Reviva Pharmaceuticals (US:RVPH)2023-05-15 20:18Financial Performance - The company reported an accumulated deficit of $97.8 million as of March 31, 2023, with a net loss of approximately $6.6 million for Q1 2023, compared to $7.4 million for Q1 2022 [91]. - The company has not generated any revenues from product sales and has a history of operating losses since inception, expecting to continue incurring losses for the foreseeable future [91]. - The company reported a net loss of $6.6 million for the three months ended March 31, 2023, compared to a net loss of $7.4 million for the same period in 2022 [106]. - Net cash used in operating activities increased by 26.9% to approximately $8.0 million for the three months ended March 31, 2023, compared to $6.3 million for the same period in 2022 [123]. - Total stockholders' equity decreased by 53.0% to $5.8 million as of March 31, 2023, from $12.3 million as of March 31, 2022 [112]. Research and Development - The company anticipates significant increases in expenses related to ongoing research and development activities, including clinical trials for brilaroxazine and pre-clinical research for RP1208 [92]. - The lead drug candidate, brilaroxazine, is in a Phase 3 trial for acute schizophrenia, with over 30% enrollment achieved by October 31, 2022, and approximately 400 patients targeted for the study [82]. - The company plans to submit Phase 2 trial protocols for brilaroxazine in ADHD and pulmonary arterial hypertension (PAH) in the second half of 2023 [83]. - The company is developing RP1208 for depression and obesity, subject to additional financing [85]. - The company has completed Phase 1 trials for multiple indications of brilaroxazine, including bipolar disorder, major depressive disorder, and Alzheimer's-related psychosis [96]. - The company expects to incur approximately $14.5 million in costs related to the ongoing Phase 3 clinical study for brilaroxazine, with $10.8 million payable in 2023 [100]. Financial Position and Capital Needs - As of March 31, 2023, the company had cash and cash equivalents of approximately $11.3 million, indicating a need for additional capital to fund ongoing operations and development [93]. - Cash and cash equivalents decreased by 39.2% to $11.3 million as of March 31, 2023, down from $18.5 million as of March 31, 2022 [112]. - The company emphasizes the need for substantial additional capital to continue clinical development and potential commercialization activities [93]. - The company anticipates needing additional fundraising activities during the fourth quarter of fiscal year 2023 to cover anticipated outlays [113]. - The company raised approximately $8.5 million in gross proceeds from the September 2022 Offering, with net proceeds totaling approximately $7.8 million after transaction costs [117]. Expenses - Research and development expenses decreased by $0.6 million, or 10%, to approximately $5.2 million for the three months ended March 31, 2023, primarily due to lower Phase 3 clinical trial expenses [107]. - General and administrative expenses were approximately $1.5 million for the three months ended March 31, 2023, a decrease of 7% compared to $1.6 million in the same period of 2022 [108]. - Interest income increased significantly to $147,011 for the three months ended March 31, 2023, compared to $1,735 in the same period of 2022, reflecting higher market interest rates [106].