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Reviva Pharmaceuticals (RVPH) - 2021 Q1 - Quarterly Report

Financial Performance - Reviva Pharmaceuticals has an accumulated deficit of 59.3millionasofMarch31,2021,andreportedanetlossofapproximately59.3 million as of March 31, 2021, and reported a net loss of approximately 949,000 for the three months ended March 31, 2021[88]. - The net loss for the three months ended March 31, 2021, was approximately 949,000,comparedtoanetlossof949,000, compared to a net loss of 749,000 for the same period in 2020[101]. - Net cash used in operating activities for Q1 2021 was approximately 3.1million,significantlyhigherthan3.1 million, significantly higher than 61,000 in Q1 2020, primarily due to increased net operating assets[112]. - The gain on remeasurement of warrant liabilities for Q1 2021 was approximately 923,000,resultingfromadecreaseincalculatedfairvalueduetoadeclineinstockprice[105].AsofMarch31,2021,thecompanyhadcashofapproximately923,000, resulting from a decrease in calculated fair value due to a decline in stock price[105]. - As of March 31, 2021, the company had cash of approximately 5.6 million and expects to incur significant expenses and operating losses in the foreseeable future[106]. Research and Development - The company expects to incur significant expenses and increased operating losses for the next several years as it continues to develop its product candidates[88]. - Reviva Pharmaceuticals has two drug candidates in its pipeline: RP5063 (Brilaroxazine) and RP1208, both of which have been granted composition of matter patents in the U.S., Europe, and other countries[79]. - RP5063 is in Phase 2 clinical development for acute schizophrenia and has completed Phase 1 studies for multiple indications, including bipolar disorder and major depressive disorder[93]. - The company anticipates that its research and development expenses will increase significantly as it advances its development programs and prepares for potential commercialization[92]. - Research and development expenses increased by approximately 120,000,or44120,000, or 44%, from 271,000 in Q1 2020 to 391,000inQ12021,primarilyduetohighersalaryexpendituresandincreasedconsultingcosts[102].OperationalChallengesRevivaPharmaceuticalshastakenprecautionarymeasuresinresponsetoCOVID19,whichmaydisruptclinicaltrialsandoperations[82].Thecompanydoesnotcurrentlyhaveanycommittedexternalsourcesofcapitalandmayneedtofinancecashneedsthroughequityordebtfinancings[107].FuturePlansThecompanyisfocusingoncompletingtheclinicaldevelopmentofRP5063forvariousneuropsychiatricandrespiratoryindications,subjecttoadditionalfinancing[81].TheestimatedinitialcostsforconductingthePhase3clinicalstudyforRP5063areapproximately391,000 in Q1 2021, primarily due to higher salary expenditures and increased consulting costs[102]. Operational Challenges - Reviva Pharmaceuticals has taken precautionary measures in response to COVID-19, which may disrupt clinical trials and operations[82]. - The company does not currently have any committed external sources of capital and may need to finance cash needs through equity or debt financings[107]. Future Plans - The company is focusing on completing the clinical development of RP5063 for various neuropsychiatric and respiratory indications, subject to additional financing[81]. - The estimated initial costs for conducting the Phase 3 clinical study for RP5063 are approximately 21.0 million, with 7.0millionpayablein2021,7.0 million payable in 2021, 10.0 million in 2022, and 4.0millionin2023[96].Thecompanyplanstoestablishasales,marketing,anddistributioninfrastructuretocommercializeanydrugsthatreceivemarketingapproval[89].Thecompanyexpectsgeneralandadministrativeexpensestoincreaseasitexpandsinfrastructureandcontinuesclinicalprogramdevelopment[98].AdministrativeExpensesGeneralandadministrativeexpensesrosebyapproximately4.0 million in 2023[96]. - The company plans to establish a sales, marketing, and distribution infrastructure to commercialize any drugs that receive marketing approval[89]. - The company expects general and administrative expenses to increase as it expands infrastructure and continues clinical program development[98]. Administrative Expenses - General and administrative expenses rose by approximately 1.1 million, or 327%, from 347,000inQ12020to347,000 in Q1 2020 to 1.5 million in Q1 2021, driven by increased use of consultants and higher insurance costs[103]. - The company incurred no interest expense in Q1 2021, a decrease from approximately $130,000 in Q1 2020, due to the conversion of all investor notes prior to the Business Combination[104].