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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): May 9, 2024
APPLIED THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-38898 |
|
81-3405262 |
(State or Other Jurisdiction of
Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
545 Fifth Avenue, Suite 1400 New York, NY 10017 |
|
10017 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number,
including area code: (212) 220-9226
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
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 |
|
APLT |
|
The Nasdaq Global Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or
Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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.
Item 2.02. | Results
of Operations and Financial Condition. |
On May [9], 2024, Applied Therapeutics, Inc. (the “Company”)
issued a press release announcing its financial results for the quarter ended March 31, 2024. A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided in this Form 8-K, including Exhibit 99.1
hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth
by specific reference in such filing.
Item 9.01. | Financial Statements
and Exhibits. |
The following exhibit is attached with this current report on Form 8-K:
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
APPLIED THERAPEUTICS, INC. |
|
|
|
Dated: May 9, 2024 |
By: |
/s/
Shoshana Shendelman |
|
Name: |
Shoshana Shendelman |
|
Title: |
President and Chief Executive
Officer |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1697532/000110465924059107/tm2413888d2_ex99-1img001.jpg)
Applied Therapeutics Reports First Quarter 2024
Financial Results
- Govorestat
NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024
- Govorestat
MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision expected in early Q1 2025
- Company
discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division
of FDA
NEW
YORK, May 9, 2024 – Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage
biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet
medical need, today reported financial results for the first quarter ended March 31, 2024.
“Preparations are underway for the potential approval and commercial
launch of govorestat for the treatment of Classic Galactosemia in the US and EU, following the significant regulatory progress we have
already made in 2024,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “We are also discussing a potential
NDA submission for SORD Deficiency with the Neurology Division at FDA, further advancing our objective of bringing first ever treatment
to patients with rare diseases.”
Recent Highlights
| · | Govorestat NDA Under Priority Review by US FDA for Treatment of Classic Galactosemia, PDUFA Target Action Date of November 28,
2024; MAA under CHMP Review by EMA. In March 2024, the Company announced that the U.S. Food and Drug Administration (FDA) has
extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia to allow
more time to review supplemental analyses of previously submitted data that had been provided by Applied in response to the FDA’s
routine information requests. No additional data or studies have been requested by the FDA at this time. The new PDUFA action date is
November 28, 2024. The NDA was granted Priority Review Status, and the FDA also noted that it plans to hold an advisory committee
meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority
Review Voucher (PRV) upon approval. The Company has also submitted a Marketing Authorization Application (MAA) for govorestat for the
treatment of Classic Galactosemia to the European Medicines Agency (EMA), which was validated in December 2023 and is under review
by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In April 2024, the EMA granted a 3-month extension to the
Day 120 clock stop period to allow sufficient time for responses to the CHMP’s Day 120 list of questions. As a result, the Company
now expects a decision by the EMA in early first quarter of 2025. The NDA and MAA submission packages include clinical outcomes data from
the Phase 3 registrational ACTION-Galactosemia Kids study in children aged 2-17 with Galactosemia, the Phase 1/2 ACTION-Galactosemia study
in adult patients with Galactosemia, and preclinical data. |
| · | Appointed Dale Hooks as Chief Commercial Officer. In April 2024, the Company appointed Dale Hooks as Chief Commercial
Officer to lead Applied’s commercial preparations for the potential launch of govorestat for the treatment of Classic Galactosemia
and SORD. Mr. Hooks brings over 30 years of biopharmaceutical experience in leadership, rare disease marketing and sales roles to
Applied Therapeutics. |
| · | Presented Full Results from Phase 3 ARISE-HF Study of AT-001 (caficrestat) in Diabetic Cardiomyopathy at the 2024 American College
of Cardiology Annual Scientific Session. In April 2024, the Company presented full results from the Phase 3 ARISE-HF study of
AT-001 in patients with diabetic cardiomyopathy (DbCM) in an oral presentation at the 2024 American College of Cardiology (ACC) Annual
Scientific Session. In the ARISE-HF study, treatment with AT-001 demonstrated a strong trend in stabilizing cardiac functional capacity,
and a statistically significant difference in cardiac functional capacity in a prespecified subgroup of patients not receiving concomitant
treatment with an SGLT2 or GLP-1 while preventing clinically significant worsening. Furthermore, AT-001 treatment prevented progression
to overt heart failure in patients with DbCM as compared to placebo (p=0.0285). Data also demonstrated that AT-001 was safe and well tolerated
in a large cohort of patients, providing proof of concept that the technology has overcome the selectivity and safety issues of “old”
aldose reductase inhibitors. Following the presentation, the full study results were published in the Journal of the American College
of Cardiology (JACC). |
Financial Results
| · | Cash and cash equivalents and short-term investments totaled $146.5 million as of March 31,
2024, compared with $49.9 million at December 31, 2023. |
| · | Research and development expenses for the three months ended March 31, 2024, were $12.2
million, compared to $15.9 million for the three months ended March 31, 2023. The decrease of approximately $3.7 million
was primarily attributed to decreased expenses related to contract research organizations (CROs) and drug manufacturing and
formulation costs, partially offset by an increase in regulatory and personnel expenses. |
| · | General and administrative expenses were $9.1 million for the three months ended March 31,
2024, compared to $5.6 million for the three months ended March 31, 2023. The increase of approximately $3.5 million was primarily
related to an increase in legal and professional fees of $1.2 million and $1.4 million in commercial expenses to support planned commercialization
of govorestat, and an increase in other expenses of $0.9 million due to an overall increase in data storage costs to support planned commercialization. |
| · | Net loss for the first quarter of 2024 was $83.9 million, or $0.67 per basic and diluted common
share, compared to a net loss of $10.1 million, or $0.18 per basic and diluted common share, for the first quarter 2023. |
| · | Cash runway: The Company expects that its cash and cash equivalents will fund the business into
2026. Additionally, the sale of the priority review voucher (PRV), which would be granted upon a potential NDA approval of govorestat
for the treatment of Galactosemia could substantially extend the Company’s cash runway. |
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company
developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company’s
lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS
rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent
ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The preclinical pipeline also includes AT-003,
an ARI designed to cross through the back of the eye when dosed orally, for the treatment of Diabetic retinopathy.
To learn more, please visit www.appliedtherapeutics.com
and follow the company on Twitter @Applied_Tx.
Forward-Looking Statements
This press release contains “forward-looking statements”
that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations,
prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,”
“plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding the
(i) Company’s expectation that its cash and cash equivalents will fund the business into 2026; (ii) the likelihood that
the Company’s ongoing NDA and MMA submissions will be approved and the timing of any approval decision and (iii) statements
related to the potential commercial launch of govorestat. Forward-looking statements in this release involve substantial risks and uncertainties
that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore
cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.
Such risks and uncertainties include, without limitation, (i) our
plans to develop, market and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current
and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage
of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital
requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates
on reasonable terms and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain
and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory approval of our current
and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our expectations
regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our ability to fund
our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation of
our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and the
duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights,
(xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in
the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating
to our competitors and our industry, (xviii) our ability to achieve the anticipated benefits from the agreements entered into in
connection with our partnership with Advanz Pharma and (xiv) other factors that may impact our financial results. In light of the
significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future
events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot
guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements
will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking
statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk
Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances
or otherwise.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902 or
appliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
Applied Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
| |
As of | | |
As of | |
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | | |
| | |
CURRENT ASSETS: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 146,484 | | |
$ | 49,898 | |
Security deposits and leasehold improvements | |
| 253 | | |
| 254 | |
Prepaid expenses and other current assets | |
| 4,169 | | |
| 4,234 | |
Total current assets | |
| 150,906 | | |
| 54,386 | |
Operating lease right-of-use asset | |
| 328 | | |
| 447 | |
TOTAL ASSETS | |
$ | 151,234 | | |
$ | 54,833 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Current portion of operating lease liabilities | |
$ | 308 | | |
$ | 429 | |
Accounts payable | |
| 4,019 | | |
| 1,742 | |
Accrued expenses and other current liabilities | |
| 14,641 | | |
| 15,286 | |
Warrant liabilities | |
| 64,937 | | |
| 53,725 | |
Total current liabilities | |
| 83,905 | | |
| 71,182 | |
NONCURRENT LIABILITIES: | |
| | | |
| | |
Noncurrent portion of operating lease liabilities | |
| 35 | | |
| 38 | |
Clinical holdback - long-term portion | |
| — | | |
| 759 | |
Total noncurrent liabilities | |
| 35 | | |
| 797 | |
Total liabilities | |
| 83,940 | | |
| 71,979 | |
STOCKHOLDERS’ EQUITY/(DEFICIT): | |
| | | |
| | |
Common stock, $0.0001 par value; 200,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 114,241,803 shares issued and outstanding as of March 31, 2024 and 84,869,832 shares issued and outstanding as of December 31, 2023 | |
| 11 | | |
| 8 | |
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 | |
| — | | |
| — | |
Additional paid-in capital | |
| 619,807 | | |
| 451,432 | |
Accumulated deficit | |
| (552,524 | ) | |
| (468,586 | ) |
Total stockholders' equity/(deficit) | |
| 67,294 | | |
| (17,146 | ) |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | |
$ | 151,234 | | |
$ | 54,833 | |
Applied Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
REVENUE: | |
| | |
| |
License revenue | |
$ | — | | |
$ | 10,660 | |
Research and development services revenue | |
| 190 | | |
| — | |
Total revenue | |
| 190 | | |
| 10,660 | |
COSTS AND EXPENSES: | |
| | | |
| | |
Research and development | |
| 12,217 | | |
| 15,935 | |
General and administrative | |
| 9,066 | | |
| 5,583 | |
Total costs and expenses | |
| 21,283 | | |
| 21,518 | |
LOSS FROM OPERATIONS | |
| (21,093 | ) | |
| (10,858 | ) |
OTHER (EXPENSE) INCOME, NET: | |
| | | |
| | |
Interest income | |
| 586 | | |
| 221 | |
Change in fair value of warrant liabilities | |
| (63,405 | ) | |
| 469 | |
Other expense | |
| (26 | ) | |
| 31 | |
Total other (expense) income, net | |
| (62,845 | ) | |
| 721 | |
Net loss | |
$ | (83,938 | ) | |
$ | (10,137 | ) |
Net loss per share attributable to common stockholders—basic and diluted | |
$ | (0.67 | ) | |
$ | (0.18 | ) |
Weighted-average common stock outstanding—basic and diluted | |
| 125,318,993 | | |
| 56,357,983 | |
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