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1週前
Whitehawk Therapeutics Presents Real-World Analysis Confirming SEZ6 as a Highly Expressed, Clinically Relevant Target for SCLC and Other Neuroendocrine Tumors at ASCO 2026May 30, 2026 2:30 PM
PR Newswire (US) SEZ6 expression exceeds that of approved and emerging ADC targets in SCLC SEZ6 expression is positively correlated with DLL3 expression across neuroendocrine carcinomas, indicating potential for combination Findings support Whitehawk's development of SEZ6-directed ADC, HWK-206, with an IND submission expected mid-2026MORRISTOWN, N.J., May 30, 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 the presentation of a real world analysis supporting the therapeutic potential of targeting seizure related homolog protein 6 (SEZ6) with a next-generation ADC for the treatment of neuroendocrine tumors, including small cell lung cancer (SCLC). These data will be presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29-June 2, 2026, in Chicago, Illinois.SEZ6 is a cell surface transmembrane protein involved in neuronal development that is primarily expressed in central nervous system (CNS) tissues. A large-scale RNA analysis demonstrated that SEZ6 is highly expressed across SCLC and other tumors of neuroendocrine origin. In SCLC, expression exceeds other approved and emerging ADC targets. SEZ6 expression is positively correlated with DLL3, indicating the potential for combination approaches with DLL3-targeted therapies. Together, these data support its potential as a clinically meaningful ADC target and reinforce the rationale for clinical development of HWK-206."SEZ6 demonstrates a compelling expression profile across SCLC and other neuroendocrine malignancies. In SCLC, it has levels of expression that are consistently high across disease stages and metastatic settings," said Afshin Dowlati, MD, University Hospitals Seidman Cancer Center and Case Western Reserve University. "The magnitude of SEZ6 expression relative to other therapeutic targets, along with its enrichment in neuroendocrine-high SCLC subtypes, supports its potential as an ADC target."Key Findings Include: SEZ6 is highly expressed in SCLC and other tumors of neuroendocrine origin.Expression exceeds other established and emerging ADC targets.SCLC – SEZ6 expression was at least 3-fold higher than HER2, B7-H3, DLL3, PD-L1 and PD-1.Prostate neuroendocrine carcinoma – SEZ6 expression was 2- to 6-fold higher than B7-H3, DLL3 and TROP2.Among SCLC molecular subtypes, SEZ6 expression is highest in SCLC-A and SCLC-N, which accounts for ~90% of subtypes and are characterized by high expression of neuroendocrine transcription factors.Expression is high across SCLC disease stages and metastatic status, supporting potential relevance across treatment settings.Correlative expression in DLL3 supports combination strategies.HWK-206 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve binding and internalization of the ADC. In preclinical models, HWK-206 has demonstrated the potential to outperform other single epitope ADCs in development. An Investigational New Drug application to evaluate HWK-206 in SCLC and neuroendocrine tumors is expected to be submitted in mid-2026, with a Phase 1 start planned in Q3 2026."This real-world characterization of SEZ6 expression across small cell lung cancer and other neuroendocrine tumors reinforce our conviction in SEZ6 as a clinically meaningful target for ADC development," said Margaret Dugan, MD, Chief Medical Officer of Whitehawk Therapeutics. "These findings add to the body of evidence supporting our biparatopic SEZ6-directed ADC, HWK-206, and its potential to have a meaningful impact on patients with SCLC and neuroendocrine tumors."Poster Presentation Details:Title: Real-world characterization of SEZ6, a transmembrane protein expressed in various solid tumors
Poster: 219
Abstract: 3082
Presenter: Afshin Dowlati, MD, University Hospitals Seidman Cancer Center and Case Western Reserve University
Date & Time: May 30th, 2026, 1:30 - 4:30 PM CDTThe 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. Any references to the Company's website or other online resources are provided solely for convenience and are not incorporated by reference into this press release. Investors should rely only on the information contained in this press release and the Company's filings with the Securities and Exchange Commission.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, the anticipated timing of the Company's development of HWK-206, including the expected submission of Investigational New Drug applications for HWK-206 in mid-2026; statements relating to expectations regarding the beneficial characteristics, optimized ADC design features, safety, efficacy, and therapeutic effects of HWK-206; the size and opportunity of the potential targeted markets with respect to HWK-206; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund its 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 Company's portfolio, including failure to demonstrate the efficacy of the such 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," 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/whitehawk-therapeutics-presents-realworld-analysis-confirming-sez6-as-a-highly-expressed-clinically-relevant-target-for-sclc-and-other-neuroendocrine-tumors-at-asco-2026-302786256.htmlSOURCE Whitehawk Therapeutics, Inc. Original: Whitehawk Therapeutics Presents Real-World Analysis Confirming SEZ6 as a Highly Expressed, Clinically Relevant Target for SCLC and Other Neuroendocrine Tumors at ASCO 2026
US Market News
2週前
Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-PayloadMay 21, 2026 5:05 PM
PR Newswire (US) Agreement with Hangzhou DAC Provides Option for Up to Five New, Internally Developed ADC Programs, Including Dual-Payload VariationsHangzhou DAC's DXC006 Data at ASCO Reinforce Conviction for CPT113, a Core Technology of Whitehawk's ADC PlatformPhase 1 Dose-Escalation Trials of HWK-007 and HWK-016 are Currently Enrolling; HWK-007 Trials-in-Progress Poster to be Presented at ASCOMORRISTOWN, N.J., May 21, 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 it entered into a new option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. Whitehawk's ADC platform leverages CPT113 as the core linker-payload technology, adding its own proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index.Per the terms of the option agreement, Whitehawk will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs. Whitehawk anticipates submitting Investigational New Drug (IND) applications for multiple new programs over the next 12-24 months."This option agreement reflects our conviction in CPT113 as the core linker-payload foundation of our ADC platform, supported both by increasing external validation and by what we are seeing in our own existing programs. By layering on our proprietary CBCR bioconjugation process, we believe we further enhance ADC stability to deliver potential best-in-class ADCs," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "With HWK-007 and HWK-016 enrolling, and an IND for HWK-206 anticipated mid-year, we are building execution momentum across our portfolio. We now have the opportunity to further scale our pipeline and advance novel ADC programs toward the clinic in the next 12-24 months."External Programs Validate CPT113 Linker-Payload Technology Hangzhou DAC's DXC006 is a CD56-directed ADC that utilizes CPT113. DXC006 is being evaluated in first-in-human Phase 1 dose escalation/expansion study in China (NCT06224855) in solid tumor populations, including small-cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and neuroendocrine neoplasms. Data from DXC006 were accepted for oral presentation at the American Society of Clinical Oncology Annual Meeting (ASCO). The abstract points to this highly potent linker-payload translating to clinical activity and a favorable safety profile characterized by an absence of key safety concerns typically associated with a Top1i class. These abstract data were as of December 26, 2025.Separately, at the American Association for Cancer Research (AACR) Annual Meeting, Johnson & Johnson disclosed JNJ-95437446, an amivantamab-based EGFR/MET ADC that uses CPT113. In the poster, JNJ-95437446 reported preclinical findings that support its ongoing Phase 1 clinical development (NCT07107230).Whitehawk's ADC platform builds on the CPT113 linker-payload technology with its proprietary CBCR bioconjugation process. Based on key nonclinical measures, Whitehawk's CBCR-based ADC platform has demonstrated higher Drug-to-Antibody Ratio (DAR) and improved therapeutic index compared to DXC006. Whitehawk recently reported comprehensive preclinical data for its existing pipeline programs at AACR.Whitehawk's Clinical PipelinePhase 1 trials for PTK7-directed HWK-007 and MUC16-directed HWK-016 are advancing through dose-escalation, with data expected in the first half of 2027. Based on non-clinical modeling, both programs' starting dose is expected to be above the anticipated minimally effective dose.HWK-007 completed the first dose cohort at 2 mg/kg and is enrolling the second cohort at 4 mg/kg. HWK-007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). The design of this Phase 1 study will be presented during a Trials-in-Progress poster at ASCO.Title: A phase 1 study of HWK-007, a next-generation, protein tyrosine kinase 7 (PTK7)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumorsDate & Time: May 30, 2026, 1:30-4:30 PM CDTPoster: 292bHWK-016 is enrolling the first dose cohort at 2.5 mg/kg. HWK-016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).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. Any references to the Company's website or other online resources are provided solely for convenience and are not incorporated by reference into this press release. Investors should rely only on the information contained in this press release and the Company's filings with the Securities and Exchange Commission.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, the anticipated timing of the Company's development of the new programs under its option agreement with Hangzhou DAC, including the expected submission of Investigational New Drug applications for multiple new programs over the next 12-24 months; anticipated timing of initial Phase 1 data from clinical trials for HWK-007 and HWK-016 in 1H 2027 and expectations with respect to both programs' starting dose; statements relating to expectations regarding the beneficial characteristics, optimized ADC design features, safety, efficacy, and therapeutic effects of the Company's portfolio, including expected enhanced ADC stability to deliver potential best-in-class ADCs; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund its 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 Company's portfolio, including failure to demonstrate the efficacy of the such 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," 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/whitehawk-therapeutics-expands-adc-pipeline-with-new-option-agreement-for-use-of-cpt113-linker-payload-302779285.htmlSOURCE Whitehawk Therapeutics, Inc. Original: Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-Payload
US Market News
2月前
Whitehawk Therapeutics Presents Comprehensive Preclinical Data Highlighting its Next-Generation ADC Portfolio at the AACR 2026April 19, 2026 6:00 PM
PR Newswire (US)
Data demonstrate preclinical proof-of-concept for HWK-007, HWK-016 and HWK-206, underpinned by Whitehawk's proprietary Carbon Bridge Cysteine Re-pairing platformTumor regressions observed across various cancer models at low single-digit mg/kg doses, with favorable tolerability (HNSTD 60 mg/kg) and low systemic levels of free payload (≤0.01% AUC)Phase 1 trials for HWK-007 and HWK-016 are ongoing; an IND submission for HWK-206 is on track for mid-2026MORRISTOWN, N.J., April 19, 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 the presentation of new preclinical data across its ADC portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22, 2026, in San Diego, CA."Across our three ADC programs, we have a consistent preclinical profile characterized by potent tumor regressions, high plasma stability and favorable tolerability in non-human primates, coupled with low systemic levels of free payload," said David Dornan, PhD, Chief Scientific Officer of Whitehawk Therapeutics. "These data support the potential for our next-generation bioconjugation and proprietary Carbon Bridge Cysteine Re-pairing linker-payload to deliver a differentiated, potentially best-in-class therapeutic index among TOP1i-based ADCs, which is fundamental to realizing the promise of ADCs for patients."Overview of Preclinical Presentations "Preclinical assessment of HWK-007, a next-generation, PTK7-targeting ADC with novel bioconjugation and linker-payload technology" (Poster #4439)HWK-007 targets PTK7, the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. HWK-007 is being evaluated in an ongoing Phase 1 clinical trial in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). Key preclinical findings include:High-affinity binding and efficient internalization across a range of PTK7 expression levelsDemonstrates potent binding, internalization and tumor cell-killing in a range of solid cancer cell linesExhibits bystander activity and produces tumor regressions at doses as low as 1 mg/kg in small cell lung cancer and ovarian cancer modelsDemonstrates favorable pharmacokinetics and is well tolerated in non-human primates with an HNSTD of 60 mg/kg (the maximal dose tested)Demonstrates high stability with free payload of 0.0067% AUC detected in circulation"Preclinical assessment of HWK-016, a next-generation, MUC16-targeting ADC with novel bioconjugation and linker-payload technology" (Minisymposium Oral Presentation #1324)HWK-016 targets the non-shed extracellular domain of MUC16 to avoid binding to circulating CA125 and associated antigen sink effects observed with earlier MUC16-directed ADCs. HWK-016 is being evaluated in an ongoing Phase 1 clinical trial in patients with advanced ovarian and endometrial cancers (NCT07470853). Key preclinical findings include:Selectively binds membrane-bound MUC16 to ensure delivery to the tumor instead of circulating CA125Demonstrates potent binding, internalization and tumor cell-killing, and is minimally impacted by exogenous CA125Exhibits bystander activity, and produces tumor regressions at doses as low as 1 mg/kg in ovarian cancer xenograft models that shed high levels of CA125Demonstrates favorable pharmacokinetics and is well tolerated in non-human primates with an HNSTD of 60 mg/kg (the maximal dose tested)Demonstrates high stability with free payload of
US Market News
2月前
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/whitehawk-therapeutics-presents-real-world-analysis-confirming-muc16-as-a-highly-expressed-clinically-relevant-target-for-gynecologic-cancers-at-sgo-2026-302738766.htmlSOURCE Whitehawk Therapeutics, Inc.
Original: Whitehawk Therapeutics Presents Real-World Analysis Confirming MUC16 as a Highly Expressed, Clinically Relevant Target for Gynecologic Cancers at SGO 2026
US Market News
3月前
Whitehawk Therapeutics to Highlight its Next-Generation ADC Portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026March 17, 2026 4:30 PM
PR Newswire (US)
MORRISTOWN, N.J., March 17, 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 it will present three preclinical abstracts, including an oral minisymposium and two posters, highlighting its next-generation antibody-drug conjugate (ADC) portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22, 2026, in San Diego, CA."For the first time, we will present comprehensive preclinical proof-of-concept for our three ADC programs, HWK-007, HWK-016 and HWK-206," said David Dornan, PhD, Chief Scientific Officer of Whitehawk Therapeutics. "These data will highlight the optimized ADC design features aimed at delivering a differentiated ADC profile with the goal of improving outcomes for cancer patients."Whitehawk's comprehensive preclinical abstracts demonstrate a potential best-in-class therapeutic index among next-generation TOP1i-based ADCs. These data showed high potency with tumor regressions in xenograft studies at low single-digit mg/kg doses, and in non-human primate studies, Whitehawk's ADCs demonstrated a high tolerability with a highest non-severely toxic dose (HNSTD) of 60 mg/kg. Underpinning these results is one of the lowest reported free payload in circulation, driven by Whitehawk's proprietary "carbon-bridge cysteine repairing" linker-payload. Presentation details:HWK-016 – MUC16-Targeted ADC (Minisymposium Oral Presentation)
Title: Preclinical assessment of HWK-016, a next-generation, MUC16-targeting ADC with novel bioconjugation and linker–payload technology
Presenter: David Dornan, PhD, CSO, Whitehawk Therapeutics
Session: Advanced Antibody, Conjugate, and Targeted Therapeutic Platforms
Presentation Number: 1324
Date & Time: April 19, 2026, 3:00 – 5:00 pmHWK-007 – PTK7-Targeted ADC (Poster Presentation)
Title: Preclinical assessment of HWK-007, a next-generation, PTK7-targeting ADC with novel bioconjugation and linker–payload technology
Presenter: Kathleen S. Keegan, PhD, VP of R&D, Whitehawk Therapeutics
Section 12: Antibody-Drug Conjugates and Linker Engineering 3
Poster Number: 4439
Date & Time: April 21, 2026, 9:00 am – 12:00 pmHWK-206 – SEZ6-Targeted ADC (Poster Presentation)
Title: Preclinical assessment of HWK-206, a next-generation, biparatopic, SEZ6-targeting ADC with novel bioconjugation and linker–payload technology
Presenter: Kathleen S. Keegan, PhD, VP of R&D, Whitehawk Therapeutics
Section 12: Antibody-Drug Conjugates and Linker Engineering 3
Poster Number: 4440
Date & Time: April 21, 2026, 9:00 am – 12:00 pmThese abstracts are currently available on the AACR 2026 meeting website, and the presentation and 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 and the size of the potential targeted markets with respect to the Company's ADC assets and the potential best-in-class therapeutic index among next-generation TOP1i-based ADCs. 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 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.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
View original content to download multimedia:https://www.prnewswire.com/news-releases/whitehawk-therapeutics-to-highlight-its-next-generation-adc-portfolio-at-the-american-association-for-cancer-research-aacr-annual-meeting-2026-302716323.htmlSOURCE Whitehawk Therapeutics, Inc.
Original: Whitehawk Therapeutics to Highlight its Next-Generation ADC Portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026
US Market News
3月前
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
crudeoil24
5年前
This prospectus covers the offer and resale from time to time of up to 17,629,522 shares (the “Shares”) of common stock, par value $0.0001 per share, of Aadi Bioscience, Inc. (formerly known as Aerpio Pharmaceuticals, Inc. (“Aerpio”)), a Delaware corporation (the “Company”), by the selling stockholders identified in this prospectus, including their transferees, pledgees or donees or their respective successors. The Shares offered by the selling stockholders consist of: (i) 5,776,660 shares that were privately issued pursuant to an Agreement and Plan of Merger, dated May 16, 2021 (the “Merger Agreement”), by and among the Company, Aspen Merger Subsidiary, Inc. (“Merger Sub”), and Aadi Subsidiary, Inc. (formerly known as Aadi Bioscience, Inc. (“Private Aadi”)), pursuant to which Merger Sub merged with and into Private Aadi, with Private Aadi surviving as a wholly-owned subsidiary of the Company (the “Merger”), and (ii) 11,852,862 shares that were sold and issued to certain of the selling stockholders in a private placement pursuant to a Subscription Agreement, dated May 16, 2021, which closed on August 26, 2021 (the “PIPE Financing”). As a result of the Merger, the outstanding shares of common stock of Private Aadi were converted into the right to receive shares of our common stock on the terms set forth in the Merger Agreement. For accounting purposes, Private Aadi is considered to have acquired Aerpio in the Merger.
The selling stockholders identified in this prospectus may offer the shares of common stock pursuant to this prospectus from time to time through public or private transactions at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market prices or at privately negotiated prices. The selling stockholders may sell shares to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions from the selling stockholders, the purchasers of the shares, or both. For additional information on the methods of sale that may be used by the selling stockholders, see the section entitled “Plan of Distribution” on page 16. For a list of the selling stockholders, see the section entitled “Selling Stockholders” on page 10.
We are not selling any shares of common stock under this prospectus and will not receive any proceeds from the sale by the selling stockholders of such shares. We are paying the cost of registering the shares of common stock covered by this prospectus as well as various related expenses. The selling stockholders are responsible for all selling commissions, transfer taxes and other costs related to the offer and sale of their shares.
You should carefully read this prospectus and any amendments or supplements accompanying this prospectus, together with any documents incorporated by reference herein or therein, before you make your investment decision.
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