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

MWN-AI** Summary

Whitehawk Therapeutics, Inc. (NASDAQ: WHWK) reported its financial results for the fourth quarter and full-year ending December 31, 2025, highlighting significant operational progress and a notable improvement in financial position. With a robust cash, cash equivalents, and short-term investments balance of $145.7 million by year-end 2025—up from $47.2 million the previous year—the company anticipates having sufficient funds to support its operations into 2028.

For Q4 2025, Whitehawk recorded a net loss of $23.3 million compared to $18.3 million in Q4 2024, attributed largely to increased operational expenses. However, the company significantly reduced its full-year net loss to $20.6 million from $63.7 million in 2024, aided by an $87.3 million gain from the divestiture of its AADI subsidiary.

Operationally, Whitehawk has made substantial strides in developing its portfolio of antibody-drug conjugates (ADCs). The company announced active recruitment for Phase 1 clinical trials of two ADCs—HWK-007, targeting PTK7 in lung and ovarian cancers, and HWK-016, targeting MUC16 in gynecologic cancers. Additionally, Whitehawk plans to submit an Investigational New Drug (IND) application for HWK-206 mid-year, with Phase 1 trials expected to commence in Q3 2026.

The appointment of Dr. Margaret Dugan as Chief Medical Officer further bolsters Whitehawk's management team, as she brings over three decades of oncology experience. The company also shared promising data underscoring PTK7's potential as a pan-tumor target, presenting at the AACR-NCI-EORTC conference.

Whitehawk is actively pursuing preclinical data presentations in spring 2026 and anticipates initial results from its ongoing Phase 1 trials in 2027, as it continues to carve a path in oncology therapeutics.

MWN-AI** Analysis

Whitehawk Therapeutics (Nasdaq: WHWK) has recently announced its fourth quarter and full-year financial results for 2025, highlighting significant operational strides as well as a healthy cash position to fuel future growth. As of year-end, the company reported cash and short-term investments amounting to $145.7 million, a substantial increase from $47.2 million in 2024, allowing visibility into funding operations well into 2028.

The company’s progress on multiple clinical fronts, particularly the advancements in PTK7-targeted ADC HWK-007 and MUC16-targeted ADC HWK-016, are promising. Both are currently in Phase 1 trials, targeting specific cancers with established efficacy. Notably, HWK-206 is positioned for a mid-2026 IND submission, with a Phase 1 trial expected to begin shortly thereafter. This pipeline appears robust, supported by the introduction of Margaret Dugan, MD, as Chief Medical Officer, who brings valuable experience in oncology development.

The financial landscape also reflects an improvement in net loss, which narrowed to $20.6 million in 2025 from $63.7 million in the previous year, despite elevated operating expenses primarily driven by research and development. This suggests a more streamlined pathway towards commercial viability, especially as real-world data strengthens the case for PTK7 as a broadly expressed target.

Investors looking for potential in the biopharmaceutical sector may find Whitehawk intriguing, given its promising ADC technologies, solid cash reserve, and a strategic focus on clinical development. The market should keep an eye on clinical trial results slated for 2027, as upcoming data will likely influence investor sentiment and stock performance. Caution is warranted, however, due to the inherently volatile nature of clinical trials and the broader regulatory environment.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: PR Newswire

PR Newswire

Actively recruiting Phase 1 trials for PTK7-targeted antibody-drug conjugate (ADC) HWK-007 and MUC16-targeted ADC HWK-016

HWK-206 on track for planned IND submission in mid-2026 and Phase 1 start in Q3

Cash, cash equivalents and short-term investments balance of $145.7M at YE2025, anticipated to fund operations into 2028

MORRISTOWN, 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


2024

Assets




Current assets:





Cash and cash equivalents

           37,568


28,670


Short-term investments

108,129


18,567


Accounts receivable, net

-


5,903


Inventory

-


5,311


Prepaid expenses and other current assets

3,316


2,836

Total current assets

149,013


61,287

Property and equipment, net

3


6,846

Operating lease right-of-use assets

-


787

Other assets

1,814


1,399

Total assets

         150,830


70,319






Liabilities and stockholders' equity




Current liabilities:





Accounts payable

917


2,159


Accrued liabilities

13,602


14,647


Operating lease liabilities, current portion

-


268

Total current liabilities

14,519


17,074

Operating lease liabilities, net of current portion

-


565

Other liabilities

-


202

Total liabilities

14,519


17,841

Stockholders' equity:





Common stock

4


2


Additional paid-in capital

489,437


385,114


Accumulated other comprehensive income

120


16


Accumulated deficit

(353,250)


(332,654)

Total stockholders' equity 

136,311


52,478

Total 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

 

 

SOURCE Whitehawk Therapeutics, Inc.

FAQ**

What specific strategies does Whitehawk Therapeutics Inc. (WHWK) plan to employ to ensure the successful recruitment and progression of Phase 1 trials for its HWK-007 and HWK-0ADCs amid potential challenges in clinical development?

Whitehawk Therapeutics Inc. (WHWK) plans to leverage strategic partnerships, enhance patient engagement initiatives, and implement adaptive trial designs to navigate challenges and ensure successful recruitment and progression of Phase 1 trials for HWK-007 and HWK-016 ADCs.

Given the reported $87.3 million gain from the divestiture of the AADI Subsidiary, how does Whitehawk Therapeutics Inc. (WHWK) plan to reinvest this capital to advance its ADC portfolio and support its growth strategy?

Whitehawk Therapeutics Inc. (WHWK) plans to reinvest the $87.3 million gain from the AADI Subsidiary divestiture by strategically advancing its antibody-drug conjugate (ADC) portfolio and enhancing its growth strategy through research, development, and potential partnerships.

With cash balances anticipated to fund operations into 2028, what are the key milestones Whitehawk Therapeutics Inc. (WHWK) aims to achieve by then, and how will these milestones impact the company’s overall financial health and investor confidence?

Whitehawk Therapeutics Inc. aims to achieve key milestones such as advancing clinical trials, securing partnerships, and enhancing product pipelines by 2028, which are expected to strengthen financial health and boost investor confidence through potential revenue growth and market validation.

Can Whitehawk Therapeutics Inc. (WHWK) elaborate on the implications of the real-world analysis confirming PTK7 as a broadly expressed target across solid tumors, particularly regarding its potential impact on future drug development and market positioning?

Whitehawk Therapeutics Inc. (WHWK) may leverage the real-world analysis confirming PTK7 as a broadly expressed target across solid tumors to enhance drug development strategies and strengthen market positioning by focusing on therapies that effectively engage this target in diverse oncology indications.

**MWN-AI FAQ is based on asking OpenAI questions about Whitehawk Therapeutics Inc. (NASDAQ: WHWK).

Whitehawk Therapeutics Inc.

NASDAQ: WHWK

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