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KYTX on Nasdaq

Kyverna Therapeutics, Inc.

Kyverna Therapeutics, Inc. is an American biological products company based in Emeryville.1 Its shares trade on Nasdaq under the symbol KYTX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerKYTX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersEmeryville, California1
  • Incorporated inDE2
  • Business address5980 Horton Street, Suite 200, Emeryville, Ca2
  • Filer category, Emerging growth company2
  • Legal formCorporation

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Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income34-$169.8M in 2025+172% since 2023
-$200.0M-$150.0M-$100.0M-$50.0M02023: -$62.4M-$62.4M20232024: -$142.6M-$142.6M2024+129%2025: -$169.8M-$169.8M2025+19%
Net income34-$161.3M in 2025+167% since 2023
-$200.0M-$150.0M-$100.0M-$50.0M02023: -$60.4M-$60.4M20232024: -$127.5M-$127.5M2024+111%2025: -$161.3M-$161.3M2025+27%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Research and development$133.7M$112.5M
General and administrative$36.1M$30.1M
Total operating expenses$169.8M$142.6M
Loss from operations-$169.8M-$142.6M
Interest income$9.1M$15.4M
Interest expense-$489.0K-$142.0K
Other expense, net-$85.0K-$90.0K
Total other income, net$8.5M$15.1M
Net loss-$161.3M-$127.5M
Unrealized gain (loss) on available-for-sale marketable securities, net-$8.0K$101.0K
Total other comprehensive gain (loss)-$8.0K$101.0K
Net loss and other comprehensive loss-$161.3M-$127.4M
Net loss per share attributable to common stockholders, basic-$3.64-$3.33
Net loss per share attributable to common stockholders, diluted-$3.64-$3.33
Weighted-average shares of common stock outstanding, basic44.3M shares38.3M shares
Weighted-average shares of common stock outstanding, diluted44.3M shares38.3M shares

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Corporate structure

Kyverna Therapeutics, 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 Kyverna Therapeutics, Inc.

  • Kyverna Therapeutics, Inc. Emeryville, California

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

What it owns

What Kyverna Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$5.3M4 Dec 31, 2025$7.0M4 Dec 31, 2024−24.5%
Accumulated depreciation$3.8M4 Dec 31, 2025$3.7M4 Dec 31, 2024+2.1%
Property and equipment, net$1.5M4 Dec 31, 2025$3.3M4 Dec 31, 2024−53.8%
Finance-lease assets$305.0K4 Dec 31, 2025$841.0K4 Dec 31, 2024−63.7%
Operating-lease assets (leased space)$3.6M4 Dec 31, 2025$6.5M4 Dec 31, 2024−44.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$124.1M4 Dec 31, 2025$96.6M4 Dec 31, 2024+28.4%
Marketable securities, current$155.2M4 Dec 31, 2025$189.4M4 Dec 31, 2024−18.1%
Debt securities available for sale$277.3M4 Dec 31, 2025$285.4M4 Dec 31, 2024−2.8%

Properties, in its own words

Our corporate headquarters are located in Emeryville, California, where we house our administrative, manufacturing and R&D activities. We currently lease approximately 68,000 square feet of space as our primary headquarters in Emeryville, California under a lease, as amended, that expires on August 31, 2030. Under the amended lease, we will decrease total space to 45,980 square feet on or around July 2026, as we believe this slightly reduced footprint is adequate to meet our current needs, particularly given a more remote workforce, and that suitable additional alternative spaces will be available in the future, as needed, on commercially reasonable terms.

Item 2 of the 10-K filed Mar 26, 2026.7

Leadership

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

Chief executive

  1. Peter Maag2024
  2. Warner Weston Biddle2024–now

Chair

  1. Christi Shaw2026–now

Chief financial officer

  1. Ryan Alexander Jones2024–2025
  2. Marc Grasso2025–2026
  3. Gregory S. Martini2026–now
2025
Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerDominic Borie named Nov 7, 202327
  • Executive OfficerJames Chung named Nov 7, 202327
  • Executive OfficerKaren Walker named Nov 7, 202327
  • DirectorBeth Spiegelman named Nov 7, 202327

Timeline

  1. Sep 24, 20268-K Regulation FD disclosure28
  2. Aug 11, 20268-K Results of operations29
  3. Jul 27, 20268-K Entered a material agreement; Regulation FD disclosure30
  4. Jul 9, 20268-K Entered a material agreement31
  5. Jun 2, 20268-K Shareholder vote32
  6. May 18, 20268-K Executive or director change; Other events33
  7. May 12, 20268-K Results of operations34
  8. May 4, 20268-K Other events35
  9. Apr 22, 20268-K Regulation FD disclosure36
  10. Apr 22, 20268-K Regulation FD disclosure37
  11. Apr 20, 20268-K Regulation FD disclosure38
  12. Mar 26, 20268-K Results of operations39
  13. Sep 18, 2024New chief executive Warner Weston Biddle becomes CEO9
  14. Feb 7, 2024New chief executive Peter Maag becomes CEO8

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.85) a share, on Nov 12, 2025.40

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results29
  2. May 12, 2026Reported quarterly or annual results34
  3. Mar 26, 2026Reported quarterly or annual results39
  4. Jan 12, 2026Reported quarterly or annual results41
  5. Nov 12, 2025Reported quarterly or annual results42
  6. Aug 12, 2025Reported quarterly or annual results43
  7. May 13, 2025Reported quarterly or annual results44
  8. Mar 27, 2025Reported quarterly or annual results45

Drug trials and FDA: coming up

  1. Apr 2027Phase 2 trial readout expected Phase 2 trial of KYV-101, Standard lymphodepletion regimen and others in Multiple Sclerosis, Primary Progressive: primary completion expected Apr 2027 (ClinicalTrials.gov NCT06384976).46
  2. Sep 2027Phase 2/3 trial readout expected Phase 2/3 trial of Standard of Care Treatment, Standard lymphodepletion regimen and others in Myasthenia Gravis: primary completion expected Sep 2027 (ClinicalTrials.gov NCT06193889).47

Drug trials and FDA: recently

  1. Jun 25, 2026Phase 2 trial completed Phase 2 trial of Standard lymphodepletion regimen in Stiff-Person Syndrome: primary completion Jun 25, 2026, no results posted yet (ClinicalTrials.gov NCT06588491).48

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

186 filings to the SEC since October 2021: 3 annual reports, 8 quarterly reports, 41 major events, 68 insider forms, 12 large holders, 1 private raises, 53 other. The latest 20:

  1. Sep 24, 20268-K EDGAR
  2. Aug 14, 2026SCHEDULE 13G/A EDGAR
  3. Aug 11, 202610-Q EDGAR
  4. Aug 11, 20268-K EDGAR
  5. Jul 29, 2026SCHEDULE 13G EDGAR
  6. Jul 27, 20268-K EDGAR
  7. Jul 9, 20268-K EDGAR
  8. Jun 2, 20268-K EDGAR
  9. May 29, 20264 EDGAR
  10. May 29, 20264 EDGAR
  11. May 29, 20264 EDGAR
  12. May 29, 20264 EDGAR
  13. May 29, 20264 EDGAR
  14. May 20, 20263 EDGAR
  15. May 20, 20264 EDGAR
  16. May 18, 20268-K EDGAR
  17. May 12, 202610-Q EDGAR
  18. May 12, 20268-K EDGAR
  19. May 6, 20264 EDGAR
  20. May 6, 20263 EDGAR

The 186 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

7 open-market trades by officers, directors and large owners since October 2021: 6 buys and 1 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 18, 2025SEIDENBERG BETH CDirectorBuy133,333$7.50$1.0MForm 4
Dec 18, 2025Westlake BioPartners Opportunity Fund I, L.P.10% ownerBuy133,333$7.50$1.0MForm 4
Dec 15, 2025Walker Karen MarieChief Technology OfficerSale23,998$12.20$292.8KForm 4
Feb 12, 2024GILEAD SCIENCES, INC.10% ownerBuy910,000$22.00$20.0MForm 4
Feb 12, 2024Vida Ventures GP III, L.L.C.10% ownerBuy253,136$22.00$5.6MForm 4
Feb 12, 2024Bain Capital Life Sciences Fund III, L.P.10% ownerBuy450,000$22.00$9.9MForm 4
Feb 12, 2024Northpond Ventures III GP, LLCBuy450,000$22.00$9.9MForm 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
2025Naji GehchanM.D.44$481.7K$2.1M57
2025Warner Biddle59$625.0K$1.8M57
2025Marc GrassoM.D.53$257.0K$1.7M57
2024Chief Executive Officer$182.3K$15.0M57

Funding

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

Money received by year$152.0M 2021–2021
Money received by yearMoney received by year, 2021–2021: $152.0M in all. Private raises (Form D) $152.0M.$0$50M$100M$150M$200M2021 · Private raises (Form D): $152.0M2021
Figures by year
YearPrivate raises (Form D)Total
2021$152.0M$152.0M

Private raises

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

  1. Nov 9, 2021Raised $152 million in a private offering of equity27 Form D: 24 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 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
GordonMD Global Investments LP4,244,818$37.8M18.3%No change
Gilead Sciences, Inc.4,126,119$36.8M2.2%No change
BlackRock, Inc.3,134,807$27.9M0.0%+2,257,729
Bain Capital Life Sciences Investors, LLC2,885,000$25.7M1.5%−225,000
AIGH Capital Management LLC2,795,797$24.9M2.3%+795,797
Deerfield Management Company, L.P.2,000,000$17.8M0.2%No change
Vanguard Capital Management LLC1,897,451$16.9M0.0%+114,109
Geode Capital Management, LLC1,049,430$9.4M0.0%+625,604
Insight Holdings Group, LLC989,054$8.8M0.7%No change
Morgan Stanley982,307$8.8M0.0%+5,018
State Street Corp982,233$8.8M0.0%+843,933
Propel Bio Management, LLC883,198$7.9M4.1%+238,777
Woodline Partners LP845,325$7.5M0.0%No change
Millennium Management LLC639,780$5.7M0.0%−365,728
Mbb Public Markets I LLC614,477$5.5M0.6%No change
Adage Capital Partners Gp, L.l.c.500,000$4.5M0.0%No change
D. E. Shaw & Co., Inc.469,346$4.2M0.0%−252,235
Wells Fargo & Company/mn373,009$3.3M0.0%+258,610
UBS Group AG365,574$3.3M0.0%−84,176
Goldman Sachs Group Inc335,230$3.0M0.0%+122,320
Renaissance Technologies LLC333,899$3.0M0.0%−33,593
Charles Schwab Investment Management Inc319,666$2.8M0.0%+108,578
Northern Trust Corp315,354$2.8M0.0%+237,312
Bnp Paribas Financial Markets310,632$2.8M0.0%−101,400
Vanguard Portfolio Management LLC282,189$2.5M0.0%New

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

SEC filer profile

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

  • Name on EDGARKyverna Therapeutics, Inc.1
  • CIK0001994702
  • Employer ID (EIN)83-13654417
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • 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 address5980 Horton Street, Suite 200, Emeryville, CA1
  • Phone51092524921
  • Shares outstanding61,843,444 as of Aug 3, 20266
  • Public float$64.5M as of Jun 30, 20257
  • AuditorBDO USA, P.C., San Diego, California PCAOB ID 243; no auditor attestation of internal control over financial reporting7
  • On EDGAR sinceOct 5, 20231
  • Filings186 in all: 4 (41), 8-K (41), 3 (27), 10-Q (8), UPLOAD (7), CORRESP (6), 144 (5), SC 13G (5)1
    All 30 form types

    424B5 (4), S-8 (4), SCHEDULE 13G/A (4), 10-K (3), DRS/A (3), DRSLTR (3), EFFECT (3), ARS (2), DEF 14A (2), DEFA14A (2), S-1/A (2), S-3 (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), CERT (1), D (1), DRS (1), FWP (1), S-1 (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 13, 2026
    Latest 8-K (8-K) Sep 24, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.00001 per shareKYTXThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Kyverna Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 73 risks under these headings, as written.7

  • Risks Related to Our Business, Limited Operating History and Financial Position
  • We have limited operating history, have incurred substantial net losses and anticipate that we will continue to incur net losses for the foreseeable future. We have no products approved for commercial sale, have never generated any revenue from product sales and may never be profitable.
  • We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • Our business depends entirely on the success of our product candidates and we cannot guarantee that any or all of our product candidates will successfully complete development, receive regulatory approval, or be successfully commercialized. If we are unable to develop, receive regulatory approval for, and ultimately successfully commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We 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 and resources to new compliance initiatives.
  • We have previously identified material weaknesses in our internal control over financial reporting, which were subsequently remediated. If we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • If our product candidates, if approved, do not achieve broad market acceptance, the revenue that we generate from their sales will be limited.
  • Covenants and other provisions in the Loan and Security Agreement with Oxford Finance may restrict our business and operations, and if we do not effectively manage our covenants, our financial conditions and results of operations could be adversely affected. In addition, our operations may not provide sufficient cash to meet the repayment obligations of our debt incurred under the Loan and Security Agreement.
  • Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could adversely affect our business, financial condition, results of operations and prospects.
  • We will need to grow our organization, and we may experience difficulties in managing our growth and expanding our operations, which could adversely affect our business. In addition, if we lose key management or other scientific or clinical personnel, or if we fail to recruit additional highly skilled personnel, our business, results of operations and financial condition could be adversely affected.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could adversely affect our business, results of operations and financial condition.
  • We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
The other 62 risks
  • Our ability to use our net operating loss, or NOL, carryforwards and certain other tax attributes to offset taxable income or taxes may be limited.
  • Recent and future changes to tax laws could materially adversely affect our company.
  • Our operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by a wildfire and earthquake or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • The increasing use of social media platforms presents new risks and challenges.
  • Unfavorable global economic conditions, including any adverse macroeconomic conditions or geopolitical events, could adversely affect our business, financial condition, results of operations or liquidity, either directly or through adverse impacts on certain of the third parties on which we rely to conduct certain aspects of our preclinical studies or clinical trials.
  • We or our directors or officers may be subject to securities litigation, which is expensive and could divert management attention.
  • Risks Related to Research, Development and Commercialization
  • We have never successfully completed any large-scale or pivotal clinical trials, and we may be unable to do so for any product candidates we develop.
  • Results of any patient who receives our product candidate in an investigator-initiated trial or on a named patient basis should not be viewed as representative of how the product candidate will perform in our clinical trials and may not be able to be used to establish safety or efficacy for regulatory approval.
  • Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome, 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 our current product candidates or any future product candidates.
  • If we encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected, which could adversely affect our business, results of operations and financial condition.
  • Interim, top-line 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.
  • We may expend our limited resources to pursue a particular product candidate in specific indications and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We may seek to establish commercial collaborations for our product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We face competition from entities that have made substantial investments into the rapid development of novel treatments for immunological indications, including large and specialty pharmaceutical and biotechnology companies, some of which already have approved therapies in our current indications.
  • If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our programs may be delayed and our expenses may increase and, as a result, our stock price may decline.
  • Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could cause us to suspend or discontinue clinical trials, cause us to abandon a product candidate, delay or preclude approval, prevent market acceptance, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, results of operations and financial condition.
  • Changes in product candidate manufacturing, formulation or analytical methods may result in additional costs or delay, which could adversely affect our business, results of operations and financial condition.
  • A variety of risks associated with conducting research and clinical trials abroad and marketing our product candidates internationally could materially adversely affect our business.
  • The manufacturing process for any products that we may develop is subject to the FDA or comparable foreign authority approval process, and we currently, and will need to continue to, contract with manufacturers who can meet our and all applicable FDA or comparable foreign authority requirements on an ongoing basis.
  • Risks Related to Intellectual Property
  • We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which could adversely affect our business, results of operations and financial condition.
  • If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates and any future product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and
  • commercialize products similar or identical to ours, and our ability to successfully develop and commercialize our product candidates may be adversely affected.
  • We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue, or that our issued patents or patents that issue in the future will not be challenged and rendered invalid and/or unenforceable.
  • Our pending and future patent applications may not result in patents being issued that protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive products.
  • If we fail to comply with our obligations under our patent licenses with third parties, we could lose license rights that are important to our business, which could adversely affect our business, results of operations and financial condition.
  • We cannot prevent other companies from licensing some of the same intellectual properties that we have licensed or from otherwise duplicating our business model and operations.
  • We may not be successful in obtaining or maintaining necessary rights to develop current and any future product candidates on acceptable terms.
  • Our product candidates licensed from various third parties may be subject to retained rights.
  • 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 product candidates. We may infringe the intellectual property rights of others, which may prevent or delay our drug development efforts and prevent us from commercializing or increase the costs of commercializing our products.
  • We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • We may become subject to claims challenging the inventorship or ownership of our or our licensors’ patents and other intellectual property or claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers.
  • Patent terms may be inadequate to protect our competitive position on products or 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.
  • 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.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • 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.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Government Regulation
  • 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 adversely affect our business, results of operations and financial condition.
  • We have conducted, are currently conducting, and may in the future conduct clinical trials for our product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Even if we receive marketing approval for our current or future product candidates in the United States, we may never receive regulatory approval to market outside of the United States.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Even if we commercialize any product candidates, alone or with our partners, such product may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.
  • Our relationships with healthcare providers and physicians and third-party payors may be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • We may not be successful in pursuing or maintaining Fast Track or other regulatory designations for our product candidates, and such designations may not actually lead to a faster development or regulatory approval process.
  • We may not be able to maintain or obtain additional orphan drug designation or orphan drug exclusivity for our product candidates.
  • We have received RMAT designation for miv-cel for the treatment of SPS and for the treatment of MG. This designation may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that such product candidates will receive marketing approval.
  • Recently enacted legislation, future legislation and other healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and may affect the prices we may set.
  • Changing regulatory environments could negatively impact our business.
  • Our business may be impacted by actions of the current U.S. administration, including executive orders, policies, new legislation and judicial decisions.
  • 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.
  • Disruptions at the FDA, the SEC and other government agencies, including from government shutdowns, or funding changes, or other disruptions to these agencies’ operations, could negatively impact our business, operations, regulatory interactions and access to capital.
  • Risks Related to Data and Privacy
  • If our internal information technology systems, or those used by our CROs, CMOs, clinical sites or other contractors or consultants upon which we rely, are or were compromised, become unavailable or suffer security breaches, loss or leakage of data or other disruptions, we could suffer material adverse consequences resulting from such compromise, including, but not limited to, operational or service interruption, harm to our reputation, litigation, fines, penalties and liability, compromise of sensitive information related to our business, and other adverse consequences.
  • Failure to comply with data privacy and security laws, regulations and other obligations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, negative publicity, and/or other adverse consequences that could negatively affect our operating results and business.
  • Foreign data protection laws, including the European Union’s General Data Protection Regulation, or the EU GDPR, and the UK equivalent of the same, or UK GDPR, may also apply to our processing of health-related and other personal data regardless of where the processing in question is carried out.
  • Artificial intelligence presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information and personal data.
  • Risks Related to Our Reliance on Third Parties
  • We have relied and expect to continue to rely on third parties to conduct our preclinical studies and clinical trials, as well as investigator-initiated trials. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss expected deadlines or terminate the relationship, our development programs could be delayed, or become more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.
  • We rely on third-party manufacturers and suppliers to supply our product candidates. The loss of our third-party manufacturers or suppliers, or their failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, within acceptable timeframes, or at all, would materially and adversely affect our business.
  • We depend on limited source suppliers for certain drug substances, drug products, raw materials, samples, components, and other materials used in our product candidates. If we are unable to source these supplies on a timely basis, or establish longer-term contracts with our CMOs, we will not be able to complete our clinical trials on time and the development of our product candidates may be delayed.
  • We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, which may be important to our business. If we are unable to enter into new collaborations, or if these or any of our current collaborations are not successful and we fail to realize the benefits of such collaborations or licensing arrangements, our business, results of operations and financial condition could be adversely affected.
  • Risks Related to Ownership of Our Common Stock
  • Our stock price may be volatile.
  • Our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts or any guidance we may publicly provide, each of which may cause our stock price to fluctuate or decline.
  • The market opportunities for our product candidates and forecasts of market growth may not be accurate, and the actual market for our products may be smaller than we estimate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. In December 2024, a shareholder class action complaint was filed in the United States District Court for the Northern District of California against our Company, certain of our current and former officers and directors, and the underwriters of our initial public offering. Per a stipulated schedule, an amended complaint was filed on May 2, 2025, or the Amended Complaint. The Amended Complaint alleges that the registration statement on Form S-1 filed in connection with our initial public offering and the prospectus contained therein contained material misstatements or omissions in violation of federal securities laws. Pursuant to a stipulated order setting a response schedule, on June 26, 2025, the defendants filed a motion to dismiss the Amended Complaint. Defendants filed a motion to dismiss all of the claims on June 26, 2025, with plaintiff filing an opposition on August 18, 2025. Defendants filed their reply brief in support of the motion to dismiss on September 26, 2025. Following oral argument, on March 23, 2026, the court issued an order granting defendants’ motion to dismiss on all claims. Plaintiff was provided leave to file an amended complaint within 28 days of the court’s March 23 order.

The opening of Item 3, Legal Proceedings.7

Sources

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