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Aerpio Pharmaceuticals(AADI) - 2024 Q4 - Annual Report

Financial Performance - For the fiscal year ended December 31, 2024, the company recorded net revenue from product sales of 26.0million,comparedto26.0 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 63.7millionforthefiscalyearendedDecember31,2024,animprovementfromanetlossof63.7 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 1.9millionfortheyearendedDecember31,2024,comparedto1.9 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 63.7millionfortheyearendedDecember31,2024,comparedtoanetlossof63.7 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 332.7millionasofDecember31,2024,reflectingongoingnetlossessinceinception[571]Cashusedinoperatingactivitiesfor2024was332.7 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 59.7millionin2023,drivenbynetlossesandchangesinoperatingassetsandliabilities[595][596]Otherincome,netfortheyearendedDecember31,2024,was59.7 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 6.2millionin2023,primarilyduetoadecreaseinshortterminvestments[586]Thecompanyincurrednetlossesof6.2 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 65.8millionin2023,contributingtoanaccumulateddeficitof65.8 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 6.0millionandanadditional6.0 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 51.0millionin2024from51.0 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 38millioninApril2025forinlicensingADCTherapies,indicatingongoinginvestmentinresearchanddevelopment[570]ThecompanyanticipatescontinuedsignificantexpensesandoperatinglossesduetoongoingresearchanddevelopmentactivitiesrelatedtoADCTherapies[572]CorporateChangesThecompanychangeditsnamefromAadiBioscience,Inc.toWhitehawkTherapeutics,Inc.onMarch18,2025,followingthedivestitureoftheFYARROBusiness[559]ThecompanycompletedthedivestitureofitsFYARROBusinessfor38 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 47.2millionincash,cashequivalents,andshortterminvestments,whichincreasedtoapproximately47.2 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 25.2million,comparedto25.2 million, compared to 83.2 million in 2023, reflecting maturities of short-term investments[597][598] - Cash provided by financing activities was 0.1millionin2024,downfrom0.1 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 93.4million,adecreasefrom93.4 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 7.8millionin2024,primarilyduetoreductionsincommercialandmarketingexpensesandpersonnelcosts[583]SharebasedcompensationexpensefortheyearendedDecember31,2024,totaled7.8 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 11.954millionin2023[617]Selling,generalandadministrativeexpensesrelatedtosharebasedcompensationwere11.954 million in 2023[617] - Selling, general and administrative expenses related to share-based compensation were 6.782 million in 2024, down from 7.450millionin2023[617]Researchanddevelopmentexpensesrelatedtosharebasedcompensationwere7.450 million in 2023[617] - Research and development expenses related to share-based compensation were 4.057 million in 2024, compared to 4.504millionin2023[617]SecuritiesandOfferingsThecompanyhasaSalesAgreementwithCowenforan"atthemarketoffering"ofupto4.504 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 150millionofvarioussecurities,providingflexibilityforfuturecapitalneeds[591]StockOptionsandCompensationAsofDecember31,2024,totalunrecognizedcompensationcostrelatedtostockoptionswas150 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 1.8million[618]TheintrinsicvalueofalloutstandingrestrictedstockunitsasofDecember31,2024,was1.8 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]