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Reviva Pharmaceuticals (RVPH) - 2021 Q3 - Quarterly Report
RVPHReviva Pharmaceuticals (RVPH)2021-11-15 13:00

Financial Performance - Reviva Pharmaceuticals has an accumulated deficit of 63.1millionasofSeptember30,2021,withanetlossofapproximately63.1 million as of September 30, 2021, with a net loss of approximately 4.8 million for the nine months ended September 30, 2021[73]. - The company has not generated any revenues from product sales and has never been profitable[73]. - The net loss for the nine months ended September 30, 2021, was approximately 4.8million,comparedtoanetlossof4.8 million, compared to a net loss of 2.3 million for the same period in 2020[92]. - The company reported a gain on remeasurement of warrant liabilities of approximately 1.3millionfortheninemonthsendedSeptember30,2021,resultingfromadeclineinstockprice[95].−NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2021,wasapproximately1.3 million for the nine months ended September 30, 2021, resulting from a decline in stock price[95]. - Net cash provided by financing activities for the nine months ended September 30, 2021, was approximately 31.5 million, primarily from a public offering[105]. - Net cash used in operating activities for the nine months ended September 30, 2021, was approximately 6.8million,primarilyduetoanetlossandchangesinoperatingassets[103].ResearchandDevelopment−TheleaddrugcandidateRP5063isreadyforcontinuedclinicaldevelopmentformultipleneuropsychiatricindications,includingschizophreniaandbipolardisorder,withafocusoninitiatingapivotalPhase3studyinacuteschizophrenia[65][78].−RP5063hascompletedPhase1studiesforseveralindications,includingmajordepressivedisorderandattentiondeficithyperactivitydisorder[78].−Theseconddrugcandidate,RP1208,hascompletedpre−clinicaldevelopmentstudiesandisreadyforINDenablingstudiesfordepressionandobesity[78].−Researchanddevelopmentexpensesareexpectedtoincreasesignificantlyasthecompanyadvancesitsdevelopmentprogramsandpreparesforpotentialcommercialization[77].−Researchanddevelopmentexpensesincreasedbyapproximately6.8 million, primarily due to a net loss and changes in operating assets[103]. Research and Development - The lead drug candidate RP5063 is ready for continued clinical development for multiple neuropsychiatric indications, including schizophrenia and bipolar disorder, with a focus on initiating a pivotal Phase 3 study in acute schizophrenia[65][78]. - RP5063 has completed Phase 1 studies for several indications, including major depressive disorder and attention deficit hyperactivity disorder[78]. - The second drug candidate, RP1208, has completed pre-clinical development studies and is ready for IND enabling studies for depression and obesity[78]. - Research and development expenses are expected to increase significantly as the company advances its development programs and prepares for potential commercialization[77]. - Research and development expenses increased by approximately 1.4 million, or 148,943%, for the three months ended September 30, 2021, compared to the same period in 2020, primarily due to higher drug development costs and salary expenditures[87]. - The estimated initial costs for conducting the Phase 3 clinical study for RP5063 are approximately 21.0million,withpaymentsscheduledover2021to2023[81].OperationalExpenses−Generalandadministrativeexpensesrosetoapproximately21.0 million, with payments scheduled over 2021 to 2023[81]. Operational Expenses - General and administrative expenses rose to approximately 1.1 million for the three months ended September 30, 2021, reflecting an increase of 542,000,or106542,000, or 106%, mainly due to higher salaries and insurance costs[88]. - The company expects general and administrative expenses to increase as it expands infrastructure and continues clinical program development[83]. Capital Requirements - Reviva Pharmaceuticals has cash of approximately 33.5 million as of September 30, 2021, but will need to raise additional capital to fund its operations beyond December 2022[75]. - The company does not currently have any committed external sources of capital and may need to raise additional funds through equity or debt financings[98]. Impact of COVID-19 - The impact of the COVID-19 pandemic may adversely affect clinical trials, including patient recruitment and dosing[68]. Future Plans - Reviva Pharmaceuticals plans to seek regulatory and marketing approvals for its product candidates and establish a sales and marketing infrastructure[74].