Whitehawk Therapeutics Inc【WHWK】株式ニュース

Whitehawk Therapeutics Presents Real-World Analysis Confirming MUC16 as a Highly Expressed, Clinically Relevant Target for Gynecologic Cancers at SGO 2026April 10, 2026 7:00 AM
PR Newswire (US)

MUC16 is the highest-expressing ADC target in ovarian cancer, at least two-fold higher than other emerging targets MUC16 is highly and stably expressed in the most aggressive and most common subtypes of endometrial cancerFindings support Whitehawk's development of MUC16-directed ADC, HWK-016, currently being explored in Phase 1 for advanced ovarian and endometrial cancersMORRISTOWN, N.J., April 10, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today presented three posters from a real-world analysis supporting the therapeutic potential of targeting mucin 16 (MUC16) with a next-generation ADC for the treatment of ovarian and endometrial cancers at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women's Cancer, being held April 10-13, 2026, in San Juan, Puerto Rico. MUC16 is a cell-surface glycoprotein that promotes tumor cell proliferation, metastasis and immune evasion. MUC16 is overexpressed in multiple tumor types with limited expression in normal tissue. A large-scale RNA analysis demonstrated that MUC16 is highly and stably expressed across ovarian cancers and in the most aggressive and most common subtypes of endometrial cancer, including in later-stage disease, supporting its potential as a clinically meaningful ADC target and reinforcing the rationale for clinical development of HWK-016."Across both ovarian and endometrial cancers, MUC16 shows a high level of stable expression that is uncommon among many therapeutic targets," said Kathleen N. Moore, MD, Deputy Director and Director of Phase 1 Oncology Trials, The Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center. "The consistency of MUC16 expression across disease stage and platinum sensitivity supports the relevance of a MUC16-targeted ADC in earlier-line settings, as well as for heavily pretreated patients and as part of combination strategies."Key Findings Include:MUC16 in Ovarian CancerMUC16 has high, tumor-selective expression, with concordance between MUC16 mRNA expression and MUC16 protein abundance by IHC.MUC16 is highly expressed across most histologic subtypes, including the most common subtype, high-grade serous ovarian carcinoma (HGSOC), which accounts for ~70% of cases.In HGSOC, MUC16 expression is stable across disease stages, metastatic status and platinum sensitivity, underscoring relevance in early- and late-line treatment settings.MUC16 has the highest median expression, ranging from 2- to >100-fold higher than other clinically validated and emerging ADC targets, including NaPi2b, HER2, FRa, TROP2, B7-H4, CDH6 and CLDN6.MUC16 in Endometrial CancerMUC16 has high, tumor-selective expression, with concordance with MUC16 protein abundance by IHC.MUC16 is most highly expressed in serous adenocarcinoma (the most aggressive subtype accounting for ~40% of deaths), followed by endometrioid adenocarcinoma (the most common subtype, accounting for ~90% of cases).In serous adenocarcinoma, MUC16 expression is stable across disease stages and metastatic status, and has the highest median expression, 1.4- to 3.7-fold higher than other clinically validated and emerging ADC targets, including NaPi2b, HER2, TROP2, FRa and B7H4.Earlier MUC16-directed ADCs targeted the cleaved extracellular portion of the protein (CA125), which is shed into circulation, limiting tumor delivery. HWK-016, Whitehawk's investigational, next-generation MUC16-targeted ADC, is designed to overcome this antigen sink effect by selectively targeting the membrane-bound, non-shed portion of MUC16. HWK-016 leverages a stable, cleavable linker to deliver a novel topoisomerase I (TOP1) inhibitor payload. HWK-016 is currently being evaluated in a Phase 1 clinical trial in patients with advanced ovarian and endometrial cancers [NCT07470853]. Initial clinical data are expected in the first half of 2027."The real-world data reported at SGO reinforce MUC16 as a 'super expressed' and durable target for gynecological cancers, strengthening the biological rationale for HWK-016," said Margaret Dugan, MD, Chief Medical Officer of Whitehawk Therapeutics. "By combining selective targeting of the membrane-bound, non-shed portion of MUC16 with our differentiated carbon-bridge cystine-repairing linker-payload technology, HWK-016 exemplifies our broader strategy of applying advanced ADC engineering to well-validated tumor biology to potentially generate meaningfully improved outcomes for patients."Poster Presentation Details:Title: MUC16 in ovarian cancer: high, stable expression across histologic subtypes, disease stages, and platinum sensitivity status supports antibody-drug conjugate development
Presenter: Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
Date & Time: April 12, 2026, 11:00 AM – 12:00 PM and 4:00 – 4:45 PMTitle: MUC16 as a therapeutic target: advancing antibody-drug conjugates for ovarian cancer treatment
Presenter: David M. O'Malley, MD, The Ohio State University
Date & Time: April 12, 2026, 11:00 AM – 12:00 PM and 4:00 – 4:45 PMTitle: High and stable MUC16 expression in endometrial cancer highlights potential for targeted antibody-drug conjugate development
Presenter: Kathleen N. Moore, MD, University of Nebraska Medical Center
Poster Tour – Group 9: Targeted Tactics and Therapies
Date & Time: April 12, 2026, 11:30 AM – 12:00 PMThe analysis was conducted as part of a previously announced collaboration between Whitehawk and Tempus AI. The posters will be accessible on the Presentations page of the Investors & News section of the Company's website at www.whitehawktx.com.About Whitehawk Therapeutics
Whitehawk Therapeutics is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.Forward-Looking Statements
This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to expectations regarding the beneficial characteristics, optimized ADC design features, safety, efficacy, therapeutic effects, the size of the potential targeted markets with respect to HWK-016 and anticipated timing of the data release of initial Phase 1 data from clinical trial HWK-016 in the first half of 2027. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, uncertainties associated with clinical development of HWK-016, including potential delays in the commencement, enrollment and completion of clinical trials; failure to demonstrate the efficacy of clinical studies for HWK-016; and the risk that unforeseen adverse reactions or side effects may occur in the course of testing of HWK-016.Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, including under the caption "Item 1A. Risk Factors," and in Whitehawk's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Whitehawk's reports and other documents that Whitehawk has filed, or will file, with the SEC from time to time and available at www.sec.gov.All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Whitehawk undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.Contact:IR@whitehawktx.com

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Original: Whitehawk Therapeutics Presents Real-World Analysis Confirming MUC16 as a Highly Expressed, Clinically Relevant Target for Gynecologic Cancers at SGO 2026

Whitehawk Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent HighlightsMarch 12, 2026 8:00 AM
PR Newswire (US)

Actively recruiting Phase 1 trials for PTK7-targeted antibody-drug conjugate (ADC) HWK-007 and MUC16-targeted ADC HWK-016HWK-206 on track for planned IND submission in mid-2026 and Phase 1 start in Q3Cash, cash equivalents and short-term investments balance of $145.7M at YE2025, anticipated to fund operations into 2028MORRISTOWN, N.J., March 12, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced financial results for the fourth quarter and full-year ended December 31, 2025, and provided recent corporate highlights."Last year marked our evolution into Whitehawk Therapeutics, a boldly pragmatic company developing the next generation of ADC cancer treatments. We progressed three programs through IND-enabling work in tandem, while building the capabilities required to execute efficiently in the clinic as we enter 2026," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "Whitehawk combines established but underexploited tumor targets with a differentiated ADC platform. With two active Phase 1 studies for HWK-007 and HWK-016, and a third IND submission for HWK-206 planned mid-year, we are energized by the opportunity to translate our strategy into clinical data with the potential to have a meaningful impact for patients."Q4 2025 and Recent Operational Highlights:Advanced development of PTK7-targeted HWK-007 and MUC16-targeted HWK-016 into Phase 1. In January, Whitehawk announced regulatory progress for these programs, which are both now actively recruiting Phase 1 trials.The HWK-007 Phase 1 trial will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.The HWK-016 Phase 1 trial will initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.Strengthened management with new CMO. In December 2025, Whitehawk appointed Margaret Dugan, MD, as Chief Medical Officer (CMO). Dr. Dugan brings more than 30 years of global oncology drug development experience, with extensive expertise in early-stage clinical development and regulatory strategy.Presented real-world analysis confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. Whitehawk presented data at the AACR-NCI-EORTC meeting that established PTK7 as the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. We believe these findings support the potential of PTK7 as a pan-tumor target.Fourth Quarter and Full Year 2025 Financial Results:Cash, cash equivalents and short-term investments as of December 31, 2025, were $145.7 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.Net loss for the three months ended December 31, 2025, was $23.3 million as compared to $18.3 million for the three months ended December 31, 2024. Net loss for the full-year ended December 31, 2025, was $20.6 million, as compared to $63.7 million for the same period in 2024. The full-year net loss includes an $87.3 million gain on the divestiture of AADI Subsidiary.Anticipated Milestones:Preclinical data – expect to present preclinical data across the portfolio at an upcoming medical congress in Spring 2026.HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.About Whitehawk Therapeutics
Whitehawk Therapeutics is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.Forward-Looking Statements
This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the potential therapeutic value and market opportunity for the Company's ADC portfolio; plans related to the Company's development of its portfolio of ADC assets, including the anticipated timing of the submission of an IND in mid-2026 for HWK-206 and commencement of recruitment in the related Phase 1 trial in Q3 2026 and data releases of preclinical data across the Company's portfolio in Spring 2026 and initial Phase 1 data from clinical trials for HWK-007 and HWK-016; expectations regarding the beneficial characteristics, design features, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company's ADC assets, including the potential of PTK7 as a pan-tumor target; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, uncertainties associated with preclinical and clinical development of the ADC portfolio, including potential delays in the commencement, enrollment and completion of clinical trials; failure to demonstrate the efficacy of the ADC portfolio in preclinical and clinical studies; the risk that unforeseen adverse reactions or side effects may occur in the course of testing of the ADC assets; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing.Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, including under the caption "Item 1A. Risk Factors," filed on or about the date hereof, and in Whitehawk's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Whitehawk's reports and other documents that Whitehawk has filed, or will file, with the SEC from time to time and available at www.sec.gov.All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Whitehawk undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.Contact:
IR@whitehawktx.com WHITEHAWK THERAPEUTICS, INC.CONDENSED BALANCE SHEETS(In thousands)(Unaudited)

December 31,
December 31,

2025
2024Assets

Current assets:

Cash and cash equivalents$ 37,568
$            28,670
Short-term investments108,129
18,567
Accounts receivable, net-
5,903
Inventory-
5,311
Prepaid expenses and other current assets3,316
2,836Total current assets149,013
61,287Property and equipment, net3
6,846Operating lease right-of-use assets-
787Other assets1,814
1,399Total assets$ 150,830
$            70,319

Liabilities and stockholders' equity

Current liabilities:

Accounts payable$                  917
$              2,159
Accrued liabilities13,602
14,647
Operating lease liabilities, current portion-
268Total current liabilities14,519
17,074Operating lease liabilities, net of current portion-
565Other liabilities-
202Total liabilities14,519
17,841Stockholders' equity:

Common stock4
2
Additional paid-in capital489,437
385,114
Accumulated other comprehensive income120
16
Accumulated deficit(353,250)
(332,654)Total stockholders' equity 136,311
52,478Total liabilities and stockholders' equity$ 150,830
$            70,319 WHITEHAWK THERAPEUTICS, INC.CONDENSED STATEMENTS OF OPERATIONS(In thousands, except share data and earnings per share amounts)(Unaudited)

Three months ended
Twelve months ended

December 31,
December 31,

2025
2024
2025
2024
Revenue

Product sales, net
$ -
$         7,239
$         7,145
$       25,983
Total Revenue
-
7,239
7,145
25,983
Operating expenses

Selling, general and administrative
5,866
11,051
29,822
36,749

Research and development
19,021
14,347
90,963
51,030

Restructuring charges
-
-
-
2,638

Cost of goods sold
-
790
760
3,024
Total operating expenses
24,887
26,188
121,545
93,441
Loss from operations
(24,887)
(18,949)
(114,400)
(67,458)
Other income (expense)

Gain on sale of business
-
-
87,266
-

Foreign exchange gain (loss)
8
-
5
(4)

Other income
17
-
302
-

Interest income
1,611
676
6,231
3,925

Interest expense
-
-
-
(154)
Total other income (expense), net
1,636
676
93,804
3,767
Net loss
$ (23,251)
$ (18,273)
$ (20,596)
$ (63,691)
Net loss per share, basic and diluted

$          (0.34)
$          (0.67)
$          (0.33)
$          (2.36)

Weighted average number of common shares outstanding,
basic and diluted
69,212,823
27,086,979
61,886,765
27,029,942

View original content to download multimedia:https://www.prnewswire.com/news-releases/whitehawk-therapeutics-reports-fourth-quarter-and-full-year-2025-financial-results-and-recent-highlights-302711592.htmlSOURCE Whitehawk Therapeutics, Inc.

Original: Whitehawk Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Highlights