Financial Performance - The net loss for the three months ended March 31, 2025, was 3,563,238,adecreaseof297,602, or 7.7%, compared to the net loss of 3,860,840forthesameperiodin2024[121]−NetlossforthethreemonthsendedMarch31,2025,was3,563,238, an improvement from a net loss of 3,860,840forthesameperiodin2024[130]−Otherincome,netdecreasedbyapproximately63,000, or 35%, for the three months ended March 31, 2025, primarily due to a decrease in interest and dividends[128] Expenses - For the three months ended March 31, 2025, general and administrative expenses decreased by approximately 341,000,or1519,000, or 1%, for the three months ended March 31, 2025, primarily due to decreases in preclinical research and consulting expenses[126] - The company anticipates an increase in research and development expenses in fiscal year 2025 due to ongoing clinical trials for PAS-004[127] - The primary use of cash is to fund operating expenses, primarily general and administrative and research and development expenditures[134] Cash Flow and Working Capital - Working capital decreased by approximately 1.7millionfrom6,248,444 as of December 31, 2024, to 4,530,046asofMarch31,2025,primarilyduetocashusedtofundoperations[129]−Cashandcashequivalentsdecreasedbyapproximately1.6 million for the three months ended March 31, 2025, compared to a decrease of approximately 4.3millionforthesameperiodin2024[130]−AsofMarch31,2025,thecompanyhadapproximately5.3 million in operating bank accounts and money market funds, with a working capital of approximately 4.5million[132]−Thecompanyisdependentonobtainingadditionalworkingcapitalfundingfromthesaleofequityand/ordebtsecuritiestocontinueoperationsandexecutedevelopmentplans[132]−Futurefundingrequirementswilldependonvariousfactors,includingthecostsofclinicaltrialsandbusinessdevelopmentactivities,withnocommittedsourcesofcapitalcurrentlyavailable[135]RegulatoryandDevelopmentUpdates−ThecompanyreceivedFDAclearancefortheInvestigationalNewDrugapplicationforPAS−004inDecember2023[114]−TheongoingFIHPhase1DoseEscalationStudyofPAS−004isbeingconductedatfourclinicalsitesintheUnitedStatesandthreeadditionalsitesinEasternEurope[114]−ThecompanyplanstoseekmarketingapprovalforPAS−004inspecificpatientpopulations,includingadultsandpediatricpatientswithneurofibromatosistype1−associatedplexiformneurofibromas[114]PublicOfferingandCapitalRestrictions−ThecompanycompletedapublicofferingonMay7,2025,raisingtotalgrossproceedsofapproximately6.3 million[119] - The calculated public float as of March 31, 2025, is below $75 million, restricting the company from raising more than one-third of its public float through primary public offerings in any twelve-month period[133] Accounting Policies - There were no material changes to the company's critical accounting policies and estimates during the three months ended March 31, 2025[139] - The company has no off-balance sheet arrangements during the periods presented[138]
