CCCC on Nasdaq

C4 Therapeutics (United States)

Logo: c4therapeutics.com3

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation, or TPD, science to create a new generation of small-molecule medicines that transform patients’ lives. Our clinical pipeline has two oncology degraders, cemsidomide, an IKZF1 and IKZF3 degrader, for multiple myeloma, or MM, and CFT8919, an EGFR L858R degrader for non-small-cell lung cancer, or NSCLC.”6 It was founded in 2015.1 It is headquartered in Watertown, Massachusetts.1 Its shares trade on Nasdaq under the symbol CCCC.1

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Last updated Oct 21, 2026.

Overview

2015Founded1

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  • TickerCCCC on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersWatertown, Massachusetts1
  • Websitec4therapeutics.com
  • Incorporated inDE4
  • Business address490 Arsenal Way, Suite 120, Watertown, Ma 024724
  • Filer categoryNon-accelerated filer, Smaller reporting company4

We are a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation, or TPD, science to create a new generation of small-molecule medicines that transform patients’ lives. Leveraging our proprietary TORPEDO platform, we efficiently design and optimize small molecule protein degraders that are highly active against their desired targets by harnessing the body’s natural process for destroying unwanted proteins. Our strategy is to develop degraders that modulate clinically validated disease pathways with best-in-class or first-in-class potential to address significant unmet patient needs. To date, our degraders have demonstrated oral bioavailability and catalytic activity, and we have also leveraged our capability to design compounds that are brain penetrant.6 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

-320.5%Operating margin7
-292.1%Net margin7
1.0%Revenue growth, 20257
-40.9%Return on equity7
-$99.3MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$104.2M
  • Income tax0¢$121.0K

Out of $35.9M in revenue.7 The company lost money this year.

Financial statements

Revenue89107$35.9M in 2025−21% since 2021
0$20.0M$40.0M$60.0M2021: $45.8M$45.8M20212022: $31.1M$31.1M2022−32%2023: $20.8M$20.8M2023−33%2024: $35.6M$35.6M2024+71%2025: $35.9M$35.9M2025+1%
Operating income1189107-$115.2M in 2025+225% since 2019
-$150.0M-$100.0M-$50.0M02019: -$35.5M-$35.5M20192020: -$60.4M-$60.4M2020+71%2021: -$82.1M-$82.1M2021+36%2022: -$129.5M-$129.5M2022+58%2023: -$139.0M-$139.0M2023+7%2024: -$119.6M-$119.6M2024−14%2025: -$115.2M-$115.2M2025−4%
Net income1189107-$105.0M in 2025+208% since 2019
-$150.0M-$100.0M-$50.0M02019: -$34.1M-$34.1M20192020: -$66.3M-$66.3M2020+95%2021: -$83.9M-$83.9M2021+26%2022: -$128.2M-$128.2M2022+53%2023: -$132.5M-$132.5M2023+3%2024: -$105.3M-$105.3M2024−21%2025: -$105.0M-$105.0M2025−0%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Revenue from collaboration agreements$35.9M$35.6M
Research and development$104.2M$110.6M
General and administrative$36.2M$42.1M
Impairment loss on right-of-use asset$10.7M$0
Restructuring$0$2.4M
Total operating expenses$151.2M$155.2M
Loss from operations-$115.2M-$119.6M
Interest and other income, net$10.3M$14.4M
Total other income, net$10.3M$14.4M
Loss before income taxes-$104.9M-$105.2M
Income tax expense-$121.0K-$131.0K
Net loss-$105.0M-$105.3M
Net loss per share basic (in dollars per share)-$1.27-$1.52
Net loss per share diluted (in dollars per share)-$1.27-$1.52
Weighted-average number of shares - basic (in shares)82.9M shares69.4M shares
Weighted-average number of shares - diluted (in shares)82.9M shares69.4M shares
Unrealized (loss) gain on marketable securities-$3.0K$180.0K
Comprehensive loss-$105.0M-$105.1M

Compare C4 Therapeutics (United States) with another company

Corporate structure

C4 Therapeutics (United States) sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of C4 Therapeutics (United States)

  • Lynx1 Capital Management LP Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Aug 14, 2026 (5 filings since Nov 13, 2023)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Aug 14, 2026 (4 filings since Dec 26, 2023)
  • Squadron Capital Management LLC Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Aug 14, 2026 (2 filings since May 19, 2026)
  • Morgan Stanley Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Aug 12, 2026 (4 filings since Feb 3, 2025)
  • BlackRock Filed SCHEDULE 13G on C4 Therapeutics (United States), latest Jul 27, 2026 (7 filings since Feb 4, 2022)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest May 15, 2026 (4 filings since Jan 4, 2024)
  • Sirenia Capital Management LP Filed SCHEDULE 13G on C4 Therapeutics (United States), latest May 15, 2026
  • WASATCH ADVISORS LP Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Apr 22, 2026 (7 filings since Jun 6, 2022)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Feb 17, 2026 (4 filings since Nov 14, 2024)
  • Soleus Capital Master Fund, L.P. Filed SCHEDULE 13G/A on C4 Therapeutics (United States), latest Feb 12, 2026 (5 filings since Apr 14, 2023)
  • Bain Capital Life Sciences Fund II, L.P. Filed SCHEDULE 13G on C4 Therapeutics (United States), latest Oct 24, 2025
  • Commodore Capital LP Filed SC 13G/A on C4 Therapeutics (United States), latest Nov 14, 2024 (2 filings since Dec 22, 2023)
  • C4 Therapeutics (United States) Watertown, Massachusetts
    • C4T Securities Corporation 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 C4 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$15.5M7 Dec 31, 2025$15.1M7 Dec 31, 2024+2.9%
Accumulated depreciation$10.8M7 Dec 31, 2025$9.2M7 Dec 31, 2024+16.7%
Property and equipment, net$4.7M7 Dec 31, 2025$5.8M7 Dec 31, 2024−18.8%
Operating-lease assets (leased space)$40.5M7 Dec 31, 2025$57.5M7 Dec 31, 2024−29.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$74.6M7 Dec 31, 2025$55.5M7 Dec 31, 2024+34.4%

Properties, in its own words

We currently lease approximately 111,611 square feet of office and laboratory space in Watertown, Massachusetts under a lease that expires in 2032. We sublease approximately 33,447 square feet of our office and laboratory space in Watertown, Massachusetts, under a sublease arrangement that expires in 2029. We believe that our facilities are sufficient to meet our current needs for the foreseeable future and that suitable additional space will be available as and when needed.

Item 2 of the 10-K filed Feb 26, 2026.6

Leadership

Who has led C4 Therapeutics (United States), and when. Pick a name to see everywhere that person has worked.

Board members and other officers (23)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • C4T Securities Corporation Massachusetts5

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

Timeline

  1. Sep 25, 20268-K Regulation FD disclosure; Other events41
  2. Aug 11, 20268-K Results of operations42
  3. Jun 24, 20268-K Shareholder vote43
  4. Jun 11, 20268-K Regulation FD disclosure; Other events44
  5. May 15, 20268-K Executive or director change45
  6. May 12, 20268-K Results of operations; Regulation FD disclosure46
  7. Apr 10, 20268-K Bylaws or fiscal year changed47
  8. Apr 9, 20268-K Entered a material agreement; Regulation FD disclosure48
  9. Feb 26, 20268-K Results of operations49
  10. Jan 14, 20268-K Regulation FD disclosure50
  11. Nov 6, 20258-K Results of operations51
  12. Oct 16, 20258-K Other events52
  13. Feb 23, 2022New chief executive Andrew Hirsch becomes CEO15
  14. Oct 1, 2020New chief executive Marc A. Cohen becomes CEO16
  15. 2015Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.44) a share, on Nov 6, 2025.53

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results42
  2. May 12, 2026Reported quarterly or annual results46
  3. Feb 26, 2026Reported quarterly or annual results49
  4. Nov 6, 2025Reported quarterly or annual results51
  5. Aug 7, 2025Reported quarterly or annual results54
  6. May 7, 2025Reported quarterly or annual results55
  7. Feb 27, 2025Reported quarterly or annual results56
  8. Jan 14, 2025Reported quarterly or annual results57

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

Filings

422 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 65 major events, 221 insider forms, 62 large holders, 54 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Sep 25, 20268-K EDGAR
  4. Sep 21, 20264 EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026144 EDGAR
  7. Aug 14, 2026144 EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 13, 2026144 EDGAR
  11. Aug 12, 2026144 EDGAR
  12. Aug 12, 2026SCHEDULE 13G/A EDGAR
  13. Aug 11, 202610-Q EDGAR
  14. Aug 11, 20268-K EDGAR
  15. Jul 27, 2026SCHEDULE 13G EDGAR
  16. Jul 13, 20264 EDGAR
  17. Jul 2, 20264 EDGAR
  18. Jul 2, 20264 EDGAR
  19. Jun 26, 20264 EDGAR
  20. Jun 26, 20264 EDGAR

The 422 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

10 open-market trades by officers, directors and large owners since October 2021: 2 buys and 8 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 16, 2026REYNO LEONARDChief Medical OfficerSale10,000$2.22$22.2KForm 4
Feb 18, 2025Boyle Scott NChief Business OfficerSale669$3.15$2.1KForm 4
Feb 14, 2025Boyle Scott NChief Business OfficerSale490$3.15$1.5KForm 4
Feb 8, 2023Koppikar UtpalDirectorBuy5,667$5.60$31.7KForm 4
Apr 12, 2022Hirsch AndrewPresident & CEOBuy10,000$8.40$84.0KForm 4
Jan 4, 2022Crystal AdamChief Medical OfficerSale15,000$31.67$475.0KForm 4
Dec 17, 2021Salter MalcolmDirectorSale755$30.25$22.8KForm 4
Nov 19, 2021Salter MalcolmDirectorSale755$40.11$30.3KForm 4
Oct 15, 2021Salter MalcolmDirectorSale755$44.94$33.9KForm 4
Oct 1, 2021Crystal AdamChief Medical OfficerSale15,000$45.43$681.4KForm 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 J. Hirsch55$694.9K$2.9M78
2025Leonard ReynoM.D.64$597.7K$1.6M78
2025Kendra R. Adams49$506.8K$1.5M78
2024President & Chief Executive Officer$665.0K$4.6M78
2024Chief Medical Officer$572.0K$2.1M78
2024Chief Financial Officer$485.0K$2.0M78

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
Morgan Stanley8,867,338$41.4M0.0%−205,062
Ra Capital Management, L.P.8,000,000$37.4M0.3%No change
BlackRock, Inc.7,896,718$36.9M0.0%+5,848,192
Lynx1 Capital Management LP7,326,691$34.2M4.0%+327,789
Squadron Capital Management LLC7,200,000$33.6M11.5%+4,950,000
Bain Capital Life Sciences Investors, LLC7,171,910$33.5M2.0%No change
Jpmorgan Chase & Co4,747,424$20.7M0.0%+1,524,370
Vanguard Capital Management LLC4,417,731$20.6M0.0%+555,879
Citadel Advisors LLC4,187,580$19.6M0.0%+1,676,565
Goldman Sachs Group Inc3,530,991$16.5M0.0%+1,143,613
Wasatch Advisors LP3,522,644$16.5M0.1%+560,883
Two Sigma Investments, LP3,469,707$16.2M0.0%+434,073
Soleus Capital Management, L.P.3,377,981$15.8M0.5%−425,961
Silverarc Capital Management, LLC3,032,060$14.2M1.6%+1,120,275
Bank Of America Corp /de/2,656,359$12.4M0.0%+297,118
Geode Capital Management, LLC2,522,163$11.8M0.0%+1,571,120
Ikarian Capital, LLC2,433,000$11.4M1.9%New
State Street Corp2,115,621$9.9M0.0%+1,732,648
Candriam S.C.A.1,796,937$8.4M0.0%New
D. E. Shaw & Co., Inc.1,740,989$8.1M0.0%+680,658
Susquehanna International Group, Llp1,732,210$8.1M0.0%+445,370
Patient Square Capital LP1,608,815$7.5M1.2%New
HighVista Strategies LLC1,348,136$6.3M1.4%New
Renaissance Technologies LLC1,189,828$5.6M0.0%−1,271,987
Dimensional Fund Advisors LP1,188,507$5.5M0.0%+745,989

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

SEC filer profile

How C4 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 EDGARC4 Therapeutics, Inc.2
  • CIK0001662579
  • Employer ID (EIN)47-56176276
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address490 Arsenal Way, Suite 120, Watertown, MA 024722
  • Phone(617) 231-07002
  • Shares outstanding123,025,136 as of Jul 31, 202613
  • Public float$100.1M as of Jun 30, 20256
  • AuditorKPMG LLP, Boston, MA, United States PCAOB ID 185; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceJan 11, 20162
  • Filings546 in all: 4 (260), 8-K (75), 3 (27), SC 13G/A (22), SC 13G (19), 10-Q (18), SCHEDULE 13G/A (17), 144 (9)2
    All 39 form types

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

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Sep 25, 2026

Securities registered for trading

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

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks C4 Therapeutics (United States) names in Item 1A of its 10-K filed Feb 26, 2026: 72 risks under these headings, as written.6

  • Risks related to our financial position and need for additional capital
  • We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We expect to incur losses over at least the next several years and may never achieve or maintain profitability.
  • We will need substantial additional funding to pursue our business objectives and continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce, or terminate our research or product development programs or future commercialization efforts.
  • We remain early in the development lifecycle, which may make it difficult for you to evaluate the success of our business to date and assess our future viability.
  • 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 discovery and development of our product candidates
  • Our approach to the discovery and development of product candidates based on our TORPEDO platform for targeted protein degradation is unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products.
  • We are a clinical stage biotechnology company and, while we have commenced clinical trials of certain of our product candidates, our other product candidates are still in the discovery stage. If we are unable to advance to clinical development, develop, obtain regulatory approval for and commercialize our product candidates or experience significant delays in doing so, our business may be materially harmed.
  • Relative to companies that are more established than we are or that have a larger footprint than we do, we have relatively limited experience as a company in completing preclinical studies to enable the filing of INDs, submitting INDs or commencing, enrolling, and conducting clinical trials.
  • Our preclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval, and commercialization. Further, the results of preclinical studies may not be predictive of future results in later studies or trials and initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later stage clinical trials.
  • The conclusions and analyses drawn from announced or published interim top-line and preliminary data from our clinical trials from time to time may change as more patient data become available. Further, all interim data that we provide remains subject to audit and verification procedures that could result in material changes in the final data.
  • Drug development is a lengthy and expensive process with an uncertain outcome. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
The other 62 risks
  • Targeted protein degradation is a novel modality that continues to attract substantial interest from existing and emerging biotechnology and pharmaceutical companies. As a result, we face substantial competition, which may result in others discovering, developing or commercializing products for the same indication and/or patient population before or more successfully than we do.
  • Our ability to use our net operating loss carryforwards and research and development tax credit carryforwards may be limited.
  • Changes in tax laws could adversely affect our business and financial condition.
  • If serious adverse events, undesirable side effects or unexpected characteristics or results are identified during the development of any product candidates we may develop, we may need to modify, abandon, or limit our further clinical development of those product candidates.
  • If we experience delays or difficulties in the enrollment of patients in our clinical trials, our timelines for submitting applications for and receiving necessary marketing approvals could be delayed, or we may be prevented from obtaining marketing approvals altogether.
  • 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 or our partners may develop our product candidates in combination with other drugs. If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs, revoke their approval of these other drugs or if safety, efficacy, manufacturing or supply issues arise with the drugs we choose to evaluate in combination with our product candidates, we may be unable to obtain approval of or market our product candidates.
  • We may not be successful in our efforts to identify or discover additional potential product candidates.
  • If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.
  • Risks related to dependence on third parties
  • We expect to rely on third parties to conduct our current and future clinical trials and those third parties may not perform satisfactorily, including by failing to meet deadlines for the completion of our clinical trials or failing to comply with contractual obligations, regulatory requirements, or our clinical protocols.
  • We have existing collaborations and may enter into future collaborations, strategic alliances, or licensing arrangements with third parties for the research, development and commercialization of certain product candidates. If any of these existing or future arrangements are not successful, or if we are unable to enter into such arrangements on favorable terms or at all, we may not be able to capitalize on the market potential of those product candidates. In addition, these collaborations or other arrangements could impact our intellectual property rights and business operations.
  • 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.
  • As a company, we currently have no marketing and sales organization and no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
  • The market opportunities for our product candidates may be relatively small as we expect that they will initially be approved only for those patients who are ineligible for other approved treatments or have failed prior treatments. In addition, our estimates of the prevalence of our target patient populations may be inaccurate.
  • Even if we or, in the case of CFT8919, Betta Pharma, receive marketing approval of any of our product candidates, our products may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives, any of which would impact our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks related to our intellectual property
  • If we are unable to obtain and maintain patent protection for our technology, product candidates, and products or if the scope of the patent protection obtained is not sufficiently broad or enforceable, our competitors could develop and commercialize technology, product candidates, and products similar or identical to ours, our ability to successfully commercialize our technology, product candidates, and products may be impaired or we may not be able to compete effectively in our market.
  • Changes in patent laws or patent jurisprudence could diminish the value of our patents in general or increase third party challenges to our patents, thereby impairing our ability to protect our product candidates.
  • We may become involved in lawsuits or other proceedings to protect or enforce our patents, the patents of our licensors or other intellectual property, or to defend against challenges, which could be expensive, time-consuming and unsuccessful.
  • We may need to license intellectual property from third parties and such licenses may not be available, or may not be available on commercially reasonable terms.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have an adverse effect on the success of our business.
  • A number of other companies, as well as universities and other organizations, file and obtain patents in the same areas as our product candidates, which are TPDs, or our platform technologies, and these patent filings could be asserted against us or our collaborators in the future, which could adversely affect our business and, if successful, could lead to expensive litigation, affect the profitability of any future products and/or prohibit the sale or use of our product candidates or any future products.
  • Our product candidates, if approved, will be subject to The Drug Price Competition and Patent Term Restoration Act of 1984, which is also referred to as the Hatch-Waxman Act, in the United States, which can increase the risk of litigation with generic companies trying to sell our potential future products and may cause us to lose patent protection and could adversely affect the exclusivity of any approved products.
  • Pharmaceutical companies are subject to intense review by the U.S. Federal Trade Commission and comparable agencies in other countries regarding how they conduct or settle patent litigation, and we may face similar scrutiny that could result in fines, penalties or loss of rights..
  • We may not be able to obtain patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 in the United States and, as a result, our product candidates, if approved, may not have patent protection for a sufficient period.
  • Weakening patent laws and enforcement by courts in the United States and changes in the legal landscape may impact our ability to protect our markets.
  • We may be subject to claims by third parties asserting that we, our employees, consultants or contractors have misappropriated third party’s intellectual property or claiming ownership of what we regard as our own intellectual property.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by governmental patent offices, and the protection of our patents could be reduced or eliminated if we fail to comply with these requirements.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We only have limited geographical protection with respect to certain of our patents and we may not be able to protect our intellectual property rights throughout the world.
  • Risks related to regulatory matters
  • Receiving regulatory approval from the FDA and foreign regulatory authorities is lengthy, time-consuming and inherently unpredictable and, if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed.
  • Even if we obtain FDA approval for any of our product candidates in the United States, we may never obtain approval for or commercialize any of them in any other jurisdiction, which would limit our ability to realize their full market potential.
  • Even if we receive regulatory approval of any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our 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 marketing approval.
  • A Fast Track designation by the FDA, even if granted for one or all of our lead product candidates, or any of our other current or future product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • We have obtained Orphan Drug Designation for cemsidomide for the treatment of MM and, if we decide to seek Orphan Drug Designation for any other current or future product candidates, we may be unsuccessful or may be unable to
  • maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity.
  • We may seek approval of our product candidates, where applicable, under the FDA’s accelerated approval pathway. This pathway 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 marketing approval.
  • The FDA may identify in a written request that pediatric information would be beneficial for a product candidate for which we obtained approval and request that we conduct pediatric studies. We may elect not to perform these studies or, if we opted to conduct these studies, we may not be able to complete them or the data generated from these studies may not be acceptable to the FDA.
  • Disruptions at the FDA, the SEC and other government agencies caused by the change in presidential administration, funding shortages or potential funding shortages 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.
  • Our relationships with customers, healthcare providers, and third-party payors are or will be subject, directly or indirectly, to foreign, federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply or have not fully complied with these laws, we could face substantial penalties.
  • The successful commercialization of our product candidates in the United States and abroad will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide coverage and adequate reimbursement levels, as well as implement pricing policies favorable for our product candidates. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to progress our clinical programs and obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • We may face potential liability under applicable privacy and data protection laws, rules, regulations, or standards or contractual obligations in the United States, the European Union, the United Kingdom, or other jurisdictions with respect to our processing of personal information, including patient health information from clinical trials sponsored by us and compliance with these evolving requirements could require significant resources and adversely affect our business.
  • If we or our third-party manufacturers and suppliers 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 an adverse effect on the success of our business.
  • We are subject to United States and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • We use artificial intelligence throughout our business in our ongoing effort to be innovative and increase efficiency, but the challenges we may face in its implementation and use could adversely impact our business.
  • Risks related to employee matters, managing growth, and operational matters
  • We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • Our internal computer systems, or those of any of our collaborators, vendors, contractors, or consultants, may fail or suffer security breaches, incidents or compromises, which could result in a disruption of our product development programs and could harm our reputation or subject us to liability, and adversely affect our business and financial results.
  • Our employees, independent contractors, vendors, principal investigators, CROs, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading laws.
  • Risks related to our common stock
  • Future sales and issuances of our common stock or rights to purchase common stock and issuances of common stock upon the exercise of outstanding warrants would result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
  • Our outstanding Class A Warrants and Class B Warrants may not be exercised, and we may therefore not receive any additional funds notwithstanding our issuance of these warrants.
  • Currently, our common stock is listed on the Nasdaq Global Select Market. However, there may not be enough liquidity in that market to enable you to sell your shares of our common stock.
  • If securities or industry analysts do not publish or cease publishing research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • 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 have broad discretion in the use of the capital we have raised and may not use our capital effectively.
  • Our executive officers, directors, and principal stockholders will have the ability to control or significantly influence matters submitted to stockholders for approval.
  • 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.
  • We will continue to incur additional costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.
  • Our amended and restated by-laws 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.
  • 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.
  • Business disruptions, including due to natural disasters, global conflicts or political unrest, and unstable market conditions and downturns in economic and market conditions may have serious adverse consequences on our business, financial condition and stock price.

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.6

Sources

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