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ARTV on Nasdaq

Artiva Biotherapeutics, Inc.

Artiva Biotherapeutics, Inc. is an American biological products company, incorporated in Delaware.1 It is headquartered in San Diego, California.1 Its shares trade on Nasdaq under the symbol ARTV.1

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Last updated Oct 21, 2026.

Overview

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  • TickerARTV on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersSan Diego, California1
  • Incorporated inDE2
  • Business address5505 Morehouse Drive, San Diego, Ca 921212
  • Filer category, Emerging growth company2

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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

-100.0%Revenue growth, 20253
-76.3%Return on equity3
-$79.3MFree cash flow3

Financial statements

Revenue43$0 in 2025
0$10.0M$20.0M$30.0M$40.0M2023: $32.9M$32.9M20232024: $251.0K$251.0K2024−99%2025: $0$02025
Operating income43-$89.8M in 2025+193% since 2023
-$100.0M-$75.0M-$50.0M-$25.0M02023: -$30.7M-$30.7M20232024: -$67.3M-$67.3M2024+119%2025: -$89.8M-$89.8M2025+33%
Net income43-$83.9M in 2025+192% since 2023
-$100.0M-$75.0M-$50.0M-$25.0M02023: -$28.7M-$28.7M20232024: -$65.4M-$65.4M2024+128%2025: -$83.9M-$83.9M2025+28%

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

Period ending2025-12-312024-12-31
License and development support revenue (including related party amounts of $0 and $251, respectively)$0$251.0K
Research and development (including related party amounts of $76 and $3,168, respectively)$69.5M$50.3M
General and administrative$20.3M$17.2M
Total operating expenses$89.8M$67.5M
Loss from operations-$89.8M-$67.3M
Interest income$6.0M$5.3M
Change in fair value of SAFEs (including related party amounts of $0 and $2,911, respectively)$0-$3.6M
Other (expense) income, net-$14.0K$157.0K
Total other income, net$5.9M$1.9M
Net loss per share - basic-$3.43-$5.81
Net loss per share - diluted-$3.43-$5.81
Weighted average common shares outstanding - basic24.4M shares11.3M shares
Weighted average common shares outstanding - diluted24.4M shares11.3M shares
Net Income (Loss)-$83.9M-$65.4M
Unrealized gain (loss) on investments, net$232.0K-$437.0K
Comprehensive loss-$83.6M-$65.8M

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Corporate structure

Artiva Biotherapeutics, 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 Artiva Biotherapeutics, Inc.

  • Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13G/A on Artiva Biotherapeutics, Inc., latest Aug 14, 2026 (2 filings since Aug 1, 2024)
  • 5AM Ventures VI, L.P. Filed SCHEDULE 13G/A on Artiva Biotherapeutics, Inc., latest Aug 10, 2026 (2 filings since Aug 1, 2024)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13D/A on Artiva Biotherapeutics, Inc., latest Jul 23, 2026 (5 filings since Jul 29, 2024)
  • GC Corp. Filed SCHEDULE 13D/A on Artiva Biotherapeutics, Inc., latest May 28, 2026 (2 filings since Jul 29, 2024)
  • VIKING GLOBAL INVESTORS LP Filed SCHEDULE 13G on Artiva Biotherapeutics, Inc., latest May 18, 2026
  • BlackRock Filed SCHEDULE 13G/A on Artiva Biotherapeutics, Inc., latest Jul 16, 2025 (2 filings since Apr 23, 2025)
  • venBio Global Strategic Fund III, L.P. Filed SCHEDULE 13G/A on Artiva Biotherapeutics, Inc., latest May 15, 2025 (3 filings since Aug 1, 2024)
  • Artiva Biotherapeutics, Inc. San Diego, California

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

What it owns

What Artiva Biotherapeutics, 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$15.1M3 Dec 31, 2025$12.3M3 Dec 31, 2024+22.6%
Accumulated depreciation$8.5M3 Dec 31, 2025$5.9M3 Dec 31, 2024+42.8%
Property and equipment, net$6.6M3 Dec 31, 2025$6.4M3 Dec 31, 2024+3.9%
Finance-lease assets$212.0K3 Dec 31, 2025$261.0K3 Dec 31, 2024−18.8%
Operating-lease assets (leased space)$10.5M3 Dec 31, 2025$13.8M3 Dec 31, 2024−23.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$26.7M3 Dec 31, 2025$40.2M3 Dec 31, 2024−33.6%
Marketable securities, current$81.3M3 Dec 31, 2025$145.2M3 Dec 31, 2024−44.0%

Properties, in its own words

Our principal office is located at 5505 Morehouse Drive, Suite 100, San Diego, California 92121, where we lease 51,621 square feet of space to house our principal office, research and process development laboratories and a cGMP manufacturing center to support our pipeline development and clinical trial supply. This lease will expire in 2029, subject to our option to an additional five-year term. Additionally, we have a lease agreement for an additional 13,405 square feet of office space in San Diego, California. This lease expired in December 2025. In addition, we have entered into a temporary license agreement for our occupation and use of an additional 11,960 square feet of office and laboratory space in San Diego, California which expires in August 2026. Further, we have a lease agreement for a warehouse and storage facility space in San Diego which has an initial term through August 2029. We believe that these facilities will be adequate for our near-term needs. If required, we believe that suitable additional or alternative space would be available in the future on commercially reasonable terms.

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

Leadership

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

Chief executive

  1. Fred Aslan2024–now

President

  1. Fred Aslan2024–2026
  2. Gines Diego Miralles2026–now

Chief financial officer

  1. Neha Krishnamohan2024–2026
  2. Thad Allen Huston2026–now
2025
Board members and other officers (15)

Timeline

  1. Sep 11, 20268-K Executive or director change; Shareholder vote25
  2. Aug 6, 20268-K Results of operations26
  3. Jul 22, 20268-K Other events27
  4. May 19, 20268-K Executive or director change28
  5. May 8, 20268-K Results of operations; Regulation FD disclosure; Other events29
  6. May 8, 20268-K Other events30
  7. Mar 10, 20268-K Results of operations31
  8. Feb 24, 20268-K Executive or director change32
  9. Feb 19, 20268-K Executive or director change33
  10. Dec 12, 20258-K Executive or director change34
  11. Nov 12, 20258-K Results of operations35
  12. Nov 12, 20258-K Regulation FD disclosure; Other events36
  13. Jul 18, 2024New chief executive Fred Aslan becomes CEO8

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.88) a share, on Nov 12, 2025.37

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results26
  2. May 8, 2026Reported quarterly or annual results29
  3. Mar 10, 2026Reported quarterly or annual results31
  4. Nov 12, 2025Reported quarterly or annual results35
  5. Aug 6, 2025Reported quarterly or annual results38
  6. May 8, 2025Reported quarterly or annual results39
  7. Mar 24, 2025Reported quarterly or annual results40
  8. Nov 12, 2024Reported quarterly or annual results41

Drug trials and FDA: recently

  1. Oct 6, 2025Phase 1/2 trial completed Phase 1/2 trial of AB-101, Rituximab and others in Non Hodgkin Lymphoma: primary completion Oct 6, 2025, no results posted yet (ClinicalTrials.gov NCT04673617).42

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

223 filings to the SEC since October 2021: 3 annual reports, 7 quarterly reports, 21 major events, 122 insider forms, 17 large holders, 53 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Oct 6, 2026144 EDGAR
  3. Oct 6, 20264 EDGAR
  4. Oct 6, 20264 EDGAR
  5. Oct 6, 20264 EDGAR
  6. Oct 6, 20264 EDGAR
  7. Sep 15, 20264 EDGAR
  8. Sep 14, 20264 EDGAR
  9. Sep 14, 20264 EDGAR
  10. Sep 14, 20264 EDGAR
  11. Sep 14, 20264 EDGAR
  12. Sep 14, 20264 EDGAR
  13. Sep 14, 20264 EDGAR
  14. Sep 14, 20264 EDGAR
  15. Sep 14, 20264 EDGAR
  16. Sep 11, 20264 EDGAR
  17. Sep 11, 20264 EDGAR
  18. Sep 11, 20264 EDGAR
  19. Sep 11, 20264 EDGAR
  20. Sep 11, 2026S-8 EDGAR

The 223 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

42 open-market trades by officers, directors and large owners since October 2021: 26 buys and 16 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 8, 2026Aslan FredChief Executive OfficerSale23,429$10.92$255.8KForm 4
Sep 3, 2026Horan ChristopherChief Tech Operations OfficerSale10,366$11.16$115.7KForm 4
Sep 3, 2026Bush JenniferCOO, CLO, Compliance OfficerSale8,391$11.16$93.6KForm 4
Sep 3, 2026Banerjee SubhashisChief Medical OfficerSale1,100$11.16$12.3KForm 4
Sep 3, 2026Aslan FredChief Executive OfficerSale61,888$11.16$690.7KForm 4
Aug 27, 2026Banerjee SubhashisChief Medical OfficerSale8,222$12.01$98.7KForm 4
Aug 18, 2026Banerjee SubhashisChief Medical OfficerSale429$12.00$5.1KForm 4
Jul 31, 2026RA Capital Healthcare Fund LPDirectorBuy24,944$9.93$247.7KForm 4
Jul 29, 2026RA Capital Healthcare Fund LPDirectorBuy20,824$9.99$208.0KForm 4
Jul 24, 2026RA Capital Nexus Fund III, L.P.DirectorBuy41,319$9.99$412.8KForm 4
Jul 23, 2026Kolchinsky PeterDirectorBuy59,880$9.96$596.4KForm 4
Jul 22, 2026Kolchinsky PeterDirectorBuy84,124$9.93$835.4KForm 4
Jul 21, 2026Kolchinsky PeterDirectorBuy120,582$9.55$1.2MForm 4
Jul 17, 2026RA Capital Healthcare Fund LPDirectorBuy7,882$8.95$70.5KForm 4
Jul 16, 2026RA Capital Healthcare Fund LPDirectorBuy152,472$8.93$1.4MForm 4
Jul 13, 2026RA Capital Nexus Fund, L.P.DirectorBuy6,522$8.94$58.3KForm 4
Jul 13, 2026Shah Rajeev M.DirectorBuy6,552$8.94$58.6KForm 4
Jul 10, 2026Shah Rajeev M.DirectorBuy15,102$8.97$135.5KForm 4
Jun 26, 2026RA CAPITAL MANAGEMENT, L.P.DirectorBuy1,876$8.98$16.8KForm 4
Jun 25, 2026RA CAPITAL MANAGEMENT, L.P.DirectorBuy31,000$8.88$275.3KForm 4

All 42 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
2025Fred AslanM.D.52$665.0K$6.7M50
2025Jennifer Bush51$520.0K$1.5M50
2025Christopher Horan59$490.0K$1.4M50
2024Chief Executive Officer$621.6K$7.8M50
2024Chief Operating OfficerChief Legal Officer and Compliance Officer$478.2K$1.5M50

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
Ra Capital Management, L.P.17,955,642$174.2M1.5%+8,102,340
Viking Global Investors LP2,604,166$25.3M0.1%New
Blackstone Inc.2,403,437$23.3M0.1%New
5AM Venture Management, LLC2,353,304$22.8M7.9%No change
Venrock Adviser, LLC2,043,596$19.8M0.6%+434,027
Franklin Resources Inc1,997,223$19.4M0.0%+1,476,896
Caligan Partners LP1,736,111$16.8M0.8%New
Vanguard Capital Management LLC981,815$9.5M0.0%+774,129
Samsara Biocapital, LLC954,861$9.3M0.8%New
Blue Owl Capital Holdings LP874,542$8.5M1.3%New
Propel Bio Management, LLC696,436$6.8M3.5%+550,067
BlackRock, Inc.694,726$6.7M0.0%+481,338
Citadel Advisors LLC609,376$5.9M0.0%+593,506
Nantahala Capital Management, LLC600,000$5.8M0.2%New
Silverarc Capital Management, LLC525,000$5.1M0.6%New
Geode Capital Management, LLC353,845$3.4M0.0%+252,150
Boothbay Fund Management, LLC314,375$3.0M0.1%New
Revelation Capital Management, LLC299,311$2.9M2.7%No change
Alyeska Investment Group, L.P.273,615$2.7M0.0%+173,615
Acuta Capital Partners, LLC260,416$2.5M1.8%New
KVP Capital Advisors, LP200,000$1.9M1.4%New
Wellington Management Group Llp194,108$1.9M0.0%No change
UBS Group AG184,020$1.8M0.0%+182,493
Seven Grand Managers, LLC175,000$1.7M0.1%New
State Street Corp165,764$1.6M0.0%+129,940

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

SEC filer profile

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

  • Name on EDGARArtiva Biotherapeutics, Inc.1
  • CIK0001817241
  • Employer ID (EIN)83-36143167
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address5505 Morehouse Drive, San Diego, CA 921211
  • Phone(858) 267-44671
  • Shares outstanding48,890,121 as of Jul 31, 20266
  • Public float$15.0M as of Jun 30, 20257
  • AuditorKPMG LLP, San Diego, California PCAOB ID 185; no auditor attestation of internal control over financial reporting7
  • On EDGAR sinceJul 10, 20201
  • Filings227 in all: 4 (99), 3 (22), 8-K (21), 144 (13), 10-Q (7), CORRESP (5), S-1/A (5), S-8 (4)1
    All 37 form types

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

  • Latest filingsAnnual report (10-K) Mar 10, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Aug 3, 2026
    Latest 8-K (8-K) Sep 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareARTVThe Nasdaq Global Market

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

Risk factors and legal proceedings

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

  • Risks Related to Our Limited Operating History, Financial Position and Need for Additional Capital
  • We have a limited operating history and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
  • We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
  • We will need to obtain substantial additional funding to complete the development and any commercialization of our current and any future product candidates, which may cause dilution to our stockholders. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our research and development programs or other operations.
  • Risks Related to the Discovery and Development of our Product Candidates
  • Our approach to the development of NK cell-based product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our platform obsolete.
  • There is currently no cell therapy approved in the United States or elsewhere in the world for the treatment of any autoimmune disease, and our research and development activities related to AlloNK for treatment of autoimmune diseases, such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, and other autoimmune diseases, may never lead to an approved product.
  • Our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of developing product candidates and obtaining regulatory approval for any product candidates that we develop.
  • We are substantially dependent on the success of our lead product candidate, AlloNK, which is in clinical development. Although we have other product candidates in our pipeline being developed by our partners, all of our other internally developed product candidates are in the preclinical or discovery stage. If we are unable to advance our product candidates in clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Current clinical data regarding the efficacy of NK cell therapies against autoimmune diseases are limited, raising uncertainties about the therapeutic benefits of treatments like AlloNK for conditions such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, and other autoimmune diseases. Moreover, these therapies may not prove to be competitive compared to existing treatments for autoimmune diseases.
  • We are developing, and in the future may develop, other product candidates in combination with other therapies, which exposes us to additional risks.
  • Interim, topline and preliminary data from our preclinical studies or clinical trials that we announce or publish from time to time may not be predictive of future results and may change as more patient data become available and are subject to audit and verification procedures, which could result in material changes to the final data.
The other 62 risks
  • Clinical trials are expensive, time-consuming, difficult to design and implement, and have an uncertain outcome. Further, we may encounter substantial delays in our clinical trials.
  • Our product candidates may cause serious adverse events or undesirable side effects or have other properties that may delay or prevent regulatory approval, cause us to suspend or discontinue clinical trials, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • We study our product candidates in patient populations with significant comorbidities, and these patients may also receive treatment with cytotoxic lymphodepletion agents, cytokines, monoclonal antibodies and/or other treatments that may result in deaths or serious adverse or unacceptable side effects and require us to abandon or limit our clinical development activities.
  • Enrollment and retention of patients in clinical trials is an expensive and time-consuming process subject to various external factors beyond our control that may cause delays or complications.
  • Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
  • We may not 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.
  • Results of any patient who receives our product candidate in an IIT may not be representative of how the product candidate will perform in our clinical trials and may not be able to be used to establish safety or efficacy for regulatory approval.
  • The affected populations for our product candidates may be smaller than we or third parties currently project, which may affect the addressable markets for our product candidates.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
  • Disruptions to the operations of the FDA, the SEC, other U.S. governmental agencies or comparable foreign regulatory authorities caused by funding shortages, leadership changes, staffing cuts or other staffing shortages, along with uncertainty regarding the potential for new initiatives, laws, regulations, policies and guidance affecting our product candidates or other aspects of our business, could materially and adversely affect our business.
  • Risks Related to Manufacturing and Our Reliance on Third Parties
  • If third parties that we rely on to conduct clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our product candidates.
  • Our collaboration agreement with GC Cell and any future collaborations with third parties to develop or commercialize our product candidates, mean that our prospects with respect to the product candidates involved will depend in significant part on the success of those collaborations.
  • We may seek to form collaborations in the future with respect to our product candidates, but may not be able to do so, which may cause us to alter our development and commercialization plans.
  • The manufacture of cell therapy products is novel, complex and subject to multiple risks. We have built and are operating our own clinical manufacturing facility and may decide to operate our manufacturing facility at commercial scale, but we could encounter manufacturing problems such as delays or quality issues, and/or we could be required to or choose to modify our manufacturing processes, which could result in delays in the development or commercialization of our product candidates or otherwise harm our business.
  • Our partial reliance on third parties for manufacturing increases the risk that supply of our product candidates may become limited or interrupted or may not be of satisfactory quality and quantity.
  • We are dependent on third parties to acquire, ship and store our cord blood units, NK cell intermediate cell banks and drug product lots, and master and working feeder cell banks, and any disruption, quality concerns, damage or loss would cause delays in replacement and our business could suffer.
  • If our third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Any contamination or interruption in our manufacturing process, shortages of raw materials or failure of our suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules.
  • Risks Related to Commercialization of Our Product Candidates
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our product candidates, if approved, profitably.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
  • Risks Related to Government Regulation
  • The regulatory approval process of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval for any of our product candidates, and any such regulatory approval may be for a narrower indication than we seek.
  • The regulatory landscape that will govern our product candidates is uncertain; regulations relating to cell therapy products are still developing, and changes in regulatory requirements could result in delays or discontinuation of development of our product candidates or unexpected costs in obtaining regulatory approval.
  • The FDA, the EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • We may seek orphan drug designation for some or all of our product candidates across various indications, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • We may seek special designations by the regulatory authorities to expedite regulatory approvals, but may not be successful in receiving these designations, and even if received, they may not benefit the development and regulatory approval process.
  • 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.
  • 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 and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Our relationships with customers, physicians, other healthcare professionals and third-party payors are subject, directly or indirectly, to federal, state, local and foreign healthcare fraud and abuse laws, false claims laws, transparency laws, health information privacy and security laws and other healthcare laws and regulations. If we or our employees, independent contractors, consultants, commercial partners and vendors violate these laws, we could face substantial penalties.
  • We expect the product candidates we develop will be regulated as biologics, and therefore they may be subject to competition sooner than anticipated.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, rheumatology clinics, cancer treatment centers and others in the medical community.
  • The advancement of healthcare reform may negatively impact our ability to profitably sell our product candidates, if approved.
  • Our business activities may be subject to the U.S. Foreign Corrupt Practices Act (FCPA) and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S. and certain foreign export controls, trade sanctions and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • We are subject to various laws relating to foreign investment and the export of certain technologies, and our failure to comply with these laws or adequately monitor the compliance of our suppliers and others we do business with could subject us to substantial fines, penalties and even injunctions, the imposition of which on us could have a material adverse effect on the success of our business.
  • Risks Related to Our Intellectual Property
  • We depend substantially on intellectual property rights granted under our agreements with GC Cell. If we lose our existing licenses or are unable to acquire or license additional proprietary rights from third parties, we may not be able to continue developing our product candidates.
  • If we are unable to obtain and maintain patent protection for our technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • Third parties may assert claims against us alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to defend or enforce our patents, either of which could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of our product candidates, prohibit our use of proprietary technology or sale of products or put our patents and other proprietary rights at risk.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop, manufacture and market our product candidates.
  • Our intellectual property licenses 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.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • 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 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.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be harmed.
  • Our proprietary rights may not adequately protect our technologies and product candidates, and do not necessarily address all potential threats to our competitive advantage.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
  • 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 need to license additional intellectual property from third parties, and any such licenses may not be available or may not be available on commercially reasonable terms.
  • We may fail to obtain or enforce assignments of intellectual property rights from our employees and contractors.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • Risks Related to Our Industry and Business
  • We will need to expand our organization, and we may experience challenges in managing this growth as we build our capabilities, which could disrupt our operations.
  • Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
  • 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 impacts resulting from such compromise or failure, including, but not limited to, interruptions to our operations such as our clinical trials, regulatory investigations or actions; litigation; fines and penalties; claims that we breached our data protection obligations; harm to our reputation; a loss of customers or sales; and other adverse consequences.
  • Our business could be affected by litigation, government investigations, and enforcement actions.
  • Our employees and independent contractors, including consultants, vendors and any third parties we may engage in connection with development and commercialization may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could harm our business.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
  • Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.
  • Risks Related to the Ownership of Our Common Stock
  • The trading price of our common stock is likely to be volatile and you could lose all or part of your investment.
  • Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.7

Sources

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