PTHS on NYSE

Pelthos Therapeutics Inc.

American biological products company based in Durham, incorporated in Nevada1

In its 2026 annual report the company says: “Pelthos Therapeutics Inc. is a bio-pharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The Company currently has three U.S. Food and Drug Administration approved products in its commercial portfolio, in various stages of commercialization, including ZELSUVMI TM, XEPI ®, and XEGLYZE ®.”4 Its shares trade on NYSE under the symbol PTHS.1

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Last updated Oct 21, 2026.

Overview

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  • TickerPTHS on NYSE1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersDurham, North Carolina1
  • Incorporated inNV2
  • Business address4020 Stirrup Creek Drive, Suite 110, Durham, Nc 277032
  • Filer category, Emerging growth company2
  • Legal formCorporation

Pelthos Therapeutics Inc. (the “Company”) is a bio-pharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The Company currently has three U.S. Food and Drug Administration (“FDA”) approved products in its commercial portfolio, in various stages of commercialization, including ZELSUVMI TM , XEPI ® , and XEGLYZE ® .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 2025

-193.1%Operating margin5
-257.9%Net margin5
-111.4%Return on equity5
-$22.7MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Business segments

Commercial Operations brought in 96% of the revenue Pelthos Therapeutics Inc. broke down this way in fiscal 2025.

  1. Commercial Operations$16.2M596%
  2. Research And Development Operations$589.0K54%
Business segments by year
Business segments20242025
Commercial Operations$0$16.2M
Research And Development Operations$0$589.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue7¢$4.0M
  • Research and development2¢$1.2M
  • Selling, general and admin77¢$42.5M
  • Income tax13¢$7.4M

Out of $16.8M in revenue.5 The company lost money this year.

Financial statements

Revenue5$16.8M in 2025
0$5.0M$10.0M$15.0M$20.0M2024: $0$020242025: $16.8M$16.8M2025
Operating income675-$32.4M in 2025+1299% since 2022
-$40.0M-$30.0M-$20.0M-$10.0M02022: -$2.3M-$2.3M20222023: -$6.9M-$6.9M2023+196%2024: -$7.6M-$7.6M2024+10%2025: -$32.4M-$32.4M2025+328%
Net income675-$43.3M in 2025+1662% since 2022
-$60.0M-$40.0M-$20.0M02022: -$2.5M-$2.5M20222023: -$7.4M-$7.4M2023+200%2024: -$8.0M-$8.0M2024+8%2025: -$43.3M-$43.3M2025+445%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Total revenue$16.8M$0
Cost of goods sold$4.0M$0
Selling, general and administrative$42.5M$6.4M
Research and development$1.2M$1.2M
Amortization of intangible assets$1.6M$0
Total operating expenses$49.2M$7.6M
Operating loss-$32.4M-$7.6M
Interest expense-$3.0M-$786.0K
Impairment of intangible assets-$285.0K$0
Change in fair value of convertible debt-$15.0M$0
Interest income and other income$5.0K$402.0K
Total other (expense) income-$18.3M-$384.0K
Net loss before provision for income taxes-$50.7M-$8.0M
Provision for income taxes-$7.4M$0
Net loss-$43.3M-$8.0M
Comprehensive loss-$43.3M-$8.0M
Net loss per common share, basic (in dollars per share)-$23.04-$14.27
Net loss per common share, diluted (in dollars per share)-$23.04-$14.27
Weighted average number of common shares outstanding, basic (in shares)1.9M shares557.4K shares
Weighted average number of common shares outstanding, diluted (in shares)1.9M shares557.4K shares

Compare Pelthos Therapeutics Inc. with another company

Corporate structure

Pelthos Therapeutics Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Pelthos Therapeutics Inc.

  • Pelthos Therapeutics Inc. Durham, North Carolina
    • Channel Pharmaceutical Corporation Subsidiary · Nevada, United States
    • LNHC, Inc. Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Pelthos 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$10.5M5 Dec 31, 2025$05 Dec 31, 2024
Accumulated depreciation$932.0K5 Dec 31, 2025$05 Dec 31, 2024
Property and equipment, net$9.6M5 Dec 31, 2025$05 Dec 31, 2024
Operating-lease assets (leased space)$3.2M5 Dec 31, 2025$05 Dec 31, 2024

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$18.0M5 Dec 31, 2025$513.0K5 Dec 31, 2024+3403.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$24.7M5 Dec 31, 2025$05 Dec 31, 2024
Finite-lived intangibles, gross$41.3M5 Dec 31, 2025
Accumulated amortization$1.6M5 Dec 31, 2025$05 Dec 31, 2024
Finite-lived intangibles, net$39.5M5 Dec 31, 2025$05 Dec 31, 2024

Inventory

ItemLatestA year beforeChange
Inventory, total$23.6M5 Dec 31, 2025$05 Dec 31, 2024
Raw materials$436.0K5 Dec 31, 2025$05 Dec 31, 2024
Work in process$16.6M5 Dec 31, 2025$05 Dec 31, 2024
Finished goods$6.6M5 Dec 31, 2025$05 Dec 31, 2024

Properties, in its own words

Our principal executive offices and primary API manufacturing operations are located in leased facilities in Durham, North Carolina. We lease approximately 19,265 rentable square feet within the Triangle Business Center pursuant to a lease that commenced in January 2021 and, as amended, has a term extending into 2032. The facility serves as our corporate headquarters and our primary site for the manufacturing of berdazimer sodium API used in ZELSUVMI. We own and operate the specialized manufacturing equipment used in API production at this site. The lease includes one option to extend the term for an additional five years at market rates, which we have not yet elected.

The Durham facility contains validated production suites, quality control laboratories, warehouse space, and administrative offices that support our commercial API manufacturing activities. We believe this facility provides sufficient capacity to meet our current commercial demand forecasts and allows for operational expansion through additional shifts without the need for significant new capital investment.

The rest of Item 2

We do not own any real property. Other than the Durham facility described above, we do not lease any additional properties that we consider material to our business. Manufacturing of our finished drug product, ZELSUVMI, is conducted by a third-party contract manufacturer and does not require us to maintain additional owned or leased manufacturing real estate.

We believe our existing facilities are adequate for our current needs and that suitable additional space would be available on commercially reasonable terms if required in the future.

Item 2 of the 10-K filed Mar 19, 2026.4

Leadership

Who has led Pelthos Therapeutics Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (10)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Chief Financial OfficerFrancis Knuettel II named Aug 6, 2024 to Nov 19, 202522
  • DirectorTodd Davis named Aug 6, 2024 to Nov 19, 202522

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Channel Pharmaceutical Corporation Nevada3
  • Channel Pharmaceutical Corporation Pty Ltd. Australia3
  • LNHC, Inc. Delaware3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • Channel Therapeutics CorpNov 18, 2024 to May 27, 20252
  • Chromocell Therapeutics CorpSep 6, 2022 to Nov 15, 20242

Timeline

  1. Oct 1, 20268-K Executive or director change; Shareholder vote23
  2. Aug 13, 20268-K Earlier financial statements no longer reliable24
  3. Aug 13, 20268-K Results of operations; Regulation FD disclosure25
  4. May 28, 20268-K Regulation FD disclosure26
  5. May 21, 20268-K Change of auditor; Executive or director change27
  6. May 14, 20268-K Results of operations; Regulation FD disclosure28
  7. Apr 14, 20268-K Regulation FD disclosure29
  8. Apr 10, 20268-K Executive or director change; Regulation FD disclosure30
  9. Mar 19, 20268-K Results of operations; Regulation FD disclosure31
  10. Jan 13, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares32
  11. Jan 12, 20268-K Executive or director change; Regulation FD disclosure33
  12. Jan 2, 20268-K Entered a material agreement; Other events34
  13. Jul 23, 2025New chief executive Scott M. Plesha becomes CEO10
  14. Feb 15, 2024New chief executive Knuettel Francis Ii. becomes CEO11

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($5.30) a share, on Nov 13, 2025.35

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results25
  2. May 14, 2026Reported quarterly or annual results28
  3. Mar 19, 2026Reported quarterly or annual results31
  4. Nov 13, 2025Reported quarterly or annual results36
  5. Sep 16, 2025Reported quarterly or annual results37
  6. Aug 18, 2025Reported quarterly or annual results38

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

249 filings to the SEC since October 2021: 3 annual reports, 9 quarterly reports, 34 major events, 80 insider forms, 21 large holders, 4 private raises, 98 other. The latest 20:

  1. Oct 6, 20264 EDGAR
  2. Oct 6, 20264 EDGAR
  3. Oct 6, 20264 EDGAR
  4. Oct 1, 20268-K EDGAR
  5. Aug 18, 2026ARS EDGAR
  6. Aug 18, 2026DEFA14A EDGAR
  7. Aug 18, 2026DEF 14A EDGAR
  8. Aug 13, 202610-Q EDGAR
  9. Aug 13, 20268-K EDGAR
  10. Aug 13, 202610-Q/A EDGAR
  11. Aug 13, 20268-K EDGAR
  12. Aug 7, 2026PRE 14A EDGAR
  13. Jul 7, 20264 EDGAR
  14. Jul 7, 20264 EDGAR
  15. Jul 7, 20264 EDGAR
  16. Jun 17, 20264 EDGAR
  17. Jun 15, 20264 EDGAR
  18. May 28, 20268-K EDGAR
  19. May 26, 20264 EDGAR
  20. May 22, 2026144 EDGAR

The 249 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

17 open-market trades by officers, directors and large owners since October 2021: 7 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 2, 2026Friedberg Ezra MDirectorSale558$26.09$14.6KForm 4
Jul 2, 2026Pauls MatthewDirectorSale786$26.16$20.6KForm 4
Jul 2, 2026Greenleaf PeterDirectorSale797$26.14$20.8KForm 4
Jun 15, 2026Friedberg Ezra MDirectorSale283$27.29$7.7KForm 4
Jun 11, 2026Davis Todd CDirectorBuy35,948$27.81$999.8KForm 4
May 22, 2026Francis Knuettel IICFO, Treas & SectySale1,500$26.84$40.3KForm 4
Apr 2, 2026Malamut RichardDirectorSale590$20.91$12.3KForm 4
Apr 2, 2026Friedberg Ezra MDirectorSale558$20.91$11.7KForm 4
Apr 2, 2026Pauls MatthewDirectorSale786$20.92$16.4KForm 4
Apr 2, 2026Greenleaf PeterDirectorSale797$20.92$16.7KForm 4
Nov 25, 2025Friedberg Ezra MDirectorSale10,000$28.03$280.3KForm 4
Sep 13, 2024Francis Knuettel IICFO, Treas & SectyBuy3,500$0.97$3.4KForm 4
Sep 12, 2024Malamut RichardDirectorBuy10,400$0.94$9.8KForm 4
Sep 12, 2024Francis Knuettel IICFO, Treas & SectyBuy1,700$0.97$1.6KForm 4
Sep 11, 2024Francis Knuettel IICFO, Treas & SectyBuy5,500$0.94$5.2KForm 4
Sep 10, 2024Francis Knuettel IICFO, Treas & SectyBuy6,500$0.89$5.8KForm 4
Feb 21, 2024Friedberg Ezra MDirectorBuy16,667$6.00$100.0KForm 4

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.

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.

YearExecutiveAgeSalaryTotal pay
2025Scott M. Plesha62$219.8K$4.2M50
2025Francis Knuettel II$410.0K$2.3M50
2025Sai Rangarao42$200.7K$1.7M50
2024Former Chief Financial Officer;Former Chief Executive Officer$424.9K$1.2M50

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$68.8M 2024–2025
Money received by yearMoney received by year, 2024–2025: $68.8M in all. Private raises (Form D) $68.8M.$0$20M$40M$60M$80M2024 · Private raises (Form D): $750.0K20242025 · Private raises (Form D): $68.1M2025
Figures by year
YearPrivate raises (Form D)Total
2025$68.1M$68.1M
2024$750.0K$750.0K

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Nov 6, 2025Raised $18 million in a private offering of securities22 Form D: 8 investors so far Form D
  2. Jul 1, 2025Raised $50.1 million in a private offering of equity51 Form D: 13 investors so far Form D
  3. Aug 6, 2024Filed a private offering of equity52 Form D: $30 million offered in all Form D
  4. Jul 24, 2024Raised $750,000 in a private offering of debt53 Form D: 1 investor so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
AIGH Capital Management LLC329,098$9.3M0.8%New
Murchinson Ltd.304,302$8.6M4.2%+7,988
Ikarian Capital, LLC256,598$7.3M1.2%No change
Boothbay Fund Management, LLC101,976$2.9M0.1%+20,118
Vanguard Capital Management LLC97,134$2.7M0.0%+4,041
Cantor Fitzgerald, L. P.76,246$2.2M0.0%+34,823
J. Goldman & Co LP38,075$1.1M0.0%−12,340
Diadema Partners LP24,773$700.1K0.3%No change
Wexford Capital LP22,364$632.0K0.1%New
Knott David M Jr22,073$623.8K0.3%+1,000
Citadel Advisors LLC15,046$425.2K0.0%New
Geode Capital Management, LLC14,650$414.0K0.0%−640
Pale Fire Capital SE12,919$365.1K0.0%No change
1492 Capital Management LLC10,380$293.3K0.1%New
Vanguard Fiduciary Trust Co9,873$279.0K0.0%+56
State Street Corp9,800$276.9K0.0%New
Persistent Asset Partners Ltd6,007$169.8K0.1%No change
BlackRock, Inc.5,324$150.5K0.0%New
UBS Group AG2,217$62.7K0.0%+1,453
China Universal Asset Management Co., Ltd.2,160$61.0K0.0%New
Tower Research Capital LLC (TRC)205$5.8K0.0%New
Farther Finance Advisors, LLC40$1.1K0.0%No change
Barclays PLC20$5650.0%New
Royal Bank Of Canada6$00.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Pelthos 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 EDGARPelthos Therapeutics Inc.1
  • CIK0001919246
  • Employer ID (EIN)86-33354494
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inNevada4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address4020 Stirrup Creek Drive, Suite 110, Durham, NC 277031
  • Phone919-908-24221
  • Shares outstanding3,828,469 as of Aug 10, 20269
  • Public float$6.7M as of Jun 30, 20254
  • AuditorCBIZ CPAs P.C., Hartford, Connecticut PCAOB ID 199; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceSep 6, 20221
  • Filings249 in all: 4 (50), 8-K (33), 3 (18), CORRESP (14), 424B3 (13), S-1/A (13), UPLOAD (12), 4/A (11)1
    All 45 form types

    10-Q (8), EFFECT (6), SC 13G (6), SCHEDULE 13G/A (6), FWP (5), D (4), SCHEDULE 13G (4), 10-K (3), DEF 14A (3), POS AM (3), PRE 14A (3), 424B4 (2), ARS (2), POS EX (2), S-1 (2), S-3 (2), S-8 (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 10-Q/A (1), 144 (1), 3/A (1), 8-A12B (1), 8-K/A (1), 8-K12G3 (1), CERT (1), DEFA14A (1), DEFM14C (1), DRS (1), DRS/A (1), DRSLTR (1), NT 10-K (1), PREM14C (1), S-3/A (1), SC 13D (1), SC 13G/A (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 19, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Aug 18, 2026
    Latest 8-K (8-K) Oct 1, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per sharePTHSThe NYSE American LLC

From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Pelthos Therapeutics Inc. names in Item 1A of its 10-K filed Mar 19, 2026: 60 risks under these headings, as written.4

  • Risks Related to Our Financial Condition and Capital Needs
  • The report of the independent registered public accounting firm on our 2024 financial statements contained a going concern qualification. The report of the independent registered public firm on our 2025 financial statements does not contain a going concern qualification; however, if we are unable to maintain sustainable revenues, we may be unable to continue as a going concern.
  • We have incurred significant losses since our inception. We expect to incur losses until revenue from ZELSUVMI is sufficient to fund our operations, if ever, and may never achieve or maintain profitability. If we do not achieve or maintain profitability, we may need additional funding to continue our business operations.
  • We have a limited operating history and history of commercializing products, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Risks Related to Commercialization of Our Products and any Future Product Candidates
  • We depend heavily on the commercial success of ZELSUVMI, which was approved by the FDA in January 2024, which we have only recently launched in the United States. There is no assurance that our commercialization efforts in the United States with respect to ZELSUVMI will be successful or that we will be able to generate profit at the levels or within the timing we expect.
  • Our two recently acquired products, XEPI and XEGLYZE, both of which have been FDA approved, require substantial preparation prior to commercial launch. If we are unable to meet the manufacturing, regulatory, and commercialization requirements to successfully prepare these products for launch, including expanding our current commercial infrastructure to sell these products, our results of operations may be negatively impacted.
  • ZELSUVMI, our approved products that have not yet been launched and any of our product candidates that receive regulatory approval, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • If we are unable to establish effective sales, marketing and distribution capabilities for ZELSUVMI, approved products not yet launched or any product candidate that may receive regulatory approval, we may not be successful in commercializing ZELSUVMI, approved products not yet launched or our other product candidates if and when they are approved.
  • ZELSUVMI, approved products not yet launched or our product candidates may cause undesirable side effects or have other properties that could limit their commercial profile, expose us to product liability claims, delay or prevent regulatory approval of our product candidates or additional indications, or result in significant negative consequences following any additional marketing approval, any of which may adversely impact our business, financial condition, operating results and prospects.
  • We face substantial competition, which may result in a smaller than expected commercial opportunity and/or other firms may discover, develop or commercialize products before or more successfully than we do.
  • Our gross to net (“GTN”) expenses could increase, resulting in a negative impact to our net revenues, causing a reduction in cash flow, potential impact to our stock price and have other deleterious effects to our investors.
The other 50 risks
  • The commercial success of our products and product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community.
  • Our products may become subject to unfavorable third-party coverage or reimbursement policies, which would harm our business.
  • The market for ZELSUVMI, approved products not yet launched and our future product candidates may not be as large as we expect.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Product liability lawsuits could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • Risks Related to Our Operations and Manufacturing
  • Delays or disruptions in our supply chain and manufacturing of our products, including ZELSUVMI, approved products not yet launched and potential product candidates could adversely affect our sales and marketing efforts and our development and commercialization timelines and could result in increased costs or in our breaching our obligations to others.
  • Unexpected results in the analysis of raw materials, the API or drug product or problems with the execution of or quality systems supporting the analytical testing work, whether conducted internally or by third-party service providers, could adversely affect our development and commercialization timelines and result in increased costs of potential development programs initiated by us.
  • Our business involves the use of hazardous materials, and we and our third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • The seasonal nature of our business may cause fluctuations in operations.
  • We may be adversely affected by the effects of inflation or trade tariffs.
  • Risks Related to Our Dependence on Third Parties
  • We will rely on third parties to conduct any preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize any of our future product candidates.
  • Our employees, independent contractors, principal investigators, CMOs, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputation.
  • We sell to a limited number of wholesalers who have significant market share and if we lose our relationship with any one of those wholesalers, our revenue could be impacted and business could materially suffer.
  • Risks Related to Intellectual Property
  • We rely on in-licenses from third parties. If we lose these rights, our business may be materially and adversely affected, our ability to develop improvements to our technology platform may be negatively and substantially impacted, and if disputes arise, we may be subjected to future litigation, as well as the potential loss of or limitations on our ability to incorporate the technology covered by these license agreements.
  • Third party intellectual property may prevent us from developing our potential products; our intellectual property may not prevent competition; and any intellectual property issues may be expensive and time consuming to resolve.
  • If we are unable to obtain and maintain sufficient intellectual property protection for our products and technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies similar to ours, and our ability to successfully sell our products and services may be impaired.
  • Issued patents directed to the NITRICIL platform and technology could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing Ligand’s ability to protect our products, platform and technology on which we rely.
  • We may be subject to claims challenging the inventorship of the patents and other intellectual property on which we rely.
  • If we are unable to protect the confidentiality of our information and our trade secrets, the value of our technology could be materially and adversely affected and our business could be harmed.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed.
  • Risks Related to Regulatory and Legal Compliance
  • Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize our products and may adversely affect the prices we may obtain and may have a negative impact on our business and results of operations.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in which we participate, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • We are subject to federal, state and foreign healthcare laws and regulations, including fraud and abuse laws. If we are unable to comply or have not fully complied with such laws and regulations, we could face criminal sanctions, damages, substantial civil penalties, reputational harm and diminished profits and future earnings.
  • Changes in and actual or perceived failures to comply with applicable data privacy, security and protection laws, regulations, standards and contractual obligations may adversely affect our business, operations and financial performance.
  • If plaintiffs bring product liability lawsuits against us or our partners, we or our partners may incur substantial liabilities and may be required to limit commercialization of our approved products, approved products not yet launched and product candidates.
  • We face risks related to handling of hazardous materials and other regulations governing environmental safety.
  • We may also be subject to other laws and regulations not specifically targeting the healthcare industry.
  • Risks Related to our Common Stock
  • The market price and trading volume of our shares of Common Stock may experience rapid and substantial price volatility, which could cause purchasers of our Common Stock to incur substantial losses.
  • Our Common Stock is currently listed on NYSE American. NYSE American may delist our Common Stock from trading, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
  • We could issue “blank check” preferred stock without stockholder approval with the effect of diluting then current stockholder interests and impairing their voting rights; and provisions in our charter documents could discourage a takeover that stockholders may consider favorable.
  • Our articles of incorporation designate the Second Judicial District Court, in and for the State of Nevada, located in Washoe County, Nevada, as the exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.
  • Our Series A Preferred Stock and Series C Preferred Stock have liquidation preferences over our Common Stock.
  • If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, or we don’t meet expectations in those research reports, our Common Stock price and trading volume could decline.
  • The price of our securities may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our securities.
  • We have broad discretion in the use of our cash and may not use them effectively.
  • The requirements of being a public company may strain our resources and divert management’s attention.
  • 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.
  • Other Risks and Uncertainties Affecting Our Business
  • The occurrence of a catastrophic disaster could disrupt our business, damage our facilities beyond insurance limits, increase our costs and expenses, or we could lose key data which could cause us to curtail or cease operations.
  • Impairment charges pertaining to goodwill, identifiable intangible assets or other long-lived assets from our mergers and acquisitions could have an adverse impact on our results of operations and our market value.
  • Our results of operations and liquidity needs could be materially negatively affected by market fluctuations and economic downturn.
  • The biopharmaceutical industry may be negatively affected by federal government deficit reduction policies, which could reduce the value of ZELSUVMI.
  • We may pursue strategic transactions, including asset divestitures, sales, spin‑outs or other distributions, which could materially adversely affect our business, financial condition, results of operations and the value of our securities.
  • Our business could be adversely impacted if there are deficiencies in our disclosure controls and procedures or our internal control over financial reporting.
  • We have previously identified material weaknesses in our internal control over financial reporting.
  • Our failure to maintain compliance with stock exchange listing requirements could result in our Common Stock being delisted.
  • 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 material disruption of our product development programs.
  • Cyber-security incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of services, damaging our reputation or exposing us to liability.
  • We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make our Common Stock less attractive to investors.

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of our management, would have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputation harm, and other factors.

Kopfli Matter

On February 14, 2024, Chromocell’s board of directors received a demand letter from an attorney representing Chromocell Holdings and its former Chief Executive Officer and former Chief Strategy Officer, Mr. Christian Kopfli, who was released for “cause.” Mr. Kopfli alleged an improper termination for “cause” and claimed to seek monetary damages in the amount of $479,169. Of the $479,169 asserted by Mr. Kopfli, as of September 30, 2024, Chromocell had accrued $363,091 in compensation expenses associated with Mr. Kopfli’s prior employment with Chromocell. However, Chromocell believed the assertions made by Mr. Kopfli were without merit and commenced a lawsuit against Mr. Kopfli and Chromocell Holdings in the Supreme Court for the State of New York, County of New York on June 7, 2024 (Index No. 652917/2024, the “New York Action”), asserting causes of action against Mr. Kopfli for breach of the Employment Agreement entered into on January 10, 2023 between Chromocell and Mr. Kopfli, breach of fiduciary duty by Mr. Kopfli, as well as breach of contract against Chromocell Holdings. Chromocell also asserted a “faithless servant” claim against Mr. Kopfli, seeking a ruling that Mr. Kopfli was not entitled to compensation from Chromocell. Chromocell sought monetary damages against Mr. Kopfli and Chromocell Holdings in the New York Action, plus disgorgement of all compensation previously paid or accrued to Mr. Kopfli by Chromocell.

The opening of Item 3, Legal Proceedings.4

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