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SPRB on Nasdaq

SPRUCE BIOSCIENCES, INC.

In its 2026 annual report the company says: “We are a biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. We have a diverse portfolio of product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are either no approved therapies treating the underlying disease or suboptimal treatment options.”4 It is headquartered in South San Francisco, California.1 Its shares trade on Nasdaq under the symbol SPRB.1

$40.47 up 1.49 (3.82%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerSPRB on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSouth San Francisco, California1
  • Incorporated inDE3
  • Business address611 Gateway Boulevard, Suite 740, South San Francisco, Ca 940803
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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We are a biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. We have a diverse portfolio of product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are either no approved therapies treating the underlying disease or suboptimal treatment options. We were founded in April 2016 and are led by a management team experienced in the development and commercialization of groundbreaking therapeutics.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

-100.0%Revenue growth, 20255
-91.7%Return on equity5
0.00×Debt to equity5

Financial statements

Revenue675$0 in 2025
0$5.0M$10.0M$15.0M2022: $0$020222023: $10.1M$10.1M20232024: $4.9M$4.9M2024−51%2025: $0$02025
Operating income8910675-$36.5M in 2025+179% since 2019
-$60.0M-$40.0M-$20.0M02019: -$13.1M-$13.1M20192020: -$29.4M-$29.4M2020+124%2021: -$42.1M-$42.1M2021+43%2022: -$47.3M-$47.3M2022+12%2023: -$52.0M-$52.0M2023+10%2024: -$56.2M-$56.2M2024+8%2025: -$36.5M-$36.5M2025−35%
Net income8910675-$39.0M in 2025+198% since 2019
-$60.0M-$40.0M-$20.0M02019: -$13.1M-$13.1M20192020: -$29.5M-$29.5M2020+126%2021: -$42.3M-$42.3M2021+43%2022: -$46.2M-$46.2M2022+9%2023: -$47.9M-$47.9M2023+4%2024: -$53.0M-$53.0M2024+11%2025: -$39.0M-$39.0M2025−27%

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

Period ending2025-12-312024-12-31
Collaboration revenue$0$4.9M
Research and development$19.5M$46.4M
General and administrative$17.0M$14.6M
Total operating expenses$36.5M$61.1M
Loss from operations-$36.5M-$56.2M
Interest expense-$90.0K-$307.0K
Change in fair value of warrant liability-$3.5M$0
Interest and other income, net$1.1M$3.4M
Net loss and comprehensive loss-$39.0M-$53.0M
Net loss per share, basic-$50.83-$96.40
Net loss per share, diluted-$50.83-$96.40
Weighted-average shares of common stock outstanding, basic766.6K shares550.1K shares
Weighted-average shares of common stock outstanding, diluted766.6K shares550.1K shares

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Corporate structure

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

Major holders of SPRUCE BIOSCIENCES, INC.

  • SPRUCE BIOSCIENCES, INC. South San Francisco, California

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

What it owns

What SPRUCE BIOSCIENCES, 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.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$48.9M5 Dec 31, 2025$38.8M5 Dec 31, 2024+26.2%
Debt securities available for sale$07 Dec 31, 2024$07 Dec 31, 2023

Properties, in its own words

Our corporate headquarters are located at 611 Gateway Boulevard, Suite 740, South San Francisco, California 94080, where we occupy approximately 6,500 square feet of office space pursuant to a lease entered in December 2022, which began in December 2022 and expires in February 2028.

We believe our existing facility meets our current needs.

Item 2 of the 10-K filed Mar 9, 2026.4

Leadership

Who has led SPRUCE BIOSCIENCES, INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Javier B. Szwarcberg2022–now

Chair

  1. Michael G. Grey2020–now

President

  1. Samir M. Gharib2022–now

Chief financial officer

  1. Samir M. Gharib2020–now
2025
Board members and other officers (16)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorSimpson Camilla named Feb 28, 2023 to Oct 17, 202532
  • DirectorDina Chaya named Feb 28, 202333

Timeline

  1. Aug 12, 20268-K Results of operations34
  2. Jul 27, 20268-K Executive or director change35
  3. May 26, 20268-K Shareholder vote36
  4. May 13, 20268-K Results of operations37
  5. Apr 22, 20268-K Entered a material agreement; Other events38
  6. Mar 20, 20268-K Ended a material agreement39
  7. Mar 9, 20268-K Entered a material agreement; Ended a material agreement; Results of operations40
  8. Feb 5, 20268-K Regulation FD disclosure; Other events41
  9. Jan 8, 20268-K Entered a material agreement; Results of operations; New debt or obligation42
  10. Dec 15, 20258-K Executive or director change43
  11. Dec 12, 20258-K Executive or director change44
  12. Nov 10, 20258-K Results of operations45
  13. Jan 10, 2022New chief executive Javier B. Szwarcberg becomes CEO13

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($14.58) a share, on Nov 10, 2025.46

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results34
  2. May 13, 2026Reported quarterly or annual results37
  3. Mar 9, 2026Reported quarterly or annual results40
  4. Jan 8, 2026Reported quarterly or annual results42
  5. Nov 10, 2025Reported quarterly or annual results45
  6. Aug 14, 2025Reported quarterly or annual results47
  7. May 6, 2025Reported quarterly or annual results48
  8. Apr 15, 2025Reported quarterly or annual results49

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

Filings

279 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 52 major events, 98 insider forms, 60 large holders, 2 private raises, 47 other. The latest 20:

  1. Aug 14, 2026SCHEDULE 13G EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 14, 2026SCHEDULE 13G EDGAR
  5. Aug 12, 202610-Q EDGAR
  6. Aug 12, 20268-K EDGAR
  7. Aug 4, 2026SCHEDULE 13G/A EDGAR
  8. Jul 30, 2026SCHEDULE 13G EDGAR
  9. Jul 29, 20264 EDGAR
  10. Jul 29, 20263 EDGAR
  11. Jul 27, 2026SCHEDULE 13G EDGAR
  12. Jul 27, 20268-K EDGAR
  13. Jul 9, 20264 EDGAR
  14. May 26, 20264 EDGAR
  15. May 26, 20264 EDGAR
  16. May 26, 20264 EDGAR
  17. May 26, 20264 EDGAR
  18. May 26, 20264 EDGAR
  19. May 26, 20268-K EDGAR
  20. May 15, 2026SCHEDULE 13G/A EDGAR

The 279 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

11 open-market trades by officers, directors and large owners since October 2021: 4 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 6, 2025Parkman Healthcare Partners LLC10% ownerBuy256$17.91$4.6KForm 4
Oct 6, 2025Parkman Healthcare Partners LLC10% ownerSale257$19.15$4.9KForm 4
Oct 6, 2025Parkman Healthcare Partners LLC10% ownerBuy256$17.91$4.6KForm 4
Oct 6, 2025Parkman Healthcare Partners LLC10% ownerSale257$19.15$4.9KForm 4
Mar 21, 2024Novo Holdings A/S10% ownerSale465,021$0.75$348.8KForm 4
Mar 20, 2024Novo Holdings A/S10% ownerSale359,979$0.73$262.8KForm 4
Mar 19, 2024Novo Holdings A/S10% ownerSale593,000$0.76$450.7KForm 4
Mar 18, 2024Novo Holdings A/S10% ownerSale842,020$0.77$648.4KForm 4
Mar 14, 2024Novo Holdings A/S10% ownerSale1,912,316$0.89$1.7MForm 4
Feb 16, 2023O'Donnell NiallDirectorBuy630,400$3.17$2.0MForm 4
Feb 16, 2023Novo Holdings A/S10% ownerBuy2,208,000$3.17$7.0MForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Javier SzwarcbergM.D., MPH$610.0K$2.9M75
2025Samir Gharib43$465.1K$1.5M75
2025Kirk Ways, M.D., Ph.D.Interim Chief Medical Officer74$442.1K$1.0M75
2024Chief Executive Officer$610.0K$1.5M75
2024President and Chief Financial Officer$465.1K$929.7K75

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Oct 9, 2025Raised $50 million in a private offering of equity Form D: 21 investors so far Form D
  2. Feb 16, 2023Raised $53.6 million in a private offering of equity Form D: 20 investors so far 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 63. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
AIGH Capital Management LLC250,000$13.5M1.2%New
Orbimed Advisors LLC200,000$10.8M0.2%New
BlackRock, Inc.187,836$10.1M0.0%+170,898
Millennium Management LLC160,981$8.7M0.0%+49,093
Ikarian Capital, LLC121,356$6.6M1.1%No change
Vanguard Capital Management LLC119,331$6.4M0.0%+100,994
Alyeska Investment Group, L.P.81,671$4.4M0.0%+30,000
Geode Capital Management, LLC70,548$3.8M0.0%+57,659
ADAR1 Capital Management, LLC67,717$3.7M0.2%+9,117
Cable Car Capital, LP60,000$3.2M0.1%New
Citadel Advisors LLC51,905$2.8M0.0%−18,094
State Street Corp50,450$2.7M0.0%+45,050
Boothbay Fund Management, LLC42,080$2.3M0.0%No change
Stempoint Capital LP41,388$2.2M0.4%+28,668
Eversept Partners, LP40,000$2.2M0.1%New
Carlyle Group Inc.38,620$2.1M0.0%No change
Goldman Sachs Group Inc32,348$1.7M0.0%+26,842
Affinity Asset Advisors, LLC30,000$1.6M0.1%New
Diadema Partners LP30,000$1.6M0.6%+20,000
Stonepine Capital Management, LLC28,795$1.6M1.2%New
Point72 Asset Management, L.P.28,278$1.5M0.0%New
Quinn Opportunity Partners LLC26,810$1.4M0.1%No change
UBS Group AG23,381$1.3M0.0%+19,462
ExodusPoint Capital Management, LP22,000$1.2M0.0%No change
Northern Trust Corp21,083$1.1M0.0%New

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

SEC filer profile

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

  • Name on EDGARSPRUCE BIOSCIENCES, INC.1
  • CIK0001683553
  • Employer ID (EIN)81-21542634
  • 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)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address611 Gateway Boulevard, Suite 740, South San Francisco, CA 940801
  • Phone(415) 655-41681
  • Shares outstanding2,874,013 as of Aug 10, 202612
  • Public float$2.8M as of Jun 30, 20254
  • AuditorBDO USA, P.C., San Jose, California PCAOB ID 243; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 28, 20201
  • Filings366 in all: 4 (111), 8-K (63), 3 (24), 10-Q (18), SC 13G/A (16), SCHEDULE 13G/A (14), SC 13D/A (13), SCHEDULE 13G (13)1
    All 37 form types

    SC 13G (10), DEFA14A (9), CORRESP (8), S-8 (8), 10-K (6), DEF 14A (6), EFFECT (5), 424B5 (4), ARS (4), S-3 (4), SC 13D (4), D (3), SCHEDULE 13D/A (3), UPLOAD (3), 144 (2), SEC STAFF LETTER (2), 4/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS (1), NT 10-K (1), PRE 14A (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3/A (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 9, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareSPRBNasdaq

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks SPRUCE BIOSCIENCES, INC. names in Item 1A of its 10-K filed Mar 9, 2026: 76 risks under these headings, as written.4

  • Risks Related to Our Business and Industry
  • We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern.
  • We will need substantial additional financing to develop our product candidates and implement our operating plan. If we fail to obtain additional financing, including as a result of geopolitical uncertainty and macroeconomic events, we may be forced to delay, reduce or eliminate our product development programs or commercialization efforts, which could significantly harm our business, financial condition, results of operations and prospects.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • We have a limited operating history, have incurred significant net losses since our inception, and anticipate that we will continue to incur significant net losses for the foreseeable future, and such net losses are expected to increase as we continue our clinical development of, and seek regulatory approvals for, our product candidate, TA-ERT, and our other current and future product candidates.
  • If we are unable to advance our product candidates in clinical development, obtain regulatory approval, and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We intend to seek FDA approval of TA-ERT for MPS IIIB through the accelerated approval pathway. If we are unable to obtain accelerated approval, we may be required to conduct additional preclinical studies or clinical trials beyond the confirmatory Phase 3 trial that we currently contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approval.
  • Our clinical trials may fail to adequately demonstrate that our product candidates are well tolerated and provide sufficient clinical benefits for patients, which could prevent or delay regulatory approval and commercialization.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • Preclinical and clinical drug development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results. We may incur additional costs or
  • experience delays in completing, or ultimately be unable to complete, the development and commercialization of TA-ERT and our other current and future product candidates.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
The other 65 risks
  • Any delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue, and adversely affect our commercial prospects.
  • TA-ERT and our other current and future product candidates will be subject to extensive regulation and compliance obligations, which are costly and time-consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize TA-ERT and our other current and future product candidates.
  • Interim, topline, and 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.
  • If the market opportunities for TA-ERT and our other current and future product candidates are smaller than we believe they are, our future revenue, if any, may be adversely affected, and our business may suffer.
  • Obtaining and maintaining regulatory approval for a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval for that product candidate in other jurisdictions.
  • We currently have no marketing and sales organization and have yet to commercialize a product. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell TA-ERT and our other current and future product candidates, we may not be able to generate any product revenues.
  • Unfavorable U.S. and global economic and geopolitical conditions could adversely affect our business, financial condition, results of operations and prospects.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • Use of TA-ERT and our other current and future product candidates could be associated with side effects, adverse events or other properties that could delay or prevent regulatory approval or result in significant negative consequences following marketing approval, if any.
  • If we receive regulatory approval for TA-ERT and our other current and future product 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 any product.
  • Changes in funding for the FDA and other government agencies, or comparable foreign regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
  • Even if we obtain regulatory approval for TA-ERT and our other current and future product candidates, they may not gain market acceptance among physicians, patients, healthcare payors and others in the medical community.
  • If TA-ERT and any other current or future product candidate is approved for marketing, and we are found to have improperly promoted off-label uses, or if physicians prescribe or use TA-ERT and any other current or future product candidates off-label, we may become subject to prohibitions on the sale or marketing of TA-ERT
  • and any other current or future product candidates, significant fines, penalties, sanctions, or product liability claims, and our image and reputation within the industry and marketplace could be harmed.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for TA-ERT and our other current or future product candidates, which could make it difficult for us to sell TA-ERT and our other current or future product candidates profitably.
  • Current and future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize TA-ERT and any other current or future product candidates and may affect the prices we may set.
  • Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates internationally.
  • Even if we obtain the necessary regulatory approvals, a variety of risks associated with marketing TA-ERT and any other current or future product candidates internationally could materially adversely affect our business.
  • If we fail to develop and commercialize additional product candidates, we may be unable to grow our business.
  • We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our indebtedness to Avenue Capital may limit our flexibility in operating our business and adversely affect our financial health and competitive position, and our obligations to Avenue Capital are secured by substantially all of our assets, including our intellectual property assets. If we default on these obligations, Avenue Capital could foreclose on our assets, which could materially adversely affect our business, financial condition, results of operations and prospects.
  • Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses.
  • Our employees, independent contractors, principal investigators, CROs, consultants, strategic partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our relationships with customers, healthcare providers and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other comparable foreign healthcare laws and regulations. If we or our employees, independent contractors, consultants, commercial partners, or vendors violate these laws, we could face substantial penalties.
  • If our information technology systems or data, or those of third parties with whom we work, 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 revenue or profits; and other adverse consequences.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of TA-ERT and any other current or future product candidates.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • 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.
  • Risks Related to Ownership of Our Common Stock
  • If we are unable to maintain compliance with all applicable requirements of the Nasdaq Capital Market (“Nasdaq”), our common stock could be subject to delisting which would adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.
  • The trading price of our common stock has been, and may continue to be volatile, and you could lose all or part of your investment.
  • We could be subject to securities class action litigation.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval.
  • We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • As a result of being a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock.
  • We have incurred and will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to registration statements, warrants, the Loan Agreement, any future loan agreements, and our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum 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 Reliance on Third Parties
  • We depend on intellectual property licensed from others, the termination of which could result in the loss of significant rights, which would harm our business.
  • We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize TA-ERT and our other current and future product candidates.
  • We rely completely on third parties to manufacture our preclinical and clinical drug supplies and we intend to rely on third parties to produce commercial supplies of TA-ERT and our other current and future product candidates, if approved, and these third parties may fail to obtain and maintain regulatory approval for their facilities, fail to provide us with sufficient quantities of drug product or fail to do so at acceptable quality levels or prices.
  • If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Social media platforms and AI-based platforms present new risks and challenges to our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain sufficient intellectual property protection for TA-ERT and our other current and future product candidates, and other proprietary technologies we develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize TA-ERT and our other current and future product candidates and other proprietary technologies, if approved, may be adversely affected.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties, such as our license agreement with Lilly and HBM License Agreement, or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, 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.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Third-party claims alleging intellectual property infringement may prevent or delay our drug discovery and development efforts.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees or consultants have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. Our reliance on third 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.
  • 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.
  • 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.

Legal proceedings

In January 2025, Neurocrine Biosciences, Inc. (“Neurocrine”) initiated proceedings seeking to invalidate European Patent 3,784,233 (the “Patent”) in the United Kingdom Patents Court (“UKPC”), and in August 2025, initiated similar proceeds before the Unified Patent Court (collectively, the “Patent Proceedings”). In February 2026, the UKPC issued a judgment ordering us to pay Neurocrine an interim payment of approximately $1.2 million for its legal costs. As of the year ended December 31, 2025, we accrued $1.9 million for loss contingencies associated with the Patent Proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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