CUPERTINO, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) ("Reviva" or the "Company"), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in a panel discussion at the BIO International Convention, taking place June 3-6, 2024, in ...

NEW YORK, May 16, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Reviva Pharmaceuticals Holdings, Inc. ("Reviva" or the "Company") (NASDAQ: RVPH). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980 The investigation concerns whether Reviva and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On Apri ...

"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 ...

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 ...

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 ...

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 ...

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 ...

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].

Financial Performance - The company reported an accumulated deficit of $97.8 million as of March 31, 2023, with a net loss of approximately $6.6 million for Q1 2023, compared to $7.4 million for Q1 2022 [91]. - The company has not generated any revenues from product sales and has a history of operating losses since inception, expecting to continue incurring losses for the foreseeable future [91]. - The company reported a net loss of $6.6 million for the three months ended March 31, 2023, compared to a net loss of $7.4 million for the same period in 2022 [106]. - Net cash used in operating activities increased by 26.9% to approximately $8.0 million for the three months ended March 31, 2023, compared to $6.3 million for the same period in 2022 [123]. - Total stockholders' equity decreased by 53.0% to $5.8 million as of March 31, 2023, from $12.3 million as of March 31, 2022 [112]. Research and Development - The company anticipates significant increases in expenses related to ongoing research and development activities, including clinical trials for brilaroxazine and pre-clinical research for RP1208 [92]. - The lead drug candidate, brilaroxazine, is in a Phase 3 trial for acute schizophrenia, with over 30% enrollment achieved by October 31, 2022, and approximately 400 patients targeted for the study [82]. - The company plans to submit Phase 2 trial protocols for brilaroxazine in ADHD and pulmonary arterial hypertension (PAH) in the second half of 2023 [83]. - The company is developing RP1208 for depression and obesity, subject to additional financing [85]. - The company has completed Phase 1 trials for multiple indications of brilaroxazine, including bipolar disorder, major depressive disorder, and Alzheimer's-related psychosis [96]. - The company expects to incur approximately $14.5 million in costs related to the ongoing Phase 3 clinical study for brilaroxazine, with $10.8 million payable in 2023 [100]. Financial Position and Capital Needs - As of March 31, 2023, the company had cash and cash equivalents of approximately $11.3 million, indicating a need for additional capital to fund ongoing operations and development [93]. - Cash and cash equivalents decreased by 39.2% to $11.3 million as of March 31, 2023, down from $18.5 million as of March 31, 2022 [112]. - The company emphasizes the need for substantial additional capital to continue clinical development and potential commercialization activities [93]. - The company anticipates needing additional fundraising activities during the fourth quarter of fiscal year 2023 to cover anticipated outlays [113]. - The company raised approximately $8.5 million in gross proceeds from the September 2022 Offering, with net proceeds totaling approximately $7.8 million after transaction costs [117]. Expenses - Research and development expenses decreased by $0.6 million, or 10%, to approximately $5.2 million for the three months ended March 31, 2023, primarily due to lower Phase 3 clinical trial expenses [107]. - General and administrative expenses were approximately $1.5 million for the three months ended March 31, 2023, a decrease of 7% compared to $1.6 million in the same period of 2022 [108]. - Interest income increased significantly to $147,011 for the three months ended March 31, 2023, compared to $1,735 in the same period of 2022, reflecting higher market interest rates [106].

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].