INBX on Nasdaq

Inhibrx Biosciences, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates, developed using our proprietary modular protein engineering platforms.”3 It is headquartered in La Jolla, California.1 Its shares trade on Nasdaq under the symbol INBX.1

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Last updated Oct 20, 2026.

Overview

Compare with Scinai Immunotherapeutics Ltd., SAB Biotherapeutics, Inc. or Cidara Therapeutics, or pick any stock.

  • TickerINBX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersLa Jolla, California1
  • Incorporated inDE2
  • Business address11025 N. Torrey Pines Road, Suite 140, La Jolla, Ca 920372
  • Filer category, Emerging growth company2

We are a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates, developed using our proprietary modular protein engineering platforms. We leverage our innovative protein engineering technologies and deep understanding of target biology to create therapeutic candidates with attributes and mechanisms we believe to be superior to current approaches and applicable to a range of challenging, validated targets with high potential.3 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

-10386.5%Operating margin4
-10773.5%Net margin4
550.0%Revenue growth, 20254
-1752.2%Return on equity4
12.58×Debt to equity4
-$129.8MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

License brought in 50% of the revenue Inhibrx Biosciences, Inc. broke down this way in fiscal 2025.

  1. License$1.3M450%up 550% from 2024
  2. License, Non-Affiliate$1.3M450%up 550% from 2024
Products and services by year
Products and services20242025
License$200.0K$1.3M
License, Non-Affiliate$200.0K$1.3M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$113.0M
  • Income tax0¢$2.0K

Out of $1.3M in revenue.4 The company lost money this year.

Financial statements

Revenue54$1.3M in 2025−28% since 2023
0$500.0K$1.0M$1.5M$2.0M2023: $1.8M$1.8M20232024: $200.0K$200.0K2024−89%2025: $1.3M$1.3M2025+550%
Operating income54-$135.0M in 2025−38% since 2023
-$400.0M-$300.0M-$200.0M-$100.0M02023: -$219.2M-$219.2M20232024: -$331.4M-$331.4M2024+51%2025: -$135.0M-$135.0M2025−59%
Net income54-$140.1M in 2025−42% since 2023
-$500.0M0$500.0M$1.0B$1.5B$2.0B2023: -$241.4M-$241.4M20232024: $1.7B$1.7B20242025: -$140.1M-$140.1M2025

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

Period ending2025-12-312024-12-31
Total revenue$1.3M$200.0K
Research and development$113.0M$203.7M
General and administrative$23.3M$127.9M
Total operating expenses$136.3M$331.6M
Loss from operations-$135.0M-$331.4M
Gain related to transaction with Acquirer$0$2.0B
Interest expense-$12.2M-$13.5M
Interest income$7.5M$10.9M
Other income (expense), net-$381.0K$75.0K
Total other income (expense)-$5.0M$2.0B
Income (loss) before provision for income taxes-$140.1M$1.7B
Provision for income taxes$2.0K$2.0K
Net income (loss)-$140.1M$1.7B
Basic (in dollars per share)-$9.04$114.01
Diluted (in dollars per share)-$9.04$112.62
Basic (in shares)15.5M shares14.8M shares
Diluted (in shares)15.5M shares15.0M shares

Compare Inhibrx Biosciences, Inc. with another company

Corporate structure

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

Major holders of Inhibrx Biosciences, Inc.

  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Inhibrx Biosciences, Inc., latest Aug 14, 2026 (3 filings since Nov 14, 2024)
  • Schonfeld Strategic Advisors LLC Filed SCHEDULE 13G on Inhibrx Biosciences, Inc., latest Aug 14, 2026
  • VIKING GLOBAL INVESTORS LP Filed SCHEDULE 13G/A on Inhibrx Biosciences, Inc., latest Aug 14, 2026 (4 filings since Jun 7, 2024)
  • Bank of America Filed SCHEDULE 13G on Inhibrx Biosciences, Inc., latest Aug 3, 2026
  • Morgan Stanley Filed SCHEDULE 13G on Inhibrx Biosciences, Inc., latest Feb 11, 2026
  • BlackRock Filed SCHEDULE 13G on Inhibrx Biosciences, Inc., latest Jan 21, 2026 (3 filings since Feb 4, 2025)
  • Jon Faiz Kayyem Filed SCHEDULE 13D/A on Inhibrx Biosciences, Inc., latest Feb 26, 2025 (2 filings since Jun 3, 2024)
  • Mark Lappe Filed SCHEDULE 13D/A on Inhibrx Biosciences, Inc., latest Feb 26, 2025 (2 filings since Jun 3, 2024)
  • Inhibrx Biosciences, Inc. La Jolla, California

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

What it owns

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

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$14.9M4 Dec 31, 2025$15.1M4 Dec 31, 2024−1.6%
Accumulated depreciation$11.1M4 Dec 31, 2025$8.9M4 Dec 31, 2024+25.1%
Property and equipment, net$3.7M4 Dec 31, 2025$6.2M4 Dec 31, 2024−39.8%
Operating-lease assets (leased space)$5.5M4 Dec 31, 2025$7.3M4 Dec 31, 2024−24.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$124.2M4 Dec 31, 2025$152.6M4 Dec 31, 2024−18.6%

Properties, in its own words

Our headquarters are located in La Jolla, California where we currently lease approximately 43,000 square feet of laboratory and office space under a lease that expires in 2028. We have an option to extend the lease an additional three years. We believe that this space is sufficient to meet our needs for the foreseeable future and that any additional space we may require will be available on commercially reasonable terms.

Item 2 of the 10-K filed Mar 19, 2026.3

Leadership

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

Chief executive

  1. Mark Lappe2024–now

Chief financial officer

  1. Kelly Deck2024–now
2025
Board members and other officers (6)

Timeline

  1. Sep 28, 20268-K Regulation FD disclosure16
  2. Sep 8, 20268-K Regulation FD disclosure; Other events17
  3. Aug 13, 20268-K Results of operations18
  4. Jul 16, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares19
  5. Jun 15, 20268-K Regulation FD disclosure; Other events20
  6. Jun 3, 20268-K Shareholder vote21
  7. May 14, 20268-K Results of operations22
  8. May 11, 20268-K Regulation FD disclosure; Other events23
  9. Apr 21, 20268-K Regulation FD disclosure; Other events24
  10. Mar 19, 20268-K Results of operations25
  11. Feb 23, 20268-K Regulation FD disclosure26
  12. Dec 16, 20258-K Regulation FD disclosure; Other events27
  13. May 24, 2024New chief executive Mark Lappe becomes CEO8

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($2.28) a share, on Nov 14, 2025.28

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results18
  2. May 14, 2026Reported quarterly or annual results22
  3. Mar 19, 2026Reported quarterly or annual results25
  4. Nov 14, 2025Reported quarterly or annual results29
  5. Aug 13, 2025Reported quarterly or annual results30
  6. May 14, 2025Reported quarterly or annual results31
  7. Mar 17, 2025Reported quarterly or annual results32
  8. Nov 14, 2024Reported quarterly or annual results33

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

Filings

157 filings to the SEC since October 2021: 2 annual reports, 7 quarterly reports, 27 major events, 59 insider forms, 18 large holders, 44 other. The latest 20:

  1. Oct 14, 20264 EDGAR
  2. Sep 28, 20268-K EDGAR
  3. Sep 28, 20264 EDGAR
  4. Sep 23, 20264 EDGAR
  5. Sep 18, 20264/A EDGAR
  6. Sep 18, 20264/A EDGAR
  7. Sep 18, 20264/A EDGAR
  8. Sep 18, 20264/A EDGAR
  9. Sep 17, 20264 EDGAR
  10. Sep 15, 2026144 EDGAR
  11. Sep 15, 20264 EDGAR
  12. Sep 14, 2026144 EDGAR
  13. Sep 11, 2026144 EDGAR
  14. Sep 10, 20264 EDGAR
  15. Sep 9, 2026144 EDGAR
  16. Sep 8, 20268-K EDGAR
  17. Sep 8, 2026144 EDGAR
  18. Sep 8, 20264 EDGAR
  19. Sep 8, 20264 EDGAR
  20. Sep 8, 20264 EDGAR

The 157 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

36 open-market trades by officers, directors and large owners since October 2021: 30 buys and 6 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 28, 2026Lappe MarkChief Executive OfficerBuy4,500$100.76$453.4KForm 4
Sep 25, 2026Lappe MarkChief Executive OfficerBuy5,500$99.16$545.4KForm 4
Sep 23, 2026Kayyem Jon FaizDirectorBuy5,000$100.00$500.0KForm 4
Sep 16, 2026Kayyem Jon FaizDirectorBuy5,000$100.00$500.0KForm 4
Sep 15, 2026MANHARD KIMBERLYDirectorSale500$105.05$52.5KForm 4
Sep 14, 2026MANHARD KIMBERLYDirectorSale500$110.26$55.1KForm 4
Sep 11, 2026MANHARD KIMBERLYDirectorSale500$111.78$55.9KForm 4
Sep 9, 2026MANHARD KIMBERLYDirectorSale500$115.80$57.9KForm 4
Sep 8, 2026Kayyem Jon FaizDirectorBuy5,000$113.52$567.6KForm 4
Sep 8, 2026Lappe MarkChief Executive OfficerBuy25,000$105.81$2.6MForm 4
Sep 8, 2026FORSYTH DOUGLASDirectorBuy2,500$114.65$286.6KForm 4
Sep 8, 2026MANHARD KIMBERLYDirectorSale500$115.14$57.6KForm 4
Oct 7, 2025Viking Global Opportunities Parent GP LLC10% ownerSale350,000$32.25$11.3MForm 4
Nov 20, 2024Kayyem Jon FaizDirectorBuy37,500$14.19$532.1KForm 4
Nov 19, 2024Kayyem Jon FaizDirectorBuy69,686$14.23$991.6KForm 4
Oct 3, 2024Vuori Kristiina MDDirectorBuy6,667$15.00$100.0KForm 4
Sep 16, 2024Lappe MarkChief Executive OfficerBuy13,037$17.13$223.3KForm 4
Sep 12, 2024Lappe MarkChief Executive OfficerBuy26,963$15.05$405.8KForm 4
Sep 11, 2024Vuori Kristiina MDDirectorBuy6,457$15.07$97.3KForm 4
Sep 10, 2024Vuori Kristiina MDDirectorBuy179$15.00$2.7KForm 4

All 36 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
2025Mark P. Lappe59$695.2K$2.9M42
2025David J. MatlyM.B.A.40$589.2K$1.4M42
2025Kelly D. DeckC.P.A.46$493.5K$923.7K42
2024Chief Executive Officer and Chairman of the Board of Directors$695.2K$4.7M42
2024Chief Financial Officer$460.1K$4.3M42

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
Morgan Stanley1,308,051$123.9M0.0%+44,973
Perceptive Advisors LLC1,297,763$123.0M1.9%−144,944
Sanofi1,157,926$109.7M20.5%No change
Viking Global Investors LP1,123,929$106.5M0.3%−313,776
HighTower Advisors, LLC870,551$82.5M0.1%+351
Bank Of America Corp /de/841,141$79.7M0.0%+808,458
BlackRock, Inc.825,972$78.3M0.0%+27,074
Schonfeld Strategic Advisors LLC697,586$66.1M0.4%+442,759
State Street Corp640,458$60.7M0.0%+89,613
Vanguard Capital Management LLC492,477$46.7M0.0%+6,055
Woodline Partners LP400,892$38.0M0.1%+16,459
Capital Research Global Investors363,050$34.4M0.0%−29,797
Goldman Sachs Group Inc338,176$32.0M0.0%+243,102
PFM Health Sciences, LP308,385$29.2M2.5%+2,954
Sofinnova Investments, Inc.303,103$28.7M1.5%−102,926
Healthcare Of Ontario Pension Plan Trust Fund271,700$25.7M0.0%+101,000
Parkman Healthcare Partners LLC256,950$24.3M2.5%New
Geode Capital Management, LLC256,175$24.3M0.0%+24,666
First Turn Management, LLC164,783$15.6M1.7%New
Millennium Management LLC147,200$13.9M0.0%−180,660
CDC Financial, Inc.140,130$13.3M10.2%+15,600
First Trust Advisors LP128,424$12.2M0.0%New
Vanguard Portfolio Management LLC122,557$11.6M0.0%+50,097
Capitolis Liquid Global Markets LLC119,200$11.3M0.0%−5,800
Northern Trust Corp100,957$9.6M0.0%+7,261

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

SEC filer profile

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

  • Name on EDGARInhibrx Biosciences, Inc.1
  • CIK0002007919
  • Employer ID (EIN)99-06135233
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • 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 address11025 N. Torrey Pines Road, Suite 140, La Jolla, CA 920371
  • Phone(858) 795-42201
  • Shares outstanding14,717,660 as of Aug 7, 20266
  • Public float$174.6M as of Jun 30, 20253
  • AuditorBDO USA, P.C., San Diego, California PCAOB ID 243; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJan 29, 20241
  • Filings157 in all: 4 (45), 8-K (27), 424B3 (11), 3 (10), 10-Q (7), SCHEDULE 13G/A (6), 144 (5), SCHEDULE 13G (5)1
    All 30 form types

    4/A (4), CORRESP (3), EFFECT (3), SC 13G (3), UPLOAD (3), 10-12B/A (2), 10-K (2), ARS (2), DEF 14A (2), DEFA14A (2), POS AM (2), SC 13D (2), SCHEDULE 13D/A (2), 10-12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), POS EX (1), S-1 (1), S-8 (1), SEC STAFF ACTION (1)

  • Latest filingsAnnual report (10-K) Mar 19, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Sep 28, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001INBXThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Inhibrx Biosciences, Inc. names in Item 1A of its 10-K filed Mar 19, 2026: 75 risks under these headings, as written.3

  • Risks Related to Our Financial Condition and Need for Additional Capital
  • Risks Related to the Development, Clinical Testing and Commercialization of Our Therapeutic Candidates
  • Risks Related to Our Organization and Operations
  • Risks Related to Intellectual Property
  • Risks Related to Government Regulation
  • Risks Related to Ownership of Our Common Stock
  • We have a limited operating history, have incurred significant operating losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We may never generate product revenue or become profitable in the future, or if we achieve profitability in the future, we may not be able to sustain it.
  • Biotechnology product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have never generated any revenue from product sales and may never be profitable.
  • We expect we will need to raise substantial additional funds to advance development of our therapeutic candidates, and we cannot guarantee this additional funding will be available on acceptable terms or at all. Failure to obtain this funding when needed may force us to delay, limit or terminate our development efforts and, if any of our therapeutic candidates are approved, our commercialization efforts.
  • Raising additional capital by issuing equity or debt securities may cause dilution to existing stockholders, and raising funds through lending and licensing or collaboration agreements may restrict our operations or require us to relinquish proprietary rights.
  • We may be adversely affected by the effects of inflation.
  • We maintain our cash and cash equivalents at financial institutions. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.
The other 68 risks
  • Our approach to the discovery and development of therapeutic candidates is based on our proprietary modular protein engineering platforms and is novel and unproven, and the cost and time to develop them and the likelihood of success may be more uncertain than if we had employed more established drug development approaches.
  • The results of preclinical studies and early stage clinical trials of our therapeutic candidates may not be predictive of the results of later stage clinical trials. Initial results or observations in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.
  • Our therapeutic candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • We expect to develop certain of our therapeutic candidates in combination with other therapies, and safety or supply issues with combination use products may delay or prevent development and approval of our therapeutic candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary marketing approvals could be delayed or prevented.
  • From time to time we evaluate and pursue potential alternatives for monetizing our assets, which may not result in the consummation of any transaction, or achieve the desired objectives of such a transaction. Our efforts may create a distraction for our management team and adversely affect our business operations.
  • If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of any of our therapeutic candidates may be delayed, and our business may be harmed.
  • Initial, interim, topline and preliminary data from our clinical trials that we may announce, observe 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 market opportunities for any current or future therapeutic candidate we develop, if and when approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small or smaller than we may expect.
  • We rely on third parties to conduct a portion of our clinical trials and certain of our preclinical studies and contract manufacturing. If these third parties do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our development programs could be delayed with material and adverse effects on our business, financial condition, results of operations and prospects.
  • We do not track our research and development expenses on a program-by-program basis, which may impact our ability to efficiently allocate resources and could adversely affect our financial condition and results of operation.
  • We may expend our limited resources to pursue a particular therapeutic candidate and fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We have existing collaborations with third parties, and may in the future enter into additional collaborations, to develop or commercialize our therapeutic candidates. If these collaborations are not successful, our business could be harmed.
  • The manufacture of biotechnology products is complex, and manufacturers often encounter difficulties in production. If we or any of our third party manufacturers encounter such difficulties, or otherwise fail to comply with their contractual obligations, the development or commercialization of our therapeutic candidates could be delayed or stopped.
  • We rely on third parties to supply and manufacture our therapeutic candidates, and we expect to continue to rely on third parties to manufacture and supply our therapeutics, if approved. The development of therapeutic candidates and the commercialization of any therapeutic candidates, if approved, could be stopped, delayed or made less profitable if any of these third parties fail to provide us with sufficient quantities of therapeutic candidates or therapeutics, fail to do so at acceptable quality levels or prices, or fail to maintain or achieve satisfactory regulatory compliance.
  • Our third-party manufacturers may be unable to successfully scale up manufacturing of our therapeutic candidates in sufficient quality and quantity, which would delay or prevent us from developing our therapeutic candidates and commercializing any approved therapeutic candidates.
  • Failure to successfully identify, develop and commercialize additional therapeutics or therapeutic candidates could impair our ability to grow.
  • Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
  • If our therapeutic candidates are approved for marketing and commercialization and we are unable to establish effective sales, marketing and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to commercialize successfully any such therapeutic candidates.
  • The future commercial success of our therapeutic candidates will depend on the degree of market acceptance of our therapeutic candidates among physicians, patients, healthcare payors and the medical community.
  • We face significant competition and if our competitors develop and market products that are more effective, safer or less expensive than the therapeutic candidates we develop, our commercial opportunities will be negatively impacted.
  • Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan.
  • We have a significant amount of debt which may affect our ability to operate our business and secure additional financing in the future. If we fail to comply with the terms of our loan agreement with Oxford, our business, prospects and results of operations could be materially and adversely affected.
  • We are subject to continuing contingent liabilities of the Former Parent following the Separation and Distribution.
  • Use of any net operating loss carryforwards and other tax attributes may be limited.
  • Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including non-compliance with governmental and regulatory bodies.
  • Our insurance may not provide adequate levels of coverage against claims which may adversely affect our financial condition.
  • As we expand our development and regulatory capabilities, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We may not be able to integrate efficiently or achieve the expected benefits of any acquisitions of complementary businesses, therapeutic candidates or technologies.
  • Our business may be adversely affected as a result of major computer system failures.
  • Security incidents or other compromises of our information technology environment could expose us to material liability, damage our reputation, compromise our confidential information or otherwise adversely affect our business.
  • Our current operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by earthquakes, medical epidemics or pandemics, or other natural disasters.
  • If we are not able to obtain and enforce intellectual property protection for our technologies or therapeutic candidates, the development and commercialization of our therapeutic candidates may be adversely affected.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Changes in patent laws could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may be required to reduce the scope of our intellectual property due to intellectual property claims included in the patents or patent applications of others.
  • We or our licensors, licensees or any future strategic partners may become subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights, and we may need to resort to litigation to protect or enforce our patents or other proprietary rights, all of which could be costly, time consuming, delay or prevent the development and commercialization of our therapeutic candidates, or put our patents and other proprietary rights at risk.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If we fail to comply with our obligations under the agreements pursuant to which we license intellectual property rights from third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose the rights to intellectual property licensed to us.
  • Our intellectual property agreements with our licensors, licensees, and third parties may be subject to disagreements over contract interpretation, which could narrow the scope of, or result in termination of, our rights to the relevant intellectual property or technology or increase our financial or other obligations to such third parties, or reduce the financial or other obligations our licensees have to us.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets or confidential information of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.
  • 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.
  • If our patent terms expire before or soon after our therapeutic candidates are approved, or if manufacturers of biosimilar drugs successfully challenge our patents, our business may be materially harmed.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • We may be unable to obtain marketing approval for any product that we may develop and the marketing approval processes of the FDA and other comparable regulatory authorities outside the United States are lengthy, time-consuming and inherently unpredictable.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted outside of their respective jurisdictions. While we have previously formed partnerships in China designed to provide access to patient populations outside of the United States and in the future may conduct clinical trials in other foreign jurisdictions, there can be no assurance these data will be accepted by the FDA or EMA or other comparable foreign regulatory authorities as a basis for a product’s marketing approval.
  • Disruptions at the FDA and other government agencies caused by funding or staffing shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, review, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Our partnerships in China subject us to risks and uncertainties relating to the laws and regulations of China and the changes in relations between the United States and China.
  • The successful commercialization of any product candidates for which we obtain approval will depend in part on the extent to which governmental authorities, private health insurers, and other third-party payors provide coverage and adequate reimbursement. Unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives could harm our business in the future.
  • Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to commercialize our product candidates, may adversely affect the prices we may obtain and may have a material and adverse effect on our business, financial condition, results of operations, and prospects.
  • If we or our partners, manufacturers or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions, which could affect our ability to develop, market and sell our products and may harm our reputation.
  • We received orphan drug status for ozekibart for the treatment of patients with metastatic or unresectable chondrosarcoma. We may seek orphan drug status for additional therapeutic candidates, but even if it is granted, we may be unable to maintain any benefits associated with orphan drug status, including the potential for market exclusivity.
  • We received Fast Track designation for ozekibart for the treatment of patients with metastatic or unresectable chondrosarcoma. We may seek Fast Track designation for other of our therapeutic candidates. Even if received, Fast Track designation may not actually lead to a faster review process.
  • Our therapeutic candidates for which we intend to seek approval may face competition sooner than anticipated.
  • Unfavorable global economic conditions and an uncertain geopolitical environment could have an adverse effect on our business, financial condition, results of operations and prospects
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Actual or perceived failures to comply with applicable privacy, data protection and information security laws, regulations and standards and other requirements could adversely affect our business, results of operations, and financial performance.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
  • 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.
  • We do not know whether an active, liquid and orderly trading market will continue to develop or be sustained for our common stock and as a result it may be difficult for you to sell your shares of our common stock.
  • We expect that our stock price may fluctuate significantly.
  • Our executive officers, directors and holders of more than 5% of our capital stock own a significant percentage of our stock and are able to exercise significant control over matters subject to stockholder approval.
  • Future sales of our common stock in the public market could cause our stock price to fall.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. 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.3

Sources

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