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Reviva Reports Second Quarter 2025 Financial Results and Recent Business Highlights

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Reviva Pharmaceuticals (NASDAQ: RVPH) has reported significant progress in its brilaroxazine development program for schizophrenia treatment, alongside Q2 2025 financial results. The company successfully completed its Phase 3 RECOVER open-label extension (OLE) 1-year study, demonstrating sustained efficacy across all symptom domains and a well-tolerated safety profile.

Key clinical achievements include robust broad-spectrum efficacy with improvements in PANSS total score (-18.1), positive symptoms (-5.0), and negative symptoms (-4.4). The company plans to meet with the FDA in Q4 2025 to discuss the path to approval, with a potential NDA submission targeted for Q2 2026.

Financially, Reviva reported a net loss of $6.1 million ($0.12 per share) for Q2 2025, compared to $7.9 million in Q2 2024. The company's cash position stands at $10.4 million, bolstered by a recent $10.0 million public equity offering.

Reviva Pharmaceuticals (NASDAQ: RVPH) ha annunciato progressi rilevanti nel suo programma di sviluppo di brilaroxazina per il trattamento della schizofrenia e ha comunicato i risultati finanziari del secondo trimestre 2025. L'azienda ha completato con successo lo studio di estensione in aperto (OLE) di 1 anno della Fase 3 RECOVER, dimostrando efficacia duratura su tutti i domini sintomatologici e un profilo di sicurezza ben tollerato.

I principali risultati clinici includono una solida efficacia ad ampio spettro con miglioramenti nel punteggio PANSS totale (-18,1), nei sintomi positivi (-5,0) e in quelli negativi (-4,4). La società prevede un incontro con la FDA nel quarto trimestre 2025 per discutere il percorso verso l'approvazione, con l'obiettivo di una possibile presentazione della NDA nel secondo trimestre 2026.

Sul fronte finanziario, Reviva ha registrato una perdita netta di 6,1 milioni di dollari (0,12$ per azione) nel Q2 2025, rispetto a 7,9 milioni nel Q2 2024. La liquidità disponibile è pari a 10,4 milioni di dollari, rafforzata da un recente aumento di capitale pubblico di 10,0 milioni di dollari.

Reviva Pharmaceuticals (NASDAQ: RVPH) ha informado avances significativos en su programa de desarrollo de brilaroxazina para el tratamiento de la esquizofrenia y sus resultados financieros del segundo trimestre de 2025. La compañía completó con éxito el estudio de extensión abierta (OLE) de 1 año de la Fase 3 RECOVER, mostrando eficacia sostenida en todos los dominios de síntomas y un perfil de seguridad bien tolerado.

Entre los logros clínicos clave figura una robusta eficacia de amplio espectro con mejoras en la puntuación PANSS total (-18,1), en los síntomas positivos (-5,0) y en los negativos (-4,4). La empresa planea reunirse con la FDA en el cuarto trimestre de 2025 para abordar la vía hacia la aprobación, con la posible presentación de una NDA prevista para el segundo trimestre de 2026.

En lo financiero, Reviva reportó una pérdida neta de 6,1 millones de dólares (0,12$ por acción) en el Q2 de 2025, frente a 7,9 millones en el Q2 de 2024. La posición de efectivo asciende a 10,4 millones de dólares, reforzada por una reciente oferta pública de acciones por 10,0 millones de dólares.

Reviva Pharmaceuticals (NASDAQ: RVPH)� 조현� 치료� 브릴라록사진(Brilaroxazine) 개발 프로그램에서 중요� 진전� 보고하고 2025� 2분기 재무실적� 발표했습니다. 회사� 3� RECOVER 공개연장(OLE) 1� 연구� 성공적으� 완료했으�, 모든 증상 영역에서 지속적� 효능� 양호� 내약성의 안전� 프로파일� 입증했습니다.

주요 임상 성과로는 PANSS 총점(-18.1), 양성 증상(-5.0), 음성 증상(-4.4)에서� 개선� 포함� 광범위하� 강력� 효능� 있습니다. 회사� 승인 경로� 논의하기 위해 2025� 4분기� FDA와 회의� 가� 계획이며, 2026� 2분기 NDA 제출� 목표� 하고 있습니다.

재무적으� Reviva� 2025� 2분기� 순손� 610� 달러(주당 0.12달러)� 보고했으�, 이는 2024� 2분기� 790� 달러� 비해 감소� 수치입니�. 현금 보유액은 최근 1000� 달러� 공모 자금 확보� 1040� 달러입니�.

Reviva Pharmaceuticals (NASDAQ: RVPH) a annoncé des progrès significatifs dans son programme de développement de la brilaroxazine pour le traitement de la schizophrénie, ainsi que ses résultats financiers du deuxième trimestre 2025. La société a mené à bien l'étude d'extension en ouvert (OLE) d'un an de la Phase 3 RECOVER, démontrant une efficacité soutenue sur tous les domaines symptomatiques et un profil de sécurité bien toléré.

Parmi les principales avancées cliniques figurent une efficacité large et robuste avec des améliorations du score total PANSS (-18,1), des symptômes positifs (-5,0) et des symptômes négatifs (-4,4). La société prévoit de rencontrer la FDA au 4e trimestre 2025 pour discuter de la voie d'approbation, avec une éventuelle soumission de NDA ciblée au 2e trimestre 2026.

Sur le plan financier, Reviva a affiché une perte nette de 6,1 millions de dollars (0,12 $ par action) au T2 2025, contre 7,9 millions au T2 2024. La trésorerie s'élève à 10,4 millions de dollars, soutenue par une récente levée de fonds publique de 10,0 millions de dollars.

Reviva Pharmaceuticals (NASDAQ: RVPH) hat bedeutende Fortschritte in seinem Entwicklungsprogramm für Brilaroxazin zur Behandlung von Schizophrenie gemeldet und die Finanzergebnisse für das 2. Quartal 2025 veröffentlicht. Das Unternehmen schloss die offene Verlängerungsstudie (OLE) der Phase�3‑Studie RECOVER über ein Jahr erfolgreich ab und zeigte anhalte Wirksamkeit in allen Symptombereichen sowie ein gut verträgliches Sicherheitsprofil.

Zu den wichtigsten klinischen Ergebnissen zählen eine robuste breit angelegte Wirksamkeit mit Verbesserungen im PANSS‑Gesamtwert (-18,1), bei positiven Symptomen (-5,0) und bei negativen Symptomen (-4,4). Das Unternehmen plant, sich im 4. Quartal 2025 mit der FDA zu treffen, um den Zulassungsweg zu besprechen, mit einer möglichen NDA‑Einreichung im 2. Quartal 2026.

Finanziell verzeichnete Reviva im 2. Quartal 2025 einen Nettogewinnverlust von 6,1 Mio. USD (0,12 USD je Aktie), gegenüber 7,9 Mio. USD im Q2 2024. Die liquiden Mittel belaufen sich auf 10,4 Mio. USD, gestützt durch ein jüngstes öffentliches Aktienangebot in Höhe von 10,0 Mio. USD.

Positive
  • Successful completion of Phase 3 RECOVER open-label extension trial showing sustained efficacy over 1 year
  • Improved PANSS scores across all symptom domains including negative symptoms
  • Reduced quarterly net loss from $7.9M in Q2 2024 to $6.1M in Q2 2025
  • Raised $10.0M through public equity offering
  • Patent portfolio potentially extending to 2045 and beyond
Negative
  • 35% discontinuation rate in 1-year trial
  • Cash position decreased from $13.5M in December 2024 to $10.4M in June 2025
  • Additional Phase 3 RECOVER-2 trial may be required pending FDA feedback

Insights

Reviva's brilaroxazine shows promising 1-year safety/efficacy data for schizophrenia, positioning for potential NDA filing in Q2 2026.

Reviva has reached a significant milestone with the successful completion of its 1-year open-label extension (OLE) trial for brilaroxazine in schizophrenia. The data package now includes two large randomized double-blind trials (Phase 2 and Phase 3), a 1-year OLE trial, and supporting clinical pharmacology studies—essentially completing the clinical requirements for FDA submission.

The OLE results demonstrate sustained efficacy across all symptom domains, with meaningful improvements in the challenging-to-treat negative symptoms (PANSS negative symptom reduction of -4.4 points). This is particularly noteworthy as negative symptoms often remain resistant to current antipsychotics and significantly impact functional outcomes and quality of life.

The discontinuation rate of 35% over one year suggests reasonable tolerability compared to typical attrition rates for antipsychotics. Most importantly, this completed data package has given the company confidence to seek an FDA meeting in Q4 2025 to potentially bypass the planned RECOVER-2 trial and proceed directly to NDA submission by Q2 2026.

The company is simultaneously expanding its intellectual property portfolio with patents potentially extending to 2045, which would provide crucial market exclusivity well beyond the initial approval. Additionally, Reviva is exploring a novel liposomal-gel formulation of brilaroxazine for psoriasis, suggesting potential for label expansion into inflammatory conditions—a strategically sound approach to maximize the commercial potential of their lead compound.

Positive clinical progress coupled with narrowing losses and $10.4M cash position creates cautious optimism amid upcoming regulatory milestones.

Reviva's financial position shows some improvement with quarterly losses narrowing to $6.1 million ($0.12 per share) compared to $7.9 million ($0.26 per share) in the same quarter last year. This 23% reduction in net loss reflects improved operational efficiency as the company transitions from late-stage clinical development toward regulatory submission.

The current cash position stands at $10.4 million, down from $13.5 million at year-end 2024. The company successfully raised $10 million through a public equity offering, which has bolstered its runway. However, this level of cash reserves requires careful management given the substantial costs associated with NDA preparation and submission.

While no explicit cash runway guidance was provided, pharmaceutical companies typically require significant capital for NDA submissions and pre-commercial activities. With quarterly cash burn likely in the $5-7 million range based on recent performance, Reviva may need additional financing before reaching potential approval in late 2026 or 2027.

The company's pursuit of partnership opportunities for pipeline development is strategically sound, as it could provide non-dilutive capital while leveraging external expertise. A successful FDA meeting in Q4 2025 potentially eliminating the need for an additional Phase 3 trial would significantly reduce future capital requirements and accelerate the timeline to potential commercialization—representing a crucial inflection point for investor sentiment.

� Well-tolerated safety profile and robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms in open label extension (OLE) 1-year trial�

� Successful completion of two large randomized double-blind clinical trials, including one Phase 2 and one Phase 3 trial, a 1-year OLE trial, and clinical pharmacology studies designed to support filing of New Drug Application (NDA) �

� Planned meeting with Food and Drug Administration (FDA) to discuss brilaroxazine’s path to approval for schizophrenia in Q4 2025; potential NDA submission targeted for Q2 2026 �

CUPERTINO, Calif., Aug. 14, 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 second quarter ended June 30, 2025 and summarized recent business highlights.

“The successful completion of our global OLE 1-year trial marks a major milestone for the brilaroxazine program as we advance toward potential registration,� said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “This comprehensive dataset reinforces our prior positive clinical results and highlights the long-term safety, broad-spectrum sustained efficacy, and strong adherence profile of once daily brilaroxazine. We believe all key clinical data required for NDA are completed and we are preparing for an End-of-Phase 3 meeting with the FDA planned in the fourth quarter of the year to discuss our future NDA submission based on the current data package and excluding the planned Phase 3 RECOVER-2 trial. Pending favorable feedback from the FDA, we will target an NDA submission in the second quarter of 2026. Brilaroxazine continues to demonstrate a differentiated and durable clinical profile, positioning it as a potential new standard of care in schizophrenia and a meaningful driver of long-term value.�

Second Quarter 2025 and Recent Business Highlights

Clinical Program and Business Highlights

  • Announced a positive full dataset and successful completion of the Company’s Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia
    • Once daily brilaroxazine (pooled 15, 30, and 50 mg, N=446) led to robust broad-spectrum efficacy that was sustained over 1-year including PANSS total score (�18.1), positive symptoms (�5.0), negative symptoms (�4.4) and negative Marder factor (-4.4)
    • Generally well tolerated with a discontinuation rate of 35% after 1-year for pooled doses of brilaroxazine (pooled 15, 30, and 50 mg, N=446)

  • Continuing efforts aimed at expansion of strong diversified patent portfolio comprising composition of matter and lifecycle management strategies for innovative formulations and method of treatment for different major indications with clear regulatory path including potential patent and/or market exclusivity up to 2045 and beyond.

  • Presented a late-breaking poster presentation on the RECOVER 12-month OLE trial for brilaroxazine in schizophrenia at the 2025 American Society of Clinical Psychopharmacology (ASCP) annual meeting on Wednesday May 28, 2025, in Scottsdale, AZ.

  • Completed public equity offering raising gross proceeds of $10.0 million, before deducting placement agent fees and other offering expenses.

Anticipated Milestones and Events

  • Planned meeting with FDA to discuss brilaroxazine’s path to approval in Q4 2025
  • Potential NDA submission for brilaroxazine in schizophrenia targeted in Q2 2026
  • Plans are being assessed to initiate a potential registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia pending FDA recommendation for a path to approval
  • Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected by Q2- 2026
  • Pursuing partnership opportunities for the development of our pipeline

Financial Results for June 30, 2025

  • The Company reported a net loss of approximately $6.1 million, or $0.12 per share, for the three months ended June 30, 2025, compared to a net loss of approximately $7.9 million, or $0.26 per share, for the three months ended June 30, 2024.

  • As of June 30, 2025, the Company’s cash and cash equivalents totaled approximately $10.4 million compared to approximately $13.5 million as of December 31, 2024.

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 plans for its brilaroxazine program including intended steps towards potential approval, the Company’s plans for meeting with FDA and plans for potential NDA submission, the Company’s statements regarding assessment of plans for a potential registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia, if required, statements about potential IND submissions, 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 and the timing thereof, including the anticipated timing of the availability of trial data, 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 for the fiscal year ended December 31, 2024, 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

Investor Relations Contact:
LifeSci Advisors, LLC
PJ Kelleher

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
June 30,December 31,
20252024
Assets
Cash and cash equivalents$10,363,714$13,476,331
Prepaid clinical trial costs104,447540,601
Prepaid expenses and other current assets346,964666,435
Total current assets10,815,12514,683,367
Non-current prepaid clinical trial costs819,721819,721
Total Assets$11,634,846$15,503,088
Liabilities and Stockholders� Equity (Deficit)
Liabilities
Short-term debt$113,246$458,154
Accounts payable4,968,6886,283,430
Accrued clinical expenses5,470,1856,723,719
Accrued compensation602,592635,587
Other accrued liabilities922,592500,616
Total current liabilities12,077,30314,601,506
Warrant liabilities16,69089,010
Total Liabilities12,093,99314,690,516
Commitments and contingencies
Stockholders� Equity (Deficit)
Common stock, par value of $0.0001; 315,000,000 shares authorized; 68,003,613 and 46,579,199 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively6,8004,658
Preferred Stock, par value of $0.0001; 10,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2025 and December 31, 2024
Additional paid-in capital176,293,553165,080,964
Accumulated deficit(176,759,500)(164,273,050)
Total stockholders' equity (deficit)(459,147)812,572
Total Liabilities and Stockholders� Equity (Deficit)$11,634,846$15,503,088


REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
Three Months Ended June 30,Six Months Ended June 30,
2025202420252024
Operating expenses
Research and development$3,724,755$5,584,347$7,838,292$11,368,212
General and administrative2,348,2272,545,2964,772,8574,683,537
Total operating expenses6,072,9828,129,64312,611,14916,051,749
Loss from operations(6,072,982)(8,129,643)(12,611,149)(16,051,749)
Other income (expense)
Gain on remeasurement of warrant liabilities11,126200,27372,320656,450
Interest expense(4,797)(5,153)(16,417)(8,640)
Interest income22,84787,610108,958260,708
Other (expense) income, net(1,850)(5,621)(26,995)(135,515)
Total other (expense) income, net27,326277,109137,866773,003
Loss before provision for income taxes(6,045,656)(7,852,534)(12,473,283)(15,278,746)
Provision for income taxes7,9547,38513,16714,781
Net loss$(6,053,610)$(7,859,919)$(12,486,450)$(15,293,527)
Net loss per share:
Basic and diluted$(0.12)$(0.26)$(0.25)$(0.51)
Weighted average shares outstanding
Basic and diluted49,847,87230,555,01249,249,43030,221,168

FAQ

What were the key findings from Reviva's Phase 3 RECOVER trial for brilaroxazine?

The trial demonstrated sustained efficacy over 1 year with improvements in PANSS total score (-18.1), positive symptoms (-5.0), and negative symptoms (-4.4), along with a generally well-tolerated safety profile.

When does Reviva (RVPH) plan to submit its NDA for brilaroxazine?

Reviva targets NDA submission in Q2 2026, pending favorable feedback from their planned FDA meeting in Q4 2025.

What was Reviva's (RVPH) financial position in Q2 2025?

Reviva reported $10.4 million in cash, a net loss of $6.1 million ($0.12 per share), and raised $10.0 million through a public equity offering.

What is the patent protection timeline for Reviva's brilaroxazine?

Reviva's patent portfolio includes composition of matter and lifecycle management strategies with potential patent and/or market exclusivity extending up to 2045 and beyond.

What are the next major milestones for Reviva (RVPH)?

Key upcoming milestones include an FDA meeting in Q4 2025, potential NDA submission in Q2 2026, and a possible Phase 3 RECOVER-2 trial pending FDA recommendation.
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Biotechnology
Pharmaceutical Preparations
United States
CUPERTINO