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INAB on Nasdaq

IN8BIO, INC.

In its 2026 annual report the company says: “We are a leading clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cellular therapy product candidates and gamma-delta T cell engagers for cancer and autoimmune diseases.”5 It is headquartered in New York, United States.2 Its shares trade on Nasdaq under the symbol INAB.2

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Last updated Oct 21, 2026.

Overview

-$19.4MNet income, fiscal 20253

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  • TickerINAB on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersNew York, United States2
  • Incorporated inDE4
  • Business addressEmpire State Building, 350 5Th Avenue, Suite 5330, New York, Ny 101184
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company4
  • Legal formCorporation2
  • LEI549300H68IVCRKSGSL942
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 68743422

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We are a leading clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cellular therapy product candidates and gamma-delta T cell engagers ("TCEs") for cancer and autoimmune diseases. Gamma-delta T cells are a specialized population of T cells that possess unique properties. They are naturally occurring immune cells that can intrinsically regulate immune responses and have the ability to differentiate between healthy and diseased tissue. These cells serve as a functional bridge between innate and adaptive immunity, contributing to direct tumor-killing as well as immune cell recruitment and activation to drive deeper, more comprehensive immune responses. Multiple studies have demonstrated the robust tumor-killing ability of gamma-delta T cells and superior outcomes in cancer patients with elevated levels of gamma-delta T cell…5 From its latest annual report

Financials

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

Key numbers, fiscal 2025

-70.5%Return on equity3

Financial statements

Operating income67893-$19.4M in 2025+127% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$8.6M-$8.6M20202021: -$14.7M-$14.7M2021+71%2022: -$28.5M-$28.5M2022+95%2023: -$30.0M-$30.0M2023+5%2024: -$30.4M-$30.4M2024+1%2025: -$19.4M-$19.4M2025−36%
Net income67893-$19.4M in 2025+127% since 2020
-$40.0M-$30.0M-$20.0M-$10.0M02020: -$8.6M-$8.6M20202021: -$14.7M-$14.7M2021+71%2022: -$28.5M-$28.5M2022+95%2023: -$30.0M-$30.0M2023+5%2024: -$30.4M-$30.4M2024+1%2025: -$19.4M-$19.4M2025−36%

Every line of the income statement as filed: the last 2 fiscal years, latest first.3

Period ending2025-12-312024-12-31
Research and development$10.2M$17.0M
General and administrative$9.7M$12.6M
Severance and related charges$0$1.1M
Total operating expenses$19.9M$30.7M
Interest income$421.0K$230.0K
Loss from operations-$19.4M-$30.4M
Net loss-$19.4M-$30.4M
Net loss per share - basic-$4.44-$17.05
Net loss per share - diluted-$4.44-$17.05
Weighted-average number of shares used in computing net loss per common share - basic4.4M shares1.8M shares
Weighted average number of shares used in computing net loss per share - diluted4.4M shares1.8M shares

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Corporate structure

IN8BIO, 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 IN8BIO, INC.

  • IN8BIO, INC. New York, New York, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What IN8BIO, 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
Computer equipment and software$09 Dec 31, 2024$182.0K9 Dec 31, 2023−100.0%
Construction in progress$09 Dec 31, 2024$182.0K9 Dec 31, 2023−100.0%
Accumulated depreciation$3.2M3 Dec 31, 2025$2.3M3 Dec 31, 2024+41.4%
Property and equipment, net$1.9M3 Dec 31, 2025$2.9M3 Dec 31, 2024−35.0%
Finance-lease assets$296.0K3 Dec 31, 2025$1.1M3 Dec 31, 2024−72.3%
Operating-lease assets (leased space)$1.9M3 Dec 31, 2025$3.9M3 Dec 31, 2024−51.7%

Properties, in its own words

We lease approximately 3,900 square feet of office space for our principal executive offices in New York, New York, under an operating lease that expires on February 28, 2027, with no renewal option. We are also leasing approximately 10,000 square feet of space located in the Martin Biscuit Building in Birmingham, Alabama. The lease is a 68-month term, expiring on October 31, 2029 and has an option for a five-year extension. We developed approximately 5,250 square feet of this space as laboratory space, as well as approximately 3,700 square feet as office and conference space. Our Birmingham facilities are both located within Qualified Opportunity Zones as defined in Section 1400Z-2 of the Internal Revenue Code. We will seek to use commercially reasonable efforts to expand our facilities within Qualified Opportunity Zones, as long as it remains consistent with the best interests of the Company. We believe that our facilities are adequate to meet our current needs and that additional space can be obtained on commercially reasonable terms as needed.

Item 2 of the 10-K filed Mar 12, 2026.5

Leadership

Who has led IN8BIO, INC., and when. Pick a name to see everywhere that person has worked.

President

  1. Kate Rochlin2026–now

Chief operating officer

  1. Kate Rochlin2021–now
2025
Board members and other officers (12)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerPatrick McCall named Dec 28, 2023 to Dec 30, 202526
  • Executive Officer, DirectorWilliam Ho named Dec 28, 2023 to Dec 30, 202526

Former names

  • Incysus Therapeutics, Inc.May 22, 2018 to Sep 20, 20184

Timeline

  1. Aug 6, 20268-K Results of operations27
  2. Jun 1, 20268-K Entered a material agreement; Ended a material agreement28
  3. May 7, 20268-K Results of operations; Executive or director change; Shareholder vote29
  4. Mar 12, 20268-K Results of operations30
  5. Feb 27, 20268-K Executive or director change31
  6. Feb 9, 20268-K Executive or director change32
  7. Dec 19, 20258-K Entered a material agreement; Unregistered sale of shares33
  8. Nov 24, 20258-K Other events34
  9. Nov 6, 20258-K Results of operations35
  10. Oct 27, 20258-K Other events36
  11. Aug 7, 20258-K Results of operations37
  12. Jun 30, 20258-K Other events38
  13. May 7, 2018Founded IN8BIO, INC. is founded2

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.85) a share, on Nov 6, 2025.39

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results27
  2. May 7, 2026Reported quarterly or annual results29
  3. Mar 12, 2026Reported quarterly or annual results30
  4. Nov 6, 2025Reported quarterly or annual results35
  5. Aug 7, 2025Reported quarterly or annual results37
  6. May 7, 2025Reported quarterly or annual results40
  7. Mar 13, 2025Reported quarterly or annual results41
  8. Nov 12, 2024Reported quarterly or annual results42

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

Filings

350 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 74 major events, 158 insider forms, 26 large holders, 3 private raises, 68 other. The latest 20:

  1. Aug 13, 2026SCHEDULE 13G/A EDGAR
  2. Aug 7, 2026S-8 EDGAR
  3. Aug 6, 202610-Q EDGAR
  4. Aug 6, 20268-K EDGAR
  5. Jun 1, 20268-K EDGAR
  6. Jun 1, 2026424B5 EDGAR
  7. May 29, 2026SCHEDULE 13D/A EDGAR
  8. May 29, 20264 EDGAR
  9. May 19, 2026EFFECT EDGAR
  10. May 18, 2026S-3/A EDGAR
  11. May 15, 2026CORRESP EDGAR
  12. May 12, 20264 EDGAR
  13. May 12, 20264 EDGAR
  14. May 12, 20264 EDGAR
  15. May 12, 20264 EDGAR
  16. May 12, 20264 EDGAR
  17. May 12, 20264 EDGAR
  18. May 12, 20264 EDGAR
  19. May 12, 20264 EDGAR
  20. May 12, 20264 EDGAR

The 350 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

24 open-market trades by officers, directors and large owners since October 2021: 24 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 13, 2023Graff Jeremy R.DirectorBuy2,500$0.95$2.4KForm 4
Aug 25, 2023McCall PatrickCHIEF FINANCIAL OFFICERBuy1,000$1.03$1.0KForm 4
Aug 24, 2023Ho William Tai-WeiCEOBuy23,800$1.05$25.0KForm 4
Dec 12, 2022Kreis Leslie W.10% ownerBuy75,001$2.48$186.0KForm 4
Dec 12, 2022BIOS Fund III QP, LP10% ownerBuy75,001$2.48$186.0KForm 4
Sep 28, 2022BIOS Fund II NT, LP10% ownerBuy25,000$2.02$50.5KForm 4
Sep 28, 2022Bios Equity Partners II, LP10% ownerBuy25,000$2.02$50.5KForm 4
Aug 29, 2022BIOS Fund II QP, LP10% ownerBuy40,000$2.02$80.8KForm 4
Aug 29, 2022Cavu Advisors, LLC10% ownerBuy40,000$2.02$80.8KForm 4
Aug 26, 2022BIOS Fund II QP, LP10% ownerBuy11,214$2.01$22.5KForm 4
Aug 26, 2022Cavu Advisors, LLC10% ownerBuy11,214$2.01$22.5KForm 4
Aug 17, 2022BIOS Fund II NT, LP10% ownerBuy50,000$1.93$96.5KForm 4
Aug 17, 2022Cavu Management, LP10% ownerBuy50,000$1.93$96.5KForm 4
Aug 16, 2022Transcend Partners Opportunity Fund LLC10% ownerBuy789,473$1.90$1.5MForm 4
Aug 16, 2022Ho William Tai-WeiCEOBuy26,315$1.90$50.0KForm 4
Aug 16, 2022Rochlin KatePresident and COOBuy5,263$1.90$10.0KForm 4
Aug 16, 2022McCall PatrickCHIEF FINANCIAL OFFICERBuy5,263$1.90$10.0KForm 4
Aug 16, 2022Goswami TrishnaChief Medical OfficerBuy2,631$1.90$5.0KForm 4
Aug 16, 2022Lamb LawrenceEVP and CSOBuy526$1.90$999Form 4
Aug 16, 2022Greenwood LubaDirectorBuy526$1.90$999Form 4

All 24 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

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

Executive pay

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

YearExecutiveAgeSalaryTotal pay
2025William Ho50$397.8K$953.7K53
2025Kate RochlinPh.D.$417.9K$688.9K53
2025Patrick McCall43$404.9K$677.2K53
2024Chief Executive Officer$552.8K$1.5M53
2024President and Chief Operating Officer$457.6K$790.1K53
2024Chief Financial Officer$438.3K$780.4K53

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$46.9M 2023–2025
Money received by yearMoney received by year, 2023–2025: $46.9M in all. Private raises (Form D) $46.9M.$0$10M$20M$30M2023 · Private raises (Form D): $14.4M20232024 · Private raises (Form D): $12.4M20242025 · Private raises (Form D): $20.1M2025
Figures by year
YearPrivate raises (Form D)Total
2025$20.1M$20.1M
2024$12.4M$12.4M
2023$14.4M$14.4M

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. Dec 22, 2025Raised $20.1 million in a private offering of equity26 Form D: $40.2 million offered in all Form D
  2. Oct 4, 2024Raised $12.4 million in a private offering of equity54 Form D: 73 investors so far Form D
  3. Dec 13, 2023Raised $14.4 million in a private offering of equity55 Form D: 20 investors so far Form D

Held by these funds

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

FundSharesValueShare of the fundChange
Alyeska Investment Group, L.P.944,319$1.3M0.0%No change
Franklin Resources Inc914,531$1.3M0.0%No change
683 Capital Management, LLC724,637$1.0M0.1%No change
Stonepine Capital Management, LLC695,287$980.4K0.7%+31,875
Vanguard Capital Management LLC88,865$126.5K0.0%No change
BIOS Capital Management, LP80,957$114.1K0.3%−86,848
Geode Capital Management, LLC72,550$102.3K0.0%−13,689
Citadel Advisors LLC63,055$88.9K0.0%New
Oppenheimer & Co Inc63,042$88.9K0.0%+39,009
Vanguard Fiduciary Trust Co43,570$62.0K0.0%No change
Captrust Financial Advisors33,295$46.9K0.0%No change
Texas Capital Bank Wealth Management Services Inc24,406$34.4K0.0%+656
Northern Trust Corp21,734$30.6K0.0%+1,294
Renaissance Technologies LLC12,100$17.1K0.0%New
Tower Research Capital LLC (TRC)3,738$5.3K0.0%+2,473
Northwestern Mutual Wealth Management Co2,785$3.9K0.0%No change
Jones Financial Companies Lllp768$1.0K0.0%No change
BlackRock, Inc.84$1180.0%No change
Rockefeller Capital Management L.P.83$1170.0%No change
Barclays PLC28$390.0%New
UBS Group AG1$10.0%−479

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

SEC filer profile

How IN8BIO, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARIN8BIO, INC.1
  • CIK0001740279
  • Employer ID (EIN)82-54625855
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • 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 addressEmpire State Building, 350 5Th Avenue, Suite 5330, New York, NY 101181
  • Phone(646) 600-64381
  • Shares outstanding9,858,383 as of Aug 3, 202611
  • Public float$7.6M as of Jun 30, 20255
  • AuditorCohnReznick LLP, New York, New York PCAOB ID 596; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMay 22, 20181
  • Filings410 in all: 4 (162), 8-K (75), 3 (17), 10-Q (16), CORRESP (15), 424B5 (7), EFFECT (7), S-8 (7)1
    All 42 form types

    S-8 POS (7), SCHEDULE 13G/A (7), UPLOAD (7), 4/A (6), S-1/A (6), SCHEDULE 13G (6), 10-K (5), DEF 14A (5), DEFA14A (5), S-3 (5), ARS (4), D (4), SC 13G (4), 424B3 (3), SC 13G/A (3), SCHEDULE 13D/A (3), 424B4 (2), D/A (2), DRS (2), S-1 (2), SC 13D/A (2), SEC STAFF LETTER (2), 10-K/A (1), 8-A12B (1), 8-K/A (1), CERT (1), DEFR14A (1), DRS/A (1), DRSLTR (1), POS EX (1), PRE 14A (1), S-3/A (1), SC 13D (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Mar 26, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareINABThe Nasdaq Stock Market LLC

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

Risk factors and legal proceedings

The risks IN8BIO, INC. names in Item 1A of its 10-K filed Mar 12, 2026: 71 risks under these headings, as written.5

  • Risks Related to Our Financial Position and Capital Needs
  • There is substantial doubt regarding our ability to continue as a going concern. We will require substantial additional funding to finance our operations, and if we are unable to raise capital, we could be forced to delay, reduce or explore other strategic options for certain of our development programs, or even terminate our operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
  • A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
  • Our outstanding warrants may not be exercised and we may not receive any cash proceeds from any exercise of warrants.
  • We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
  • Our ability to raise capital may be limited by applicable laws and regulations.
  • We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Risks Related to the Development of Our Product Candidates
  • We are dependent on the successful clinical development, regulatory approval and commercialization of our gamma-delta T cell product candidates. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.
  • Our product candidates are in early stages of development, and therefore they will require extensive additional preclinical and clinical testing. Success in preclinical studies or early-stage clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.
  • 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.
The other 61 risks
  • Our DeltEx product candidates utilize novel approaches to cell therapies, including cancer treatment, which presents significant challenges to successfully develop, manufacture and commercialize our product candidates.
  • The clinical and commercial utility of our DeltEx platform is uncertain and may never be realized. Additionally, certain aspects of the function and production of gamma-delta T cells are poorly understood or currently unknown and may only become known through further preclinical and clinical testing.
  • Clinical product candidate development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials.
  • Development of a product candidate intended for use in combination with an already approved therapy may present increased complexity and more or different challenges than development of a product candidate for use as a single agent or monotherapy.
  • If we encounter difficulties in enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified during development or after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates thereby limiting the commercial potential of such product candidate.
  • We may not be able to file IND applications to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
  • We may seek Breakthrough Therapy, RMAT or Fast Track designations and may pursue accelerated approval for some or all of our current product candidates, but we may be unable to obtain such designations or, where obtained, we may be unable to maintain Breakthrough Therapy or RMAT designation or obtain or maintain the benefits associated with such designations.
  • Although we have received orphan drug designation for INB-400 in the past and may continue to seek orphan drug designation for some or all of our current or future product candidates, we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for supplemental market exclusivity.
  • We may not be able to identify or discover other product candidates and may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.
  • Public opinion and scrutiny of our competitors, cell-based immunotherapy, T cell engagers, and genetic modification approaches may impact public perception of our company and product candidates, or may adversely affect our ability to raise capital, conduct our business and our business plans.
  • We face significant competition, and many of our competitors have substantially greater experience and resources than we have.
  • We expect the product candidates we develop will be regulated as biologics, and therefore they may be subject to competition sooner than anticipated.
  • Risks Related to Manufacturing and Our Dependence on Third Parties
  • Our manufacturing processes are complex, and we may encounter difficulties in production, which would delay or prevent our ability to provide a sufficient supply of our product candidates for future clinical trials or commercialization, if approved.
  • We may rely on third-party contractors or contract development manufacturing organization for the manufacturing of our product candidates, and failure by those parties to adequately perform their obligations could harm our business.
  • We currently store our gamma-delta T cells and biologic correlative and research specimens from clinical trials and development programs and clinical lentivectors at our research and development facilities and at the facilities of our clinical and/or manufacturing partners, and any damage or loss to our storage freezers and/or facilities from natural disasters or otherwise would cause delays in replacement, and our business could suffer.
  • We are currently dependent on a single third-party supplier for manufacture of our automated manufacturing device and our lentiviral vectors for our cellular therapies. These are critical products required for the manufacturing of our product candidates, including INB-100, INB-200 and INB-400. Any damage or loss to the ability of our suppliers to deliver supplies in a timely manner could cause delays in manufacturing, and our clinical trials and our business could suffer.
  • We rely on third-party healthcare professionals to administer gamma-delta T cells to patients, and our business could be harmed if these third parties administer these cells incorrectly.
  • We believe we may require an updated and validated protocol for commercial-scale expansion and manufacturing of gamma-delta T cells for conducting pivotal trials and for commercialization of our product candidates, if approved.
  • We have not yet developed commercial-scale infrastructure for freezing and thawing large quantities of gamma-delta T cells, which we believe will be required for the storage and distribution of our gamma-delta T cell product candidates at commercial scale.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict or interrupt our business.
  • We intend to partner with third parties, such as academic institutions and CROs, to conduct, supervise and monitor some of our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business and delay or impair our ability to obtain regulatory approval or otherwise commercialize our product candidates.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being advanced, developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Risks Related to Our Intellectual Property
  • Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we breach our license agreements with the University of Alabama at Birmingham Research Foundation, Children’s Healthcare of Atlanta, Inc. and Emory University, or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product.
  • If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
  • Obtaining and maintaining our patent rights 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 for noncompliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights and/or trademark, 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 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.
  • We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats to our business.
  • Risks Related to Our Business Operations, Employee Matters and Managing Growth
  • We plan to expand our organization in the future, and we may experience difficulties in managing this growth, which could disrupt our operations.
  • We may explore strategic collaborations that may not have the intended benefits or never materialize, or we may be required to relinquish important rights to and control over the development and commercialization of our product candidates to any future collaborators.
  • If our information technology systems, or those of the third parties with whom we work, or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to, a significant disruption of our product development programs and our ability to operate our business effectively, regulatory investigations or actions, litigation, fines and penalties, reputational harm, loss of revenue or profits, and other adverse consequences.
  • Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
  • There are risks inherent in our business that may subject us to potential product liability suits and other claims, which may require us to engage in expensive and time-consuming litigation or pay substantial damages and may harm our reputation and reduce the demand for our product.
  • Risks Related to Commercialization and Regulatory Compliance
  • Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight.
  • Even if any product candidate receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be successful in commercializing them, if and when they are approved.
  • Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities.
  • If we commercialize our product candidates outside the United States, a variety of risks associated with international operations could harm our business.
  • Our relationships with customers, physicians, and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, including anti-kickback and false claims laws, transparency laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell profitably, if approved.
  • Healthcare legislative reform measures may have a negative impact on our business and results of operations.
  • The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, statutory, regulatory and policy changes and global health concerns.
  • Our (or the third parties with whom we work) actual or perceived failures to comply with applicable data privacy and security obligations, including laws, regulations, contractual obligations, industry standards and other obligations could lead to regulatory investigations or actions, litigation (including class claims), fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, and other adverse business consequences.
  • Risks Related to the Ownership of Our Common Stock
  • An active trading market for our common stock may not be sustained, and you may not be able to sell your shares quickly or at the market price.
  • The market price of our common stock is volatile and may fluctuate substantially, and you could lose all or part of your investment.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • General Risk Factors
  • Unstable market and economic conditions, including as a result of increases in inflation, the price of oil, and interest rates, tariffs and trade wars, geopolitical tensions such as wars and terrorism and future U.S. government shutdowns, may have serious adverse consequences on our business, financial condition and share price.
  • If research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • We will continue to incur increased costs as a result of operating as a public company, and our management will continue to be required to devote substantial time to new compliance initiatives.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Legal proceedings

From time to time, we may become involved in various legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings that we believe could have a material adverse effect on our business, operating results or financial condition.

The opening of Item 3, Legal Proceedings.5

Sources

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