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AARD on Nasdaq

Aardvark Therapeutics, Inc.

Aardvark Therapeutics, Inc. is an American pharmaceutical preparations company based in San Diego.1

$3.86 down 0.02 (0.52%)Price as of Oct 15, 2026 at 14:59 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerAARD on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSan Diego, California1
  • Incorporated inDE3
  • Business address4370 La Jolla Village Drive, Suite 1050, San Diego, Ca 921223
  • Filer category, Emerging growth company3
  • Legal formCorporation

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Financials

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

Key numbers, fiscal 2025

-54.0%Return on equity5
-$54.3MFree cash flow5

Financial statements

Operating income5-$62.7M in 2025+175% since 2024
-$80.0M-$60.0M-$40.0M-$20.0M02024: -$22.8M-$22.8M20242025: -$62.7M-$62.7M2025+175%
Net income5-$57.6M in 2025+180% since 2024
-$60.0M-$40.0M-$20.0M02024: -$20.6M-$20.6M20242025: -$57.6M-$57.6M2025+180%

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

Period ending2025-12-312024-12-31
Research and development$48.9M$17.4M
General and administrative$13.8M$5.3M
Credit loss - related party accounts receivable$0$117.0K
Total operating expenses$62.7M$22.8M
Loss from operations-$62.7M-$22.8M
Unrealized loss on short-term investments-$5.0K-$217.0K
Interest and dividend income$5.1M$2.4M
Total other income, net$5.1M$2.2M
Net Loss-$57.6M-$20.6M
Net loss per share of common stock, basic-$2.93-$5.15
Net loss per share of common stock, diluted-$2.93-$5.15
Weighted-average shares used in net loss per share calculation, basic19.6M shares4.0M shares
Weighted-average shares used in net loss per share calculation, diluted19.6M shares4.0M shares
Unrealized gain on short-term investments$81.0K$0
Comprehensive loss-$57.5M-$20.6M

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Corporate structure

Aardvark Therapeutics, Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Aardvark Therapeutics, Inc.

  • Aardvark Therapeutics, Inc. San Diego, California
    • Ardia Therapeutics, Inc. Subsidiary · Delaware, United States
    • Artisan Therapeutics, Inc. Subsidiary · Delaware, United States

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 Aardvark 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
Operating-lease assets (leased space)$355.0K5 Dec 31, 2025$735.0K5 Dec 31, 2024−51.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$47.1M5 Dec 31, 2025$61.6M5 Dec 31, 2024−23.7%
Marketable securities, current$63.0M5 Dec 31, 2025$12.0M5 Dec 31, 2024+423.8%
Debt securities available for sale$62.9M5 Dec 31, 2025$12.0M5 Dec 31, 2024+425.2%

Properties, in its own words

We currently lease approximately 8,000 square feet of space as our primary headquarters in San Diego, California. The lease expires in December 2026. We believe that our existing facility is adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate spaces for our operations. We believe suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 23, 2026.8

Leadership

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

Chief executive

  1. Tien-Li Lee2025–now

Chief financial officer

  1. Nelson Sun2025–now

Chief operating officer

  1. Bryan Jones2025–now
Board members and other officers (6)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorVictor Tong named May 15, 202417

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Ardia Therapeutics, Inc. Delaware4
  • Artisan Therapeutics, Inc. Delaware4

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

Timeline

  1. Oct 8, 20268-K Executive or director change; Other events18
  2. Aug 17, 20268-K Shareholder vote19
  3. Aug 11, 20268-K Results of operations20
  4. Jun 12, 20268-K Executive or director change21
  5. May 14, 20268-K Other events22
  6. May 7, 20268-K Results of operations23
  7. Mar 24, 20268-K Entered a material agreement24
  8. Mar 23, 20268-K Results of operations25
  9. Feb 27, 20268-K Other events26
  10. Feb 12, 20268-K Executive or director change; Other events27
  11. Feb 10, 20268-K Other events28
  12. Jan 12, 20268-K Other events29
  13. Feb 12, 2025New chief executive Tien-Li Lee becomes CEO9

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.75) a share, on Nov 13, 2025.30

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results20
  2. May 7, 2026Reported quarterly or annual results23
  3. Mar 23, 2026Reported quarterly or annual results25
  4. Nov 13, 2025Reported quarterly or annual results31
  5. Aug 13, 2025Reported quarterly or annual results32
  6. May 14, 2025Reported quarterly or annual results33
  7. Mar 31, 2025Reported quarterly or annual results34

Drug trials and FDA: recently

  1. Sep 24, 2024Phase 2 trial completed Phase 2 trial of ARD-101 in Prader-Willi Syndrome: primary completion Sep 24, 2024, results posted Sep 8, 2026 (ClinicalTrials.gov NCT05153434).35

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

110 filings to the SEC since October 2021: 2 annual reports, 5 quarterly reports, 23 major events, 43 insider forms, 4 large holders, 1 private raises, 32 other. The latest 20:

  1. Oct 8, 20264 EDGAR
  2. Oct 8, 20263 EDGAR
  3. Oct 8, 20268-K EDGAR
  4. Sep 11, 2026144 EDGAR
  5. Sep 11, 20264 EDGAR
  6. Sep 10, 2026144 EDGAR
  7. Aug 21, 20264 EDGAR
  8. Aug 21, 20264 EDGAR
  9. Aug 21, 20264 EDGAR
  10. Aug 21, 20264 EDGAR
  11. Aug 17, 20268-K EDGAR
  12. Aug 11, 202610-Q EDGAR
  13. Aug 11, 20268-K EDGAR
  14. Jul 10, 2026ARS EDGAR
  15. Jul 10, 2026DEF 14A EDGAR
  16. Jun 29, 2026PRE 14A EDGAR
  17. Jun 12, 20268-K EDGAR
  18. May 14, 20268-K EDGAR
  19. May 7, 202610-Q EDGAR
  20. May 7, 20268-K EDGAR

The 110 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

13 open-market trades by officers, directors and large owners since October 2021: 11 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 11, 2026Sun NelsonSee RemarksSale62,000$5.18$321.2KForm 4
Sep 10, 2026Sun NelsonSee RemarksSale14,754$5.00$73.8KForm 4
Dec 11, 2025Sun NelsonSee RemarksBuy3,000$14.40$43.2KForm 4
Dec 11, 2025Lee Tien-LiChief Executive OfficerBuy7,000$14.49$101.4KForm 4
Sep 15, 2025Lee Tien-LiChief Executive OfficerBuy10,000$9.66$96.6KForm 4
Sep 12, 2025Lee Tien-LiChief Executive OfficerBuy5,000$8.50$42.5KForm 4
Sep 11, 2025Lee Tien-LiChief Executive OfficerBuy6,000$7.82$46.9KForm 4
Sep 10, 2025Lee Tien-LiChief Executive OfficerBuy9,000$7.91$71.2KForm 4
Sep 9, 2025Sun NelsonSee RemarksBuy6,000$8.07$48.4KForm 4
Feb 14, 2025Decheng Capital Global Life Sciences Fund IV, L.P.10% ownerBuy1,250,000$16.00$20.0MForm 4
Feb 14, 2025Lee Tien-LiChief Executive OfficerBuy16,542$16.00$264.7KForm 4
Feb 14, 2025Sun NelsonSee RemarksBuy10,000$16.00$160.0KForm 4
Feb 14, 2025Chen BihuaBuy187,500$16.00$3.0MForm 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
2025Tien-Li LeeM.D.51$630.8K$6.1M40
2025Nelson Sun49$432.7K$2.5M40
2025Manasi JaimanM.D., M.P.H.45$496.0K$1.9M40
2024Chief Executive Officer$423.0K$906.3K40
2024Chief Medical Officer$150.6K$812.5K40

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$85.0M 2024–2024
Money received by yearMoney received by year, 2024–2024: $85.0M in all. Private raises (Form D) $85.0M.$0$25M$50M$75M$100M2024 · Private raises (Form D): $85.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$85.0M$85.0M

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. May 1, 2024Raised $85 million in a private offering of equity17 Form D: 31 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 72. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Decheng Capital LLC3,917,299$22.6M3.1%No change
Citadel Advisors LLC1,283,166$7.4M0.0%+40,389
Laurion Capital Management LP1,034,459$6.0M0.4%No change
Vanguard Capital Management LLC562,877$3.2M0.0%+8,776
Aqr Capital Management LLC480,249$2.8M0.0%+345,754
EcoR1 Capital, LLC396,194$2.3M0.1%New
Adage Capital Partners Gp, L.l.c.300,000$1.7M0.0%No change
Cantor Fitzgerald, L. P.233,164$1.3M0.0%+166,482
BlackRock, Inc.187,045$1.1M0.0%−605,526
Geode Capital Management, LLC149,844$863.5K0.0%−159,605
Two Sigma Investments, LP108,377$624.3K0.0%−54,978
Raymond James Financial Inc79,284$456.7K0.0%+68,394
Vanguard Fiduciary Trust Co75,172$433.0K0.0%−8,038
Woodline Partners LP72,429$417.2K0.0%No change
Millennium Management LLC69,948$402.9K0.0%−28,386
State Street Corp59,273$341.4K0.0%−140,049
J. Goldman & Co LP40,500$233.3K0.0%New
Ieq Capital, LLC38,382$221.1K0.0%+21,897
UBS Group AG35,639$205.3K0.0%−122,249
Morgan Stanley30,177$173.8K0.0%+12,615
Northern Trust Corp28,080$161.7K0.0%−60,519
Citigroup Inc26,299$151.5K0.0%−19,966
Cresset Asset Management, LLC24,033$138.4K0.0%−19,226
Susquehanna International Group, Llp24,025$138.4K0.0%New
Bridgeway Capital Management, LLC24,000$138.2K0.0%−3,000

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

SEC filer profile

How Aardvark 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 EDGARAardvark Therapeutics, Inc.1
  • CIK0001774857
  • Employer ID (EIN)82-16063678
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company8
  • Incorporated inDelaware8
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address4370 La Jolla Village Drive, Suite 1050, San Diego, CA 921221
  • Phone(858) 225-76961
  • Shares outstanding21,884,846 as of Jul 31, 20267
  • Public float$162.9M as of Jun 30, 20258
  • AuditorBDO USA, P.C, San Diego, California PCAOB ID 243; no auditor attestation of internal control over financial reporting8
  • On EDGAR sinceMay 24, 20191
  • Filings112 in all: 4 (31), 8-K (23), 3 (12), 10-Q (5), 144 (5), CORRESP (4), SCHEDULE 13G (4), D (3)1
    All 25 form types

    S-8 (3), UPLOAD (3), 10-K (2), DRS/A (2), DRSLTR (2), EFFECT (2), 424B4 (1), 424B5 (1), 8-A12B (1), ARS (1), CERT (1), DEF 14A (1), DRS (1), PRE 14A (1), S-1 (1), S-1/A (1), S-3 (1)

  • Latest filingsAnnual report (10-K) Mar 23, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Jul 10, 2026
    Latest 8-K (8-K) Oct 8, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Mar 23, 2026 (Section 12(b) of the Exchange Act).8

Risk factors and legal proceedings

The risks Aardvark Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 23, 2026: 72 risks under these headings, as written.8

  • Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
  • We have incurred significant losses since our inception and expect to incur losses over the next several years and may never achieve or maintain profitability.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
  • Risks Related to the Research, Development and Approval of Our Product Candidates
  • Our business is heavily dependent on the successful development, regulatory approval and commercialization of our lead product candidate, ARD-101.
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain required regulatory approval for our product candidates, our business will be substantially harmed.
  • Preclinical and clinical drug development involves a lengthy and expensive process, with uncertain timelines and outcomes, and results of earlier studies and trials may not be predictive of future trial results. If development of our product candidates is unsuccessful or delayed, we may be unable to obtain required regulatory approvals and we may be unable to commercialize our product candidates on a timely basis, if at all.
  • Certain disorders we seek to treat, such as PWS, have low prevalence and it may be difficult to identify and enroll patients with these disorders. If we encounter difficulties or delays enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Interim “topline” and preliminary results from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Our clinical trials may fail to demonstrate safety and efficacy of our product candidates, or serious adverse events or side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some of our product candidates.
  • As an organization, we have not previously conducted pivotal clinical trials, and we may be unable to do so successfully for any product candidates we may develop.
The other 61 risks
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may 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 are conducting and plan to conduct certain 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 regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
  • Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, government shutdowns or global health concerns could negatively impact our business operations, regulatory interactions and access to capital.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
  • We have received Orphan Drug Designation and Rare Pediatric Disease Designation for ARD-101 for the treatment of PWS, and we may seek Orphan Drug Designation and/or Rare Pediatric Disease Designation for some or all of our other product candidates. However, we may not receive either such designation, and we may not be able to maintain Orphan Drug Designation or Rare Pediatric Disease Designation or obtain a Rare Pediatric Disease priority review voucher or orphan drug exclusivity for ARD-101, which could limit the potential profitability of our product candidates.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, 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 in the United States.
  • We may not be successful in pursuing or maintaining fast track or other expedited regulatory designations for our product candidates, and such designations may not actually lead to a faster development or regulatory approval process.
  • Risks Related to Our Dependence 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, more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.
  • We rely completely on third parties to manufacture our clinical drug supplies and we intend to rely on third parties to produce commercial supplies of any approved product candidate, and our commercialization of any of our product candidates could be stopped, delayed or made less profitable if those third parties fail to obtain approval of the FDA or comparable regulatory authorities, fail to provide us with sufficient quantities of drug product or fail to do so at acceptable quality levels or prices.
  • We have entered into collaborations with third parties for the development of certain potential product candidates, and we may seek additional collaborations in the future for the development and commercialization of these or other potential candidates. If our collaborations are not successful, our ability to develop and commercialize our product candidates could be adversely affected.
  • If conflicts arise between us and our collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.
  • 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.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
  • The operations of our suppliers, some of which may source raw materials and other supplies outside of the United States, are subject to additional risks that are beyond our control and that could adversely affect our business, financial condition, results of operations and prospects.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain, maintain and enforce intellectual property protection directed to our current and any future technologies that we develop, others may be able to make, use or sell product candidates substantially the same as ours, which could adversely affect our ability to compete in the market.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • We may be unsuccessful in licensing or acquiring intellectual property from third parties that may be required to develop and commercialize our current or future product candidates.
  • We license or otherwise have access to patent rights from third-party owners. Such licenses or other arrangements may be subject to early termination if we fail to comply with our obligations in our agreements with third parties, which could result in the loss of rights or technology that are material to our business.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • Our intellectual property licensed from third parties may be subject to retained rights.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming, and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • Obtaining and maintaining 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.
  • Patent terms may be inadequate to establish 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.
  • 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 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 enjoy only limited geographical protection with respect to certain patents and 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.
  • Risks Related to Legal and Regulatory Compliance Matters
  • Our relationships with customers, physicians, and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, other healthcare laws and regulations and health data privacy and security laws and regulations, contractual obligations and self-regulatory schemes. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • 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.
  • 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.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Even if we commercialize any product candidates, alone or with our partners, any such product may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could adversely affect our business.
  • Risks Related to the Operation of Our Business
  • We have previously identified a material weakness in our internal control over financial reporting, which was 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.
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • There is a scarcity of experienced professionals in our industry. If we are not able to retain and recruit personnel with the requisite technical skills, we may be unable to successfully execute our business strategy.
  • We have in the past acquired, and may in the future acquire other assets, businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
  • We expect to expand our clinical development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • 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.
  • Our ability to use our net operating loss (NOL) carryforwards and certain other tax attributes to offset taxable income or taxes may be limited.
  • 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.
  • International expansion of our business will expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Significant disruptions of our information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us.
  • 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 (the EU GDPR), and the United Kingdom’s equivalent of the same (the 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.
  • Risks Related to Artificial Intelligence
  • Risks Related to the Commercialization of Our Product Candidates
  • Even if any of 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.
  • If we are unable to establish sales, marketing and distribution capabilities for our product candidates that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
  • We face substantial competition, which may result in a smaller than expected commercial opportunity and/or others discovering, developing or commercializing products before or more successfully than we do.
  • The success of our product candidates will depend significantly on coverage and adequate reimbursement or the willingness of patients to pay for these products.
  • If the market opportunities for any of our product candidates are smaller than we estimate, even assuming approval of a product candidate, our revenue may be adversely affected, and our business may suffer.
  • The increasing use of social media platforms presents new risks and challenges.
  • 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 develop and you may not be able to resell your shares of common stock at or above the public offering price, if at all.

Legal proceedings

From time to time, we may be involved in legal proceedings arising in the ordinary course of our 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, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

The opening of Item 3, Legal Proceedings.8

Sources

The numbers on this page point here. Each one links to the record it came from.

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