Aadi Bioscience Relaunches as Whitehawk Therapeutics Marking Evolution into ADC Company
New name reflects focus on accelerating portfolio of advanced ADC therapies with speed, agility and precision
Upon closing of strategic transactions, cash expected to fund operations into 2028 enabling anticipated key clinical data readouts for its ADC assets
Company shares to trade on Nasdaq under the symbol "WHWK" effective March 19, 2025
Company reports financial results for the fourth quarter and full-year 2024, and will host a conference call tomorrow, March 19 at 8:30 am ET
MORRISTOWN, N.J., March 18, 2025 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), formerly known as Aadi Bioscience, Inc., an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments, today announced it changed its name to Whitehawk Therapeutics, reflecting the Company's evolution and focus on accelerating its portfolio of antibody drug conjugates (ADCs) with speed, agility and precision. The Company's common stock will begin trading under the ticker "WHWK" effective March 19, 2025.
The three assets in the portfolio are in-licensed from WuXi Biologics and utilize HANGZHOU DAC's advanced ADC technology platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The platform is coupled with clinically validated tumor targets that are upregulated in high-potential cancer indications, including lung and ovarian. These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors.
"Today marks a transformative moment as we reintroduce ourselves as Whitehawk Therapeutics - a focused oncology company combining science, strategy and execution to swiftly advance our portfolio of promising ADC assets," said David Lennon, President and CEO, Whitehawk Therapeutics. "By leveraging the foundation of well-established tumor biology and integrating cutting-edge technologies, our strategy is designed to address the challenges of treating the most difficult cancers efficiently and effectively. Our goal is to bring all three assets to IND in the next 15 months. Importantly, we believe our robust balance sheet will enable us to see these three assets through early clinical inflections. We are invigorated by the opportunity we have to overcome the limitations of first-generation ADCs to make a meaningful impact for patients."
Recent Operational Highlights:
-- All proposals were approved at the Company's Special Meeting of
Stockholders on February 28, 2025. Subsequently, the $100 million PIPE
financing closed. The closing of the divestiture of Aadi Subsidiary,
Inc. ("Aadi Sub") to Kaken Pharmaceuticals ("Kaken") is pending.
-- Aadi Bioscience divided into two organizations. Upon the divestiture of
Aadi Sub to Kaken, Kaken will assume ownership of Aadi Sub, including
the Aadi name, trademark and the FYARRO(®) business. As of March 18,
2025, the Aadi parent company has become Whitehawk Therapeutics, with a
focus on its portfolio of ADC assets.
Fourth Quarter and Full-year 2024 Financial Results:
-- Cash, cash equivalents and short-term investments as of December 31,
2024, were $47.2 million as compared to $108.8 million as of December
31, 2023.
-- Following closing of the strategic transactions, we expect to have cash
and cash equivalents in the range of $170 million to $180 million,
including the payment of the upfront and early milestones under the Wuxi
ADC agreement.
-- Total revenue for the quarter ended December 31, 2024, was $7.2 million,
and $26.0 million for the full-year ended December 31, 2024, resulting
from sales of FYARRO.
-- Net loss for the three months ended December 31, 2024, was $18.3 million
as compared to $16.3 million for the three months ended December 31,
2023. Net loss for the full-year ended December 31, 2024, was $63.7
million, as compared to $65.8 million for the same period in 2023.
About the ADC Portfolio
-- HWK-007 represents a differentiated opportunity to potentially be among
the first next-wave ADCs in clinical development for high PTK7
expressing cancers. HWK-007 is being evaluated in IND-enabling studies.
The Phase 1 trial is planned in non-small cell lung cancer and platinum
resistant ovarian cancer, with potential to expand into novel
indications (e.g. gastrointestinal, gynecological).
-- HWK-016 is the first ADC that targets the membrane-bound portion of
MUC16, a glycoprotein often overexpressed in cancers of female origin.
HWK-016 is currently being evaluated in IND-enabling studies. The Phase
1 trial is planned in ovarian cancer, with potential to expand into
additional indications (e.g. endometrial, cervical).
-- HWK-206 is designed to address the neuronal target, SEZ6, which is often
overexpressed in cancers of neuroendocrine origin. HWK-206 utilizes a
dual epitope binding, or biparatopic, approach which can potentially
improve internalization and effectiveness of the ADC. HWK-206 is
currently in candidate selection. The Phase 1 trial is planned in
small-cell lung cancer and neuroendocrine neoplasms, where there are
limited treatment options.
Conference Call Information
The Whitehawk management team is hosting a conference call and webcast tomorrow at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the fourth quarter and full-year 2024.
Participants may access a live webcast of the call and the associated slide presentation on the "Investors & News" page of the Whitehawk Therapeutics website at whitehawktx.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days.
About Whitehawk Therapeutics
Whitehawk Therapeutics is a preclinical 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 Company's cash runway extending into 2028; the closing of the strategic transactions, including the pending sale of Aadi Sub to Kaken and the payment of the upfront and early milestones under the Wuxi ADC agreement; the anticipated timing of the Company's development of its portfolio of ADC assets, including the expected timing regarding the commencement of IND-enabling studies; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company's ADC assets; 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; the risk that one or more closing conditions to the pending sale of Aadi Sub to Kaken may not be satisfied; 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, 2024, 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, including the Definitive Proxy Statement filed on January 31, 2025.
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
AADI BIOSCIENCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
December 31, December 31,
2024 2023
Assets
Current assets:
Cash and cash equivalents $28,670 $62,888
Short-term investments 18,567 45,957
Accounts receivable, net 5,903 5,488
Inventory 5,311 6,427
Prepaid expenses and other
current assets 2,836 3,826
Total current assets 61,287 124,586
Property and equipment, net 6,846 4,802
Operating lease right-of-use
assets 787 1,169
Other assets 1,399 1,866
Total assets $70,319 $132,423
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $2,159 $5,898
Accrued liabilities 14,647 14,306
Operating lease liabilities,
current portion 268 434
Due to licensor payable - 5,757
Total current liabilities 17,074 26,395
Operating lease liabilities,
net of current portion 565 833
Other liabilities 202
Total liabilities 17,841 27,228
Stockholders' equity:
Common stock 2 2
Additional paid-in capital 385,114 374,129
Accumulated other
comprehensive income 16 27
Accumulated deficit (332,654) (268,963)
Total stockholders' equity 52,478 105,195
Total liabilities and
stockholders' equity $70,319 $132,423
AADI BIOSCIENCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share data and earnings per share amounts)
(Unaudited)
Three months ended Twelve months ended
December 31, December 31,
2024 2023 2024 2023
Revenue
Product sales, net $7,239 $6,326 $25,983 $24,354
Total Revenue 7,239 6,326 25,983 24,354
Operating expenses
Selling, general and administrative 11,051 10,345 36,749 44,549
Research and development 14,347 12,768 51,030 48,929
Restructuring charges 2,638
Cost of goods sold 790 927 3,024 2,809
Total operating expenses 26,188 24,040 93,441 96,287
Loss from operations (18,949) (17,714) (67,458) (71,933)
Other income (expense)
Foreign exchange gain (loss) 2 (4) (1)
Interest income 676 1,500 3,925 6,400
Interest expense (57) (154) (231)
Total other income (expense), net 676 1,445 3,767 6,168
Net loss $(18,273) $(16,269) $(63,691) $(65,765)
Net loss per share, basic and diluted
$(0.67) $(0.60) $(2.36) $(2.44)
Weighted average number of common shares outstanding,
basic and diluted 27,086,979 26,965,909 27,029,942 26,917,967
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SOURCE Whitehawk Therapeutics, Inc.
