Phase 1 trials for HWK-007 and HWK-016 continue to enroll; the Phase 1 trial for HWK-206 is on track to initiate in Q3 2026
Cash, cash equivalents and short-term investments of $190.0 million as of June 30, 2026, anticipated to fund operations into 2H 2028
MORRISTOWN, N.J., Aug. 6, 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 quarter ended June 30, 2026, and provided recent corporate highlights.
"The second quarter saw meaningful progress for our three assets. We continued enrollment in our Phase 1 studies for HWK-007 and HWK-016 and remain on track to initiate the Phase 1 trial for HWK-206 in Q3. We extended our anticipated runway into 2H 2028 following our recent upsized financing and we believe we are well positioned to support clinical execution against these programs," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "While our focus, investment priorities and execution efforts remain on our existing portfolio, we also took steps to enhance the long-term potential of our Whitehawk platform. The Hangzhou DAC option agreement reflects our conviction in CPT113, while our collaboration with Biocytogen provides access to bispecific antibody formats. These selective opportunities support future programs and our ambition to deliver new ADC INDs in the next 12-24 months."
Q2 2026 and Recent Operational Highlights:
-- In May 2026, Whitehawk announced an $87.5M private placement equity
financing. The financing included participation from existing investors
including Avoro Capital, QVT, Coastlands Capital, KVP Capital, ADAR1
Capital Management, Acuta Capital Partners, StemPoint Capital LP, Invus,
as well as members of Whitehawk's executive team.
-- Continued to enroll patients into ongoing Phase 1 trials for HWK-007 and
HWK-016.
-- 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 study design was
presented as a Trials-in-Progress poster at the American Society
of Clinical Oncology (ASCO) 2026.
-- HWK--016 is being evaluated in patients with advanced ovarian and
endometrial cancers (NCT07470853).
-- 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.
-- Presented real-world analysis confirming SEZ6 as a highly expressed,
clinically relevant target for small-cell lung cancer (SCLC) and other
neuroendocrine tumors at ASCO 2026. 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 with DLL3-targeted therapies.
-- Entered into a global collaboration with Biocytogen for bispecific
antibody ADC (BsADC) development. Biocytogen will provide access to up to
five bispecific antibodies using its proprietary RenLite$(R)$ platform, and
Whitehawk will evaluate these in combination with its ADC linker-payload
platform technologies. Whitehawk then has the option to advance any
resulting BsADC candidates as part of its pipeline.
Second Quarter 2026 Financial Results:
-- Cash, cash equivalents and short-term investments as of June 30, 2026,
were $190.0 million as compared to $145.7 million as of December 31,
2025. Cash is anticipated to fund operations into 2H 2028 based on
current plans.
-- Research and development expenses were $12.9 million for the three months
ended June 30, 2026, as compared to $48.8 million for the three months
ended June 30, 2025. The prior year quarter included the $38.0 million
up-front license fee paid to WuXi Biologics.
-- Net loss for the three months ended June 30, 2026, was $16.6 million as
compared to $52.6 million for the three months ended June 30, 2025.
Anticipated Milestones:
-- HWK-206 -- a Phase 1 study in small-cell lung cancer and neuroendocrine
tumors is planned to initiate 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 portfolio includes HWK-007, HWK-016 and HWK-206, ADCs 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.
Whitehawk's underlying ADC platform leverages CPT113 as the core linker-payload technology, enhanced with its proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index. Whitehawk has an option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. 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, 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 commencement of recruitment in a Phase 1 trial for HWK-206 in Q3 2026 and initial Phase 1 data from clinical trials for HWK-007 and HWK-016 in 1H 2027; 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; potential opportunities arising under or related to the Hangzhou DAC option agreement and the Biocytogen collaboration; the Company's ability to expand its pipeline opportunities, including its ability to deliver multiple new ADC INDs in the next 12-24 months, 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," 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 CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
June 30, December 31,
2026 2025
--------------------------- -----------------------------
Assets
Current assets:
Cash and cash
equivalents $ 85,234 $ 37,568
Short-term
investments 104,748 108,129
Prepaid
expenses and
other current
assets 2,432 3,316
Total current
assets 192,414 149,013
Property and
equipment,
net 1 3
Other assets 1,579 1,814
Total assets $ 193,994 $ 150,830
=========================== =============================
Liabilities and
stockholders'
equity
Current
liabilities:
Accounts
payable $ 1,105 $ 917
Accrued
liabilities 9,964 13,602
Total current
liabilities 11,069 14,519
--------------------------- -----------------------------
Total
liabilities 11,069 14,519
Stockholders'
equity:
Common stock 5 4
Additional
paid-in
capital 575,067 489,437
Accumulated
other
comprehensive
(loss) income (63) 120
Accumulated
deficit (392,084) (353,250)
Total
stockholders'
equity 182,925 136,311
--------------------------- -----------------------------
Total
liabilities
and
stockholders'
equity $ 193,994 $ 150,830
=========================== =============================
WHITEHAWK THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share data and earnings per share amounts)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
-------------------------------------------- ------------------------------------------
2026 2025 2026 2025
--------------------- --------------------- --------------------- -------------------
Revenue
Product sales,
net $ - $ - $ - $ 7,145
Total Revenue - - - 7,145
--------------------- --------------------- --------------------- -------------------
Operating
expenses
Selling, general
and
administrative 5,216 5,940 11,506 18,755
Research and
development 12,893 48,809 30,125 57,597
Cost of goods
sold - - - 760
Total operating
expenses 18,109 54,749 41,631 77,112
--------------------- --------------------- --------------------- -------------------
Loss from
operations (18,109) (54,749) (41,631) (69,967)
Other income
(expense)
Gain on sale of
business - - - 87,443
Foreign exchange
loss (6) (3) (6) (3)
Other income - 158 - 158
Interest income 1,475 1,979 2,803 2,770
--------------------- --------------------- --------------------- -------------------
Total other
income
(expense), net 1,469 2,134 2,797 90,368
--------------------- --------------------- --------------------- -------------------
Loss before
income tax
expense (16,640) (52,615) (38,834) 20,401
Income tax
expense - - - -
--------------------- --------------------- --------------------- -------------------
Net (loss)
income $ (16,640) $ (52,615) $ (38,834) $ 20,401
===================== ===================== ===================== ===================
Net (loss)
income per
share:
Basic $ (0.20) $ (0.76) $ (0.51) $ 0.37
===================== ===================== ===================== ===================
Diluted $ (0.20) $ (0.76) $ (0.51) $ 0.37
===================== ===================== ===================== ===================
Weighted average
number of common
shares
outstanding
Basic 82,886,196 69,083,127 76,099,275 54,443,309
===================== ===================== ===================== ===================
Diluted 82,886,196 69,083,127 76,099,275 54,908,715
===================== ===================== ===================== ===================
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SOURCE Whitehawk Therapeutics, Inc.