.53 | | |
| 2.96 – 3.84 | |
Risk-free interest rate (%) | |
| 4.26% – 4.51% | | |
| 3.84% – 3.92% | |
Volatility (%) | |
| 100.00% - 101.03% | | |
| 100.00% | |
Expected dividend yield (%) | |
| 0% | | |
| 0% | |
|
SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES |
The
following table provides a summary of the activity on the derivative liabilities (in thousands):
SCHEDULE OF ACTIVITY OF DERIVATIVE LIABILITIES
| |
| | |
Derivative liabilities as of December 31, 2023 | |
$ | — | |
Fair value of derivatives issued in connection with Loan Agreement | |
| 822 | |
Gain recognized in earnings from change in fair value | |
| (154 | ) |
Derivative liabilities as of June 30, 2024 | |
$ | 668 | |
|
SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES |
SCHEDULE OF ESTIMATE FAIR VALUE OF DERIVATIVES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Common share price | |
| $4.24 | | |
| — | |
Expected term (years) | |
| 3.00 | | |
| — | |
Risk-free interest rate (%) | |
| 4.40 | % | |
| — | |
Volatility (%) | |
| 97.78 | % | |
| — | |
|
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v3.24.2.u1
ACCRUED EXPENSES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
The
following table provides a summary of the components of accrued expenses (in thousands):
SCHEDULE OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Accrued employee compensation | |
$ | 3,423 | | |
$ | 3,688 | |
Accrued contracted services and other | |
| 1,501 | | |
| 2,297 | |
Total accrued expenses | |
$ | 4,924 | | |
$ | 5,985 | |
|
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
SUMMARY OF OPERATING LEASE LIABILITIES |
The
following table provides a summary of the Company’s operating lease liabilities (in thousands):
SUMMARY OF OPERATING LEASE LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Current operating lease liability | |
$ | 1,792 | | |
$ | 998 | |
Non-current operating lease liability | |
| 3,018 | | |
| 4,402 | |
Total operating lease liability | |
$ | 4,810 | | |
$ | 5,400 | |
|
SCHEDULE OF COMPONENTS OF LEASE COST |
Lease
costs and rent are reflected in general and administrative expenses and research and development expenses in the consolidated statements
of operations and comprehensive income (loss), as determined by the underlying activities. The following table provides a summary of the components
of lease costs and rent (in thousands):
SCHEDULE OF COMPONENTS OF LEASE COST
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Operating lease cost | |
$ | 328 | | |
$ | 353 | | |
$ | 662 | | |
$ | 708 | |
Variable lease cost | |
| 122 | | |
| 116 | | |
| 196 | | |
| 215 | |
Short-term lease cost | |
| 11 | | |
| 13 | | |
| 34 | | |
| 31 | |
Total operating lease costs | |
$ | 461 | | |
$ | 482 | | |
$ | 892 | | |
$ | 954 | |
|
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES |
Future
minimum lease payments and obligations, which do not include short-term leases, related to the Company’s operating lease liabilities
as of June 30, 2024 were as follows (in thousands):
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Future minimum lease payments and obligations | |
Operating Leases | |
| |
| |
2024, remainder | |
$ | 886 | |
2025 | |
| 853 | |
2026 | |
| 791 | |
2027 | |
| 807 | |
2028 | |
| 823 | |
Thereafter | |
| 1,693 | |
Total undiscounted operating lease payments | |
| 5,853 | |
Less: imputed interest | |
| 1,043 | |
Present value of operating lease liabilities | |
$ | 4,810 | |
|
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE |
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE
| |
Operating | |
Future cash receipts | |
Subleases | |
| |
| |
2024, remainder | |
$ | 319 | |
2025 | |
| 485 | |
Total future cash receipts | |
$ | 804 | |
|
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v3.24.2.u1
DEBT (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS |
The
following table provides a summary of the Company’s debt, net of debt issuance costs and discounts (in thousands):
SCHEDULE
OF COMPANY DEBT AND NET OF DEBT ISSUANCE COSTS
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
Loan Agreement Principal | |
$ | 20,000 | | |
$ | — | |
Accreted final payment fee | |
| 162 | | |
| — | |
Unamortized debt issuance costs and discounts | |
| (1,807 | ) | |
| — | |
Total long-term debt | |
| 18,355 | | |
| — | |
Less: current maturities | |
| 2,222 | | |
| — | |
Long-term debt, net of current maturities | |
$ | 16,133 | | |
$ | — | |
|
SCHEDULE OF FUTURE PAYMENT OBLIGATIONS |
The
future payment obligations of the principal are as follows (in thousands):
SCHEDULE
OF FUTURE PAYMENT OBLIGATIONS
| |
|
| |
2024, remainder | |
$ |
— | |
2025 | |
| 6,667 | |
2026 | |
| 8,889 | |
2027 | |
| 4,444 | |
Total principal | |
$ | 20,000 | |
|
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v3.24.2.u1
STOCK-BASED COMPENSATION (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
SCHEDULE OF STOCK BASED COMPENSATION |
The
following table summarizes stock-based compensation expense for the three and six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF STOCK BASED COMPENSATION
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the three months ended June
30 | | |
For the six months ended June 30 | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 224 | | |
$ | 218 | | |
$ | 570 | | |
$ | 404 | |
General and administrative | |
| 1,099 | | |
| 709 | | |
| 2,299 | | |
| 1,293 | |
Total stock-based compensation expense | |
$ | 1,323 | | |
$ | 927 | | |
$ | 2,869 | | |
$ | 1,697 | |
|
SCHEDULE OF STOCK OPTION ACTIVITY |
The
following table summarizes stock option activity during the six months ended June 30, 2024:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Number of
Options | | |
Weighted
Average
Exercise Price | | |
Weighted
Average
Remaining
Contractual
Term (years) | | |
Aggregate
Intrinsic Value (in thousands) | |
| |
| | |
| | |
| | |
| |
Outstanding at December 31, 2023 | |
| 179,001 | | |
$ | 38.58 | | |
| 6.83 | | |
$ | 3 | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Cancelled/forfeited | |
| (142 | ) | |
$ | 43.71 | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2024 | |
| 178,859 | | |
$ | 38.58 | | |
| 6.29 | | |
$ | 1 | |
Exercisable | |
| 151,580 | | |
$ | 38.70 | | |
| 6.16 | | |
$ | 1 | |
Unvested | |
| 27,279 | | |
$ | 37.85 | | |
| 7.03 | | |
$ | — | |
|
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY |
The
following table summarizes restricted stock award activity during the six months ended June 30, 2024:
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY
| |
Number of
Awards | | |
Weighted Average
Grant Date Fair
Value Per Unit | |
| |
| | |
| |
Outstanding at December 31, 2023 | |
| 2,448,169 | | |
$ | 4.25 | |
Granted | |
| 180,200 | | |
$ | 5.17 | |
Cancelled/forfeited | |
| (161,835 | ) | |
$ | 3.67 | |
Vested | |
| (818,868 | ) | |
$ | 4.80 | |
Outstanding at June 30, 2024 | |
| 1,647,666 | | |
$ | 4.14 | |
|
X |
- DefinitionTabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement.
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v3.24.2.u1
SCHEDULE OF COMPUTATION OF THE NUMERATORS AND DENOMINATORS USED IN THE BASIC AND DILUTED NET LOSS PER SHARE AMOUNTS (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
Net income (loss) |
$ 7,406
|
$ (16,654)
|
$ (24,172)
|
$ (25,761)
|
Fair value adjustments for warrant and derivative liabilities |
(20,854)
|
|
|
|
Numerator for dilutive net income (loss) per share - net income available for common shareholders’ after the effect of dilutive securities |
$ (13,448)
|
$ (16,654)
|
$ (24,172)
|
$ (25,761)
|
Weighted average number of common shares outstanding - basic |
40,010,481,000
|
18,017,874,000
|
33,662,908,000
|
17,464,026,000
|
Shares of common stock issuable upon exercise of stock options |
178,931,000
|
|
|
|
Shares of common stock underlying restricted stock |
2,293,570,000
|
|
|
|
Shares of common stock issuable upon exercise of warrants |
8,165,236,000
|
|
|
|
Shares of common stock issuable upon exercise of conversion feature of loan agreement |
578,497,000
|
|
|
|
Dilutive potential common shares |
11,216,234,000
|
|
|
|
Denominator for dilutive net income (loss) per share - adjusted weighted average shares used in computing net income (loss) per share - dilutive |
51,226,715
|
18,017,874
|
33,662,908
|
17,464,026
|
Earnings per share: |
|
|
|
|
Basic income (loss) per common share |
$ 0.19
|
$ (0.92)
|
$ (0.72)
|
$ (1.48)
|
Dilutive income (loss) per common share |
$ (0.26)
|
$ (0.92)
|
$ (0.72)
|
$ (1.48)
|
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SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
1,788,000
|
12,194,905
|
12,428,336
|
12,194,905
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
|
230,723
|
178,859
|
230,723
|
Restricted Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
|
2,566,303
|
1,647,666
|
2,566,303
|
Loan Agreement [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
|
|
614,251
|
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total |
1,788,000
|
9,397,879
|
9,987,560
|
9,397,879
|
X |
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v3.24.2.u1
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
1 Months Ended |
6 Months Ended |
|
|
|
|
Jan. 31, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
May 07, 2024 |
Jan. 08, 2024 |
Dec. 31, 2023 |
Dec. 21, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Net loss |
|
$ 24,200,000
|
$ 25,800,000
|
|
|
|
|
Accumulated deficit |
|
773,696,000
|
|
|
|
$ 749,524,000
|
|
Cash, cash equivalents, restricted cash and short-term investments |
|
123,000,000.0
|
|
|
|
|
|
Other receivables |
|
$ 1,600,000
|
|
|
|
$ 2,100,000
|
|
Unfounded exercise price per share |
|
$ 0.0001
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
|
$ 9.75
|
Loan and Security Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase shares |
$ 2,400,000
|
|
|
|
|
|
|
Warrants exercise price |
$ 4.75
|
|
|
|
$ 4.75
|
|
|
2024 Loan Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Warrants exercise price |
|
$ 4.07
|
|
$ 4.07
|
|
|
|
Shares of common stock issuable upon exercise of warrants |
|
589,681
|
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Marketable Securities [Line Items] |
|
|
Amortized cost |
$ 88,416
|
$ 37,819
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
(134)
|
(66)
|
Fair Value |
88,282
|
37,753
|
Gross Unrealized Loss |
134
|
66
|
US Treasury Securities [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized cost |
68,918
|
8,406
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
(106)
|
(13)
|
Fair Value |
68,812
|
8,393
|
Gross Unrealized Loss |
106
|
13
|
US Government Corporations and Agencies Securities [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized cost |
5,998
|
29,413
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
(35)
|
(53)
|
Fair Value |
5,963
|
29,360
|
Gross Unrealized Loss |
35
|
$ 53
|
Certificates of Deposit [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized cost |
13,500
|
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
(7)
|
|
Fair Value |
13,507
|
|
Gross Unrealized Loss |
$ 7
|
|
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v3.24.2.u1
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Subtotal |
$ 17,941
|
$ 16,524
|
Less: accumulated depreciation |
(13,966)
|
(12,991)
|
Total property and equipment, net |
$ 3,975
|
3,533
|
Laboratory Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful lives (years) |
5 years
|
|
Subtotal |
$ 8,140
|
6,935
|
Furniture, Software and Office Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Subtotal |
$ 1,057
|
986
|
Furniture, Software and Office Equipment [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful lives (years) |
3 years
|
|
Furniture, Software and Office Equipment [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful lives (years) |
5 years
|
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Subtotal |
$ 8,744
|
$ 8,603
|
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] |
Useful Life, Lease Term [Member]
|
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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v3.24.2.u1
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
$ 121,662
|
$ 38,787
|
Total liabilities measured at fair value |
29,573
|
35,932
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
115,699
|
9,427
|
Total liabilities measured at fair value |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
5,963
|
29,360
|
Total liabilities measured at fair value |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
|
|
Total liabilities measured at fair value |
29,573
|
35,932
|
Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
33,380
|
1,034
|
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
33,380
|
1,034
|
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
|
|
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
|
|
US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
68,812
|
8,393
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
68,812
|
8,393
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
US Government Corporations and Agencies Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
5,963
|
29,360
|
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
5,963
|
29,360
|
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
Certificates of Deposit [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
13,507
|
|
Certificates of Deposit [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
13,507
|
|
Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
Certificates of Deposit [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
Payable to Licensor [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
4,805
|
4,580
|
Payable to Licensor [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
|
|
Payable to Licensor [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
|
|
Payable to Licensor [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
4,805
|
4,580
|
Derivative Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
668
|
|
Derivative Liabilities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
|
|
Derivative Liabilities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
|
|
Derivative Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
668
|
|
Warrant Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
24,100
|
31,352
|
Warrant Liabilities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
|
|
Warrant Liabilities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
|
|
Warrant Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value, liabilities |
$ 24,100
|
$ 31,352
|
X |
- DefinitionFair value portion of asset recognized for present right to economic benefit.
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SCHEDULE OF OUTSTANDING WARRANT LIABILITIES (Details) - shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
2021 Public Offering Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Outstanding warrants |
1,788,000
|
1,788,000
|
2022 Private Placement Offering [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Outstanding warrants |
7,609,879
|
7,609,879
|
2024 Loan Agreement Warrants [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
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Outstanding warrants |
589,681
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v3.24.2.u1
SETTLEMENT LIABILITY (Details Narrative) - USD ($) $ in Thousands |
Nov. 12, 2021 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
Long term debt |
|
$ 18,355
|
|
REGENXBIO [Member] |
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
Settlement liabilities, current |
$ 30,000
|
|
|
Loss contingency settlement agreement terms |
(1) $20.0 million paid in November 2021
after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement
(paid in November 2022), and (3) $5.0 million upon the earlier of (i) the third anniversary of the effective date of the Settlement Agreement
or (ii) the closing of a Strategic Transaction, as defined in the Settlement Agreement.
|
|
|
Effective interest rate stated percentage |
|
9.60%
|
|
REGENXBIO [Member] | Due in November 2024 [Member] |
|
|
|
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|
|
|
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|
$ 4,800
|
$ 4,600
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v3.24.2.u1
DEBT (Details Narrative) - Loan and Security Agreement [Member] - USD ($)
|
Apr. 08, 2025 |
Jan. 08, 2024 |
Jun. 30, 2024 |
Debt Instrument [Line Items] |
|
|
|
Aggregate principal amount |
|
$ 50,000,000
|
|
Prime rate percentage |
|
|
13.50%
|
Percentage fee, description |
|
the Company is required to pay a prepayment fee equal to 3.00% of the principal amount of the
Loans prepaid; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the
Closing Date, the Company is required to pay a fee equal to 2.00% of the principal amount of the Loans; if prepayment occurs after
the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to 1.00% of the principal amount of the Loans.
A final payment fee of 5.00% of the principal amount of the funded Tranche 1, Tranche 2 Loans and Discretionary Tranche Loans is also
due upon the Maturity Date or any earlier date of prepayment
|
|
Unrestricted cash |
|
$ 5,000,000
|
|
Outstanding principal amount of loan |
|
3,000,000
|
|
Fair value of conversion right |
|
800,000
|
|
Aggregate transaction amount |
|
$ 1,000,000
|
|
Participation right description |
|
The Participation Right automatically terminates upon the earliest of (i) July 1, 2027, (ii) such time that the Lenders have purchased
$1 million of the Company’s equity securities in the aggregate pursuant to the Participation Right, and (iii) the repayment in
full of all of the obligations under the Loan Agreement.
|
|
Warrant [Member] | Avenue [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Warrants purchase amount |
|
$ 480,000
|
|
Warrant [Member] | Avenue 2 [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Warrants purchase amount |
|
1,920,000
|
|
Forecast [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Cumulative equity and nondilutive capital |
$ 90,000,000
|
|
|
Forecast [Member] | Minimum [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Prime rate percentage |
5.00%
|
|
|
Forecast [Member] | Maximum [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Prime rate percentage |
13.50%
|
|
|
Tranche 1 [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Aggregate principal amount |
|
20,000,000
|
|
Tranche 1 [Member] | Warrant [Member] | Avenue [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Warrants purchase amount |
|
480,000
|
|
Tranche 1 [Member] | Warrant [Member] | Avenue 2 [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Warrants purchase amount |
|
1,920,000
|
|
Tranche 2 [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Aggregate principal amount |
|
10,000,000
|
|
Discretionary Tranche [Member] |
|
|
|
Debt Instrument [Line Items] |
|
|
|
Aggregate principal amount |
|
$ 20,000,000
|
|
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v3.24.2.u1
EQUITY (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
Jun. 24, 2024 |
May 09, 2024 |
May 07, 2024 |
Jan. 08, 2024 |
Jul. 06, 2023 |
Nov. 03, 2022 |
Dec. 21, 2021 |
Aug. 17, 2018 |
Jan. 31, 2024 |
Dec. 31, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2023 |
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
issuance of shares |
|
|
|
|
|
|
1,788,000
|
|
|
|
|
|
|
|
|
|
Public offering price |
|
|
|
|
|
|
$ 9.75
|
|
|
|
|
|
|
|
|
|
Warrants purchase, shares |
|
|
|
|
|
|
1,788,000
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
|
$ 9.75
|
|
|
|
|
|
|
|
|
|
Proceeds from public offering |
|
|
|
|
|
|
$ 16,000,000.0
|
|
|
|
|
|
|
|
|
|
Stock issuance costs |
|
|
|
|
|
|
1,500,000
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
|
|
|
|
7,000,000.0
|
|
|
|
|
|
|
|
|
|
Warrant liabilities |
|
|
|
|
|
|
$ 9,000,000.0
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
|
|
|
|
|
$ 0.0001
|
|
$ 0.0001
|
|
|
|
Shares issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
$ 9,962,000
|
$ 6,623,000
|
|
|
Fair value of warrants |
|
|
|
|
|
|
|
|
|
|
$ (24,927,000)
|
$ 8,629,000
|
$ (7,626,000)
|
6,364,000
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
issuance of shares |
|
|
12,285,056
|
|
3,284,407
|
|
|
|
|
|
12,285,056
|
|
12,285,056
|
|
|
|
Offering price |
|
|
$ 4.07
|
|
$ 4.03
|
|
|
|
|
|
|
|
|
|
|
|
Private Placement Offerings [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
issuance of shares |
|
|
|
|
|
7,065,946
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
$ 4.75
|
|
|
|
|
|
|
|
|
|
|
Fair value of warrants |
|
|
|
|
|
$ 22,000,000.0
|
|
|
|
|
|
|
|
|
|
|
Warrant outstanding |
|
|
|
|
|
|
|
|
|
|
$ 7,609,879
|
|
$ 7,609,879
|
|
|
|
Private Placement Offerings [Member] | Pre Funded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants purchase, shares |
|
|
|
|
|
7,609,879
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
$ 0.01
|
|
|
|
|
|
|
|
|
|
|
Sale of stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,609,879
|
|
Warrants exercised |
|
|
|
|
|
543,933
|
|
|
|
543,933
|
|
|
|
|
|
|
Purchase price of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 35,000,000.0
|
|
Shares issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32,600,000
|
|
Additional paid in capital stock reduction |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
900,000
|
|
Private Placement Offerings [Member] | Pre Funded Warrant [Member] | General and Administrative Expense [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1,500,000
|
|
Private Placement Offerings [Member] | Common Stock And Accompanying Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
$ 4.60
|
|
|
|
|
|
|
|
|
|
|
Private Placement Offerings [Member] | Pre Funded Warrant And Accompanying Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
$ 4.59
|
|
|
|
|
|
|
|
|
|
|
Private Placement Offerings [Member] | Additional Paid-in Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
|
|
|
$ 12,900,000
|
|
|
|
|
|
|
|
|
|
|
Private Placement Offerings [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
|
|
|
$ 100,000
|
|
|
|
|
|
|
|
|
|
|
Open Market Sale Agreements [Member] | Jefferies LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds |
|
|
|
|
|
|
|
$ 75,000,000.0
|
|
|
$ 3,500,000
|
$ 6,400,000
|
$ 10,000,000.0
|
$ 6,600,000
|
|
|
Sale of stock |
|
|
|
|
|
|
|
|
|
|
1,013,061
|
1,891,761
|
1,902,376
|
1,990,321
|
|
|
Loan and Security Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
$ 4.75
|
|
|
|
|
$ 4.75
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
|
|
|
|
|
|
$ 2,400,000
|
|
|
|
|
|
|
|
Fair value of warrants |
|
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan and Security Agreement [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
issuance of shares |
|
|
|
589,681
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan and Security Agreement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per share |
|
|
4.07
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per share |
|
|
|
$ 4.07
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan and Security Agreement [Member] | Avenue [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants purchase amount |
|
|
|
$ 480,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Loan and Security Agreement [Member] | Avenue 2 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants purchase amount |
|
|
|
$ 1,920,000
|
|
|
|
|
|
|
|
|
|
|
|
|
2021 Public Offering Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
|
|
|
|
|
$ 9.75
|
|
$ 9.75
|
|
|
|
Warrants outstanding |
|
|
|
|
|
|
|
|
|
|
1,788,000
|
|
1,788,000
|
|
|
1,788,000
|
2023 Pre-Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
|
|
|
|
|
2,619,140
|
|
2,619,140
|
|
|
|
Warrants exercised |
|
300,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 Pre-Funded Warrants [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercised |
|
|
|
|
2,919,140
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price of common stock |
|
|
|
|
$ 25,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
Shares issuance costs |
|
|
|
|
$ 23,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
Offering price |
|
|
|
|
$ 4.0299
|
|
|
|
|
|
|
|
|
|
|
|
2024 Pre-Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
|
|
|
|
|
5,442,656
|
|
5,442,656
|
|
|
|
Warrants exercised |
700,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2024 Pre-Funded Warrants [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercised |
|
|
6,142,656
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price of common stock |
|
|
$ 75,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issuance costs |
|
|
$ 70,200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Offering price |
|
|
$ 4.0699
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SCHEDULE OF STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 1,323
|
$ 927
|
$ 2,869
|
$ 1,697
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
224
|
218
|
570
|
404
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 1,099
|
$ 709
|
$ 2,299
|
$ 1,293
|
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- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($) $ / shares in Units, $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
|
Number of options, balance |
179,001
|
|
Weighted average exercise price, balance |
$ 38.58
|
|
Weighted average remaining contractual term (years), outstanding |
6 years 3 months 14 days
|
6 years 9 months 29 days
|
Aggregate intrinsic value, balance |
$ 3
|
|
Number of options, granted |
|
|
Weighted average exercise price, granted |
|
|
Number of options, cancelled/forfeited |
(142)
|
|
Weighted average exercise price, cancelled/forfeited |
$ 43.71
|
|
Number of options, exercised |
|
|
Weighted average exercise price, exercised |
|
|
Number of options, balance |
178,859
|
179,001
|
Weighted average exercise price, balance |
$ 38.58
|
$ 38.58
|
Aggregate intrinsic value, balance |
$ 1
|
$ 3
|
Number of options, exerciasble |
151,580
|
|
Weighted average exercise price, exercisable |
$ 38.70
|
|
Weighted average remaining contractual term (years), exercisable |
6 years 1 month 28 days
|
|
Aggregate intrinsic value, exercisable |
$ 1
|
|
Number of options, unvested |
27,279
|
|
Weighted average exercise price, unvested |
$ 37.85
|
|
Weighted average remaining contractual term (years), unvested |
7 years 10 days
|
|
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v3.24.2.u1
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY (Details) - Restricted Stock [Member]
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Restricted common stock awards, balance | shares |
2,448,169
|
Weighted-average grant date fair value, balance | $ / shares |
$ 4.25
|
Restricted common stock awards, granted | shares |
180,200
|
Weighted-average grant date fair value, granted | $ / shares |
$ 5.17
|
Restricted common stock awards, cancelled/forfeited | shares |
(161,835)
|
Weighted-average grant date fair value, cancelled/forfeited | $ / shares |
$ 3.67
|
Restricted common stock awards, vested | shares |
(818,868)
|
Weighted-average grant date fair value, vested | $ / shares |
$ 4.80
|
Restricted common stock awards, balance | shares |
1,647,666
|
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$ 4.14
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6 Months Ended |
|
May 16, 2022 |
Oct. 31, 2020 |
Aug. 31, 2020 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Revenue recognized |
|
|
|
|
$ 3,500
|
|
$ 3,500
|
|
License Agreement Terms [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Milestone payments |
$ 30,000
|
|
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Fixed consideration |
|
|
$ 7,000
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] | Event Based Milestone Payments [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Variable consideration |
|
|
26,000
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Variable consideration |
|
|
$ 30,000
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] | License [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Revenue recognized |
|
|
|
|
|
0
|
0
|
|
Contract assets |
|
|
|
0
|
|
0
|
|
$ 0
|
Sublicense Agreement Relating to Rett Syndrome [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Fixed consideration |
|
$ 3,000
|
|
|
|
|
|
|
Sublicense Agreement Relating to Rett Syndrome [Member] | Event Based Milestone Payments [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Variable consideration |
|
26,500
|
|
|
|
|
|
|
Sublicense Agreement Relating to Rett Syndrome [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Variable consideration |
|
$ 30,000
|
|
|
|
|
|
|
Sublicense Agreement Relating to Rett Syndrome [Member] | License [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Revenue recognized |
|
|
|
|
$ 3,500
|
|
$ 3,500
|
|
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v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ in Thousands |
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Jul. 31, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
Number of stock awards, shares |
|
178,859
|
|
178,859
|
|
179,001
|
Total stock compensation estimated |
|
$ 1,323
|
$ 927
|
$ 2,869
|
$ 1,697
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Number of stock awards, shares |
1,659,484
|
|
|
|
|
|
Total stock compensation estimated |
$ 8,000
|
|
|
|
|
|
Subsequent Event [Member] | Three Equal Annual Installments [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Total stock compensation estimated |
7,300
|
|
|
|
|
|
Subsequent Event [Member] | One Annual Installment [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Total stock compensation estimated |
$ 700
|
|
|
|
|
|
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