Aadi Bioscience Relaunches as Whitehawk Therapeutics Marking Evolution into ADC Company
Whitehawk Therapeutics (Nasdaq: WHWK), formerly Aadi Bioscience, announced its strategic transformation into an ADC-focused oncology company. The company will begin trading under the ticker 'WHWK' on March 19, 2025.
The company's portfolio includes three assets in-licensed from WuXi Biologics, utilizing HANGZHOU DAC's advanced ADC technology platform. These assets feature a stable linker delivering a Topoisomerase I inhibitor payload, targeting lung and ovarian cancers with minimal off-target toxicity.
Following recent developments, including a $100 million PIPE financing and pending divestiture of Aadi Subsidiary to Kaken Pharmaceuticals, Whitehawk expects cash reserves of $170-180 million, funding operations into 2028. The company reported Q4 2024 revenue of $7.2 million and full-year 2024 revenue of $26.0 million from FYARRO sales, with a Q4 net loss of $18.3 million and full-year net loss of $63.7 million.
Whitehawk Therapeutics (Nasdaq: WHWK), precedentemente Aadi Bioscience, ha annunciato la sua trasformazione strategica in un'azienda oncologica focalizzata sugli ADC. L'azienda inizierà a essere quotata con il ticker 'WHWK' il 19 marzo 2025.
Il portafoglio dell'azienda comprende tre asset in licenza da WuXi Biologics, che utilizzano la piattaforma tecnologica avanzata ADC di HANGZHOU DAC. Questi asset presentano un linker stabile che eroga un payload inibitore della Topoisomerasi I, mirato ai tumori polmonari e ovarici con tossicità off-target minima.
A seguito degli sviluppi recenti, inclusi un finanziamento PIPE di 100 milioni di dollari e la prossima cessione della filiale Aadi a Kaken Pharmaceuticals, Whitehawk prevede riserve di liquidità tra 170 e 180 milioni di dollari, che finanzieranno le operazioni fino al 2028. L'azienda ha riportato un fatturato nel quarto trimestre del 2024 di 7,2 milioni di dollari e un fatturato annuale del 2024 di 26,0 milioni di dollari dalle vendite di FYARRO, con una perdita netta nel quarto trimestre di 18,3 milioni di dollari e una perdita netta annuale di 63,7 milioni di dollari.
Whitehawk Therapeutics (Nasdaq: WHWK), anteriormente Aadi Bioscience, anunció su transformación estratégica en una empresa oncológica enfocada en ADC. La compañía comenzará a cotizar bajo el ticker 'WHWK' el 19 de marzo de 2025.
El portafolio de la compañía incluye tres activos licenciados de WuXi Biologics, utilizando la avanzada plataforma tecnológica ADC de HANGZHOU DAC. Estos activos cuentan con un enlace estable que entrega un fármaco inhibidor de la Topoisomerasa I, dirigido a los cánceres de pulmón y ovario con mínima toxicidad fuera del objetivo.
Tras los recientes desarrollos, que incluyen un financiamiento PIPE de 100 millones de dólares y la inminente venta de la filial Aadi a Kaken Pharmaceuticals, Whitehawk espera reservas de efectivo de entre 170 y 180 millones de dólares, financiando operaciones hasta 2028. La compañía reportó ingresos del cuarto trimestre de 2024 de 7,2 millones de dólares y unos ingresos anuales de 2024 de 26,0 millones de dólares por ventas de FYARRO, con una pérdida neta en el cuarto trimestre de 18,3 millones de dólares y una pérdida neta anual de 63,7 millones de dólares.
Whitehawk Therapeutics (Nasdaq: WHWK), 이전 Aadi Bioscience,는 ADC 중심의 종양학 회사로의 전략적 변화를 발표했습니다. 이 회사는 2025년 3월 19일부터 'WHWK'라는 티커로 거래를 시작할 예정입니다.
회사의 포트폴리오에는 WuXi Biologics로부터 라이센스 받은 세 가지 자산이 포함되어 있으며, HANGZHOU DAC의 첨단 ADC 기술 플랫폼을 활용하고 있습니다. 이러한 자산은 폐암과 난소암을 목표로 하며 최소한의 오프 타겟 독성을 가진 Topoisomerase I 억제제를 전달하는 안정적인 링커를 특징으로 합니다.
최근 1억 달러 규모의 PIPE 자금 조달 및 Aadi 자회사를 Kaken Pharmaceuticals에 매각하는 과정 등 최근 개발에 따라 Whitehawk는 1억 7천만에서 1억 8천만 달러의 현금 보유고를 예상하며, 이는 2028년까지 운영 자금을 지원할 것입니다. 이 회사는 2024년 4분기 매출이 720만 달러, 2024년 전체 연도 매출이 FYARRO 매출로 2천6백만 달러에 달하며, 4분기 순손실이 1천8백30만 달러, 연간 순손실이 6천3백70만 달러라고 보고했습니다.
Whitehawk Therapeutics (Nasdaq: WHWK), anciennement Aadi Bioscience, a annoncé sa transformation stratégique en une entreprise oncologique axée sur les ADC. L'entreprise commencera à être cotée sous le ticker 'WHWK' le 19 mars 2025.
Le portefeuille de l'entreprise comprend trois actifs sous licence de WuXi Biologics, utilisant la plateforme technologique avancée ADC de HANGZHOU DAC. Ces actifs présentent un lien stable délivrant un charge utile inhibiteur de la Topoisomérase I, ciblant les cancers du poumon et de l'ovaire avec une toxicité hors cible minimale.
À la suite des développements récents, y compris un financement PIPE de 100 millions de dollars et la cession imminente de la filiale Aadi à Kaken Pharmaceuticals, Whitehawk s'attend à des réserves de liquidités de 170 à 180 millions de dollars, finançant ses opérations jusqu'en 2028. L'entreprise a rapporté un chiffre d'affaires de 7,2 millions de dollars pour le quatrième trimestre 2024 et un chiffre d'affaires annuel de 26,0 millions de dollars pour 2024 provenant des ventes de FYARRO, avec une perte nette de 18,3 millions de dollars pour le quatrième trimestre et une perte nette annuelle de 63,7 millions de dollars.
Whitehawk Therapeutics (Nasdaq: WHWK), ehemals Aadi Bioscience, hat seine strategische Transformation zu einem auf ADC fokussierten Onkologieunternehmen angekündigt. Das Unternehmen wird am 19. März 2025 unter dem Ticker 'WHWK' gehandelt werden.
Das Portfolio des Unternehmens umfasst drei von WuXi Biologics lizenzierte Vermögenswerte, die die fortschrittliche ADC-Technologieplattform von HANGZHOU DAC nutzen. Diese Vermögenswerte verfügen über einen stabilen Linker, der einen Topoisomerase I-Inhibitor-Laststoff liefert, der auf Lungen- und Eierstockkrebs abzielt und dabei minimale Off-Target-Toxizität aufweist.
Nach den jüngsten Entwicklungen, einschließlich einer PIPE-Finanzierung in Höhe von 100 Millionen US-Dollar und der bevorstehenden Veräußertung der Aadi-Tochtergesellschaft an Kaken Pharmaceuticals, erwartet Whitehawk einen Bargeldbestand von 170 bis 180 Millionen US-Dollar, der die Betriebsabläufe bis 2028 finanzieren wird. Das Unternehmen berichtete von einem Umsatz im vierten Quartal 2024 von 7,2 Millionen US-Dollar und einem Gesamtjahresumsatz 2024 von 26,0 Millionen US-Dollar aus FYARRO-Verkäufen, mit einem Nettoverlust im vierten Quartal von 18,3 Millionen US-Dollar und einem Nettoverlust für das gesamte Jahr von 63,7 Millionen US-Dollar.
- Secured $100 million PIPE financing
- Strong cash position expected ($170-180 million) funding operations into 2028
- Revenue generation of $26.0 million in 2024
- Slight improvement in net loss from $65.8M in 2023 to $63.7M in 2024
- Significant cash burn with Q4 2024 cash position decreased to $47.2M from $108.8M in 2023
- Increased quarterly net loss to $18.3M in Q4 2024 from $16.3M in Q4 2023
Insights
Aadi Bioscience's transformation into Whitehawk Therapeutics represents a strategic pivot from a commercial-stage company with modest revenue to a development-stage ADC-focused oncology firm. The $100 million PIPE financing that recently closed, combined with their existing resources and pending divestiture of the FYARRO business to Kaken, is expected to provide $170-180 million in cash. This substantial war chest should fund operations into 2028, giving the company runway through early clinical development of its three ADC candidates.
The financial profile has fundamentally changed. In 2024, Aadi generated
The ambitious timeline to advance all three ADC assets to IND within 15 months creates a clear series of catalysts but also represents significant execution risk. The ADC platform appears to leverage established tumor targets with claimed improvements in toxicity profile and stability, though clinical validation remains pending. This restructuring effectively resets the investment thesis from a specialty pharmaceutical play to an early-stage oncology development company with no near-term revenue prospects but substantial development potential in a hot therapeutic area.
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
The three assets in the portfolio are in-licensed from WuXi Biologics and utilize
"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
PIPE financing closed. The closing of the divestiture of Aadi Subsidiary, Inc. ("Aadi Sub") to Kaken Pharmaceuticals ("Kaken") is pending.$100 million - 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
as compared to$47.2 million as of December 31, 2023.$108.8 million - Following closing of the strategic transactions, we expect to have cash and cash equivalents in the range of
to$170 million , including the payment of the upfront and early milestones under the Wuxi ADC agreement.$180 million - Total revenue for the quarter ended December 31, 2024, was
, and$7.2 million for the full-year ended December 31, 2024, resulting from sales of FYARRO.$26.0 million - Net loss for the three months ended December 31, 2024, was
as compared to$18.3 million for the three months ended December 31, 2023. Net loss for the full-year ended December 31, 2024, was$16.3 million , as compared to$63.7 million for the same period in 2023.$65.8 million
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.