– RECOVER-1 Phase 3 global trial successfully met all primary and secondary endpoints with statistically significant reductions across all major symptom domains in schizophrenia –
– Initiation of registrational RECOVER-2 trial expected in the second quarter of 2024; topline data expected Q2 2025 –
– Topline data from 1-year open-label extension (OLE) trial expected Q4 2024 –
– Most non-clinical activities completed and preparation is underway to support a New Drug Application (NDA) submission for brilaroxazine in schizophrenia targeted for Q3 2025 –
“2023 was an exciting and productive year for
Full Year 2023 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 ) - Completed
$30 million registered direct offering (November 2023 ) - Joined the Russell Microcap® Index with automatic inclusion in the appropriate growth and value style indexes (
June 2023 ) - Hosted KOL webinar on brilaroxazine for the treatment of schizophrenia, featuring a presentation by
Larry Ereshefsky , PharmD (Follow theMolecule LLC ) (May 2023 )
Clinical Program Highlights
- Announced positive topline results and successful completion of Reviva’s pivotal Phase 3 RECOVER-1 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.
- Presented promising clinical pharmacology and safety data for brilaroxazine at the
American Society for Pharmacology and Experimental Therapeutics (ASPET) 2023 annual meeting (May 2023 )
Preclinical Program Highlights
- Announced positive preclinical data for brilaroxazine in idiopathic pulmonary fibrosis (IPF) at the 2023
American Thoracic Society (ATS) International Conference and publication in Medical Research Archives (May 2023 ) - Presented on preclinical data on the potential of a brilaroxazine liposomal-gel formulation in psoriasis at the International Societies for Investigative Dermatology (ISID) Meeting (
May 2023 ) - Presented foundational preclinical data on brilaroxazine in schizophrenia at the 78th Annual
Scientific Convention of the Society of Biological Psychiatry (SOBP) and publication in Medical Research Archives (May 2023 )
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 Q2 2025
- Potential NDA submission for brilaroxazine in schizophrenia targeted for Q3 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
Financial Results for 2023 and Restatement
For the year ended
As of
The financial and related data for 2022 included in this press release, including in this “Financial Results” section and in the attached tables, is reflective of the restatement adjustments to the Company’s previously issued financial statements for the year ended
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
To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.
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, 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, and the Company’s other filings from time to time with the
Corporate Contact:
www.revivapharma.com
Investor Relations Contact:
bmackle@lifesciadvisors.com
Media Contact:
kpoliti@lifescicomms.com
(646) 876-4783
CONSOLIDATEDBALANCE SHEETS | ||||||||
2023 | 2022 | |||||||
(As restated) | ||||||||
Assets | ||||||||
Cash and cash equivalents | $ | 23,367,456 | $ | 18,519,856 | ||||
Prepaid expenses and other current assets | 332,932 | 403,819 | ||||||
Total Assets | $ | 23,700,388 | $ | 18,923,675 | ||||
Liabilities and Stockholders' Equity | ||||||||
Liabilities | ||||||||
Accounts payable | $ | 3,849,108 | $ | 3,520,271 | ||||
Accrued clinical expenses | 11,966,812 | 5,578,374 | ||||||
Accrued compensation | 958,607 | 564,646 | ||||||
Other accrued liabilities | 400,490 | 298,699 | ||||||
Total current liabilities | 17,175,017 | 9,961,990 | ||||||
Warrant liabilities | 806,655 | 567,439 | ||||||
Total Liabilities | 17,981,672 | 10,529,429 | ||||||
Commitments and contingencies | ||||||||
Stockholders' Equity | ||||||||
Common stock, par value of | 2,792 | 2,045 | ||||||
Preferred Stock, par value of | — | — | ||||||
Additional paid-in capital | 140,070,172 | 103,485,612 | ||||||
Accumulated deficit | (134,354,248 | ) | (95,093,411 | ) | ||||
Total stockholders' equity | 5,718,716 | 8,394,246 | ||||||
Total Liabilities and Stockholders' Equity | $ | 23,700,388 | $ | 18,923,675 |
CONSOLIDATED STATEMENTS OF OPERATIONS For the Years Ended | ||||||||
Year Ended | ||||||||
2023 | 2022 | |||||||
(As restated) | ||||||||
Operating expenses | ||||||||
Research and development | $ | 31,419,817 | $ | 22,870,024 | ||||
General and administrative | 8,083,819 | 5,358,734 | ||||||
Total operating expenses | 39,503,636 | 28,228,758 | ||||||
Loss from operations | (39,503,636 | ) | (28,228,758 | ) | ||||
Other income (expense) | ||||||||
Loss on remeasurement of warrant liabilities | (239,216 | ) | (194,709 | ) | ||||
Interest and other income, net | 498,964 | 182,802 | ||||||
Total other income (expense), net | 259,748 | (11,907 | ) | |||||
Loss before provision for income taxes | (39,243,888 | ) | (28,240,665 | ) | ||||
Provision for income taxes | (16,949 | ) | (20,777 | ) | ||||
Net loss | $ | (39,260,837 | ) | $ | (28,261,442 | ) | ||
Net loss per share: | ||||||||
Basic and diluted | $ | (1.65 | ) | $ | (1.45 | ) | ||
Weighted average shares outstanding | ||||||||
Basic and diluted | 23,798,203 | 19,516,479 |
RESTATEMENT ADJUSTMENTS For the Years Ended | ||||||||||||
Balance Sheet and Statement of Changes in Stockholders’ Equity | 2022 As Previously Reported | Adjustment | 2022 As Restated | |||||||||
Accrued clinical expenses | $ | 1,656,224 | $ | 3,922,150 | $ | 5,578,374 | ||||||
Total current liabilities | 6,039,840 | 3,922,150 | 9,961,990 | |||||||||
Total liabilities | 6,607,279 | 3,922,150 | 10,529,429 | |||||||||
Accumulated deficit | (91,171,261 | ) | (3,922,150 | ) | (95,093,411 | ) | ||||||
Total Stockholders' Equity | 12,316,396 | (3,922,150 | ) | 8,394,246 |
Statement of Operations | Year Ended 2022 As Previously Reported | Adjustment | Year Ended 2022 As Restated | |||||||||
Research and development | $ | 18,947,874 | $ | 3,922,150 | $ | 22,870,024 | ||||||
Total operating expenses | 24,306,608 | 3,922,150 | 28,228,758 | |||||||||
Loss from operations | (24,306,608 | ) | (3,922,150 | ) | (28,228,758 | ) | ||||||
Net loss | (24,339,292 | ) | (3,922,150 | ) | (28,261,442 | ) | ||||||
Basic and diluted | $ | (1.25 | ) | $ | (0.20 | ) | $ | (1.45 | ) |
Statement of Cash Flows | Year Ended 2022 As Previously Reported | Adjustment | Year Ended 2022 As Restated | |||||||||
Cash flows from operating activities | ||||||||||||
Net loss | $ | (24,339,292 | ) | $ | (3,922,150 | ) | $ | (28,261,442 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||||||
Changes in operating assets and liabilities | ||||||||||||
Accrued expenses and other current liabilities | 684,341 | 3,922,150 | 4,606,491 | |||||||||
Net cash used in operating activities | (18,960,581 | ) | — | (18,960,581 | ) |
Source:
2024 GlobeNewswire, Inc., source