Whitehawk Therapeutics Inc (WHWK) 2024 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to Whitehawk Therapeutics fourth quarter and full year 2024 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded. I would like now to turn the conference over to Audrey Gross, Head of Corporate Communications for Whitehawk Therapeutics.

女士們、先生們，感謝你們的支持。歡迎參加 Whitehawk Therapeutics 2024 年第四季和全年財報電話會議。（操作員指示）請注意，今天的會議正在錄音。現在我想將會議交給 Whitehawk Therapeutics 公司企業傳播主管 Audrey Gross。

Ms. Gross, please go ahead.

格羅斯女士，請繼續。

Thank you. Good morning, and welcome to the Whitehawk Therapeutics conference call. We will be presenting slides as part of the live webcast of this call. Such slides will be posted on the Investor News page of the Whitehawk Therapeutics website at whitehawktx.com following the conference call.

謝謝。早安，歡迎參加 Whitehawk Therapeutics 電話會議。我們將在本次電話會議的網路直播中展示投影片。電話會議結束後，這些投影片將發佈在 Whitehawk Therapeutics 網站 whitehawktx.com 的投資者新聞頁面上。

A reminder that statements made on the call today will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those set forth in the Risk Factors section of our annual and quarterly filings with the Securities and Exchange Commission, which can be found at www.sec.gov or on our website at whitehawktx.com.

提醒一下，今天電話會議的陳述將包括前瞻性陳述。由於各種風險、不確定性和其他因素，實際事件或結果可能與任何前瞻性陳述所表達或暗示的情況存在重大差異，包括我們向美國證券交易委員會提交的年度和季度文件中「風險因素」部分所述的因素，這些文件可在 www.sec.gov 或我們的網站 whitehawktx.com 上找到。

In addition, any forward-looking statements made on this call represent our views only as of today, March 19, 2025, and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements.

此外，本次電話會議中所做的任何前瞻性陳述僅代表我們截至 2025 年 3 月 19 日的觀點，不應被視為代表我們在任何後續日期的觀點。我們明確否認有更新或修改任何前瞻性陳述的義務。

On the call today is Dr. Dave Lennon, our President and CEO; Scott Giacobello, our CFO; and Dr. David Dornan, our newly appointed CSO. Today, we will introduce Whitehawk Therapeutics and provide an overview of Q4 and full year 2024 financial results before turning the line open for questions.

今天參加電話會議的有我們的總裁兼執行長戴夫·列儂博士、我們的財務長 Scott Giacobello 和我們新任命的首席策略長戴維·多南博士。今天，我們將介紹 Whitehawk Therapeutics，並概述第四季度和 2024 年全年的財務業績，然後開放提問。

I'll now turn the call over to Dave. Dave?

我現在將電話轉給戴夫。戴夫？

Thanks, Audrey. Hello, everyone. Good morning. Thank you for joining. I'm Dave Lennon, the President and CEO of the newly launched Whitehawk Therapeutics. We are extremely excited about the transformation from Aadi Biosciences to Whitehawk. I look forward to walking you through our vision, strategy, and opportunity, and what we -- the opportunity we have to deliver a meaningful impact for patients with our advanced ADC portfolio.

謝謝，奧黛麗。大家好。早安.感謝您的加入。我是戴夫‧列儂 (Dave Lennon)，新成立的 Whitehawk Therapeutics 公司的總裁兼執行長。我們對 Aadi Biosciences 向 Whitehawk 的轉型感到非常興奮。我期待著向您介紹我們的願景、策略和機遇，以及我們利用先進的 ADC 產品組合為患者帶來有意義影響的機會。

As a reminder, in December, we announced a series of strategic transactions, including the in-licensing of three ADCs from Wuxi Biologics, the divestiture of FYARRO to Kaken Pharmaceuticals, and $100 million PIPE financing that were subsequently approved during a special meeting of stockholders last month.

提醒一下，12 月，我們宣布了一系列策略交易，包括從藥明生物獲得三種 ADC 的許可、將 FYARRO 剝離給 Kaken Pharmaceuticals，以及 1 億美元的 PIPE 融資，這些融資隨後在上個月的特別股東大會上獲得批准。

As a next step in our evolution Aadi Biosciences is now divided into two organizations. Upon the divestiture of Aadi's subsidiary to Kaken. Kaken will assume ownership of the Aadi name, trademark, and the FYARRO business. And today, Aadi Parent Company, relaunches as Whitehawk Therapeutics, formalizing our transition into an ADC-focused company.

隨著我們發展的下一步，Aadi Biosciences 現已分為兩個組織。在 Aadi 的子公司剝離給 Kaken 之後。Kaken 將擁有 Aadi 名稱、商標和 FYARRO 業務的所有權。今天，Aadi 母公司更名為 Whitehawk Therapeutics，正式轉型為專注於 ADC 的公司。

While we remain rooted in our legacy, that is to make bold choices in applying technology to deliver improved precision oncology therapies, Whitehawk carries several important distinctions. As Aadi, we were focused on mTOR inhibition in rare cancer settings and were built on the foundation of a single commercial product. Conversely, Whitehawk is focused on rapidly progressing a multi-asset portfolio of advanced ADC therapy, all with the broad potential to make a meaningful difference in a large number of different cancer populations.

雖然我們仍然根植於我們的傳統，即在應用技術以提供改進的精準腫瘤治療方面做出大膽的選擇，但 Whitehawk 具有幾個重要的區別。作為 Aadi，我們專注於罕見癌症環境中的 mTOR 抑制，並以單一商業產品為基礎。相反，Whitehawk 專注於快速推進先進 ADC 療法的多資產組合，這些療法都具有對大量不同癌症人群產生重大影響的廣泛潛力。

Turning to slide 6, as Whitehawk, we developed a framework that establishes a clear value proposition and investment thesis as an ADC company. Firstly, we are building on the foundation of established tumor biology. We are deliberate in identifying promising tumor targets that are both clinically validated and broadly overexpressed.

翻到投影片 6，作為 Whitehawk，我們發展了一個框架，確立了作為 ADC 公司的明確價值主張和投資論點。首先，我們正在建立腫瘤生物學的基礎。我們特意尋找經過臨床驗證且廣泛過度表達的有前景的腫瘤標靶。

By leveraging clinical validation, we know we have drug-able tumor targets. And because these targets are broadly overexpressed, we can apply them to high-potential cancer indications with significant patient populations and unmet needs.

透過臨床驗證，我們知道我們有可用藥物的腫瘤標靶。由於這些標靶被廣泛過度表達，我們可以將它們應用於具有大量患者和未滿足需求的高潛力癌症適應症。

While first-generation ADCs offered significant advances for patients, we know they were hindered by limitations largely driven by lack of therapeutic index. To overcome these challenges, we are applying an advanced ADC platform technology that is engineered for minimal off-target toxicity, greater stability and higher therapeutic index compared to first-generation predecessors.

雖然第一代 ADC 為患者帶來了重大進展，但我們知道它們受到了很大程度上由治療指數不足造成的限制。為了克服這些挑戰，我們正在應用一種先進的 ADC 平台技術，與第一代產品相比，該技術旨在最大限度地減少脫靶毒性、提高穩定性並提高治療指數。

Lastly, we are hyper focused on speed and efficiency to major data inflections. We are rapidly advancing our portfolio to the clinic with INDs for all three candidates anticipated in the next 15 months. So what are these candidates?

最後，我們高度關注主要數據變化的速度和效率。我們正在迅速推進我們的產品組合，並預計在未來 15 個月內為所有三種候選藥物提交 IND 申請。那麼這些候選人是誰呢？

Looking at slide 7, our portfolio consists of three assets focused on validated tumor targets. HWK-007 targets protein tyrosine kinase 7 or PTK7. PTK7 is an oncofetal pseudokinase that drives early embryonic development.

從投影片 7 可以看出，我們的投資組合由三種專注於已驗證的腫瘤目標的資產組成。HWK-007 標靶蛋白酪胺酸激酶 7 或 PTK7。PTK7 是一種驅動早期胚胎發育的癌胎假激酶。

Subsequently as minimally expressed in adult tissues but becomes highly overexpressed in a broad range of tumors as they arise. There are no approved PTK7 ADCs, though it is becoming a popular target for research given this broad and deep overexpression in multiple cancers.

隨後在成人組織中最低限度表達，但在多種腫瘤出現時變得高度過度表達。儘管 PTK7 ADC 尚未獲得批准，但鑑於其在多種癌症中廣泛而深入的過度表達，它正成為一種熱門的研究目標。

HWK-016 is the only known ADC that targets the membrane-bound portion of MUC16, a glycoprotein with low level of expression in normal adult tissues, but often overexpressed and even shed from tumors of female origin, including ovarian cervical and endometrial cancers.

HWK-016 是已知的唯一一種針對 MUC16 膜結合部分的 ADC，MUC16 是一種在正常成人組織中表達水平較低的糖蛋白，但經常在女性來源的腫瘤（包括子宮頸癌和子宮內膜癌）中過度表達甚至脫落。

Shed MUC16, better known as CA125 is a biomarker for cancer screening and disease monitoring, especially in ovarian cancer. So MUC16 is a widely utilized and clinically validated target for ovarian cancer and was previously studied as an ADC target by Genentech, who had two different ADCs against MUC16.

脫落的 MUC16，更廣為人知的名稱是 CA125，是癌症篩檢和疾病監測的生物標記物，尤其是在卵巢癌中。因此，MUC16 是廣泛使用且經過臨床驗證的卵巢癌靶點，先前曾被 Genentech 作為 ADC 標靶進行研究，該公司針對 MUC16 有兩種不同的 ADC。

And we have HWK-206, which is designed to address the neuronal target seizure protein 6 or SEZ6. SEZ6 is a CNS limited protein overexpressed in tumors of neuroendocrine origins, most prominent example includes small cell lung cancer.

我們有 HWK-206，旨在解決神經元靶向癲癇蛋白 6 或 SEZ6。SEZ6 是一種中樞神經系統受限蛋白，在神經內分泌來源的腫瘤中過度表達，最突出的例子是小細胞肺癌。

Small cell lung cancer is an aggressive high-grade neuroendocrine carcinoma, which limited targeted their treatment options exist and class competition is limited. To our knowledge, AbbVie is the -- has the only SEZ6 ADC currently in development.

小細胞肺癌是一種侵襲性較高的高級別神經內分泌癌，其針對性的治療選擇有限，同類競爭也有限。據我們所知，AbbVie 是目前唯一正在開發的 SEZ6 ADC。

Underlying each of these programs is the advanced ADC technology platform developed by HANGZHOU DAC, known as CPT113. This advanced ADC architecture is based on the novel TOPO1 payload and a highly stable linker chemistry. Though not part of this portfolio, it's important to note that HANGZHOU DAC has two internally develop programs utilizing the exact same platform, DXC006 and DXC1002, these had successful INDs and are currently in dose escalating Phase I clinical trials in China.

這些計畫的基礎是杭州DAC開發的先進ADC技術平台，稱為CPT113。這種先進的 ADC 架構是基於新型 TOPO1 有效載荷和高度穩定的連接化學。雖然不屬於該產品組合的一部分，但值得注意的是，杭州 DAC 有兩個利用完全相同平台的內部開發項目 DXC006 和 DXC1002，這兩個項目都已成功獲得 IND，目前正在中國進行劑量遞增的 I 期臨床試驗。

Turning to slide 8. As you can see, we're working toward rapidly filing INDs with a plan to submit all three INDs in 15 months, as I said. To reiterate, these assets are designed to target proteins that are broadly expressed across multiple tumor types with significant unmet needs.

翻到幻燈片 8。正如您所看到的，我們正在努力快速提交 IND，並計劃在 15 個月內提交所有三個 IND，正如我所說的那樣。需要重申的是，這些資產旨在針對廣泛表達於多種腫瘤類型且存在大量未滿足需求的蛋白質。

This slide highlights the cancer indications where these targets have established clinical data from previous ADCs and also shows the numerous expansion opportunities showcasing the substantial market potential of the entire portfolio.

這張投影片重點介紹了這些目標已從先前的 ADC 建立的臨床數據的癌症適應症，同時也展示了眾多擴展機會，展示了整個產品組合的巨大市場潛力。

Starting with HWK-007, this candidate represents a different opportunity -- sorry, differentiated opportunity potentially be among the first wave ADCs in clinical development for high-expressing PTK7 cancers. HWK-007 is currently being evaluated in IND-enabling studies. The Phase I trial is planned for non-small cell lung cancer and platinum-resistant ovarian cancer with the potential to spend into novel indications, including the full range of gastrointestinal in gynecological cancers.

從 HWK-007 開始，這個候選藥物代表著不同的機會——抱歉，差異化機會可能成為高表達 PTK7 癌症臨床開發中的第一波 ADC 之一。HWK-007 目前正在接受 IND 支持研究評估。此 I 期試驗計劃針對非小細胞肺癌和鉑耐藥性卵巢癌，並有可能用於新的適應症，包括婦科癌症的全部胃腸道疾病。

HWK-016 targeting membrane-bound MUC16 is currently being evaluated in IND-enabling study. The Phase I trial is planned in ovarian cancer with the potential to expand in additional indications such as endometrial, cervical, and pancreatic cancers. HWK-206 starting SEZ6 is currently in candidate selection, the Phase I trials planted in small cell lung cancer and neuroendocrine neoplasias where there are limited treatment options today.

針對膜結合 MUC16 的 HWK-016 目前正在 IND 支持研究中進行評估。此 I 期試驗計劃針對卵巢癌進行，並有可能擴展到子宮內膜癌、子宮頸癌和胰腺癌等其他適應症。從 SEZ6 開始的 HWK-206 目前處於候選藥物篩選階段，其 I 期試驗針對的是目前治療選擇有限的小細胞肺癌和神經內分泌腫瘤。

Turning now to more detail on the platform on slide 9. First-generation ADCs were challenged by the high free payload release in circulation, limiting their therapeutic window as high free payload can generate significant off-target side effects.

現在轉到幻燈片 9 上有關平台的更多細節。第一代 ADC 面臨的挑戰是循環中高自由有效載荷的釋放，限制了它們的治療窗口，因為高自由有效載荷會產生顯著的脫靶副作用。

Advanced ADC platforms that are in development today, including the CPT113 platform we utilize across our portfolio, are improving on the limitations of first-generation platforms by engineering three critical components: one, payload. We use TOPO -- a proprietary TOPO1 inhibitor payload that minimizes off-target effects and supports higher therapeutic index; two, linker design. We use a highly stable cleavable linker that supports low free payload release in circulation; and three, pharmacokinetics profile, the ability to support higher DAR with an enhanced PK profile enables optimal dosing.

目前正在開發的先進 ADC 平台（包括我們在整個產品組合中使用的 CPT113 平台）透過設計三個關鍵組件來改進第一代平台的限制：一是有效載荷。我們使用TOPO——一種專有的TOPO1抑制劑有效載荷，可最大限度地減少脫靶效應並支持更高的治療指數；二、接頭設計。我們使用高度穩定的可裂解連接體，支持循環中低自由有效載荷的釋放；第三，藥物動力學特性，支持更高 DAR 的能力以及增強的 PK 特性可實現最佳劑量。

The right-hand side of this slide highlights the generalized concept of therapeutic index improvements that you can expect by implementing an advanced ADC platform as compared to first-generation ADCs. With advanced ADC platforms, we're expanding the lower bound of the minimally effective dose with more potent targeting and increasing the upper bound of maximally tolerated dose with optimized payloads. We, thereby, are increasing the potential dose intensity for which we can treat patients and improve efficacy.

這張投影片的右側重點介紹了與第一代 ADC 相比，透過實施先進的 ADC 平台可以預期的治療指數改善的一般概念。借助先進的 ADC 平台，我們正在透過更有效的靶向性擴大最低有效劑量的下限，並透過優化的有效載荷提高最大耐受劑量的上限。因此，我們正在增加治療患者的潛在劑量強度並提高療效。

To further illustrate this point, let's turn to the next slide. On slide 10, you can see that we are looking at examples of how a switch from first-generation ADC platform delivers substantial efficacy gains in real-world examples. I won't go through all of these, but as you can see it, agnostic to target or indication, switching from an older platform to advanced ADC technology platform generated notable objective response rate gains ranging from 16 to 45 ORR point improvement.

為了進一步說明這一點，我們來看下一張投影片。在第 10 張投影片上，您可以看到我們正在研究從第一代 ADC 平台轉換如何在現實世界中帶來顯著的功效提升的範例。我不會詳細介紹這些，但正如您所見，無論目標或指示如何，從舊平台切換到先進的 ADC 技術平台都會產生顯著的客觀響應率提升，範圍從 16 到 45 ORR 點的提高。

On average, we see a 30-point improvement in the typical switch. This along -- this is alongside coinciding with notable improvement in durability of response, thereby advanced ADC platforms have the potential to disrupt the standard of care for treatment options today and have demonstrated the ability to help many more patients by increasing response rates and time line therapy.

平均而言，我們看到典型的轉變帶來了 30 點的改善。同時，反應持久性的顯著改善也隨之而來，因此先進的 ADC 平台有可能顛覆當今治療方案的護理標準，並已證明能夠透過提高反應率和時間線治療來幫助更多的患者。

So now if we move to slide 11, we can apply this example to our own portfolio. Starting with PTK7 and share why specifically we're so excited about the potential of our assets. We want to start with the fact that PTK7 has precedented data from Pfizer's first-gene MMAE-based ADC, cofetuzumab pelidotin. Response rates seen in Phase I trials were across a range of tumor types tested, including ovarian, lung, which are shown here.

現在如果我們轉到投影片 11，我們可以將這個範例應用到我們自己的投資組合中。從 PTK7 開始，分享為什麼我們對資產的潛力如此興奮。首先我們要說明的是，PTK7 已獲得輝瑞基於第一基因 MMAE 的 ADC cofetuzumab pelidotin 的先例數據。第一階段試驗中所觀察到的反應率涵蓋了多種受試腫瘤類型，包括卵巢癌、肺癌，如下所示。

Response rates were particularly robust in moderate and high expressing groups with ORR up to 46%. Despite these encouraging signals, co-compete was limited by the reduced dose intensity in narrow therapeutic index driven by toxicities consistent with class effects from the first-generation payload MMAE. So what happens if we apply an advanced ADC platform to this validated tumor target?

中度和高表達組的反應率尤其高，ORR 高達 46%。儘管存在這些令人鼓舞的信號，但由於與第一代有效載荷 MMAE 的類效應一致的毒性導致治療指數較窄，劑量強度降低，共同競爭受到限制。那麼，如果我們將先進的 ADC 平台應用於這個已驗證的腫瘤標靶，會發生什麼事？

On slide 12, what these graphs represent is first placement of the Phase I cofe-p data in the context of currently approved late-stage ADC benchmarks for efficacy in lung and ovarian cancer. HWK-007 is a PTK7 switch to an advanced platform. And therefore, if we extrapolate from prior examples, we may expect to generate efficacy gains of 15% to 30%, points more in objective response rate over cofe-p. This level of improvement will be disruptive to first-generation ADC standards of care in lung and ovarian cancer.

在第 12 張投影片上，這些圖表代表的是將 I 期 cofe-p 數據首次放置在目前核准的肺癌和卵巢癌後期 ADC 療效基準的背景下。HWK-007 是 PTK7 切換到進階平台。因此，如果我們根據先前的例子推斷，我們可能會期望產生 15% 到 30% 的功效增益，客觀反應率比 cofe-p 高出幾個點。這種程度的改善將會顛覆第一代 ADC 在肺癌和卵巢癌治療中的標準。

In both indications, we believe they have an opportunity to significantly surpass the established ADC efficacy bar, representing a meaningful clinical benefit to patients. And this is just the example for HWK-007 and PTK7. We expect similar improvements with our other two programs, which also take advantage of tumor targeting advances in addition to the advanced ADC platform switch, like we show here. We are enthusiastic about the potential of our portfolio and look forward to getting into the clinic quickly.

在這兩種適應症中，我們相信它們都有機會顯著超越既定的 ADC 療效標準，為患者帶來有意義的臨床益處。這只是 HWK-007 和 PTK7 的範例。我們期望我們的另外兩個項目也能取得類似的改進，除了先進的 ADC 平台轉換之外，它們還利用了腫瘤靶向進展，就像我們在這裡展示的那樣。我們對我們的產品組合的潛力充滿熱情，並期待著迅速進入臨床階段。

With that, I'll now turn it over to Scott for updates on our financial progress. Scott?

好了，現在我將把時間交給史考特，讓他報告我們的財務進展。史考特？

Thanks, Dave. Moving to slide 14. We ended 2024 with $47.2 million in cash, cash equivalents and short-term investments. Following the close of our recent 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 ADC license agreement. We anticipate that cash will fund operations into [2028] based on current plans.

謝謝，戴夫。移至投影片 14。截至 2024 年，我們擁有 4,720 萬美元的現金、現金等價物和短期投資。在我們最近的策略交易結束後，我們預計現金和現金等價物將在 1.7 億美元至 1.8 億美元之間，其中包括根據 ADC 許可協議支付的預付款和早期里程碑款項。根據目前的計劃，我們預計現金將為 [2028] 年的營運提供資金。

FYARRO net product sales were $7.2 million for the fourth quarter, representing 14% growth over the prior year quarter. Full year FYARRO sales were $26 million, an increase of 7% over 2023. Research and development expenses for the quarter increased to $14.3 million compared to $12.8 million in the prior year quarter.

FYARRO 第四季淨產品銷售額為 720 萬美元，比去年同期成長 14%。FYARRO 全年銷售額為 2,600 萬美元，比 2023 年成長 7%。本季研發費用增至 1,430 萬美元，去年同期為 1,280 萬美元。

For the year, R&D expense amounted to $51 million compared to $48.9 million last year. This increase is driven mainly by in-process R&D expenses of $6 million related to the recently acquired ADC programs, offset in part by reductions in clinical expenses, personnel, and other expenses.

今年的研發費用為 5,100 萬美元，而去年為 4,890 萬美元。這一增長主要得益於最近收購的 ADC 項目相關的 600 萬美元在研研發費用，但臨床費用、人員和其他費用的減少部分抵消了這一增長。

Selling, general and administrative expenses for the fourth quarter were $11.1 million compared to $10.3 million in the same period in 2023. This increase was due mainly to increased legal and consulting expenses offset in part by lower commercial expenses. For the year, SG&A expenses decreased to $36.7 million compared to $44.5 million in the prior year, driven primarily by reductions in commercial and personnel expenses. Operating expenses for the year included $2.6 million of restructuring costs. Net loss for the fourth quarter was $18.3 million compared to $16.3 million in the fourth quarter of 2023. Net loss for the year was $63.7 million compared to $65.8 million in the prior year.

第四季銷售、一般及行政開支為 1,110 萬美元，而 2023 年同期為 1,030 萬美元。這一增長主要是由於法律和諮詢費用的增加，但商業費用的降低部分抵消了這一增長。本年度，銷售、一般及行政費用由上年度的 4,450 萬美元降至 3,670 萬美元，主要由於商業和人事費用的減少。本年度的營運費用包括 260 萬美元的重組成本。第四季淨虧損為 1,830 萬美元，而 2023 年第四季淨虧損為 1,630 萬美元。全年淨虧損為 6,370 萬美元，而上年為 6,580 萬美元。

I'll now hand the call back over to Dave for his closing comments. Dave?

我現在將電話轉回給戴夫，請他發表最後評論。戴夫？

Thanks, Scott. Looking to slide 16. We are enormously excited about the potential of Whitehawk to make a transformative impact to patients with our portfolio. We're advancing three clinically validated tumor targets using next-generation ADC technology with the goal of outperforming first-generation predecessors. With a focus on high potential indications, we aim to file three US INDs within 15 months. And we're well positioned to fund operations, as Scott said, into 2028, covering anticipated clinical inflections.

謝謝，斯科特。請參閱第 16 張投影片。我們對 Whitehawk 利用我們的產品組合為患者帶來變革性影響的潛力感到非常興奮。我們正在利用下一代 ADC 技術來推進三個經過臨床驗證的腫瘤靶點，目標是超越第一代技術。我們專注於高潛力適應症，目標是在 15 個月內提交三項美國 IND。正如斯科特所說，我們已做好準備，為 2028 年的營運提供資金，以應對預期的臨床變化。

Importantly, Whitehawk is backed by an outstanding veteran team. I'm also pleased to say this includes our recent addition of David Dornan, who joined us as Chief Scientific Officer. Many of you will know David, as the former CSO of Elevation Oncology. David contributes more than two decades of experience in oncology drug, discovery, and development with deep expertise in ADCs and other targeted cancer therapies.

重要的是，Whitehawk 擁有一支優秀的資深團隊作為後盾。我也很高興地說，其中包括我們最近加入的 David Dornan，他以首席科學官的身份加入我們。你們中的許多人可能都知道 David，他是 Elevation Oncology 的前任首席策略長。David 在腫瘤藥物研發領域擁有超過二十年的經驗，在 ADC 和其他標靶癌症療法方面擁有深厚的專業知識。

He has a successful track record of separating drugs from discovery stage through the clinic for advanced modalities, including ADCs, encompassing numerous INDs, NDAs and BLAs. His experience at Elevation is particularly relevant as the spearhead of the company's strategic pivot towards a portfolio of ADCs. We welcome David, and glad he is able to join us on the call today.

他曾成功地將藥物從發現階段分離到臨床階段，用於先進的治療模式，包括 ADC，涵蓋眾多 IND、NDA 和 BLA。他在 Elevation 的經歷對於引領公司向 ADC 組合策略轉型具有重要意義。我們歡迎大衛，很高興他今天能參加我們的電話會議。

With that, I'll open the call for questions.

現在，我將開始回答問題。

(Operator Instructions)

（操作員指示）

Tara Bancroft, TD Securities.

塔拉·班克羅夫特（Tara Bancroft），道明證券。

Hi, this is Greg Wesner on for Tara Bancroft. So considering that Regeneron is developing a Mucin 16 targeted bispec antibody for ovarian, how do you anticipate that the clinical activity and safety profile of your ADC might compare to the bispecific approach within this indication? Thank you.

大家好，我是 Greg Wesner，代表 Tara Bancroft 報道。因此，考慮到 Regeneron 正在開發一種針對卵巢的 Mucin 16 靶向雙特異性抗體，您如何預期您的 ADC 的臨床活性和安全性與該適應症中的雙特異性方法相比如何？謝謝。

Super. Thanks, Greg, for stepping in for Tara, and thanks for the question. I'll start a little bit and then turn it over to David for his comments since he is an expert in this target. I mean the first concept is, obviously, ADCs and bispecific TCEs are very different modalities in terms of their mechanism.

極好的。謝謝格雷格代替塔拉發言，也謝謝你提出這個問題。我將先講一點，然後交給 David 徵求他的意見，因為他是這個目標的專家。我的意思是，第一個概念顯然是，ADC 和雙特異性 TCE 在機制方面是非常不同的模式。

Certainly, there's commonality in the tumor targeting. And we're encouraged by the fact that Regeneron uses the same targeting approach to the membrane-bound type MUC16. But obviously, as a TCE that is targeting an immune modulating response, which will be very different from an ADC chemo-based response that we're developing here.

當然，在腫瘤靶向方面存在著共同點。令我們感到鼓舞的是，Regeneron 對膜結合型 MUC16 採用了相同的標靶方法。但顯然，作為一種針對免疫調節反應的 TCE，它與我們在此開發的基於 ADC 化學的反應非常不同。

We think both are complementary and important options for patient treatment regardless of the tumor target here. So we don't necessarily have a direct comparison we would highlight for this indication, but we do, obviously, pay close attention to that program. But David, do you want to say a little more about MUC16?

我們認為，無論腫瘤目標是什麼，這兩者都是患者治療的互補和重要選擇。因此，我們不一定會針對這一跡象進行直接的比較，但我們顯然會密切關注該計劃。但大衛，你想多說一點關於 MUC16 的事情嗎？

Yes, sure. I think this is what is fair to say with respect to targeting, obviously, the membrane portion that we're targeting MUC16 certainly makes it help avoid antigen [sync], as Dave has mentioned in the presentation. And with respect to the different modalities of targeting, I think you specifically asked about the CD3 redirection approach. I think it's fair to say like a CD3 redirection approach, sometimes they have challenges with like a cytokine release like syndrome.

是的，當然。我認為就標靶性而言，這是公平的說法，顯然，我們針對 MUC16 的膜部分肯定有助於避免抗原 [同步]，正如 Dave 在演講中提到的那樣。關於不同的目標定位方式，我想您特別詢問的是 CD3 重定向方法。我認為可以公平地說，像 CD3 重定向方法一樣，有時他們會面臨像細胞激素釋放症候群這樣的挑戰。

So obviously, as a cytotoxic ADC, we don't have the same AE problems in that realm. But obviously, with our ADC, cytox ADCs, they certainly have their own profiles, but the promise of our technology using our stable linker technology really will mitigate that potential risk. And so that's how we feel that positioning wise that this ADC will certainly be differentiated from a CD3 redirected, but largely would have significant gains and efficacy, as Dave already mentioned.

因此顯然，作為細胞毒性 ADC，我們在該領域不會遇到相同的 AE 問題。但顯然，我們的 ADC、Cytox ADC 肯定有自己的特性，但我們使用穩定連接技術的技術前景確實會減輕這種潛在風險。因此，我們認為從定位上看，這個 ADC 肯定會與 CD3 重定向有所區別，但在很大程度上會有顯著的收益和功效，正如 Dave 已經提到的那樣。

Thanks, David. Operator, next question.

謝謝，大衛。接線員，下一個問題。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Hi, good morning. Thanks for taking my question. This is Liang Cheng on for Roger. First, congrats on the new chapter. So I guess, question from us. One is on the three targets. So understanding the prevalence there. So maybe could you help us understanding about the distribution of the high, medium, low expression levels for each of these three targets. And the second question is about the financials. So understanding about 2028 runway. So does that cover all the three Phase I studies? Thank you.

嗨，早安。感謝您回答我的問題。梁成代表羅傑發言。首先，祝賀新篇章的到來。所以我想，這是我們的問題。一是三個目標。因此了解那裡的流行情況。所以也許您能幫助我們了解這三個目標中高、中、低表現量的分佈。第二個問題是關於財務的。所以了解一下 2028 年的跑道。那麼這涵蓋了所有三個第一階段的研究嗎？謝謝。

Liang, thanks again. Thanks for joining the call. Good to hear from you again. And thanks for the questions. So on the first question, in terms of the prevalence, obviously, there's a lot of data to cover in context. What we would say is that, first on PTK7, it is one of the most broadly overexpressed tumor targets in development today. And so it impacts a large portion of patients who develop cancer overall, very highly expressed target, also a broad range of [tumor].

梁，再次感謝你。感謝您參加電話會議。很高興再次收到您的來信。感謝您的提問。因此，關於第一個問題，就流行程度而言，顯然需要涵蓋大量數據。我們想說的是，首先是 PTK7，它是當今開發中最廣泛過度表達的腫瘤標靶之一。因此，它影響了很大一部分患有癌症的患者，整體而言，它影響了表達水平非常高的目標，也影響了廣泛的[瘤]。

What we really like about this target is that when it is expressed in patients, it's often expressed at a moderate to high level. So we'll generally find that the majority of patients who express PTK7 do so across different [cancers], which we know correlates with potential for improved responses as patients who have higher expression generally responding better. And so we're really encouraged by both of those, the broad expression of PTK7, but also the relatively deep impression that we see in individual patients, a high proportion of patients that potentially could respond very well to therapy.

我們真正喜歡這個目標的原因是，當它在患者體內表達時，它通常以中等到高的水平表達。因此，我們通常會發現，大多數表達 PTK7 的患者都患有不同的 [癌症]，我們知道這與改善反應的可能性相關，因為表達量較高的患者通常反應較好。因此，我們確實對這兩者都感到鼓舞，PTK7 的廣泛表達以及我們在個別患者身上看到的相對較深的印象，很大比例的患者可能對治療有很好的反應。

On MUC16, it's a similar story. But I think in MUC16 case, we really have an advantage that MUC16 is a tumor target that tends to increase as the disease progresses and so higher expression is often associated with worse disease, and that is -- allows us to really target the patients who are most in need of care.

在 MUC16 上也有類似的故事。但我認為在 MUC16 案例中，我們確實有一個優勢，即 MUC16 是一個腫瘤靶點，它會隨著疾病的進展而增加，因此更高的表達通常與更嚴重的疾病相關，這使我們能夠真正針對最需要護理的患者。

And secondly, with the circulating CA125, we have a proxy for expression across patients rather than looking at IHC-based expression, we can also screen patients using circulating CA125 biomarker. And so we think, in this case, we really have both this high-level compression, particularly across gynecological cancers, deep expression overall, and ability to monitor that from (inaudible)

其次，透過循環 CA125，我們可以獲得患者表達的代理，而不是查看基於 IHC 的表達，我們也可以使用循環 CA125 生物標記來篩檢患者。因此，我們認為，在這種情況下，我們確實擁有這種高水平的壓縮，特別是在婦科癌症方面，總體深度表達，以及從（聽不清楚）

And then SEZ6. SEZ6 is highly impressed across a broad range of -- well, across the full range of small cell lung cancer. And this has already been typified by AbbVie's program where they're actually not selecting patients with extremely high response rates for non-selected small cell lung cancer patients on that SEZ6.

然後是 SEZ6。SEZ6 對各種小細胞肺癌都表現出了極高的評價。這已經是 AbbVie 計畫的典型代表，他們實際上並沒有選擇 SEZ6 上未經選擇的小細胞肺癌患者俱有極高反應率的患者。

So overall, I think these are not only really interesting targets for the fact that they have key roles in each of these indications, but they're highly and deeply expressed across the vast majority of patients (inaudible) and as well, as we mentioned before, are not yet so competitive, like the TROP2 area or Claudin18.2 or other areas that we believe would be first or second to market on each of these indications or each of these targets.

所以總的來說，我認為這些不僅是真正有趣的目標，因為它們在每種適應症中都發揮著關鍵作用，而且它們在絕大多數患者中都具有高度和深度的表達（聽不清），而且正如我們之前提到的，它們還沒有那麼有競爭力，比如 TROP2 區域或 Claudin18.2 或我們認為在每個適應症或每個目標上首先進入市場的其他區域。

And then your second question on data availability. Our goal is to get meaningful clinical Phase I data for all three programs under the current funding that will obviously be slightly different amounts of data for each program, just given that they are staggered by a few months each. But ultimately, our goal in establishing Whitehawk as we did and capital as it is was to ensure that we would generate that meaningful clinical data before our next go back to the market for additional financing.

然後您的第二個問題是關於數據可用性。我們的目標是在現有資金的支持下為所有三個項目獲取有意義的臨床 I 期數據，由於每個項目的時間相隔幾個月，因此每個項目的數據量顯然會略有不同。但最終，我們建立 Whitehawk 的目標和資本是為了確保我們能夠在下次重返市場尋求額外融資之前產生有意義的臨床數據。

Thanks for the question. Operator, next question.

謝謝你的提問。接線員，下一個問題。

I show no further questions at this time in the queue. I would like to turn the call back to Dave for closing remarks.

目前隊列中沒有其他問題。我想將電話轉回給戴夫，請他做最後發言。

Thank you, operator, and thank you to the team and everyone who joined us on the call today. We are really excited about the launch of Whitehawk Therapeutics, a new ADC company out of the transformation we've just performed with Aadi Bioscience.

謝謝接線員，也感謝團隊和今天參加我們電話會議的所有人。我們對 Whitehawk Therapeutics 的成立感到非常興奮，這是一家新的 ADC 公司，是我們剛與 Aadi Bioscience 合作完成轉型後成立的。

We reiterate these three clinically validated broadly overexpressed tumor targets are leveraging an advanced ADC linker payload architecture with key features that we believe will allow us to outperform first-generation ADCs.

我們重申，這三個經過臨床驗證的廣泛過度表現的腫瘤標靶正在利用先進的 ADC 連接體有效載荷架構，其關鍵特性我們相信將使我們超越第一代 ADC。

We're moving quickly, targeting filing of three US INDs in the next 15 months, including HWK-007 in the second half of 2025, and HWK-016 by the end of this year. With our experienced team and collaborative partners, we are singularly focused on executing to ensure these goals are met. Lastly, upon closing, we expect we will capitalize. And as I mentioned, we have cash to fund our operations into 2028 and with anticipated key clinical data. So thank you for joining us for this introduction of Whitehawk Therapeutics and have a great day.

我們正在快速行動，目標是在未來 15 個月內提交三項美國 IND，包括 2025 年下半年的 HWK-007 和今年年底的 HWK-016。我們擁有經驗豐富的團隊和合作夥伴，專注於執行以確保實現這些目標。最後，我們預期在交易完成後能夠實現資本化。正如我所提到的，我們有足夠的現金來資助我們到 2028 年的運營，並獲得預期的關鍵臨床數據。感謝您參加 Whitehawk Therapeutics 的介紹，祝您有個愉快的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。