- RECOVER global Phase 3 trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo in schizophrenia –
- Consistent Phase 3 RECOVER and Phase 2 REFRESH findings reinforce meaningful improvements across domains, well-tolerated safety, and low discontinuation rates for brilaroxazine vs. placebo –
- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 -
“Our brilaroxazine clinical program continues to advance, and we were pleased to recently announce positive topline results for our global Phase 3 RECOVER trial in adults with schizophrenia. The RECOVER trial met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine compared to placebo,” said
Recent Business Highlights
- Announced positive topline results and successful completion of Reviva’s pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine in adults with schizophrenia (
October 2023 )- Trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4.
- Brilaroxazine achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo.
- The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints and reached statistical significance on two key secondary endpoints.
- Generally well-tolerated with a side effect profile comparable to placebo for the 15 and 50 mg doses of brilaroxazine; discontinuation rates for brilaroxazine lower than placebo.
- Over 50% of patients currently enrolled in the 1-year OLE study for brilaroxazine in schizophrenia
Anticipated Milestones and Events
- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024
- Initiation of a registrational Phase 3 RECOVER-2 trial expected Q1 2024
- May initiate Phase 2a studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024
- Submit investigational new drug application (IND) for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2024
- Pursue partnership opportunities for the development of our pipeline
- Evaluate grant and other non-dilutive financing opportunities for our product candidates from Federal and State Healthcare Agencies and Foundations
Third Quarter 2023 Financial Results
The Company reported a net loss of approximately
As of
First Nine Months Fiscal Year 2023 Financial Results
The Company reported a net loss of approximately
About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor.
Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the
To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.
About
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability, registrational global, randomized 6-week Phase RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development, clinical and regulatory timelines and expenses, planned or additional studies, planned or intended regulatory submissions, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended
Corporate Contact:
www.revivapharma.com
Investor Relations Contact:
bmackle@lifesciadvisors.com
Media Contact:
kpoliti@lifescicomms.com
(646) 876-4783
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
2023 | 2022 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 4,972,298 | $ | 18,519,856 | ||||
Prepaid expenses and other current assets | 414,743 | 403,819 | ||||||
Total Assets | $ | 5,387,041 | $ | 18,923,675 | ||||
Liabilities and Stockholders' Equity | ||||||||
Liabilities | ||||||||
Short-term debt | $ | 222,500 | $ | — | ||||
Accounts payable | 5,278,375 | 3,520,271 | ||||||
Accrued expenses and other current liabilities | 7,532,187 | 2,519,569 | ||||||
Total current liabilities | 13,033,062 | 6,039,840 | ||||||
Warrant liabilities | 873,411 | 567,439 | ||||||
Total Liabilities | 13,906,473 | 6,607,279 | ||||||
Commitments and contingencies (Note 7) | ||||||||
Stockholders' equity | ||||||||
Common stock, par value of | 2,265 | 2,045 | ||||||
Additional paid-in capital | 112,185,998 | 103,485,612 | ||||||
Accumulated deficit | (120,707,695 | ) | (91,171,261 | ) | ||||
Total stockholders' equity | (8,519,432 | ) | 12,316,396 | |||||
Total Liabilities and Stockholders' Equity | $ | 5,387,041 | $ | 18,923,675 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||||||
For the Three and Nine Months Ended | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 8,717,273 | $ | 2,305,981 | $ | 22,943,522 | $ | 12,650,388 | ||||||||
General and administrative | 1,991,774 | 1,256,972 | 6,571,629 | 3,882,210 | ||||||||||||
Total operating expenses | 10,709,047 | 3,562,953 | 29,515,151 | 16,532,598 | ||||||||||||
Loss from operations | (10,709,047 | ) | (3,562,953 | ) | (29,515,151 | ) | (16,532,598 | ) | ||||||||
Other (expense) income | ||||||||||||||||
Gain (loss) on remeasurement of warrant liabilities | 139,079 | — | (305,972 | ) | 267,031 | |||||||||||
Interest expense | (5,901 | ) | — | (20,414 | ) | — | ||||||||||
Interest income | 91,763 | 53,150 | 341,854 | 68,710 | ||||||||||||
Other income (expense) | 5,194 | (3,641 | ) | (15,220 | ) | (11,749 | ) | |||||||||
Total other (expense) income, net | 230,135 | 49,509 | 248 | 323,992 | ||||||||||||
Loss before provision for income taxes | (10,478,912 | ) | (3,513,444 | ) | (29,514,903 | ) | (16,208,606 | ) | ||||||||
Provision for income taxes | 12,117 | 1,864 | 21,531 | 12,414 | ||||||||||||
Net loss | $ | (10,491,029 | ) | $ | (3,515,308 | ) | $ | (29,536,434 | ) | $ | (16,221,020 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.44 | ) | $ | (0.18 | ) | $ | (1.30 | ) | $ | (0.87 | ) | ||||
Weighted average shares outstanding | ||||||||||||||||
Basic and diluted | 24,033,665 | 19,269,989 | 22,775,407 | 18,737,330 |
Source:
2023 GlobeNewswire, Inc., source