VYNE Therapeutics Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>VYNE Therapeutics Inc. has submitted its 2023 annual report (10-K), detailing financial performance and corporate history.</b>

AI Summary

VYNE Therapeutics Inc. (VYNE) filed a Annual Report (10-K) with the SEC on March 1, 2024. VYNE Therapeutics Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company was formerly known as Menlo Therapeutics Inc. and Tigercat Pharma, Inc. The filing includes financial data for the fiscal years 2023, 2022, and 2021. VYNE Therapeutics Inc. is classified under Pharmaceutical Preparations (SIC code 2834).

Why It Matters

For investors and stakeholders tracking VYNE Therapeutics Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of VYNE's financial health, operational activities, and strategic positioning for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. Understanding the historical company names and the period covered by the report helps in tracking the company's evolution and comparing its performance over different stages of its corporate life.

Risk Assessment

Risk Level: medium — VYNE Therapeutics Inc. shows moderate risk based on this filing. The company's financial performance and future viability are subject to the inherent risks of the pharmaceutical industry, including regulatory approvals, market competition, and research and development success, as indicated by the nature of its business classification.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand VYNE's current financial standing and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period end date)
• 2024-03-01 — Filing Date (Date the 10-K was filed)
• 0001566044 — Central Index Key (Unique identifier for the filer)
• 001-38356 — SEC File Number (SEC registration number)

Key Players & Entities

• VYNE Therapeutics Inc. (company) — Filer and subject of the report
• Menlo Therapeutics Inc. (company) — Former company name
• Tigercat Pharma, Inc. (company) — Former company name
• 2023-12-31 (date) — Fiscal year end
• 2024-03-01 (date) — Filing date
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive government regulation, including the FDA, which can impact product development, approval, and marketing.
• Market Competition [high — market]: The pharmaceutical market is highly competitive, with potential for new entrants and existing competitors developing superior products or therapies.
• Funding and Liquidity [medium — financial]: The company may require additional funding to support its ongoing operations and development programs, and its ability to secure such funding is not guaranteed.
• Research and Development Risks [high — operational]: Drug development is a lengthy, expensive, and uncertain process, with a high failure rate for product candidates.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 2023 10-K.
• 2024-03-01: Filing Date — The date VYNE Therapeutics Inc. officially submitted its 2023 10-K to the SEC.

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 VYNE The Nasdaq Stock Market LLC Secu

Filing Documents

• vyne-20231231.htm (10-K) — 1894KB
• exhibit103-vynexcowensales.htm (EX-10.3) — 307KB
• exhibit1017-nonxemployeedi.htm (EX-10.17) — 16KB
• exhibit211listofsubsidiari.htm (EX-21.1) — 4KB
• exhibit231consentus12312023.htm (EX-23.1) — 2KB
• vyne-20231231xexx311.htm (EX-31.1) — 10KB
• vyne-20231231xexx312.htm (EX-31.2) — 10KB
• vyne-20231231xexx321.htm (EX-32.1) — 7KB
• vyne-20231231xexx322.htm (EX-32.2) — 7KB
• exhibit971-vynerecoupmentp.htm (EX-97.1) — 34KB
• vyne-20231231_g1.jpg (GRAPHIC) — 245KB
• vyne-20231231_g2.jpg (GRAPHIC) — 570KB
• 0001628280-24-008178.txt (&nbsp;) — 10448KB
• vyne-20231231.xsd (EX-101.SCH) — 54KB
• vyne-20231231_cal.xml (EX-101.CAL) — 83KB
• vyne-20231231_def.xml (EX-101.DEF) — 333KB
• vyne-20231231_lab.xml (EX-101.LAB) — 702KB
• vyne-20231231_pre.xml (EX-101.PRE) — 506KB
• vyne-20231231_htm.xml (XML) — 835KB

Business

Business 7 ITEM 1A.

Risk Factors

Risk Factors 25 ITEM 1B. Unresolved Staff Comments 57

C

ITEM 1 C . Cybersecurity 57 ITEM 2.

Properties

Properties 58 ITEM 3.

Legal Proceedings

Legal Proceedings 58 ITEM 4. Mine Safety Disclosures 58 PART II ITEM 5. Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 59 ITEM 6. [Reserved] 59 ITEM 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 60 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 68 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 69 ITEM 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 72 ITEM 9A.

Controls and Procedures

Controls and Procedures 72 ITEM 9B. Other Information 72 ITEM 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 72 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 73 ITEM 11.

Executive Compensation

Executive Compensation 79 ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 85 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 88 ITEM 14. Principal Accountant Fees and Services 89 PART IV ITEM 15. Exhibits and Financial Statement Schedules 91 ITEM 16. Form 10-K Summary 94

Signatures

Signatures 95 3 Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of Section 21E the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of historical facts contained in this Annual Report on Form 10-K are statements that could be deemed forward-looking statements reflecting the current beliefs and expectations of management with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These statements are often identified by the use of words such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "if," "intend," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "should," "target," "until," "will," "would," and similar expressions or variations. These forward-looking statements include, but are not limited to, statements regarding the following matters: our ability to successfully execute our business strategy, including our ability to successfully develop our bromodomain and extra-terminal domain ("BET") inhibitor platform for immuno-inflammatory conditions; the timing of commencement of future preclinical studies and clinical trials and timing of data from those studies and trials; our ability to enroll patients and successfully complete, and receive favorable results in, clinical trials for our product candidates; the regulatory approval process for our product candidates, including any delay or failure in obtaining requisite approvals; our pursuit of, and ability to successfully identify and execute, strategic transactions; estimat

- BUSINESS

ITEM 1 - BUSINESS Overview We are a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. In August 2021, we entered into a transaction with Tay Therapeutics Ltd., formerly known as In4Derm Ltd. ("Tay"), providing us with exclusive worldwide rights to research, develop and commercialize products containing bromodomain and extra-terminal domain ("BET") inhibitors for the treatment of any disease, disorder or condition in humans. Through our access to this library of new chemical BET inhibitor compounds, we plan to develop product candidates for a diverse set of indications. Based on data generated to date, we have chosen to focus our initial efforts for this platform on select therapeutic areas in immuno-inflammatory disease. Our lead program is VYN201, a locally administered pan-bromodomain ("BD") BET inhibitor designed as a "soft" drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. In preclinical testing, VYN201 produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity across a variety of inflammatory and fibrotic models. In November 2022, we initiated a Phase 1a/b clinical trial evaluating a VYN201 ointment for the treatment of nonsegmental vitiligo. In the first quarter of 2023, we announced positive preliminary safety and tolerability, pharmacokinetic and hematology data from the Phase 1a portion of the trial . The first nonsegmental vitiligo patient was dosed in the Phase 1b portion of the trial in January 2023, and on October 30, 2023, we announced positive data from the Phase 1b trial, in which significant clinical improvement in facial vitiligo area scoring index ("F-VASI") was observed in the 1% and 2% dose cohorts after 16 weeks of treatment. We have initiated Phase 2b preparatory activities and expec

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View this 10-K filing on SEC EDGAR