– Gained alignment with
– 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 –
“This quarter we made strong progress across our late-stage brilaroxazine program in schizophrenia. Importantly, we gained registrational clarity from the FDA on the requirements for an NDA submission which we are on track to complete in the fourth quarter of 2025,” said
First Quarter 2024 and Recent Business Highlights
Corporate Highlights
- Hosted key opinion leader (KOL) webinar on topline RECOVER-1 Phase 3 data for brilaroxazine and the unmet medical need and current treatment landscape for schizophrenia, featuring presentations by
Larry Ereshefsky , PharmD,BCPP , FCCP, of Follow the Molecule andMark Opler , PhD, MPH of WCG (February 2024 )
Clinical Program Highlights
- Announced alignment with the
U.S. Food and Drug Administration (FDA) on registrational Phase 3 program for brilaroxazine in schizophrenia (April 2024 )- Acceptance of a 4-week RECOVER-2 study
- Indication that two positive Phase 3 studies showing efficacy at week 4 that are accompanied by long-term safety data of at least 12 months could be supportive of an NDA submission for the acute treatment of schizophrenia
- Requirement of a long-term randomized withdrawal study post-approval to support maintenance of effect
- Presented successful RECOVER-1 Phase 3 clinical trial data for brilaroxazine in schizophrenia at the 2024
Schizophrenia International Research Society (SIRS) Annual Meeting (April 2024 ) - Presented successful RECOVER-1 Phase 3 clinical trial data for brilaroxazine in schizophrenia at the
American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2024 Annual Meeting (March 2024 )
Anticipated Milestones and Events
- Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in Q2 2024
- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024
- Topline data from registrational Phase 3 RECOVER-2 trial expected Q3 2025
- Potential NDA submission for brilaroxazine in schizophrenia targeted for Q4 2025
- May initiate Phase 2a studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024
- Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2025
- 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
First Quarter 2024 Financial Results
The Company reported a net loss of approximately
As of
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-1 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
About Reviva
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 for brilaroxazine in schizophrenia, the registrational Phase 3 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 including statements about the Company’s expectations regarding its planned New Drug Application (NDA) submission in schizophrenia, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, 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 (UNAUDITED) | |||||||
2024 | 2023 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 11,973,647 | $ | 23,367,456 | |||
Prepaid clinical trial costs | 779,602 | 78,295 | |||||
Prepaid expenses and other current assets | 743,381 | 254,637 | |||||
Total Assets | $ | 13,496,630 | $ | 23,700,388 | |||
Liabilities and Stockholders' Equity (Deficit) | |||||||
Liabilities | |||||||
Short-term debt | $ | 332,000 | $ | — | |||
Accounts payable | 5,720,455 | 3,849,108 | |||||
Accrued clinical expenses | 6,845,910 | 11,966,812 | |||||
Accrued compensation | 1,216,237 | 958,607 | |||||
Other accrued liabilities | 377,367 | 400,490 | |||||
Total current liabilities | 14,491,969 | 17,175,017 | |||||
Warrant liabilities | 350,478 | 806,655 | |||||
Total Liabilities | 14,842,447 | 17,981,672 | |||||
Commitments and contingencies | |||||||
Stockholders' Equity (Deficit) | |||||||
Common stock, par value of | 2,792 | 2,792 | |||||
Preferred Stock, par value of | — | — | |||||
Additional paid-in capital | 140,439,247 | 140,070,172 | |||||
Accumulated deficit | (141,787,856 | ) | (134,354,248 | ) | |||
Total stockholders' equity (deficit) | (1,345,817 | ) | 5,718,716 | ||||
Total Liabilities and Stockholders' Equity (Deficit) | $ | 13,496,630 | $ | 23,700,388 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||
For the Three Months Ended | |||||||
Three Months Ended | |||||||
2024 | 2023 (as restated) | ||||||
Operating expenses | |||||||
Research and development | $ | 5,783,865 | $ | 5,484,145 | |||
General and administrative | 2,138,241 | 1,500,554 | |||||
Total operating expenses | 7,922,106 | 6,984,699 | |||||
Loss from operations | (7,922,106 | ) | (6,984,699 | ) | |||
Other income (expense) | |||||||
Gain on remeasurement of warrant liabilities | 456,177 | 11,126 | |||||
Interest expense | (3,487 | ) | (7,655 | ) | |||
Interest income | 173,098 | 147,011 | |||||
Other expense | (129,894 | ) | (14,494 | ) | |||
Total other income, net | 495,894 | 135,988 | |||||
Loss before provision for income taxes | (7,426,212 | ) | (6,848,711 | ) | |||
Provision for income taxes | 7,396 | 2,978 | |||||
Net loss | $ | (7,433,608 | ) | $ | (6,851,689 | ) | |
Net loss per share: | |||||||
Basic and diluted | $ | (0.25 | ) | $ | (0.31 | ) | |
Weighted average shares outstanding | |||||||
Basic and diluted | 29,887,325 | 21,833,598 |
Source:
2024 GlobeNewswire, Inc., source