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Reviva Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia
Newsfilter· 2024-05-15 12:00
"We are very pleased with the pace of enrollment of our OLE study, which is progressing well across sites in the USA, Europe and Asia. As of mid-May we have 358 patients enrolled in the study, 223 patients that are currently on treatment, over 90 patients have completed 6-9 months, and 23 patients who have completed one year of treatment," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "Importantly, we are close to gathering long-term safety data in 100 patients with one year of treat ...
Reviva Pharmaceuticals (RVPH) - 2024 Q1 - Quarterly Report
2024-05-14 12:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38634 Reviva Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 85-4306526 incorpor ...
Reviva Pharmaceuticals (RVPH) - 2024 Q1 - Quarterly Results
2024-05-14 12:12
Exhibit 99.1 Reviva Reports First Quarter 2024 Financial Results and Recent Business Highlights – Gained alignment with U.S. Food and Drug Administration (FDA) on brilaroxazine clinical trials for New Drug Application (NDA) submission in schizophrenia – – Registrational RECOVER-2 trial expected to initiate Q2 2024; topline data expected Q3 2025 – – Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 – Cupertino, Calif., May 14, 2024 – Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVP ...
Reviva Pharmaceuticals (RVPH) - 2023 Q4 - Annual Report
2024-04-15 12:22
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number: 001-38634 REVIVA PHARMACEUTICALS HOLDINGS, INC. (Exact name of registrant as specified in its char ...
Reviva Pharmaceuticals (RVPH) - 2023 Q3 - Quarterly Report
2023-11-14 21:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ———————————————————— FORM 10-Q ———————————————————— (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ___ Commission file number: 001-38634 ———————————————————— Reviva Pharmaceuticals Holdings, Inc. (Exact ...
Reviva Pharmaceuticals (RVPH) - 2023 Q2 - Quarterly Report
2023-08-14 20:16
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 Q1 - Quarterly Report
2023-05-15 20:18
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38634 Reviva Pharmaceuticals Holdings, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 85-4306526 (State or O ...
Reviva Pharmaceuticals (RVPH) - 2022 Q4 - Annual Report
2023-03-30 11:51
Financial Performance - The company reported an accumulated deficit of $91.2 million as of December 31, 2022, with a net loss of approximately $24.3 million for the year ended December 31, 2022, compared to a net loss of $8.5 million in 2021[365]. - The net loss for 2022 was $24.3 million, compared to a net loss of $8.5 million in 2021, reflecting a significant increase in operational losses[374]. - Cash and cash equivalents decreased by 37.6% to approximately $18.5 million in 2022 from $29.7 million in 2021, indicating a substantial decline in liquidity[381]. - Net cash used in operating activities increased by 77.7% to approximately $19.0 million in 2022 from $10.7 million in 2021, primarily due to higher net losses[394]. - The company raised approximately $7.8 million from financing activities in 2022, a decrease of 75.3% compared to $31.6 million in 2021[396]. - The provision for income taxes increased to $20,777 in 2022 from $6,004 in 2021, primarily due to increased taxable income from subsidiary operations[380]. - The company has raised concerns regarding its ability to continue as a going concern due to the need for additional fundraising activities in the future[382]. Research and Development - The ongoing Phase 3 clinical study for brilaroxazine is estimated to cost approximately $16.9 million, with $13.2 million payable in 2023 and $3.7 million in 2024[370]. - The company is developing Phase 2 trial protocols for brilaroxazine in ADHD and pulmonary arterial hypertension (PAH), with submissions anticipated in the first half of 2023[357]. - The company has completed Phase 1 studies for brilaroxazine across multiple indications, including schizophrenia, bipolar disorder, and major depressive disorder[369]. - The company expects research and development expenses to increase significantly as it advances its development programs and prepares for potential commercialization[368]. - Research and development expenses increased to approximately $18.9 million in 2022 from $4.9 million in 2021, representing a 291% increase, primarily due to Phase 3 clinical trial activities and higher drug development costs[375]. - The company is focused on completing the clinical development of brilaroxazine for acute and maintenance schizophrenia[357]. - The company has received Orphan Drug designation from the FDA for brilaroxazine for the treatment of PAH and idiopathic pulmonary fibrosis (IPF)[355]. Capital and Financing - The company had cash and cash equivalents of approximately $18.5 million as of December 31, 2022, and anticipates needing additional capital to fund ongoing operations and clinical development[366]. - The company plans to seek additional financing through public or private equity or debt financings to support its clinical development and commercialization activities[366]. - As of December 31, 2022, the company had not exercised any of the Private Pre-Funded Warrants or Private Placement Warrants issued in the September 2022 Offering[387]. Accounting and Valuation - The company utilizes the Black-Scholes-Merton option pricing model to determine the fair value of stock options, relying on historical volatility data from comparable publicly traded companies due to the lack of specific historical data[400]. - The fair value hierarchy under ASC 820 consists of three levels, with the highest priority given to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1)[401]. - The company employs valuation techniques that maximize observable inputs and minimize unobservable inputs in determining the fair value of warrants[402]. - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[405]. - As an emerging growth company, the company will adopt new or revised accounting standards at the same time as private companies, which may complicate financial statement comparisons with other public companies[404]. - The company expects its eligibility as an emerging growth company to end on December 31, 2023, following the fifth anniversary of its initial public offering[404]. - The company does not anticipate paying cash dividends on shares of its common stock[400]. General and Administrative Expenses - General and administrative expenses remained relatively stable at approximately $5.4 million in 2022 compared to $5.3 million in 2021, with a slight increase of 2% attributed to higher consultant fees and recruiting expenses[376].
Reviva Pharmaceuticals (RVPH) - 2022 Q3 - Quarterly Report
2022-11-14 21:10
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 Q2 - Quarterly Report
2022-08-15 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☒ 1934 For the quarterly period ended June 30, 2022 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☐ 1934 For the transition period from to Commission File Number: 001-38634 Reviva Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 85-4306526 (State or ...