Reviva Reports Full Year 2024 Financial Results and Recent Business Highlights
Reviva Pharmaceuticals (NASDAQ: RVPH) reported its 2024 financial results and key developments for brilaroxazine, its late-stage schizophrenia treatment. The preliminary topline data from the open-label extension (OLE) trial showed sustained efficacy over one year with dose-dependent improvements in PANSS scores ranging from -15.2 to -20.8 points across different dosages.
The drug demonstrated favorable safety with no single side effect exceeding 5% and a low treatment-related adverse event rate of 15.2%. The company reported a net loss of $29.9 million ($0.90 per share) for 2024, compared to $39.3 million in 2023. Cash position stood at $13.5 million as of December 31, 2024.
Key upcoming milestones include full OLE trial data analysis in Q2 2025, initiation of Phase 3 RECOVER-2 trial in mid-2025, and targeted NDA submission in Q4 2026. The company completed an $18 million public offering in December 2024.
Reviva Pharmaceuticals (NASDAQ: RVPH) ha riportato i risultati finanziari per il 2024 e gli sviluppi chiave per brilaroxazina, il suo trattamento per la schizofrenia in fase avanzata. I dati preliminari del trial di estensione in aperto (OLE) hanno mostrato un'efficacia sostenuta per oltre un anno, con miglioramenti dipendenti dalla dose nei punteggi PANSS che vanno da -15,2 a -20,8 punti a seconda delle diverse dosi.
Il farmaco ha dimostrato un buon profilo di sicurezza, senza alcun effetto collaterale che superi il 5% e con un basso tasso di eventi avversi correlati al trattamento del 15,2%. La società ha riportato una perdita netta di 29,9 milioni di dollari (0,90 dollari per azione) per il 2024, rispetto ai 39,3 milioni di dollari del 2023. La posizione di cassa si attestava a 13,5 milioni di dollari al 31 dicembre 2024.
I principali traguardi futuri includono l'analisi completa dei dati del trial OLE nel secondo trimestre del 2025, l'inizio del trial di Fase 3 RECOVER-2 a metà del 2025 e la presentazione della NDA prevista per il quarto trimestre del 2026. La società ha completato un'offerta pubblica di 18 milioni di dollari a dicembre 2024.
Reviva Pharmaceuticals (NASDAQ: RVPH) informó sus resultados financieros de 2024 y desarrollos clave para brilaroxazina, su tratamiento para la esquizofrenia en etapa avanzada. Los datos preliminares del ensayo de extensión abierto (OLE) mostraron una eficacia sostenida durante más de un año, con mejoras dependientes de la dosis en los puntajes PANSS que oscilan entre -15.2 y -20.8 puntos en diferentes dosis.
El medicamento demostró un perfil de seguridad favorable, sin ningún efecto secundario que superara el 5% y una baja tasa de eventos adversos relacionados con el tratamiento del 15.2%. La compañía reportó una pérdida neta de 29.9 millones de dólares (0.90 dólares por acción) para 2024, en comparación con 39.3 millones de dólares en 2023. La posición de efectivo se situó en 13.5 millones de dólares al 31 de diciembre de 2024.
Los hitos clave que se avecinan incluyen el análisis completo de los datos del ensayo OLE en el segundo trimestre de 2025, el inicio del ensayo de Fase 3 RECOVER-2 a mediados de 2025 y la presentación de la NDA prevista para el cuarto trimestre de 2026. La compañía completó una oferta pública de 18 millones de dólares en diciembre de 2024.
Reviva Pharmaceuticals (NASDAQ: RVPH)는 2024년 재무 결과와 브릴라록사진에 대한 주요 개발 사항을 보고했습니다. 이 약물은 후기 단계의 정신분열증 치료제입니다. 개방형 확장 연구(OLE)의 예비 데이터는 1년 이상 지속적인 효능을 보여주었으며, 다양한 용량에 따라 PANSS 점수가 -15.2에서 -20.8 포인트까지 개선되었습니다.
이 약물은 5%를 초과하는 부작용이 없고, 치료와 관련된 부작용 발생률이 15.2%로 낮아 안전성이 좋음을 입증했습니다. 회사는 2024년 동안 2,990만 달러의 순손실 (주당 0.90달러)을 보고했으며, 이는 2023년의 3,930만 달러에 비해 감소한 수치입니다. 2024년 12월 31일 기준 현금 보유액은 1,350만 달러였습니다.
주요 향후 이정표로는 2025년 2분기 OLE 연구 데이터 분석 완료, 2025년 중반 Phase 3 RECOVER-2 연구 시작, 2026년 4분기 NDA 제출 예정이 포함됩니다. 회사는 2024년 12월에 1,800만 달러 규모의 공모를 완료했습니다.
Reviva Pharmaceuticals (NASDAQ: RVPH) a annoncé ses résultats financiers pour 2024 et les développements clés concernant brilaroxazine, son traitement de la schizophrénie en phase avancée. Les données préliminaires de l'essai d'extension en ouvert (OLE) ont montré une efficacité soutenue sur plus d'un an, avec des améliorations dépendantes de la dose dans les scores PANSS allant de -15,2 à -20,8 points selon les différentes doses.
Le médicament a démontré un profil de sécurité favorable, sans qu'aucun effet secondaire n'excède 5 % et un faible taux d'événements indésirables liés au traitement de 15,2 %. La société a rapporté une perte nette de 29,9 millions de dollars (0,90 dollar par action) pour 2024, contre 39,3 millions de dollars en 2023. La position de trésorerie s'élevait à 13,5 millions de dollars au 31 décembre 2024.
Les principales étapes à venir comprennent l'analyse complète des données de l'essai OLE au deuxième trimestre 2025, le lancement de l'essai de phase 3 RECOVER-2 à la mi-2025 et la soumission prévue de la NDA au quatrième trimestre 2026. La société a complété une offre publique de 18 millions de dollars en décembre 2024.
Reviva Pharmaceuticals (NASDAQ: RVPH) hat seine finanziellen Ergebnisse für 2024 und wichtige Entwicklungen zu Brilaroxazin, seiner späten Behandlung von Schizophrenie, veröffentlicht. Die vorläufigen Daten aus der offenen Verlängerungsstudie (OLE) zeigten über ein Jahr hinweg eine anhaltende Wirksamkeit mit dosisabhängigen Verbesserungen der PANSS-Werte zwischen -15,2 und -20,8 Punkten bei unterschiedlichen Dosierungen.
Das Medikament zeigte ein günstiges Sicherheitsprofil, ohne dass ein einzelner Nebenwirkung 5% überschritt und mit einer niedrigen Rate von behandlungsbedingten unerwünschten Ereignissen von 15,2%. Das Unternehmen berichtete von einem Nettoverlust von 29,9 Millionen Dollar (0,90 Dollar pro Aktie) für 2024, verglichen mit 39,3 Millionen Dollar im Jahr 2023. Die Liquiditätsposition betrug zum 31. Dezember 2024 13,5 Millionen Dollar.
Wichtige bevorstehende Meilensteine umfassen die vollständige Datenanalyse der OLE-Studie im 2. Quartal 2025, den Beginn der Phase-3-Studie RECOVER-2 Mitte 2025 und die geplante NDA-Einreichung im 4. Quartal 2026. Das Unternehmen hat im Dezember 2024 eine öffentliche Platzierung über 18 Millionen Dollar abgeschlossen.
- Sustained efficacy over 1-year with significant PANSS score improvements
- Strong safety profile with no serious adverse events and low side effect rates
- Reduced net loss from $39.3M in 2023 to $29.9M in 2024
- Successfully raised $18M through public offering in December 2024
- Continued net losses of $29.9M in 2024
- Cash position decreased from $23.4M to $13.5M year-over-year
- Phase 3 RECOVER-2 trial initiation dependent on additional financing
- 35% discontinuation rate in OLE trial
Insights
Reviva's year-end results present a mixed but largely promising picture for its lead candidate brilaroxazine in schizophrenia. The preliminary topline data from the open-label extension (OLE) portion of the Phase 3 RECOVER study revealed sustained efficacy over 1 year with clinically meaningful decreases in PANSS total scores (-18.6 points pooled across doses with p≤0.0001). The 15%, 30%, and 50 mg doses demonstrated dose-dependent efficacy, which strengthens the clinical profile.
The safety profile appears favorable with no single side effect exceeding 5% and only 1.6% discontinuation due to treatment-related adverse events. The most common treatment-related adverse events were weight increase (3.2%), insomnia (1.8%), and somnolence (1.6%) - notably milder than many competing antipsychotics. Importantly, no drug-related serious adverse events were reported after up to 1 year of treatment.
Financially, Reviva ended 2024 with $13.5 million cash, down from $23.4 million in 2023, reflecting ongoing R&D investment. The $29.9 million net loss for 2024 represents an improvement from 2023's $39.3 million loss. The company's $18 million public offering in December provides some runway, but additional financing will likely be needed before the targeted Q4 2026 NDA submission.
The critical factor is whether the full OLE data expected in Q2 2025 will maintain this promising profile and support the initiation of the pivotal RECOVER-2 trial. The explicit statement that the Phase 3 RECOVER-2 trial is "subject to receipt of additional financing" signals a near-term capital requirement that investors should monitor closely.
Brilaroxazine's clinical profile shows important differentiation in the crowded antipsychotic market. The sustained broad-spectrum efficacy across all major symptom domains deserves particular attention. The drug demonstrated statistically significant improvements in not just PANSS total scores but also specifically in positive symptoms (-5.2 points, p≤0.0001) and negative symptoms (-4.5 points, p≤0.0001).
The ability to address negative symptoms is particularly noteworthy, as this remains one of the most challenging aspects of schizophrenia treatment with current therapies. The dose-dependent response pattern provides flexibility for clinical management, with the 50mg dose showing the strongest effect (-20.8 point reduction in PANSS total).
The safety profile appears remarkably clean for an antipsychotic medication. The 35% discontinuation rate is better than typically seen in long-term schizophrenia trials, with only 1.6% discontinuing due to treatment-related adverse events. Metabolic parameters appear well-controlled with only 3.2% reporting weight increase, substantially lower than atypical antipsychotics like olanzapine or quetiapine.
The upcoming biomarker data from vocal and blood samples represents an innovative approach to objectively measuring treatment response. If positive, these biomarkers could provide independent validation of efficacy beyond the standard rating scales and potentially help identify patients most likely to respond.
The mention of a "liposomal-gel formulation" for psoriasis signals potential broader applications leveraging brilaroxazine's mechanism of action in inflammatory conditions, which could expand the drug's commercial potential beyond CNS indications if successful.
– Favorable long-term safety and robust broad-spectrum efficacy sustained over 1-year for once daily brilaroxazine in open-label extension (OLE) trial –
– Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine expected mid-2025 –
– Full data set from RECOVER OLE expected in Q2 2025 –
CUPERTINO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the full year ended December 31, 2024 and summarized recent business highlights.
“Our late stage brilaroxazine program has consistently shown what we believe to be robust broad-spectrum efficacy across all major symptom domains of schizophrenia and a well-tolerated safety profile. Importantly, initial long-term data from our OLE study showed that these favorable efficacy and safety findings were sustained over time. We expect to report the full data set from the RECOVER OLE study, which will also include vocal and blood biomarker data as additional independent measures of efficacy, in the second quarter of 2025,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Brilaroxazine has a robust data package that includes a successful placebo-controlled Phase 3 trial with a long-term open label extension for up to 1-year, a successful Phase 2 study and a compelling drug-drug interaction study. We believe the differentiated potential of once daily brilaroxazine to address all major unmet needs for patients with schizophrenia continues to be strong, and we are targeting a potential New Drug Application (NDA) submission for brilaroxazine in the fourth quarter of 2026.”
Fourth Quarter 2024 and Recent Business Highlights
Clinical Program Highlights
- Positive preliminary topline data for the OLE portion of the Company's ongoing Phase 3 RECOVER study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia announced (December 2024)
- Robust broad-spectrum efficacy that was sustained over 1 year
- Dose dependent efficacy, with decreases in PANSS total scores of -15.2, -18.6 and -20.8 points at the 15, 30, and 50 mg doses respectively, from baseline to end-of-treatment at 52 weeks (1 year)
- Pooled data of brilaroxazine at the 15, 30, and 50 mg doses (N = 113) demonstrated clinically meaningful and sustained long-term (1-year) efficacy for schizophrenia:
- PANSS Total scores: 18.6-point decrease (71.6 → 53), p ≤ 0.0001
- PANSS Positive Symptoms: 5.2-point decrease (17.7 →12.5), p ≤ 0.0001
- PANSS Negative Symptoms: 4.5-point decrease (19.5 →15.0), p ≤ 0.0001
- Generally well tolerated with no single side effect >
5% - Favorable compliance, with a discontinuation rate of
35% , primarily due to withdrawal of consent (22% ), participant lost to follow up (7% ), and treatment-related adverse events (TRAE) (1.6% ) 15.2% reported at least one TRAE, which were mostly mild (12.2% ) or moderate (3% ) in severity and transient in nature- Most common TRAEs ≥
1% were weight increase (3.2% ), insomnia (1.8% ) and somnolence (1.6% )
- No drug-related serious adverse events (SAEs) observed or major safety concerns reported for brilaroxazine after up to 1 year of treatment
Corporate Highlights
- Positive topline data from the long-term OLE portion of the Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia presented as an oral presentation on March 30th at the 2025 Congress of the Schizophrenia International Research Society (SIRS) in Chicago, Illinois
- Completed a public follow-on offering with aggregate gross proceeds of approximately
$18.0 million (December 2024) - Positive speech latency data for brilaroxazine in schizophrenia from the Phase 3 RECOVER trial presented as a poster presentation at the Central Nervous System (CNS) Summit 2024 on November 12th in Boston, Massachusetts
Anticipated Milestones and Events
- Full data analysis of the OLE trial including long-term safety, tolerability and efficacy, as well as vocal and blood biomarker data expected in Q2 2025
- Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in mid-2025, subject to receipt of additional financing
- Potential NDA submission for brilaroxazine in schizophrenia targeted for the fourth quarter of 2026
- Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected later in 2025
- Pursue partnership opportunities for the development of our pipeline
Financial Results for 2024
The Company reported a net loss of approximately
As of December 31, 2024, the Company’s cash and cash equivalents totaled approximately
About Reviva
Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva's current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva's pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.
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 and clinical trial plans, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, 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 Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
bmackle@lifesciadvisors.com
| REVIVA PHARMACEUTICALS HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 13,476,331 | $ | 23,367,456 | ||||
| Prepaid clinical trial costs | 540,601 | 78,295 | ||||||
| Prepaid expenses and other current assets | 666,435 | 254,637 | ||||||
| Total current assets | 14,683,367 | 23,700,388 | ||||||
| Non-current prepaid clinical trial costs | 819,721 | — | ||||||
| Total Assets | $ | 15,503,088 | $ | 23,700,388 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Liabilities | ||||||||
| Short-term debt | $ | 458,154 | $ | — | ||||
| Accounts payable | 6,283,430 | 3,849,108 | ||||||
| Accrued clinical expenses | 6,723,719 | 11,966,812 | ||||||
| Accrued compensation | 635,587 | 958,607 | ||||||
| Other accrued liabilities | 500,616 | 400,490 | ||||||
| Total current liabilities | 14,601,506 | 17,175,017 | ||||||
| Warrant liabilities | 89,010 | 806,655 | ||||||
| Total Liabilities | 14,690,516 | 17,981,672 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' Equity | ||||||||
| Common stock, par value of | 4,658 | 2,792 | ||||||
| Preferred Stock, par value of | — | — | ||||||
| Additional paid-in capital | 165,080,964 | 140,070,172 | ||||||
| Accumulated deficit | (164,273,050 | ) | (134,354,248 | ) | ||||
| Total stockholders' equity | 812,572 | 5,718,716 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 15,503,088 | $ | 23,700,388 | ||||
REVIVA PHARMACEUTICALS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Year Ended December 31, | |||||||||
| 2024 | 2023 | ||||||||
| Operating expenses | |||||||||
| Research and development | $ | 22,907,368 | $ | 31,419,817 | |||||
| General and administrative | 7,891,521 | 8,083,819 | |||||||
| Total operating expenses | 30,798,889 | 39,503,636 | |||||||
| Loss from operations | (30,798,889 | ) | (39,503,636 | ) | |||||
| Other income (expense) | |||||||||
| Gain (loss) on remeasurement of warrant liabilities | 717,645 | (239,216 | ) | ||||||
| Interest expense | (18,497 | ) | (33,725 | ) | |||||
| Interest income | 361,369 | 398,413 | |||||||
| Other (expense) income, net | (160,916 | ) | 134,276 | ||||||
| Total other income, net | 899,601 | 259,748 | |||||||
| Loss before provision for income taxes | (29,899,288 | ) | (39,243,888 | ) | |||||
| Provision for income taxes | 19,514 | 16,949 | |||||||
| Net loss | $ | (29,918,802 | ) | $ | (39,260,837 | ) | |||
| Net loss per share: | |||||||||
| Basic and diluted | $ | (0.90 | ) | $ | (1.65 | ) | |||
| Weighted average shares outstanding | |||||||||
| Basic and diluted | 33,147,424 | 23,798,203 | |||||||
FAQ
What were the key efficacy results from RVPH's brilaroxazine OLE trial in 2024?
What is the safety profile of RVPH's brilaroxazine in the long-term study?
When does RVPH plan to submit the New Drug Application (NDA) for brilaroxazine?
What is RVPH's current cash position and financial performance for 2024?
What are the next major clinical milestones for RVPH's brilaroxazine?
