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ANRO on NYSE

Alto Neuroscience, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options.”4 It is headquartered in Mountain View, California.1 Its shares trade on NYSE under the symbol ANRO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerANRO on NYSE1
  • IndustryPharmaceutical Preparations1
  • HeadquartersMountain View, California1
  • Incorporated inDE2
  • Business address650 Castro Street, Suite 450, Mountain View, Ca 940412
  • Filer category, Emerging growth company2
  • Legal formCorporation

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We are a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Through insig hts derived from our scalable and proprietary Precision Psychiatry Platform, or our Platform, we aim to discover brain-based biomarkers to better identify which patients are more likely to respond to our novel product candidates. Our current pipeline consists of seven clinical-stage assets addressing high-need therapeutic areas, including major depressive disorder, or MDD, bipolar depression, or BPD, treatment resistant depression, or TRD, schizophrenia, and Parkinson’s disease. Each of our programs, including our most advanced program — ALTO-207, are supported by robust clinical data in the respective patient populations in which we are developing them.4 From its latest annual report

Financials

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

Financial statements

Operating income56-$66.4M in 2025+76% since 2023
-$80.0M-$60.0M-$40.0M-$20.0M02023: -$37.8M-$37.8M20232024: -$68.6M-$68.6M2024+81%2025: -$66.4M-$66.4M2025−3%
Net income56-$63.2M in 2025+74% since 2023
-$80.0M-$60.0M-$40.0M-$20.0M02023: -$36.3M-$36.3M20232024: -$61.4M-$61.4M2024+69%2025: -$63.2M-$63.2M2025+3%

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

Period ending2025-12-312024-12-31
Research and development$45.6M$47.0M
General and administrative$20.7M$21.6M
Total operating expenses$66.4M$68.6M
Loss from operations-$66.4M-$68.6M
Interest income$6.6M$8.9M
Interest expense-$2.5M-$1.4M
Loss on debt extinguishment-$681.0K$0
Other, net-$327.0K-$297.0K
Total other income, net$3.1M$7.2M
Net loss-$63.2M-$61.4M
Change in fair value attributable to instrument specific credit risk$153.0K$0
Foreign currency translation-$30.0K-$22.0K
Total other comprehensive income (loss)$123.0K-$22.0K
Comprehensive loss-$63.1M-$61.5M
Net loss per share attributable to common stockholders, basic (in dollars per share)-$2.19-$2.50
Net loss per share attributable to common stockholders, diluted (in dollars per share)-$2.19-$2.50
Weighted-average number of common shares outstanding, basic (in shares)28.9M shares24.6M shares
Weighted-average number of common shares outstanding, diluted (in shares)28.9M shares24.6M shares

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Corporate structure

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

Major holders of Alto Neuroscience, Inc.

  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Aug 14, 2026 (3 filings since Oct 10, 2025)
  • Sirenia Capital Management LP Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Aug 14, 2026 (2 filings since May 15, 2026)
  • Vestal Point Capital, LP Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Aug 14, 2026 (3 filings since Feb 17, 2026)
  • BlackRock Filed SCHEDULE 13G on Alto Neuroscience, Inc., latest Jul 27, 2026 (4 filings since Oct 21, 2024)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G on Alto Neuroscience, Inc., latest Jul 20, 2026
  • Commodore Capital LP Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest May 15, 2026 (3 filings since Oct 27, 2025)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest May 15, 2026 (5 filings since Feb 7, 2024)
  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Feb 18, 2026 (4 filings since May 15, 2025)
  • K2 HealthVentures Equity Trust LLC Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Feb 17, 2026 (2 filings since May 15, 2025)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Feb 14, 2025 (3 filings since Mar 29, 2024)
  • FMR LLC Filed SCHEDULE 13G/A on Alto Neuroscience, Inc., latest Feb 12, 2025 (2 filings since Nov 12, 2024)
  • Amit Etkin Filed SC 13G on Alto Neuroscience, Inc., latest Nov 14, 2024
  • Alto Neuroscience, Inc. Mountain View, California
    • Alto Neuroscience (Australia) Pty Ltd Subsidiary · Australia

Built from 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 Alto Neuroscience, 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$1.5M6 Dec 31, 2025$1.0M6 Dec 31, 2024+52.0%
Property and equipment, net$1.9M6 Dec 31, 2025$2.7M6 Dec 31, 2024−29.8%
Operating-lease assets (leased space)$4.3M6 Dec 31, 2025$5.0M6 Dec 31, 2024−15.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$176.5M6 Dec 31, 2025$168.2M6 Dec 31, 2024+4.9%

Properties, in its own words

Our principal office is located at 650 Castro Street, Suite 450, Mountain View, CA 94041, where we lease 16,332 square feet of office space in a multi-tenant building under a lease with an initial lease term of 65 months that terminates in March 2030 with an option to extend up to an additional three years. We also have a one-time option to terminate the lease after the third lease year. We believe that our existing facility is 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 16, 2026.4

Leadership

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

Chief executive

  1. Amit Etkin2024–now

President

  1. Amit Etkin2024–now

Chief financial officer

  1. Nicholas Conrad Smith2024–now

Chief operating officer

  1. Michael Conick Hanley Jr.2024–now
2025
Board members and other officers (8)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorChristopher Nixon Cox named Nov 27, 2023 to Oct 27, 202519
  • DirectorRaymond Nixon Sanchez named Oct 27, 202519
  • DirectorAaron Weaver named Nov 27, 202320
  • DirectorChris Nixon Dimitropoulos named Nov 27, 202320
  • DirectorMichael Nixon Liang named Nov 27, 202320

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Alto Neuroscience (Australia) Pty Ltd Australia3

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

Timeline

  1. Aug 27, 20268-K Executive or director change21
  2. Aug 12, 20268-K Results of operations22
  3. Jul 14, 20268-K Entered a material agreement23
  4. Jul 13, 20268-K Results of operations; Other events24
  5. May 28, 20268-K Executive or director change25
  6. May 13, 20268-K Results of operations26
  7. May 13, 20268-K Executive or director change; Shareholder vote27
  8. Apr 1, 20268-K Other events28
  9. Mar 16, 20268-K Results of operations29
  10. Mar 16, 20268-K Entered a material agreement; Unregistered sale of shares; Other events30
  11. Nov 12, 20258-K Results of operations31
  12. Oct 20, 20258-K Entered a material agreement; Ended a material agreement; Unregistered sale of shares32
  13. Feb 1, 2024New chief executive Amit Etkin becomes CEO9

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.52) a share, on Nov 12, 2025.33

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results22
  2. Jul 13, 2026Reported quarterly or annual results24
  3. May 13, 2026Reported quarterly or annual results26
  4. Mar 16, 2026Reported quarterly or annual results29
  5. Nov 12, 2025Reported quarterly or annual results31
  6. Aug 13, 2025Reported quarterly or annual results34
  7. May 14, 2025Reported quarterly or annual results35
  8. Mar 20, 2025Reported quarterly or annual results36

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

Filings

195 filings to the SEC since October 2021: 3 annual reports, 8 quarterly reports, 30 major events, 70 insider forms, 34 large holders, 5 private raises, 45 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 1, 20264 EDGAR
  3. Sep 29, 2026144 EDGAR
  4. Aug 27, 20268-K EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 12, 202610-Q EDGAR
  9. Aug 12, 20268-K EDGAR
  10. Jul 27, 2026SCHEDULE 13G EDGAR
  11. Jul 20, 2026SCHEDULE 13G EDGAR
  12. Jul 14, 20268-K EDGAR
  13. Jul 14, 2026424B5 EDGAR
  14. Jul 13, 20268-K EDGAR
  15. May 29, 20264 EDGAR
  16. May 29, 20263 EDGAR
  17. May 28, 20268-K EDGAR
  18. May 15, 20264 EDGAR
  19. May 15, 2026SCHEDULE 13G/A EDGAR
  20. May 15, 2026SCHEDULE 13G/A EDGAR

The 195 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: 7 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 10, 2024Savitz AdamCHIEF MEDICAL OFFICERBuy2,931$13.22$38.7KForm 4
Jul 9, 2024Savitz AdamCHIEF MEDICAL OFFICERBuy12,069$12.60$152.1KForm 4
Mar 28, 2024Smith Nicholas ConradCHIEF FINANCIAL OFFICER & CBOBuy6,150$16.36$100.6KForm 4
Feb 6, 2024Smith Nicholas ConradCHIEF FINANCIAL OFFICER & CBOBuy1,563$16.00$25.0KForm 4
Feb 6, 2024Savitz AdamCHIEF MEDICAL OFFICERBuy17,000$16.00$272.0KForm 4
Feb 6, 2024Etkin AmitPRESIDENT AND CEOBuy3,125$16.00$50.0KForm 4
Feb 6, 2024Alpha Wave Global, LP10% ownerBuy600,000$16.00$9.6MForm 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
2025Amit Etkin, M.D., Ph.D.President, Chief Executive Officer, and Chair of the Board49$650.7K$2.2M50
2025Nicholas SmithChief Financial Officer and Chief Business Officer37$493.7K$1.5M50
2025Michael HanleyChief Operating Officer53$488.8K$1.2M50
2024Amit Etkin, M.D., Ph.D.President, Chief Executive Officer, and Chair of the Board49$603.0K$4.1M50
2024Michael HanleyChief Operating Officer53$283.2K$2.4M50
2024Nicholas SmithChief Financial Officer and Chief Business Officer37$466.5K$2.0M50

Money raised

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

  1. Oct 21, 2025Raised $50 million in a private offering of equity Form D: 7 investors so far Form D
  2. Nov 20, 2023Raised $45 million in a private offering of equity Form D: 16 investors so far Form D
  3. Apr 6, 2022Raised $59.3 million in a private offering of equity Form D: 26 investors so far Form D
  4. May 3, 2021Raised $31.9 million in a private offering of equity Form D: 19 investors so far Form D
  5. Sep 13, 2019Raised $7.7 million in a private offering of equity Form D: 16 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
Alpha Wave Global, LP3,707,757$97.8M1.6%No change
Commodore Capital LP2,723,196$71.9M4.3%No change
BlackRock, Inc.2,121,009$56.0M0.0%+1,454,821
Perceptive Advisors LLC1,609,893$42.5M0.7%−400,000
Adage Capital Partners Gp, L.l.c.1,600,000$42.2M0.1%+1,215,000
Vanguard Capital Management LLC1,389,477$36.7M0.0%+182,452
Spruce Street Capital LP1,353,047$35.7M7.0%+27,837
Vivo Capital, LLC1,208,858$31.9M2.9%+173,307
Franklin Resources Inc1,013,307$26.7M0.0%−88,567
Armistice Capital, LLC864,000$22.8M0.6%−48,000
Affinity Asset Advisors, LLC850,000$22.4M1.1%+350,000
Vestal Point Capital, LP785,000$20.7M0.5%−1,279,075
State Street Corp685,945$18.1M0.0%+486,442
Geode Capital Management, LLC678,199$17.9M0.0%+385,300
72 Investment Holdings, LLC667,778$17.6M35.3%No change
Northern Trust Corp632,701$16.7M0.0%+159,298
Millennium Management LLC558,320$14.7M0.0%−263,662
Point72 Asset Management, L.P.502,950$13.3M0.0%−137
Venrock Adviser, LLC500,000$13.2M0.4%No change
Integral Health Asset Management, LLC500,000$13.2M0.5%No change
Driehaus Capital Management LLC487,576$12.9M0.1%+850
Parkman Healthcare Partners LLC429,035$11.3M1.2%New
Ikarian Capital, LLC407,338$10.7M1.8%−107,662
Orbimed Advisors LLC257,852$6.8M0.1%+90,352
Schonfeld Strategic Advisors LLC257,631$6.8M0.0%New

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

SEC filer profile

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

  • Name on EDGARAlto Neuroscience, Inc.1
  • CIK0001999480
  • Employer ID (EIN)83-42101244
  • Filer statusNon-accelerated filer 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 address650 Castro Street, Suite 450, Mountain View, CA 940411
  • Phone773-255-50121
  • Shares outstanding39,242,104 as of Aug 7, 20268
  • Public float$55.2M as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, Chicago, Illinois PCAOB ID 34; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceNov 22, 20231
  • Filings195 in all: 4 (55), 8-K (30), SCHEDULE 13G/A (18), 3 (15), CORRESP (9), 10-Q (8), SCHEDULE 13G (8), SC 13G (7)1
    All 31 form types

    D (5), UPLOAD (5), EFFECT (4), 10-K (3), S-3 (3), S-8 (3), ARS (2), DEF 14A (2), DEFA14A (2), S-1/A (2), SEC STAFF LETTER (2), 144 (1), 424B4 (1), 424B5 (1), 8-A12B (1), CERT (1), DEFR14A (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-1MEF (1), SC 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Mar 26, 2026
    Latest 8-K (8-K) Aug 27, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareANRONew York Stock Exchange

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Alto Neuroscience, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 73 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Position, and Need for Capital
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no history of commercializing products, which may make it difficult to evaluate our approach to the discovery and development of product candidates and the prospects for our future viability.
  • We have incurred substantial losses since our inception. We anticipate incurring substantial and increasing losses for the foreseeable future and may never achieve or maintain profitability.
  • We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms to us, could cause us to delay, limit, reduce, or terminate our product development or future commercialization efforts.
  • The obligations from our license and asset acquisition agreements may cause dilution to our stockholders, may be a drain on our cash resources, or may cause us to incur debt obligations to satisfy the payment obligations.
  • Risks Related to Product Candidate Development and Commercialization
  • 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 the FDA does not conclude that ALTO-207 satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements under Section 505(b)(2) are not as we expect, the approval pathway for ALTO-207 will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated and may not be successful.
  • We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Use of our product candidates could be associated with adverse side effects, adverse events, or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved product, or result in other significant negative consequences that could severely harm our business, prospects, operating results, and financial condition.
  • We rely heavily on the biomarker data gathered from our Platform. We currently anticipate that certain of our therapeutic product candidates will require us to develop and obtain FDA approval of a companion diagnostic for such therapeutic product candidates. If the FDA does not agree with our approach, or if we are unable to successfully develop and obtain regulatory approval for certain companion diagnostic tools needed to leverage our Platform, or experience significant delays in doing so, our business will be materially harmed.
  • Our approach to the discovery and development of precision medicines based on our Platform is unproven, and we do not know whether we will be able to develop any therapeutics or companion diagnostics of commercial value, or if competing technological approaches will limit the commercial value of our product candidates and Platform.
The other 63 risks
  • We have never commercialized a product candidate and may experience delays or unexpected difficulties in obtaining, or fail to obtain, regulatory approval for our product candidates.
  • Additional time may be required to obtain marketing authorizations for any of our product candidates that we develop as drug/device combination products.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming, and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of our 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 we fail to develop and commercialize our current product candidates for additional indications or fail to discover, develop, and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed.
  • We may expend our resources to pursue a particular product candidate or indication and forgo the opportunity to capitalize on product candidates or indications that may ultimately be more profitable or for which there is a greater likelihood of success.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • We may conduct certain of our clinical trials for our product candidates outside of the United States. However, the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
  • Even if our product candidates receive regulatory approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
  • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels, and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates could limit our ability to market those products and decrease our ability to generate revenue.
  • Risks Related to Our Business and Operations
  • We were founded with a mission to redefine neuropsychiatric drug development, a field that has seen very limited success. The ability to successfully develop drugs in this field is extremely difficult and is subject to a number of unique challenges.
  • Our business depends on the success of our product candidates. If we are ultimately unable to successfully commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • We rely on, and intend to continue to rely on, our internal clinical development expertise to conduct our current and future clinical trials. This model includes internal teams and systems as well as external vendors and CROs to comprise a full clinical trial team. If our clinical trial team does not comply with applicable regulatory requirements, meet expected deadlines, or run trials effectively, our development programs and our ability to seek or obtain regulatory approval for or commercialize our product candidates may be delayed.
  • The terms of our Amended Loan Agreement and our Convertible Grant Agreement place restrictions on our operating and financial flexibility and may cause dilution to our stockholders. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business or result in further dilution to you.
  • Competitive products may reduce or eliminate the commercial opportunity for our product candidates for our current or future indications. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies are more effective or safer than ours, our ability to develop and successfully commercialize our current products may be adversely affected.
  • 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.
  • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
  • Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • 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 may seek Breakthrough Therapy Designation by the FDA for a product candidate that we develop, and we may be unsuccessful. If we are successful, the designation may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • We may seek Fast Track Designation by the FDA for a product candidate that we develop, and we may be unsuccessful. If we are successful, the designation may not actually lead to a faster development or regulatory review or approval process, and would not increase the likelihood that our product candidates will receive marketing approval.
  • Many of our operations are concentrated in California, 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.
  • Our projections regarding the market opportunities for our product candidates may not be accurate, and the actual market for our products may be smaller than we estimate.
  • Our business could be adversely affected by the effects of health pandemics or epidemics, which could cause significant disruptions in our operations and those of our current or future CMOs, CROs, and other third parties upon whom we rely.
  • Risks Related to Collaborations, Intellectual Property, and Related Agreements
  • If we are unable to obtain and maintain sufficient intellectual property protection for our Platform, technologies, and 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.
  • Issued patents covering our product candidates, or the method of use of our product candidates or associated companion diagnostics could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • We may not be successful in obtaining or maintaining necessary rights to third party patents for our product candidates through acquisitions and in-licenses.
  • We may form or seek collaborations or strategic alliances, enter into additional licensing arrangements or other business transactions in the future, and we may not realize the benefits of such transactions.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • 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 be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • Our product candidates licensed from various third parties may be subject to retained rights.
  • 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.
  • We may become subject to claims challenging the inventorship or ownership of our or our licensors’ patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on products or product candidates for a sufficient amount of time.
  • If we do not obtain patent term extension for our product candidate, our business may be materially harmed.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated as a result of noncompliance with these requirements.
  • 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 may be subject to claims asserting that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Risks Related to Our Reliance on Third Parties
  • We have relied and expect to continue to rely on third parties to conduct certain aspects of our clinical 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, 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.
  • If any third-party manufacturer of our product candidates is unable to increase the scale of its production of our product candidates, and/or increase the product yield of its manufacturing, then our costs to manufacture product candidates may increase and commercialization may be delayed.
  • We depend on sole source and 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.
  • The operations of our suppliers that are located outside of the United States are subject to additional risks that are beyond our control and that could harm our business, financial condition, results of operations, and prospects.
  • The manufacturing of our product candidates is complex, and our third-party manufacturers may encounter difficulties in production. If our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials, our ability to obtain marketing approval, or provide supply of our products for participants, if approved, could be delayed or halted.
  • We may have conflicts with our current or future licensors or collaborators that could delay or prevent the development or commercialization of our product candidates.
  • We have historically relied on an affiliated third party to provide certain business services and the replacement of such services could adversely affect our business operations.
  • 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.
  • Risks Related to Government Regulation
  • Our current and future 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.
  • Drug marketing and reimbursement regulations in the EU may materially affect our ability to market and receive coverage for our products in the EU member states.
  • Even if we receive regulatory approval of any 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 our product candidates.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Ongoing healthcare legislative and regulatory reform measures may adversely affect our business, results of operations, and financial condition.
  • Disruptions at the FDA and other national and foreign government authorities caused by funding shortages, global health concerns, or additional regulatory changes could hinder their ability to hire, retain, or deploy key leadership and other personnel, or prevent new or modified products from being developed, reviewed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
  • We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards, and other requirements could adversely affect our business, results of operations, and financial condition.
  • Additional laws and regulations governing international operations could adversely affect our business, results of operations and financial condition.
  • 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.
  • Risks Related to Ownership of Our Common Stock and Our Status as a Public Company
  • An active and liquid trading market for our common stock may not continue to develop or be sustained.

Legal proceedings

Information pertaining to legal proceedings can be found in Part II of this Annual Report under “Item 8. Financial Statements and Supplementary Data - Note 15. Commitments and Contingencies” and is incorporated by reference herein.

In addition, from time to time, we may be involved in legal proceedings arising in the ordinary course of business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputational harm.

The opening of Item 3, Legal Proceedings.4

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