Financial Performance - The company reported a net loss of approximately $12.4 million for the three months ended June 30, 2023, compared to a net loss of $5.3 million for the same period in 2022[96]. - The accumulated deficit as of June 30, 2023, was $110.2 million, indicating ongoing financial challenges[96]. - The company has not generated any revenues from product sales and may never achieve profitability[96]. - The company reported a net loss of $12.4 million for the three months ended June 30, 2023, compared to a net loss of $5.3 million for the same period in 2022, representing a 133% increase in loss[108]. - Total operating expenses for the six months ended June 30, 2023, were approximately $18.8 million, an increase of 45% compared to $13.0 million for the same period in 2022[113]. - For the six months ended June 30, 2023, net cash used in operating activities was approximately $13.3 million, primarily due to a net loss of $19.0 million[132]. Research and Development - The company expects to incur significant expenses and increased operating losses for the next several years due to ongoing research and development activities[96]. - The company anticipates submitting Phase 2 trial protocols for brilaroxazine in ADHD and pulmonary arterial hypertension (PAH) in the second half of 2023[89]. - Over 80% of patients have been enrolled in the Phase 3 RECOVER Trial for brilaroxazine, with topline data expected in October 2023[88]. - The company has been granted Orphan Drug Designation for brilaroxazine for the treatment of PAH and idiopathic pulmonary fibrosis (IPF)[84]. - The company plans to continue the clinical development of brilaroxazine for multiple indications, including bipolar disorder (BD) and major depressive disorder (MDD), subject to additional financing[90]. - Research and development expenses are expected to increase significantly as the company advances its development programs and prepares for potential commercialization[99]. - Research and development expenses increased by 99% to approximately $9.0 million for the three months ended June 30, 2023, primarily due to Phase 3 clinical trial expenses for brilaroxazine[109]. - The company has completed Phase 1 studies for multiple indications of brilaroxazine, with Phase 3 data expected in October 2023[100]. Cash and Financing - As of June 30, 2023, the company had cash and cash equivalents of approximately $11.2 million, which is insufficient to complete the development of its product candidates[97]. - Cash and cash equivalents decreased by 39.8% to approximately $11.2 million as of June 30, 2023, compared to $18.5 million as of June 30, 2022[119]. - The company anticipates needing additional fundraising activities during the fourth quarter of fiscal year 2023 to cover anticipated outlays[120]. - The September 2022 Offering generated approximately $8.5 million in gross proceeds, with net proceeds totaling around $7.8 million after deducting transaction costs of $0.7 million[126]. - Net cash provided by financing activities for the six months ended June 30, 2023, included approximately $5.7 million from the exercise of warrants for common stock[135]. - The company expects to finance cash needs through equity or debt financings and collaboration agreements, with no committed external sources of capital currently available[128]. - If additional funds are raised through collaboration agreements, the company may have to relinquish valuable rights to technologies or future revenue streams[130]. - The balance of insurance financing debt payable as of June 30, 2023, was $222,500, recorded as short-term debt[127]. Expenses and Liabilities - General and administrative expenses rose by 206% to approximately $3.1 million for the three months ended June 30, 2023, driven by increased stock-based compensation and legal expenses[110]. - The company expects remaining costs for the ongoing Phase 3 clinical study for brilaroxazine to be approximately $9.2 million, with $5.5 million payable in 2023 and $3.7 million in 2024[102]. - The company incurred a loss on remeasurement of warrant liabilities of $0.4 million for the six months ended June 30, 2023, compared to a gain of $0.3 million for the same period in 2022[117]. - Interest income increased significantly to $250,091 for the six months ended June 30, 2023, compared to $15,560 for the same period in 2022, reflecting higher market interest rates[118]. - The company reported an increase of approximately $2.7 million in stock-based compensation expense for the six months ended June 30, 2023[132]. Company Status - The company anticipates that its eligibility as an emerging growth company will end on December 31, 2023[137].
Reviva Pharmaceuticals (RVPH) - 2023 Q2 - Quarterly Report