DERM on Nasdaq

Journey Medical Corp

In its 2026 annual report the company says: “We are a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration approved prescription pharmaceutical products for the treatment of dermatological conditions.”5 It is headquartered in Scottsdale, Arizona.1

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Last updated Oct 21, 2026.

Overview

$61.2MRevenue, fiscal 20252
-$11.4MNet income, fiscal 20252

Compare with Tango Therapeutics (United States), Nuvation Bio Inc. or Fortress Biotech, or pick any stock.

  • TickerDERM on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersScottsdale, Arizona1
  • Incorporated inDE3
  • Business address9237 E Via De Ventura Blvd., Suite 105, Scottsdale, Az 852583
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3
  • Legal formCorporation

We are a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions. Our current product portfolio includes eight FDA-approved prescription drugs for dermatological conditions that are marketed in the U.S. We acquire rights to products and product candidates by licensing or otherwise acquiring an ownership interest in, funding the research and development of, and eventually commercializing the products through our field sales organization. We are a controlled subsidiary of Fortress Biotech, Inc. (“Fortress” or “Parent”).5 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

-13.3%Operating margin2
-18.7%Net margin2
11.1%Revenue growth, 20252
-35.9%Return on equity2
0.79×Debt to equity2

What sells

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

Products and services

Qbrexza brought in 41% of the revenue Journey Medical Corp broke down this way in fiscal 2025.

  1. Qbrexza$25.0M241%down 0% from 2024
  2. Emrosi$14.7M224%
  3. Accutane$12.9M221%down 34% from 2024
  4. Foam franchise products Amzeeq & Zilxi$5.9M210%down 12% from 2024
  5. Other (Legacy)$2.7M24%down 31% from 2024
Products and services by year
Products and services20242025
Qbrexza$25.1M$25.0M
Emrosi$14.7M
Accutane$19.4M$12.9M
Foam franchise products Amzeeq & Zilxi$6.7M$5.9M
Other (Legacy)$4.0M$2.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue32¢$20.9M
  • Research and development1¢$480.0K
  • Selling, general and admin67¢$44.4M
  • Income tax0¢$60.0K

Out of $61.2M in revenue.2 The company lost money this year.

Financial statements

Revenue67892$61.2M in 2025+38% since 2020
0$20.0M$40.0M$60.0M$80.0M2020: $44.5M$44.5M20202021: $63.1M$63.1M2021+42%2022: $71.0M$71.0M2022+12%2023: $59.7M$59.7M2023−16%2024: $55.1M$55.1M2024−8%2025: $61.2M$61.2M2025+11%
Operating income67892-$8.2M in 2025
-$40.0M-$20.0M0$20.0M2020: $7.9M$7.9M20202021: -$34.9M-$34.9M20212022: -$27.5M-$27.5M2022−21%2023: -$2.1M-$2.1M2023−92%2024: -$13.7M-$13.7M2024+560%2025: -$8.2M-$8.2M2025−40%
Net income67892-$11.4M in 2025
-$60.0M-$40.0M-$20.0M0$20.0M2020: $5.3M$5.3M20202021: -$44.0M-$44.0M20212022: -$29.6M-$29.6M2022−33%2023: -$3.9M-$3.9M2023−87%2024: -$14.7M-$14.7M2024+281%2025: -$11.4M-$11.4M2025−22%

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

Period ending2025-12-312024-12-31
Product revenue, net$61.2M$55.1M
Other revenue$619.0K$1.0M
Total revenue$61.9M$56.1M
Cost of goods sold - (excluding amortization of acquired intangible assets)$20.9M$20.9M
Amortization of acquired intangible assets$4.3M$3.4M
Research and development$480.0K$9.9M
Selling, general and administrative$44.4M$40.2M
Loss recovery-$4.6M
Total operating expenses$70.0M$69.8M
Loss from operations-$8.2M-$13.7M
Interest income-$589.0K-$757.0K
Interest expense$3.7M$2.7M
Gain on extinguishment of debt-$1.1M
Foreign exchange transaction losses$90.0K$116.0K
Total other expense$3.2M$934.0K
Loss before income taxes-$11.4M-$14.6M
Income tax expense$60.0K$61.0K
Net loss-$11.4M-$14.7M
Basic (In dollars per share)-$0.47-$0.72
Diluted (In dollars per share)-$0.47-$0.72
Basic (In shares)24.5M shares20.4M shares
Diluted (In shares)24.5M shares20.4M shares

Compare Journey Medical Corp with another company

Corporate structure

Journey Medical Corp is part of a group headed by Fortress Biotech. 11 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Journey Medical Corp

  • Fortress Biotech New York, New York, United States
    • Journey Medical Corp Scottsdale, Arizona
      • JG Pharma Inc. Subsidiary · Delaware, United States
    • ● Aevitas Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Avenue Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Cellvation, Inc. Subsidiary · Delaware, United States
    • ● Cyprium Therapeutics, Inc. Subsidiary · Delaware, United States
    • ● Helocyte, Inc. Subsidiary · Delaware, United States
    • ● Mustang Bio, Inc. Subsidiary · Delaware, United States
    • ● Oncogenuity, Inc. Subsidiary · Delaware, United States
    • ● Urica Therapeutics, Inc. Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Journey Medical Corp 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
Operating-lease assets (leased space)$111.0K2 Dec 31, 2025$199.0K2 Dec 31, 2024−44.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$24.1M2 Dec 31, 2025$20.3M2 Dec 31, 2024+18.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$27.6M2 Dec 31, 2025$31.9M2 Dec 31, 2024−13.4%
Finite-lived intangibles, gross$52.9M2 Dec 31, 2025$52.9M2 Dec 31, 20240%
Accumulated amortization$22.2M2 Dec 31, 2025$17.9M2 Dec 31, 2024+23.8%
Finite-lived intangibles, net$27.6M2 Dec 31, 2025$31.9M2 Dec 31, 2024−13.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$9.6M2 Dec 31, 2025$14.4M2 Dec 31, 2024−33.3%
Raw materials$3.1M2 Dec 31, 2025$3.2M2 Dec 31, 2024−4.3%
Work in process$174.0K2 Dec 31, 2025$367.0K2 Dec 31, 2024−52.6%
Finished goods$7.4M2 Dec 31, 2025$11.4M2 Dec 31, 2024−35.1%

Properties, in its own words

Our executive offices are located at 9237 E Via de Ventura Blvd. Suite 105, Scottsdale, AZ 85258. The term of the lease for this space commenced on February 2025 and will expire on February 28, 2027, and we pay an average annual rent of $0.1 million. We believe that our existing facilities are adequate to meet our current requirements. We do not own any real property.

Item 2 of the 10-K filed Mar 26, 2026.5

Leadership

Who has led Journey Medical Corp, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (8)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Serves as Interim Chief Financial OfficerRobyn Hunter named Oct 5, 202125
  • DirectorJustin Smith named Oct 5, 202125

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • JG Pharma Inc. Delaware4

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

Timeline

  1. Aug 12, 20268-K Results of operations26
  2. Jun 26, 20268-K Shareholder vote27
  3. May 13, 20268-K Results of operations28
  4. Apr 21, 20268-K Other events29
  5. Mar 25, 20268-K Results of operations30
  6. Nov 12, 20258-K Results of operations31
  7. Sep 26, 20258-K Entered a material agreement; New debt or obligation32
  8. Aug 28, 20258-K Entered a material agreement; Ended a material agreement33
  9. Aug 12, 20258-K Results of operations34
  10. Jul 14, 20258-K Other events35
  11. Jun 26, 20258-K Bylaws or fiscal year changed; Shareholder vote36
  12. Jun 24, 20258-K Other events37
  13. Nov 26, 2021New chief executive Claude Maraoui becomes CEO14

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.09) a share, on Nov 12, 2025.38

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results26
  2. May 13, 2026Reported quarterly or annual results28
  3. Mar 25, 2026Reported quarterly or annual results30
  4. Nov 12, 2025Reported quarterly or annual results31
  5. Aug 12, 2025Reported quarterly or annual results34
  6. May 14, 2025Reported quarterly or annual results39
  7. Mar 26, 2025Reported quarterly or annual results40
  8. Feb 5, 2025Reported quarterly or annual results41

Drug trials and FDA: recently

  1. Nov 1, 2024FDA approval FDA approved Emrosi (minocycline hydrochloride) (NDA 219015).42

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

222 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 48 major events, 88 insider forms, 12 large holders, 1 private raises, 53 other. The latest 20:

  1. Oct 9, 2026SCHEDULE 13G/A EDGAR
  2. Aug 12, 202610-Q EDGAR
  3. Aug 12, 20268-K EDGAR
  4. Jul 31, 2026SCHEDULE 13G/A EDGAR
  5. Jul 15, 2026SCHEDULE 13G/A EDGAR
  6. Jul 2, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Jul 2, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Jul 2, 20264 OWNERSHIP DOCUMENT EDGAR
  9. Jun 29, 20264 OWNERSHIP DOCUMENT EDGAR
  10. Jun 26, 20264 OWNERSHIP DOCUMENT EDGAR
  11. Jun 26, 20264 OWNERSHIP DOCUMENT EDGAR
  12. Jun 26, 20264 OWNERSHIP DOCUMENT EDGAR
  13. Jun 26, 20264 OWNERSHIP DOCUMENT EDGAR
  14. Jun 26, 20268-K EDGAR
  15. May 13, 202610-Q EDGAR
  16. May 13, 20268-K EDGAR
  17. Apr 30, 2026SCHEDULE 13G EDGAR
  18. Apr 30, 2026DEFA14A EDGAR
  19. Apr 30, 2026DEF 14A EDGAR
  20. Apr 24, 20264 OWNERSHIP DOCUMENT EDGAR

The 222 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

32 open-market trades by officers, directors and large owners since October 2021: 9 buys and 23 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 2, 2025Maraoui ClaudePresident & CEOSale4,834$6.84$33.1KForm 4
May 2, 2025Benesch JosephCFOSale2,409$6.84$16.5KForm 4
May 2, 2025Alloush RamseyChief Operating OfficerSale2,857$6.84$19.5KForm 4
Mar 11, 2025Maraoui ClaudePresident & CEOSale49,271$5.01$246.8KForm 4
Mar 7, 2025Maraoui ClaudePresident & CEOSale14,905$5.01$74.7KForm 4
Mar 6, 2025Maraoui ClaudePresident & CEOSale25,551$5.04$128.8KForm 4
Mar 5, 2025Maraoui ClaudePresident & CEOSale18,147$5.13$93.1KForm 4
Mar 4, 2025Maraoui ClaudePresident & CEOSale28,901$5.04$145.7KForm 4
Mar 3, 2025Maraoui ClaudePresident & CEOSale23,508$5.19$122.0KForm 4
Feb 21, 2025Benesch JosephCFOSale1,365$5.19$7.1KForm 4
Aug 1, 2024Benesch JosephCFOSale9,324$5.47$51.0KForm 4
Jul 23, 2024Benesch JosephCFOSale4,055$5.40$21.9KForm 4
Mar 25, 2024ROSENWALD LINDSAY A MDDirectorBuy10,000$3.04$30.4KForm 4
Mar 22, 2024Maraoui ClaudePresident & CEOBuy10,000$3.48$34.8KForm 4
Mar 22, 2024Smith Justin AdamDirectorBuy30,000$3.47$104.1KForm 4
Mar 22, 2024ROSENWALD LINDSAY A MDDirectorBuy20,000$3.40$68.0KForm 4
Feb 22, 2024Benesch JosephCFOSale2,450$3.75$9.2KForm 4
Nov 28, 2023Paley JeffreyDirectorSale1,745$5.22$9.1KForm 4
Nov 8, 2023Paley JeffreyDirectorSale255$3.76$959Form 4
Nov 7, 2023Paley JeffreyDirectorSale2,245$3.48$7.8KForm 4

All 32 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.

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
2025Claude MaraouiPresident and Chief Executive Officer60$583.5K$1.7M48
2025Ramsey AlloushChief Operating Officer, Corporate Secretary and General Counsel41$392.9K$1.2M48
2025Joseph BeneschChief Financial Officer59$318.3K$823.7K48
2024Claude MaraouiPresident and Chief Executive Officer60$566.5K$2.6M48
2024Ramsey AlloushChief Operating Officer, Corporate Secretary and General Counsel41$360.5K$1.6M48
2024Joseph BeneschChief Financial Officer59$309.0K$1.2M48

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$19.0M 2021–2021
Money received by yearMoney received by year, 2021–2021: $19.0M in all. Private raises (Form D) $19.0M.$0$5M$10M$15M$20M2021 · Private raises (Form D): $19.0M2021
Figures by year
YearPrivate raises (Form D)Total
2021$19.0M$19.0M

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. Mar 31, 2021Raised $19 million in a private offering of equity25 Form D: $30 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 71. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Wasatch Advisors LP2,858,930$20.2M0.1%+725,560
Tang Capital Management LLC1,610,000$11.4M0.5%No change
Vanguard Capital Management LLC675,185$4.8M0.0%−406,895
Punch & Associates Investment Management, Inc.536,000$3.8M0.2%New
Pale Fire Capital SE528,584$3.7M0.3%+46,597
Opaleye Management Inc.350,000$2.5M0.2%−610,000
Summit Financial, LLC346,748$2.5M0.0%−33,059
Jane Street Group, LLC320,021$2.3M0.0%New
Diametric Capital, LP295,663$2.1M0.2%+99,251
Ikarian Capital, LLC251,436$1.8M0.3%No change
Renaissance Technologies LLC229,700$1.6M0.0%−12,800
Geode Capital Management, LLC216,004$1.5M0.0%−247,198
American Financial Group Inc180,000$1.3M0.4%No change
Trexquant Investment LP171,338$1.2M0.0%+143,242
Marshall Wace, Llp139,843$990.1K0.0%New
J. Goldman & Co LP137,584$974.1K0.0%−362,604
Millennium Management LLC110,016$778.9K0.0%−273,051
BlackRock, Inc.100,981$714.9K0.0%−871,881
XTX Topco Ltd100,923$714.5K0.0%+71,559
Vanguard Fiduciary Trust Co94,729$670.7K0.0%−42,977
Goldman Sachs Group Inc90,294$639.3K0.0%+20,905
UBS Group AG83,514$591.3K0.0%−306,624
Citadel Advisors LLC82,149$581.6K0.0%New
Pvg Asset Management Corp79,573$563.4K0.3%−190
Integrated Wealth Concepts LLC78,928$558.8K0.0%+38,559

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

SEC filer profile

How Journey Medical Corp is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARJourney Medical Corp1
  • CIK0001867066
  • Employer ID (EIN)47-18795395
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address9237 E Via De Ventura Blvd., Suite 105, Scottsdale, AZ 852581
  • Phone480-434-66701
  • Shares outstanding6,000,000 Common Class A shares; 21,330,696 Common Excluding Class shares as of Mar 25, 20265
  • Public float$84.7M as of Jun 30, 20255
  • AuditorKPMG LLP, Short Hills, New Jersey PCAOB ID 185; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceJul 22, 20211
  • Filings229 in all: 4 (75), 8-K (48), 10-Q (15), 3 (11), UPLOAD (9), CORRESP (8), SCHEDULE 13G/A (6), 10-K (5)1
    All 32 form types

    424B3 (5), DEF 14A (5), DEFA14A (5), S-1/A (4), S-8 (4), EFFECT (3), SC 13G (3), DRS (2), DRS/A (2), DRSLTR (2), S-3 (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 3/A (1), 4/A (1), 424B5 (1), 8-A12B (1), CERT (1), D (1), D/A (1), NT 10-Q (1), PRE 14A (1), S-1 (1), SC 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareDERMNasdaq

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Journey Medical Corp names in Item 1A of its 10-K filed Mar 26, 2026: 68 risks under these headings, as written.5

  • Risks Related to Our Business, Industry and Existing Operating Revenue Stream
  • Future revenue from sales of our dermatology products may be lower than expected or lower than in previous periods.
  • We face challenges as our products face generic competition and/or losses of exclusivity.
  • Any disruptions to the capabilities, composition, size or existence of our field sales force may have a significant adverse impact on our existing revenue stream. Further, our ability to effectively market and sell any future products that we may develop will depend on our ability to establish and maintain sales and marketing capabilities or to enter into agreements with third parties to market, distribute and sell any such products.
  • Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
  • If the FDA does not conclude that a product candidate satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidate under Section 505(b)(2) are not as we expect, the approval pathway for the product candidate will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
  • If any of our contract manufacturers fails to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of our products or development and commercialization of any future product candidate, if approved, or be unable to meet market demand, and may lose potential revenues.
  • If serious adverse events are identified during the development of any future product candidates, we may need to abandon or limit our development of these product candidates.
  • All of our current and future products will remain subject to substantial regulatory scrutiny even after receiving regulatory approval.
  • Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Our products and future product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Public concern regarding the safety of any of our products and any future product candidates could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to incur additional costs.
The other 57 risks
  • Our potential future product candidates may not receive regulatory approval, or such approval may be delayed, which would have a material adverse effect on our business and financial condition. Further, even if a product candidate receives regulatory approval, such product will remain subject to substantial regulatory scrutiny.
  • If we experience delays or difficulties in the enrollment of patients in any future clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • We expect intense competition for our products and any future product candidates, and new products may emerge that provide different or better therapeutic alternatives for our targeted indications.
  • If our products do not achieve broad market acceptance, including by government and third-party payors, the revenues that we generate from sales will be limited.
  • Risks Related to Our Reliance on Third Parties
  • If we are unable to maintain sales, marketing, and distribution capabilities, or to enter into agreements with third parties to market and sell our current products or any future product candidates for which we receive marketing authorization, we may not be successful in generating revenues from selling and commercializing our current products and any future product candidates for which we receive marketing authorization.
  • We are dependent on third parties to supply raw materials used in our products, to manufacture our products, and to provide services for certain core aspects of our business. Any interruption or failure by these suppliers, distributors, and collaboration partners to meet their contractual obligations to us or obligations pursuant to applicable laws and regulations may materially adversely affect our business, financial condition, results of operations and cash flows.
  • We expect to rely on third parties to conduct any future preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including by failing to meet deadlines for the completion of such trials or to comply with applicable regulatory requirements.
  • We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable.
  • If successful product liability claims are brought against us, we may incur substantial liability, and may have to limit the commercialization of certain current or future products or product candidates.
  • The use of artificial intelligence in the healthcare industry and challenges with properly managing its use could adversely affect our business.
  • Risks Related to our Growth
  • A significant part of our future growth may depend on our ability to identify and acquire or in-license products, and if we do not successfully identify and acquire or in-license related product candidates or integrate them into our operations, we may have limited growth opportunities.
  • Our growth is subject to economic and political conditions.
  • Our business may be materially adversely affected by the imposition of duties and tariffs and other trade barriers and retaliatory countermeasures implemented by the U.S. and other governments.
  • We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
  • We may not be able to attract or retain qualified management and commercial, sales, scientific and clinical personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses. If we are not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede sales growth of our branded and generic products, the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.
  • We may decide to sell assets, which could adversely affect our prospects and opportunities for growth.
  • There is substantial doubt regarding our ability to continue as a going concern. We may need to raise additional funding (which may not be available on acceptable terms to the Company, or at all) and/or to delay, limit or terminate certain of our product development and commercialization efforts or other operations.
  • Risks Related to Development and Regulatory Approval of Our Future Product Candidates
  • Our business is dependent on the successful development and regulatory approval of future product candidates.
  • If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to successfully complete and obtain regulatory approvals of any future product candidates, which could materially adversely affect our business, results of operations, financial condition or cash flows.
  • Clinical drug development is very expensive, time-consuming and uncertain. Our clinical trials may fail to adequately demonstrate the safety and efficacy of any future product candidates, which could prevent or delay regulatory approval and commercialization.
  • We expect to rely on third-party CROs and other third parties to conduct and oversee our clinical trials, other aspects of our product development and our regulatory submission process for any future product candidates. If these third parties do not meet our requirements, conduct the trials as required or otherwise provide services as anticipated, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or successfully commercialize, any future product candidates when expected or at all.
  • We are currently dependent on DRL for the manufacture and clinical supply of Emrosi drug product. Any interruption in our supply may cause serious delays in the timing of our clinical trials, increase our costs and adversely impact our financial results.
  • We may be unable to obtain regulatory approval for any of our future product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates. The delay, limitation or denial of any regulatory approval would adversely impact our business and our operating results.
  • We may conduct clinical trials for any future product candidates, in whole or in part, outside of the United States and the FDA and applicable foreign regulatory authorities may not accept data from such trials, which would likely result in additional costs to us and delay our business plan.
  • Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.
  • Risks Related to Intellectual Property, Generic Competition and Paragraph IV Litigation
  • If we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
  • Generic drug approvals and successful challenges against the validity of our patents may cause us to lose exclusivity of some of our products.
  • Enforcing our proprietary rights is difficult and costly and we may be unable to ensure their protection.
  • If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in any litigation would harm our business.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, or if we breach an agreement under which we license rights to any product or future product candidate, we could lose rights that are important to our business.
  • Risks Related to our Platform and Data
  • Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.
  • Risks Related to Our Finances and Capital Requirements
  • We have incurred net losses in recent fiscal years, and we may incur losses for the foreseeable future and may not be able to achieve or maintain profitability.
  • We may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate any future product development programs or commercialization, manufacturing and/or sales efforts.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
  • Risks Related to Owning our Common Stock
  • If we fail to maintain or implement effective internal controls, we may not be able to report financial results accurately or on a timely basis, or to detect fraud, which could have a material adverse effect on our business and the per share price of our common stock.
  • Our charter documents and Delaware law could discourage takeover attempts and other corporate governance changes.
  • Our Fourth Amended and Restated Certificate of Incorporation provides, subject to limited exceptions, that the Court of Chancery of the State of Delaware is the sole and exclusive forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a chosen judicial forum for disputes with us or our directors, officers, employees or stockholders.
  • The requirements of being a public company may strain our resources, divert our management’s attention and affect our ability to attract and retain qualified board members.
  • Reduced reporting and disclosure requirements applicable to us as an EGC could make our common stock less attractive to investors.
  • Our shares of common stock are subject to potential delisting if we do not continue to maintain the listing requirements of Nasdaq.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains.
  • The trading price of the shares of our common stock is likely to be volatile, and purchasers of our common stock could incur substantial losses.
  • Risks Related to our Relationship with Fortress Biotech, Inc.
  • Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders.
  • We are a “controlled company” within the meaning of Nasdaq listing standards and, as a result, qualify for exemptions from certain corporate governance requirements. Although we do not presently intend to take advantage of these exemptions, we may do so in the future.
  • We may have received better terms from unaffiliated third parties than the terms we receive in our arrangements with Fortress.
  • The ownership by our executive officers and some of our directors of shares of equity securities of Fortress and/or rights to acquire equity securities of Fortress might create, or appear to create, conflicts of interest.
  • Fortress’ current or future financial obligations and arrangements, or an event of default thereon, may change the ownership dynamic of us by Fortress.
  • General Risks
  • Failure to manage our growth effectively could cause our business to suffer and have an adverse effect on our business, operating results and financial condition.
  • If securities or industry analysts do not publish research or reports about our business, or publish inaccurate or unfavorable research reports about our business, our share price and trading volume could decline.
  • Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the United States. If our estimates or judgments relating to our critical accounting policies prove to be incorrect, our results of operations could be adversely affected.
  • Global and national financial events may have an impact on our business and financial condition in ways that we currently cannot predict.
  • If our estimates or judgments relating to our critical accounting policies are erroneous or based on assumptions that change or prove to be incorrect, our operating results could fall below the expectations of securities analysts and investors, resulting in a decline in our stock price.
  • Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations.

Legal proceedings

To our knowledge, there are no legal proceedings pending against us, other than routine actions, administrative proceedings, and other actions not deemed material, that are expected to have a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages.

On February 25, 2026, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (‘the Court”) against Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. (“Lupin”). This lawsuit was filed following receipt of a “paragraph IV certification” notice from Lupin regarding its respective filing of an ANDA with the FDA seeking approval to engage in the commercial manufacture, use or sale of a generic version of Emrosi in the U.S. prior to the expiration of certain of the Company’s U.S. patents. The notice alleged that certain of the Company’s patents related to Emrosi, with expiration dates through 2039 are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed generic products. The Company intends to vigorously defend its intellectual property. The filing of each lawsuit within 45 days of receipt of each of the respective notices triggered stays of FDA approval of each of the respective ANDAs for up to 30 months in accordance with the Hatch-Waxman Act.

The opening of Item 3, Legal Proceedings.5

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