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Aerpio Pharmaceuticals(AADI) - 2025 Q1 - Quarterly Report
AADIAerpio Pharmaceuticals(AADI)2025-05-08 21:28

Financial Performance - FYARRO generated net product sales of 7.1millionforQ12025,comparedto7.1 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 73.0millionforthethreemonthsendedMarch31,2025,primarilyduetoagainonthesaleofFYARRO,comparedtoanetlossof73.0 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 7.1millionforthethreemonthsendedMarch31,2025,anincreaseof7.1 million for the three months ended March 31, 2025, an increase of 1.7 million from 5.4millioninthesameperiodin2024,drivenbystrongerdemand[180].−Totaloperatingexpensesdecreasedto5.4 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 24.9millioninthesameperiodin2024[179].−Researchanddevelopmentexpensesdecreasedto24.9 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 13.6millionin2024,primarilyduetoreducedpersonnelandclinicaldevelopmentcosts[183].−Selling,generalandadministrativeexpensesincreasedto13.6 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 10.6millionin2024,largelyduetohigherconsultingandinsuranceexpensesrelatedtothedivestitureofFYARRO[181].−TheaccumulateddeficitasofMarch31,2025,was10.6 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 102.4milliontothecompanyfromKAKENfortheacquisitionofAadiSubsidiary,closingonMarch25,2025[153].−ThedivestitureofFYARROwascompletedonMarch25,2025,andthecompanynolongercommercializesthisproduct[169].ResearchandDevelopment−ThecompanyplanstosubmitthreeINDapplicationstotheFDAbymid−2026,targetingsolidtumors,cancersoffemaleorigin,andneuroendocrinecancers[150].−ThecompanyanticipatespursuingmultiplecancerindicationswithhighpotentialinlargepatientpopulationsthroughitsADCpipeline[150].−ThecompanyplanstoincreaseinvestmentinresearchanddevelopmentrelatedtoADCTherapies,withupfrontnon−refundablelicensefeesof102.4 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 38.0millionpaidtoWuXiBiologicsin2024and2025,respectively[169].−Thecompanyhasongoingcontractsforresearchanddevelopmentactivities,whichcanbemodifiedorcanceledwithwrittennotice[205].FinancingActivities−The2024PIPEFinancingraised38.0 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 2.40eachand20,076,500pre−fundedwarrants[156].−ThecompanyenteredintoaSalesAgreementwithCowenforan"atthemarketoffering"ofcommonstockwithgrossproceedsofupto2.40 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 150.0millionofvarioussecurities,providingflexibilityforfuturecapitalneeds[191].−The2022PIPEFinancingresultedinthesaleof3,373,526sharesat150.0 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 72.2millionafterexpenses[192].−Cashprovidedbyfinancingactivitiesincluded72.2 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 231.1millionincash,cashequivalents,andshort−terminvestments,whichisexpectedtosupportoperationsuntil2028[167].−ForthethreemonthsendedMarch31,2025,cashusedinoperatingactivitieswas231.1 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 73.0millionand73.0 million and 85.6 million in non-cash adjustments[196]. - Cash provided by investing activities for the same period was 115.5million,primarilyfromthesaleofbusinessandmaturitiesofshort−terminvestments[194].−ThecompanyenteredintoaLicenseAgreementwithWuXiBiologics,paying115.5 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 38.0millionforexclusiverightstocertainpatentsandknow−how[206].RentandLeaseExpenses−Thecompanyrecordedrentexpensesof38.0 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].