Clinical 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].

Core Insights - Reviva Pharmaceuticals is preparing for a pre-New Drug Application (NDA) meeting with the FDA in Q4 2025, targeting a potential NDA submission for brilaroxazine for schizophrenia in Q2 2026 [1][2] - The company has received a European patent for brilaroxazine's use in treating pulmonary fibrosis, adding to its existing patent protections in major markets [1][3] - Brilaroxazine has shown promising results in clinical trials, demonstrating broad-spectrum efficacy and a favorable safety profile [2][3] Clinical Program and Business Highlights - The European Patent Office granted a patent (EP3749324) for brilaroxazine's use in pulmonary fibrosis, complementing existing protections in the US, China, and Japan [3] - Brilaroxazine received Orphan Drug Designation from the FDA for treating idiopathic pulmonary fibrosis in July 2024 [3] - A Phase 3 study showed that once-daily brilaroxazine led to significant improvements in various psychiatric symptoms over one year, with a total PANSS score reduction of 18.1 [3] - The treatment was well-tolerated, with no significant movement disorders or clinically meaningful side effects reported [3] - Weight gain was benign at approximately 1.5 kg over 52 weeks, and improvements in lipid profiles and blood sugar levels were noted [3] Financial Results - For the three months ended September 30, 2025, the company reported a net loss of approximately $4.0 million, or $0.06 per share, compared to a net loss of $8.4 million, or $0.25 per share, for the same period in 2024 [9][14] - As of September 30, 2025, cash and cash equivalents totaled approximately $13.2 million, a slight decrease from $13.5 million at the end of 2024 [9][11] Anticipated Milestones and Events - The company plans to submit an investigational new drug application (IND) for a liposomal-gel formulation of brilaroxazine for psoriasis by H2 2026 [9] - Reviva is actively pursuing partnership opportunities for the development of its pipeline [9]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][3] - The company will present findings on the anti-inflammatory effects of brilaroxazine from the Phase 3 RECOVER trial at the 2025 Neuroscience meeting [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - The company has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Core Insights - Reviva Pharmaceuticals has received a European patent for brilaroxazine, which is aimed at treating pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF) [1][2] - The patent strengthens the company's intellectual property portfolio and highlights the therapeutic potential of brilaroxazine in chronic fibrotic disorders [2] - Brilaroxazine has shown a novel mechanism of action targeting serotonin signaling, which is involved in the pathogenesis of pulmonary fibrosis [1][3] Company Overview - Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [6] - The company's pipeline includes two drug candidates, brilaroxazine and RP1208, both of which are new chemical entities discovered in-house [6] Clinical Development - Brilaroxazine has demonstrated positive topline data from the global Phase 3 RECOVER trial in schizophrenia, meeting all primary and secondary endpoints with significant reductions in symptoms [4] - The drug has a well-tolerated side effect profile and lower discontinuation rates compared to placebo [4] - Reviva plans to expand the clinical development of brilaroxazine into other neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD) [4][5] Regulatory Status - Brilaroxazine has received Orphan Drug Designation from the FDA for the treatment of IPF and pulmonary arterial hypertension (PAH) [5] - The company believes it has completed a comprehensive set of regulatory compliant toxicology and safety pharmacology studies for brilaroxazine [4]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][4] - The company will be represented by its Founder, President, and CEO, Laxminarayan Bhat, at the Spartan Capital Securities Second Annual Investor Conference on November 3, 2025, in New York City [1] Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [4] - The company has been granted composition of matter patents for both drug candidates in the United States, Europe, and several other countries [4] Conference Details - The Spartan Capital Securities conference will feature over 60 selected companies across various sectors, including technology, healthcare, and consumer [2] - More than 500 institutional and high-net-worth investors are expected to attend, providing opportunities for dialogue between growth companies and the investment community [2]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][3] - The company will present negative symptom data for brilaroxazine from the Phase 3 RECOVER trial at the CNS Summit 2025 [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - The company has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Group 1: Reviva Pharmaceuticals Holdings, Inc. (RVPH) - RVPH is a clinical-stage biopharmaceutical company focused on therapies for central nervous system, respiratory, and metabolic diseases [1] - The current trading price is $0.44, with a target price of $0.39, indicating a potential downside of approximately -11.09% [1] - The significant gap between the current and target price suggests a pessimistic outlook from investment analysts, leading to its exclusion from coverage [1] Group 2: PDS Biotechnology Corporation (PDSB) - PDSB is trading at $0.93, with a discounted cash flow (DCF) valuation of $0.54, resulting in a price percentage difference of -41.72% [2] - The market cap of PDSB is $43.63 million, and it has an earnings per share (EPS) of -0.91, with a negative price-to-earnings (P/E) ratio of -1.58 [2] - This reflects the company's current unprofitability [2] Group 3: IO Biotech, Inc. (IOBT) - IOBT has a current stock price of $1.17 and a DCF valuation of $0.88, leading to a price percentage difference of -24.60% [3] - The market cap of IOBT is $77.08 million, with an EPS of -1.58 and a P/E ratio of -0.63 [3] - This indicates that IOBT is also trading above its intrinsic value, similar to PDSB, but with a slightly better valuation [3] Group 4: Skye Bioscience, Inc. (SKYE) - SKYE has a current stock price of $1.47 and a DCF valuation of $1.86, resulting in a positive price percentage difference of 26.28% [4] - The market cap of SKYE is $45.71 million, with an EPS of -1.06 and a P/E ratio of -3.89 [4] - This suggests that SKYE is undervalued compared to its intrinsic value, indicating potential growth despite current losses [4]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [1][4] - The company will participate in a fireside chat and KOL webinar on October 10, 2025, featuring discussions on schizophrenia treatment and clinical data for its lead drug candidate, brilaroxazine [1][2] Company Overview - Reviva's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [4] - The company has secured composition of matter patents for both drug candidates in the United States, Europe, and several other countries [4]

Group 1: Telomir Pharmaceuticals Inc. (TELO) - Shares surged 43% in after-hours trading, climbing from $1.42 to $2.03 on light volume of 213,569 shares, below the average daily volume of 4.67 million [2] - The spike reflects renewed interest in recent in vitro data showing Telomir-1's ability to target additional histone demethylase families, indicating a unique epigenetic profile [3] Group 2: Processa Pharmaceuticals Inc. (PCSA) - Shares rose 32.6% in after-hours trading to $0.37, following a 30.9% gain during the regular session, with a closing price of $0.2790 on volume exceeding 31.9 million shares [4] - The price movement occurred without any official news or updates from the company, suggesting speculative momentum or technical positioning [5] Group 3: Reviva Pharmaceuticals Holdings Inc. (RVPH) - Shares increased 33.7% in after-hours trading to $0.8950 after a regular session gain of 22.8%, closing at $0.6693 with significant trading volume of 34.2 million shares [6] - The rally happened despite no recent official news, with the last update being four days prior regarding a healthcare conference [7] Group 4: NeuroOne Medical Technologies Corp. (NMTC) - Shares rose 9.5% in after-hours trading to $1.09, extending a 7.1% gain during the regular session, with a closing price of $0.9956 and trading volume of 1.21 million shares [8] - The increase followed the announcement of preliminary unaudited product revenue of $9.1 million for fiscal year 2025, up 163% from the prior year, and an upcoming virtual webinar [9] Group 5: BioRestorative Therapies Inc. (BRTX) - Shares edged 4.6% higher in after-hours trading to $1.60, following a modest 2% gain during the regular session, with a closing price of $1.53 and trading volume of 415,798 shares [10] - The increase followed the announcement of a $1.085 million registered direct offering priced at $1.60 per share, with proceeds aimed at advancing clinical trials and other corporate purposes [11]

Core Insights - Actelis Networks Inc (NASDAQ:ASNS) shares increased significantly in pre-market trading following the announcement of a new contract valued at approximately $0.3 million, which represents about 5.45% of the company's current market capitalization [1] Company Performance - Actelis Networks shares surged by 40.8%, reaching $0.52 in pre-market trading [2] - Other companies also experienced notable pre-market trading movements, with XCel Brands Inc (NASDAQ:XELB) gaining 49.7% to $2.59 and Cheer Holding Inc (NASDAQ:CHR) rising 45.8% to $0.19 [5]