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].

☒ 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 ...

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].

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]

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 ...

Financial Performance - Reviva Pharmaceuticals has not generated any revenues from product sales and has an accumulated deficit of $74.2 million as of March 31, 2022[66]. - The net loss for the three months ended March 31, 2022, was approximately $7.4 million, compared to $0.9 million for the same period in 2021[66]. - The net loss for the three months ended March 31, 2022, was approximately $7.4 million, compared to a net loss of $949,000 for the same period in 2021[77]. - Net cash used in operating activities was approximately $6.3 million for the three months ended March 31, 2022, compared to $3.1 million for the same period in 2021, representing an increase of 101%[89]. - The gain on remeasurement of warrant liabilities decreased to approximately $89,000 for the three months ended March 31, 2022, from $923,000 in the same period of 2021, a decline of 90%[80]. Research and Development - The company expects significant expenses and increased operating losses for the next several years due to ongoing research and development activities[66]. - Research and development expenses are expected to increase significantly as the company advances its development programs and prepares for potential commercialization[69]. - Research and development expenses increased by approximately $5.4 million, or 1,390%, to $5.8 million for the three months ended March 31, 2022, compared to $0.4 million in the same period of 2021[78]. - The lead drug candidate, RP5063, is in Phase 3 clinical trials for acute schizophrenia, with approximately 400 patients expected to be enrolled[57][70]. - The company plans to continue the clinical development of RP1208 for depression and obesity, pending additional financing[58]. - The company expects to incur significant costs for the Phase 3 clinical study of RP5063, estimated at approximately $26.0 million, with $15.1 million payable in 2022[73]. - The company has completed Phase 1 studies for multiple indications of RP5063, including bipolar disorder, major depressive disorder, and ADHD[70]. Financial Position and Capital Needs - As of March 31, 2022, Reviva had cash of approximately $23.4 million, which is insufficient to complete the development of its product candidates without raising additional capital[67]. - As of March 31, 2022, the company had cash of approximately $23.4 million and anticipates continued operating losses as it advances its product candidates[83]. - The company completed a public offering on June 1, 2021, raising net proceeds of approximately $31.5 million[81]. - The company has entered into an At The Market Offering Agreement for gross proceeds of up to $12.9 million, but has not made any sales to date[82]. Administrative Expenses - General and administrative expenses rose by $0.1 million, or 9%, to $1.6 million for the three months ended March 31, 2022, from $1.5 million in the prior year[79]. - The company expects general and administrative expenses to increase as it expands infrastructure and continues clinical program development[75]. Impact of COVID-19 - Reviva Pharmaceuticals has taken precautionary measures in response to COVID-19, which may impact clinical trials and operations[60].

Financial Performance - The company has an accumulated deficit of $66.8 million as of December 31, 2021, with a net loss of $8.5 million for the year ended December 31, 2021[349]. - The net loss for the year ended December 31, 2021, was $8.5 million, compared to a net loss of $3.8 million in 2020[374]. - Net cash used in operating activities for 2021 was $10.7 million, an increase of 162% from $4.1 million in 2020[387]. - General and administrative expenses also saw a substantial increase, reaching approximately $5.3 million in 2021, up 146% from $2.1 million in 2020, primarily due to higher consulting and insurance costs[376]. - For the year ended December 31, 2021, operating expenses increased significantly, with research and development expenses rising to $4.9 million from $0.3 million in 2020, representing a 1544% increase[375]. Cash Position and Capital Needs - As of December 31, 2021, the company had cash and cash equivalents of approximately $29.7 million, which is insufficient to complete the development of its product candidates without raising additional capital[350]. - As of December 31, 2021, the company had cash and cash equivalents of approximately $29.7 million, with expectations of incurring significant expenses and operating losses in the foreseeable future[379]. - The company anticipates needing to raise additional capital to fund operations, including clinical trials, and may face dilution of existing stockholders' interests[383]. - The company completed a public offering on June 1, 2021, raising approximately $31.5 million in net proceeds from the sale of 4,133,400 Units and 5,066,600 Pre-Funded Warrants[381]. - Net cash provided by financing activities in 2021 was $31.6 million, primarily from a public offering, compared to $12.8 million in 2020[390]. - The company has entered into an At The Market Offering Agreement in January 2022, allowing for the potential sale of shares for gross proceeds of up to $12.9 million[382]. Research and Development - The company plans to invest significantly in research and development, including clinical trials for RP5063 and pre-clinical research for RP1208[351]. - The estimated initial costs for conducting the Phase 3 clinical study for RP5063 are approximately $25.5 million, with $1.0 million paid in 2021 and $12.0 million expected in 2022[357]. - RP1208 has completed pre-clinical development studies and is ready for IND enabling studies for depression and obesity[355]. - The company is advancing RP5063 through a Phase 3 trial for schizophrenia, with topline data anticipated in mid-2023[355]. - The successful development of the company's product candidates is highly uncertain, and there is no assurance of achieving marketing approval[357]. Future Outlook - The company expects significant expenses and increased operating losses for the next several years due to ongoing research, development, and commercialization activities[349]. - General and administrative expenses are expected to increase as the company expands its infrastructure and clinical programs[360]. - A valuation allowance of 100% has been established for deferred tax assets due to uncertainty regarding their realization[370]. - The company has not generated any revenues from product sales and has never been profitable[349].

Financial Performance - Reviva Pharmaceuticals has an accumulated deficit of $63.1 million as of September 30, 2021, with a net loss of approximately $4.8 million for the nine months ended September 30, 2021[73]. - The company has not generated any revenues from product sales and has never been profitable[73]. - The net loss for the nine months ended September 30, 2021, was approximately $4.8 million, compared to a net loss of $2.3 million for the same period in 2020[92]. - The company reported a gain on remeasurement of warrant liabilities of approximately $1.3 million for the nine months ended September 30, 2021, resulting from a decline in stock price[95]. - Net cash provided by financing activities for the nine months ended September 30, 2021, was approximately $31.5 million, primarily from a public offering[105]. - Net cash used in operating activities for the nine months ended September 30, 2021, was approximately $6.8 million, primarily due to a net loss and changes in operating assets[103]. Research and Development - The lead drug candidate RP5063 is ready for continued clinical development for multiple neuropsychiatric indications, including schizophrenia and bipolar disorder, with a focus on initiating a pivotal Phase 3 study in acute schizophrenia[65][78]. - RP5063 has completed Phase 1 studies for several indications, including major depressive disorder and attention deficit hyperactivity disorder[78]. - The second drug candidate, RP1208, has completed pre-clinical development studies and is ready for IND enabling studies for depression and obesity[78]. - Research and development expenses are expected to increase significantly as the company advances its development programs and prepares for potential commercialization[77]. - Research and development expenses increased by approximately $1.4 million, or 148,943%, for the three months ended September 30, 2021, compared to the same period in 2020, primarily due to higher drug development costs and salary expenditures[87]. - The estimated initial costs for conducting the Phase 3 clinical study for RP5063 are approximately $21.0 million, with payments scheduled over 2021 to 2023[81]. Operational Expenses - General and administrative expenses rose to approximately $1.1 million for the three months ended September 30, 2021, reflecting an increase of $542,000, or 106%, mainly due to higher salaries and insurance costs[88]. - The company expects general and administrative expenses to increase as it expands infrastructure and continues clinical program development[83]. Capital Requirements - Reviva Pharmaceuticals has cash of approximately $33.5 million as of September 30, 2021, but will need to raise additional capital to fund its operations beyond December 2022[75]. - The company does not currently have any committed external sources of capital and may need to raise additional funds through equity or debt financings[98]. Impact of COVID-19 - The impact of the COVID-19 pandemic may adversely affect clinical trials, including patient recruitment and dosing[68]. Future Plans - Reviva Pharmaceuticals plans to seek regulatory and marketing approvals for its product candidates and establish a sales and marketing infrastructure[74].

Financial Performance - Reviva Pharmaceuticals has an accumulated deficit of $60.9 million as of June 30, 2021, with a net loss of approximately $2.6 million for the six months ended June 30, 2021[103]. - The net loss for the six months ended June 30, 2021, was approximately $2.6 million, compared to a net loss of $1.6 million for the same period in 2020[122]. - Net cash used in operating activities for the six months ended June 30, 2021, was approximately $4.5 million, compared to $415,000 for the same period in 2020[134]. - Research and development expenses for Q2 2021 were approximately $374,000, a 926% increase from $36,000 in Q2 2020[116]. - General and administrative expenses for Q2 2021 were approximately $1.4 million, reflecting a 91% increase from $741,000 in Q2 2020[118]. - Research and development expenses for the six months ended June 30, 2021, were approximately $765,000, a 160% increase from $294,000 in the same period in 2020[123]. Future Outlook - The company expects significant expenses and increased operating losses for the next several years due to ongoing research, development, and commercialization activities[104]. - The company anticipates incurring significant expenses and operating losses as it continues its research and development efforts[128]. - Reviva intends to seek additional capital through public or private equity or debt financings to support its clinical development and commercialization efforts[105]. - The company expects general and administrative expenses to increase as it expands infrastructure and clinical programs[113]. Drug Development - Reviva's lead drug candidate, RP5063, is in Phase 2 for schizophrenia and has completed Phase 1 for multiple indications including bipolar disorder and major depressive disorder[108]. - The company has two drug candidates, RP5063 and RP1208, both of which have been granted composition of matter patents in the U.S. and Europe[94]. - The company plans to continue the clinical development of RP5063 for various neuropsychiatric and respiratory indications, subject to additional financing[96]. - The impact of the COVID-19 pandemic may adversely affect clinical trials, including patient recruitment and drug distribution[98]. Capital and Funding - As of June 30, 2021, Reviva had cash of approximately $35.8 million, which is expected to fund operations through at least September 2022[105]. - The company completed a public offering on June 1, 2021, raising approximately $31.5 million in net proceeds[127]. - Reviva has not generated any revenues from product sales and has never been profitable, indicating a reliance on external funding for future operations[103]. Other Financial Metrics - The gain on remeasurement of warrant liabilities for Q2 2021 was approximately $189,000, compared to no gain in Q2 2020[120].

Financial Performance - Reviva Pharmaceuticals has an accumulated deficit of $59.3 million as of March 31, 2021, and reported a net loss of approximately $949,000 for the three months ended March 31, 2021[88]. - The net loss for the three months ended March 31, 2021, was approximately $949,000, compared to a net loss of $749,000 for the same period in 2020[101]. - Net cash used in operating activities for Q1 2021 was approximately $3.1 million, significantly higher than $61,000 in Q1 2020, primarily due to increased net operating assets[112]. - The gain on remeasurement of warrant liabilities for Q1 2021 was approximately $923,000, resulting from a decrease in calculated fair value due to a decline in stock price[105]. - As of March 31, 2021, the company had cash of approximately $5.6 million and expects to incur significant expenses and operating losses in the foreseeable future[106]. Research and Development - The company expects to incur significant expenses and increased operating losses for the next several years as it continues to develop its product candidates[88]. - Reviva Pharmaceuticals has two drug candidates in its pipeline: RP5063 (Brilaroxazine) and RP1208, both of which have been granted composition of matter patents in the U.S., Europe, and other countries[79]. - RP5063 is in Phase 2 clinical development for acute schizophrenia and has completed Phase 1 studies for multiple indications, including bipolar disorder and major depressive disorder[93]. - The company anticipates that its research and development expenses will increase significantly as it advances its development programs and prepares for potential commercialization[92]. - Research and development expenses increased by approximately $120,000, or 44%, from $271,000 in Q1 2020 to $391,000 in Q1 2021, primarily due to higher salary expenditures and increased consulting costs[102]. Operational Challenges - Reviva Pharmaceuticals has taken precautionary measures in response to COVID-19, which may disrupt clinical trials and operations[82]. - The company does not currently have any committed external sources of capital and may need to finance cash needs through equity or debt financings[107]. Future Plans - The company is focusing on completing the clinical development of RP5063 for various neuropsychiatric and respiratory indications, subject to additional financing[81]. - The estimated initial costs for conducting the Phase 3 clinical study for RP5063 are approximately $21.0 million, with $7.0 million payable in 2021, $10.0 million in 2022, and $4.0 million in 2023[96]. - The company plans to establish a sales, marketing, and distribution infrastructure to commercialize any drugs that receive marketing approval[89]. - The company expects general and administrative expenses to increase as it expands infrastructure and continues clinical program development[98]. Administrative Expenses - General and administrative expenses rose by approximately $1.1 million, or 327%, from $347,000 in Q1 2020 to $1.5 million in Q1 2021, driven by increased use of consultants and higher insurance costs[103]. - The company incurred no interest expense in Q1 2021, a decrease from approximately $130,000 in Q1 2020, due to the conversion of all investor notes prior to the Business Combination[104].