Financial Performance - The net loss for the three months ended September 30, 2023, was 16.6million,adecreaseof1.6 million compared to a net loss of 18.2millionforthesameperiodin2022[101].−Thecompanyincurredanetlossof53.2 million for the nine months ended September 30, 2023, compared to a net loss of 54.0millionforthesameperiodin2022,reflectingadecreaseof0.8 million[106]. - The accumulated deficit reached 294.2millionasofSeptember30,2023,withcashoperatingexpendituresof43.6 million for the nine months ended September 30, 2023, compared to 48.4millionin2022[117].ResearchandDevelopmentExpenses−ResearchanddevelopmentexpensesforthethreemonthsendedSeptember30,2023,were13.6 million, a slight decrease of 0.1millionfrom13.7 million in the same period in 2022[102]. - Research and development expenses for the nine months ended September 30, 2023, totaled 42.5million,anincreaseof5.5 million from 37.0millioninthesameperiodin2022[107].−Thecompanyexpectssignificantincreasesinoperatingexpensesasitadvancesproductcandidatesthroughclinicaldevelopmentandseeksregulatoryapproval[90].CashandFinancialAssets−AsofSeptember30,2023,totalfinancialassetswere238.1 million, a decrease of 5.4millionfrom243.5 million as of December 31, 2022[111]. - The company expects its cash, cash equivalents, and marketable securities as of September 30, 2023, to be sufficient to fund operations at least through 2025[117]. - As of September 30, 2023, the company had cash, cash equivalents, and marketable securities totaling 238.1million,withrestrictedcashof0.8 million[139]. Interest Income - Interest income, net for the three months ended September 30, 2023, was 3.0million,anincreaseof1.9 million compared to 1.1millionforthesameperiodin2022,drivenbyhigherinterestrates[105].−Interestincome,netroseto8.0 million for the nine months ended September 30, 2023, an increase of 6.2millioncomparedtothesameperiodin2022,drivenbyhigherinterestrates[109].OperatingActivities−Cashusedinoperatingactivitieswas43.6 million for the nine months ended September 30, 2023, down from 48.4millioninthesameperiodof2022[120].−TotaloperatingexpensesfortheninemonthsendedSeptember30,2023,were61.2 million, an increase of 5.4millioncomparedto55.9 million for the same period in 2022[106]. Financing Activities - Financing activities generated 35.3millionincashduringtheninemonthsendedSeptember30,2023,mainlyfromtheissuanceofcommonstockundertheATMProgram[125].−Thecompanyhasapproximately113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program as of September 30, 2023[113]. Market Risks - The company is exposed to market risks primarily related to interest rate risks in the ordinary course of business[138]. - The company is not currently exposed to significant market risk related to changes in foreign currency exchange rates, but future contracts with foreign vendors may introduce such risks[140]. Stock-Based Compensation - Stock-based compensation expense is recognized on a straight-line basis over the associated service period of the award[132]. - The company uses the Black-Scholes option pricing model to estimate the fair value of stock options on the date of grant[134]. - Expected volatility for stock options is derived from the average historical stock volatility over the expected term of the awards[135]. Other Information - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[94]. - The company plans to continue using third-party service providers for clinical development and manufacturing, as it does not currently have a sales force[92]. - The company engages vendors, CROs, and CMOs for preclinical development activities and clinical trials[133]. - Recent accounting pronouncements are detailed in Note 2 of the unaudited condensed financial statements for the nine months ended September 30, 2023[137].