Summary of Whitehawk Therapeutics Fireside Chat - June 26, 2025 Company Overview - Whitehawk Therapeutics, formerly known as Adi Bioscience, underwent a transformation completed in Q1 2025, focusing on developing an advanced ADC (antibody-drug conjugate) portfolio after selling its mTOR inhibitor product to Kaken Pharmaceuticals for $100 million [3][4][15]. Pipeline and Technology - The company is developing a three-asset ADC portfolio targeting various cancers, including lung, ovarian, and gastrointestinal cancers, with a focus on established tumor biology and clinically validated tumor markers [4][5][14]. - All three programs are currently in preclinical stages, with IND (Investigational New Drug) filings anticipated by mid-2026 [6][13]. - The ADC platform utilizes a linker payload technology designed for greater stability, reduced off-target toxicity, and improved therapeutic index [5][12][13]. Key Programs 1. **HAWK 007 (PTK7-targeted ADC)** - PTK7 is broadly overexpressed in various solid tumors, with expression rates of 60-70% in cancer patients [20][21]. - The program aims to demonstrate differentiation from previous compounds, with a focus on lung cancer, ovarian cancer, and triple-negative breast cancer [24][26]. - Initial phase one trials will target patients with moderate to high expression of PTK7, aiming for a minimum response rate of 40% in lung cancer and 50% in ovarian cancer [56]. 2. **HAWK 016 (MUC16-targeted ADC)** - MUC16 is a circulating biomarker in ovarian cancer, with the approach focusing on targeting the membrane-bound portion to avoid complications from circulating biomarkers [60][63]. - The program will initially focus on gynecological cancers, with potential expansion into pancreatic and non-small cell lung cancers in the future [70]. 3. **HAWK 206 (SEZ6-targeted ADC)** - This program is in the early stages, with a biparatopic approach aimed at enhancing internalization and efficacy in neuroendocrine tumors and small cell lung cancer [71][78]. Competitive Landscape - The ADC market is competitive, with other companies like Zymeworks and Day One Pharmaceuticals developing next-generation ADCs. Whitehawk believes its platform offers superior optimization in terms of linker stability, hydrophilicity, and therapeutic index [36][46]. - The company aims to differentiate its products by demonstrating better efficacy and safety profiles compared to existing therapies [30][46]. Financial Position and Future Outlook - Whitehawk started Q2 2025 with approximately $185 million in cash, providing operational runway into early 2028 to generate clinical data before seeking additional funding [88][90]. - The company plans to release more preclinical data in 2026, focusing on a comprehensive view of its products' potential before public disclosures [89][90]. Conclusion - Whitehawk Therapeutics is positioned to make significant advancements in the ADC space with its innovative platform and targeted therapies. The upcoming IND filings and clinical trials will be critical in validating its approach and establishing its market presence.

Whitehawk Therapeutics (AADI) 2025 Conference June 04, 2025 02:00 PM ET Speaker0 Alright. Alright. Welcome everyone to Jefferies twenty twenty five global health care conference. My name is Roger Song, one of the senior analysts covers MiCA Biotech in The US. It's my pleasure to have to introduce our next printing company, Whitehawk Therapeutics, and then CEO, Dave. And then it will be a presentation. And then if we have some time to do a q and a, we'll save that toward the end. Dave? Speaker1 Well, thank y ...

Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company Name**: Whitehawk Therapeutics - **Background**: Whitehawk Therapeutics was formed from the previous company Adi Biosciences, which commercialized an mTOR inhibitor called Fiaro, generating approximately $25 million in annual sales in the US. The company underwent a transformation by selling Fiaro to a Japanese pharmaceutical company and raised about $250 million to license a portfolio of antibody-drug conjugates (ADCs) for oncology treatments [4][5][6]. Core Points and Arguments - **Focus on Oncology**: Whitehawk is focused on developing a portfolio of ADCs for various cancers, marking its first participation in the ASCO conference as a newly branded entity [4][6]. - **Strategic Partnerships**: The company partnered with WuXi Biologics and Hangzhou DAC to access innovative ADC platforms, paying $44 million upfront for three next-generation ADC assets [10][12]. - **Technology Differentiation**: The ADC platform is differentiated by its targeting approach, linker system, and payload delivery, which are optimized for stability and efficacy [15][16][20]. - **Clinical Development**: Whitehawk plans to bring its ADC portfolio into clinical trials over the next year, with IND filings for three ADCs (HAWK007, MUC16, and SCC6) planned in rapid succession [6][41][42]. Important Insights - **Market Opportunity**: There is significant unmet need in the oncology space, particularly for patients with EGFR wild-type lung cancer, where ADCs have not yet made substantial inroads [28][30]. - **Precedent Data**: The three ADC targets (PTK7, MUC16, and SCC6) have shown promising efficacy signals in previous programs, which were discontinued due to safety concerns with first-generation ADCs [39][40]. - **Potential for Best-in-Class**: Whitehawk believes its next-generation ADCs can outperform existing therapies, with the potential for improved overall response rates and progression-free survival [46][51]. - **Focus on Specific Indications**: The company aims to build on existing data by focusing on specific indications, such as lung and ovarian cancer, rather than a broad approach, to demonstrate efficacy [50][51]. Additional Noteworthy Content - **Clinical Experience**: Early data from Hangzhou DAC's internal programs indicate good tolerability and potency, which supports Whitehawk's investment in this platform [32][33]. - **Payload Variations**: The company is utilizing a proprietary topoisomerase inhibitor payload, which is believed to have a better safety profile compared to existing options [25][26]. - **Future Directions**: Whitehawk is considering expanding its focus to include endometrial cancer due to high expression levels of PTK7 and unmet medical needs in that area [52][53]. This summary encapsulates the key points discussed during the conference call, highlighting Whitehawk Therapeutics' strategic direction, technological innovations, and market opportunities in the oncology sector.

Corporate Presentation May 2025 Forward-Looking Statements Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to plac ...

Financial Performance - FYARRO generated net product sales of $7.1 million for Q1 2025, compared to $5.4 million in Q1 2024, reflecting a 31.6% year-over-year increase[153]. - The company recorded net income of $73.0 million for the three months ended March 31, 2025, primarily due to a gain on the sale of FYARRO, compared to a net loss of $18.3 million for the same period in 2024[179][187]. - Product sales for FYARRO were $7.1 million for the three months ended March 31, 2025, an increase of $1.7 million from $5.4 million in the same period in 2024, driven by stronger demand[180]. - Total operating expenses decreased to $22.4 million for the three months ended March 31, 2025, from $24.9 million in the same period in 2024[179]. - Research and development expenses decreased to $8.8 million for the three months ended March 31, 2025, down from $13.6 million in 2024, primarily due to reduced personnel and clinical development costs[183]. - Selling, general and administrative expenses increased to $12.8 million for the three months ended March 31, 2025, from $10.6 million in 2024, largely due to higher consulting and insurance expenses related to the divestiture of FYARRO[181]. - The accumulated deficit as of March 31, 2025, was $259.6 million, reflecting ongoing losses primarily from research and development and operational costs[187]. - The company expects to continue incurring significant expenses and operating losses in the foreseeable future due to ongoing research and development activities[167][187]. Divestiture and Acquisitions - The FYARRO Divestiture resulted in a cash payment of $102.4 million to the company from KAKEN for the acquisition of Aadi Subsidiary, closing on March 25, 2025[153]. - The divestiture of FYARRO was completed on March 25, 2025, and the company no longer commercializes this product[169]. Research and Development - The company plans to submit three IND applications to the FDA by mid-2026, targeting solid tumors, cancers of female origin, and neuroendocrine cancers[150]. - The company anticipates pursuing multiple cancer indications with high potential in large patient populations through its ADC pipeline[150]. - The company plans to increase investment in research and development related to ADC Therapies, with upfront non-refundable license fees of $6.0 million and $38.0 million paid to WuXi Biologics in 2024 and 2025, respectively[169]. - The company has ongoing contracts for research and development activities, which can be modified or canceled with written notice[205]. Financing Activities - The 2024 PIPE Financing raised $94.5 million through the sale of 21,592,000 shares at $2.40 each and 20,076,500 pre-funded warrants[156]. - The company entered into a Sales Agreement with Cowen for an "at the market offering" of common stock with gross proceeds of up to $75.0 million, with no shares sold as of March 31, 2025[189]. - The Shelf Registration Statement allows the company to sell up to $150.0 million of various securities, providing flexibility for future capital needs[191]. - The 2022 PIPE Financing resulted in the sale of 3,373,526 shares at $12.50 per share, generating net proceeds of $72.2 million after expenses[192]. - Cash provided by financing activities included $100.0 million from the sale of common stock and pre-funded warrants to the 2024 PIPE Investors[200]. Leadership and Organizational Changes - The company appointed David Dornan, PhD, as Chief Scientific Officer, bringing over 20 years of oncology drug discovery experience[155]. - The company changed its name from Aadi Bioscience, Inc. to Whitehawk Therapeutics, Inc. on March 18, 2025, following the FYARRO Divestiture[156]. Cash Flow and Investments - As of March 31, 2025, the company had $231.1 million in cash, cash equivalents, and short-term investments, which is expected to support operations until 2028[167]. - For the three months ended March 31, 2025, cash used in operating activities was $11.9 million, with a net income of $73.0 million and $85.6 million in non-cash adjustments[196]. - Cash provided by investing activities for the same period was $115.5 million, primarily from the sale of business and maturities of short-term investments[194]. - The company entered into a License Agreement with WuXi Biologics, paying $6.0 million and $38.0 million for exclusive rights to certain patents and know-how[206]. Rent and Lease Expenses - The company recorded rent expenses of $0.1 million for both the Pacific Palisades and Morristown leases for the three months ended March 31, 2025[203].

Financial Performance - Total revenue for Q1 2025 was $7.1 million, an increase from $5.4 million in Q1 2024, representing a 32.5% year-over-year growth[7] - Net income for Q1 2025 was $73.0 million, including a gain of $87.4 million from the sale of Aadi Subsidiary, compared to a net loss of $18.3 million in Q1 2024[7] - Basic net income per share for Q1 2025 was $1.84, compared to a loss of $0.68 per share in Q1 2024[16] Cash and Investments - Cash, cash equivalents, and short-term investments as of March 31, 2025, were $231.1 million, up from $47.2 million as of December 31, 2024[7] - The company expects to have approximately $185 million in cash and cash equivalents post-transaction payments, which is anticipated to fund operations into 2028[7] Operational Highlights - Operating expenses for Q1 2025 totaled $22.4 million, a decrease from $24.9 million in Q1 2024[16] - The company completed a $100 million PIPE financing and divested Aadi Subsidiary for $102.4 million[7] - The total assets as of March 31, 2025, were $234.0 million, significantly higher than $70.3 million as of December 31, 2024[14] Development Pipeline - The company aims to bring all three ADC assets to IND by mid-2026, with the first IND expected to be filed in Q4 2025[3] - The ADC portfolio targets PTK7, MUC16, and SEZ6, which are believed to have broad clinical impact potential comparable to established targets like HER2 and TROP2[3]

Financial Performance - For the fiscal year ended December 31, 2024, the company recorded net revenue from product sales of $26.0 million, compared to $24.4 million in the fiscal year ended December 31, 2023, reflecting a growth of 6.6%[558] - The company reported a net loss of $63.7 million for the fiscal year ended December 31, 2024, an improvement from a net loss of $65.8 million in the previous fiscal year[558] - The company recorded royalties on net product sales of $1.9 million for the year ended December 31, 2024, compared to $1.8 million for the year ended December 31, 2023[562] - The company incurred a net loss of $63.7 million for the year ended December 31, 2024, compared to a net loss of $65.8 million in 2023, indicating a slight improvement in financial performance[581] - The company has an accumulated deficit of $332.7 million as of December 31, 2024, reflecting ongoing net losses since inception[571] - Cash used in operating activities for 2024 was $59.6 million, slightly lower than $59.7 million in 2023, driven by net losses and changes in operating assets and liabilities[595][596] - Other income, net for the year ended December 31, 2024, was $3.8 million, a decrease from $6.2 million in 2023, primarily due to a decrease in short-term investments[586] - The company incurred net losses of $63.7 million in 2024 and $65.8 million in 2023, contributing to an accumulated deficit of $332.7 million as of December 31, 2024[588] Research and Development - The company entered into a License Agreement with WuXi Biologics for the development and commercialization of three next-generation antibody drug conjugates (ADCs), with an upfront payment of $6.0 million and an additional $38.0 million expected by April 17, 2025[559] - The ADC Therapies are targeting tumor antigens MUC16, PTK7, and SEZ6, with plans to submit three investigational new drug (IND) applications to the FDA within the next 12 to 24 months[555] - Research and development expenses increased to $51.0 million in 2024 from $48.9 million in 2023, with significant costs related to clinical development and upfront payments to WuXi Biologics[584] - The company expects to pay $38 million in April 2025 for in-licensing ADC Therapies, indicating ongoing investment in research and development[570] - The company anticipates continued significant expenses and operating losses due to ongoing research and development activities related to ADC Therapies[572] Corporate Changes - The company changed its name from Aadi Bioscience, Inc. to Whitehawk Therapeutics, Inc. on March 18, 2025, following the divestiture of the FYARRO Business[559] - The company completed the divestiture of its FYARRO Business for $102.4 million in cash, which closed on March 25, 2025[558] - The arbitration panel ruled in favor of the company, concluding that it did not breach the EOC License Agreement, thus avoiding any liability for damages[561] Cash and Investments - As of December 31, 2024, the company had $47.2 million in cash, cash equivalents, and short-term investments, which increased to approximately $202.4 million by March 26, 2025, following strategic transactions[570] - Cash provided by investing activities in 2024 was $25.2 million, compared to $83.2 million in 2023, reflecting maturities of short-term investments[597][598] - Cash provided by financing activities was $0.1 million in 2024, down from $0.3 million in 2023, primarily related to the employee stock purchase plan[599][600] Expenses - Total operating expenses for the year ended December 31, 2024, were $93.4 million, a decrease from $96.3 million in 2023, primarily due to reduced selling, general, and administrative expenses[581] - Selling, general, and administrative expenses decreased by $7.8 million in 2024, primarily due to reductions in commercial and marketing expenses and personnel costs[583] - Share-based compensation expense for the year ended December 31, 2024, totaled $10.839 million, a decrease from $11.954 million in 2023[617] - Selling, general and administrative expenses related to share-based compensation were $6.782 million in 2024, down from $7.450 million in 2023[617] - Research and development expenses related to share-based compensation were $4.057 million in 2024, compared to $4.504 million in 2023[617] Securities and Offerings - The company has a Sales Agreement with Cowen for an "at the market offering" of up to $75 million, but no shares have been sold under this agreement as of December 31, 2024[589][590] - The Shelf Registration Statement allows the company to sell up to $150 million of various securities, providing flexibility for future capital needs[591] Stock Options and Compensation - As of December 31, 2024, total unrecognized compensation cost related to stock options was $9.9 million, expected to be recognized over a weighted average period of 1.8 years[617] - The intrinsic value of all outstanding stock options as of December 31, 2024, was $1.8 million[618] - The intrinsic value of all outstanding restricted stock units as of December 31, 2024, was $0.8 million[618] - Unrecognized compensation cost related to restricted stock units was $0.4 million, expected to be recognized over a weighted average period of 3.2 years[618] Company Classification - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[620]

Corporate Governance - Whitehawk Therapeutics, Inc. has amended and restated its bylaws on multiple occasions, with the latest amendment on March 18, 2025[1]. - The company’s registered office will be fixed in its certificate of incorporation, which may be amended from time to time[6]. - Stockholder meetings can be held remotely as authorized by Delaware General Corporation Law, allowing flexibility in meeting arrangements[9]. - The annual meeting of stockholders is to be held each year, with the Board of Directors having the authority to cancel or reschedule meetings[10]. - Special meetings of stockholders can be called by the Board of Directors or certain executives, but not by other persons[11]. - Stockholders must provide timely notice for nominations or proposals at annual meetings, with specific deadlines outlined[15]. - A stockholder's notice must include detailed information about proposed director nominees, including their shareholdings and any compensatory arrangements[17]. - The company requires stockholders to provide a detailed notice for any business they wish to bring before the annual meeting, including a brief description and reasons for the proposal[18]. - Stockholders must disclose their material interests and any agreements related to the proposal, including beneficial ownership and affiliations[19]. - A stockholder's notice must include the number of shares held and any agreements that may affect voting rights or dividends[19]. - The company mandates that stockholders update their notices to ensure accuracy as of the record date and within specified timeframes[21]. - Nominations for directors must be submitted within a specific timeframe, no earlier than 120 days and no later than 10 days after the public announcement of the special meeting[23]. - Proposed nominees must provide a signed questionnaire and representations regarding their eligibility and compliance with company policies[24]. - The chairperson of the meeting has the authority to determine if nominations or business proposals were made in accordance with the bylaws[28]. - If a stockholder or their representative does not appear at the meeting, the nomination or business proposal will be disregarded[29]. - Compliance with the 1934 Act is required for all nominations and proposals made by stockholders[31]. - The company reserves the right to request additional information from stockholders to determine the propriety of proposed business items[18]. - The notice requirements for stockholder proposals are satisfied if the proposal complies with Rule 14a-8 and is included in the company's proxy statement[32]. - Stockholders must receive notice of meetings at least 10 days and no more than 60 days before the meeting date[33]. - A quorum for stockholder meetings requires a majority of the voting power of the capital stock issued and outstanding[34]. - If a quorum is not present, the meeting can be adjourned without further notice until a quorum is achieved[35]. - The chairperson of the meeting has the authority to determine the order of business and adjourn the meeting if necessary[37]. - Each stockholder is entitled to one vote per share of capital stock held[39]. - Actions by stockholders must occur at a duly called meeting and cannot be taken by written consent[41]. - The Board of Directors may fix a record date for determining stockholders entitled to notice and vote, which cannot be more than 60 days before the meeting[42]. - The company must prepare a complete list of stockholders entitled to vote at least 10 days before each meeting[48]. - Inspectors of election must be appointed to ensure the validity of votes and proxies at stockholder meetings[49]. Board of Directors - The Board of Directors may hold regular meetings without notice at times and places determined by the Board[63]. - Special meetings can be called by the chairperson, CEO, president, or a majority of the Board, with notice required at least 24 hours in advance[64][66]. - A majority of the Whole Board constitutes a quorum for business transactions[67]. - Actions can be taken without a meeting if all directors consent in writing or electronically[70]. - The Board has the authority to fix the compensation of directors[71]. - Directors may be removed by stockholders as specified in the certificate of incorporation[72]. - Committees may be designated by the Board to exercise powers in managing the business[74]. - Each committee must keep regular minutes of its meetings[75]. - The Board of Directors appoints the officers of the Company, including a president and a secretary[81][82]. Financial Matters - The Company may issue shares as partly paid, with the total consideration stated on the stock certificates[93]. - The Board of Directors has the authority to declare and pay dividends on the Company's capital stock, which may be in cash, property, or shares[97]. - Transfers of stock must be made on the Company's books by the holders, either in person or through an authorized attorney, and require the surrender of certificates if applicable[98]. - The Company can enter into agreements with stockholders to restrict the transfer of shares in compliance with the DGCL[99]. - The Company recognizes the exclusive rights of registered stockholders to receive dividends and vote, and is not bound to recognize claims from other parties[100]. Indemnification and Insurance - The Company may indemnify directors and officers to the fullest extent permitted by the DGCL for expenses incurred in legal proceedings, provided they acted in good faith[108]. - Indemnification is also available for directors and officers in actions brought by or in the right of the Company, subject to certain conditions[110]. - The Company may advance expenses incurred by officers or directors in defending proceedings, contingent upon a written request and an undertaking to repay if not entitled to indemnification[113]. - The Company has the power to purchase insurance for its directors, officers, and employees against liabilities incurred in their capacities[119]. - Rights to indemnification and advancement of expenses continue for individuals who have ceased to be directors or officers, benefiting their heirs[120]. - Amendments to the bylaws or certificate of incorporation cannot eliminate or impair rights to indemnification for acts occurring prior to such changes[121]. Miscellaneous Provisions - The Company has established a corporate seal that may be altered by the Board of Directors[127]. - The fiscal year of the Company will be determined by a resolution from the Board of Directors[126]. - The Board of Directors has the authority to authorize any officer or employee to enter into contracts on behalf of the Company[125]. - The Company will require a 66 2/3% affirmative vote from stockholders to amend certain bylaws[133]. - The Court of Chancery of the State of Delaware will be the exclusive forum for specific legal actions involving the Company[129]. - The federal district courts of the United States will handle complaints arising under the Securities Act of 1933 related to the Company's securities[130]. - References to "Company" include any constituent company involved in a merger or consolidation[123]. - The Company may adopt and use a corporate seal in various manners[127]. - The definitions and provisions in the DGCL will govern the construction of the Company's bylaws[128]. - The Board of Directors has the power to amend or repeal bylaws, but certain amendments require stockholder approval[133].

Company Overview - Aadi Bioscience, Inc. is a precision oncology company focused on delivering improved therapies for difficult-to-treat cancers [2] Financial Results Announcement - Aadi will host a webcast on March 19, 2025, to discuss its fourth quarter and full-year 2024 financial results [1] - The financial results will be accessible on the "Investors & News" page of Aadi's website [1]

Core Viewpoint - Aadi Bioscience, Inc. is anticipated to report a year-over-year increase in earnings driven by higher revenues for the quarter ending December 2024, with the actual results being crucial for its near-term stock price movement [1][2]. Financial Expectations - The consensus estimate indicates a quarterly loss of $0.25 per share, reflecting a year-over-year improvement of +58.3%. Revenues are projected to reach $7.6 million, marking a 20.1% increase from the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has remained unchanged over the past 30 days, indicating that analysts have not significantly altered their initial projections during this period [4]. Earnings Surprise Prediction - The Zacks Earnings ESP model shows that the Most Accurate Estimate for Aadi Bioscience is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +9.21%, suggesting a bullish outlook from analysts [10]. Zacks Rank - Aadi Bioscience holds a Zacks Rank of 2, which, combined with the positive Earnings ESP, indicates a strong likelihood of beating the consensus EPS estimate [11]. Historical Performance - In the last reported quarter, Aadi Bioscience met the expected loss of $0.46 per share, resulting in no surprise. Over the past four quarters, the company has exceeded consensus EPS estimates twice [12][13]. Conclusion - Aadi Bioscience is positioned as a compelling candidate for an earnings beat, although investors should consider additional factors beyond earnings expectations when making investment decisions [16].