Sign in

TNGX on Nasdaq

Tango Therapeutics (United States)

American pharmaceutical preparations company based in Boston, founded in 20171

In its 2026 annual report the company says: “We are a precision oncology company with a limited operating history. We have no products approved for commercial sale, have not generated any revenue from product sales and may never become profitable. We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.”11 Its shares trade on Nasdaq under the symbol TNGX.1

Price unavailable

Last updated Oct 21, 2026.

Overview

2017Founded1

Compare with Nuvation Bio Inc., Fortress Biotech or Journey Medical Corp, or pick any stock.

  • TickerTNGX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBoston, Massachusetts1
  • Websitewww.tangotx.com
  • Incorporated inDE3
  • Business address201 Brookline Avenue, Suite 901, Boston, Ma 022153
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

See how the biggest companies compare on our leaderboards

Financials

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

Key numbers, fiscal 2025

-178.4%Operating margin4
-162.9%Net margin4
48.3%Revenue growth, 20254
-29.3%Return on equity4
-$139.9MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$132.2M
  • Income tax0¢$4.0K

Out of $62.4M in revenue.4 The company lost money this year.

Financial statements

Revenue5674$62.4M in 2025+715% since 2020
0$20.0M$40.0M$60.0M$80.0M2020: $7.7M$7.7M20202021: $37.0M$37.0M2021+384%2022: $24.9M$24.9M2022−33%2023: $36.5M$36.5M2023+47%2024: $42.1M$42.1M2024+15%2025: $62.4M$62.4M2025+48%
Operating income5674-$111.3M in 2025+113% since 2020
-$150.0M-$100.0M-$50.0M02020: -$52.2M-$52.2M20202021: -$58.2M-$58.2M2021+11%2022: -$111.1M-$111.1M2022+91%2023: -$114.2M-$114.2M2023+3%2024: -$145.6M-$145.6M2024+28%2025: -$111.3M-$111.3M2025−24%
Net income5674-$101.6M in 2025+95% since 2020
-$150.0M-$100.0M-$50.0M02020: -$52.0M-$52.0M20202021: -$58.2M-$58.2M2021+12%2022: -$108.2M-$108.2M2022+86%2023: -$101.7M-$101.7M2023−6%2024: -$130.3M-$130.3M2024+28%2025: -$101.6M-$101.6M2025−22%

Every line of the income statement as filed: the last 3 fiscal years, latest first.4

Period ending2025-12-312024-12-312023-12-31
Total Revenue$62.4M$42.1M$36.5M
Research and development$132.2M$143.9M$115.2M
General and administrative$41.5M$43.7M$35.5M
Total operating expenses$173.7M$187.7M$150.7M
Loss from operations-$111.3M-$145.6M-$114.2M
Interest income$5.6M$7.9M$6.6M
Other income, net$4.1M$7.6M$5.9M
Total other income, net$9.7M$15.5M$12.6M
Loss before income taxes-$101.6M-$130.1M-$101.6M
Provision for income taxes-$4.0K-$208.0K-$134.0K
Net loss-$101.6M-$130.3M-$101.7M
Net loss per common share - basic-$0.87-$1.19-$1.08
Net loss per common share - diluted-$0.87-$1.19-$1.08
Weighted average number of common shares outstanding - basic116.2M shares109.2M shares94.6M shares
Weighted average number of common shares outstanding - diluted116.2M shares109.2M shares94.6M shares
Unrealized (loss) gain on marketable securities-$112.0K$150.0K$3.9M
Comprehensive loss-$101.7M-$130.2M-$97.9M

Compare Tango Therapeutics (United States) with another company

Corporate structure

Tango Therapeutics (United States) 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 Tango Therapeutics (United States)

  • Nextech Crossover I GP S.a r.l. Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Aug 14, 2026 (3 filings since Aug 21, 2023)
  • FARALLON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Aug 14, 2026
  • Goldman Sachs Filed SCHEDULE 13G on Tango Therapeutics (United States), latest Aug 14, 2026
  • TCG Crossover GP II, LLC Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Aug 14, 2026 (5 filings since Nov 20, 2024)
  • Woodline Partners LP Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Aug 14, 2026 (4 filings since Aug 14, 2025)
  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Aug 12, 2026 (5 filings since Aug 12, 2025)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G on Tango Therapeutics (United States), latest May 15, 2026
  • Farallon Capital Partners, L.P. Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest May 11, 2026 (4 filings since Jun 13, 2025)
  • FMR LLC Filed SCHEDULE 13G on Tango Therapeutics (United States), latest May 6, 2026 (6 filings since Feb 9, 2022)
  • Invus Global Management, LLC Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest May 4, 2026 (3 filings since Sep 22, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Mar 27, 2026 (2 filings since Jan 30, 2026)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Tango Therapeutics (United States), latest Feb 17, 2026 (4 filings since Sep 21, 2023)
  • Tango Therapeutics (United States) Boston, Massachusetts

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

What it owns

What Tango Therapeutics (United States) 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$17.4M4 Dec 31, 2025$16.5M4 Dec 31, 2024+5.7%
Accumulated depreciation$10.5M4 Dec 31, 2025$8.4M4 Dec 31, 2024+26.0%
Property and equipment, net$6.9M4 Dec 31, 2025$8.1M4 Dec 31, 2024−15.2%
Operating-lease assets (leased space)$35.6M4 Dec 31, 2025$39.5M4 Dec 31, 2024−9.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$112.3M4 Dec 31, 2025$69.5M4 Dec 31, 2024+61.5%
Marketable securities, current$230.9M4 Dec 31, 2025$188.4M4 Dec 31, 2024+22.5%

Properties, in its own words

Our corporate headquarters is located at 201 Brookline Avenue, Boston, Massachusetts, where we lease approximately 64,805 square feet of office and laboratory space. The term of our amended lease with respect to this facility expires on January 31, 2033, however, under certain circumstances, this lease may terminate on an earlier date.

Item 2 of the 10-K filed Mar 5, 2026.11

Leadership

Who has led Tango Therapeutics (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Aaron I. Davis2020
  2. Barbara Weber2021–2025
  3. Malte Peters2026–now

Chair

  1. Barbara Weber2026–now

President

  1. Christopher Fuglesang2020
  2. Malte Peters2026
  3. Adam Crystal2026–now

Chief financial officer

  1. Michael Beauchamp2020
  2. Daniella Beckman2021–2026
  3. Matthew Gall2026–now

Chief operating officer

  1. Andrew Ruel Ellis2020
20202025
Board members and other officers (22)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorMace Ann Rothenberg named Aug 24, 2023 to Oct 28, 202541

Former names

  • BCTG Acquisition Corp.Jul 30, 2020 to Aug 9, 20213

Timeline

  1. Aug 11, 20268-K Results of operations42
  2. Aug 11, 20268-K Other events43
  3. Aug 7, 20268-K Executive or director change; Regulation FD disclosure44
  4. Aug 6, 20268-K Executive or director change45
  5. Jun 23, 20268-K Executive or director change46
  6. Jun 10, 20268-K Entered a material agreement47
  7. Jun 8, 20268-K Regulation FD disclosure; Other events48
  8. Jun 4, 20268-K Shareholder vote49
  9. May 13, 20268-K Results of operations; Executive or director change50
  10. May 8, 20268-K Executive or director change51
  11. Apr 15, 20268-K Executive or director change; Regulation FD disclosure52
  12. Mar 5, 20268-K Results of operations53
  13. Jan 12, 2026New chief executive Malte Peters becomes CEO12
  14. Aug 12, 2021New chief executive Barbara Weber becomes CEO13
  15. Sep 3, 2020New chief executive Aaron I. Davis becomes CEO14
  16. 2017Founded Founded1

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.13 a share, on Nov 4, 2025.54

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results42
  2. May 13, 2026Reported quarterly or annual results50
  3. Mar 5, 2026Reported quarterly or annual results53
  4. Jan 8, 2026Reported quarterly or annual results55
  5. Nov 4, 2025Reported quarterly or annual results56
  6. Oct 23, 2025Reported quarterly or annual results57
  7. Aug 5, 2025Reported quarterly or annual results58
  8. May 12, 2025Reported quarterly or annual results59

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

Filings

350 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 45 major events, 124 insider forms, 63 large holders, 2 private raises, 96 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Sep 24, 20264 EDGAR
  3. Sep 22, 2026144 EDGAR
  4. Sep 3, 20264 EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 14, 2026SCHEDULE 13G EDGAR
  10. Aug 12, 2026SCHEDULE 13G/A EDGAR
  11. Aug 11, 20268-K EDGAR
  12. Aug 11, 2026424B5 EDGAR
  13. Aug 11, 20268-K EDGAR
  14. Aug 11, 202610-Q EDGAR
  15. Aug 7, 20268-K/A EDGAR
  16. Aug 6, 20268-K EDGAR
  17. Aug 5, 20264 EDGAR
  18. Aug 3, 2026144 EDGAR
  19. Jul 2, 20264 EDGAR
  20. Jun 23, 20264 EDGAR

The 350 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

84 open-market trades by officers, directors and large owners since October 2021: 13 buys and 71 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 22, 2026Newcomb JessicaPrincipal Accounting OfficerSale8,200$24.22$198.6KForm 4
Sep 1, 2026Crystal AdamPresident, R&DSale27,000$22.37$604.0KForm 4
Aug 3, 2026Crystal AdamPresident, R&DSale27,000$27.24$735.5KForm 4
Jul 1, 2026Crystal AdamPresident, R&DSale27,000$29.59$798.9KForm 4
Jun 1, 2026Crystal AdamPresident, R&DSale27,000$22.88$617.6KForm 4
May 1, 2026Crystal AdamPresident, R&DSale27,000$21.22$573.0KForm 4
Apr 15, 2026Crystal AdamPresident, R&DSale38,460$25.00$961.5KForm 4
Apr 1, 2026Crystal AdamPresident, R&DSale27,000$21.20$572.4KForm 4
Mar 25, 2026Crystal AdamPresident, R&DSale12,000$20.11$241.3KForm 4
Mar 5, 2026Crystal AdamPresident, R&DSale20,251$15.00$303.8KForm 4
Feb 25, 2026Crystal AdamPresident, R&DSale54,345$12.77$694.0KForm 4
Feb 3, 2026Beckman DaniellaChief Financial OfficerSale10,317$12.27$126.6KForm 4
Feb 3, 2026Weber BarbaraDirector, Executive ChairSale30,519$12.27$374.4KForm 4
Feb 3, 2026Crystal AdamPresident, R&DSale18,452$12.27$226.3KForm 4
Oct 23, 2025TRV GP IV, LLC10% ownerSale477,401$10.15$4.8MForm 4
Sep 25, 2025TRV GP IV, LLC10% ownerSale500,000$8.02$4.0MForm 4
Sep 16, 2025TRV GP IV, LLC10% ownerSale363,541$7.04$2.6MForm 4
Sep 8, 2025TRV GP IV, LLC10% ownerSale86,459$7.04$608.7KForm 4
Sep 5, 2025TRV GP IV, LLC10% ownerSale642,906$7.00$4.5MForm 4
Aug 22, 2025Third Rock Ventures GP IV, L.P.10% ownerSale302,194$7.00$2.1MForm 4

All 84 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
2025Barbara WeberM.D.69$698.0K$2.8M84
2025Adam CrystalM.D., Ph.D.$588.6K$1.7M84
2025Daniella Beckman47$502.9K$1.2M84
2024Executive Chairman$660.0K$6.5M84
2024President of Research and Development$569.2K$3.8M84
2024Former Chief Financial Officer$486.3K$3.2M84
2023Executive Chairman$626.0K$3.4M84
2023President of Research and Development$454.8K$3.1M84
2023Former Chief Financial Officer$441.8K$1.5M84

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$95.0M 2023–2025
Money received by yearMoney received by year, 2023–2025: $95.0M in all. Private raises (Form D) $95.0M.$0$25M$50M$75M$100M2023 · Private raises (Form D): $80.0M202320242025 · Private raises (Form D): $15.0M2025
Figures by year
YearPrivate raises (Form D)Total
2025$15.0M$15.0M
2023$80.0M$80.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Oct 24, 2025Raised $15 million in a private offering of equity41 Form D: 1 investor so far Form D
  2. Aug 11, 2023Raised $80 million in a private offering of equity85 Form D: 17 investors so far Form D

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
Rtw Investments, LP13,900,620$434.5M3.7%+600,000
BlackRock, Inc.12,438,444$388.8M0.0%+3,690,399
Fmr LLC12,333,339$385.5M0.0%+2,427,420
Farallon Capital Management, L.l.c.12,277,000$383.8M2.3%+3,179,589
Boxer Capital Management, LLC10,876,219$340.0M25.6%No change
Goldman Sachs Group Inc9,980,620$312.0M0.0%+4,904,228
TCG Crossover Management, LLC9,081,201$283.9M6.8%−1,449,870
Paradigm Biocapital Advisors LP6,357,523$198.7M3.7%+2,347,844
Siren, L.L.C.6,179,364$193.2M3.9%+522,259
State Street Corp5,979,806$186.9M0.0%+1,327,912
Vanguard Capital Management LLC5,957,348$186.2M0.0%+795,917
Adage Capital Partners Gp, L.l.c.5,600,000$175.1M0.2%−7,209,485
Jupiter Topco LLC5,056,352$158.0M0.1%New
Deep Track Capital, LP4,200,000$131.3M1.9%+1,450,000
Deerfield Management Company, L.P.4,190,611$131.0M1.6%+43,798
Woodline Partners LP4,000,567$125.1M0.4%−3,999,446
Trv Gp Iv, LLC6,374,574$120.2M47.4%No change
Geode Capital Management, LLC3,742,791$117.0M0.0%+1,067,014
Perceptive Advisors LLC3,377,000$105.6M1.6%+2,568,847
Seven Fleet Capital Management LP3,228,144$95.7M15.8%+2,726,132
Logos Global Management LP2,850,000$89.1M3.8%−150,000
Caligan Partners LP2,500,103$78.2M3.8%+91,305
Holocene Advisors, LP2,410,939$75.4M0.2%−1,521,664
Commodore Capital LP2,250,000$70.3M4.2%New
Balyasny Asset Management L.P.2,016,379$63.0M0.1%−1,810,280

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

SEC filer profile

How Tango Therapeutics (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTango Therapeutics, Inc.2
  • CIK0001819133
  • Employer ID (EIN)85-119503611
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company11
  • Incorporated inDelaware11
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address201 Brookline Avenue, Suite 901, Boston, MA 022152
  • Phone(857) 320-49002
  • Shares outstanding168,610,367 as of Aug 4, 20269
  • Public float$528.4M as of Jun 30, 202511
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; no auditor attestation of internal control over financial reporting11
  • On EDGAR sinceJul 30, 20202
  • Filings420 in all: 4 (114), 8-K (49), 144 (43), 3 (36), SCHEDULE 13G/A (23), 10-Q (18), SC 13G (11), SC 13G/A (11)2
    All 41 form types

    SCHEDULE 13G (11), EFFECT (9), CORRESP (8), SC 13D/A (8), 424B3 (7), 10-K (6), S-8 (6), UPLOAD (6), DEF 14A (5), 424B5 (4), ARS (4), DEFA14A (4), S-3 (4), SCHEDULE 13D/A (4), S-4/A (3), 4/A (2), D (2), FWP (2), POS AM (2), PRE 14A (2), S-1 (2), SC 13D (2), SEC STAFF LETTER (2), 424B4 (1), 425 (1), 8-A12B (1), 8-K/A (1), CERT (1), DEFR14A (1), S-1/A (1), S-1MEF (1), S-3ASR (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.001 per shareTNGXNasdaq Global Market

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).11

Risk factors and legal proceedings

The risks Tango Therapeutics (United States) names in Item 1A of its 10-K filed Mar 5, 2026: 74 risks under these headings, as written.11

  • Risks Related to Our Limited Operating History, Financial Position, and Capital Requirements
  • We are a precision oncology company with a limited operating history.
  • We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.
  • We expect our operating results to fluctuate significantly in the future as our business advances
  • We have no products approved for commercial sale and have not generated any revenue from product sales.
  • We will need to raise substantial additional funding. If we are unable to raise capital when needed or on terms acceptable to us, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Risks Related to the Development of our Precision Oncology and Other Programs and Product Candidates
  • We have never successfully completed any clinical trials and we may be unable to do so for any product candidates we develop. Certain of our programs are still in preclinical development and may never advance to clinical development.
  • Our programs are focused on the development of oncology therapeutics for patients with genetically defined or biomarker-driven cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs is novel and may never lead to approved or marketable products.
  • Clinical product development involves a lengthy and expensive process, with an uncertain outcome.
  • If we or third parties are unable to successfully develop screening technology for biomarkers that enable patient selection and/or target engagement, or experience significant delays in doing so, we may be unable to commercialize our product candidates or we may not realize the full commercial potential of our product candidates.
The other 62 risks
  • If we are unable to successfully validate, develop and obtain regulatory approval for diagnostic tests for our product candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these product candidates.
  • Initial, interim and top-line data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to confirmation, audit and verification procedures that could result in material changes in the final data.
  • We may incur additional costs or experience delays in initiating or completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Certain of our current and future product candidates are being used in combination or we anticipate could be used in combination with third-party drugs or biologics, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such other drugs or biologics.
  • Development of combination therapies may present more or different challenges than development of single agent therapies.
  • Results from earlier preclinical studies of our programs and product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our programs and product candidates. If we cannot replicate the results from our earlier preclinical studies of our programs and product candidates in our later preclinical studies and clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates.
  • Our clinical trials or those of our current or future collaborators may reveal significant adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
  • Some of our product candidates modulate pathways for which there are currently no approved or effective therapies, and utilize novel binding locations, which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or discovery of unknown or unanticipated adverse effects.
  • We conduct clinical trials for our product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • We may fail to identify viable new product candidates for clinical development for a number of reasons. If we fail to identify additional product candidates, our business could be materially harmed.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • Public health crises, such as a pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates and the initiation and completion of clinical trials.
  • Risks Related to Commercialization
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • If the market opportunities for our programs and product candidates are smaller than we estimate or if any regulatory approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially.
  • If our current product candidates or any future product candidates do not achieve broad market acceptance, the revenue that we generate from their sales may be limited, and we may never become profitable.
  • Risks Related to Our Reliance on Third Parties
  • We currently rely, and expect to continue to rely, on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may
  • not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • We have entered into collaborations and we may seek to establish additional collaborations in the future, and we might not realize the anticipated benefits of such collaborations. If we are not able to establish additional collaborations on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
  • We contract with a limited number of third parties for the manufacture of our product candidates for preclinical development and clinical testing and expect to continue to do so for clinical testing and commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products 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 active pharmaceutical ingredients and drug product to be used in our product candidates are our sole sources of supply, and the loss of any of these suppliers could significantly harm our business.
  • Risks Related to Our Intellectual Property
  • If we cannot obtain new patents, maintain our existing patents and protect the confidentiality and proprietary nature of our trade secrets and other intellectual property, our business and competitive position may be harmed.
  • If we are found to be infringing third party patents, we may be forced to pay damages to the patent owner and/or obtain a license to continue the manufacture, sale or development of our products. If we cannot obtain a license, we may be prevented from the manufacture, sale or development of our products or product candidates, which may adversely affect our business.
  • It is possible that we could lose market exclusivity for a product earlier than expected, which may harm our competitive position.
  • We may initiate, become a defendant in, or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
  • Intellectual property litigation and administrative patent office patent validity challenges in one or more countries could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • We may be unable to obtain patent or other intellectual property protection for our current or future product candidates or our future products, if any, in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek or obtain intellectual property protection.
  • If we fail to comply with our obligations in any agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our current or future product candidates.
  • Intellectual property rights do not guarantee commercial success of current or future product candidates or other business activities. Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Risks Related to Government Regulation
  • Our future commercial success depends on gaining regulatory approval for new products and obtaining approvals for new indications.
  • 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.
  • 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 a faster regulatory review or approval process.
  • We may seek orphan drug designation for certain of our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • A breakthrough therapy designation and fast track designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development, regulatory review or approval process, and each designation does not increase the likelihood that any of our product candidates will receive regulatory approval in the United States.
  • We may seek accelerated approval of our current or future product candidates using the FDA’s accelerated approval pathway. Accelerated approval by the FDA, even if granted for our current or any other future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive regulatory approval.
  • The FDA, the EMA and other regulatory authorities may implement additional regulations or restrictions on the development and commercialization of our product candidates, and such changes can be difficult to predict.
  • Inadequate funding for the FDA, the SEC and other U.S. government agencies or the EMA or comparable foreign regulatory authorities, including from government shut downs, or other disruptions to these agencies’ operations, including significant leadership, personnel, and policy changes, could prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those drugs and decrease our ability to generate revenue.
  • Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
  • 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.
  • Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered following approval. In addition, we may be subject to penalties or other enforcement action if we fail to comply with regulatory requirements.
  • European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the United States and require us to develop and implement costly compliance programs.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
  • Risks Related to Employee Matters and Managing Anticipated Growth
  • Our future success depends on our ability to retain key executives and experienced scientists and to attract, retain and motivate qualified personnel.
  • We may be unable to adequately protect our information technology systems from cyberattacks, cyber intrusions or otherwise which could result in damage to our information technology system and unauthorized disclosure or use of confidential or proprietary information, including personal data.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
  • We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Risks Related to Our Common Stock
  • Our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our bylaws designate specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.
  • 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.
  • Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.

We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business.

The opening of Item 3, Legal Proceedings.11

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
    SEC EDGAROther events
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74
  75. 75
  76. 76
  77. 77
  78. 78
  79. 79
  80. 80
  81. 81
  82. 82
  83. 83
  84. 84
  85. 85