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LONA on Nasdaq

LeonaBio, Inc.

Biological products company, listed on Nasdaq (LONA)1

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis, with the goal of improving patients’ lives. We are leveraging this scientific momentum to advance a pipeline of innovative, late-stage assets both internally developed and strategically in-licensed with the goal of accelerating their path to market and maximizing their clinical and commercial impact.”4 It is headquartered in Bothell, Washington.1

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Last updated Oct 21, 2026.

Overview

-$105.6MNet income, fiscal 20252

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  • TickerLONA on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersBothell, Washington1
  • Business address18706 North Creek Parkway, Suite 104, Bothell, Wa 980113
  • Filer categoryNon-accelerated filer, Smaller reporting company3

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We are a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for high unmet medical needs, including treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (“ALS”), with the goal of improving patients’ lives.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

-380.0%Return on equity2

Financial statements

Operating income567892-$102.3M in 2025+1777% since 2019
-$150.0M-$100.0M-$50.0M02019: -$5.4M-$5.4M20192020: -$20.0M-$20.0M2020+267%2021: -$64.0M-$64.0M2021+220%2022: -$104.0M-$104.0M2022+62%2023: -$125.5M-$125.5M2023+21%2024: -$100.9M-$100.9M2024−20%2025: -$102.3M-$102.3M2025+1%
Net income567892-$105.6M in 2025+1946% since 2019
-$150.0M-$100.0M-$50.0M02019: -$5.2M-$5.2M20192020: -$20.0M-$20.0M2020+287%2021: -$54.9M-$54.9M2021+175%2022: -$95.6M-$95.6M2022+74%2023: -$117.7M-$117.7M2023+23%2024: -$96.9M-$96.9M2024−18%2025: -$105.6M-$105.6M2025+9%

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

Period ending2025-12-312024-12-31
Research and development$17.5M$70.7M
Acquired in-process research and development$68.1M
General and administrative$16.7M$26.1M
Legal expense$4.1M
Total operating expenses$102.3M$100.9M
Loss from operations-$102.3M-$100.9M
Other income, net$1.2M$4.0M
Sermonix pre-funded warrant change in fair value-$4.6M
Net loss-$105.6M-$96.9M
Unrealized (loss) gain on available-for-sale securities-$5.0K$350.0K
Comprehensive loss attributable to common stockholders-$105.6M-$96.6M
Net loss per share attributable to common stockholders, basic-$24.70-$25.19
Net loss per share attributable to common stockholders, diluted-$24.70-$25.19
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic4.3M shares3.8M shares
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted4.3M shares3.8M shares

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Corporate structure

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

Major holders of LeonaBio, Inc.

  • Sermonix Pharmaceuticals, Inc. Filed SCHEDULE 13D on LeonaBio, Inc., latest Aug 31, 2026
  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13D/A on LeonaBio, Inc., latest Aug 25, 2026 (8 filings since Jul 1, 2022)
  • ACORN BIOVENTURES, L.P. Filed SCHEDULE 13G/A on LeonaBio, Inc., latest Aug 20, 2026 (3 filings since Dec 23, 2025)
  • ADAR1 Capital Management, LLC Filed SCHEDULE 13G on LeonaBio, Inc., latest May 15, 2026
  • Baselake Partners, LP Filed SCHEDULE 13G/A on LeonaBio, Inc., latest Feb 6, 2026 (2 filings since Nov 14, 2025)
  • BML Investment Partners, L.P. Filed SCHEDULE 13G/A on LeonaBio, Inc., latest Dec 18, 2025 (4 filings since Nov 7, 2024)
  • Steven Michael Oliveira Filed SCHEDULE 13G/A on LeonaBio, Inc., latest Oct 10, 2025 (2 filings since Apr 16, 2025)
  • BAKER BROS. ADVISORS LP Filed SC 13G/A on LeonaBio, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
  • BlackRock Filed SC 13G/A on LeonaBio, Inc., latest Jul 7, 2023 (3 filings since Feb 4, 2022)
  • Richard A. Kayne Filed SC 13G on LeonaBio, Inc., latest Apr 20, 2023
  • RTW INVESTMENTS, LP Filed SC 13G/A on LeonaBio, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • Franklin Templeton Investments Filed SC 13G/A on LeonaBio, Inc., latest Jan 30, 2023 (2 filings since Feb 3, 2022)
  • LeonaBio, Inc. Bothell, Washington

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What LeonaBio, 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$5.7M2 Dec 31, 2025$5.7M2 Dec 31, 20240%
Accumulated depreciation$4.3M2 Dec 31, 2025$3.3M2 Dec 31, 2024+29.5%
Property and equipment, net$1.5M2 Dec 31, 2025$2.4M2 Dec 31, 2024−39.8%
Operating-lease assets (leased space)$535.0K2 Dec 31, 2025$808.0K2 Dec 31, 2024−33.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$69.3M2 Dec 31, 2025$48.4M2 Dec 31, 2024+43.0%
Marketable securities, current$19.1M2 Dec 31, 2025$2.8M2 Dec 31, 2024+571.7%

Properties, in its own words

Our corporate headquarters is located in Bothell, Washington, where we currently lease approximately 19,326 square feet of laboratory and office space, which leases expire in August 2027. We believe these facilities will be adequate for the foreseeable future and that suitable additional or substitute space will be available as and when needed.

Item 2 of the 10-K filed Mar 31, 2026.4

Leadership

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

Chief executive

  1. Leen Kawas2020–2021
  2. Mark James Litton2022–now

President

  1. Leen Kawas2020–2021
  2. Mark James Litton2024–now

Chief financial officer

  1. Glenna Mileson2020–2023
  2. Andrew Gengos2024
  3. Robert Renninger2025–now

Chief operating officer

  1. Mark James Litton2020–2021
  2. Rachel Lenington2021–2024
2025
Board members and other officers (19)

Former names

  • Athira Pharma, Inc.Sep 19, 2019 to Jan 8, 20263
  • M3 Biotechnology, Inc.Oct 3, 2014 to Jan 23, 20193

Timeline

  1. Sep 22, 20268-K Other events37
  2. Aug 26, 20268-K Other events38
  3. Aug 14, 20268-K Results of operations; Regulation FD disclosure39
  4. Jun 23, 20268-K Shareholder vote40
  5. May 7, 20268-K Results of operations; Regulation FD disclosure41
  6. Mar 31, 20268-K Completed an acquisition or sale42
  7. Mar 26, 20268-K Results of operations; Regulation FD disclosure43
  8. Mar 19, 20268-K Executive or director change; Shareholder vote; Other events44
  9. Jan 9, 20268-K Executive or director change; Bylaws or fiscal year changed; Regulation FD disclosure45
  10. Dec 18, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure46
  11. Dec 18, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure47
  12. Nov 6, 20258-K Results of operations; Regulation FD disclosure48
  13. Jan 31, 2022New chief executive Mark James Litton becomes CEO12
  14. Sep 17, 2020New chief executive Leen Kawas becomes CEO13

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.68) a share, on Nov 6, 2025.49

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results39
  2. May 7, 2026Reported quarterly or annual results41
  3. Mar 26, 2026Reported quarterly or annual results43
  4. Nov 6, 2025Reported quarterly or annual results48
  5. Aug 7, 2025Reported quarterly or annual results50
  6. May 9, 2025Reported quarterly or annual results51
  7. Feb 27, 2025Reported quarterly or annual results52
  8. Nov 7, 2024Reported quarterly or annual results53

Drug trials and FDA: coming up

  1. Apr 2027Phase 3 trial readout expected Phase 3 trial of Lasofoxifene in combination with abemaciclib and Fulvestrant in combination with abemaciclib in Metastatic Breast Cancer: primary completion expected Apr 2027 (ClinicalTrials.gov NCT05696626).54

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

358 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 48 major events, 168 insider forms, 33 large holders, 88 other. The latest 20:

  1. Sep 22, 20268-K EDGAR
  2. Sep 3, 20263 PRIMARY DOCUMENT EDGAR
  3. Aug 31, 2026SCHEDULE 13D EDGAR
  4. Aug 26, 20268-K EDGAR
  5. Aug 25, 2026SCHEDULE 13D/A EDGAR
  6. Aug 20, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 202610-Q EDGAR
  8. Aug 14, 20268-K EDGAR
  9. Jul 10, 20264 EDGAR
  10. Jul 9, 20264 EDGAR
  11. Jun 24, 20264 EDGAR
  12. Jun 24, 20264 EDGAR
  13. Jun 24, 20264 EDGAR
  14. Jun 24, 20264 EDGAR
  15. Jun 24, 20264 EDGAR
  16. Jun 24, 20264 EDGAR
  17. Jun 24, 20264 EDGAR
  18. Jun 24, 20264 EDGAR
  19. Jun 24, 20264 EDGAR
  20. Jun 23, 20268-K EDGAR

The 358 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

58 open-market trades by officers, directors and large owners since October 2021: 18 buys and 40 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 4, 2026Renninger RobertCHIEF FINANCIAL OFFICERSale906$5.37$4.9KForm 4
Mar 4, 2026Worthington MarkGENERAL COUNSEL and CCOSale1,328$5.37$7.1KForm 4
Mar 4, 2026CHURCH KEVINCHIEF SCIENTIFIC OFFICERSale1,359$5.37$7.3KForm 4
Mar 4, 2026San Martin JavierCHIEF MEDICAL OFFICERSale1,720$5.37$9.2KForm 4
Mar 4, 2026Litton Mark JamesPRESIDENT and CEOSale5,156$5.37$27.7KForm 4
Jan 2, 2026Renninger RobertCHIEF FINANCIAL OFFICERSale297$6.88$2.0KForm 4
Jan 2, 2026Worthington MarkGENERAL COUNSEL and CCOSale876$6.88$6.0KForm 4
Jan 2, 2026CHURCH KEVINCHIEF SCIENTIFIC OFFICERSale876$6.88$6.0KForm 4
Jan 2, 2026San Martin JavierCHIEF MEDICAL OFFICERSale1,644$6.88$11.3KForm 4
Jan 2, 2026Litton Mark JamesPRESIDENT and CEOSale2,586$6.88$17.8KForm 4
Jul 1, 2025CHURCH KEVINCHIEF SCIENTIFIC OFFICERSale8,526$0.29$2.5KForm 4
Jul 1, 2025Litton Mark JamesPRESIDENT and CEOSale25,123$0.29$7.3KForm 4
Jul 1, 2025San Martin JavierCHIEF MEDICAL OFFICERSale10,842$0.29$3.1KForm 4
Jul 1, 2025Worthington MarkGENERAL COUNSEL and CCOSale8,526$0.29$2.5KForm 4
Jul 1, 2025Renninger RobertCHIEF FINANCIAL OFFICERSale2,897$0.29$840Form 4
Jan 2, 2025San Martin JavierCHIEF MEDICAL OFFICERSale10,826$0.56$6.1KForm 4
Jan 2, 2025Litton Mark JamesPRESIDENT and CEOSale25,107$0.56$14.1KForm 4
Jan 2, 2025CHURCH KEVINCHIEF SCIENTIFIC OFFICERSale8,510$0.56$4.8KForm 4
Jan 2, 2025Renninger RobertCHIEF FINANCIAL OFFICERSale2,881$0.56$1.6KForm 4
Jan 2, 2025Worthington MarkGENERAL COUNSEL and CCOSale8,510$0.56$4.8KForm 4

All 58 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
2025Mark Litton, Ph.D.President and Chief Executive Officer58$625.0K$1.4M69
2025Javier San Martin, M.D.Chief Medical Officer$500.0K$810.1K69
2025Mark WorthingtonGeneral Counsel, Chief Compliance Officer and Corporate Secretary$450.0K$731.5K69
2024Mark Litton, Ph.D.President and Chief Executive Officer58$625.0K$3.2M69
2024Mark WorthingtonGeneral Counsel, Chief Compliance Officer and Corporate Secretary$450.0K$1.3M69

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 44. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Perceptive Advisors LLC1,859,322$17.1M0.3%No change
Kalehua Capital Management LLC787,402$7.2M2.3%No change
ADAR1 Capital Management, LLC777,100$7.1M0.3%+49,619
Acorn Capital Advisors, LLC634,539$5.8M1.6%No change
NEA Management Company, LLC464,398$4.3M0.3%No change
Commodore Capital LP464,398$4.3M0.3%No change
TCG Crossover Management, LLC464,398$4.3M0.1%No change
Spruce Street Capital LP393,701$3.6M0.7%No change
Blackstone Inc.324,638$3.0M0.0%New
Adage Capital Partners Gp, L.l.c.300,000$2.8M0.0%New
Vanguard Capital Management LLC275,233$2.5M0.0%+80,473
Seven Fleet Capital Management LP154,153$1.4M0.2%−10,523
Simplify Asset Management Inc.149,279$1.4M0.0%No change
Propel Bio Management, LLC149,279$1.4M0.7%No change
Geode Capital Management, LLC80,418$739.5K0.0%+95
BlackRock, Inc.79,186$727.7K0.0%+23,135
Renaissance Technologies LLC77,424$711.5K0.0%+13,202
Vanguard Fiduciary Trust Co42,814$393.5K0.0%+2,775
Bank Of America Corp /de/32,557$299.2K0.0%−9
Millennium Management LLC32,450$298.2K0.0%+772
Laird Norton Wetherby Trust Company, LLC21,818$200.5K0.0%No change
State Street Corp16,337$150.1K0.0%No change
Dimensional Fund Advisors LP14,728$135.4K0.0%New
Northern Trust Corp14,394$132.3K0.0%No change
Two Sigma Investments, LP13,276$122.0K0.0%No change

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

SEC filer profile

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

  • Name on EDGARLeonaBio, Inc.1
  • CIK0001620463
  • Employer ID (EIN)45-33684874
  • 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)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address18706 North Creek Parkway, Suite 104, Bothell, WA 980111
  • Phone(425) 620-85011
  • Shares outstanding9,421,663 as of Aug 4, 202611
  • Public float$9.9M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Seattle, Washington PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceOct 3, 20141
  • Filings464 in all: 4 (175), 8-K (56), 3 (24), DEFA14A (20), 10-Q (18), CORRESP (14), DFAN14A (11), SC 13G/A (11)1
    All 45 form types

    144 (10), SC 13G (9), UPLOAD (9), 4/A (8), S-8 (8), SCHEDULE 13G/A (7), 10-K (6), D/A (6), DEF 14A (6), EFFECT (6), S-1/A (5), SCHEDULE 13D/A (5), ARS (4), D (4), S-3 (4), SCHEDULE 13G (4), PRE 14A (3), PREC14A (3), SC 13D/A (3), 424B3 (2), 424B4 (2), 8-K/A (2), DEFC14A (2), DRS (2), S-1 (2), SEC STAFF LETTER (2), 10-Q/A (1), 3/A (1), 424B5 (1), 5 (1), 8-A12B (1), CERT (1), DEFR14A (1), DRSLTR (1), S-1MEF (1), SC 13D (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) May 11, 2026
    Latest 8-K (8-K) Sep 22, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareLONAThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks LeonaBio, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 80 risks under these headings, as written.4

  • We are a clinical-stage biopharmaceutical company with a limited operating history.
  • Our approach to inhibiting estrogen receptor signaling in both wild-type and ESR1-mutated breast cancer through treatment by lasofoxifene exposes us to unforeseen risks. We have limited data from preclinical studies and clinical trials to date, and we cannot be certain that future trials will yield data in support of the safety, efficacy and tolerability of our drug candidates.
  • Our approach to targeting neurotrophic factors through the use of small molecules like ATH-1105 is based on a novel therapeutic approach, which exposes us to unforeseen risks. We have limited data from preclinical studies and clinical trials to date, including for ATH-1105, and we cannot be certain that future trials will yield data in support of the safety, efficacy and tolerability of our drug candidates.
  • Our development of lasofoxifene or ATH-1105 may never lead to marketable products.
  • Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve a number of objectives.
  • Treatment of central and peripheral nervous system degenerative disorders is a field that has seen very limited success in product development and our research and development efforts may be unsuccessful.
  • We have no marketed proprietary products and have not yet completed any Phase 3 clinical trials, which makes it difficult to assess our ability to develop our future product candidates and commercialize any resulting products independently.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of preclinical studies and earlier clinical trials with a single or few clinical trial sites may not be predictive of eventual safety or effectiveness in large-scale potentially pivotal clinical trials across multiple clinical trial sites. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials on the expected timelines, if at all.
  • We may not be successful in integrating lasofoxifene into our pipeline of product candidates.
  • We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our long-term prospects depend in part upon discovering, developing and commercializing additional drug candidates, which may fail in development or suffer delays that adversely affect their commercial viability.
  • We have been and may in the future be subject to claims, lawsuits, arbitration proceedings, government investigations, securities class action litigation and other legal, regulatory and administrative proceedings and face potential liability and expenses related thereto, which could divert management’s attention, and insurance coverage may not be sufficient to cover all costs and damages. This could have a material adverse effect on our business, operating results and financial condition.
The other 68 risks
  • Washington State University (“WSU”) previously announced that it had undertaken a review of prior claims of potential research misconduct involving our former chief executive officer’s doctoral research at WSU. We cannot predict what conclusions WSU has reached or may reach in the future, whether or when WSU would share its conclusions with us or the public, and what effect, if any, this review could have on our business and reputation.
  • Any “topline”, interim, initial, or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our reporting of topline or final data for our clinical trials may be delayed and our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
  • We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer, or less expensive than the drug candidates we develop, our commercial opportunities will be negatively impacted.
  • We may develop drug candidates in combination with other therapies, which exposes us to additional risks.
  • We may not realize all the anticipated benefits of our corporate rebranding and it may result in unanticipated disruptions to our on-going business.
  • We will require substantial additional funding to finance our operations, complete the development and commercialization of our product candidates, and develop and commercialize other current and potential drug candidates. If we are unable to raise this funding and access capital when needed, we may be forced to delay, reduce, or eliminate our drug product development programs, commercialization efforts or other operations.
  • As a result of our failure to timely file a Current Report on Form 8-K, we are currently ineligible to file registration statements on Form S-3, which may impair our ability to raise capital on terms favorable to us, in a timely manner or at all.
  • We may become obligated to pay liquidated damages if we fail to obtain effectiveness and maintain effectiveness of registration statements in accordance with the terms of registration rights agreements related to our December 2025 private placement and Sermonix Securities issuance.
  • We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.
  • Adverse events or perceptions affecting the financial services industry could adversely affect our operating results, liquidity, financial condition and prospects.
  • The value of our investments is subject to significant capital markets risk related to changes in interest rates and credit spreads as well as other investment risks, which may adversely affect our operating results, liquidity, financial condition and prospects.
  • Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
  • Changes in tax laws could have a material adverse effect on our business, cash flows, results of operations or financial condition.
  • The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our drug candidates, we will not be able to commercialize, or will be delayed in commercializing, our drug candidates, and our ability to generate revenue will be materially impaired.
  • Our current or future drug candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could inhibit regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
  • Obtaining and maintaining regulatory approval of our drug candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our drug candidates in other jurisdictions.
  • Even if we receive regulatory approval of our drug candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drug candidates.
  • Disruptions at the FDA, the SEC and other government agencies under the current administration, funding cuts or shortages, global health concerns, or other events could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We may face difficulties from changes to current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • We may use strategic collaborations, licensing arrangements or partnerships to accelerate the development and maximize the commercial potential of our programs, and we may not realize the benefits of such collaborations, arrangements or partnerships.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • We rely on third parties to conduct our nonclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our drug candidates.
  • We contract with third parties for the manufacture of our drug candidates for nonclinical studies and our clinical trials, and expect to continue to do so for additional clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
  • If our third-party manufacturers use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Even if approved, our drug candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
  • We have never commercialized a drug candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any drug products on our own or together with suitable collaborators.
  • If the market opportunity for any drug candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Our drug candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current drug products could limit our ability to market those drug products and decrease our ability to generate revenue.
  • A variety of risks associated with marketing our drug candidates internationally may materially adversely affect our business.
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • If the scope of any patent protection we obtain is not sufficiently broad or the term is not sufficiently long, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to our drug candidates through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our patents or any current or future licensors’ patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents or any current or future licensors’ patents could be found invalid or unenforceable if challenged in court.
  • Intellectual property litigation or legal proceedings may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications or those of any current or future licensors and the enforcement or defense of our issued patents or those of any current or future licensors.
  • Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on our drug candidates for an adequate amount of time.
  • If we do not obtain patent term extension for our drug candidates, our business may be materially harmed.
  • We will not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of third parties.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • Our rights to develop and commercialize our drug candidates may be subject, in part, to the terms and conditions of licenses granted to us by others.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights or other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • The patent protection and patent prosecution for some of our drug candidates may be dependent on third parties.
  • Intellectual property discovered or developed through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a manufacturing preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers, which could adversely affect our ability to successfully develop and commercialize our drug products.
  • We are dependent on networks, infrastructure and data, which exposes us to data security risks, including security failures or breaches of our systems or those used by our CROs or other contractors or consultants. We are dependent upon our own or third-party information technology systems, infrastructure and data, including mobile technologies, to operate our business. The multitude and complexity of our computer systems may fail or suffer security breaches.
  • Data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
  • We do not know whether an active market for our common stock will be sustained, and, as a result, it may be difficult for you to sell your shares of our common stock.
  • The market price of our common stock has been and may continue to be volatile, which could result in substantial losses for investors.
  • Future sales, or the perception of future sales, of a substantial amount of our common stock could depress the trading price of our common stock.
  • Our reverse stock split to regain compliance with the Nasdaq Capital Market Minimum Bid Requirement may not result in a lasting proportional increase in the per share price of our common stock and may decrease the liquidity of our common stock.
  • We and certain of our directors and executive officers have previously been, and may in the future be, named as defendants in lawsuits that could result in substantial costs and divert management’s attention.
  • Actions by activist stockholders have in the past been, and may in the future be, disruptive and could cause uncertainty about the strategic direction of our business.
  • A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
  • Our directors, executive officers and significant stockholders collectively own a substantial percentage of our common stock, which could limit your ability to affect the outcome of key transactions, including a change of control.

Legal proceedings

From time to time, we are subject to various legal proceedings or claims that arise in the ordinary course of business. As of December 31, 2025, we are not a party to any legal proceedings that, in the opinion of our management, would reasonably be expected to have a material adverse effect on our business, financial condition, operating results or cash flows if determined adversely to us. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.4

Sources

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