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Aerpio Pharmaceuticals(AADI) - 2024 Q2 - Quarterly Report
AADIAerpio Pharmaceuticals(AADI)2024-08-07 20:16
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Financial Performance - FYARRO recognized net product sales of 6.2millionand6.2 million and 11.5 million for the three and six months ended June 30, 2024, respectively[101]. - Product sales for the three months ended June 30, 2024, were 6.2million,consistentwiththesameperiodin2023,whilesalesforthesixmonthswere6.2 million, consistent with the same period in 2023, while sales for the six months were 11.5 million, down from 12.1millionin2023[119].−Selling,general,andadministrativeexpensesdecreasedto12.1 million in 2023[119]. - Selling, general, and administrative expenses decreased to 7.9 million for the three months ended June 30, 2024, from 11.8millionin2023,andto11.8 million in 2023, and to 18.5 million for the six months from 23.0million[120].−ResearchanddevelopmentexpensesforthethreemonthsendedJune30,2024,were23.0 million[120]. - Research and development expenses for the three months ended June 30, 2024, were 13.1 million, slightly down from 13.3millionin2023,whileexpensesforthesixmonthsincreasedto13.3 million in 2023, while expenses for the six months increased to 26.7 million from 24.3million[123].−OtherincomeforthethreemonthsendedJune30,2024,was24.3 million[123]. - Other income for the three months ended June 30, 2024, was 1.0 million, down from 1.6millionin2023,andforthesixmonths,itwas1.6 million in 2023, and for the six months, it was 2.2 million compared to 3.2million[125].−Thecompanyreportednetlossesof3.2 million[125]. - The company reported net losses of 14.6 million and 18.0millionforthethreemonthsendedJune30,2024and2023,respectively,and18.0 million for the three months ended June 30, 2024 and 2023, respectively, and 32.9 million and 33.2millionforthesixmonthsendedJune30,2024and2023,respectively[126].−CashusedinoperatingactivitiesforthesixmonthsendedJune30,2024was33.2 million for the six months ended June 30, 2024 and 2023, respectively[126]. - Cash used in operating activities for the six months ended June 30, 2024 was 28.8 million, compared to 38.1millionforthesameperiodin2023[129].−CashprovidedbyinvestingactivitiesforthesixmonthsendedJune30,2024was38.1 million for the same period in 2023[129]. - Cash provided by investing activities for the six months ended June 30, 2024 was 7.0 million, significantly lower than 66.9millionforthesameperiodin2023[130].−CashprovidedbyfinancingactivitiesforthesixmonthsendedJune30,2024was66.9 million for the same period in 2023[130]. - Cash provided by financing activities for the six months ended June 30, 2024 was 0.1 million, compared to 0.3millionforthesameperiodin2023[131].−TheaccumulateddeficitasofJune30,2024,was0.3 million for the same period in 2023[131]. - The accumulated deficit as of June 30, 2024, was 301.8 million, primarily due to research and development costs and administrative expenses[109]. - The company has an accumulated deficit of 301.8millionasofJune30,2024[126].ResearchandDevelopment−Researchanddevelopmentcostsareexpectedtoincreasein2024duetosignificantexpensesrelatedtothePRECISION1trialandotherclinicalprograms[107].−ThecompanyplanstoincreaseinvestmentinresearchanddevelopmenttoadvanceFYARROinadditionalindicationsthroughclinicaltrials[114].−ThecompanyiscurrentlyenrollingpatientsinPhase2trialsforadvancedorrecurrentendometrioidendometrialcancerandneuroendocrinetumors[108].−ThePRECISION1trialwasfullyenrolledinApril2024andisexpectedtobecompletedbytheendof2024,withresultsanticipatedinearly2025[102].−Thecompanyhascontractswithvariousorganizationsforresearchanddevelopmentactivities,includingclinicaltrialmanagementanddrugmanufacturing[132].CommercializationandSales−Thecompanyhasbuiltacross−functionalcommercialteamandexpectsadecreaseincommercializationexpensescomparedtopriorperiods[107].−ThedecreaseinproductsalesforthesixmonthsendedJune30,2024,wasattributedtodistributororderingpatternsandfewernewpatientinitiations[119].−RoyaltiesonnetproductsalesundertheBMSLicenseAgreementwere301.8 million as of June 30, 2024[126]. Research and Development - Research and development costs are expected to increase in 2024 due to significant expenses related to the PRECISION1 trial and other clinical programs[107]. - The company plans to increase investment in research and development to advance FYARRO in additional indications through clinical trials[114]. - The company is currently enrolling patients in Phase 2 trials for advanced or recurrent endometrioid endometrial cancer and neuroendocrine tumors[108]. - The PRECISION1 trial was fully enrolled in April 2024 and is expected to be completed by the end of 2024, with results anticipated in early 2025[102]. - The company has contracts with various organizations for research and development activities, including clinical trial management and drug manufacturing[132]. Commercialization and Sales - The company has built a cross-functional commercial team and expects a decrease in commercialization expenses compared to prior periods[107]. - The decrease in product sales for the six months ended June 30, 2024, was attributed to distributor ordering patterns and fewer new patient initiations[119]. - Royalties on net product sales under the BMS License Agreement were 0.5 million for the three months ended June 30, 2024, consistent with the same period in 2023[103]. - A payment of 5.8milliontoBMSisduenolaterthanAugust26,2024,undertheBMSLicenseAgreement[108].−TheEOCarbitrationprocessisexpectedtoyieldadecisioninthesecondhalfof2024,whichmaysignificantlyimpactsales,general,andadministrativeexpenses[108].CashandFinancialPosition−AsofJune30,2024,thecompanyhad5.8 million to BMS is due no later than August 26, 2024, under the BMS License Agreement[108]. - The EOC arbitration process is expected to yield a decision in the second half of 2024, which may significantly impact sales, general, and administrative expenses[108]. Cash and Financial Position - As of June 30, 2024, the company had 78.6 million in cash, cash equivalents, and short-term investments, expected to fund operations into Q4 2025[109]. - The company has a shelf registration statement allowing it to sell up to $150.0 million of various securities, providing flexibility for future capital needs[127]. - The company entered into a lease for 10,615 square feet of office space in Morristown, New Jersey, with a term of seventy-three months[132]. Collaboration and Partnerships - The company terminated its collaboration with Mirati Therapeutics in May 2024, discontinuing enrollment in the Phase 1/2 trial[102].