Reviva Pharmaceuticals (US:RVPH)2025-11-13 21:11Clinical Trial Results - The company announced positive topline results from the Phase 3 RECOVER-1 trial, achieving a statistically significant 10.1-point reduction in PANSS total score at the 50 mg dose compared to placebo (p<0.001) after 4 weeks [91]. - The trial included approximately 400 patients with acute schizophrenia, demonstrating clinically meaningful improvements across all major symptom domains [93]. - The Phase 3 RECOVER trial included 411 patients with a mean PANSS total score of 97-99 at baseline, highlighting the severity of the condition being treated [94]. - Brilaroxazine demonstrated a significant, sustained efficacy with less than 1% of patients reporting symptom relapse over 1 year of treatment [100]. - Treatment adherence was consistently high, with 37.3% of patients showing a greater than 1-point improvement in CGI-S score at 6 months [100]. - The overall treatment emergent adverse event (TEAE) rate was 37.2%, with the most common TEAEs being headache (2.7%) and insomnia (4.0%) [100]. - No serious adverse events (SAEs) or major safety concerns were reported during the 1-year treatment period [100]. Drug Development and Pipeline - Brilaroxazine has been granted Orphan Drug Designation by the FDA for the treatment of pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) [89]. - The company plans to continue the clinical development of brilaroxazine for additional indications, including bipolar disorder, major depressive disorder, and attention-deficit/hyperactivity disorder, subject to financing [92]. - The company has two drug candidates in its pipeline, brilaroxazine and RP1208, both of which are new chemical entities discovered in-house [88]. - The company aims to expand its product pipeline by identifying and developing additional product candidates and acquiring or in-licensing other drugs and technologies [115]. - The company has completed Phase 1 studies for multiple indications of brilaroxazine, including schizophrenia, bipolar disorder, and depression [117]. - The company is assessing next steps for brilaroxazine's approval following the successful completion of the Phase 3 RECOVER-1 trial and ongoing long-term safety studies [113]. Financial Performance - The company has been operating at a loss since inception and expects to continue incurring operating losses for the foreseeable future [87]. - The net loss for the three months ended September 30, 2025, was approximately $4.0 million, a decrease of 52.5% compared to a net loss of $8.4 million for the same period in 2024 [124]. - Research and development expenses for the three months ended September 30, 2025, were approximately $2.1 million, a decrease of 68.9% from $6.9 million in the same period in 2024 [126]. - General and administrative expenses for the three months ended September 30, 2025, were approximately $1.9 million, an increase of 18.3% from $1.6 million in the same period in 2024 [129]. - For the nine months ended September 30, 2025, research and development expenses decreased to approximately $10.0 million from $18.2 million in 2024, a reduction of 45.3% [134]. - General and administrative expenses increased to approximately $6.7 million for the nine months ended September 30, 2025, compared to $6.3 million in 2024, reflecting a 6.1% increase [139]. - The company reported a net loss of approximately $23.7 million for the nine months ended September 30, 2024, compared to a net loss of approximately $16.5 million in the same period of 2025 [153]. Capital and Funding - The company entered into an at-the-market (ATM) sales agreement with an aggregate offering price of up to $50 million, raising approximately $1.2 million in net proceeds from stock sales [102]. - A public offering in June 2025 raised gross proceeds of $10.0 million, with net proceeds of approximately $9.0 million after expenses [103]. - A subsequent public offering in September 2025 raised gross proceeds of $9.0 million, with net proceeds of approximately $8.1 million after expenses [104]. - The company expects to incur approximately $60 million in clinical costs over the next two years related to the development of brilaroxazine for schizophrenia, including potential Phase 3 RECOVER-2 Trial expenses [119]. - The company anticipates needing to raise significant additional capital to fund ongoing operations and development efforts beyond existing cash reserves [145]. - The company does not currently have any committed external sources of capital and may face dilution of stockholder ownership if additional capital is raised [151]. - The company experienced a decrease in net operating assets and liabilities totaling approximately $4.0 million, mainly from reduced accrued clinical expenses and accounts payable [152]. Cash Flow and Working Capital - As of September 30, 2025, the company had a working capital surplus of approximately $3.8 million, an accumulated deficit of $180.8 million, and cash and cash equivalents of approximately $13.2 million [112]. - Net cash used in operating activities improved to $(18.8 million) for the nine months ended September 30, 2025, compared to $(24.4 million) in 2024, a reduction of 23.1% [144]. - Cash and cash equivalents as of September 30, 2025, were approximately $13.2 million, a decrease of 2.2% from $13.5 million as of December 31, 2024 [144]. - The company reported a working capital surplus of $3.8 million as of September 30, 2025, compared to $81.9 thousand at the end of 2024, an increase of 4510.9% [144]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $18.5 million, driven by $19.0 million in gross proceeds from public offerings [154]. - The company incurred transaction costs of approximately $1.9 million related to financing activities during the nine months ended September 30, 2025 [154]. - In comparison, net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $6.6 million, indicating a significant increase in financing activity year-over-year [155].