Form 8-K - Current report
06 Septiembre 2023 - 6:12AM
Edgar (US Regulatory)
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2023-09-06
2023-09-06
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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): September 6, 2023
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 8.01. Other Events.
On September 6, 2023, Applied Therapeutics, Inc.
(the “Company”) announced successful completion of a recent pre-New Drug
Application (“NDA”) meeting with the Food and Drug Administration (FDA) regarding
its govorestat (AT-007) Galactosemia program. In the pre-NDA meeting, the FDA expressed their support for a potential NDA based on the
govorestat data generated to date in Galactosemia, and provided constructive recommendations for successful NDA acceptance and review.
Based on discussions with the FDA, the Company plans to submit an NDA for govorestat (AT-007) for the treatment of Galactosemia in the
fourth quarter of this year, assuming the FDA grants certain necessary waivers, including a carcinogenicity waiver and a QT study waiver.
In the event the waivers are not granted, the timing of the submission could be delayed.
This report 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 report 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) timing for the Company’s submission of an NDA for govorestat (AT-007) for the treatment of Galactosemia and (ii) strength of
the submission package and likelihood that the NDA submission will be accepted. 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 report, 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 report 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.
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: September 6, 2023 |
By: |
/s/ Shoshana Shendelman |
|
Name: |
Shoshana Shendelman |
|
Title: |
President and Chief Executive Officer |
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