Private company
Applied Therapeutics, Inc.
In its 2025 annual report the company says: “We are a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates against molecular targets in indications of high unmet medical need. We focus on previously identified disease processes where other molecules have failed to yield successful products due to poor efficacy and tolerability. Our unique approach to drug development leverages recent technological advances to design improved drugs, employs early use of biomarkers to confirm biological activity and focuses on potentially accelerated regulatory pathways.”4 It is headquartered in New York, United States.2
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersNew York, United States2
- Incorporated inDE3
- Business address545 Fifth Avenue, Suite 1400, New York, Ny 100173
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300KL3IJPHZM2GR042
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 59421552
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We are a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates against molecular targets in indications of high unmet medical need. We focus on previously identified disease processes where other molecules have failed to yield successful products due to poor efficacy and tolerability. Our unique approach to drug development leverages recent technological advances to design improved drugs, employs early use of biomarkers to confirm biological activity and focuses on potentially accelerated regulatory pathways. Our first molecular target is aldose reductase, or AR, an enzyme that converts glucose to sorbitol under oxidative stress conditions, and is implicated in multiple diseases. Prior attempts to inhibit this enzyme were hindered by nonselective, nonspecific inhibition, which resulted in limited efficacy and significant off-target safety effects. The…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Research and development100¢$48.7M
Out of $455.0K in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $10.0M5 | $455.0K5 | |||||
| Research and development | $11.5M6 | $32.4M7 | $61.8M8 | $62.6M9 | $55.6M10 | $53.9M5 | $48.7M5 |
| Operating expenses | $105.6M9 | $83.0M10 | $74.5M5 | $104.8M5 | |||
| Operating income | -$13.5M6 | -$45.6M7 | -$94.5M8 | -$105.6M9 | -$83.0M10 | -$64.5M5 | -$104.3M5 |
| Net income | -$16.5M6 | -$45.5M7 | -$94.0M8 | -$105.6M9 | -$82.5M10 | -$119.8M5 | -$105.6M5 |
| Earnings per share | -$4.288 | -$4.129 | -$2.1810 | -$1.425 | -$0.765 | ||
| Earnings per share (diluted) | -$4.288 | -$4.129 | -$2.1810 | -$1.425 | -$0.765 | ||
| Shares (weighted, basic) | 25.6M shares9 | 37.8M shares10 | 84.2M shares5 | 139.5M shares5 | |||
| Shares (weighted, diluted) | 25.6M shares9 | 37.8M shares10 | 84.2M shares5 | 139.5M shares5 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $18.7M6 | $18.9M7 | $57.5M8 | $53.9M9 | $16.7M10 | $49.9M5 | $79.4M5 |
| Current assets | $20.2M6 | $46.2M7 | $102.6M8 | $88.4M9 | $37.3M10 | $54.4M5 | $83.6M5 |
| Total assets | $20.2M6 | $48.4M7 | $104.5M8 | $89.9M9 | $38.4M10 | $54.8M5 | $86.7M5 |
| Accounts payable | $9.5M9 | $4.5M10 | $1.7M5 | $4.4M5 | |||
| Current liabilities | $4.4M6 | $14.1M7 | $21.2M8 | $26.5M9 | $33.4M10 | $71.2M5 | $27.3M5 |
| Long-term liabilities | $891.0K9 | $878.0K10 | $797.0K5 | $2.4M5 | |||
| Total liabilities | $4.4M6 | $15.8M7 | $22.6M8 | $27.4M9 | $34.3M10 | $72.0M5 | $29.7M5 |
| Retained earnings | -$266.3M9 | -$348.8M10 | -$468.6M5 | -$574.2M5 | |||
| Shareholders’ equity | -$19.6M7 | $32.6M8 | $81.9M9 | $62.5M10 | $4.1M5 | -$17.1M5 | $57.0M5 |
| Shares outstanding | 5.5M shares6 | 18.5M shares7 | 22.5M shares8 | 26.2M shares9 | 48.1M shares10 | 84.9M shares5 | 137.2M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Corporate structure
Applied Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Applied Therapeutics, Inc.
- Vestal Point Capital, LP Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Feb 17, 2026 (4 filings since Feb 13, 2024)
- Propel Bio Management, LLC Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Dec 31, 2025 (3 filings since May 2, 2023)
- Alexandria Real Estate Equities Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Dec 15, 2025 (5 filings since Feb 11, 2022)
- T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Nov 14, 2025 (4 filings since May 7, 2025)
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Jul 29, 2025 (2 filings since Apr 30, 2025)
- BlackRock Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Jul 16, 2025 (4 filings since Oct 24, 2024)
- Schonfeld Strategic Advisors LLC Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest May 15, 2025 (2 filings since Feb 14, 2025)
- Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest May 15, 2025 (5 filings since May 8, 2023)
- Alyeska Investment Group, L.P. Filed SCHEDULE 13G on Applied Therapeutics, Inc., latest Feb 14, 2025 (4 filings since Feb 14, 2023)
- Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Feb 14, 2025 (4 filings since Mar 8, 2024)
- PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Feb 14, 2025 (4 filings since Dec 6, 2023)
- Morgan Stanley Filed SCHEDULE 13G/A on Applied Therapeutics, Inc., latest Feb 7, 2025 (3 filings since Nov 6, 2024)
- Applied Therapeutics, Inc. New York, New York, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Applied Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Operating-lease assets (leased space) | $2.8M5 Dec 31, 2024 | $447.0K5 Dec 31, 2023 | +524.6% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $79.4M5 Dec 31, 2024 | $49.9M5 Dec 31, 2023 | +59.1% |
| Debt securities available for sale | $010 Dec 31, 2023 | $13.9M10 Dec 31, 2022 | −100.0% |
Properties, in its own words
Our corporate headquarters are located at 545 Fifth Ave, Suite 1400 and 1401, New York, NY 10017 where we lease office space pursuant to a lease agreement amended on September 11, 2024 and expires on October 31, 2029. We also occupy space for offices in Englewood Cliffs, New Jersey pursuant to a lease which commenced on November 1, 2020 for a three year period and subsequently renewed through 2026. We believe that our existing facilities are suitable and adequate to meet our current needs. We intend to add new facilities or expand existing facilities as we add employees, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.
Item 2 of the 10-K filed Apr 15, 2025.4
Leadership
Who has led Applied Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerShoshana Shendelman May 13, 2019 to now13
- PresidentShoshana Shendelman May 13, 2019 to now13
- Chief financial officerLeslie D. Funtleyder Nov 20, 2023 to now14
- Chief financial officerCharles Silberstein May 26, 2020 to Jan 11, 202215
- Chief financial officerMark J. Vignola May 13, 2019 to May 15, 201916
Board members and other officers (15)
- Chief Medical OfficerEvan Prescott Bailey Jun 17, 2025 to now17
- OfficerConstantine Chinoporos Mar 18, 2024 to now18
- Chief Commercial OfficerCorwin Dale Hooks Apr 15, 2024 to now19
- OfficerLeslie D. Funtleyder Dec 20, 2024 to now20
- Chief Accounting OfficerCatherine Thorpe Jun 23, 2023 to Jun 23, 202321
- Principal Accounting OfficerSteven A. Ortega Mar 18, 2022 to Nov 17, 202222
- Chief Commercial OfficerAdam Hansard Mar 5, 2020 to Mar 18, 202423
- Chief Accounting OfficerChids Mahadevan Apr 3, 2020 to Aug 4, 202224
- Chief Medical OfficerRiccardo Perfetti May 13, 2019 to now25
- Board memberJay S. Skyler May 13, 2019 to now26
- Board memberJoel S. Marcus May 13, 2019 to Jun 7, 202427
- Board memberLeslie D. Funtleyder May 13, 2019 to now28
- Board memberShoshana Shendelman May 13, 2019 to now13
- Board memberStacy J. Kanter May 13, 2019 to now29
- Board memberTeena Lerner May 13, 2019 to now30
Former names
- Applied Therapeutics Inc.Feb 8, 2017 to Mar 11, 20243
Timeline
- Feb 3, 20268-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights31
- Dec 12, 20258-K Entered a material agreement; New debt or obligation; Regulation FD disclosure32
- Nov 20, 20258-K Other events33
- Nov 13, 20258-K Results of operations; Executive or director change34
- Aug 29, 20258-K Entered a material agreement; Other events35
- Aug 14, 20258-K Other events36
- Aug 13, 20258-K Results of operations37
- Aug 12, 20258-K Results of operations; Other events38
- Jun 17, 20258-K Executive or director change; Regulation FD disclosure; Other events39
- Jun 12, 20258-K Shareholder vote40
- May 13, 20258-K Results of operations41
- Apr 15, 20258-K Results of operations42
- May 13, 2019New chief executive Shoshana Shendelman becomes CEO13
- Jan 20, 2016Founded Applied Therapeutics, Inc. is founded2
Calendar
When it reported results
- Nov 13, 2025Reported quarterly or annual results34
- Aug 13, 2025Reported quarterly or annual results37
- Aug 12, 2025Reported quarterly or annual results38
- May 13, 2025Reported quarterly or annual results41
- Apr 15, 2025Reported quarterly or annual results42
- Nov 7, 2024Reported quarterly or annual results43
- Aug 7, 2024Reported quarterly or annual results44
- May 9, 2024Reported quarterly or annual results45
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
331 filings to the SEC since October 2021: 4 annual reports, 13 quarterly reports, 58 major events, 114 insider forms, 71 large holders, 2 private raises, 69 other. The latest 20:
- Feb 17, 2026SCHEDULE 13G/A EDGAR
- Feb 13, 202615-12G EDGAR
- Feb 6, 2026EFFECT EDGAR
- Feb 6, 2026EFFECT EDGAR
- Feb 4, 20264 EDGAR
- Feb 3, 20264 EDGAR
- Feb 3, 20264 EDGAR
- Feb 3, 20264 EDGAR
- Feb 3, 20264 EDGAR
- Feb 3, 20264 EDGAR
- Feb 3, 20264 EDGAR
- Feb 3, 2026POS AM EDGAR
- Feb 3, 2026POS AM EDGAR
- Feb 3, 2026S-8 POS EDGAR
- Feb 3, 2026S-8 POS EDGAR
- Feb 3, 2026S-8 POS EDGAR
- Feb 3, 2026S-8 POS EDGAR
- Feb 3, 20268-K EDGAR
- Feb 3, 2026SC 14D9/A EDGAR
- Feb 3, 2026SC TO-T/A EDGAR
The 331 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
43 open-market trades by officers, directors and large owners since October 2021: 8 buys and 35 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 16, 2025 | Kanter Stacy J.Director | Sale | 43,000 | $0.11 | $4.7K | Form 4 |
| Mar 4, 2025 | Perfetti RiccardoChief Medical Officer | Sale | 10,366 | $0.44 | $4.6K | Form 4 |
| Mar 4, 2025 | Funtleyder Leslie D.Chief Financial Officer | Sale | 14,502 | $0.44 | $6.4K | Form 4 |
| Mar 4, 2025 | Chinoporos ConstantineSee Remarks | Sale | 447 | $0.44 | $197 | Form 4 |
| Feb 6, 2025 | Funtleyder Leslie D.Chief Financial Officer | Sale | 22,950 | $0.61 | $14.0K | Form 4 |
| Feb 6, 2025 | Perfetti RiccardoChief Medical Officer | Sale | 86,078 | $0.61 | $52.5K | Form 4 |
| Feb 6, 2025 | Chinoporos ConstantineSee Remarks | Sale | 28,117 | $0.61 | $17.2K | Form 4 |
| Aug 22, 2024 | Funtleyder Leslie D.Chief Financial Officer | Sale | 13,530 | $5.83 | $78.9K | Form 4 |
| Aug 22, 2024 | Perfetti RiccardoChief Medical Officer | Sale | 22,681 | $5.83 | $132.2K | Form 4 |
| Aug 14, 2024 | Shendelman ShoshanaPresident and CEO | Sale | 119,591 | $5.93 | $709.2K | Form 4 |
| Aug 13, 2024 | Shendelman ShoshanaPresident and CEO | Sale | 357,423 | $6.18 | $2.2M | Form 4 |
| Aug 12, 2024 | Shendelman ShoshanaPresident and CEO | Sale | 300,000 | $5.98 | $1.8M | Form 4 |
| Jun 6, 2024 | Shendelman ShoshanaPresident and CEO | Sale | 61,795 | $4.32 | $267.0K | Form 4 |
| Jun 6, 2024 | Perfetti RiccardoChief Medical Officer | Sale | 22,003 | $4.32 | $95.1K | Form 4 |
| Jun 6, 2024 | Funtleyder Leslie D.Chief Financial Officer | Sale | 16,980 | $4.32 | $73.4K | Form 4 |
| Jun 5, 2024 | Alexandria Equities No. 7, LLC10% owner | Sale | 150,000 | $4.24 | $636.0K | Form 4 |
| Jun 4, 2024 | Alexandria Equities No. 7, LLC10% owner | Sale | 150,000 | $4.21 | $631.5K | Form 4 |
| Mar 14, 2024 | Shendelman ShoshanaPresident and CEO | Sale | 318,573 | $5.39 | $1.7M | Form 4 |
| Mar 14, 2024 | Perfetti RiccardoChief Medical Officer | Sale | 110,804 | $5.39 | $597.2K | Form 4 |
| Mar 14, 2024 | Hansard AdamChief Commercial Officer | Sale | 48,871 | $5.39 | $263.4K | Form 4 |
All 43 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Vestal Point Capital, LPSCHEDULE 13G/A, 4 filings Feb 13, 2024 to Feb 17, 202646
- Propel Bio Management, LLCSCHEDULE 13G/A, 3 filings May 2, 2023 to Dec 31, 202547
- Alexandria Real Estate EquitiesSCHEDULE 13G/A, 5 filings Feb 11, 2022 to Dec 15, 202548
- T. Rowe Price Investment Management, Inc.SCHEDULE 13G/A, 4 filings May 7, 2025 to Nov 14, 202549
- VANGUARD GROUP INCSCHEDULE 13G/A, 2 filings Apr 30, 2025 to Jul 29, 202550
- BlackRockSCHEDULE 13G/A, 4 filings Oct 24, 2024 to Jul 16, 202551
- Schonfeld Strategic Advisors LLCSCHEDULE 13G/A, 2 filings Feb 14, 2025 to May 15, 202552
- Venrock Healthcare Capital Partners III, L.P.SCHEDULE 13G/A, 5 filings May 8, 2023 to May 15, 202553
- Alyeska Investment Group, L.P.SCHEDULE 13G, 4 filings Feb 14, 2023 to Feb 14, 202554
- Janus Henderson Group Ltd.SCHEDULE 13G/A, 4 filings Mar 8, 2024 to Feb 14, 202555
- PERCEPTIVE ADVISORS LLCSCHEDULE 13G/A, 4 filings Dec 6, 2023 to Feb 14, 202556
- Morgan StanleySCHEDULE 13G/A, 3 filings Nov 6, 2024 to Feb 7, 202557
- Franklin Templeton InvestmentsSCHEDULE 13G/A, 7 filings Jul 8, 2022 to Jan 27, 202558
- Shoshana ShendelmanSC 13D/A, 6 filings Jan 28, 2022 to Aug 14, 202459
- ARMISTICE CAPITAL, LLCSC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202460
- ORBIMED ADVISORS LLCSC 13G/A, 3 filings Feb 11, 2022 to Feb 14, 202461
- FMR LLCSC 13G/A, 4 filings Feb 9, 2022 to Feb 9, 202462
- Propel Bio Partners L.P.SC 13G/A, 2 filings Feb 14, 2023 to Mar 31, 202363
- Point72 Asset Management, L.P.SC 13G/A, 2 filings Jan 4, 2022 to Feb 14, 202364
- Knoll Capital Management, LLCSC 13G, 1 filing Jan 23, 202365
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Shoshana | $646.5K | $3.8M66 | |
| 2024 | John JohnsonExecutive Chairman | $31.6K | $2.8M66 | |
| 2024 | Dale HooksChief Commercial Officer | $375.9K | $2.1M66 | |
| 2024 | Les FuntleyderInterim Chief Executive Officer and Chief Financial Officer | $530.6K | $1.1M66 | |
| 2023 | Shendelman, Ph.D.Former President, Chief Executive Officer and Secretary | $630.0K | $9.5M66 |
Money raised
Private offerings the company reported to the SEC on Form D.
SEC filer profile
How Applied Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARApplied Therapeutics, Inc.1
- CIK0001697532
- Employer ID (EIN)81-34052624
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address545 Fifth Avenue, Suite 1400, New York, NY 100171
- Phone212-220-92261
- Shares outstanding144,300,674 as of Nov 12, 202512
- Public float$478.5M as of Jun 28, 20244
- AuditorErnst & Young LLP, New York, New York PCAOB ID 42; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceFeb 8, 20171
- Filings529 in all: 4 (177), 8-K (87), SC 13G/A (29), 10-Q (21), SC 13G (19), SCHEDULE 13G/A (19), 3 (18), CORRESP (12)1
All 47 form types
144 (10), EFFECT (10), SC 13D/A (9), UPLOAD (9), 424B5 (7), DEF 14A (7), DEFA14A (7), 10-K (6), 4/A (6), D (6), SC TO-T/A (5), SCHEDULE 13G (5), 424B3 (4), POS AM (4), S-1/A (4), S-8 (4), S-8 POS (4), SC 14D9/A (4), 424B4 (3), 5 (3), ARS (3), PRE 14A (3), S-1 (3), S-3 (3), DRS (2), DRS/A (2), DRSLTR (2), 15-12G (1), 25-NSE (1), 3/A (1), 8-A12B (1), CERT (1), NT 10-K (1), S-1MEF (1), S-3/A (1), SC 13D (1), SC 14D9 (1), SC TO-T (1), SC14D9C (1)
- Latest filingsAnnual report (10-K) Apr 15, 2025
Quarterly report (10-Q) Nov 13, 2025
Proxy statement (DEF 14A) Apr 28, 2025
Latest 8-K (8-K) Feb 3, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | APLT | The Nasdaq Global Market |
From the cover page of the 10-K filed Apr 15, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Applied Therapeutics, Inc. names in Item 1A of its 10-K filed Apr 15, 2025: 70 risks under these headings, as written.4
- Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations and the market price of our common stock.
- Risks Related to Our Financial Position and Capital Needs
- Risks Related to the Development and Commercialization of Our Product Candidates
- Risks Related to Regulatory Compliance
- Risks Related to Our Dependence on Third Parties
- Risks Related to Our Intellectual Property
- Risks Related to Our Business Operations, Employee Matters and Managing Growth
- Risks Related to Ownership of Our Common Stock
- General Risk Factors
- We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
- The report of our independent registered public accounting firm included a “going concern” explanatory paragraph.
- We identified a material weakness in our internal control over financial reporting as of December 31, 2024 and this or other material weaknesses could continue to materially impair our ability to report accurate financial information in a timely manner.
The other 66 risks
- If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which would adversely affect investor confidence in our company and harm our business.
- Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
- We will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
- Raising additional capital may cause dilution to our stockholders and restrict our operations or require us to relinquish rights to our product candidates.
- Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
- We received a Warning Letter from the FDA for our NDA filed in December 2023 for our AT-007-1002 study. Failure to resolve the matters addressed in the Warning Letter could negatively impact our company’s ability to undertake clinical trials in the future or timely complete future NDA submissions.
- We recently received a Complete Response Letter from the FDA for our NDA for govorestat (AT-007) for the treatment of Classic Galactosemia, one of our lead product candidates, and we are currently evaluating our development program for Classic Galactosemia and SORD Deficiency, and do not currently know if govorestat will ever receive regulatory approval for any indication, which is necessary before it can be commercialized.
- Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.
- Changes in funding for the FDA and other government agencies and the implementation of tariffs could prevent new products and services from being developed or commercialized in a timely manner or at all, which could negatively impact our business.
- We or Advanz Pharma may fail to perform under any of the agreements entered into in connection with the partnership for the potential commercialization of AT-007, which may subject us to liabilities, and we may fail to achieve anticipated benefits of the partnership.
- The development of additional product candidates is risky and uncertain, and we can provide no assurances that we will be able to replicate our approach to drug development for other disease indications.
- Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.
- Clinical drug development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials.
- All of our current product candidates that have proceeded to clinical trials target inhibition of aldose reductase. There can be no assurance that aldose reductase inhibitors will ever receive regulatory approval.
- We may not be able to obtain or maintain rare pediatric disease designation or exclusivity for our product candidates, which could limit the potential profitability of our product candidates.
- A breakthrough therapy designation by the FDA for a product candidate may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the product candidate will receive marketing approval.
- We have sought, and may in the future seek, fast track designation from the FDA for our product candidates. Even if granted, fast track designation may not actually lead to a faster development, regulatory review or approval process.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.
- Interim, “top-line” and preliminary data from our clinical trials that we have announced or published, has changed and may continue to change as more patient data becomes available and are subject to audit and verification procedures that has resulted and could in the future result in material changes in the final data.
- The incidence and prevalence for target patient populations of our product candidates have not been established with precision. If the market opportunities for our product candidates are smaller than we believe they are or any approval we obtain is based on a narrower definition of the patient population, our business may suffer.
- We face competition, which may result in others developing or commercializing drugs before or more successfully than us.
- We may explore strategic collaborations that may never materialize or we may be required to relinquish important rights to and control over the development and commercialization of our product candidates to any future collaborators.
- Even if any product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be successful in commercializing them, if and when they are approved.
- Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities.
- If we commercialize our product candidates outside the United States, a variety of risks associated with international operations could harm our business.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
- Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
- Our relationships with customers, physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell profitably, if approved.
- Healthcare reform measures may have a negative impact on our business and results of operations.
- One of our clinical investigators received a warning letter from the FDA following a site inspection. Failure to resolve the matters addressed in the warning letter and any similar issues at other clinical trial sites could negatively impact the continuance of our govorestat clinical program, our ability to rely on the data collected in our clinical trials for regulatory submissions and approval, and our ability to undertake clinical trials in the future or timely complete future NDA submissions.
- We rely on third parties to produce clinical and commercial supplies of our product candidates.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt our, business.
- We rely on third-parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we breach our license agreements with Columbia University or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product.
- If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
- Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- Third-parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
- We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
- Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
- Intellectual property rights do not necessarily address all potential threats to our business.
- We are involved in a securities-related class action and derivative litigation and defending against these claims could result in substantial costs and divert management time and resources, damages and have a material adverse effect on our results of operations. These lawsuits, and any other lawsuits to which we are subject, will be costly to defend or pursue and are uncertain in their outcome.
- We recently experienced the departure of our founder and CEO and changes to our board and our executive management. These changes may create uncertainty and, more generally, if we are unable to attract and retain qualified management, clinical and scientific personnel, our business will be harmed.
- If we determine to bring in-house some functions that we are currently outsourcing and if we commercialize any of our product candidates we may experience difficulties in managing this growth, which could disrupt our operations.
- Our internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a significant disruption of our product development programs and our ability to operate our business effectively, and adversely affect our business and operating results.
- Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Any future acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and/or subject us to other risks.
- The market price of our common stock is volatile and has fluctuated substantially, which could result in substantial losses for purchasers of our common stock.
- If we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- Future sales of common stock by holders of our common stock, or the perception that such sales may occur, could depress the market price of our common stock.
- If research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- We have broad discretion in the use of our cash and cash equivalents and may use them ineffectively, in ways with which you do not agree or in ways that do not increase the value of your investment.
- We no longer qualify as an “emerging growth company,” and as a result, we have to comply with increased disclosure and compliance requirements.
- We have incurred increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our governing documents designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Legal proceedings
Securities Class Action Litigation
On December 17, 2024, a purported stockholder filed a putative class action lawsuit against the Company and certain current and former Company officers and directors in the United States District Court for the Southern District of New York (Alexandru v. Applied Therapeutics, Inc., et al., No. 1:24-cv-09715). The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder by making false and/or misleading statements between January 3, 2024 to December 2, 2024 in connection with the Company’s NDA to the FDA for govorestat for the treatment of Classic Galactosemia, and seeks unspecified damages. On December 27, 2024, another purported stockholder filed a putative class action lawsuit against the Company and a former Company officer and director in the United States District Court for the Southern District of New York (Ikram v. Applied Therapeutics, Inc., et al., No. 1:24-cv-09973). The complaint alleges claims substantially similar to those alleged in the Alexandru action and also seeks unspecified damages. On February 18, 2025, several purported stockholders filed motions seeking to consolidate the Alexandru and Ikram actions and seeking appointment as lead plaintiff in the consolidated action. On March 11, 2025, the court consolidated the Alexandru and Ikram actions (In re Applied Therapeutics Securities Litigation, No. 1:24-cv-9715) and appointed a lead plaintiff and lead counsel. The deadline for lead plaintiff to file a consolidated amended complaint is May 2, 2025.
Shareholder Derivative Litigation
The opening of Item 3, Legal Proceedings.4
Sources
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- 18SEC EDGARConstantine Chinoporos, Officer
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- 20SEC EDGARLeslie D. Funtleyder, Officer
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- 26SEC EDGARJay S. Skyler, Board member
- 27SEC EDGARJoel S. Marcus, Board member
- 28SEC EDGARLeslie D. Funtleyder, Board member
- 29SEC EDGARStacy J. Kanter, Board member
- 30SEC EDGARTeena Lerner, Board member
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- 37SEC EDGARResults of operations
- 38SEC EDGARResults of operations; Other events
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- 40SEC EDGARShareholder vote
- 41SEC EDGARResults of operations
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