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COGT on Nasdaq

Cogent Biosciences, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company focused on developing precision therapies for genetically defined diseases. Our approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Our most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.”4 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol COGT.1

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Last updated Oct 21, 2026.

Overview

Compare with Aclaris Therapeutics, Inc., Pulmatrix, Inc. or Coya Therapeutics, Inc., or pick any stock.

  • TickerCOGT on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address180 Third Avenue, 4Th Floor, Waltham, Ma2
  • Filer categoryLarge accelerated filer2

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We are a clinical-stage biotechnology company focused on developing precision therapies for genetically defined diseases. Our approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients. Our most advanced program is bezuclastinib, also known as CGT9486, a highly selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (“SM”), a serious and rare disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (“GIST”), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib is a highly selective and potent KIT inhibitor with the potential to prov…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 2020

-1044.3%Operating margin5
-950.4%Net margin5
-65.0%Revenue growth, 20205
-31.9%Return on equity6

Where the money goes

Where each dollar of revenue went, fiscal 2020

  • Research and development100¢$25.7M

Out of $7.9M in revenue.5 The company lost money this year.

Financial statements

Revenue75$7.9M in 2020−65% since 2019
0$10.0M$20.0M$30.0M2019: $22.5M$22.5M20192020: $7.9M$7.9M2020−65%
Operating income75-$82.2M in 2020+155% since 2019
-$100.0M-$75.0M-$50.0M-$25.0M02019: -$32.2M-$32.2M20192020: -$82.2M-$82.2M2020+155%
Net income75-$74.8M in 2020+135% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$31.8M-$31.8M20192020: -$74.8M-$74.8M2020+135%

Every line of the income statement as filed: the last 3 fiscal years, latest first.10

Period ending2025-12-312024-12-312023-12-31
Research and development$269.8M$232.7M$173.8M
General and administrative$63.6M$43.3M$34.4M
Total operating expenses$333.4M$275.9M$208.1M
Loss from operations-$333.4M-$275.9M-$208.1M
Interest income$14.7M$18.1M$13.1M
Interest expense-$3.1M
Loss on debt extinguishment-$7.2M$0$0
Change in fair value of CVR liability$0$0$1.7M
Other income (expense), net-$20.0K$2.0M$943.0K
Total other income, net$4.4M$20.1M$15.7M
Net loss-$328.9M-$255.9M-$192.4M
Net loss per share, basic-$2.16-$1.94-$1.94
Net loss per share, diluted-$2.16-$1.94-$1.94
Weighted average common stock outstanding, basic128.9M shares103.9M shares79.7M shares
Weighted average common stock outstanding, diluted128.9M shares103.9M shares79.7M shares
Net unrealized gains (losses) on marketable securities-$92.0K$201.0K$350.0K
Total other comprehensive income (loss)-$92.0K$201.0K$350.0K
Comprehensive loss-$329.0M-$255.7M-$192.1M

Compare Cogent Biosciences, Inc. with another company

Corporate structure

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

Major holders of Cogent Biosciences, Inc.

  • James E. Flynn Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Aug 13, 2026 (5 filings since Jun 17, 2022)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Cogent Biosciences, Inc., latest Jul 31, 2026
  • BlackRock Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Jul 27, 2026 (7 filings since Feb 4, 2022)
  • Fairmount Funds Management LLC Filed SCHEDULE 13D/A on Cogent Biosciences, Inc., latest Mar 31, 2026 (10 filings since Jun 21, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Mar 26, 2026 (3 filings since Feb 13, 2024)
  • Commodore Capital LP Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Feb 17, 2026 (9 filings since Nov 4, 2021)
  • Kynam Capital Management, LP Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Feb 17, 2026 (4 filings since Feb 14, 2024)
  • Paradigm Biocapital Advisors LP Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Nov 14, 2025 (4 filings since Feb 12, 2025)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Nov 14, 2025 (5 filings since Jun 1, 2023)
  • TCG Crossover GP I, LLC Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Nov 14, 2025 (3 filings since Feb 14, 2023)
  • Venrock Healthcare Capital Partners II, L.P. Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Aug 14, 2025 (6 filings since Feb 14, 2022)
  • FMR LLC Filed SCHEDULE 13G/A on Cogent Biosciences, Inc., latest Feb 12, 2025 (4 filings since Feb 9, 2024)
  • Cogent Biosciences, Inc. Waltham, Massachusetts
    • Kiq Bio LLC Subsidiary · Delaware, United States
    • Mono Inc. Subsidiary · Massachusetts, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Cogent 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$14.1M10 Dec 31, 2025$12.6M10 Dec 31, 2024+12.4%
Accumulated depreciation$8.7M10 Dec 31, 2025$6.1M10 Dec 31, 2024+41.9%
Property and equipment, net$5.5M10 Dec 31, 2025$6.5M10 Dec 31, 2024−15.6%
Operating-lease assets (leased space)$18.1M10 Dec 31, 2025$20.1M10 Dec 31, 2024−10.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$312.0M10 Dec 31, 2025$98.2M10 Dec 31, 2024+217.8%
Marketable securities, current$588.8M10 Dec 31, 2025$188.9M10 Dec 31, 2024+211.7%
Debt securities available for sale$588.8M10 Dec 31, 2025$188.9M10 Dec 31, 2024+211.7%

Properties, in its own words

Waltham, Massachusetts

Our corporate headquarters are located in Waltham, Massachusetts, where we sublease approximately 17,749 square feet of office space pursuant to a sublease agreement that commenced in June 2022 and expires in September 2026. This facility primarily houses our clinical, regulatory, and administrative personnel.

The rest of Item 2

In September 2025, we entered into a new lease agreement pursuant to which we will lease approximately 31,518 square feet of office space in Waltham, Massachusetts. This will serve as our corporate headquarters and replace our existing headquarters in Waltham, Massachusetts. This lease is expected to commence in May 2026.

Boulder, Colorado

We lease approximately 44,657 square feet of office and laboratory space in Boulder, Colorado. The lease has an initial term of 12 years, commencing in June 2022 and expiring in June 2035, with the option to extend for three successive five-year terms. This facility primarily houses our research and other administrative personnel.

We believe that our current facilities are adequate to meet our immediate needs.

Item 2 of the 10-K filed Feb 17, 2026.4

Leadership

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

Chief executive

  1. Andrews R. Robbins2020–now

President

  1. Christiana Stamoulis2018
  2. Andrews R. Robbins2020–now

Chief financial officer

  1. Matthew Scott Osborne2019–2020
  2. John L. Green2020–now
20202025
Board members and other officers (17)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Kiq Bio LLC Delaware3
  • Mono Inc. Massachusetts3

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

Former names

  • Unum Therapeutics Inc.Dec 4, 2017 to Oct 5, 20202
  • Unum Therapeutics, Inc.Oct 20, 2014 to Mar 30, 20182

Timeline

  1. Sep 2, 20268-K Entered a material agreement31
  2. Aug 10, 20268-K Results of operations32
  3. Aug 10, 20268-K Other events33
  4. Jun 11, 20268-K Shareholder vote34
  5. May 5, 20268-K Results of operations35
  6. Feb 17, 20268-K Results of operations36
  7. Dec 8, 20258-K Other events37
  8. Nov 18, 20258-K Entered a material agreement; New debt or obligation38
  9. Nov 13, 20258-K Entered a material agreement; Other events39
  10. Nov 10, 20258-K Regulation FD disclosure; Other events40
  11. Nov 3, 20258-K Results of operations41
  12. Sep 11, 20258-K Entered a material agreement; New debt or obligation42
  13. Oct 27, 2020New chief executive Andrews R. Robbins becomes CEO11

Calendar

Coming up

  1. Nov 6, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.50) a share, on Nov 7, 2025.43

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results32
  2. May 5, 2026Reported quarterly or annual results35
  3. Feb 17, 2026Reported quarterly or annual results36
  4. Nov 3, 2025Reported quarterly or annual results41
  5. Aug 5, 2025Reported quarterly or annual results44
  6. Jul 10, 2025Reported quarterly or annual results45
  7. May 6, 2025Reported quarterly or annual results46
  8. Feb 25, 2025Reported quarterly or annual results47

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

Filings

314 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 48 major events, 107 insider forms, 81 large holders, 58 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Sep 2, 20268-K EDGAR
  3. Aug 31, 20264 EDGAR
  4. Aug 27, 2026144 EDGAR
  5. Aug 13, 2026SCHEDULE 13G/A EDGAR
  6. Aug 10, 20268-K EDGAR
  7. Aug 10, 2026424B5 EDGAR
  8. Aug 10, 202610-Q EDGAR
  9. Aug 10, 20268-K EDGAR
  10. Jul 31, 2026SCHEDULE 13G EDGAR
  11. Jul 27, 2026SCHEDULE 13G/A EDGAR
  12. Jul 6, 20264 EDGAR
  13. Jun 11, 20264 EDGAR
  14. Jun 11, 20264 EDGAR
  15. Jun 11, 20264 EDGAR
  16. Jun 11, 20264 EDGAR
  17. Jun 11, 20264 EDGAR
  18. Jun 11, 20264 EDGAR
  19. Jun 11, 20268-K EDGAR
  20. May 21, 20264 EDGAR

The 314 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

11 open-market trades by officers, directors and large owners since October 2021: 4 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 27, 2026Morris ArleneDirectorSale45,510$37.12$1.7MForm 4
Mar 31, 2026Fairmount Funds Management LLCDirectorSale7,000,000$34.66$242.6MForm 4
Jan 22, 2026Fairmount Funds Management LLCDirectorSale3,500,000$36.40$127.4MForm 4
Dec 26, 2025Kearns EvanChief Legal OfficerSale65,000$38.70$2.5MForm 4
Dec 26, 2025Green John L.Chief Financial OfficerSale77,000$38.68$3.0MForm 4
Dec 26, 2025Sachs JessicaChief Medical OfficerSale82,642$38.70$3.2MForm 4
Dec 26, 2025Robinson John EdwardChief Scientific OfficerSale90,000$38.74$3.5MForm 4
Jul 10, 2025Fairmount Funds Management LLCDirectorBuy2,777,777$9.00$25.0MForm 4
Jan 14, 2025Pinnow ColeChief Commercial OfficerBuy43,750$7.60$332.5KForm 4
Jun 9, 2023Fairmount Funds Management LLCDirectorBuy800,000$12.00$9.6MForm 4
Jun 16, 2022Fairmount Funds Management LLCDirectorBuy1,200,000$8.25$9.9MForm 4

From Forms 4 filed with the SEC.

Major holders

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

Executive pay

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

YearExecutiveAgeSalaryTotal pay
2025Andrew RobbinsChief Executive Officer50$724.6K$27.8M72
2025Jessica SachsChief Medical Officer51$549.4K$9.2M72
2025John RobinsonChief Scientific Officer$532.0K$9.2M72
2025Cole PinnowChief Commercial Officer51$482.3K$8.8M72
2025John GreenChief Financial Officer45$510.7K$8.5M72
2024Andrew RobbinsChief Executive Officer50$692.0K$4.9M72
2024Cole PinnowChief Commercial Officer51$265.4K$4.0M72
2024Jessica SachsChief Medical Officer51$527.4K$1.8M72
2024John RobinsonChief Scientific Officer$510.8K$1.8M72
2024John GreenChief Financial Officer45$490.0K$1.7M72
2023Andrew RobbinsChief Executive Officer50$656.1K$7.9M72
2023Jessica SachsChief Medical Officer51$507.1K$3.0M72
2023John RobinsonChief Scientific Officer$491.1K$3.0M72

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
Fmr LLC25,681,174$993.9M0.0%+2,558,426
BlackRock, Inc.17,352,646$671.5M0.0%+1,307,632
Vanguard Portfolio Management LLC8,072,411$312.4M0.0%+739,078
Vanguard Capital Management LLC7,412,330$286.9M0.0%+517,371
State Street Corp6,964,919$269.5M0.0%+1,301,376
Jupiter Topco LLC6,624,848$256.4M0.1%New
Fairmount Funds Management LLC5,503,418$213.0M14.1%No change
Deerfield Management Company, L.P.5,006,104$193.7M2.4%−4,037,799
TCG Crossover Management, LLC4,854,436$187.9M4.5%−92,458
Geode Capital Management, LLC4,508,998$174.5M0.0%+809,479
Wellington Management Group Llp4,343,977$168.1M0.0%+765,355
Kynam Capital Management, LP3,667,097$141.9M7.8%−370,234
Polar Capital Holdings Plc3,232,905$125.1M0.4%New
Commodore Capital LP3,050,000$118.0M7.0%+161,993
Assenagon Asset Management S.A.2,883,512$111.6M0.1%+2,587,862
Invesco Ltd.2,609,141$101.0M0.0%+179,512
Woodline Partners LP2,603,162$100.7M0.3%+1,093,605
Pictet Asset Management Holding SA2,393,515$92.6M0.1%+594,747
Octagon Capital Advisors LP2,350,000$90.9M8.3%No change
Rtw Investments, LP2,309,021$89.4M0.8%−3,149,654
Goldman Sachs Group Inc2,288,633$88.6M0.0%−2,145,421
Candriam S.C.A.2,088,369$80.7M0.4%+572,072
Deep Track Capital, LP2,000,000$77.4M1.1%+1,000,000
Siren, L.L.C.1,859,279$72.0M1.5%+150,000
Orbimed Advisors LLC1,681,300$65.1M1.2%+1,359,200

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

Members of Congress who traded it

1 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Dec 12, 2022Christopher L. Jacobs, HouseBuy$1,001 - $15,000+50.5%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Cogent 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 EDGARCogent Biosciences, Inc.1
  • CIK0001622229
  • Employer ID (EIN)46-53082484
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address180 Third Avenue, 4Th Floor, Waltham, MA1
  • Phone617-945-55761
  • Shares outstanding173,524,982 as of Aug 6, 20269
  • Public float$772.9M as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceOct 20, 20141
  • Filings614 in all: 4 (216), 8-K (98), SC 13G/A (42), 3 (28), SC 13G (28), 10-Q (26), SCHEDULE 13G/A (21), 424B5 (15)1
    All 46 form types

    S-8 (13), CORRESP (12), UPLOAD (10), DEF 14A (9), 10-K (8), EFFECT (8), 144 (7), DEFA14A (7), SC 13D/A (6), PRE 14A (5), S-3 (5), ARS (4), D (4), PRER14A (4), SCHEDULE 13D/A (4), SCHEDULE 13G (4), FWP (3), 3/A (2), 4/A (2), CT ORDER (2), POS AM (2), S-3ASR (2), SEC STAFF LETTER (2), 10-Q/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DEFM14A (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-1/A (1), SC 13D (1), SC TO-I (1), SC TO-I/A (1)

  • Latest filingsAnnual report (10-K) Feb 17, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Sep 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 Par ValueCOGTNasdaq

From the cover page of the 10-K filed Feb 17, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Cogent Biosciences, Inc. names in Item 1A of its 10-K filed Feb 17, 2026: 62 risks under these headings, as written.4

  • Risks Related to our Business
  • Our business is highly dependent on the success of our bezuclastinib program and our ability to discover and develop additional product candidates. We may not be successful in our efforts to develop bezuclastinib or expand our pipeline of drug candidates.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • The incidence and prevalence for target patient populations of our drug candidates have not been established with precision. If the market opportunities for our drug candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue potential and ability to achieve profitability will be adversely affected.
  • Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available, may be interpreted differently if additional data are disclosed, and are subject to audit and verification procedures that could result in material changes in the final data.
  • The commercial success of any future approved drugs, including bezuclastinib, will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for bezuclastinib or any of our other product candidates could limit our ability to market those products and decrease our ability to generate revenue.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of bezuclastinib or any of our other product candidates.
  • Information obtained from expanded access studies may not reliably predict the efficacy of our future product candidates in company-sponsored clinical trials and may lead to adverse events that could limit approval.
  • Clinical trials are expensive, time-consuming, and difficult to design and implement.
  • If unacceptable side effects are identified during the development of our drug candidates, we may need to abandon or limit such development.
The other 51 risks
  • If difficulties arise enrolling patients in our clinical trials, clinical development activities could be delayed or otherwise adversely affected.
  • Since the number of patients that we have dosed to date in some of our clinical trials is small, the results from such clinical trials may be less reliable than results achieved in larger clinical trials.
  • We may choose not to develop a potential product candidate, or we may suspend, deprioritize or terminate one or more discovery programs or preclinical or clinical product candidates or programs.
  • We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, but we may not realize any resulting benefits.
  • Risks Related to Our Reliance on Third Parties
  • We currently rely and for the foreseeable future will continue to rely on third parties to conduct our clinical trials and to assist with various research, discovery, manufacturing and supply activities. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates or discover new product candidates on our intended timelines, if at all.
  • We contract with third parties for the manufacture of our drug candidates for preclinical development and clinical trials. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • The third parties upon whom we rely for the supply of the API and drug product used in bezuclastinib are our sole source of supply, and the loss of any of these suppliers could significantly harm our business.
  • Risks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
  • Breakthrough Therapy Designation for bezuclastinib and our other product candidates or participation in the FDA’s Real-Time Oncology Review (“RTOR”) program may not lead to a faster development or review process.
  • The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.
  • We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to faster development or regulatory review or approval process.
  • Regulatory authorities, including the FDA, may disagree with our regulatory plan and we may fail to obtain regulatory approval of our product candidates.
  • 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.
  • Evolving regulatory standards, including as a result of changes in government leadership, make it difficult to accurately predict the likelihood of marketing approval even when clinical trials meet their endpoints.
  • 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.
  • Pharmaceutical and biological product marketing is subject to substantial regulation in the United States. and any failure by us or our commercial and collaborative partners to comply with applicable statutes or regulations can adversely affect our business.
  • The impact of healthcare legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our business model.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We face potential liability related to the privacy of health information we obtain from clinical trials sponsored by us.
  • If we are unable to successfully develop companion diagnostic tests for our drug candidates that require such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these drug candidates.
  • We may not be able to file investigational new drug applications (“IND”s) or IND amendments or clinical trial authorization applications (“CTA”s) to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or other regulatory authorities may not permit us to proceed.
  • Risks Related to Our Intellectual Property
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.
  • We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
  • Patent terms may be inadequate to protect our competitive position on our product candidates and any future products for an adequate amount of time.
  • Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates and future products.
  • We may not be able to seek or obtain patent protection throughout the world or enforce such patent protection once obtained.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our trademarks of interest and our business may be adversely affected.
  • Risks Related to Employee Matters and Managing Growth
  • We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We have experienced significant growth and expect to continue to expand our company to support research, development and commercial capabilities and may face challenges in managing our growth.
  • We may have difficulty building our sales, marketing and distribution infrastructure.
  • Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or access to our systems.
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future.
  • We may require additional capital to finance our planned operations. If we fail to obtain additional financing when needed, or on attractive terms, we may be unable to complete the development and commercialization of our product candidates.
  • Our ability to use net operating losses and tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • Risks Related to Ownership of our Common Stock
  • The price of our stock may be volatile, and you could lose all or part of your investment.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.
  • An active trading market for our common stock may not be sustained.
  • Future sales and issuances of our common stock or rights to purchase common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Risks Related to our Convertible Notes
  • Our indebtedness and liabilities could limit the cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under the notes.
  • We may be unable to raise the funds necessary to repurchase the Notes for cash following a fundamental change or to pay any cash amounts due upon maturity or conversion of the Notes.
  • The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and results of operations.
  • Transactions relating to the Notes may affect the value of our common stock.
  • The accounting method for the Notes could adversely affect our reported financial condition and results.
  • The conversion of the Notes could impair our financial position and liquidity.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources, and other factors.

The opening of Item 3, Legal Proceedings.4

Sources

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