Financial Performance - The company reported a net loss of approximately $3.5 million for the three months ended September 30, 2022, compared to a net loss of $2.3 million for the same period in 2021, indicating a year-over-year increase of about 52.2%[78] - The accumulated deficit as of September 30, 2022, was $83.1 million, reflecting the company's ongoing financial challenges since inception[78] - The net loss for the three months ended September 30, 2022, was approximately $2.3 million, compared to a net loss of $3.5 million in the same period of 2021[90] - Total operating expenses for the nine months ended September 30, 2022, reached approximately $16.5 million, significantly higher than $6.1 million in 2021[96] - The company reported a gain on remeasurement of warrant liabilities of approximately $0.3 million for the nine months ended September 30, 2022, down from $1.3 million in 2021, an 80% decrease[99] - Interest and other income (expense), net for the nine months ended September 30, 2022, was approximately $56,961, a significant increase from a loss of $3,948 in 2021[100] - Net cash used in operating activities for the nine months ended September 30, 2022, was approximately $14.3 million, compared to $6.8 million in 2021, reflecting an increase of 111%[114] Research and Development - The company expects to incur significant expenses and increased operating losses for the next several years as it continues its research and development activities[78] - The estimated initial costs to conduct the Phase 3 clinical study for RP5063 are approximately $26 million, with $16.2 million payable during calendar 2022[85] - The company is currently developing Phase 2 trial protocols for RP5063 in ADHD and pulmonary arterial hypertension (PAH), with plans to submit these protocols in the first half of 2023[72] - The Phase 3 RECOVER trial for RP5063 has enrolled patients in 15 sites across the US, with over 30% enrollment reported by October 31, 2022[71] - The company has received Orphan Drug designation from the FDA for RP5063 for the treatment of PAH and idiopathic pulmonary fibrosis (IPF)[70] - The company has two drug candidates in its pipeline: RP5063 and RP1208, both of which are new chemical entities discovered in-house[69] - The company anticipates significant increases in research and development expenses as it advances its development programs and prepares for potential commercialization[81] - Research and development expenses increased to approximately $2.3 million for the three months ended September 30, 2022, up from $1.4 million in the same period of 2021, representing a 62% increase[91] - For the nine months ended September 30, 2022, research and development expenses surged to approximately $12.7 million, compared to $2.2 million in 2021, marking a 478% increase[97] Cash Position and Funding - As of September 30, 2022, the company had cash of approximately $23.2 million, which is expected to be insufficient for completing the development of its product candidates without raising additional capital[79] - As of September 30, 2022, the company had cash of approximately $23.2 million, expected to be sufficient to meet obligations through November 2023[108] - The September 2022 Offering resulted in aggregate gross proceeds of approximately $8.5 million, with net proceeds totaling approximately $7.8 million after transaction costs[107] Regulatory and Compliance - The company is classified as an emerging growth company under the JOBS Act, allowing it to take advantage of certain reporting exemptions[119] - The company has elected not to opt out of the extended transition period for adopting new or revised accounting standards[119] - This decision may complicate financial statement comparisons with other public companies that do not share the same status[119]
Reviva Pharmaceuticals (RVPH) - 2022 Q3 - Quarterly Report