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Soleno Therapeutics(SLNO) - 2021 Q1 - Quarterly Report

Financial Performance - The company reported a net loss of 8.95millionforthethreemonthsendedMarch31,2021,comparedtoanetlossof8.95 million for the three months ended March 31, 2021, compared to a net loss of 5.86 million for the same period in 2020, representing a 53% increase in losses[79]. - General and administrative expenses rose by 49% to 2.98millionforthethreemonthsendedMarch31,2021,comparedto2.98 million for the three months ended March 31, 2021, compared to 2.00 million in the prior year[79]. - The company has an accumulated deficit of 191.4millionasofMarch31,2021,primarilyduetoresearchanddevelopmentandgeneraladministrativeexpenses[77].Operatingactivitiesusednetcashof191.4 million as of March 31, 2021, primarily due to research and development and general administrative expenses[77]. - Operating activities used net cash of 7.5 million during the three months ended March 31, 2021, compared to 5.7millioninthesameperiodin2020[87].ResearchandDevelopmentResearchanddevelopmentexpensesincreasedby75.7 million in the same period in 2020[87]. Research and Development - Research and development expenses increased by 7% to 7.16 million for the three months ended March 31, 2021, up from 6.70millioninthesameperiodin2020[79].Thecompanyhasnotyetcommencedcommercializationofitsleadproduct,DCCR,andhasgeneratednorevenuefromoperationsasofMarch31,2021[80].ThecompanyisincommunicationwithregulatoryauthoritiesregardingthenextstepsforDCCRaftertheFDAindicatedanadditionalclinicaltrialwouldbenecessaryforNewDrugApproval[75].CashPositionCashandcashequivalentsstoodat6.70 million in the same period in 2020[79]. - The company has not yet commenced commercialization of its lead product, DCCR, and has generated no revenue from operations as of March 31, 2021[80]. - The company is in communication with regulatory authorities regarding the next steps for DCCR after the FDA indicated an additional clinical trial would be necessary for New Drug Approval[75]. Cash Position - Cash and cash equivalents stood at 41.6 million as of March 31, 2021, which management believes is sufficient to meet obligations for at least the next twelve months[77]. - The company raised 53.7millioninnetproceedsfromapublicofferingcompletedinJune2020[77].ContingentConsiderationThefairvalueofcontingentconsiderationrelatedtotheacquisitionofEssentialiswasestimatedat53.7 million in net proceeds from a public offering completed in June 2020[77]. Contingent Consideration - The fair value of contingent consideration related to the acquisition of Essentialis was estimated at 9.3 million as of March 31, 2021, a decrease of $1.0 million from the previous estimate[83].