RCUS on NYSE

Arcus Biosciences

Biopharmaceutical company based in Hayward, founded in 20151

In its 2026 annual report the company says: “We are a late clinical-stage biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases.”4 Its shares trade on NYSE under the symbol RCUS.1

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Last updated Oct 21, 2026.

Overview

2015Founded1

Compare with Zomedica Corp., BIOHARVEST SCIENCES INC. or Verastem Oncology, or pick any stock.

  • TickerRCUS on NYSE1
  • Industrypharmaceutical industry1
  • HeadquartersHayward1
  • Websitearcusbio.com
  • Incorporated inDE3
  • Business address3928 Point Eden Way, Hayward, Ca 945453
  • Filer categoryLarge accelerated filer3

We are a late clinical-stage biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases. Our most advanced molecules are in Phase 3 registrational studies for various cancer indications and we expect our next wave of clinical-stage molecules to come from our inflammation and autoimmune disease programs. Our vision is to leverage our internal small-molecule discovery capabilities to create, develop and commercialize highly differentiated therapies that can have a meaningful impact on patients.4 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

-1169.7%Operating margin5
-1069.7%Net margin5
-35.3%Revenue growth, 20255
-55.9%Return on equity5
0.16×Debt to equity5
-$484.0MFree cash flow5

What sells

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

Products and services

License And Development Services brought in 89% of the revenue Arcus Biosciences broke down this way in fiscal 2025.

  1. License And Development Services$221.0M589%down 0% from 2024
  2. Other Collaboration Revenue$26.0M511%down 28% from 2024
Products and services by year
Products and services202320242025
License And Development Services$80.0M$222.0M$221.0M
Other Collaboration Revenue$37.0M$36.0M$26.0M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$523.0M

Out of $33.0M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$33.0M in 2025+120% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $15.0M$15.0M20192020: $78.0M$78.0M2020+420%2021: $383.0M$383.0M2021+391%2022: $38.0M$38.0M2022−90%2023: $37.0M$37.0M2023−3%2024: $51.0M$51.0M2024+38%2025: $33.0M$33.0M2025−35%
Operating income67895-$386.0M in 2025+335% since 2019
-$400.0M-$200.0M0$200.0M2019: -$88.7M-$88.7M20192020: -$124.0M-$124.0M2020+40%2021: $54.0M$54.0M20212022: -$280.0M-$280.0M20222023: -$340.0M-$340.0M2023+21%2024: -$330.0M-$330.0M2024−3%2025: -$386.0M-$386.0M2025+17%
Net income67895-$353.0M in 2025+317% since 2019
-$400.0M-$200.0M0$200.0M2019: -$84.7M-$84.7M20192020: -$123.0M-$123.0M2020+45%2021: $53.0M$53.0M20212022: -$267.0M-$267.0M20222023: -$307.0M-$307.0M2023+15%2024: -$283.0M-$283.0M2024−8%2025: -$353.0M-$353.0M2025+25%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Research and development (Includes $25, ($39) and ($110) payments to/(from) a related party)$523.0M$448.0M$340.0M
Impairment of long-lived assets (see Note 14, Leases)$0$20.0M$0
Total operating expenses$633.0M$588.0M$457.0M
Loss from operations-$386.0M-$330.0M-$340.0M
Interest and other income, net$41.0M$52.0M$41.0M
Interest expense-$8.0M-$4.0M-$2.0M
Total non-operating income, net$33.0M$48.0M$39.0M
Loss before income taxes-$353.0M-$282.0M-$301.0M
Income tax expense$0-$1.0M-$6.0M
Net loss-$353.0M-$283.0M-$307.0M
Net loss per share, basic (in dollars per share)-$3.29-$3.14-$4.15
Net loss per share, diluted (in dollars per share)-$3.29-$3.14-$4.15
Shares used to compute net loss per share, basic (in shares)107.4M shares90.1M shares74.0M shares
Shares used to compute net loss per share, diluted (in shares)107.4M shares90.1M shares74.0M shares
Revenues$247.0M$258.0M$117.0M
General and administrative expense$110.0M$120.0M$117.0M

Compare Arcus Biosciences with another company

Corporate structure

Arcus Biosciences 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 Arcus Biosciences

  • Gilead Sciences Filed SCHEDULE 13D/A on Arcus Biosciences, latest Aug 7, 2026 (7 filings since Jul 6, 2023)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Arcus Biosciences, latest Mar 26, 2026 (3 filings since Feb 9, 2023)
  • BlackRock Filed SCHEDULE 13G/A on Arcus Biosciences, latest Jan 8, 2026 (9 filings since Feb 4, 2022)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Arcus Biosciences, latest Nov 14, 2025 (2 filings since May 13, 2025)
  • Terry J. Rosen Filed SC 13D/A on Arcus Biosciences, latest Dec 17, 2024
  • FMR LLC Filed SC 13G/A on Arcus Biosciences, latest Nov 12, 2024 (2 filings since Feb 9, 2024)
  • State Street Corporation Filed SC 13G/A on Arcus Biosciences, latest Oct 17, 2024 (2 filings since Jan 24, 2024)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Arcus Biosciences, latest Feb 14, 2023 (2 filings since Mar 14, 2022)
  • PFM Health Sciences, LP Filed SC 13G/A on Arcus Biosciences, latest Feb 14, 2023 (3 filings since Feb 14, 2022)
  • EcoR1 Capital, LLC Filed SC 13G/A on Arcus Biosciences, latest Feb 10, 2023 (2 filings since Feb 14, 2022)
  • GV 2016, L.P. Filed SC 13G/A on Arcus Biosciences, latest Feb 14, 2022
  • Arcus Biosciences Hayward

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

What it owns

What Arcus Biosciences 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$90.0M5 Dec 31, 2025$88.0M5 Dec 31, 2024+2.3%
Accumulated depreciation$50.0M5 Dec 31, 2025$41.0M5 Dec 31, 2024+22.0%
Property and equipment, net$40.0M5 Dec 31, 2025$47.0M5 Dec 31, 2024−14.9%
Operating-lease assets (leased space)$58.0M5 Dec 31, 2025$65.0M5 Dec 31, 2024−10.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$222.0M5 Dec 31, 2025$150.0M5 Dec 31, 2024+48.0%
Marketable securities, current$759.0M5 Dec 31, 2025$828.0M5 Dec 31, 2024−8.3%
Marketable securities, non-current$29.0M5 Dec 31, 2025$14.0M5 Dec 31, 2024+107.1%
Debt securities available for sale$1.0B5 Dec 31, 2025$992.0M5 Dec 31, 2024+1.8%

Properties, in its own words

As of December 31, 2025, our corporate headquarters, which includes executive offices and R&D and business operations, consist of approximately 151,000 square feet of leased office and laboratory space in an office park in Hayward, California. We also lease approximately 109,000 square feet of office space in Brisbane, California. The lease terms for both facilities expire in 2031, subject to options for us to extend the lease term. We have subleased approximately 31,000 square feet of our Brisbane office to a third-party, which commenced in October 2023 and extends through 2028. We have also subleased approximately 19,000 square feet of our Brisbane office to a third-party, which commenced in December 2024 and extends through 2031.

Item 2 of the 10-K filed Feb 25, 2026.4

Leadership

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

Chief financial officer

  1. Robert C. Goeltz Ii.2020–now

Chief operating officer

  1. Jennifer Jarrett2020–now
20202025
Board members and other officers (25)

Timeline

  1. Aug 5, 20268-K Results of operations41
  2. Jun 12, 20268-K Shareholder vote42
  3. May 5, 20268-K Results of operations43
  4. Apr 20, 20268-K Other events44
  5. Mar 23, 20268-K Executive or director change45
  6. Feb 25, 20268-K Results of operations46
  7. Dec 18, 20258-K Entered a material agreement; New debt or obligation47
  8. Dec 12, 20258-K Other events48
  9. Nov 3, 20258-K Other events49
  10. Oct 28, 20258-K Results of operations50
  11. Oct 14, 20258-K Other events51
  12. Oct 6, 20258-K Other events52
  13. Mar 15, 2018Went public Listed on NYSE1
  14. Mar 14, 2018New chief executive Terry J. Rosen becomes CEO14
  15. 2015Founded Founded1

Calendar

Coming up

  1. Oct 27, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.27) a share, on Oct 28, 2025.53

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results41
  2. May 5, 2026Reported quarterly or annual results43
  3. Feb 25, 2026Reported quarterly or annual results46
  4. Oct 28, 2025Reported quarterly or annual results50
  5. Aug 6, 2025Reported quarterly or annual results54
  6. May 6, 2025Reported quarterly or annual results55
  7. Feb 25, 2025Reported quarterly or annual results56
  8. Feb 18, 2025Reported quarterly or annual results57

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

Filings

362 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 51 major events, 175 insider forms, 34 large holders, 82 other. The latest 20:

  1. Sep 28, 2026CT ORDER EDGAR
  2. Aug 24, 20264 EDGAR
  3. Aug 21, 2026144 EDGAR
  4. Aug 7, 2026SCHEDULE 13D/A EDGAR
  5. Aug 5, 202610-Q EDGAR
  6. Aug 5, 20268-K EDGAR
  7. Jul 13, 20264 EDGAR
  8. Jul 9, 2026144 EDGAR
  9. Jun 24, 2026144 EDGAR
  10. Jun 24, 20264 EDGAR
  11. Jun 22, 2026144 EDGAR
  12. Jun 12, 20264 EDGAR
  13. Jun 12, 20264 EDGAR
  14. Jun 12, 20264 EDGAR
  15. Jun 12, 20264 EDGAR
  16. Jun 12, 20268-K EDGAR
  17. Jun 12, 20264 EDGAR
  18. Jun 12, 20264 EDGAR
  19. Jun 12, 20264 EDGAR
  20. Jun 12, 20264 EDGAR

The 362 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

92 open-market trades by officers, directors and large owners since October 2021: 5 buys and 87 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 21, 2026Azoy AlexanderChief Accounting OfficerSale2,827$30.00$84.8KForm 4
Jul 10, 2026Jaen Juan C.PresidentSale20,067$28.62$574.3KForm 4
Jul 9, 2026Jaen Juan C.PresidentSale48,502$30.05$1.5MForm 4
Jun 24, 2026Jaen Juan C.PresidentSale6,431$29.66$190.7KForm 4
Jun 23, 2026Jaen Juan C.PresidentSale15,764$27.73$437.1KForm 4
Jun 22, 2026Jaen Juan C.PresidentSale9,236$27.03$249.6KForm 4
Jun 1, 2026Azoy AlexanderChief Accounting OfficerSale2,562$25.77$66.0KForm 4
May 11, 2026Goeltz II Robert C.Chief Financial OfficerSale7,763$25.63$199.0KForm 4
Jan 5, 2026Jaen Juan C.PresidentSale31,823$21.41$681.3KForm 4
Dec 31, 2025Goeltz II Robert C.Chief Financial OfficerSale6,552$23.38$153.2KForm 4
Dec 18, 2025Azoy AlexanderChief Accounting OfficerSale4,343$22.25$96.6KForm 4
Dec 17, 2025Markus RichardChief Medical OfficerSale4,494$22.16$99.6KForm 4
Dec 17, 2025Tang Carolyn C.General CounselSale6,810$22.16$150.9KForm 4
Dec 17, 2025Azoy AlexanderChief Accounting OfficerSale2,113$22.16$46.8KForm 4
Dec 17, 2025Jarrett JenniferChief Operating OfficerSale9,983$22.16$221.2KForm 4
Dec 17, 2025Goeltz II Robert C.Chief Financial OfficerSale5,960$22.16$132.1KForm 4
Dec 17, 2025Jaen Juan C.PresidentSale9,983$22.16$221.2KForm 4
Dec 17, 2025ROSEN TERRY JChief Executive OfficerSale25,744$22.16$570.5KForm 4
Dec 16, 2025Markus RichardChief Medical OfficerSale5,052$21.88$110.5KForm 4
Dec 16, 2025Tang Carolyn C.General CounselSale7,658$21.88$167.6KForm 4

All 92 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
2025Terry Rosen, Ph.D.Chief Executive Officer and Director66$775.0K$9.7M69
2025Richard Markus, M.D., Ph.D.Chief Medical Officer60$552.3K$4.5M69
2025Juan Carlos Jaen, Ph.D.President68$660.0K$3.5M69
2025Jennifer JarrettChief Operating Officer55$660.0K$3.5M69
2025Robert C. Goeltz, IIChief Financial Officer53$540.0K$2.7M69
2024Terry Rosen, Ph.D.Chief Executive Officer and Director66$725.0K$7.3M69
2024Juan Carlos Jaen, Ph.D.President68$625.0K$3.3M69
2024Jennifer JarrettChief Operating Officer55$625.0K$3.3M69
2024Robert C. Goeltz, IIChief Financial Officer53$510.0K$2.0M69
2023Terry Rosen, Ph.D.Chief Executive Officer and Director66$650.0K$10.1M69
2023Juan Carlos Jaen, Ph.D.President68$575.0K$4.8M69
2023Jennifer JarrettChief Operating Officer55$575.0K$4.7M69
2023Robert C. Goeltz, IIChief Financial Officer53$490.0K$3.6M69

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
Gilead Sciences, Inc.31,424,760$968.8M58.8%No change
BlackRock, Inc.16,416,249$506.1M0.0%+1,189,774
State Street Corp6,029,484$185.9M0.0%+616,583
Wellington Management Group Llp5,895,448$181.8M0.0%−194,068
Montanova Capital, LLC4,776,423$147.3M3.1%−254,570
Vanguard Portfolio Management LLC4,475,528$138.0M0.0%+203,472
Fmr LLC4,049,757$124.9M0.0%+2,884,505
Vanguard Capital Management LLC3,888,346$119.9M0.0%+31,621
Citadel Advisors LLC3,135,057$96.7M0.1%+1,805,122
Woodline Partners LP3,007,798$92.7M0.3%−770,000
Geode Capital Management, LLC2,448,749$75.5M0.0%+196,382
Siren, L.L.C.2,420,430$74.6M1.5%−586,647
Fisher Asset Management, LLC2,139,396$66.0M0.0%−51,008
Marshall Wace, Llp1,945,088$60.0M0.1%−1,816,349
Samlyn Capital, LLC1,547,182$47.7M0.8%−361,230
Dimensional Fund Advisors LP1,434,320$44.2M0.0%+8,097
BNP PARIBAS ASSET MANAGEMENT Holding S.A.1,419,533$43.8M0.0%−235,221
Goldman Sachs Group Inc1,387,566$42.8M0.0%+387,780
Soleus Capital Management, L.P.1,168,738$36.0M1.2%+716,755
Sofinnova Investments, Inc.945,690$29.2M1.6%+22,604
Charles Schwab Investment Management Inc941,756$29.0M0.0%+38,118
Northern Trust Corp932,523$28.7M0.0%+92,218
Parkman Healthcare Partners LLC919,266$28.3M2.9%−288,008
Invesco Ltd.845,233$26.1M0.0%+24,413
Baker Bros. Advisors LP844,816$26.0M0.1%+429,195

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

SEC filer profile

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

  • Name on EDGARArcus Biosciences, Inc.2
  • CIK0001724521
  • Employer ID (EIN)47-38984354
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address3928 Point Eden Way, Hayward, CA 945452
  • Phone(510) 694-62002
  • Shares outstanding127,333,376 as of Jul 30, 202611
  • Public float$565.9M as of Jun 30, 20254
  • AuditorErnst & Young, LLP, San Mateo, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceDec 15, 20172
  • Filings602 in all: 4 (258), 8-K (92), 144 (50), 3 (31), 10-Q (26), SC 13G/A (24), SC 13G (17), DEFA14A (10)2
    All 36 form types

    S-8 (9), 10-K (8), DEF 14A (8), CORRESP (7), 424B5 (6), UPLOAD (6), S-3ASR (5), SCHEDULE 13D/A (5), ARS (4), SC 13D (4), SC 13D/A (4), SCHEDULE 13G/A (4), CT ORDER (3), 144/A (2), 8-K/A (2), DRS/A (2), DRSLTR (2), EFFECT (2), S-1/A (2), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), S-1 (1), S-1MEF (1), S-3 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Feb 25, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 21, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, Par Value $0.0001 Per ShareRCUSThe New York Stock Exchange

From the cover page of the 10-K filed Feb 25, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Arcus Biosciences names in Item 1A of its 10-K filed Feb 25, 2026: 63 risks under these headings, as written.4

  • Risks Related to our Limited Operating History, Financial Position and Capital Requirements
  • We have a history of operating losses, have never generated any revenue from product sales and anticipate that we will continue to incur significant losses for the foreseeable future.
  • We may need to obtain additional funding. If we do not receive or are unable to raise additional capital when needed, we may be forced to restrict our operations or delay, reduce or eliminate our product development programs.
  • Our operating activities may be restricted as a result of covenants related to the indebtedness under our loan and security agreement with Hercules Capital, Inc., as amended, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.
  • Risks Related to the Discovery and Development of our Investigational Products
  • If we are unable to obtain regulatory approval for our investigational products, or experience significant delays in doing so, our business will be materially harmed.
  • Clinical drug development is a lengthy, expensive and uncertain process. If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our investigational products, if approved, may be delayed and the credibility of our management team may be adversely affected and, as a result, our stock price may decline.
  • The results of preclinical studies and early clinical trials are not always predictive of future results.
  • Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects.
  • Preliminary, topline, and interim data from our clinical studies that we announce or publish from time to time are subject to audit and verification procedures that could result in material changes in the final data and may change as more patient data become available.
  • Most of our clinical trials are open-label studies and may be susceptible to bias.
  • Enrollment and retention of subjects in clinical trials is expensive and time consuming and can be made more difficult or rendered impossible by competing treatments, clinical trials of competing investigational products, geopolitical instability and public health epidemics, each of which could result in significant delays and additional costs in our product development activities, or in the failure of such activities.
The other 52 risks
  • Serious adverse events, undesirable side effects or other unexpected properties of our investigational products 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 investigational products or limitations on the use of our investigational products or, if discovered following marketing approval, revocation of marketing authorizations or subsequent limitations on the use of our investigational products.
  • Adverse findings from clinical trials conducted by third parties investigating the same investigational products as us in different territories or different investigational products directed to the same target as one of our programs could adversely affect our development program.
  • Development of combination therapies may present more or different challenges than development of single agent therapies.
  • Certain of our investigational products may require companion diagnostics in certain indications. Failure to successfully develop, validate and obtain regulatory clearance or approval for such tests could harm our product development strategy or prevent us from realizing the full commercial potential of our investigational products.
  • The design or our execution of our ongoing and future clinical trials may not support marketing approval.
  • We have conducted, and continue to conduct, portions of our clinical trials outside the U.S., and the FDA may not accept data from trials conducted in foreign locations.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations or policy changes 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.
  • Risks Related to Reliance on Third Parties, Manufacturing and Commercialization
  • We expect to depend on our collaboration with Gilead for the research, development, manufacture and commercialization of certain of our investigational products. If this collaboration is not successful, our business could be adversely affected.
  • We rely on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
  • Supply by third parties of the investigational products, standard-of-care drugs or comparator agents used in our clinical trials may become limited or interrupted, or more costly, which could delay, prevent or impair our development efforts.
  • Our manufacturing partners are subject to extensive regulation. In the event any of our manufacturers fail to comply with such regulations or perform its obligations, our business may be adversely affected and we may need to delay or halt the development of our investigational products.
  • Our employees, clinical trial investigators, CROs, consultants, vendors, collaboration partners and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Even if we receive regulatory approval for any investigational product, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
  • Even if we receive marketing approval, we may not be successful in commercializing our investigational products.
  • We may fail to obtain orphan drug designations from the FDA for our investigational products, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • Even if we receive marketing approval for one or more of our investigational products, our commercial success is dependent on obtaining coverage and reimbursement for a product from a government or other third-party payor, which coverage may be delayed or may not be sufficient to cover our costs.
  • Obtaining and maintaining regulatory approval of investigational products in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction. Even if our investigational products
  • are approved by the FDA, they may never be approved or commercialized outside the U.S., which would limit our ability to realize their full market potential.
  • Any investigational products for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • Risks Related to our In-Licenses and Other Strategic Agreements
  • We are currently party to several in-license agreements under which we acquired rights to use, develop, manufacture and/or commercialize certain of our investigational products. If we breach our obligations under these agreements, we may be required to pay damages, lose our rights to these investigational products or both, which would adversely affect our business and prospects.
  • We may not realize the benefits of any acquisitions, in-license or other collaborations or strategic alliances that we enter into.
  • Risks Related to Intellectual Property
  • If we are unable to obtain and maintain sufficient intellectual property protection for our investigational products, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.
  • We may become involved in lawsuits alleging that we have infringed the intellectual property rights of third parties or to protect or enforce our patents or other intellectual property, which litigation could be expensive, time consuming and adversely affect our ability to develop or commercialize our investigational products.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • We may not be able to protect our intellectual property rights outside of the U.S.
  • Changes in patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our investigational products.
  • We may rely on trade secret and proprietary know-how which can be difficult to trace and enforce and, if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on our investigational products for an adequate amount of time.
  • Risks Related to our Business Operations
  • We expect to expand our business operations and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • We are highly dependent on the services of our founders, Terry Rosen, Ph.D., who serves as our Chief Executive Officer, and Juan Jaen, Ph.D., who serves as our President.
  • We face substantial competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their investigational products are shown to be safer or more effective than ours, then our commercial opportunity will be reduced or eliminated.
  • Our internal information technology systems, and those of our third-party CROs and other third parties upon which we rely, are subject to failure, security breaches and other disruptions, which could result in a material disruption of our investigational products’ development programs, jeopardize sensitive information, prevent us from accessing critical information or result in a loss of our assets, and potentially expose us to notification obligations, loss, liability or reputational damage and otherwise adversely affect our business.
  • Unfavorable global economic, political and trade conditions could adversely affect our business, financial condition or results of operations and may exacerbate the effects of the risks described herein.
  • 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 or the third parties upon which we depend may be adversely affected by earthquakes, fires or other natural disasters.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Changes in tax laws and regulations or exposure to additional tax liabilities could adversely affect our financial results.
  • Risks Related to Our Industry
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit our commercialization of any investigational products that we may develop.
  • Failure to comply with data privacy and data protection laws, regulations, or other obligations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
  • Our business operations expose us to broadly applicable fraud and abuse, transparency, government price reporting, 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.
  • Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Risks Related to Owning our Common Stock
  • The stock price of our common stock has been and may continue to be volatile or may decline regardless of our operating performance.
  • The amount of our future losses is uncertain and our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • The concentration of our stock ownership will likely limit our stockholders’ ability to influence corporate matters, including the ability to influence the outcome of director elections and other matters requiring stockholder approval.
  • Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is 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
  • Sales of substantial amounts of our shares may cause the price of our common stock to decline.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could result in sanctions or other penalties that would harm our business.

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.4

Sources

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