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Aadi Bioscience以Whitehawk Therapeutics的名义重新启动,标志着向ADC公司的转型

Aadi Bioscience Relaunches as Whitehawk Therapeutics Marking Evolution into ADC Company

CISION 等信源发布 2025-03-19 04:00

可切换为仅中文


New name reflects focus on accelerating portfolio of advanced ADC therapies with speed, agility and precision

新名称反映了专注于以速度、敏捷性和精确性加速推进先进ADC治疗药物组合的战略重点

Upon closing of strategic transactions, cash expected to fund operations into 2028 enabling anticipated key clinical data readouts for its ADC assets

战略交易完成后,预计将有足够现金支持运营至2028年,为其ADC资产提供预期的关键临床数据读数。

Company shares to trade on Nasdaq under the symbol 'WHWK' effective March 19, 2025

公司股票将于2025年3月19日起在纳斯达克以“WHWK”代码进行交易。

Company reports financial results for the fourth quarter and full-year 2024, and will host a conference call tomorrow,

公司报告了2024年第四季度和全年的财务结果,并将于明天举行电话会议,

March 19

3月19日

at

8:30 am ET

早上8点30分(美国东部时间)

MORRISTOWN, N.J.

莫里斯敦,新泽西州

,

March 18, 2025

2025年3月18日

/PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq:

/PRNewswire/ -- 白鹰治疗公司(纳斯达克:

WHWK

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.

),前身为Aadi Bioscience, Inc.,是一家致力于将先进技术应用于成熟的肿瘤生物学以高效提供改进的癌症治疗的肿瘤治疗公司,今天宣布将其名称更改为Whitehawk Therapeutics,反映了公司的演变及其专注于以速度、敏捷性和精确性加速其抗体药物偶联物(ADC)组合的决心。

The Company's common stock will begin trading under the ticker 'WHWK' effective .

公司的普通股将开始以“WHWK”为代码进行交易,生效日期为 。

March 19, 2025

2025年3月19日

.

The three assets in the portfolio are in-licensed from WuXi Biologics and utilize

该投资组合中的三种资产是从药明生物公司获得许可,并利用

HANGZHOU

杭州

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.

DAC的先进ADC技术平台由一个高度稳定且可裂解的连接子组成,该连接子可递送拓扑异构酶I(TOPO1)抑制剂有效载荷。该平台与在高潜力癌症适应症(包括肺癌和卵巢癌)中上调的经过临床验证的肿瘤靶点相结合。

These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors..

这些药物经工程设计,产生最小的脱靶毒性,其治疗指数高于第一代药物,且稳定性更强。

'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

“今天标志着一个变革性的时刻,我们以Whitehawk Therapeutics的身份重新亮相——这是一家专注的肿瘤学公司,结合科学、战略和执行,快速推进我们富有前景的ADC资产组合,”表示

David Lennon

大卫·列侬

, 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.

,总裁兼首席执行官,Whitehawk Therapeutics。 “通过利用已建立的肿瘤生物学基础并整合前沿技术,我们的战略旨在有效应对治疗最棘手癌症的挑战。我们的目标是在未来15个月内将所有三项资产推进到IND阶段。

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.'.

重要的是,我们相信我们稳健的资产负债表将使我们能够在这三个资产早期临床转折点时完成相关工作。我们有机会克服第一代ADC的局限性,为患者带来有意义的影响,对此我们充满活力。

Recent Operational Highlights:

近期运营亮点:

All proposals were approved at the Company's Special Meeting of Stockholders on

所有提案均在公司的特别股东大会上获得批准

February 28, 2025

2025年2月28日

.

Subsequently, the

随后,

$100 million

1亿美元

PIPE financing closed. The closing of the divestiture of Aadi Subsidiary, Inc. ('Aadi Sub') to Kaken Pharmaceuticals ('Kaken') is pending.

PIPE融资已结束。将Aadi子公司(“Aadi Sub”)出售给Kaken制药公司(“Kaken”)的交易尚待完成。

Aadi Bioscience divided into two organizations.

Aadi Bioscience 分为了两个组织。

Upon the divestiture of Aadi Sub to Kaken, Kaken will assume ownership of Aadi Sub, including the Aadi name, trademark and the FYARRO

在将Aadi Sub出售给Kaken后,Kaken将拥有Aadi Sub的所有权,包括Aadi名称、商标和FYARRO。

®

®

business. As of

商业。截至

March 18, 2025

2025年3月18日

, the Aadi parent company has become Whitehawk Therapeutics, with a focus on its portfolio of ADC assets.

,Aadi母公司已更名为Whitehawk Therapeutics,专注于其ADC资产组合。

Fourth Quarter and Full-year 2024 Financial Results:

2024年第四季度和全年财务业绩:

Cash, cash equivalents and short-term investments as of

截至以下日期的现金、现金等价物和短期投资

December 31, 2024

2024年12月31日

, were

,是

$47.2 million

4720万美元

as compared to

与...相比

$108.8 million

1.088亿美元

as of

截至

December 31, 2023

2023年12月31日

.

Following closing of the strategic transactions, we expect to have cash and cash equivalents in the range of

在战略交易完成后,我们预计拥有的现金及现金等价物范围为

$170 million

1.7亿美元

to

$180 million

1亿8千万美元

, including the payment of the upfront and early milestones under the Wuxi ADC agreement.

,包括根据无锡ADC协议支付预付款和早期里程碑款项。

Total revenue for the quarter ended

截至季度末的总收入

December 31, 2024

2024年12月31日

, was

,是

$7.2 million

720万美元

, and

,以及

$26.0 million

2600万美元

for the full-year ended

截至全年结束

December 31, 2024

2024年12月31日

, resulting from sales of FYARRO.

,由FYARRO的销售产生。

Net loss for the three months ended

截至三个月末的净亏损

December 31, 2024

2024年12月31日

, was

,是

$18.3 million

1830万美元

as compared to

与...相比

$16.3 million

1630万美元

for the three months ended

截至三个月末

December 31, 2023

2023年12月31日

. Net loss for the full-year ended

. 截至全年度末的净亏损

December 31, 2024

2024年12月31日

, was

,是

$63.7 million

6370万美元

, as compared to

,与...相比

$65.8 million

6580万美元

for the same period in 2023.

2023年同期。

About the ADC Portfolio

关于ADC产品组合

HWK-007

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.

代表了一个差异化的机会,有可能成为高表达PTK7癌症临床开发中的首批下一代ADC之一。HWK-007正在IND支持性研究中进行评估。1期试验计划在非小细胞肺癌和铂耐药卵巢癌中进行,并有潜力扩展到新的适应症(例如)。

gastrointestinal, gynecological)..

胃肠道、妇科)。

HWK-016

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.

是首个靶向MUC16膜结合部分的ADC,MUC16是一种在女性起源的癌症中常过度表达的糖蛋白。HWK-016目前正在接受IND相关研究评估。一期临床试验计划在卵巢癌中进行,并有可能扩展到其他适应症(例如)。

endometrial, cervical)..

子宫内膜、宫颈)。

HWK-206

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.

旨在针对神经元靶标SEZ6,该靶标在神经内分泌起源的癌症中常过度表达。HWK-206采用双表位结合(即双价)方法,这种方法可能提高ADC的内化和有效性。HWK-206目前正处于候选物选择阶段。

The Phase 1 trial is planned in small-cell lung cancer and neuroendocrine neoplasms, where there are limited treatment options..

第一阶段试验计划在小细胞肺癌和神经内分泌肿瘤中进行,这些癌症的治疗选择有限。

Conference Call Information

电话会议信息

The Whitehawk management team is hosting a conference call and webcast tomorrow at

白鹰管理团队将于明天举办电话会议和网络直播。

8:30 am ET

早上8点30分(美国东部时间)

(

(

5:30 am PT

早上5点30分(太平洋时间)

) to provide a corporate update and discuss results for the fourth quarter and full-year 2024.

)提供公司更新,并讨论2024年第四季度和全年的结果。

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

参与者可以通过 Whitehawk Therapeutics 网站的“投资者与新闻”页面访问此次电话会议的直播和相关幻灯片演示。

whitehawktx.com

whitehawktx.com

. To participate via telephone, please register in advance at this

要通过电话参与,请提前在此注册

link

链接

. 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..

所有电话参与者在注册后都将收到一封确认电子邮件,详细说明如何加入电话会议,包括拨入号码以及可用于访问电话会议的唯一密码和注册人ID。电话会议和网络直播的重播将在公司网站上存档至少30天。

About Whitehawk Therapeutics

关于白鹰治疗公司

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.

白鹰治疗公司是一家处于临床前阶段的肿瘤治疗公司,致力于将先进技术应用于已确立的肿瘤生物学,以高效提供更佳的癌症治疗方法。白鹰先进的三资产ADC组合旨在克服第一代产品局限性,为难治性癌症患者带来有意义的影响。

These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at .

这些资产根据一项独家开发和全球商业化协议从药明生物获得许可。有关公司的更多信息,请访问 。

www.whitehawktx.com

www.whitehawktx.com

and connect with us on LinkedIn.

并在LinkedIn上与我们联系。

Forward-Looking Statements

前瞻性声明

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 sat.

本新闻稿包含某些关于Whitehawk Therapeutics业务的前瞻性陈述,这些陈述并非1995年《私人证券诉讼改革法案》所指的历史事实描述。前瞻性陈述基于公司当前的信念和预期,可能包括但不限于以下相关陈述:公司的现金流可延续至2028年;战略交易的完成,包括Aadi Sub待售予Kaken以及根据Wuxi ADC协议支付的预付款和早期里程碑款项;公司对其ADC资产组合开发的预期时间表,包括启动IND支持性研究的预计时间;对公司ADC资产的有益特性、安全性、有效性、治疗效果及潜在目标市场规模的预期;以及公司现有资本资源的充足性及其为未来运营费用和资本支出需求提供资金的预期时间框架。由于各种风险和不确定性,实际结果可能与这些前瞻性陈述中的预期有重大差异,这些风险和不确定性包括但不限于:与ADC资产组合的临床前和临床开发相关的不确定性,包括临床试验启动、招募和完成的潜在延迟;未能在临床前和临床研究中证明ADC资产组合的有效性;在ADC资产测试过程中可能出现不可预见的不良反应或副作用的风险;以及Aadi Sub待售予Kaken的一项或多项交割条件可能无法满足的风险。

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

可能导致实际结果与前瞻性陈述中预期的结果存在重大差异的其他风险和不确定性已包含在公司截至本财政年度的Form 10-K年报中。

December 31, 2024

2024年12月31日

, 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

,包括标题为“项目1A. 风险因素”下的内容,以及Whitehawk随后的季度报告Form 10-Q中,并且在Whitehawk的其他报告和文件中,Whitehawk已提交或将会不时提交给SEC,并可于以下位置查阅:

www.sec.gov

www.sec.gov

, including the Definitive Proxy Statement filed on

,包括最终代理声明已在

January 31, 2025

2025年1月31日

.

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.

本新闻稿中的所有前瞻性陈述仅截至本日期有效,除适用法律要求外,Whitehawk 没有义务修订或更新任何前瞻性陈述,也不因新信息、未来事件或其他原因做出任何其他前瞻性陈述。

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..

所有前瞻性陈述均受此警示性声明的全面约束。此警示性声明是根据1995年《私人证券诉讼改革法案》的安全港条款作出的。

Contact:

联系:

IR@whitehawktx.com

IR@whitehawktx.com

AADI BIOSCIENCE, INC.

AADI生物科学公司

CONDENSED CONSOLIDATED BALANCE SHEETS

简明综合资产负债表

(In thousands)

(单位:千)

(Unaudited)

(未经审计)

December 31,

12月31日,

December 31,

12月31日,

2024

2024

2023

2023

Assets

资产

Current assets:

当前资产:

Cash and cash equivalents

现金及现金等价物

$               28,670

¥28,670

$               62,888

¥62,888

Short-term investments

短期投资

18,567

18,567

45,957

45,957

Accounts receivable, net

应收账款,净额

5,903

5,903

5,488

5,488

Inventory

库存

5,311

5,311

6,427

6,427

Prepaid expenses and other current assets

预付费用和其他流动资产

2,836

2,836

3,826

3,826

Total current assets

总流动资产

61,287

61,287

124,586

124,586

Property and equipment, net

物业和设备,净值

6,846

6,846

4,802

4,802

Operating lease right-of-use assets

经营租赁使用权资产

787

787

1,169

1,169

Other assets

其他资产

1,399

1,399

1,866

1,866

Total assets

总资产

$               70,319

¥70,319

$             132,423

¥132,423

Liabilities and stockholders' equity

负债和股东权益

Current liabilities:

当前负债:

Accounts payable

应付账款

$                 2,159

¥ 2,159

$                 5,898

¥ 5,898

Accrued liabilities

应计负债

14,647

14,647

14,306

14,306

Operating lease liabilities, current portion

经营租赁负债,流动部分

268

268

434

434

Due to licensor payable

由于许可方应付款

-

-

5,757

5,757

Total current liabilities

流动负债总计

17,074

17,074

26,395

26,395

Operating lease liabilities, net of current portion

经营租赁负债,减去流动部分

565

565

833

833

Other liabilities

其他负债

202

202

-

-

Total liabilities

总负债

17,841

17,841

27,228

27,228

Stockholders' equity:

股东权益:

Common stock

普通股

2

2

2

2

Additional paid-in capital

额外实收资本

385,114

385,114

374,129

374,129

Accumulated other comprehensive income

累计其他综合收益

16

16

27

27

Accumulated deficit

累计赤字

(332,654)

(332,654)

(268,963)

(268,963)

Total stockholders' equity

股东权益总额

52,478

52,478

105,195

105,195

Total liabilities and stockholders' equity

总负债和股东权益

$               70,319

¥70,319

$             132,423

¥132,423

AADI BIOSCIENCE, INC.

奥迪生物科学公司

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

合并简明损益表

(In thousands, except share data and earnings per share amounts)

(单位:千,股份数据和每股收益除外)

(Unaudited)

(未经审计)

Three months ended

三个月结束

Twelve months ended

截至十二个月末

December 31,

12月31日,

December 31,

12月31日,

2024

2024

2023

2023

2024

2024

2023

2023

Revenue

收入

Product sales, net

产品销售,净额

$         7,239

¥7,239

$         6,326

¥6,326

$           25,983

¥25,983

$           24,354

¥24,354

Total Revenue

总收入

7,239

7,239

6,326

6,326

25,983

25,983

24,354

24,354

Operating expenses

营业费用

Selling, general and administrative

销售、管理和行政费用

11,051

11,051

10,345

10,345

36,749

36,749

44,549

44,549

Research and development

研究与开发

14,347

14,347

12,768

12,768

51,030

51,030

48,929

48,929

Restructuring charges

重组费用

-

-

-

-

2,638

2,638

-

-

Cost of goods sold

销售成本

790

790

927

927

3,024

3,024

2,809

2,809

Total operating expenses

总运营费用

26,188

26,188

24,040

24,040

93,441

93,441

96,287

96,287

Loss from operations

营业亏损

(18,949)

(18,949)

(17,714)

(17,714)

(67,458)

(67,458)

(71,933)

(71,933)

Other income (expense)

其他收入(支出)

Foreign exchange gain (loss)

外汇收益(损失)

-

-

2

2

(4)

(4)

(1)

(1)

Interest income

利息收入

676

六百七十六

1,500

1500

3,925

3,925

6,400

6,400

Interest expense

利息支出

-

-

(57)

(57)

(154)

(154)

(231)

(231)

Total other income (expense), net

总其他收入(支出),净额

676

676

1,445

1,445

3,767

3,767

6,168

6,168

Net loss

净亏损

$      (18,273)

$      (18,273)

$      (16,269)

$      (16,269)

$         (63,691)

$ (63,691)

$         (65,765)

$         (65,765)

Net loss per share, basic and diluted

每股净亏损,基本和稀释

$          (0.67)

$          (0.67)

$          (0.60)

$          (0.60)

$             (2.36)

$             (2.36)

$             (2.44)

$             (2.44)

Weighted average number of common shares outstanding, basic and diluted

加权平均已发行普通股股数,基本和稀释

27,086,979

27,086,979

26,965,909

26,965,909

27,029,942

27,029,942

26,917,967

26,917,967

SOURCE Whitehawk Therapeutics, Inc.

源白鹰治疗公司

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