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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended March 31, 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: 001-32188
ORAGENICS,
INC.
(Exact
name of registrant as specified in its charter)
florida |
|
59-3410522 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(IRS
Employer
Identification
No.) |
1990
Main Street Suite 750
Sarasota,
Florida 34236
(Address
of principal executive offices)
813-286-7900
(Issuer’s
telephone number)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
OGEN |
|
NYSE
American |
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 and 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, non-accelerated filer, a smaller reporting company,
or an emerging growth company. See definition of “accelerated filer”, “large accelerated filer”, “smaller
reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (check one):
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 accounting 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 ☒
Indicate
the number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date:
As
of May 13, 2024, there were 4,480,693 shares of Common Stock, $0.001 par value, outstanding.
Note
Regarding Reverse Stock Splits
We
filed an amendment to our Amended and Restated Articles of Incorporation with the Secretary of the State of Florida to effect a reverse
split of our authorized and outstanding common stock at a ratio of one for sixty (1 for 60) effective January 20, 2023. All historical
share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split.
PART
I – FINANCIAL INFORMATION
ITEM
1. |
FINANCIAL
STATEMENTS |
Oragenics,
Inc.
Condensed
Consolidated Balance Sheets
| |
March
31, 2024 | | |
December
31, 2023 | |
| |
(Unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash
equivalents | |
$ | 2,071,989 | | |
$ | 3,483,501 | |
Prepaid
expenses and other current assets | |
| 371,212 | | |
| 382,273 | |
Total current assets | |
| 2,443,201 | | |
| 3,865,774 | |
Prepaid research and development expense | |
| 1,090,750 | | |
| 1,090,750 | |
Operating lease right-of-use
assets | |
| — | | |
| 9,811 | |
Total assets | |
$ | 3,533,951 | | |
$ | 4,966,335 | |
Liabilities and Shareholders’
Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued
expenses | |
$ | 781,846 | | |
$ | 1,475,667 | |
Short-term notes payable | |
| 126,840 | | |
| 312,703 | |
Operating
lease liabilities - Current | |
| — | | |
| 9,811 | |
Total liabilities | |
| 908,686 | | |
| 1,798,181 | |
| |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Preferred stock, no
par value; 50,000,000
shares authorized; 5,417,000
and 5,417,000
Series A shares, 4,050,000
and 4,050,000
Series B shares, -0-
and -0-
Series C shares, 7,488,692
and 7,488,692
Series F shares outstanding at March 31, 2024 and December 31, 2023, respectively | |
| 1,592,723 | | |
| 1,592,723 | |
Common stock, $0.001 par
value; 350,000,000 shares authorized and 4,480,693 and 3,080,693 shares issued and outstanding at March 31, 2024 and December 31,
2023, respectively | |
| 4,480 | | |
| 3,081 | |
Additional paid-in capital | |
| 209,697,149 | | |
| 207,790,604 | |
Accumulated
Deficit | |
| (208,669,087 | ) | |
| (206,218,254 | ) |
Total shareholders’
equity | |
| 2,625,265 | | |
| 3,168,154 | |
Total liabilities and
shareholders’ equity | |
$ | 3,533,951 | | |
$ | 4,966,335 | |
The
accompanying notes to the condensed consolidated financial statements are an integral part of these statements.
Oragenics,
Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
| |
2024 | | |
2023 | |
| |
For
the Three Months Ended
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Grant revenue | |
$ | — | | |
$ | 17,024 | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 663,414 | | |
| 1,672,576 | |
General
and administrative | |
| 1,796,689 | | |
| 1,249,263 | |
Total operating expenses | |
| 2,460,103 | | |
| 2,921,839 | |
Loss from operations | |
| (2,460,103 | ) | |
| (2,904,815 | ) |
Other income (expense): | |
| | | |
| | |
Interest income | |
| 19,235 | | |
| 62,201 | |
Interest expense | |
| (7,085 | ) | |
| (3,347 | ) |
Other income | |
| — | | |
| 1,124 | |
Foreign
currency exchange, net | |
| (2,880 | ) | |
| — | |
Total other income,
net | |
| 9,270 | | |
| 59,978 | |
Income tax benefit | |
| — | | |
| — | |
Net loss | |
$ | (2,450,833 | ) | |
$ | (2,844,837 | ) |
Basic and diluted net
loss per share | |
$ | (0.70 | ) | |
$ | (1.41 | ) |
Shares used to compute
basic and diluted net loss per share | |
| 3,496,078 | | |
| 2,204,766 | |
The
accompanying notes to the condensed consolidated financial statements are an integral part of these statements.
Oragenics,
Inc.
Condensed
Consolidated Statements of Changes in Shareholders’ Equity
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Common
Stock | | |
Preferred
Stock | | |
Paid
In | | |
Accumulated | | |
Shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances
at December 31, 2023 | |
| 3,080,693 | | |
$ | 3,081 | | |
| 16,955,692 | | |
$ | 1,592,723 | | |
$ | 207,790,604 | | |
$ | (206,218,254 | ) | |
$ | 3,168,154 | |
Compensation expense relating to option issuances | |
| — | | |
| — | | |
| — | | |
| — | | |
| 69,344 | | |
| — | | |
| 69,344 | |
Sale of Common Stock | |
| 1,400,000 | | |
| 1,399 | | |
| — | | |
| — | | |
| 1,837,201 | | |
| | | |
| 1,838,600 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,450,833 | ) | |
| (2,450,833 | ) |
Balances at March 31,
2024 | |
| 4,480,693 | | |
$ | 4,480 | | |
| 16,955,692 | | |
$ | 1,592,723 | | |
$ | 209,697,149 | | |
$ | (208,669,087 | ) | |
$ | 2,625,265 | |
| |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Common
Stock | | |
Preferred
Stock | | |
Paid
In | | |
Accumulated | | |
Shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances
at December 31, 2022 | |
| 2,024,657 | | |
$ | 2,025 | | |
| 9,467,000 | | |
$ | 1,592,723 | | |
$ | 196,977,071 | | |
$ | (185,562,517 | ) | |
$ | 13,009,302 | |
Balance | |
| 2,024,657 | | |
$ | 2,025 | | |
| 9,467,000 | | |
$ | 1,592,723 | | |
$ | 196,977,071 | | |
$ | (185,562,517 | ) | |
$ | 13,009,302 | |
Compensation expense relating to option issuances | |
| — | | |
| — | | |
| — | | |
| — | | |
| 79,966 | | |
| — | | |
| 79,966 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,844,837 | ) | |
| (2,844,837 | ) |
Balances at March 31,
2023 | |
| 2,024,657 | | |
| 2,025 | | |
| 9,467,000 | | |
| 1,592,723 | | |
| 197,057,037 | | |
| (188,407,354 | ) | |
| 10,244,431 | |
Balance | |
| 2,024,657 | | |
| 2,025 | | |
| 9,467,000 | | |
| 1,592,723 | | |
| 197,057,037 | | |
| (188,407,354 | ) | |
| 10,244,431 | |
The
accompanying notes to the condensed consolidated financial statements are an integral part of these statements.
Oragenics,
Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
| |
2024 | | |
2023 | |
| |
For
the Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash flows from operating
activities: | |
| | | |
| | |
Net loss | |
$ | (2,450,833 | ) | |
$ | (2,844,837 | ) |
Adjustments to reconcile
net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| — | | |
| 11,303 | |
Stock-based compensation
expense | |
| 69,344 | | |
| 79,966 | |
Changes in operating assets
and liabilities: | |
| | | |
| | |
Prepaid expenses and other
current assets | |
| 11,061 | | |
| 300,085 | |
Operating lease right of
use assets | |
| 9,811 | | |
| 48,716 | |
Accounts payable and accrued
expenses | |
| (693,821 | ) | |
| 346,309 | |
Change in operating
lease liabilities | |
| (9,811 | ) | |
| (50,237 | ) |
Net cash used in operating activities | |
| (3,064,249 | ) | |
| (2,108,695 | ) |
Cash flows from financing
activities: | |
| | | |
| | |
Payments on short-term
notes payable | |
| (185,863 | ) | |
| (159,750 | ) |
Net
proceeds from issuance of common stock | |
| 1,838,600 | | |
| — | |
Net cash provided by
(used in) financing activities | |
| 1,652,737 | | |
| (159,750 | ) |
Net decrease in cash and
cash equivalents | |
| (1,411,512 | ) | |
| (2,268,445 | ) |
Cash
and cash equivalents at beginning of period | |
| 3,483,501 | | |
| 11,426,785 | |
Cash
and cash equivalents at end of period | |
$ | 2,071,989 | | |
$ | 9,158,340 | |
Supplemental disclosure
of cash flow information: | |
| | | |
| | |
Interest
paid | |
$ | 7,085 | | |
$ | 3,347 | |
The
accompanying notes to the condensed consolidated financial statements are an integral part of these statements.
Oragenics,
Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
1.
Organization
Oragenics,
Inc. (the “Company” or “we”, or “our”) was incorporated in November 1996. We are a development-stage
company dedicated to the research and development of nasal delivery pharmaceutical medications and vaccines.
Commencing
in December of 2023, we are focused on the development of medical products that treat brain related illnesses and diseases and our lead
product candidate and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI”
or “Concussion”).
Prior
to the purchase of our lead asset ONP-002, starting in May 2020 and through December 31, 2023 our lead asset was a nasal delivery vaccine
candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19.
Currently
research and development activities related to the nasal vaccine platform and our lantibiotic program are inactive, we will evaluate
alternative opportunities for these programs moving forward as we continue to strengthen our focus and expertise on our intranasal drug
delivery platform and drug candidates.
2.
Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial statements as of March 31, 2024 and for the three months ended March
31, 2024 and 2023, have been prepared in accordance with accounting principles generally accepted in the United States of America
(“US GAAP”) for interim condensed consolidated financial information and with the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete
condensed consolidated financial statements. In the opinion of management, the accompanying condensed consolidated financial
statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the financial
condition, results of operations and cash flows for the periods presented. The results of operations for the interim period ended
March 31, 2024 are not necessarily indicative of the results of operations that may be expected for the year ended December 31,
2024, or any future period.
These
condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto
for the year ended December 31, 2023, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 29, 2024.
Going
Concern Consideration
The
Company has incurred recurring losses and negative cash flows from operations since inception. To date, the Company has not generated
significant revenues from operations. The Company incurred a net loss of $2,450,833
and used cash of $3,064,249
in its operating activities during the three
months ended March 31, 2024. As of March 31, 2024, the Company had an accumulated deficit of $208,669,087.
The
Company expects to incur substantial expenditures to further develop its technologies. The Company believes its working capital at March
31, 2024 will be sufficient to meet the business objectives as presently structured only through the third quarter of 2024. As such,
there is substantial doubt that we can continue as a going concern beyond that date. As a result, the Company has implemented certain
cost-saving initiatives, including the termination of its lease of the corporate office located in Tampa, Florida.
The
Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional
financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those
now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical
advances, or other developments. Additional financing will be required to continue operations after the Company exhausts its current
cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any
such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is
able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations.
The
Company intends to seek additional funding through sublicensing arrangements, joint venturing or partnering, sales of rights to technology,
government grants and public or private financings. The Company’s future success depends on its ability to raise capital and ultimately
generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional
debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable
to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges
senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to
obtain funds when needed or on acceptable terms, the Company may be required to curtail its current development programs, cut operating
costs and forego future development and other opportunities.
3.
Significant Accounting Policies
Basis
of Consolidation
The
condensed consolidated financial statements include the accounts of Oragenics, Inc. and our wholly owned subsidiaries Noachis Terra,
Inc.(“NTI”) and Oragenics Australia Pty Ltd. All intercompany balances and transactions have been eliminated.
New
Accounting Standards
There
are no additional accounting pronouncements issued or effective during the three months ended March 31, 2024, that have had, or are expected
to have, a material impact on our condensed consolidated financial statements.
Use
of Estimates
The
preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period.
Actual results could differ from those estimates. The principal area of estimation reflected in the condensed consolidated financial
statements are estimates for research and development expenses and related prepaid and accrued expenses, which are based on the
percentage of completion of the Company’s contracts with Contract Research Organizations.
Net
Loss Per Share
During
all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future but
were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive because the Company reported
a net loss for all periods presented. All references to common stock for the comparative three month periods ended March 31, 2023, have
been adjusted to reflect the effect of the reverse split. Net loss per share is computed using the weighted average number of shares
of common stock outstanding.
4.
Prepaid Expense, Deposits, and Other Current Assets
Prepaid expenses, deposits, and other current assets consist of the following at March 31, 2024 and December 31, 2023:
Schedule of Prepaid Expense and Other Current Assets
| |
March
31, 2024 | | |
December
31, 2023 | |
Prepaid research and development
expense, current | |
$ | 237,235 | | |
$ | — | |
Prepaid insurance | |
| 133,977 | | |
| 334,940 | |
Other prepaid expense, current | |
| — | | |
| 47,333 | |
Prepaid research and
development expense, long-term | |
| 1,090,750 | | |
| 1,090,750 | |
Total
prepaid expense, deposits, and other current assets | |
$ | 1,461,962 | | |
$ | 1,473,023 | |
Total Current and Long-Term Prepaid Assets | |
$ | 1,461,962 | | |
$ | 1,473,023 | |
5.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consist of the following as of March 31, 2024, and December 31, 2023:
Schedule of Accounts Payable and Accrued Expenses
| |
March
31, 2024 | | |
December
31, 2023 | |
Accounts payable trade | |
$ | 695,791 | | |
$ | 1,244,947 | |
Accrued expenses | |
| 68,765 | | |
| 222,739 | |
Accrued Vacation | |
| 17,290 | | |
| 7,981 | |
Total
accounts payable and accrued expenses | |
$ | 781,846 | | |
$ | 1,475,667 | |
6.
Short-Term Notes Payable
The
Company had the following short-term notes payable as of March 31, 2024 and December 31, 2023:
Summary
of Short-Term Notes Payable
| |
March
31, 2024 | | |
December
31, 2023 | |
Directors’
and officers’ liability insurance financing of $611,109 and $528,429 due in monthly installments of $64,316 and $54,366 including
principal and interest at 9.55% and 5.34% through May 24, 2024 and May 24, 2023, respectively | |
$ | 126,840 | | |
$ | 312,703 | |
Directors’ and
officers liability insurance financing | |
$ | 126,840 | | |
$ | 312,703 | |
7.
Shareholders’ Equity
Common
Stock
Reverse
Stock Split
On
December 22, 2022, the Board of Directors approved an amendment to our Amended and Restated Articles of Incorporation to effect a reverse
stock split of our common stock by a ratio of one for sixty. The Company’s common stock began trading on a split-adjusted basis
on January 23, 2023. All references to common stock for the comparative three month period ended March 31, 2023, have been adjusted to
reflect the effect of the reverse split.
Other
Share Issuances
Pursuant
to the Company’s effective registration statement on Form S-3 (File No. 333-269225) and a related prospectus and prospectus
supplement, in each case filed with the Securities and Exchange Commission. On March 1, 2024, through an underwriting agreement with
ThinkEquity, LLC as representative (the “Representative”) of the underwriters (collectively, the
“Underwriters”), the Company sold 1,400,000
shares of our common stock at a price of $1.50
per share to the public. According to the terms of the underwriting agreement, the Underwriters agreed to purchase the common shares
at a price of $1.395
per share. The Company also granted the Underwriters an option exercisable for 45 days from the date of the underwriting agreement
to purchase up to an additional 210,000
shares of common stock solely for the purpose of covering over-allotments (the “Over-allotment Options”). No
Over-allotment Options were exercised. The
Company also agreed to issue warrants to the designees of the Representative exercisable one hundred eighty (180) days after February
27, 2024 and expiring on February
27, 2029, to purchase up to 5% of the shares sold through the underwriting agreement at an exercise price of $1.875
per share. The gross proceeds from the sale of the shares were $2.1
million before underwriting discounts and commissions and other expenses payable by the Company were deducted.
The
Underwriting Agreement contained customary representations, warranties and agreements by the Company, customary conditions to closing,
indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended,
other obligations of the parties and termination provisions.
8.
Warrants
The
Company’s outstanding and exercisable warrants as of March 31, 2024 are presented below:
Schedule
of Warrants Outstanding and Exercisable
| |
Number
of
Warrants | | |
Weighted
Average
Exercise
Price | |
Warrants outstanding at December 31, 2023 | |
| 260,995 | | |
$ | 82.55 | |
Issued | |
| 70,000 | | |
| 1.88 | |
Expired | |
| (32,033 | ) | |
| 54.00 | |
Warrants outstanding at March 31, 2024 | |
| 298,962 | | |
| 63.66 | |
Exercise
Price | | |
Warrants Outstanding | | |
Expiration Date |
$ | 186.00 | | |
| 5,135 | | |
5/10/2024 |
$ | 186.00 | | |
| 6,694 | | |
7/25/2024 |
$ | 186.00 | | |
| 10,888 | | |
11/8/2024 |
$ | 75.00 | | |
| 153,334 | | |
5/1/2025 |
$ | 60.00 | | |
| 52,911 | | |
7/17/2025 |
$ | 1.88 | | |
| 70,000 | | |
2/27/2029 |
| | | |
| 298,962 | | |
|
All
outstanding warrants are classified as equity on the Company’s Condensed Consolidated Balance Sheets.
9.
Stock Compensation Plan
On September 29, 2023 the Board of Directors approved an amendment to the
2021 Equity Incentive Plan (the “Incentive Plan”) to increase the authorized shares available under the Incentive Plan by
1,000,000. The amendment was approved by the Shareholders on December 14, 2023.
As
amended the Incentive Plan provides aggregate number of shares of Common Stock that may be issued under the 2021 Plan will not
exceed the sum of (i) 1,166,167 new shares, plus (ii) the Prior Plan’s Available Reserve; plus, (iii)
the number of Returning Shares, if any, as such shares become available from time to time.
Options are granted at the fair market value of the Company’s stock
on the date of grant which determines the exercise price after the completion of the vesting period. Options can vest either immediately
or over a period of up to three years from their respective grant dates and expire 10 years from the date of grant. As of March 31, 2024
and December 31, 2023, the Company did not award any stock appreciation rights under the 2021 Incentive Plan.
A summary of stock option activity for the three months ended March 31,
2024 is as follows:
Summary
of Stock Option Activity
| |
Number
of
Shares | | |
Weighted
Average
Exercise
Price | | |
Weighted
Average
Remaining
Contractual
Term
(In Years) | | |
Aggregate
Intrinsic
Value(1) | |
Outstanding at December 31, 2023 | |
| 244,733 | | |
$ | 20.17 | | |
| 7.96 | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
| — | | |
| — | | |
$ | — | |
Forfeited | |
| (2,919 | ) | |
| 19.57 | | |
| 6.49 | | |
$ | — | |
Outstanding at March 31, 2024 | |
| 241,814 | | |
$ | 38.30 | | |
| 7.50 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at March 31, 2024 | |
| 179,514 | | |
$ | 25.36 | | |
| 7.36 | | |
$ | — | |
As of March 31, 2024, an aggregate of 241,814
shares of common stock are covered by outstanding
option awards and 1,042,812
shares of common stock are available for future
awards under the 2021 Incentive Plan.
Total
compensation cost related to stock options was approximately $64,289 and $79,966 for the three months ended
March 31, 2024 and 2023, respectively. As of March 31, 2024, there was approximately $223,569 of unrecognized compensation costs related
to stock options, which is expected to be recognized over a weighted average period of less than one year.
Restricted
stock grant activity during the quarter ended March 31, 2024 was as follows:
Schedule
of Restricted Stock Activity
| |
Number
of Shares | | |
Weighted
Average Grant
Date Fair
Value | |
Non-vested restricted stock at December 31, 2023 | |
| 6,000 | | |
$ | 3.37 | |
Vested | |
| (6,000 | ) | |
| 3.37 | |
Non-vested restricted stock at March 31,
2024 | |
| — | | |
$ | — | |
Total compensation cost related to restricted stock awards was approximately
$5,055 for the three months ended March 31, 2024. There was no compensation cost related to restricted stock awards for the three months
ended March 31, 2024.
10.
License and Royalty Agreements
Inspirevax
License
On
February 23, 2023, the Company entered into a Commercial License Agreement (the “Inspirevax License Agreement”) for its vaccine
product candidate with Inspirevax Inc. (“Inspirevax”) pursuant to which Inspirevax granted the Company an exclusive worldwide
license to use Inspirevax’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical
information created by or on behalf of Inspirevax (the “Inspirevax Technologies”) relating to its novel lipid-protein based
intranasal adjuvants, to make, research, and develop an intra-nasal vaccine in combination with an antigen (“Combination Product”)
to be used in an intranasal vaccine for use against diseases caused by coronaviruses and any genetic variants thereof to be sold by us.
The Company agreed to pay in consideration for the Inspirevax License Agreement an upfront signing fee and to certain milestone payment
obligations. As of March 31, 2024 none of the milestone payment obligations for the Inspirevax License Agreement have been met.
11.
Commitments and Contingencies
Three-Way
Collaborative Agreement
In
May of 2023 the Company entered into a Collaborative Research Agreement (the “Collaboration”) with Inspirevax, and the NRC
(the “Collaborators”) for research related to the Company’s vaccine product candidate. The Collaboration received non-dilutive
funding from Consortium Québécois Sur La Découverte Du Médicament (the “CQDM”) a not-for-profit
corporation governed by Canada created to promote, stimulate, and support drug research, development and discovery. The CQDM also provides
funding for drug research and discovery projects. The project is budgeted to cost approximately $1.7 million Canadian dollars over 27
months. Each collaborator is responsible for funding a portion of the project with payments made upon certain milestones, the CQDM grant
award will fund approximately 40% of the budgeted project costs with the Collaborators. As part of the Company’s efforts to focus
financial resources to the development of it new lead asset, ONP-002, as of the three months ended March 31, 2024 the Company has suspended
its participation in the three-way agreement until additional financial resources can be allocated for the vaccine related research project.
12.
Subsequent Events
Noncompliance
with Shareholder equity
On
April 18, 2024, the Company received notification (the “Notice”) from the NYSE American LLC (the “NYSE American”)
that the Company was no longer in compliance with NYSE American’s continued listing standards. Specifically, the letter stated
that the Company was not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the
NYSE American Company Guide (the “Company Guide”). Section 1003(a)(ii) requires a listed company to have stockholders’
equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four
most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if
the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. The Company
reported shareholders’ equity of $3.2 million as of December 31, 2023, and losses from continuing operations and/or net losses
in its five most recent fiscal years ended December 31, 2023.
The
Notice further provided that the Company must submit a plan of compliance (the “Plan”) by May 18, 2024 addressing how it
intends to regain compliance with the continued listing standards by October 18, 2025. The Plan is required to include specific milestones,
quarterly financial projections and details related to any strategic initiatives the Company plans to complete.
The
Company has begun to prepare its Plan for submission to the NYSE American by the May 18, 2024 deadline. If the NYSE American accepts
the Company’s Plan, the Company will be able to continue its listing during the Plan period and will be subject to continued periodic
review by the NYSE American staff. If the Plan is not submitted, or not accepted, or is accepted but the Company is not in compliance
with the continued listing standards by October 18, 2025 or if the Company does not make progress consistent with the Plan during the
Plan period, the Company will be subject to delisting procedures as set forth in the NYSE American Company Guide.
The
Company is committed to undertaking a transaction or transactions in the future to achieve compliance with the NYSE American’s
requirements. However, there can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued
listing standards within the required timeframe.
The
Notice has no immediate impact on the listing of the Company’s shares of common stock, par value $0.001 per share (the “Common
Stock”), which will continue to be listed and traded on the NYSE American during this period, subject to the Company’s compliance
with the other listing requirements of the NYSE American. The Common Stock will continue to trade under the symbol “OGEN”,
but will have an added designation of “.BC” to indicate the status of the Common Stock as “below compliance”.
The notice does not affect the Company’s ongoing business operations or its reporting requirements with the Securities and Exchange
Commission.
If
the Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity
and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Common Stock,
which could negatively impact the Company’s ability to raise equity financing; and (iii) limiting the Company’s ability to
use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital
markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.
ITEM
2. |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The
following information should be read in conjunction with the Condensed Consolidated Financial Statements, including the notes
thereto, included elsewhere in this Form 10-Q as well as our Annual Report on Form 10-K for the year ended December 31, 2023 filed
on March 29, 2024.
As
used in this quarterly report the terms “we”, “us”, “our”, “Oragenics” and the “Company”
mean Oragenics, Inc. and its wholly owned subsidiary Noachis Terra Inc., unless the context otherwise requires.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q includes “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, including, but not limited to, statements regarding the Company’s future performance, business
prospects, events and product development plans. These forward-looking statements are not historical facts, but are based on current
expectations, estimates and projections about our industry, our beliefs and our assumptions. These forward-looking statements include
statements about our strategies, objectives and our future achievement. To the extent statements in this Quarterly Report involve, without
limitation, our expectations for growth, estimates of future revenue, our sources and uses of cash, our liquidity needs, our current
or planned clinical trials or research and development activities, product development timelines, our future products, regulatory matters,
expense, profits, cash flow balance sheet items or any other guidance on future periods, these statements are forward-looking statements.
These statements are often, but not always, made through the use of word or phrases such as “believe,” “will,”
“expect,” “anticipate,” “estimate,” “intend,” “plan,” and “would. “These
forward-looking statements are not guarantees of future performance and concern matters that could subsequently differ materially from
those described in the forward-looking statements. Actual events or results may differ materially from those discussed in this Quarterly
Report on Form 10-Q. Except as may be required by applicable law, we undertake no obligation to update any forward-looking statements
or to reflect events or circumstances arising after the date of this Report. Important factors that could cause actual results to differ
materially from those in these forward-looking statements are in the section entitled “Risk Factors” located below and in
the most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, and the other risks and uncertainties described
elsewhere in this report as well as other risks identified from time to time in our filings with the Securities and Exchange Commission,
press releases and other communications. In addition, the statements contained throughout this Quarterly Report concerning future events
or developments or our future activities, including concerning, among other matters, current or planned clinical trials, anticipated
research and development activities, anticipated dates for commencement of clinical trials, anticipated completion dates of clinical
trials, anticipated meetings with the FDA or other regulatory authorities concerning our product candidates, anticipated dates for submissions
to obtain required regulatory marketing approvals, anticipated dates for commercial introduction of products, and other statements concerning
our future operations and activities, are forward-looking statements that in each instance assume that we are able to obtain sufficient
funding in the near term and thereafter to support such activities and continue our operations and planned activities in a timely manner.
There can be no assurance that this will be the case. Also, such statements assume that there are no significant unexpected developments
or events that delay or prevent such activities from occurring. Failure to timely obtain sufficient funding, or unexpected developments
or events, could delay the occurrence of such events or prevent the events described in any such statements from occurring.
Overview
Oragenics,
Inc. (the “Company” or “we”, or “our”) was incorporated in November 1996. We are a development-stage
company dedicated to the research and development of nasal delivery pharmaceutical medications and vaccines.
Commencing
in December of 2023, we are focused on the development of medical products that treat brain related illnesses and diseases and our lead
product candidate is for the development, requisite clinical trials and commercialization of ONP-002 for the treatment of mild traumatic
brain injury (“mTBI” or “Concussion”).
Prior
to the purchase of our lead asset ONP-002, starting in May 2020 and through December 31, 2023 our lead asset was a nasal delivery vaccine
candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19.
In September of 2023 the Company terminated its lease for the building
where some of the research and development activities for its lantibiotic program were undertaken.
Currently
research and development activities related to the nasal vaccine platform and our lantibiotic program are inactive, we will evaluate
alternative opportunities for these programs moving forward as we continue to strengthen our focus and expertise on our intranasal drug
delivery platform and drug candidates.
About
Mild Traumatic Brain Injury (mTBI)
Concussions
are an unmet medical need that affects millions worldwide. Repetitive concussions are thought to increase the risk of developing Chronic
Traumatic Encephalopathy (CTE) and other neuropsychiatric disorders. It is estimated that 5 million concussions occur in the U.S. annually
and that as many as 50% go unreported. The worldwide incidence of concussion is estimated at 69 million. The global market for concussion
treatment was valued at $6.9 billion in 2020 and is forecast to reach $8.9 billion by 2027, according to Grandview Research. Common settings
for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living
facilities due to falls.
Our
ONP-002 Neurology Asset for Brain Related Illness and Injury
Following
our December 2023 acquisition of certain assets from Odyssey Health, Inc. (“Odyssey”) related to the segment of Odyssey’s
business focused on developing medical products that treat brain related illnesses and diseases (the “Neurology Assets”)
our lead product and focus is on the development and commercialization of ONP-002 for the treatment of mTBI.
ONP-002
to date has been shown to be stable up to 104 degrees for 18-months. The drug candidate is spray-dry manufactured into a powder and filled
into the novel intranasal device. The drug is then administered through the nasal passage from the device. The novel intranasal device
is lightweight and should be easy to use in the field.
We
believe the proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The
device is breath propelled and we expect it to allow patients to blow into the device which closes the soft palate in the back of the
nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and easily crosses the
blood brain barrier. This mechanism traps ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the
traumatized brain.
Expected
ONP-002 Product Development Timeline:
Pre-clinical
Animal Studies |
|
Phase
1 |
|
Phase
2a |
|
Phase
2b |
|
Phase
3 |
Complete |
|
Complete |
|
Estimated
Q2/Q3 2024 start |
|
Estimated
Q4 2024 start |
|
Estimated
Q4 2026 start |
This
product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
Intellectual
Property
Patents
on ONP-002 have been filed and/or issued and a patent has been filed on the nasal delivery device as follows:
|
● |
New
chemical entity patent filing concerning the C-20 Steroid compounds has been filed with the USPTO and is pending in the U.S. and
approved in Europe and Canada. |
|
o |
C-20
steroid compounds, composition and uses thereof to treat traumatic brain injury (TBI), including concussion. |
|
|
|
|
o |
Inventions
relate to, inter alia, ONP-002 compositions, methods of use to treat, minimize and/or prevent traumatic brain injury (TBI), including
severe TBI, moderate TBI, and mild TBI, including concussions, methods of manufacture and/or synthesis, products by process, and
intermediates. |
|
|
|
|
o |
An
issued U.S. patent expiration with 5-year maximum patent term extension - 9/17/2040. |
|
|
|
|
o |
An
issued U.S. patent expiration without patent term extension - 9/17/2035. |
|
● |
New
nasal delivery device filing concerning the Breath-Powered Nasal Devices has been filed with the USPTO as a utility patent application
and with the USPTO PCT Receiving Office as a PCT application. |
|
|
|
|
● |
Breath-Powered
Nasal Devices for Treatment of Traumatic Brain Injury (TBI), Including Concussion, and Methods. |
|
|
|
|
● |
Inventions
relate to, inter alia, breadth-powered nasal devices, single-directional breath-powered nasal devices for providing dual airflow
for propelling a drug substance into a nasal cavity for targeted delivery to the olfactory region in high drug substance concentration
for rapid diffusion into the brain for the treatment of local or systemic and/or central nervous system (“CNS”) injury,
disease or disorder, and methods of treating local or systemic and/or central nervous system (“CNS”) injury, disease
or disorder with such devices. |
ONP-002
Pre-Clinical Trials
The
drug has completed toxicology studies in rats and dogs. Those studies show that ONP-002 has a large safety margin of its predicted efficacious
dose. In preclinical animal studies, the drug demonstrated rapid and broad biodistribution throughout the brain while simultaneously
reducing swelling, inflammation, and oxidative stress, along with an excellent safety profile.
Results
from the preclinical studies suggest that ONP-002 has an equivalent, and potentially superior, neuroprotective effect compared to related
neurosteroids. The animals treated with the drug post-concussion showed positive behavioral outcomes using various testing platforms
including improved memory and sensory-motor performance, and reduced depression/anxiety like behavior.
ONP-002
Clinical Trials
ONP-002
has completed a Phase 1 clinical trial in healthy human subjects showing it is safe and well tolerated.
Safety
studies have established a dosing regimen of 2X/day for fourteen days. The Phase 1 clinical trial was performed in Melbourne, Australia
with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus Network Pty Ltd. The country of Australia provides a
currency exchange advantage and a tax rebate at the end of our fiscal year from the Australian government on all Research and Development
performed in Australia.
The
Phase 1 study was double-blinded, randomized and placebo controlled (3:1, drug: placebo). Phase 1 used a Single Ascending/Multiple Ascending
(SAD/MAD) drug administration design. The SAD component was a 1X treatment (low, medium, or high dose) and the MAD component was a 1X/day
treatment for five consecutive days (low and medium dose). Blood and urine samples were collected at multiple time points for safety
pharmacokinetics. Standard safety monitoring was provided for each body system.
Forty
human subjects (31 males, 9 females) were successfully enrolled in Phase 1. The Safety Review Board, made up of medical doctors, has
reviewed the trial data and has determined the drug is safe and well tolerated at all dosing levels.
We
anticipate preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy. Based on the Phase 1 data,
we plan to apply for an Investigational New Drug application with the FDA and conduct a Phase 2 trial in the United States.
We
anticipate a Phase 2 clinical trial will be performed administering ONP-002 intranasally in concussed patients 2x a day for up to fourteen
days. The Phase 2a feasibility study is expected to be performed in Australia with a target initiation date in the second or third quarter
of 2024 to be followed closely by a Phase 2b proof of concept study in the US.
Recent
Developments – Phase 2
In
the three months ended March 31, 2024 we executed agreements with several vendors to advance our efforts toward starting Phase 2 clinical
trials. Avance Clinical, a leading Contract Research Organization (CRO), was engaged to conduct Phase 2 clinical trials in Australia.
Other key third party vendors also engaged to advance our progress were Upperton Pharma Solutions, Inotiv, Inc., and Charles River Laboratories
Cleveland, Inc.
Our
Business Development Strategy
Success
in the biopharmaceutical and product development industry relies on the continuous development of novel product candidates. Most product
candidates do not make it past the clinical development stage, which forces companies to look externally for innovation. Accordingly,
we expect from time to time, to seek strategic opportunities through various forms of business development, which can include strategic
alliances, licensing deals, joint ventures, collaborations, equity-or debt-based investments, dispositions, mergers and acquisitions.
We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by
evaluating business development opportunities both within and complementary to our current business as well as opportunities that may
be new and separate from the development of our existing product candidates. Our business strategy requires significant capital.
As
part of the Company’s efforts to preserve cash resources, focus on the development of our ONP-002 concussion drug product candidate,
the Company closed its facility in Alachua Florida where some of the work related to the lantibiotics program was performed and has paused
all research and development activities related to our vaccine product candidate. Until the Company can secure additional capital and
determine an alternative solution to continue these research and development programs, they will remain paused.
Financial
Overview
Research
and Development Expenses
Research
and development consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses
consist primarily of employee-related expenses, which include salaries and benefits and attending science conferences; expenses incurred
under our License Agreements with third parties and under other agreements with contract research organizations, investigative sites
and consultants that conduct our clinical trials and a substantial portion of our nonclinical studies; the cost of acquiring and manufacturing
clinical trial materials; facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent
and maintenance of facilities and equipment, and depreciation of fixed assets; license fees, for and milestone payments related to, in-licensed
products and technology; stock-based compensation expense; and costs associated with nonclinical activities and regulatory approvals.
We expense research and development costs as incurred.
Our
research and development expenses can be divided into (i) clinical research, and (ii) nonclinical research and development activities.
Clinical research costs consist of clinical trials, manufacturing services, regulatory activities all of which are largely provided by
third parties. Nonclinical research and development costs consist of our research activities, research activities provided by third parties,
our own nonclinical studies, nonclinical studies provided by third parties, the acquisition of in process research and development, related
personnel costs and laboratory supplies, and other costs such as rent, utilities, depreciation and stock-based compensation we incur associated with the development of our product candidates. While we are currently focused on advancing our product
development programs, our future research and development expenses will depend on the clinical success of our product candidates, as
well as ongoing assessments of each product candidate’s commercial potential. In addition, we cannot forecast with any degree of
certainty which product candidates may be subject to future partnerships, when such arrangements will be secured, if at all, and to what
degree such arrangements would affect our development plans, research expenses and capital requirements.
Our
research and development expenses were $663,414 and $1,672,576 for the three months ended March 31, 2024 and 2023, respectively. In 2023
our research and development costs were tracked by our COVID vaccine program and our lantibiotics program, for the three months ended
March 31, 2024 our research and development expenses were for the development of ONP-002. Due to limited resources, while we continue
our development efforts, we have focused our research and development expenses to our ONP-002 drug and paused further development of
our vaccine product and lantibiotics research until we can raise additional capital.
Our
current product development strategy contemplates continued research and development of our ONP-002 product development. Continued research
and development expenses are subject to available capital and our ability to raise the additional required capital. The lengthy process
of completing pre-clinical studies, clinical trials; seeking regulatory approval; and expanding the potential claims we are able to make,
requires expenditure of substantial resources. Any failure or delay in completing pre-clinical studies, clinical trials, or in obtaining
regulatory approvals, could cause a delay in generating product revenues and cause our research and development expenses to increase
and, in turn, have a material adverse effect on our operations. Our current product candidate is not expected to be commercially available
until we are able to obtain regulatory approval from the FDA or the regulatory authority in other jurisdictions where we may seek approval.
Our
plan is to budget and manage expenditures in research and development such that they are undertaken in a cost-effective manner yet still
advance the research and development efforts. Subject to available capital, overall research and development expenses could increase
as a result of our concussion product candidate. Our research and development projects are currently expected to be taken to the point
where they can be licensed or partnered with larger pharmaceutical companies.
Recent
Financing
On
March 1, 2024 we announced the closing of our previously announced underwritten public offering of 1.4 million shares of our common
stock at a public offering price of $1.50 per share, with the gross proceeds of $2.1 million, before deducting underwriting
discounts. We also granted the underwriters a 45-day option to purchase up to an
additional 210,000 shares of its common stock at the public offering price, less discounts, to cover over-allotments (the
“Over-Allotment Options”). In the 45 days following the transaction there were no Over-Allotment Options
exercised.
We
intend to use the net proceeds from the offering to fund the continued development of ONP-002, and for general corporate purposes and
working capital.
ThinkEquity
and Laidlaw & Company (UK) Ltd. acted as joint book-running managers for the offering. The offering was made pursuant to an effective
shelf registration statement that has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The final
prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website at http://www.sec.gov.
Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from ThinkEquity,
17 State Street, 41st Floor, New York, New York 10004.
General
and Administrative Expenses
General
and administrative expenses consist principally of salaries and related costs for personnel in executive, finance, and administrative
functions. Other general and administrative expenses include facility costs not otherwise included in research and development expenses,
patent filing, and professional fees for legal, consulting, auditing and tax services.
We
are aware that certain general and administrative expenses could increase for, among others, the following reasons:
|
● |
the
efforts we undertake from, time to time, to raise additional capital; and |
|
|
|
|
● |
consulting,
legal, accounting and investor relations costs associated with being a public company. |
Other
Income (Expense)
Other
income (expense) includes miscellaneous income, local business taxes, as well as interest income and expense. Interest income consists
of interest earned on our cash and cash equivalents. The primary objective of our investment policy is capital preservation. Interest
expense consists primarily of interest and costs associated with our indebtedness.
Income
Taxes
At
December 31, 2023, the Company has federal and state tax net operating loss carryforwards of $153,575,836 and $137,731,183, respectively.
The State of Pennsylvania tax net operating loss carryforwards will expire through 2036. Federal and Florida tax net operating loss carryforwards
generated prior to December 31, 2017 will expire through 2037 and are not subject to taxable income limitations. Federal and Florida
tax net operating loss carryforwards generated subsequent to December 31, 2017, do not expire but may be subject to taxable income limitation
pursuant to the Tax Cuts and Jobs Act that was enacted on December 22, 2017. The Company also has federal research and development tax
credit carryforwards of $4,169,354 of which are included as an uncertain tax position. The federal tax credit carryforward will expire
beginning in 2021 and continuing through 2043 unless utilized.
Utilization
of net operating loss carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation
due to ownership change limitations that may have occurred or, could occur in the future in accordance with Section 382 of the Internal
Revenue Code of 1986 (“IRC Section 382”) and with Section 383 of the Internal Revenue Code of 1986, as well as similar state
provisions. These ownership changes may limit the amount of net operating loss carryforwards and research and development credit carryforwards
that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change, as defined by
IRC Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation
by more than 50 percentage points over a three-year period. The Company has completed several financings since its inception which may
result in a change in ownership as defined by IRC Section 382 or could result in a change in control in the future. In each period since
our inception, we have recorded a 100% valuation allowance for the full amount of our deferred tax asset, as the realization of the deferred
tax asset is uncertain. As a result, we have not recorded any federal tax benefit in our statements of operations.
Results
of Operations for the Three Months Ended March 2024 and 2023
Grant
revenue. There was no grant revenue for the three
months ended March 31, 2024. There was $17,024 for the three months ended March 31, 2023. This decrease was attributable to awards received
for a small business innovation research grant that expired in the three-month period ended September 30, 2023.
Research
and Development. Research and development expenses were $663,414 for the three months ended March 31, 2024 compared to $1,672,576
for the three months ended March 31, 2023, a decrease of $1,009,162 or 60.3%.
This
decrease was mainly driven by decreased costs associated with the development of our COVID vaccine product and our lantibiotics program.
For the three months ended March 31, 2023 research and development expense related to our COVID vaccine product were approximately $1.4
million and primarily associated with costs for outside consultants. For the same three-month period our research and development costs
related to our lantibiotic product were approximately $0.2 million. For the three-month period ended March 31, 2024 research and development
expense related to ONP-002 was approximately $0.5 million, and approximately $0.1 million related to our vaccine product candidate.
General
and Administrative. General and administrative expenses were $1,796,689 for the three months ended March 31, 2024 compared to
$1,249,263 for three months ended March 31, 2023, an increase of approximately $547,426 or 43.8% This increase was primarily due to increased
expenses related to:
|
● |
Accounting
expense - $146,132 |
|
● |
Investor
relations - $154,262 |
|
● |
Salaries,
wages, and bonus expense - $268,576 |
|
● |
Consulting
expense - $40,000 |
|
● |
Insurance
expense - $41,571 |
These
expense increases were offset by decreases in:
|
● |
Rent
and utilities expense, |
|
● |
Public
company and filing and registration expenses. |
Other
Income (Expense). Other income, net was $9,270 for the three months ended March 31, 2024 compared to $59,978 for the three months
ended March 31, 2023, resulting in a decrease of $50,708 or 84.5%. The net change was primarily attributable to a reduction in interest
income due to lower cash balances in interest earning accounts for the comparable periods.
Liquidity
and Capital Resources
Since
our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale
of equity securities and warrants in private placements, debt financing, warrant exercises, public offerings, and grants. During the
three months ended March 31, 2024 and 2023 our operating activities used cash of $3,062,249 and $2,108,695 respectively. The increase
is primarily driven by changes in net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working
capital surplus of $1,534,515 and $2,067,593 at March 31, 2024 and December 31, 2023, respectively.
During
the three months ended March 31, 2024 and 2023, our financing activities provided cash of $1,652,737 and used cash of $159,750 respectively.
The cash provided by financing activities during the three months ended March 31, 2024 was primarily due to net proceeds from our underwritten
public offering.
The
Company has made several changes to reduce cash used in operations until additional capital can be obtained. These changes include a
reduction in staffing and a reduction in research and development activity. These changes have positively impacted the forecast of cash
resources available for operations, which we believe will allow us to fund our operating plan through the third quarter of 2024.
Financing
Additional
details of our financing activities for the periods reflected in this report are provided below as well as certain information on our
outstanding shares of preferred stock:
At-the-Market
(“ATM Program”)
On
February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its
common stock. The Company did not issue any shares of common stock under its ATM with Ladenburg during the three-month periods ended
March 31, 2023 and 2024. The Company did not sell any shares through the ATM program while it was
active. The ATM program with Ladenburg terminated on January 30, 2024.
Other
Financings
We
entered into short term financing arrangements for the payment of our annual insurance premiums for our products liability insurance,
cyber coverage, products liability coverage, and directors and officers and employment practices insurance.
In
July of 2023, we entered into a short-term note payable for $611,109 bearing interest at a rate of 9.55% to finance the renewals of the
directors’ and officers’ liability, employment practices liability, products liability, cyber liability, and other liability
policies. Principal and interest payments on the note began in August of 2023 and continue through May of 2024 based on straight-line
amortization over the 10-month period.
Recent
Developments
On
March 1, 2024 we announced the closing of our previously announced underwritten public offering of 1.4 million shares of our common
stock at a public offering price of $1.50 per share, providing gross proceeds of $2.1 million, before deducting underwriting discounts and
our expenses incurred related to the offering. We also granted the underwriters a 45-day option to purchase up to an additional 210,000
shares of its common stock at the public offering price, less discounts, to cover over-allotments (the “Over-Allotment Options”).
In the 45 days following the transaction there were no Over-Allotment Options exercised.
We
intend to use the net proceeds from the offering to fund the continued development of ONP-002, and for general corporate purposes and
working capital.
ThinkEquity
and Laidlaw & Company (UK) Ltd. acted as joint book-running managers for the offering. The offering was made pursuant to an effective
shelf registration statement that has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The final
prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website at http://www.sec.gov.
Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from ThinkEquity,
17 State Street, 41st Floor, New York, New York 10004.
Our
Outstanding Preferred Stock
Series
A and Series B
During
2017, we issued shares of Series A and Series B Preferred Stock in financing transactions (the “Preferred Stock Financings”).
In connection with the Preferred Stock Financings, we filed Certificate of Designations of Preferences, Rights and Limitations of Series
A and Series B Preferred Stock with the Secretary of State of the State of Florida, effective May 10, 2017 and November 8, 2017, respectively.
On August 26, 2022, holders of 4,000,000 shares of the Company’s Series A Convertible Preferred Stock, and 2,550,000 shares of
the Company’s Series B Convertible Preferred Stock converted the Series A Convertible Preferred Stock and the Series B Convertible
Preferred Stock into an aggregate of 15,167 shares of common stock. As of March 31, 2024 our outstanding Series A and Series B Preferred
Stock and the amount of common stock that may be issued upon conversion is set forth below:
Preferred
Stock Series |
|
Outstanding
Shares |
|
Common
Stock Equivalents |
Series
A Preferred |
|
5,417,000 |
|
9,028 |
Series
B Preferred |
|
4,050,000 |
|
13,500 |
In
addition, we issued warrants to purchase shares of Common Stock to the Series A holders, and to the Series B holders in connection with
the Preferred Stock Financing. As of March 31, 2024, there are 17,742 shares of common stock able to be acquired upon exercise
of the warrants held by our Series A and Series B holders respectively.
Except
as otherwise required by law, the Series A and Series B Preferred Stock have no voting rights. However, as long as any shares of Series
A and Series B Preferred Stock are outstanding, we shall not, without the affirmative vote of the holders of a majority of the then outstanding
shares of the Series A and Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series
A or Series B Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter
documents in any manner that adversely affects any rights of the holders of Series A and Series B Preferred Stock, (c) increase the number
of authorized shares of Series A and Series B Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing.
Upon any liquidation, dissolution or winding-up by us, whether voluntary or involuntary that is not a Fundamental Transaction (as defined
in the Certificate of Designations), the holders of Series A and Series B Preferred Stock shall be entitled to receive out of the assets,
the greater of (i) the product of the number of shares of Series A and Series B Preferred Stock then held by such holder, multiplied
by the Original Issue Price; and (ii) the amount that would be payable to such holder in the Liquidation (as defined in the Certificate
of Designations) in respect of Common Stock issuable upon conversion of such shares of Series A and Series B Preferred Stock if all outstanding
shares of Series A and Series B Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The Series A and
Series B Preferred Stock is classified as permanent equity. Each of the Series A and Series B Preferred Stock have redemption rights
to the extent we have funds legally available therefore, at any time after the fifth anniversary of the original issue date of the applicable
Series A and Series B Preferred Stock. We have the right to redeem all or any portion of the outstanding shares of Series A and Series
B Preferred Stock at the original issue price by providing at least seventy-five (75) days written notice of such redemption to all holders
of the then outstanding shares of Series A and Series B Convertible Preferred Stock.
Series
F
On
December 28, 2023, as part of consideration paid to Odyssey and pursuant to an Asset Purchase Agreement executed with Odyssey, we issued
8,000,000 shares of convertible Series F Preferred Stock. The Series F Preferred Stock is convertible on a one-for one basis. The Series
F Preferred Stock has no voting rights, is ranked junior to our Series A and Series B Preferred Stock and is at parity with our common
stock, in addition there shall be no dividends paid on the Series F Preferred Stock. At the closing of the Odyssey transaction 511,308 shares of Series F Preferred
Stock were converted into 511,308 shares of common stock. At March 31, 2024, there were 7,488,692 shares of
Series F Preferred Stock outstanding.
Future
Capital Requirements
On
April 18, 2024, we received Notice from the NYSE American that we are no longer in compliance with NYSE American’s continued listing
standards. Specifically, we are not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii)
of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or
more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years.
Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported
losses from continuing operations and/or net losses in its five most recent fiscal years. We reported stockholders’ equity of $3.2
million as of December 31, 2023, and $2.6 million as of March 31, 2024. Additionally, we have reported losses from continuing operations
and/or net losses in our five most recent fiscal years ended December 31, 2023.
The
Notice further provides that we must submit a plan of compliance (the “Plan”) by May 18, 2024 addressing how we intend to
regain compliance with the continued listing standards by October 18, 2025. The Plan is required to include specific milestones, quarterly
financial projections and details related to any strategic initiatives we plan to complete.
Management
has begun to prepare its Plan for submission to the NYSE American by the May 18, 2024 deadline. If the NYSE American accepts our Plan,
we will be able to continue our listing during the Plan period and we will be subject to continued periodic review by the NYSE American
staff. If the Plan is not submitted, or not accepted, or is accepted but we are not in compliance with the continued listing standards
by October 18, 2025 or if we do not make progress consistent with the Plan during the Plan period, we will be subject to delisting procedures
as set forth in the NYSE American Company Guide.
We
are committed to undertaking a transaction or transactions in the future to achieve compliance with the NYSE American’s requirements.
However, there can be no assurance that we will be able to achieve compliance with the NYSE American’s continued listing standards
within the required timeframe. Additionally, we can provide no assurance that the transaction or transactions necessary to achieve compliance
can be obtained or that they can be obtained with terms favorable to investors.
The
Notice has no immediate impact on the listing of the Company’s shares of common stock, par value $0.001 per share (the “Common
Stock”), which will continue to be listed and traded on the NYSE American during this period, subject to the Company’s compliance
with the other listing requirements of the NYSE American. The Common Stock will continue to trade under the symbol “OGEN”,
but will have an added designation of “.BC” to indicate the status of the Common Stock as “below compliance”.
The notice does not affect the Company’s ongoing business operations or its reporting requirements with the Securities and Exchange
Commission.
If
the Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity
and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Common Stock,
which could negatively impact the Company’s ability to raise equity financing; and (iii) limiting the Company’s ability to
use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital
markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.
Our
capital requirements for the remainder of 2024 will depend on numerous factors, including our ability raise additional capital
including through possible joint ventures and/or partnerships, we expect to incur substantial expenditures to further develop or
commercialize our technologies including continued increases in costs related to research, nonclinical testing and clinical trials,
as well as costs associated with our capital raising efforts and being a public company. We will require substantial funds to
conduct research and development and nonclinical and Phase 2 clinical testing of our licensed, patented technologies and to develop
sublicensing relationships for the Phase 2 and 3 clinical testing and manufacture and marketing of any products that are approved
for commercial sale. Our plans include seeking both equity and debt financing, alliances or other partnership agreements with
entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure
continuation of our operations and research and development programs.
Our
current available cash and cash equivalents, provide us with limited liquidity. We believe our existing cash will allow us to fund our
operating plan through the third quarter of 2024. As a result, we have implemented certain cost-saving initiatives, including reducing
our efforts and staff focused on our lantibiotics program and our vaccine product candidate, which are expected to negatively impact
the development of these programs. See, “Risk Factors.” We expect to manage the timing of our development expenditures and
to continue to seek additional funding for our operations. Any required additional capital may not be available on reasonable terms,
if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all
of our planned clinical testing, research and development and commercialization activities, which could harm our business. The sale of
additional equity or debt securities may result in additional dilution to our shareholders. If we raise additional funds through the
issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain
covenants that would restrict our operations. We also will require additional capital beyond our currently forecasted amounts for
example, as we seek to move forward with the development of ONP-002 we will require additional capital. In addition, we continue to pursue
other non-dilutive opportunities for our COVID-19 research and development funding opportunities through governmental and nongovernmental
sources, as well as potential research collaboration arrangements with academic institutions and other commercial partners. Our ability
to advance the development of our ONP-002 concussion candidate at our currently anticipated pace, is dependent upon our ability to secure
additional capital resources through these funding opportunities or an alternative capital raise, such as an equity or debt financing
or other strategic business collaboration.
Because
of the numerous risks and uncertainties associated with research, development and clinical testing of our product candidates, we are
unable to estimate the exact amounts of our working capital requirements. Our future funding requirements will depend on many factors,
including, but not limited to:
|
● |
Conducting
preclinical research and phase 2 clinical trials for our ONP-002 concussion drug, |
|
● |
Our
ability to partner or collaborate with third parties; |
|
● |
Identifying
and securing clinical sites for the conduct of human trials for our product candidates; |
|
● |
The
number and characteristics of the product candidates we pursue; |
|
● |
The
scope, progress, results and costs of researching and developing our product candidate, and conducting nonclinical and clinical trials |
|
● |
The
timing of, and the costs involved in, obtaining regulatory approvals for our product candidates; |
|
● |
Our
ability to maintain current research and development licensing agreements and to establish new strategic partnerships, licensing
or other arrangements and the financial terms of such agreements; |
|
● |
The
costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs
and the outcome of such litigation; |
|
● |
The
timing, receipt and amounts of sales of, or royalties on, our products and future products, |
We
have based our estimates on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater amounts
than we currently anticipate. Potential sources of financing include strategic relationships, grants, public or private sales of our
shares or debt and other sources. We may seek to access the public or private equity markets when conditions are favorable due to our
long-term capital requirements. We do not have any committed sources of financing at this time, and it is uncertain whether additional
funding will be available when we need it on terms that will be acceptable to us, or at all. If we raise funds by selling additional
shares of common stock or other securities convertible into common stock, the ownership interest of our existing stockholders will be
diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have
to significantly limit our operations and our business, financial condition and results of operations would be materially harmed.
Critical
Accounting Estimates and Policies
Our
discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial
statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America
(“US GAAP”). The preparation of condensed consolidated financial statements in accordance with US GAAP requires us to
make estimates and assumptions that affect reported amounts and related disclosures. We consider 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 made could have a material impact on our results of operations or financial condition. The
principal area of estimation reflected in the condensed consolidated financial statements are estimates for research and development
expenses and related prepaid and accrued expenses, which are based on the percentage of completion of the Company’s contracts
with Contract Research Organizations.
Recently
Issued Accounting Pronouncements
There
are no accounting pronouncements issued or effective during the three months ended March 31, 2024 that have had or are expected to have
an impact on our condensed consolidated financial statements.
ITEM
3. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Oragenics,
Inc. is a smaller reporting company as defined by Rule 12b-2 of the Securities and Exchange Act of 1934 and is not required to provide
the information required under this item.
ITEM
4. |
CONTROLS
AND PROCEDURES |
Evaluation
of Disclosure Controls and Procedures
Management’s
evaluation of the effectiveness of the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and
15d-15(e) of the Securities Exchange Act was performed under the supervision and participation of our senior management, including
our President and Interim Principal Executive Officer and Chief Financial Officer. The purpose of disclosure controls and procedures
is to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information
is accumulated and communicated to management, including our President and Interim Principal Executive Officer and
Chief Financial Officer, to allow timely decisions regarding required disclosures. Based upon that evaluation, our Interim Principal Executive Officer and Chief Financial Officer concluded that, as
of the end of such period, our disclosure controls and procedures were effective as of March 31, 2024 in ensuring that information required
to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported with the
time periods specified in the Securities and exchange Commission’s rules and forms.
Changes
in Internal Controls over Financial Reporting
Our
management, with the participation of our President and Interim Principal Executive Officer and Chief Financial Officer,
has concluded there were no other significant changes in our internal controls over financial reporting that occurred during our
last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
Limitations
on the Effectiveness of Controls
Our
management, including our Interim Principal Executive Officer and President, and Chief Financial Officer, does not expect that our Disclosure
Controls and internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control
issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments
in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people, or by management or board override of the control.
The
design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can
be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls
may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.
Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART
II – OTHER INFORMATION
ITEM
1. |
LEGAL
PROCEEDINGS |
On December 7, 2022, the Company entered into an investment banking engagement letter with Ladenburg Thalmann, (“Ladenburg”).
The engagement letter was subsequently amended at various times (together with amendments to the “Engagement Letter”). The
Company terminated the Engagement Letter as of August 15, 2023. Ladenburg recently sent the Company an invoice in the amount of $2,500,000,
and a demand letter from Ladenburg’s general counsel demanding payment thereof followed shortly thereafter. Ladenburg is of the
view that a fee is owed based on the Company’s purchase of assets from Odyssey NeuroPharma. The Company strongly disagrees that
any such fee is due to Ladenburg and initiated a confidential action for arbitration against Ladenburg with the Financial Industry Regulatory
Authority (“FINRA”) on March 12, 2024, seeking, among other things, a declaratory judgment that no such fee is owed. On April
17, 2024 Ladenburg filed a Complaint in federal court in the Southern District of Florida, and also filed motion for a temporary restraining
order (“TRO”) and preliminary injunction seeking to move the venue from FINRA to the federal court in Miami-Dade County. On
May 3, 2024 the Magistrate Judge assigned to the case issued a Report and Recommendation denying the motion. On May 9, 2024, the Company
filed a motion to dismiss in the federal court action to ensure that the FINRA action continues. The Company believes Ladenburg’s
claims are unlikely to prevail and intends to defend itself vigorously. It is possible, however, that there could be an unfavorable outcome
or resolution of the claims asserted, which could negatively and materially impact the Company’s business, consolidated financial
position and results of operations. Litigation is inherently uncertain and there can be no assurance that the Company will prevail. The
Company does not include an estimate of legal fees and other related defense costs in its estimate of loss contingencies.
In
addition to the other information set forth in this Form 10-Q, you should carefully consider the factors discussed in Part I, Item 1A,
subsection “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 which could materially
affect our business, financial condition or future results of operations. The risks described in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2023 are not the only risks that we face. Additional risks and uncertainties not currently known to us
or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and future results
of operations. The following information updates, and should be read in conjunction with, the risk factors previously disclosed in Item
1A, subsection “Risk Factors” to Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed
on March 29, 2024. Except as set forth below, there have been no material changes to the risk factors previously disclosed under the
caption “Risk Factors” in our Annual Report on Form 10-K.
Risks
Related to Our Business
We
have incurred significant losses since our inception and expect to continue to experience losses for the foreseeable future.
We
have incurred significant net losses and negative cash flow in each year since our inception, including net losses of approximately $2.5
million and $2.8 million for the three months ended March 31, 2024 and 2023, respectively, and approximately $21 million for the year
ended December 31, 2023. As of March 31, 2024, our accumulated deficit was approximately $208.7 million. We have devoted a significant
amount of our financial resources to research and development, including our nonclinical development activities and clinical trials.
We expect that the costs associated with our plans to begin phase 2 clinical trials, contract manufacturing and file an IND for our concussion
product candidate will continue and, to have successful results, likely will require an increase in the level of our overall expenses
going forward. As a result, we expect to continue to incur substantial net losses and negative cash flow for the foreseeable future.
These losses and negative cash flows have had, and will continue to have, an adverse effect on our shareholders’ equity and working
capital. Our current cash, cash equivalents and short-term investments are not sufficient to fully implement our business strategy and
sustain our operations. As a result of our limited resources, we have undertaken cost-saving initiatives, including reducing our efforts
and staff focused on our COVID vaccine candidate and our lantibiotics program. Our actual costs may ultimately vary from our current
expectation, which could materially impact our use of capital and our forecast of the period of time through which our financial resources
will be adequate to support our operations. Because of the numerous risks and uncertainties associated with product development and commercialization,
we are unable to accurately predict the timing or amount of substantial expenses or when, or if, we will be able to generate the revenue
necessary to achieve or maintain profitability. Due to of our accumulated losses and substantial doubt that we can continue as a going
concern beyond June 2024, the Company is evaluating various opportunities for its Lantibiotics Program and its N-CoV2-1 vaccine product
candidate, as well as alternative assets that could be acquired or developed. These opportunities could include a wide range of options
including, among other things, a potential sale, spin-off, fund raising, combination or other strategic transaction, which may also include
the winding down of research and development activities. The result of this process may result in the liquidation of assets for significantly
less than amounts that have been invested in them, the write-off of prior expenses incurred in connection with the development of such
assets and may have a material adverse effect on our results of operations and liquidity. Notwithstanding the above, the Company will
seek to maximize the value of such assets to the extent possible. Until we can generate a sufficient amount of product revenue, if ever,
we expect to finance future cash needs through public or private equity offerings, debt financings or corporate or government collaboration
and licensing arrangements. If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete existing
nonclinical and planned clinical trials or obtain approval of our product candidates from the FDA and other regulatory authorities. We
believe our existing cash will allow us to fund our operating plan only through the third quarter of 2024.
We
may have difficulty raising additional capital, which could deprive us of the resources necessary to implement our business plan, which
would adversely affect our business, results of operation and financial condition.
We
need to raise additional capital to fund the development and commercialization of our product candidates and to operate our business.
The need to raise additional capital is expected to increase as we continue our work research and development activities and preparation
to start phase 2 clinical trials for ONP-002. In order to support the initiatives envisioned in our business plan, we will need to raise
additional funds through the sale of assets, public or private debt or equity financing, collaborative relationships or other arrangements.
If our operations expand faster or at a higher rate than currently anticipated, we may require additional capital sooner than we expect.
We are unable to provide any assurance or guarantee that additional capital will be available when needed by our company or that such
capital will be available under terms acceptable to our company or on a timely basis.
Our
ability to raise additional financing depends on many factors beyond our control, including the state of capital markets, the market
price of our common stock and the development or prospects for development of competitive products by others. If additional funds are
raised through the issuance of equity, convertible debt or similar securities of our company, the percentage of ownership of our company
by our company’s stockholders will be reduced, our company’s stockholders may experience additional dilution upon conversion,
and such securities may have rights or preferences senior to those of our common stock. The preferential rights granted to the providers
of such additional financing may include preferential rights to payments of dividends, super voting rights, a liquidation preference,
protective provisions preventing certain corporate actions without the consent of the fund providers, or a combination thereof. We are
unable to provide any assurance that additional financing will be available on terms favorable to us or at all.
If
adequate funds are not available or are not available on acceptable terms, with limited capital, we expect to continue to hold research
and development of our lantibiotics and Covid programs and may reduce or slow research and development activity of our ONP-002 lead asset.
Thus, the unavailability of capital could substantially harm our business, results of operations and financial condition.
With
limited resources we have paused our other product candidate research and development and now rely on the progress and success of ONP-002.
With
limited capital, we have put the research and development of our COVID vaccine program and our lantibiotics program on hold and have
chosen instead to focus the limited capital on the development of ONP-002. As such, our future success currently depends on the successful
development of ONP-002, our concussion asset, of which there can be no assurances.
Risks
Related to Our Common Stock
We
cannot assure you that we will continue to be listed on the NYSE American.
Our
common stock commenced trading on the NYSE American (formerly the NYSE MKT) on April 10, 2013, and we are subject to certain NYSE American
continued listing requirements and standards. On April 18, 2024 we received notice of non-compliance from the NYSE American due to our
shareholder equity not meeting the NYSE American’s continued listing requirements and standards for minimum stockholder’s
equity, which is below the NYSE American’s minimum requirement. We will need to raise additional capital to regain compliance,
of which there can be no assurances. We may also incur costs that we have not previously incurred for expenses for compliance with the
rules and requirements of the NYSE American. We cannot provide any assurance that we will be able to continue to satisfy the requirements
of the NYSE American’s continued listing standards. A delisting of our common stock from the NYSE American could negatively affect
the price and liquidity of our common stock and could impair our ability to raise capital in the future.
The
issuance of additional equity securities by us in the future would result in dilution to our existing common shareholders.
Our
Board of Directors has authority, without action or vote of our shareholders, to issue all or a part of our authorized but unissued shares,
except where shareholder approval is required by law or the rules of any exchange on which our shares are listed. Any issuance of additional
equity securities by us in the future could result in dilution to our existing common shareholders. Such issuances could be made at a
price that reflects a discount or a premium to the then-current trading price of our common stock. In addition, our business strategy
may include expansion through internal growth by acquiring complementary businesses, acquiring or licensing additional products or brands,
or establishing strategic relationships with targeted customers and suppliers. In order to do so, or to finance the cost of our other
activities, we may issue additional equity securities that could result in further dilution to our existing common shareholders. These
issuances would dilute the percentage ownership interest of our existing common shareholders, which would have the effect of reducing
their influence on matters on which our shareholders vote and might dilute the book value of our common stock. For example, our outstanding
shares of common stock at December 31, 2023 was 3,080,693, due to additional common stock issuances related to capital raises, at March
31, 2024 our outstanding shares of common stock was 4,480,693. Furthermore, if Odyssey or the holders of Preferred Shares Series A and
B convert their preferred shares into common stock an additional 7,511,220 shares of common stock could be issued resulting in dilution
to our existing common shareholders.
ITEM
2. |
UNREGISTERED
SALE OF EQUITY SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES |
None,
other than those previously disclosed on the Company’s Current Reports on Form 8-K.
ITEM
3. |
DEFAULTS
UPON SENIOR SECURITIES |
None.
ITEM
4. |
MINE
SAFETY DISCLOSURES |
Not
Applicable.
ITEM
5. |
OTHER
INFORMATION |
None.
Incorporated
by reference to Exhibits filed after signature page.
EXHIBIT
INDEX
*Portions
of the exhibits have been omitted pursuant to Item 601(b)(10)(iv).
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized on this 15th day of May 2024.
ORAGENICS,
INC. |
|
|
|
|
BY: |
/s/
J. Michael Redmond |
|
|
J.
Micheal Redmond, President and Interim Principal Executive Officer |
|
|
|
|
BY: |
/s/
Janet Huffman |
|
|
Janet
Huffman, Chief Financial Officer and Principal Accounting Officer |
|
Exhibit
31.1
CERTIFICATION
I,
J. Micheal Redmond, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Oragenics, 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 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:
(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:
May 15, 2024
By: |
/s/
J. Michael Redmond |
|
|
J.
Michael Redmond |
|
|
President
and Interim Principal Executive Officer |
|
Exhibit 31.2
CERTIFICATION
I, Janet Huffman,
certify that:
b.
I have reviewed this Quarterly Report on Form 10-Q of Oragenics, 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-15I and 15d-15I) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
|
(b) |
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;
I
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 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:
|
(b) |
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: May 15, 2024
By: |
/s/ Janet Huffman |
|
|
Janet Huffman |
|
|
Principal Financial Officer |
|
Exhibit
32.1
Certification
of Principal Executive Officer
Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)
In
connection with the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (the “Report”) of Oragenics, Inc.
(the “Registrant”), as filed with the Securities and Exchange Commission on the date hereof, I, J. Michael Redmond, hereby
certify, to the best of my knowledge, that:
|
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Registrant. |
/s/
J. Michael Redmond |
|
Name:
J. Michael Redmond |
|
President
and Interim Principal Executive Officer |
|
|
|
Date:
May 15, 2024 |
|
Exhibit
32.2
Certification
of Principal Financial Officer
Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)
In
connection with the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (the “Report”) of Oragenics, Inc.
(the “Registrant”), as filed with the Securities and Exchange Commission on the date hereof, I, Janet Huffman, hereby certify,
to the best of my knowledge, that:
|
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Registrant. |
/s/
Janet Huffman |
|
Name:
Janet Huffman |
|
Principal
Financial Officer |
|
|
|
Date:
May 15, 2024 |
|
v3.24.1.1.u2
Cover - shares
|
3 Months Ended |
|
Mar. 31, 2024 |
May 13, 2024 |
Cover [Abstract] |
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|
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|
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Document Period End Date |
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|
|
Document Fiscal Period Focus |
Q1
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-32188
|
|
Entity Registrant Name |
ORAGENICS,
INC.
|
|
Entity Central Index Key |
0001174940
|
|
Entity Tax Identification Number |
59-3410522
|
|
Entity Incorporation, State or Country Code |
FL
|
|
Entity Address, Address Line One |
1990
Main Street
|
|
Entity Address, Address Line Two |
Suite 750
|
|
Entity Address, City or Town |
Sarasota
|
|
Entity Address, State or Province |
FL
|
|
Entity Address, Postal Zip Code |
34236
|
|
City Area Code |
813
|
|
Local Phone Number |
286-7900
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
OGEN
|
|
Security Exchange Name |
NYSE
|
|
Entity Current Reporting Status |
Yes
|
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true
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v3.24.1.1.u2
Condensed Consolidated Balance Sheets - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 2,071,989
|
$ 3,483,501
|
Prepaid expenses and other current assets |
371,212
|
382,273
|
Total current assets |
2,443,201
|
3,865,774
|
Prepaid research and development expense |
1,090,750
|
1,090,750
|
Operating lease right-of-use assets |
|
9,811
|
Total assets |
3,533,951
|
4,966,335
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
781,846
|
1,475,667
|
Short-term notes payable |
126,840
|
312,703
|
Operating lease liabilities - Current |
|
9,811
|
Total liabilities |
908,686
|
1,798,181
|
Shareholders’ equity: |
|
|
Preferred stock, no par value; 50,000,000 shares authorized; 5,417,000 and 5,417,000 Series A shares, 4,050,000 and 4,050,000 Series B shares, -0- and -0- Series C shares, 7,488,692 and 7,488,692 Series F shares outstanding at March 31, 2024 and December 31, 2023, respectively |
1,592,723
|
1,592,723
|
Common stock, $0.001 par value; 350,000,000 shares authorized and 4,480,693 and 3,080,693 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively |
4,480
|
3,081
|
Additional paid-in capital |
209,697,149
|
207,790,604
|
Accumulated Deficit |
(208,669,087)
|
(206,218,254)
|
Total shareholders’ equity |
2,625,265
|
3,168,154
|
Total liabilities and shareholders’ equity |
$ 3,533,951
|
$ 4,966,335
|
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v3.24.1.1.u2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Preferred stock, no par value |
$ 0
|
$ 0
|
Preferred stock, shares authorized |
50,000,000
|
50,000,000
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
350,000,000
|
350,000,000
|
Common stock, shares issued |
4,480,693
|
3,080,693
|
Common stock, shares outstanding |
4,480,693
|
3,080,693
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, shares outstanding |
5,417,000
|
5,417,000
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, shares outstanding |
4,050,000
|
4,050,000
|
Series C Preferred Stock [Member] |
|
|
Preferred stock, shares outstanding |
0
|
0
|
Series F Preferred Stock [Member] |
|
|
Preferred stock, shares outstanding |
7,488,692
|
7,488,692
|
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v3.24.1.1.u2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Income Statement [Abstract] |
|
|
Grant revenue |
|
$ 17,024
|
Operating expenses: |
|
|
Research and development |
663,414
|
1,672,576
|
General and administrative |
1,796,689
|
1,249,263
|
Total operating expenses |
2,460,103
|
2,921,839
|
Loss from operations |
(2,460,103)
|
(2,904,815)
|
Other income (expense): |
|
|
Interest income |
19,235
|
62,201
|
Interest expense |
(7,085)
|
(3,347)
|
Other income |
|
1,124
|
Foreign currency exchange, net |
(2,880)
|
|
Total other income, net |
9,270
|
59,978
|
Loss before income taxes |
(2,450,833)
|
(2,844,837)
|
Income tax benefit |
|
|
Net loss |
$ (2,450,833)
|
$ (2,844,837)
|
Basic net loss per share |
$ (0.70)
|
$ (1.41)
|
Diluted net loss per share |
$ (0.70)
|
$ (1.41)
|
Shares used to compute basic net loss per share |
3,496,078
|
2,204,766
|
Shares used to compute diluted net loss per share |
3,496,078
|
2,204,766
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.1.1.u2
Condensed Consolidated Statements of Changes in Shareholders' Equity - USD ($)
|
Common Stock [Member] |
Preferred Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 2,025
|
$ 1,592,723
|
$ 196,977,071
|
$ (185,562,517)
|
$ 13,009,302
|
Balance, shares at Dec. 31, 2022 |
2,024,657
|
9,467,000
|
|
|
|
Compensation expense relating to option issuances |
|
|
79,966
|
|
79,966
|
Net loss |
|
|
|
(2,844,837)
|
(2,844,837)
|
Balance at Mar. 31, 2023 |
$ 2,025
|
$ 1,592,723
|
197,057,037
|
(188,407,354)
|
10,244,431
|
Balance, shares at Mar. 31, 2023 |
2,024,657
|
9,467,000
|
|
|
|
Balance at Dec. 31, 2023 |
$ 3,081
|
$ 1,592,723
|
207,790,604
|
(206,218,254)
|
3,168,154
|
Balance, shares at Dec. 31, 2023 |
3,080,693
|
16,955,692
|
|
|
|
Compensation expense relating to option issuances |
|
|
69,344
|
|
69,344
|
Sale of Common Stock |
$ 1,399
|
|
1,837,201
|
|
1,838,600
|
Sale of Common Stock, shares |
1,400,000
|
|
|
|
|
Net loss |
|
|
|
(2,450,833)
|
(2,450,833)
|
Balance at Mar. 31, 2024 |
$ 4,480
|
$ 1,592,723
|
$ 209,697,149
|
$ (208,669,087)
|
$ 2,625,265
|
Balance, shares at Mar. 31, 2024 |
4,480,693
|
16,955,692
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.1.1.u2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (2,450,833)
|
$ (2,844,837)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
|
11,303
|
Stock-based compensation expense |
69,344
|
79,966
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
11,061
|
300,085
|
Operating lease right of use assets |
9,811
|
48,716
|
Accounts payable and accrued expenses |
(693,821)
|
346,309
|
Change in operating lease liabilities |
(9,811)
|
(50,237)
|
Net cash used in operating activities |
(3,064,249)
|
(2,108,695)
|
Cash flows from financing activities: |
|
|
Payments on short-term notes payable |
(185,863)
|
(159,750)
|
Net proceeds from issuance of common stock |
1,838,600
|
|
Net cash provided by (used in) financing activities |
1,652,737
|
(159,750)
|
Net decrease in cash and cash equivalents |
(1,411,512)
|
(2,268,445)
|
Cash and cash equivalents at beginning of period |
3,483,501
|
11,426,785
|
Cash and cash equivalents at end of period |
2,071,989
|
9,158,340
|
Supplemental disclosure of cash flow information: |
|
|
Interest paid |
$ 7,085
|
$ 3,347
|
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v3.24.1.1.u2
Organization
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization |
1.
Organization
Oragenics,
Inc. (the “Company” or “we”, or “our”) was incorporated in November 1996. We are a development-stage
company dedicated to the research and development of nasal delivery pharmaceutical medications and vaccines.
Commencing
in December of 2023, we are focused on the development of medical products that treat brain related illnesses and diseases and our lead
product candidate and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI”
or “Concussion”).
Prior
to the purchase of our lead asset ONP-002, starting in May 2020 and through December 31, 2023 our lead asset was a nasal delivery vaccine
candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19.
Currently
research and development activities related to the nasal vaccine platform and our lantibiotic program are inactive, we will evaluate
alternative opportunities for these programs moving forward as we continue to strengthen our focus and expertise on our intranasal drug
delivery platform and drug candidates.
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v3.24.1.1.u2
Basis of Presentation
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
2.
Basis of Presentation
The
accompanying unaudited interim condensed consolidated financial statements as of March 31, 2024 and for the three months ended March
31, 2024 and 2023, have been prepared in accordance with accounting principles generally accepted in the United States of America
(“US GAAP”) for interim condensed consolidated financial information and with the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete
condensed consolidated financial statements. In the opinion of management, the accompanying condensed consolidated financial
statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the financial
condition, results of operations and cash flows for the periods presented. The results of operations for the interim period ended
March 31, 2024 are not necessarily indicative of the results of operations that may be expected for the year ended December 31,
2024, or any future period.
These
condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto
for the year ended December 31, 2023, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 29, 2024.
Going
Concern Consideration
The
Company has incurred recurring losses and negative cash flows from operations since inception. To date, the Company has not generated
significant revenues from operations. The Company incurred a net loss of $2,450,833
and used cash of $3,064,249
in its operating activities during the three
months ended March 31, 2024. As of March 31, 2024, the Company had an accumulated deficit of $208,669,087.
The
Company expects to incur substantial expenditures to further develop its technologies. The Company believes its working capital at March
31, 2024 will be sufficient to meet the business objectives as presently structured only through the third quarter of 2024. As such,
there is substantial doubt that we can continue as a going concern beyond that date. As a result, the Company has implemented certain
cost-saving initiatives, including the termination of its lease of the corporate office located in Tampa, Florida.
The
Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional
financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those
now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical
advances, or other developments. Additional financing will be required to continue operations after the Company exhausts its current
cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any
such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is
able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations.
The
Company intends to seek additional funding through sublicensing arrangements, joint venturing or partnering, sales of rights to technology,
government grants and public or private financings. The Company’s future success depends on its ability to raise capital and ultimately
generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional
debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable
to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges
senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to
obtain funds when needed or on acceptable terms, the Company may be required to curtail its current development programs, cut operating
costs and forego future development and other opportunities.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.1.1.u2
Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Significant Accounting Policies |
3.
Significant Accounting Policies
Basis
of Consolidation
The
condensed consolidated financial statements include the accounts of Oragenics, Inc. and our wholly owned subsidiaries Noachis Terra,
Inc.(“NTI”) and Oragenics Australia Pty Ltd. All intercompany balances and transactions have been eliminated.
New
Accounting Standards
There
are no additional accounting pronouncements issued or effective during the three months ended March 31, 2024, that have had, or are expected
to have, a material impact on our condensed consolidated financial statements.
Use
of Estimates
The
preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period.
Actual results could differ from those estimates. The principal area of estimation reflected in the condensed consolidated financial
statements are estimates for research and development expenses and related prepaid and accrued expenses, which are based on the
percentage of completion of the Company’s contracts with Contract Research Organizations.
Net
Loss Per Share
During
all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future but
were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive because the Company reported
a net loss for all periods presented. All references to common stock for the comparative three month periods ended March 31, 2023, have
been adjusted to reflect the effect of the reverse split. Net loss per share is computed using the weighted average number of shares
of common stock outstanding.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.1.1.u2
Prepaid Expense, Deposits, and Other Current Assets
|
3 Months Ended |
Mar. 31, 2024 |
Prepaid Expense Deposits And Other Current Assets |
|
Prepaid Expense, Deposits, and Other Current Assets |
4.
Prepaid Expense, Deposits, and Other Current Assets
Prepaid expenses, deposits, and other current assets consist of the following at March 31, 2024 and December 31, 2023:
Schedule of Prepaid Expense and Other Current Assets
| |
March
31, 2024 | | |
December
31, 2023 | |
Prepaid research and development
expense, current | |
$ | 237,235 | | |
$ | — | |
Prepaid insurance | |
| 133,977 | | |
| 334,940 | |
Other prepaid expense, current | |
| — | | |
| 47,333 | |
Prepaid research and
development expense, long-term | |
| 1,090,750 | | |
| 1,090,750 | |
Total
prepaid expense, deposits, and other current assets | |
$ | 1,461,962 | | |
$ | 1,473,023 | |
Total Current and Long-Term Prepaid Assets | |
$ | 1,461,962 | | |
$ | 1,473,023 | |
|
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v3.24.1.1.u2
Accounts Payable and Accrued Expenses
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Accounts Payable and Accrued Expenses |
5.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consist of the following as of March 31, 2024, and December 31, 2023:
Schedule of Accounts Payable and Accrued Expenses
| |
March
31, 2024 | | |
December
31, 2023 | |
Accounts payable trade | |
$ | 695,791 | | |
$ | 1,244,947 | |
Accrued expenses | |
| 68,765 | | |
| 222,739 | |
Accrued Vacation | |
| 17,290 | | |
| 7,981 | |
Total
accounts payable and accrued expenses | |
$ | 781,846 | | |
$ | 1,475,667 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.1.1.u2
Short-Term Notes Payable
|
3 Months Ended |
Mar. 31, 2024 |
Debt Disclosure [Abstract] |
|
Short-Term Notes Payable |
6.
Short-Term Notes Payable
The
Company had the following short-term notes payable as of March 31, 2024 and December 31, 2023:
Summary
of Short-Term Notes Payable
| |
March
31, 2024 | | |
December
31, 2023 | |
Directors’
and officers’ liability insurance financing of $611,109 and $528,429 due in monthly installments of $64,316 and $54,366 including
principal and interest at 9.55% and 5.34% through May 24, 2024 and May 24, 2023, respectively | |
$ | 126,840 | | |
$ | 312,703 | |
Directors’ and
officers liability insurance financing | |
$ | 126,840 | | |
$ | 312,703 | |
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v3.24.1.1.u2
Shareholders’ Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Shareholders’ Equity |
7.
Shareholders’ Equity
Common
Stock
Reverse
Stock Split
On
December 22, 2022, the Board of Directors approved an amendment to our Amended and Restated Articles of Incorporation to effect a reverse
stock split of our common stock by a ratio of one for sixty. The Company’s common stock began trading on a split-adjusted basis
on January 23, 2023. All references to common stock for the comparative three month period ended March 31, 2023, have been adjusted to
reflect the effect of the reverse split.
Other
Share Issuances
Pursuant
to the Company’s effective registration statement on Form S-3 (File No. 333-269225) and a related prospectus and prospectus
supplement, in each case filed with the Securities and Exchange Commission. On March 1, 2024, through an underwriting agreement with
ThinkEquity, LLC as representative (the “Representative”) of the underwriters (collectively, the
“Underwriters”), the Company sold 1,400,000
shares of our common stock at a price of $1.50
per share to the public. According to the terms of the underwriting agreement, the Underwriters agreed to purchase the common shares
at a price of $1.395
per share. The Company also granted the Underwriters an option exercisable for 45 days from the date of the underwriting agreement
to purchase up to an additional 210,000
shares of common stock solely for the purpose of covering over-allotments (the “Over-allotment Options”). No
Over-allotment Options were exercised. The
Company also agreed to issue warrants to the designees of the Representative exercisable one hundred eighty (180) days after February
27, 2024 and expiring on February
27, 2029, to purchase up to 5% of the shares sold through the underwriting agreement at an exercise price of $1.875
per share. The gross proceeds from the sale of the shares were $2.1
million before underwriting discounts and commissions and other expenses payable by the Company were deducted.
The
Underwriting Agreement contained customary representations, warranties and agreements by the Company, customary conditions to closing,
indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended,
other obligations of the parties and termination provisions.
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v3.24.1.1.u2
Warrants
|
3 Months Ended |
Mar. 31, 2024 |
Warrants |
|
Warrants |
8.
Warrants
The
Company’s outstanding and exercisable warrants as of March 31, 2024 are presented below:
Schedule
of Warrants Outstanding and Exercisable
| |
Number
of
Warrants | | |
Weighted
Average
Exercise
Price | |
Warrants outstanding at December 31, 2023 | |
| 260,995 | | |
$ | 82.55 | |
Issued | |
| 70,000 | | |
| 1.88 | |
Expired | |
| (32,033 | ) | |
| 54.00 | |
Warrants outstanding at March 31, 2024 | |
| 298,962 | | |
| 63.66 | |
Exercise
Price | | |
Warrants Outstanding | | |
Expiration Date |
$ | 186.00 | | |
| 5,135 | | |
5/10/2024 |
$ | 186.00 | | |
| 6,694 | | |
7/25/2024 |
$ | 186.00 | | |
| 10,888 | | |
11/8/2024 |
$ | 75.00 | | |
| 153,334 | | |
5/1/2025 |
$ | 60.00 | | |
| 52,911 | | |
7/17/2025 |
$ | 1.88 | | |
| 70,000 | | |
2/27/2029 |
| | | |
| 298,962 | | |
|
All
outstanding warrants are classified as equity on the Company’s Condensed Consolidated Balance Sheets.
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v3.24.1.1.u2
Stock Compensation Plan
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Compensation Plan |
9.
Stock Compensation Plan
On September 29, 2023 the Board of Directors approved an amendment to the
2021 Equity Incentive Plan (the “Incentive Plan”) to increase the authorized shares available under the Incentive Plan by
1,000,000. The amendment was approved by the Shareholders on December 14, 2023.
As
amended the Incentive Plan provides aggregate number of shares of Common Stock that may be issued under the 2021 Plan will not
exceed the sum of (i) 1,166,167 new shares, plus (ii) the Prior Plan’s Available Reserve; plus, (iii)
the number of Returning Shares, if any, as such shares become available from time to time.
Options are granted at the fair market value of the Company’s stock
on the date of grant which determines the exercise price after the completion of the vesting period. Options can vest either immediately
or over a period of up to three years from their respective grant dates and expire 10 years from the date of grant. As of March 31, 2024
and December 31, 2023, the Company did not award any stock appreciation rights under the 2021 Incentive Plan.
A summary of stock option activity for the three months ended March 31,
2024 is as follows:
Summary
of Stock Option Activity
| |
Number
of
Shares | | |
Weighted
Average
Exercise
Price | | |
Weighted
Average
Remaining
Contractual
Term
(In Years) | | |
Aggregate
Intrinsic
Value(1) | |
Outstanding at December 31, 2023 | |
| 244,733 | | |
$ | 20.17 | | |
| 7.96 | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
| — | | |
| — | | |
$ | — | |
Forfeited | |
| (2,919 | ) | |
| 19.57 | | |
| 6.49 | | |
$ | — | |
Outstanding at March 31, 2024 | |
| 241,814 | | |
$ | 38.30 | | |
| 7.50 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at March 31, 2024 | |
| 179,514 | | |
$ | 25.36 | | |
| 7.36 | | |
$ | — | |
(1) | The aggregate intrinsic
value is calculated as the difference between the exercise price of the underlying stock option awards and the closing market price of
our common stock as of December 31, 2023 and March 31, 2024; respectively. |
As of March 31, 2024, an aggregate of 241,814
shares of common stock are covered by outstanding
option awards and 1,042,812
shares of common stock are available for future
awards under the 2021 Incentive Plan.
Total
compensation cost related to stock options was approximately $64,289 and $79,966 for the three months ended
March 31, 2024 and 2023, respectively. As of March 31, 2024, there was approximately $223,569 of unrecognized compensation costs related
to stock options, which is expected to be recognized over a weighted average period of less than one year.
Restricted
stock grant activity during the quarter ended March 31, 2024 was as follows:
Schedule
of Restricted Stock Activity
| |
Number
of Shares | | |
Weighted
Average Grant
Date Fair
Value | |
Non-vested restricted stock at December 31, 2023 | |
| 6,000 | | |
$ | 3.37 | |
Vested | |
| (6,000 | ) | |
| 3.37 | |
Non-vested restricted stock at March 31,
2024 | |
| — | | |
$ | — | |
Total compensation cost related to restricted stock awards was approximately
$5,055 for the three months ended March 31, 2024. There was no compensation cost related to restricted stock awards for the three months
ended March 31, 2024.
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v3.24.1.1.u2
License and Royalty Agreements
|
3 Months Ended |
Mar. 31, 2024 |
License And Royalty Agreements |
|
License and Royalty Agreements |
10.
License and Royalty Agreements
Inspirevax
License
On
February 23, 2023, the Company entered into a Commercial License Agreement (the “Inspirevax License Agreement”) for its vaccine
product candidate with Inspirevax Inc. (“Inspirevax”) pursuant to which Inspirevax granted the Company an exclusive worldwide
license to use Inspirevax’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical
information created by or on behalf of Inspirevax (the “Inspirevax Technologies”) relating to its novel lipid-protein based
intranasal adjuvants, to make, research, and develop an intra-nasal vaccine in combination with an antigen (“Combination Product”)
to be used in an intranasal vaccine for use against diseases caused by coronaviruses and any genetic variants thereof to be sold by us.
The Company agreed to pay in consideration for the Inspirevax License Agreement an upfront signing fee and to certain milestone payment
obligations. As of March 31, 2024 none of the milestone payment obligations for the Inspirevax License Agreement have been met.
|
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v3.24.1.1.u2
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
11.
Commitments and Contingencies
Three-Way
Collaborative Agreement
In
May of 2023 the Company entered into a Collaborative Research Agreement (the “Collaboration”) with Inspirevax, and the NRC
(the “Collaborators”) for research related to the Company’s vaccine product candidate. The Collaboration received non-dilutive
funding from Consortium Québécois Sur La Découverte Du Médicament (the “CQDM”) a not-for-profit
corporation governed by Canada created to promote, stimulate, and support drug research, development and discovery. The CQDM also provides
funding for drug research and discovery projects. The project is budgeted to cost approximately $1.7 million Canadian dollars over 27
months. Each collaborator is responsible for funding a portion of the project with payments made upon certain milestones, the CQDM grant
award will fund approximately 40% of the budgeted project costs with the Collaborators. As part of the Company’s efforts to focus
financial resources to the development of it new lead asset, ONP-002, as of the three months ended March 31, 2024 the Company has suspended
its participation in the three-way agreement until additional financial resources can be allocated for the vaccine related research project.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.1.1.u2
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
12.
Subsequent Events
Noncompliance
with Shareholder equity
On
April 18, 2024, the Company received notification (the “Notice”) from the NYSE American LLC (the “NYSE American”)
that the Company was no longer in compliance with NYSE American’s continued listing standards. Specifically, the letter stated
that the Company was not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the
NYSE American Company Guide (the “Company Guide”). Section 1003(a)(ii) requires a listed company to have stockholders’
equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four
most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if
the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. The Company
reported shareholders’ equity of $3.2 million as of December 31, 2023, and losses from continuing operations and/or net losses
in its five most recent fiscal years ended December 31, 2023.
The
Notice further provided that the Company must submit a plan of compliance (the “Plan”) by May 18, 2024 addressing how it
intends to regain compliance with the continued listing standards by October 18, 2025. The Plan is required to include specific milestones,
quarterly financial projections and details related to any strategic initiatives the Company plans to complete.
The
Company has begun to prepare its Plan for submission to the NYSE American by the May 18, 2024 deadline. If the NYSE American accepts
the Company’s Plan, the Company will be able to continue its listing during the Plan period and will be subject to continued periodic
review by the NYSE American staff. If the Plan is not submitted, or not accepted, or is accepted but the Company is not in compliance
with the continued listing standards by October 18, 2025 or if the Company does not make progress consistent with the Plan during the
Plan period, the Company will be subject to delisting procedures as set forth in the NYSE American Company Guide.
The
Company is committed to undertaking a transaction or transactions in the future to achieve compliance with the NYSE American’s
requirements. However, there can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued
listing standards within the required timeframe.
The
Notice has no immediate impact on the listing of the Company’s shares of common stock, par value $0.001 per share (the “Common
Stock”), which will continue to be listed and traded on the NYSE American during this period, subject to the Company’s compliance
with the other listing requirements of the NYSE American. The Common Stock will continue to trade under the symbol “OGEN”,
but will have an added designation of “.BC” to indicate the status of the Common Stock as “below compliance”.
The notice does not affect the Company’s ongoing business operations or its reporting requirements with the Securities and Exchange
Commission.
If
the Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity
and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Common Stock,
which could negatively impact the Company’s ability to raise equity financing; and (iii) limiting the Company’s ability to
use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital
markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.
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v3.24.1.1.u2
Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Consolidation |
Basis
of Consolidation
The
condensed consolidated financial statements include the accounts of Oragenics, Inc. and our wholly owned subsidiaries Noachis Terra,
Inc.(“NTI”) and Oragenics Australia Pty Ltd. All intercompany balances and transactions have been eliminated.
|
New Accounting Standards |
New
Accounting Standards
There
are no additional accounting pronouncements issued or effective during the three months ended March 31, 2024, that have had, or are expected
to have, a material impact on our condensed consolidated financial statements.
|
Use of Estimates |
Use
of Estimates
The
preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period.
Actual results could differ from those estimates. The principal area of estimation reflected in the condensed consolidated financial
statements are estimates for research and development expenses and related prepaid and accrued expenses, which are based on the
percentage of completion of the Company’s contracts with Contract Research Organizations.
|
Net Loss Per Share |
Net
Loss Per Share
During
all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future but
were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive because the Company reported
a net loss for all periods presented. All references to common stock for the comparative three month periods ended March 31, 2023, have
been adjusted to reflect the effect of the reverse split. Net loss per share is computed using the weighted average number of shares
of common stock outstanding.
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v3.24.1.1.u2
Prepaid Expense, Deposits, and Other Current Assets (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Prepaid Expense Deposits And Other Current Assets |
|
Schedule of Prepaid Expense and Other Current Assets |
Prepaid expenses, deposits, and other current assets consist of the following at March 31, 2024 and December 31, 2023:
Schedule of Prepaid Expense and Other Current Assets
| |
March
31, 2024 | | |
December
31, 2023 | |
Prepaid research and development
expense, current | |
$ | 237,235 | | |
$ | — | |
Prepaid insurance | |
| 133,977 | | |
| 334,940 | |
Other prepaid expense, current | |
| — | | |
| 47,333 | |
Prepaid research and
development expense, long-term | |
| 1,090,750 | | |
| 1,090,750 | |
Total
prepaid expense, deposits, and other current assets | |
$ | 1,461,962 | | |
$ | 1,473,023 | |
Total Current and Long-Term Prepaid Assets | |
$ | 1,461,962 | | |
$ | 1,473,023 | |
|
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v3.24.1.1.u2
Accounts Payable and Accrued Expenses (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of Accounts Payable and Accrued Expenses |
Accounts
payable and accrued expenses consist of the following as of March 31, 2024, and December 31, 2023:
Schedule of Accounts Payable and Accrued Expenses
| |
March
31, 2024 | | |
December
31, 2023 | |
Accounts payable trade | |
$ | 695,791 | | |
$ | 1,244,947 | |
Accrued expenses | |
| 68,765 | | |
| 222,739 | |
Accrued Vacation | |
| 17,290 | | |
| 7,981 | |
Total
accounts payable and accrued expenses | |
$ | 781,846 | | |
$ | 1,475,667 | |
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v3.24.1.1.u2
Short-Term Notes Payable (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Debt Disclosure [Abstract] |
|
Summary of Short-Term Notes Payable |
The
Company had the following short-term notes payable as of March 31, 2024 and December 31, 2023:
Summary
of Short-Term Notes Payable
| |
March
31, 2024 | | |
December
31, 2023 | |
Directors’
and officers’ liability insurance financing of $611,109 and $528,429 due in monthly installments of $64,316 and $54,366 including
principal and interest at 9.55% and 5.34% through May 24, 2024 and May 24, 2023, respectively | |
$ | 126,840 | | |
$ | 312,703 | |
Directors’ and
officers liability insurance financing | |
$ | 126,840 | | |
$ | 312,703 | |
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v3.24.1.1.u2
Warrants (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Warrants |
|
Schedule of Warrants Outstanding and Exercisable |
The
Company’s outstanding and exercisable warrants as of March 31, 2024 are presented below:
Schedule
of Warrants Outstanding and Exercisable
| |
Number
of
Warrants | | |
Weighted
Average
Exercise
Price | |
Warrants outstanding at December 31, 2023 | |
| 260,995 | | |
$ | 82.55 | |
Issued | |
| 70,000 | | |
| 1.88 | |
Expired | |
| (32,033 | ) | |
| 54.00 | |
Warrants outstanding at March 31, 2024 | |
| 298,962 | | |
| 63.66 | |
Exercise
Price | | |
Warrants Outstanding | | |
Expiration Date |
$ | 186.00 | | |
| 5,135 | | |
5/10/2024 |
$ | 186.00 | | |
| 6,694 | | |
7/25/2024 |
$ | 186.00 | | |
| 10,888 | | |
11/8/2024 |
$ | 75.00 | | |
| 153,334 | | |
5/1/2025 |
$ | 60.00 | | |
| 52,911 | | |
7/17/2025 |
$ | 1.88 | | |
| 70,000 | | |
2/27/2029 |
| | | |
| 298,962 | | |
|
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v3.24.1.1.u2
Stock Compensation Plan (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Summary of Stock Option Activity |
Summary
of Stock Option Activity
| |
Number
of
Shares | | |
Weighted
Average
Exercise
Price | | |
Weighted
Average
Remaining
Contractual
Term
(In Years) | | |
Aggregate
Intrinsic
Value(1) | |
Outstanding at December 31, 2023 | |
| 244,733 | | |
$ | 20.17 | | |
| 7.96 | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
| — | | |
| — | | |
$ | — | |
Forfeited | |
| (2,919 | ) | |
| 19.57 | | |
| 6.49 | | |
$ | — | |
Outstanding at March 31, 2024 | |
| 241,814 | | |
$ | 38.30 | | |
| 7.50 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at March 31, 2024 | |
| 179,514 | | |
$ | 25.36 | | |
| 7.36 | | |
$ | — | |
(1) | The aggregate intrinsic
value is calculated as the difference between the exercise price of the underlying stock option awards and the closing market price of
our common stock as of December 31, 2023 and March 31, 2024; respectively. |
|
Schedule of Restricted Stock Activity |
Restricted
stock grant activity during the quarter ended March 31, 2024 was as follows:
Schedule
of Restricted Stock Activity
| |
Number
of Shares | | |
Weighted
Average Grant
Date Fair
Value | |
Non-vested restricted stock at December 31, 2023 | |
| 6,000 | | |
$ | 3.37 | |
Vested | |
| (6,000 | ) | |
| 3.37 | |
Non-vested restricted stock at March 31,
2024 | |
| — | | |
$ | — | |
|
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v3.24.1.1.u2
Basis of Presentation (Details Narrative) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
Net loss |
$ 2,450,833
|
$ 2,844,837
|
|
Operating activities |
3,064,249
|
$ 2,108,695
|
|
Accumulated deficit |
$ 208,669,087
|
|
$ 206,218,254
|
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v3.24.1.1.u2
Schedule of Prepaid Expense and Other Current Assets (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Prepaid Expense Deposits And Other Current Assets |
|
|
Prepaid research and development expense, current |
$ 237,235
|
|
Prepaid insurance |
133,977
|
334,940
|
Other prepaid expense, current |
|
47,333
|
Prepaid research and development expense, long-term |
1,090,750
|
1,090,750
|
Total prepaid expense, deposits, and other current assets |
1,461,962
|
1,473,023
|
Total Current and Long-Term Prepaid Assets |
$ 1,461,962
|
$ 1,473,023
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v3.24.1.1.u2
Schedule of Accounts Payable and Accrued Expenses (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
Accounts payable trade |
$ 695,791
|
$ 1,244,947
|
Accrued expenses |
68,765
|
222,739
|
Accrued Vacation |
17,290
|
7,981
|
Total accounts payable and accrued expenses |
$ 781,846
|
$ 1,475,667
|
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v3.24.1.1.u2
Shareholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
Mar. 01, 2024 |
Dec. 22, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
Reverse stock split, description |
|
the Board of Directors approved an amendment to our Amended and Restated Articles of Incorporation to effect a reverse
stock split of our common stock by a ratio of one for sixty
|
Underwriting Agreement [Member] |
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
Number of shares sold |
1,400,000
|
|
Shares sold price per share to public |
$ 1.50
|
|
Shares sold price per share to underwriter |
$ 1.395
|
|
Option granted to purchase common shares |
210,000
|
|
Warrant issuance description |
The
Company also agreed to issue warrants to the designees of the Representative exercisable one hundred eighty (180) days after February
27, 2024 and expiring on February
27, 2029, to purchase up to 5% of the shares sold through the underwriting agreement at an exercise price of $1.875
per share
|
|
Warrant exercisable date |
Feb. 27, 2024
|
|
Warrant maturity date |
Feb. 27, 2029
|
|
Warrant exercise price |
$ 1.875
|
|
Gross proceeds from shares sold |
$ 2.1
|
|
X |
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v3.24.1.1.u2
Schedule of Warrants Outstanding and Exercisable (Details)
|
3 Months Ended |
Mar. 31, 2024
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
Warrants outstanding, Beginning balance |
260,995
|
Weighted Average Exercise Price, Beginning balance | $ / shares |
$ 82.55
|
Warrants, Granted |
70,000
|
Weighted Average Exercise Price, Granted | $ / shares |
$ 1.88
|
Warrants, Expired |
(32,033)
|
Weighted Average Exercise Price, Expired | $ / shares |
$ 54.00
|
Warrants outstanding, Ending balance |
298,962
|
Weighted Average Exercise Price, Ending balance | $ / shares |
$ 63.66
|
Warrants Outstanding |
298,962
|
Range One [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding Exercise Price | $ / shares |
$ 186.00
|
Warrants Outstanding |
5,135
|
Expiration date |
May 10, 2024
|
Range Two [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding Exercise Price | $ / shares |
$ 186.00
|
Warrants Outstanding |
6,694
|
Expiration date |
Jul. 25, 2024
|
Range Three [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding Exercise Price | $ / shares |
$ 186.00
|
Warrants Outstanding |
10,888
|
Expiration date |
Nov. 08, 2024
|
Range Four [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding Exercise Price | $ / shares |
$ 75.00
|
Warrants Outstanding |
153,334
|
Expiration date |
May 01, 2025
|
Range Five [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding Exercise Price | $ / shares |
$ 60.00
|
Warrants Outstanding |
52,911
|
Expiration date |
Jul. 17, 2025
|
Range Six [Member] |
|
Class of Warrant or Right [Line Items] |
|
Warrants Outstanding Exercise Price | $ / shares |
$ 1.88
|
Warrants Outstanding |
70,000
|
Expiration date |
Feb. 27, 2029
|
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v3.24.1.1.u2
Summary of Stock Option Activity (Details) - USD ($)
|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Dec. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
|
|
Number of Options - Options outstanding at the beginning of the year |
|
244,733
|
|
Weighted Average Exercise Price - Options outstanding at the beginning of the year |
|
$ 20.17
|
|
Weighted average remaining contractual term |
|
7 years 6 months
|
7 years 11 months 15 days
|
Number of Options Outstanding, Granted |
|
|
|
Weighted Average Exercise Price, Granted |
|
|
|
Number of Options Outstanding, Exercised |
|
|
|
Weighted Average Exercise Price, Exercise |
|
|
|
Number of Options Outstanding, Forfeited |
|
(2,919)
|
|
Weighted Average Exercise Price, Forfeited |
|
$ 19.57
|
|
Weighted Average Remaining Contractual Term - Forfeited |
|
6 years 5 months 26 days
|
|
Number of options, outstanding, ending balance |
|
241,814
|
244,733
|
Weighted Average Exercise Price, Ending Balance |
|
$ 38.30
|
$ 20.17
|
Aggregate Intrinsic Value Outstanding, Ending |
[1] |
|
|
Number of Options Outstanding, Exercisable Ending Balance |
|
179,514
|
|
Weighted Average Exercise Price, Exercisable Ending Balance |
|
$ 25.36
|
|
Weighted average remaining contractual term, exercisable |
|
7 years 4 months 9 days
|
|
Aggregate intrinsic value, exercisable |
[1] |
|
|
|
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v3.24.1.1.u2
Stock Compensation Plan (Details Narrative) - USD ($)
|
3 Months Ended |
|
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Sep. 29, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Shares authorized |
350,000,000
|
|
350,000,000
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number |
241,814
|
|
244,733
|
|
Stock options compensation cost |
$ 64,289
|
$ 79,966
|
|
|
Unrecognized compensation costs |
$ 223,569
|
|
|
|
Unrecognized compensation period of recognition |
1 year
|
|
|
|
Compensation expense relating to restricted stock issuances, shares |
5,055
|
|
|
|
Restricted Stock [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Compensation expense relating to restricted stock issuances, shares |
0
|
|
|
|
2021 Equity Incentive Plan [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options vested |
3 years
|
|
|
|
Options expiration |
10 years
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number |
241,814
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant |
1,042,812
|
|
|
|
2021 Equity Incentive Plan [Member] | Maximum [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Shares authorized for issuance |
1,166,167
|
|
|
|
Board of Directors Chairman [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Shares authorized |
|
|
|
1,000,000
|
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v3.24.1.1.u2
Subsequent Events (Details Narrative) - USD ($)
|
Apr. 18, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
stockholders' equity |
|
$ 2,625,265
|
$ 3,168,154
|
$ 10,244,431
|
$ 13,009,302
|
Common stock, par value |
|
$ 0.001
|
$ 0.001
|
|
|
Sections One Zero Zero Three A Two [Member] | Subsequent Event [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
stockholders' equity |
$ 4,000,000
|
|
|
|
|
Sections One Zero Zero Three A Three [Member] | Subsequent Event [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
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$ 6,000,000
|
|
|
|
|
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