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FULC on Nasdaq

Fulcrum Therapeutics (United States)

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Our lead product candidate, pociredir, is an oral small molecule designed to induce fetal hemoglobin, or HbF, and is in clinical development for the treatment of sickle cell disease, or SCD.”4 It was founded in 2016.1 It is headquartered in Cambridge, Massachusetts.1 Its shares trade on Nasdaq under the symbol FULC.1

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Last updated Oct 21, 2026.

Overview

2016Founded1

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  • TickerFULC on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCambridge, Massachusetts1
  • Websitewww.fulcrumtx.com
  • Incorporated inDE3
  • Business address26 Landsdowne Street, Cambridge, Ma 021393
  • Filer categoryNon-accelerated filer, Smaller reporting company3

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We are a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need.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

-100.0%Revenue growth, 20255
-21.5%Return on equity5
-$60.4MFree cash flow5

Financial statements

Revenue67895$0 in 2025
0$20.0M$40.0M$60.0M$80.0M2020: $8.8M$8.8M20202021: $19.2M$19.2M2021+117%2022: $6.3M$6.3M2022−67%2023: $2.8M$2.8M2023−56%2024: $80.0M$80.0M2024+2752%2025: $0$02025
Operating income1067895-$84.8M in 2025+1% since 2019
-$150.0M-$100.0M-$50.0M02019: -$84.2M-$84.2M20192020: -$71.6M-$71.6M2020−15%2021: -$81.1M-$81.1M2021+13%2022: -$112.6M-$112.6M2022+39%2023: -$110.7M-$110.7M2023−2%2024: -$21.9M-$21.9M2024−80%2025: -$84.8M-$84.8M2025+287%
Net income1067895-$74.9M in 2025−9% since 2019
-$150.0M-$100.0M-$50.0M02019: -$82.7M-$82.7M20192020: -$70.8M-$70.8M2020−14%2021: -$80.8M-$80.8M2021+14%2022: -$109.9M-$109.9M2022+36%2023: -$97.3M-$97.3M2023−11%2024: -$9.7M-$9.7M2024−90%2025: -$74.9M-$74.9M2025+670%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Collaboration revenue$0$80.0M
Research and development$56.1M$63.4M
General and administrative$28.7M$36.4M
Restructuring expenses$0$2.1M
Total operating expenses$84.8M$101.9M
Loss from operations-$84.8M-$21.9M
Other income, net$9.9M$12.2M
Net loss-$74.9M-$9.7M
Net loss per share, Basic-$1.18-$0.16
Net loss per share, diluted-$1.18-$0.16
Weighted-average common shares outstanding, Diluted63.4K shares62.0K shares
Weighted-average common shares outstanding, Basic63.4K shares62.0K shares
Unrealized gain on marketable securities$44.0K$266.0K
Total other comprehensive gain$44.0K$266.0K
Comprehensive loss-$74.8M-$9.5M

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Corporate structure

Fulcrum 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 Fulcrum Therapeutics (United States)

  • MONTANOVA CAPITAL, LLC Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Aug 14, 2026 (7 filings since Feb 11, 2022)
  • Nantahala Capital Management, LLC Filed SCHEDULE 13G on Fulcrum Therapeutics (United States), latest Aug 14, 2026 (3 filings since Nov 14, 2024)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Aug 14, 2026 (8 filings since Aug 26, 2022)
  • TCG Crossover GP II, LLC Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Aug 14, 2026 (3 filings since Sep 20, 2024)
  • Bank of America Filed SCHEDULE 13G on Fulcrum Therapeutics (United States), latest Aug 3, 2026
  • BlackRock Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Jul 28, 2026 (9 filings since Feb 4, 2022)
  • BlackRock Portfolio Management LLC Filed SCHEDULE 13G on Fulcrum Therapeutics (United States), latest Jul 17, 2026
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Jul 15, 2026 (2 filings since Jun 10, 2026)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G on Fulcrum Therapeutics (United States), latest Jun 25, 2026 (2 filings since Jun 25, 2026)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Mar 26, 2026 (3 filings since Nov 4, 2024)
  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Fulcrum Therapeutics (United States), latest Nov 13, 2025 (3 filings since Feb 12, 2025)
  • RTW INVESTMENTS, LP Filed SC 13G/A on Fulcrum Therapeutics (United States), latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • Fulcrum Therapeutics (United States) Cambridge, Massachusetts

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

What it owns

What Fulcrum 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$18.5M5 Dec 31, 2025$18.2M5 Dec 31, 2024+1.7%
Accumulated depreciation$15.6M5 Dec 31, 2025$14.3M5 Dec 31, 2024+9.7%
Property and equipment, net$2.8M5 Dec 31, 2025$3.9M5 Dec 31, 2024−27.6%
Operating-lease assets (leased space)$4.2M5 Dec 31, 2025$5.7M5 Dec 31, 2024−25.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$197.5M5 Dec 31, 2025$58.2M5 Dec 31, 2024+239.3%
Debt securities available for sale$154.8M5 Dec 31, 2025$182.8M5 Dec 31, 2024−15.3%

Properties, in its own words

Our principal facilities consist of office and laboratory space. We occupy approximately 28,731 square feet of office space in Cambridge, Massachusetts under a lease that currently expires in June 2028.

Item 2 of the 10-K filed Feb 24, 2026.4

Leadership

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

Chief executive

  1. Robert J. Gould2020–2023

President

  1. Robert J. Gould2020–2023

Chief financial officer

  1. Esther Rajavelu2022–2023
  2. Alan A. Musso2023–now

Chief operating officer

  1. Bryan Stuart2019–2021
  2. Melvin H. Hayes Iii.2022–2023
20202025
Board members and other officers (25)

Timeline

  1. Aug 17, 20268-K Entered a material agreement; Unregistered sale of shares; Change in control39
  2. Aug 10, 20268-K Executive or director change40
  3. Jun 25, 20268-K Shareholder vote41
  4. Jun 11, 20268-K Executive or director change42
  5. Jun 4, 20268-K Exit or restructuring costs; Other events43
  6. Jun 1, 20268-K Other events44
  7. Apr 27, 20268-K Ended a material agreement; Results of operations; Executive or director change45
  8. Feb 24, 20268-K Results of operations46
  9. Jan 12, 20268-K Results of operations; Regulation FD disclosure47
  10. Dec 11, 20258-K Entered a material agreement; Other events48
  11. Dec 8, 20258-K Regulation FD disclosure; Other events49
  12. Oct 29, 20258-K Results of operations50
  13. Jan 27, 2020New chief executive Robert J. Gould becomes CEO13
  14. 2016Founded Founded1

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.31) a share, on Oct 29, 2025.51

When it reported results

  1. Apr 27, 2026Reported quarterly or annual results45
  2. Feb 24, 2026Reported quarterly or annual results46
  3. Jan 12, 2026Reported quarterly or annual results47
  4. Oct 29, 2025Reported quarterly or annual results50
  5. Jul 29, 2025Reported quarterly or annual results52
  6. May 1, 2025Reported quarterly or annual results53
  7. Feb 25, 2025Reported quarterly or annual results54
  8. Jan 13, 2025Reported quarterly or annual results55

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

Filings

311 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 60 major events, 116 insider forms, 61 large holders, 51 other. The latest 20:

  1. Oct 8, 2026S-4/A EDGAR
  2. Sep 2, 2026144 EDGAR
  3. Sep 2, 2026S-4 EDGAR
  4. Aug 17, 2026425 EDGAR
  5. Aug 17, 2026425 EDGAR
  6. Aug 17, 2026425 EDGAR
  7. Aug 17, 20268-K EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 14, 2026SCHEDULE 13G EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Aug 10, 20268-K EDGAR
  13. Aug 3, 2026SCHEDULE 13G EDGAR
  14. Jul 30, 202610-Q EDGAR
  15. Jul 28, 2026SCHEDULE 13G/A EDGAR
  16. Jul 20, 20264 EDGAR
  17. Jul 17, 2026SCHEDULE 13G EDGAR
  18. Jul 15, 2026SCHEDULE 13G/A EDGAR
  19. Jul 15, 20264 EDGAR
  20. Jul 15, 20263 EDGAR

The 311 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

33 open-market trades by officers, directors and large owners since October 2021: 13 buys and 20 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 17, 2026TANG KEVIN10% ownerBuy50,945$3.52$179.3KForm 4
Jul 16, 2026TANG KEVIN10% ownerBuy116,671$3.56$415.3KForm 4
Jul 15, 2026TANG CAPITAL MANAGEMENT LLC10% ownerBuy107,377$3.56$382.3KForm 4
Jul 14, 2026TANG CAPITAL MANAGEMENT LLC10% ownerBuy129,603$3.57$462.9KForm 4
Jul 13, 2026TANG CAPITAL MANAGEMENT LLC10% ownerBuy12,966$3.54$45.9KForm 4
Jun 26, 2026Ezekowitz AlanDirectorSale18,000$3.65$65.7KForm 4
Feb 2, 2026Gould Robert JDirectorSale15,000$10.72$160.8KForm 4
Jan 2, 2026Gould Robert JDirectorSale15,000$10.87$163.1KForm 4
Jan 2, 2026Gould Robert JDirectorSale15,000$11.87$178.1KForm 4
Dec 15, 2025Oltmans Curtis GaleChief Legal OfficerSale3,452$12.92$44.6KForm 4
Dec 8, 2025RA Capital Healthcare Fund LP10% ownerSale4,175,139$13.98$58.4MForm 4
Nov 19, 2025Gould Robert JDirectorSale15,000$11.03$165.4KForm 4
May 8, 2025Tourangeau GregPrincipal Accounting OfficerSale498$5.06$2.5KForm 4
May 7, 2024Tourangeau GregPrincipal Accounting OfficerSale236$7.76$1.8KForm 4
Mar 8, 2024Tourangeau GregPrincipal Accounting OfficerSale4,884$11.72$57.2KForm 4
Mar 4, 2024Sapir AlexSee RemarksBuy43,360$11.35$492.1KForm 4
May 10, 2023Tourangeau GregPrincipal Accounting OfficerSale210$3.31$695Form 4
Jan 20, 2023RA CAPITAL MANAGEMENT, L.P.10% ownerBuy1,923,076$13.00$25.0MForm 4
Jan 13, 2023Gould Robert JDirectorSale6,766$15.00$101.5KForm 4
Jan 4, 2023RA Capital Healthcare Fund LP10% ownerBuy180,703$7.28$1.3MForm 4

All 33 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
2025Alex C. Sapir$650.0K$3.3M73
2025Alan Musso$478.1K$1.8M73
2025Curtis Oltmans$472.2K$1.5M73
2024Chief Legal Officer and Head of External Affairs$454.0K$1.4M73
2024Chief Financial Officer$457.5K$1.3M73
2024President and Chief Executive Officer$650.0K$1.0M73

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
Nantahala Capital Management, LLC10,950,080$40.1M1.2%+7,900,040
BlackRock, Inc.8,824,259$32.3M0.0%+3,433,666
EcoR1 Capital, LLC6,549,866$24.0M1.2%New
Tang Capital Management LLC6,521,412$23.9M1.1%New
Montanova Capital, LLC3,680,921$13.5M0.3%−2,880,190
D. E. Shaw & Co., Inc.3,044,385$11.1M0.0%+1,421,104
Citadel Advisors LLC2,704,505$9.9M0.0%+1,412,019
Vanguard Capital Management LLC2,697,216$9.9M0.0%+4,268
Jane Street Group, LLC2,217,498$8.1M0.0%+1,907,081
State Street Corp2,037,025$7.5M0.0%+487,174
Adage Capital Partners Gp, L.l.c.2,000,000$7.3M0.0%+1,600,000
GSK plc1,785,714$6.5M1.1%No change
Qube Research & Technologies Ltd1,748,467$6.4M0.0%+773,728
Assenagon Asset Management S.A.1,670,408$6.1M0.0%+476,535
Renaissance Technologies LLC1,647,800$6.0M0.0%+1,634,200
ADAR1 Capital Management, LLC1,565,029$5.7M0.3%+1,434,469
Millennium Management LLC1,485,803$5.4M0.0%+1,129,332
Geode Capital Management, LLC1,432,133$5.2M0.0%−54,409
Marshall Wace, Llp1,358,423$5.0M0.0%New
UBS Group AG1,253,909$4.6M0.0%+938,724
Susquehanna International Group, Llp1,180,946$4.3M0.0%+1,079,610
Aqr Capital Management LLC1,103,261$4.0M0.0%+560,096
Goldman Sachs Group Inc1,094,425$4.0M0.0%+522,516
Ikarian Capital, LLC1,049,161$3.8M0.6%No change
Bank Of America Corp /de/1,043,029$3.8M0.0%+916,470

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

SEC filer profile

How Fulcrum 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 EDGARFulcrum Therapeutics, Inc.2
  • CIK0001680581
  • Employer ID (EIN)47-48399484
  • Filer statusNon-accelerated filer not an emerging growth company; 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 address26 Landsdowne Street, Cambridge, MA 021392
  • Phone617-651-88512
  • Shares outstanding76,297,257 as of Jul 23, 202612
  • Public float$296.1M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJul 25, 20162
  • Filings514 in all: 4 (183), 8-K (84), 3 (36), SC 13G/A (35), 10-Q (22), SC 13G (20), SCHEDULE 13G/A (15), 424B5 (11)2
    All 44 form types

    S-8 (10), SCHEDULE 13G (9), 10-K (7), CORRESP (7), DEF 14A (7), DEFA14A (7), 144 (6), EFFECT (6), UPLOAD (5), ARS (4), D (4), SEC STAFF LETTER (4), 10-K/A (3), 425 (3), POS AM (2), S-1 (2), S-1/A (2), S-3 (2), 4/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), D/A (1), DEFR14A (1), DRS (1), DRS/A (1), DRSLTR (1), FWP (1), POS EX (1), POSASR (1), PRE 14A (1), S-3ASR (1), S-3MEF (1), S-4 (1), S-4/A (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Jul 30, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 17, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Fulcrum Therapeutics (United States) names in Item 1A of its 10-K filed Feb 24, 2026: 71 risks under these headings, as written.4

  • Risks Related to our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate 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.
  • Our operations have been focused on research and development and conducting clinical trials, which may make it difficult for stockholders to evaluate the success of our business to date and to assess our future viability.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • Our ability to use our net operating losses and research and development tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and financial condition and results of operations.
  • Risks Related to the Discovery and Development of our Product Candidates
  • We are early in our development efforts and we currently have one product candidate in active clinical development. If we are unable to commercialize directly or out-license to a third party any of our product candidates or experience significant delays in doing so, our business will be materially harmed.
  • We may not be successful in our efforts to build a pipeline of product candidates.
  • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. The results of preclinical studies and early clinical trials may not be predictive of future results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
The other 61 risks
  • 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.
  • If serious adverse events or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of our product candidate.
  • If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drug could be compromised.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are conducting a clinical trial of pociredir in patients with SCD that includes clinical trial sites in Africa, and the FDA may not accept data from these trial sites or others located outside the United States.
  • Risks Related to the Commercialization of our Product Candidates
  • Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for any of our product candidates, if approved, may be smaller than we estimate.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates if and when they are approved.
  • 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 product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer. Because certain of the target patient populations of our product candidates are small, and the addressable patient population even smaller, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • We rely, and expect to continue to rely, on CMOs to manufacture our product candidates. If we are unable to enter into such arrangements as expected or if such organizations do not meet our supply requirements, development and/or commercialization of our product candidates may be delayed.
  • Our reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or if approved, products at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices or healthcare reform initiatives, which could harm our business.
  • Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that, if they materialize, could harm our business.
  • Clinical trial and product liability lawsuits against us could divert our resources and could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, which may harm our business.
  • We have entered into, and may in the future enter into, collaborations with third parties for the discovery, development or commercialization of our product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates and our business could be adversely affected.
  • If we are not able to establish collaborations, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • Risks Related to our Intellectual Property
  • If we are unable to obtain, maintain, enforce and protect patent protection for our technology and product candidates or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, our business may be materially harmed.
  • Our issued European patents could be subject to the jurisdiction of the UPC.
  • Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Although we or our licensors are not currently involved in any litigation to protect or enforce our patent or other intellectual property rights, we may become involved in such lawsuits, which could be expensive, time-consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • We may be subject to claims by third parties asserting that our employees, consultants or contractors have wrongfully used or disclosed confidential information of third parties, or we have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Intellectual property rights do not necessarily address all potential threats.
  • Risks Related to Regulatory Approval of our Product Candidates and Other Legal Compliance Matters
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain, and we may not obtain approvals for the commercialization of some or all of our product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
  • Disruptions at the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions, which could negatively impact our business and our timelines.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.
  • Designations by the FDA, such as fast track designation or breakthrough therapy designation, may not lead to a faster development or regulatory review or approval process, and do not increase the likelihood that our product candidates will receive marketing approval.
  • Even if the FDA agrees that we may pursue an accelerated approval NDA submission, approval of the NDA is not assured, nor does submission of an accelerated approval NDA ensure that the product candidate will have a faster development or regulatory review process.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent any product candidates from being marketed abroad.
  • Any product candidate for which we obtain marketing approval could be subject to post-marketing restrictions or withdrawal from the market under certain circumstances, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
  • Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which, in the event of a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Our use of new and evolving technologies, such as artificial intelligence, or AI, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidate and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions.
  • Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • If we or any third-party manufacturers we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.
  • We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, be precluded from developing manufacturing and selling certain products outside the United States or be required to develop and implement costly compliance programs, which could adversely affect our business, results of operations and financial condition.
  • Our employees, independent contractors, consultants and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation.
  • Our internal computer and information technology systems and infrastructure, or those of our collaborators or other contractors or consultants, may fail or suffer security compromises or breaches, which could result in a disruption of our product development programs.
  • Risks Related to Employee Matters and Managing Growth
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our development and regulatory capabilities and, if appropriate, 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 executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management.
  • If securities analysts do not publish or cease publishing research or reports or publish misleading, inaccurate or unfavorable research about our business or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
  • A significant portion of our total outstanding shares are eligible to be sold into the market, which could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • We are a “smaller reporting company,” and the scaled disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • We have incurred and will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain.
  • Our certificate of incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers and employees.

Sources

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  1. 1
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  7. 7
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  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
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  31. 31
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  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
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  45. 45
  46. 46
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  48. 48
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  56. 56
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  59. 59
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  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