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Equillium, Inc.

Equillium, Inc. is a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders.2 It is headquartered in LaJolla, United States.2

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Last updated Oct 21, 2026.

Overview

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  • TickerEQ on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersLaJolla, United States2
  • Incorporated inDE3
  • Business address2223 Avenida De La Playa, Suite 105, La Jolla, Ca 920373
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300OC7SSPSNNGHE642
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O CORPORATION SERVICE COMPANY, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 63428972

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We are a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders with the mission to develop life-changing therapeutics for patients. Our primary goal is to advance EQ504, a novel aryl hydrocarbon receptor, or AhR, modulator, into and through clinical development.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 2024

-20.1%Operating margin6
-19.6%Net margin6
13.9%Revenue growth, 20246
-42.3%Return on equity6
-$19.1MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Other costs99¢$40.7M
  • Income tax1¢$361.0K

Out of $41.1M in revenue.6 The company lost money this year.

Financial statements

Revenue786$41.1M in 2024+161% since 2022
0$20.0M$40.0M$60.0M2022: $15.8M$15.8M20222023: $36.1M$36.1M2023+129%2024: $41.1M$41.1M2024+14%
Operating income91011786-$8.3M in 2024−69% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$26.7M-$26.7M20192020: -$29.5M-$29.5M2020+11%2021: -$37.8M-$37.8M2021+28%2022: -$62.1M-$62.1M2022+64%2023: -$14.5M-$14.5M2023−77%2024: -$8.3M-$8.3M2024−43%
Net income91011786-$8.1M in 2024−68% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$25.6M-$25.6M20192020: -$29.8M-$29.8M2020+16%2021: -$39.1M-$39.1M2021+31%2022: -$62.4M-$62.4M2022+60%2023: -$13.3M-$13.3M2023−79%2024: -$8.1M-$8.1M2024−40%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Revenue$41.1M
Research and development$12.8M$37.4M
General and administrative$10.8M$11.9M
Total operating expenses$23.6M$49.4M
Loss from operations-$23.6M-$8.3M
Interest income$833.0K$1.4M
Other income (expense), net$403.0K-$818.0K
Total other income, net$1.2M$563.0K
Loss before income tax expense-$22.4M-$7.7M
Income tax expense$0$361.0K
Net loss-$22.4M-$8.1M
Unrealized loss on available-for-sale securities, net-$3.0K-$15.0K
Foreign currency translation (loss) gain-$415.0K$656.0K
Total other comprehensive (loss) income, net-$418.0K$641.0K
Comprehensive loss-$22.8M-$7.4M
Net loss per share, basic-$0.39-$0.23
Net loss per share, diluted-$0.39-$0.23
Weighted-average number of common shares outstanding, basic57.3M shares35.4M shares
Weighted-average number of common shares outstanding, diluted57.3M shares35.4M shares

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Corporate structure

Equillium, Inc. sits at the top of its group. 4 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Equillium, Inc.

  • Equillium, Inc. LaJolla, California, United States
    • Ariagen, Inc. Subsidiary · Delaware, United States
    • Bioniz Therapeutics, Inc. Subsidiary · Delaware, United States
    • Equillium AUS Pty Ltd. Subsidiary · Australia

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 Equillium, 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
Accumulated depreciation$562.0K6 Dec 31, 2025$499.0K6 Dec 31, 2024+12.6%
Property and equipment, net$164.0K6 Dec 31, 2025$262.0K6 Dec 31, 2024−37.4%
Operating-lease assets (leased space)$658.0K6 Dec 31, 2025$364.0K6 Dec 31, 2024+80.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$30.3M6 Dec 31, 2025$18.1M6 Dec 31, 2024+67.4%
Marketable securities, current$4.5M6 Dec 31, 2024$17.6M8 Dec 31, 2023−74.6%
Debt securities available for sale$06 Dec 31, 2025

Properties, in its own words

We lease a total of approximately 5,545 square feet of office space for our current headquarters in La Jolla, California under leases that expire in February 2027. We also lease a total of approximately 5,086 square feet of laboratory space in San Diego, California, under a lease that expires in January 2028.

We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 25, 2026.5

Leadership

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

Chief executive

  1. Daniel Bradbury2018–2019
  2. Bruce D. Steel2020–now

Chair

  1. Daniel Bradbury2020–now

President

  1. Bruce D. Steel2018–now

Chief financial officer

  1. Jason A. Keyes2018–now

Chief operating officer

  1. Christine Zedelmayer2020–now
20202025
Board members and other officers (13)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Ariagen, Inc. Delaware4
  • Bioniz Therapeutics, Inc. Delaware4
  • Equillium AUS Pty Ltd. Australia4

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

Timeline

  1. Oct 5, 20268-K Other events32
  2. Aug 13, 20268-K Results of operations33
  3. May 29, 20268-K Shareholder vote34
  4. May 13, 20268-K Results of operations35
  5. Mar 25, 20268-K Results of operations36
  6. Mar 13, 20268-K Entered a material agreement; Unregistered sale of shares37
  7. Nov 13, 20258-K Results of operations38
  8. Oct 24, 20258-K Change of auditor39
  9. Oct 6, 20258-K Change of auditor; Executive or director change; Other events40
  10. Sep 19, 20258-K Other events41
  11. Sep 4, 20258-K Other events42
  12. Aug 11, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure43
  13. May 21, 2020New chief executive Bruce D. Steel becomes CEO15
  14. Oct 11, 2018New chief executive Daniel Bradbury becomes CEO16

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.06) a share, on Nov 13, 2025.44

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results33
  2. May 13, 2026Reported quarterly or annual results35
  3. Mar 25, 2026Reported quarterly or annual results36
  4. Nov 13, 2025Reported quarterly or annual results38
  5. Aug 4, 2025Reported quarterly or annual results45
  6. Apr 24, 2025Reported quarterly or annual results46
  7. Mar 27, 2025Reported quarterly or annual results47
  8. Nov 13, 2024Reported quarterly or annual results48

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

Filings

276 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 62 major events, 101 insider forms, 17 large holders, 76 other. The latest 20:

  1. Oct 5, 20268-K EDGAR
  2. Aug 13, 202610-Q EDGAR
  3. Aug 13, 20268-K EDGAR
  4. Aug 13, 2026SCHEDULE 13G EDGAR
  5. Aug 12, 2026SCHEDULE 13G/A EDGAR
  6. Jun 5, 2026144 EDGAR
  7. Jun 5, 20264 EDGAR
  8. Jun 5, 20264 EDGAR
  9. Jun 4, 2026144 EDGAR
  10. May 29, 20264 EDGAR
  11. May 29, 20264 EDGAR
  12. May 29, 20264 EDGAR
  13. May 29, 20264 EDGAR
  14. May 29, 20264 EDGAR
  15. May 29, 20264 EDGAR
  16. May 29, 20264 EDGAR
  17. May 29, 20268-K EDGAR
  18. May 27, 2026144 EDGAR
  19. May 15, 2026SCHEDULE 13G/A EDGAR
  20. May 15, 2026SCHEDULE 13G/A EDGAR

The 276 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

29 open-market trades by officers, directors and large owners since October 2021: 0 buys and 29 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 5, 2026Zedelmayer ChristineSr. Vice President and COOSale14,584$2.93$42.7KForm 4
Jun 5, 2026Connelly StephenPresident and CSOSale30,975$2.94$91.1KForm 4
Jun 4, 2026Connelly StephenPresident and CSOSale200,000$3.16$632.0KForm 4
May 28, 2026Tom PennyPrincipal Accounting OfficerSale65,000$2.95$191.8KForm 4
May 28, 2026Zedelmayer ChristineSr. Vice President and COOSale86,012$2.80$240.7KForm 4
May 27, 2026Zedelmayer ChristineSr. Vice President and COOSale9,821$2.70$26.5KForm 4
Mar 13, 2026Zedelmayer ChristineSr. Vice President and COOSale120,312$2.50$300.8KForm 4
Mar 9, 2026Zedelmayer ChristineSr. Vice President and COOSale181,219$2.00$362.4KForm 4
Feb 19, 2026Zedelmayer ChristineSr. Vice President and COOSale185,937$1.76$327.9KForm 4
Feb 19, 2026Zedelmayer ChristineSr. Vice President and COOSale185,937$1.76$327.9KForm 4
Jan 8, 2026Tom PennyPrincipal Accounting OfficerSale6,533$1.29$8.4KForm 4
Dec 23, 2025Zedelmayer ChristineSr. Vice President and COOSale100,000$1.50$150.0KForm 4
Dec 15, 2025Zedelmayer ChristineSr. Vice President and COOSale11,900$1.31$15.6KForm 4
Dec 12, 2025Zedelmayer ChristineSr. Vice President and COOSale23,804$1.34$31.9KForm 4
Nov 25, 2025Zedelmayer ChristineSr. Vice President and COOSale8,098$0.95$7.7KForm 4
Jan 23, 2025Keyes Jason AChief Financial OfficerSale10,000$0.65$6.5KForm 4
Nov 14, 2024Keyes Jason AChief Financial OfficerSale10,000$0.70$7.0KForm 4
Oct 28, 2024Zedelmayer ChristineSr. Vice President and COOSale15,000$1.25$18.8KForm 4
Oct 28, 2024Tom PennyPrincipal Accounting OfficerSale2,835$1.25$3.5KForm 4
Oct 25, 2024Tom PennyPrincipal Accounting OfficerSale683$1.25$854Form 4

All 29 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
2025Bruce D. Steel$519.2K$4.3M60
2025Stephen ConnellyPh.D.$455.2K$2.7M60
2025Christine Zedelmayer$441.3K$2.1M60
2024Chief Executive Officer$471.3K$684.4K60
2024President and Chief Scientific Officer$428.5K$519.4K60
2024Chief Operating Officer$415.3K$506.2K60

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 60. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Jupiter Topco LLC6,494,571$20.7M0.0%New
Decheng Capital LLC4,447,308$14.2M1.9%No change
Affinity Asset Advisors, LLC4,100,000$13.1M0.7%+2,873,690
ADAR1 Capital Management, LLC3,758,569$12.0M0.6%+31,910
Aberdeen Group plc3,631,659$11.6M0.0%+278,822
Woodline Partners LP3,500,901$11.2M0.0%No change
Ra Capital Management, L.P.3,096,336$9.9M0.1%No change
Stempoint Capital LP2,016,607$6.5M1.1%New
Vanguard Capital Management LLC1,822,812$5.8M0.0%+38,340
Eversept Partners, LP1,520,824$4.9M0.3%+21,831
Adage Capital Partners Gp, L.l.c.1,390,253$4.4M0.0%−3,939,163
Renaissance Technologies LLC637,617$2.0M0.0%−19,347
Exome Asset Management LLC552,956$1.8M1.1%New
DG Capital Management, LLC463,396$1.5M0.6%New
Diadema Partners LP400,282$1.3M0.5%−33,562
Geode Capital Management, LLC381,175$1.2M0.0%+2,362
Balyasny Asset Management L.P.344,409$1.1M0.0%−1,294,361
Tudor Investment Corp Et Al320,100$1.0M0.0%+300,000
Ikarian Capital, LLC303,555$971.4K0.2%No change
BlackRock, Inc.285,409$913.3K0.0%+157,557
Boothbay Fund Management, LLC284,330$909.9K0.0%+191,119
Cantor Fitzgerald, L. P.218,124$698.0K0.0%−44,519
Two Sigma Investments, LP206,853$661.9K0.0%−39,320
Vanguard Fiduciary Trust Co190,810$610.6K0.0%+1,280
State Street Corp174,060$557.0K0.0%No change

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

SEC filer profile

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

  • Name on EDGAREquillium, Inc.1
  • CIK0001746466
  • Employer ID (EIN)82-15547465
  • Filer statusNon-accelerated filer not 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 address2223 Avenida De La Playa, Suite 105, La Jolla, CA 920371
  • Phone(858) 412-53021
  • Shares outstanding63,408,082 as of Aug 7, 202613
  • Public float$7.1M as of Jun 30, 20255
  • AuditorCrowe LLP, Costa Mesa, California PCAOB ID 173; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceAug 3, 20181
  • Filings463 in all: 4 (157), 8-K (108), 10-Q (24), 3 (18), 144 (15), CORRESP (14), UPLOAD (12), 425 (9)1
    All 39 form types

    S-8 (9), 10-K (8), DEF 14A (8), EFFECT (8), SC 13G/A (8), 424B5 (7), SCHEDULE 13G (7), DEFA14A (6), S-3 (5), SC 13G (5), ARS (4), PRE 14A (4), SCHEDULE 13G/A (4), 4/A (2), 424B3 (2), 8-K/A (2), S-1 (2), S-1/A (2), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), DEFR14A (1), DRS (1), DRS/A (1), DRSLTR (1), RW (1), S-4 (1), S-4/A (1), S-8 POS (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 25, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 15, 2026
    Latest 8-K (8-K) Oct 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareEQNasdaq

From the cover page of the 10-K filed Mar 25, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Equillium, Inc. names in Item 1A of its 10-K filed Mar 25, 2026: 73 risks under these headings, as written.5

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception, expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
  • We will require substantial additional funding to complete the planned or future development and any commercialization of EQ504, EQ302 and any future product candidates. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our research and development programs or other operations.
  • Risks Related to our Business and to the Development and Regulatory Approval of our Product Candidates
  • We are highly dependent on the successful planned or future development of our current product candidates, EQ504 and EQ302, and we may not be able to obtain regulatory or marketing approval of, or successfully commercialize, these product candidates in any of the indications for which we plan to develop them.
  • We have and may in the future enter into partnerships or similar arrangements or otherwise monetize our pipeline through strategic transactions, which may harm our ability to realize a return, if any, on our investments and may increase our need for external funding.
  • We may wish to acquire rights to future assets through in-licensing or may attempt to form collaborations with respect to our current or future product candidates, but may not be able to do so, which may cause us to alter or delay our development and commercialization plans.
  • We have limited experience in clinical development and have not successfully completed late-stage clinical studies or obtained regulatory approval for any product candidate.
  • If we fail to develop or acquire other product candidates or products, our business and prospects would be limited.
  • Potential natural disasters, some possibly related to the increasing effects of climate change, could damage, destroy or disrupt clinical study sites, our office spaces, laboratories, and/or warehouses, which could have a significant negative impact on our operations.
  • The development and commercialization of biopharmaceutical products are subject to extensive regulation and we may not obtain regulatory approvals of our product candidates in any of the indications for which we plan to develop them, or any future product candidates, on a timely basis or at all.
  • Any delays in the commencement and completion, or any termination or suspension, of our planned or future clinical studies could result in increased costs to us, and delay or limit our ability to raise capital or generate revenue and adversely affect our commercial prospects.
The other 62 risks
  • If we experience delays or difficulties in enrolling patients in any future clinical studies, our receipt of necessary regulatory approval could be delayed or prevented.
  • Adverse side effects or other safety risks associated with our product candidates could delay or preclude approval, cause us to suspend or discontinue planned or future clinical studies, abandon further development, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Interim, topline or preliminary data from our planned or future clinical studies 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.
  • We have previously and may in the future use sites outside of the United States for any future clinical studies, including for EQ504 and possibly EQ302 or any other future product candidates. The FDA may not accept data from any such studies, in which case our development plans will be delayed, which could materially harm our business.
  • We may not be successful in our efforts to expand our pipeline by identifying additional indications for which to test our product candidates in the future. We may expend our limited resources to pursue a particular indication for a product candidate and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Even if we receive regulatory approval of any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, any of our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
  • Even if our product candidates receive marketing approval in any indication, they may fail to achieve the degree of market acceptance by physicians, patients, hospitals, healthcare payors and others in the medical community necessary for commercial success.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with contracted third parties to market and sell any of our approved products, we may not be able to generate product revenue.
  • We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their product candidates are shown to be safer or more effective than ours, then our commercial opportunity will be reduced or eliminated.
  • If market opportunities for our product candidates are smaller than we believe they are, our potential revenue may be adversely affected and our business may suffer.
  • Even if we receive marketing approval, we may not be able to successfully commercialize any of our approved products due to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could make it difficult for us to sell any of our approved products profitably.
  • Risks Related to Manufacturing and Our Reliance on Third Parties
  • The manufacture of pharmaceutical products is complex and we may encounter difficulties in production, distribution and delivery of our product candidates. If CMOs encounter such difficulties, our ability to provide supply of our product candidates for our planned or future clinical studies, our ability to obtain marketing approval, or our ability to obtain commercial supply of our products, if approved, could be delayed or stopped.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • We rely, and intend to continue to rely, on CROs to conduct our planned or future clinical studies and perform some of our planned or future research and nonclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.
  • Our reliance on contracted parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Intellectual Property
  • If we are unable to obtain or protect intellectual property rights covering our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to our product candidates, and we may not be able to compete effectively in our market.
  • If we are not able to obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for EQ504 and EQ302 or any other product candidates that we may identify, our business may be materially harmed.
  • In the future, we may need to obtain licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.
  • Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may rely on trade secret and proprietary know-how which can be difficult to trace and enforce and, if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may become 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 product candidates for an adequate amount of time.
  • 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.
  • Intellectual property rights may not address all potential threats to our competitive advantage.
  • Risks Related to Employees, Managing Our Growth and Other Legal Matters
  • We are highly dependent on the services of our key personnel.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • Third-party expectations relating to environmental, social and governance factors may impose additional costs and expose us to new risks.
  • Our employees, clinical study investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • If our information technology systems, or those of our CROs or other third parties upon which we rely, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of potential revenue or profits; and other adverse consequences.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We conduct significant operations through our Australian wholly-owned subsidiary. If we lose our ability to operate in Australia, or if our subsidiary is unable to receive the research and development tax credit allowed by Australian regulations, our business and results of operations will suffer.
  • Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict and may have a significant adverse effect on our business and results of operations.
  • If any of our services providers are characterized as employees, we would be subject to employment and tax withholding liabilities and other additional costs.
  • We may be subject to applicable foreign, federal and state fraud and abuse, transparency, government price reporting, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We are subject to certain U.S. and certain foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • Risks Related to Ownership of our Common Stock
  • The stock price of our common stock may be volatile or may decline regardless of our operating performance, and you could lose all or part of your investment.
  • We have in the past and may in the future fail to maintain compliance with the listing requirements of the Nasdaq Capital Market, and as a result, our common stock may be delisted from the Nasdaq Capital Market which could have a material adverse effect on our financial condition and could make it difficult for you to sell your shares.
  • Raising additional equity capital may cause dilution to our stockholders, and raising additional equity or debt capital may restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • If there are substantial sales of shares of our common stock, the price of our common stock could decline.
  • We have indemnity obligations and other responsibilities under the registration rights agreement and securities purchase agreement entered into with investors on August 12, 2025 and March 13, 2026. If these obligations are not met, we may be required to pay damages and indemnify the investors.
  • The concentration of our stock ownership will likely limit your ability to influence corporate matters, including the ability to influence the outcome of director elections and other matters requiring stockholder approval.
  • Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
  • Risks Related to Our Crypto Treasury Strategy
  • Cryptocurrencies are highly volatile assets, and fluctuations in the price of cryptocurrencies are likely to influence our financial results and the market price of our common stock.
  • We may use the net proceeds from any offering by the company to purchase cryptocurrencies, the price of which has been, and will likely continue to be, highly volatile.
  • Cryptocurrency and other digital assets are novel assets, and are subject to significant legal, commercial, regulatory and technical uncertainty.
  • Cryptocurrency holdings are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents.
  • We may face risks relating to the custody of our cryptocurrency, if any, including the loss or destruction of private keys required to access our cryptocurrency and cyberattacks or other data loss relating to our cryptocurrency.
  • Regulatory change reclassifying cryptocurrency as a security could lead to our classification as an “investment company” under the Investment Company Act of 1940, or the 1940 Act, and could adversely affect the market price of cryptocurrencies and the market price of our common stock.
  • We do not currently have the expertise to implement our cryptocurrency treasury reserve strategy and may fail to identify qualified individuals or asset managers to develop and execute successful investment or trading strategies.
  • Future developments regarding the treatment of digital assets for U.S. federal income and applicable state, local and non-U.S. tax purposes could adversely impact our business.
  • General Risk Factors
  • As a public company in the United States, we incur significant legal and financial compliance costs and we are subject to the Sarbanes-Oxley Act. We can provide no assurance that we will, at all times, in the future be able to report that our internal controls over financial reporting are effective.
  • We or the parties upon whom we depend on may be adversely affected by earthquakes, fires, other natural disasters, or other sudden, unforeseen and severe adverse events, including public health epidemics or outbreaks, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit our commercialization of any product candidates that we may develop.

Sources

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