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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 ...
Reviva Pharmaceuticals (RVPH) - 2022 Q1 - Quarterly Report
2022-05-16 20:20
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].
Reviva Pharmaceuticals (RVPH) - 2021 Q4 - Annual Report
2022-03-15 21:19
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].
Reviva Pharmaceuticals (RVPH) - 2021 Q3 - Quarterly Report
2021-11-15 13:00
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].
Reviva Pharmaceuticals (RVPH) - 2021 Q2 - Quarterly Report
2021-08-16 12:01
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].
Reviva Pharmaceuticals (RVPH) - 2021 Q1 - Quarterly Report
2021-05-17 13:20
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].
Reviva Pharmaceuticals (RVPH) - 2020 Q4 - Annual Report
2021-03-22 12:00
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, 2020 (Exact name of registrant as specified in its charter) Delaware 85-4306526 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 19925 Stevens Creek Blvd., Suite 100 Cupertino, CA 95014 95014 (Address of principal executive offices) (Zip c ...