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Galectin Therapeutics(GALT) - 2020 Q4 - Annual Report

Financial Performance - Net cash used in operations increased by 9,753,000to9,753,000 to 20,601,000 in 2020, compared to 10,848,000in2019,drivenbyhigherresearchanddevelopmentactivities[196].Thecompanyraisedanettotalof10,848,000 in 2019, driven by higher research and development activities [196]. - The company raised a net total of 197.7 million from public and private offerings since inception, with 27.1millioninunrestrictedcashavailableasofDecember31,2020[195].Otherincomefor2020included27.1 million in unrestricted cash available as of December 31, 2020 [195]. - Other income for 2020 included 66,000 in interest income, offset by 87,000ininterestexpenserelatedtodebtdiscountamortization[189].Thecompanyhasnotgeneratedanyrevenuetodateandisdependentonadditionaloutsidecapitalforfutureoperations[182].ResearchandDevelopmentResearchanddevelopmentexpensesincreasedby14187,000 in interest expense related to debt discount amortization [189]. - The company has not generated any revenue to date and is dependent on additional outside capital for future operations [182]. Research and Development - Research and development expenses increased by 141% from 7,467,000 in 2019 to 17,976,000in2020,primarilyduetocostsrelatedtotheNAVIGATEclinicaltrial[185].Clinicalprogramexpensesrosefrom17,976,000 in 2020, primarily due to costs related to the NAVIGATE clinical trial [185]. - Clinical program expenses rose from 4,826,000 in 2019 to 14,229,000in2020,reflectingincreasedactivitiesinclinicaltrials[186].Thecompanyexpectstorequireanadditional14,229,000 in 2020, reflecting increased activities in clinical trials [186]. - The company expects to require an additional 45-50milliontocovercostsfortheNAVIGATEPhase2b/3clinicaltrial,withaninterimanalysisestimatedforthesecondhalfof2023[195].TheimpactofCOVID19hascauseddelaysinclinicaltrialsanddevelopmentefforts,affectingthecompanysoperationsandcapitalmarketaccess[187].AdministrativeExpensesGeneralandadministrativeexpensesdecreasedby850 million to cover costs for the NAVIGATE Phase 2b/3 clinical trial, with an interim analysis estimated for the second half of 2023 [195]. - The impact of COVID-19 has caused delays in clinical trials and development efforts, affecting the company's operations and capital market access [187]. Administrative Expenses - General and administrative expenses decreased by 8% from 5,971,000 in 2019 to 5,468,000in2020,mainlyduetoreductionsinlegalandinvestorrelationsexpenses[188].FinancialReportingandEstimatesSignificantestimatesinfinancialreportingincludestockoptionvaluations,accruedliabilities,anddeferredincometaxes,whichrequiremanagementsjudgment[207].Researchanddevelopmentexpensesarechargedasincurred,withsignificantfactorsforestimatingaccrualsincludingpatientenrollmentandactiveclinicalsites[210].Stockbasedcompensationismeasuredatgrantdatefairvalueandrecognizedasexpenseovertheserviceperiod,includingestimatesforforfeitures[211].LiquidityandCapitalResourcesTheCompanyhasnotcreatedanyoffbalancesheetentitiesthatcouldmateriallyaffectliquidityorcapitalresources[206].TheCompanyisnotexposedtosignificantmarketrisksduetothenatureofitsoperationsandabsenceofdebtasofDecember31,2020[212].TheCompanyhasnotdrawnona5,468,000 in 2020, mainly due to reductions in legal and investor relations expenses [188]. Financial Reporting and Estimates - Significant estimates in financial reporting include stock option valuations, accrued liabilities, and deferred income taxes, which require management's judgment [207]. - Research and development expenses are charged as incurred, with significant factors for estimating accruals including patient enrollment and active clinical sites [210]. - Stock-based compensation is measured at grant date fair value and recognized as expense over the service period, including estimates for forfeitures [211]. Liquidity and Capital Resources - The Company has not created any off-balance sheet entities that could materially affect liquidity or capital resources [206]. - The Company is not exposed to significant market risks due to the nature of its operations and absence of debt as of December 31, 2020 [212]. - The Company has not drawn on a 10 million unsecured line of credit available from a stockholder and director [195]. Lease Obligations - The Company entered into a one-year operating lease for office and lab space in Natick, MA, at a rate of $15,000, which has continued on a month-to-month basis since October 1, 2013 [204].