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WHWK on Nasdaq

Whitehawk Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology that are intended to efficiently deliver improved cancer treatments. We have deep experience in chemistry, formulation, and drug delivery, as well as research, clinical, and commercial pharmaceutical development, resulting in successfully taking product candidates from the clinic to approval, launch, and commercialization.”4 It is headquartered in Cincinnati, United States.2 Its shares trade on Nasdaq under the symbol WHWK.2

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Last updated Oct 21, 2026.

Overview

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  • TickerWHWK on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersCincinnati, United States2
  • Incorporated inDE3
  • Business address2 Headquarters Plaza, East Building, 11Th Floor, Morristown, Nj 079603
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300G3U7TKW1M58L092
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 44590562

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We are a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology that are intended to efficiently deliver improved cancer treatments. We have deep experience in chemistry, formulation, and drug delivery, as well as research, clinical, and commercial pharmaceutical development, resulting in successfully taking product candidates from the clinic to approval, launch, and commercialization.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

-1601.1%Operating margin5
-288.3%Net margin5
-72.5%Revenue growth, 20255
-15.1%Return on equity5
-$98.0MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue1¢$760.0K
  • Research and development75¢$91.0M
  • Selling, general and admin25¢$29.8M

Out of $7.1M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$7.1M in 2025
0$10.0M$20.0M$30.0M2019: $0$020192020: $14.0M$14.0M20202021: $14.0M$14.0M2021+0%2022: $15.2M$15.2M2022+9%2023: $24.4M$24.4M2023+60%2024: $26.0M$26.0M2024+7%2025: $7.1M$7.1M2025−73%
Operating income6107895-$114.4M in 2025+368% since 2019
-$150.0M-$100.0M-$50.0M02019: -$24.4M-$24.4M20192020: -$2.5M-$2.5M2020−90%2021: -$111.2M-$111.2M2021+4263%2022: -$62.7M-$62.7M2022−44%2023: -$71.9M-$71.9M2023+15%2024: -$67.5M-$67.5M2024−6%2025: -$114.4M-$114.4M2025+70%
Net income6107895-$20.6M in 2025−11% since 2019
-$150.0M-$100.0M-$50.0M02019: -$23.3M-$23.3M20192020: -$3.5M-$3.5M2020−85%2021: -$110.1M-$110.1M2021+3065%2022: -$60.5M-$60.5M2022−45%2023: -$65.8M-$65.8M2023+9%2024: -$63.7M-$63.7M2024−3%2025: -$20.6M-$20.6M2025−68%

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

Period ending2025-12-312024-12-31
Total revenue$7.1M$26.0M
Selling, general and administrative$29.8M$36.7M
Research and development$91.0M$51.0M
Restructuring charges$0$2.6M
Cost of goods sold$760.0K$3.0M
Total operating expenses$121.5M$93.4M
Loss from operations-$114.4M-$67.5M
Gain on sale of business$87.3M$0
Foreign exchange gain (loss)$5.0K-$4.0K
Other income$302.0K$0
Interest income$6.2M$3.9M
Interest expense$0-$154.0K
Total other income (expense), net$93.8M$3.8M
Loss before income tax expense-$20.6M-$63.7M
Income tax expense$0$0
Net loss-$20.6M-$63.7M
Unrealized gain (loss) on investments, net of tax$104.0K-$11.0K
Comprehensive loss-$20.5M-$63.7M
Net loss per share, basic (in dollars per share)-$0.33-$2.36
Net loss per share, diluted (in dollars per share)-$0.33-$2.36
Weighted average number of common shares outstanding, basic (in shares)61.9M shares27.0M shares
Weighted average number of common shares outstanding, diluted (in shares)61.9M shares27.0M shares

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Corporate structure

Whitehawk Therapeutics, Inc. 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 Whitehawk Therapeutics, Inc.

  • ABG Management Ltd. Filed SCHEDULE 13G/A on Whitehawk Therapeutics, Inc., latest Aug 14, 2026 (2 filings since Mar 10, 2025)
  • ORBIMED ADVISORS LLC Filed SCHEDULE 13G/A on Whitehawk Therapeutics, Inc., latest Aug 14, 2026 (2 filings since May 15, 2025)
  • ACUTA CAPITAL PARTNERS, LLC Filed SCHEDULE 13D/A on Whitehawk Therapeutics, Inc., latest May 18, 2026 (2 filings since Jan 24, 2025)
  • Avoro Capital Advisors LLC Filed SCHEDULE 13D/A on Whitehawk Therapeutics, Inc., latest May 14, 2026 (4 filings since Sep 26, 2022)
  • Coastlands Capital LP Filed SCHEDULE 13G on Whitehawk Therapeutics, Inc., latest Aug 25, 2025
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Whitehawk Therapeutics, Inc., latest May 15, 2025 (2 filings since Jan 29, 2025)
  • MONTANOVA CAPITAL, LLC Filed SCHEDULE 13G on Whitehawk Therapeutics, Inc., latest Mar 11, 2025
  • Neil Desai Filed SCHEDULE 13D/A on Whitehawk Therapeutics, Inc., latest Mar 6, 2025 (4 filings since Jan 17, 2023)
  • BML Investment Partners, L.P. Filed SCHEDULE 13D/A on Whitehawk Therapeutics, Inc., latest Mar 5, 2025 (6 filings since Aug 28, 2024)
  • EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Whitehawk Therapeutics, Inc., latest Feb 14, 2025 (2 filings since Sep 3, 2024)
  • Muneer A. Satter Filed SCHEDULE 13G/A on Whitehawk Therapeutics, Inc., latest Feb 14, 2025 (4 filings since Nov 12, 2021)
  • QVT Financial LP Filed SCHEDULE 13G on Whitehawk Therapeutics, Inc., latest Feb 14, 2025
  • Whitehawk Therapeutics, Inc. Cincinnati, Ohio, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Whitehawk Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$377.0K5 Dec 31, 2025$7.3M5 Dec 31, 2024−94.8%
Accumulated depreciation$374.0K5 Dec 31, 2025$463.0K5 Dec 31, 2024−19.2%
Property and equipment, net$3.0K5 Dec 31, 2025$6.8M5 Dec 31, 2024−100.0%
Operating-lease assets (leased space)$05 Dec 31, 2025$787.0K5 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$37.6M5 Dec 31, 2025$28.7M5 Dec 31, 2024+31.0%
Marketable securities, current$108.1M5 Dec 31, 2025$18.6M5 Dec 31, 2024+482.4%
Debt securities available for sale$145.4M5 Dec 31, 2025$46.1M5 Dec 31, 2024+215.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$05 Dec 31, 2025$5.3M5 Dec 31, 2024−100.0%
Work in process$05 Dec 31, 2025$05 Dec 31, 2024
Finished goods$05 Dec 31, 2025$1.8M5 Dec 31, 2024−100.0%

Properties, in its own words

As of March 25, 2025, our corporate headquarters consist of office space in Morristown, New Jersey that we license from KAKEN, which acquired the office space from us as part of the FYARRO Divestiture. We are currently in the process of extending the office license arrangement with KAKEN upon the sublandlord's and landlord's consent. Prior to March 2025, our corporate headquarters consisted of 2,760 square feet of leased office space in Pacific Palisades, California. Our Pacific Palisades lease expired on February 28, 2025.

We believe our existing facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms for our future growth.

Item 2 of the 10-K filed Mar 12, 2026.4

Leadership

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

Chief executive

  1. Stephen J. Hoffman2017–2019
  2. Scott M. Giacobello2023
  3. David James Lennon2023–now

Chair

  1. Neil Desai2023–2024

President

  1. John Pappajohn2008
  2. Joseph H. Gardner2017–2020
  3. Scott M. Giacobello2023

Chief financial officer

  1. Matthew P. Kinley2008
  2. Lance E. Thibault2021
  3. Scott M. Giacobello2021–now

Chief operating officer

  1. Brendan Delaney2021–2022
2010201520202025
Board members and other officers (35)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerLoretta Itri named Oct 11, 202252

Former names

  • Aadi Bioscience, Inc.Aug 27, 2021 to Mar 18, 20253
  • Aerpio Pharmaceuticals, Inc.Mar 17, 2017 to Aug 23, 20213
  • ZETA ACQUISITION CORP IIFeb 1, 2008 to Mar 13, 20173

Timeline

  1. Sep 10, 20268-K Executive or director change53
  2. Aug 6, 20268-K Results of operations54
  3. Jun 12, 20268-K Shareholder vote55
  4. May 21, 20268-K Other events56
  5. May 13, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure57
  6. May 7, 20268-K Results of operations58
  7. Mar 12, 20268-K Results of operations59
  8. Nov 6, 20258-K Results of operations60
  9. Aug 7, 20258-K Results of operations61
  10. Jun 13, 20258-K Shareholder vote62
  11. May 8, 20258-K Results of operations63
  12. Mar 31, 20258-K Financial statements and exhibits64
  13. Oct 3, 2023New chief executive David James Lennon becomes CEO14
  14. Apr 4, 2023New chief executive Scott M. Giacobello becomes CEO13
  15. Dec 6, 2017New chief executive Stephen J. Hoffman becomes CEO15
  16. Nov 16, 2007Founded Whitehawk Therapeutics, Inc. is founded2

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.26) a share, on Nov 6, 2025.65

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results54
  2. May 7, 2026Reported quarterly or annual results58
  3. Mar 12, 2026Reported quarterly or annual results59
  4. Nov 6, 2025Reported quarterly or annual results60
  5. Aug 7, 2025Reported quarterly or annual results61
  6. May 8, 2025Reported quarterly or annual results63
  7. Mar 18, 2025Reported quarterly or annual results66
  8. Nov 6, 2024Reported quarterly or annual results67

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

Filings

309 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 51 major events, 132 insider forms, 37 large holders, 2 private raises, 67 other. The latest 20:

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

The 309 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

62 open-market trades by officers, directors and large owners since October 2021: 0 buys and 62 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Apr 16, 2026Giacobello Scott M.CHIEF FINANCIAL OFFICERSale141,600$4.13$584.8KForm 4
Apr 15, 2026Giacobello Scott M.CHIEF FINANCIAL OFFICERSale77,000$3.86$297.2KForm 4
Apr 14, 2026BALL BRYANSee remarksSale92,460$3.64$336.6KForm 4
Apr 13, 2026BALL BRYANSee remarksSale26,389$3.46$91.3KForm 4
Apr 10, 2026BALL BRYANSee remarksSale6,596$3.43$22.6KForm 4
Apr 9, 2026Lennon David JamesCHIEF EXECUTIVE OFFICERSale14,500$3.38$49.0KForm 4
Apr 9, 2026BALL BRYANSee remarksSale50,000$3.57$178.5KForm 4
Apr 8, 2026Lennon David JamesCHIEF EXECUTIVE OFFICERSale63,945$3.40$217.4KForm 4
Apr 7, 2026Lennon David JamesCHIEF EXECUTIVE OFFICERSale94,087$3.43$322.7KForm 4
Apr 6, 2026Lennon David JamesCHIEF EXECUTIVE OFFICERSale102,395$3.51$359.4KForm 4
Apr 2, 2026Lennon David JamesCHIEF EXECUTIVE OFFICERSale26,858$3.48$93.5KForm 4
Mar 2, 2026Lennon David JamesCHIEF EXECUTIVE OFFICERSale5,100$3.31$16.9KForm 4
Mar 2, 2026BALL BRYANSee remarksSale1,834$3.31$6.1KForm 4
Mar 2, 2026Giacobello Scott M.CHIEF FINANCIAL OFFICERSale2,594$3.31$8.6KForm 4
Mar 3, 2025BALL BRYANSee remarksSale2,147$2.35$5.0KForm 4
Mar 3, 2025Giacobello Scott M.CHIEF FINANCIAL OFFICERSale2,806$2.35$6.6KForm 4
Mar 3, 2025Lennon David JamesCHIEF EXECUTIVE OFFICERSale5,690$2.35$13.4KForm 4
Oct 3, 2024Lennon David JamesCHIEF EXECUTIVE OFFICERSale9,689$1.94$18.8KForm 4
Sep 3, 2024Desai NeilDirectorSale40,000$1.71$68.4KForm 4
Aug 5, 2024Desai NeilDirectorSale5,652$1.34$7.6KForm 4

All 62 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
2025David Lennon$676.5K$3.4M85
2025Scott Giacobello55$501.6K$2.1M85
2025Bryan Ball55$477.5K$1.8M85
2024President and Chief Executive Officer$654.4K$1.0M85
2024Chief Financial Officer$483.4K$807.9K85
2024Chief Technical Operations Officer$460.2K$648.6K85

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 4, 2025Raised $100 million in a private offering of equity Form D: 17 investors so far Form D
  2. Sep 26, 2022Raised $72.5 million in a private offering of equity Form D: $72.5 million offered in all 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 78. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Yu Fan4,861,314$22.3M20.6%+2,791,314
Acuta Capital Partners, LLC4,685,912$21.5M15.0%+1,275,510
QVT Financial LP4,615,709$21.1M1.4%No change
Montanova Capital, LLC4,300,000$19.7M0.4%+600,000
Orbimed Advisors LLC3,934,296$18.0M0.3%−231,704
Avoro Capital Advisors LLC2,849,402$13.1M0.1%No change
Siren, L.L.C.2,337,102$10.7M0.2%+255,102
KVP Capital Advisors, LP2,165,997$9.9M7.3%No change
BlackRock, Inc.1,922,828$8.8M0.0%+1,571,443
Vanguard Capital Management LLC1,388,561$6.4M0.0%+72,791
ADAR1 Capital Management, LLC1,341,394$6.1M0.3%+1,212,891
Acorn Capital Advisors, LLC1,139,363$5.2M1.4%No change
Stempoint Capital LP1,021,037$4.7M0.8%−857,701
Geode Capital Management, LLC899,780$4.1M0.0%+442,240
Ally Bridge Group (NY) LLC817,939$3.7M4.8%No change
Woodline Partners LP436,614$2.0M0.0%+155,117
Renaissance Technologies LLC413,822$1.9M0.0%−14,800
State Street Corp386,982$1.8M0.0%+226,600
Millennium Management LLC380,406$1.7M0.0%+70,732
Eversept Partners, LP303,306$1.4M0.1%−3,494
Verdad Advisers, LP301,483$1.4M1.3%+185,999
Two Sigma Investments, LP296,612$1.4M0.0%+23,130
Balyasny Asset Management L.P.288,117$1.3M0.0%−262,324
Northern Trust Corp264,689$1.2M0.0%+157,423
Vanguard Fiduciary Trust Co246,907$1.1M0.0%+32,080

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

SEC filer profile

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

  • Name on EDGARWhitehawk Therapeutics, Inc.1
  • CIK0001422142
  • Employer ID (EIN)61-15478504
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address2 Headquarters Plaza, East Building, 11Th Floor, Morristown, NJ 079601
  • Phone551-321-22341
  • Shares outstanding57,009,010 as of Aug 3, 202612
  • Public float$64.9M as of Jun 30, 20254
  • AuditorBDO USA, P.C., San Diego, California PCAOB ID 243; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceFeb 1, 20081
  • Filings671 in all: 4 (217), 8-K (110), 10-Q (54), 3 (37), SC 13D/A (19), 10-K (18), DEFA14A (18), 424B3 (17)1
    All 44 form types

    144 (15), CORRESP (13), SC 13G (12), UPLOAD (12), S-8 (11), SC 13D (11), EFFECT (10), SCHEDULE 13D/A (10), DEF 14A (9), 424B5 (8), S-3 (8), SC 13G/A (7), 4/A (6), SCHEDULE 13G (6), D (5), SCHEDULE 13G/A (5), 8-K/A (4), ARS (4), 5 (3), 10QSB (2), DEFM14A (2), PREM14A (2), S-1/A (2), SCHEDULE 13D (2), 10-K/A (1), 10SB12G (1), 8-A12B (1), CERT (1), CT ORDER (1), DEFM14C (1), POS AM (1), PRE 14A (1), PREM14C (1), S-1 (1), S-3/A (1), SC 14F1 (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 10, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.0001 par value per shareWHWKThe Nasdaq Stock Market LLC

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

Risk factors and legal proceedings

The risks Whitehawk Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 76 risks under these headings, as written.4

  • Risks Related to Our Business, Financial Condition and Capital Requirements
  • We are a preclinical-stage biopharmaceutical company, have a limited operating history and had a single product approved for commercial sale that we have divested, which may make it difficult for you to evaluate our current business and likelihood of success and viability.
  • We have incurred significant net losses since our inception, and we expect to continue to incur significant net losses for the foreseeable future.
  • Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of the ADC Therapies and other product candidates that we may develop.
  • We will require additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
  • Following the FYARRO Divestiture, we do not have any approved products and our pipeline is comprised solely of preclinical and clinical assets. The ADC Therapies are early in development. Going forward, our business will depend on our ability to advance our current and future product candidates through preclinical studies and clinical trials and obtain regulatory approval of our product candidates, which may fail in development or suffer delays that adversely affect their commercial viability.
  • Through the License Agreement, we have transitioned to a new pipeline and are pursuing different targets and indications from those we have historically pursued, which has risks.
  • The ADC Therapies have never been tested in humans. They are comprised of antibodies that have never been tested in humans and linker-payloads that are currently in clinical trials run by independent third parties for other indications.
  • Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success, which would limit the revenue that we generate from our sales.
  • The market opportunities for the ADC Therapies and any other product candidates we may develop, if approved, may be limited to certain smaller patient subsets.
  • Any product candidates for which we may obtain regulatory approval, may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
The other 65 risks
  • We may not be able to obtain FDA approval of any future NDA for any other product candidates we may develop.
  • Failure to obtain marketing approval in international jurisdictions would prevent any product candidates that we may develop, if approved, from being marketed abroad.
  • A variety of risks associated with marketing any product candidates we may develop, if approved, internationally could affect our business.
  • The preclinical studies and clinical trials for the ADC Therapies or any other product candidates that we may develop may not demonstrate safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities or otherwise produce positive results, which would prevent, delay, or limit the scope of development, regulatory approval and commercialization.
  • Any product candidates that we may develop may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that could delay or prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
  • Results from early preclinical studies and clinical trials of the ADC Therapies or any other product candidates that we may develop are not necessarily predictive of the results of later preclinical studies and clinical trials of such product candidates. If we cannot replicate the results from our earlier preclinical studies and clinical trials in our later preclinical studies and clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize any product candidates.
  • We are subject to risks relating to open-label clinical trials.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted and are subject to audit, independent radiographic or clinical review, and verification procedures that could result in material changes in the final data.
  • Adverse results of clinical trials conducted by third parties investigating the same product candidates as us in different territories could adversely affect our development of such product candidate.
  • If we experience delays or difficulties in the enrollment and/or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary regulatory approvals could be delayed or prevented.
  • We may develop product candidates in combination with other therapies, which exposes us to additional risks.
  • We face substantial competition in oncology and in the ADC field, and if our competitors develop and market technologies or products more rapidly than we do or achieve regulatory approval before we do or that are more effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We may not be successful in growing our product pipeline through acquisitions and in-licenses.
  • Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have a material adverse effect on our business and financial condition.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • If the FDA does not conclude that a product candidate and/or new indications satisfy the requirements under the 505(b)(2) regulatory pathway, or if the requirements for such product candidate and/or new indications under Section 505(b)(2) are not as we expect, the approval pathway for such product candidates and/or new indications may take longer, cost more or entail greater complications and risks than anticipated, which may delay or prevent the approval of a product candidate and/or new indications for commercial use.
  • We may be unable to obtain United States approval for product candidates that we may develop or foreign regulatory approval for product candidates that we may develop and, as a result, may be unable to commercialize any product candidates and in such event our business will be substantially harmed.
  • The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for product candidates that we may develop, we will be unable to generate product revenue, and our business will be substantially harmed.
  • The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
  • We are subject to risks relating to regulatory uncertainty in foreign jurisdictions.
  • 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.
  • The ADC Therapies and any other product candidate we may develop for which we obtain marketing approval for could be, subject to post-marketing restrictions or recall or withdrawal from the market, and we may be subject to penalties if we or our collaborators fail to comply with regulatory requirements or if we or our collaborators experience unanticipated problems with any product candidate we may develop when and if any of them are approved.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • If we are required by the FDA to obtain approval of a companion diagnostic product in connection with approval of any future product candidates or new indication that we may develop, and if we fail to obtain or face delays in obtaining FDA approval of such companion diagnostic product, we will not be able to commercialize such product candidate intended
  • for use with such companion diagnostic product and our ability to generate revenue from such product candidate will be materially impaired.
  • We may seek Fast Track designations from the FDA for our product candidates. Even if one or more of our product candidates receive Fast Track designation, we may not lead to a faster development or review process, or we may be unable to maintain or effectively utilize such a designation.
  • We may not be able to obtain or maintain orphan drug designation or obtain or maintain orphan drug exclusivity for any product candidates and, even if we do, such exclusivity may not prevent the FDA, EMA or other comparable foreign regulatory authorities, from approving competing products.
  • We may face difficulties from changes to current regulations and future legislation.
  • Inadequate funding, layoffs, and other policies impacting the normal operations of the FDA, the Securities and Exchange Commission (“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 on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • If we, or any contract manufacturers and suppliers we engage, fails 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 our business.
  • Our business activities may be subject to the FCPA and similar anti-bribery and anti-corruption laws of other countries. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Our business activities may be subject to United States and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Risks Related to Our Reliance on Third Parties
  • Our product candidates are complex and can be difficult to manufacture.
  • We are currently dependent on single-source suppliers for our product candidates and their components, any issues with any such suppliers, including increases in costs or expenses or delays in supply, could harm our business.
  • We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies that were previously conducted for our product candidates.
  • We rely on third parties to conduct preclinical studies and clinical trials and for the manufacture, production, storage and distribution of our products and product candidates and certain commercialization activities for our products.
  • We rely on in-license agreements for patent rights with respect to our product candidates and may in the future acquire additional third-party intellectual property rights on which we may similarly rely. We face risks with respect to such reliance, including the risk that we could lose these rights that are important to our business if we fail to comply with our obligations under these licenses.
  • We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies.
  • We may form or seek strategic alliances or collaborations in the future. Such alliances and collaborations may inhibit future opportunities, or we may not realize the benefits of such collaborations or alliances.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • If we decide to establish collaborations but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We may enter into collaborations with third parties for the development and commercialization for any product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to our Business
  • Our success is highly dependent on our ability to attract and retain highly skilled executive officers, key scientific personnel and employees.
  • If we are unable to successfully establish and maintain sales or marketing capabilities or enter into agreements with third parties to sell or market product candidates that we may develop in the future, when approved, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
  • In order to successfully implement our plans and strategies, from time to time we may need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, or use or other processing of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
  • Our ability to utilize our net operating loss (“NOL”) carryforwards and certain other tax attributes to offset future taxable income may be limited.
  • Changes in tax laws could materially adversely affect our financial condition.
  • Risks Related to Our Intellectual Property
  • Our success depends on our ability to protect and strengthen our intellectual property and our proprietary technologies, including our ability to obtain patent term extension for our product or any future product candidates.
  • If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical products or product candidates would be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to our product or product candidates that we may develop in the future through acquisitions and in-licenses.
  • We may be involved in lawsuits or other proceedings to protect or enforce our patents or intellectual property or our licensors’ patents or intellectual property, which could be expensive, time consuming and unsuccessful. Further, our issued patents or our licensors’ patents could be found invalid or unenforceable if challenged in court.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications or those of our licensors and the enforcement or defense of our issued patents or those of our licensors.
  • Changes in United States patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product or product candidates.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on our product or product candidates that we may develop for an adequate amount of time.
  • If we do not obtain patent term extension for our product or product candidates that we may develop in the future, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Legal proceedings

For discussion of legal proceedings, see Note 13 (Commitments and contingencies) to the financial statements in Part II, Item 8 of this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.4

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