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Oragenics, Inc. Announces U.S.-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development

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Oragenics (NYSE American: OGEN) has secured a manufacturing agreement with Sterling Pharma Solutions for the GMP production of ONP-002, its lead drug candidate for concussion treatment. The U.S.-based manufacturing partnership will support Oragenics' planned Phase IIb clinical trials expected to begin in 2026.

The collaboration with Sterling's facility in Cary, North Carolina, represents a crucial milestone in Oragenics' development strategy, ensuring domestic production capabilities for their upcoming clinical and regulatory efforts. The trials will evaluate ONP-002's early efficacy in patients with mild traumatic brain injury (mTBI), addressing a condition that currently lacks FDA-approved pharmacological treatments.

Oragenics (NYSE American: OGEN) ha stipulato un accordo di produzione con Sterling Pharma Solutions per la produzione GMP di ONP-002, il suo principale candidato farmaco per il trattamento della commozione cerebrale. La partnership produttiva con sede negli Stati Uniti sosterrà i previsti trial clinici di Fase IIb di Oragenics, che dovrebbero iniziare nel 2026.

La collaborazione con l'impianto di Sterling a Cary, North Carolina, rappresenta una tappa fondamentale nella strategia di sviluppo di Oragenics, garantendo capacità produttive nazionali per i prossimi sforzi clinici e regolatori. Gli studi valuteranno l'efficacia preliminare di ONP-002 nei pazienti con trauma cranico lieve (mTBI), una condizione per la quale attualmente non esistono trattamenti farmacologici approvati dalla FDA.

Oragenics (NYSE American: OGEN) ha asegurado un acuerdo de fabricación con Sterling Pharma Solutions para la producción GMP de ONP-002, su principal candidato a medicamento para el tratamiento de conmociones cerebrales. La asociación de fabricación con sede en EE. UU. apoyará los planeados ensayos clínicos de Fase IIb de Oragenics, que se espera comiencen en 2026.

La colaboración con la planta de Sterling en Cary, Carolina del Norte, representa un hito crucial en la estrategia de desarrollo de Oragenics, asegurando capacidades de producción nacionales para los próximos esfuerzos clínicos y regulatorios. Los ensayos evaluarán la eficacia temprana de ONP-002 en pacientes con lesión cerebral traumática leve (mTBI), una condición que actualmente carece de tratamientos farmacológicos aprobados por la FDA.

Oragenics (NYSE American: OGEN)� 뇌진� 치료� 위한 주요 약물 후보� ONP-002� GMP 생산� 위해 Sterling Pharma Solutions와 제조 계약� 체결했습니다. 미국� 기반� � � 제조 파트너십은 2026년에 시작� 예정� Oragenics� 2b� 임상시험� 지원할 것입니다.

노스캐롤라이� � Cary� 위치� Sterling 시설과의 협력은 Oragenics 개발 전략에서 중요� 이정표로, 향후 임상 � 규제 활동� 위한 국내 생산 역량� 확보합니�. � 임상시험은 경미� 외상� 뇌손�(mTBI) 환자에서 ONP-002� 초기 효능� 평가� 예정이며, 현재 FDA 승인 약물 치료제가 없는 상태� 해결하고� 합니�.

Oragenics (NYSE American : OGEN) a conclu un accord de fabrication avec Sterling Pharma Solutions pour la production GMP de ONP-002, son principal candidat médicament pour le traitement de la commotion cérébrale. Ce partenariat de fabrication basé aux États-Unis soutiendra les essais cliniques de phase IIb prévus par Oragenics, qui devraient débuter en 2026.

La collaboration avec l'installation de Sterling à Cary, en Caroline du Nord, représente une étape cruciale dans la stratégie de développement d'Oragenics, garantissant des capacités de production nationales pour leurs futurs efforts cliniques et réglementaires. Les essais évalueront l'efficacité précoce de ONP-002 chez des patients souffrant de traumatisme crânien léger (mTBI), une pathologie pour laquelle il n'existe actuellement aucun traitement pharmacologique approuvé par la FDA.

Oragenics (NYSE American: OGEN) hat eine Herstellungsvereinbarung mit Sterling Pharma Solutions für die GMP-Produktion von ONP-002, ihrem führenden Arzneimittelkandidaten zur Behandlung von Gehirnerschütterungen, abgeschlossen. Die in den USA ansässige Produktionspartnerschaft wird Oragenics' geplante Phase IIb-Studien unterstützen, die voraussichtlich 2026 beginnen.

Die Zusammenarbeit mit der Einrichtung von Sterling in Cary, North Carolina, stellt einen wichtigen Meilenstein in Oragenics' Entwicklungsstrategie dar und sichert die inländischen Produktionskapazitäten für die bevorstehenden klinischen und regulatorischen Maßnahmen. Die Studien werden die frühe Wirksamkeit von ONP-002 bei Patienten mit leichter traumatischer Hirnverletzung (mTBI) bewerten, einer Erkrankung, für die derzeit keine von der FDA zugelassenen pharmakologischen Behandlungen existieren.

Positive
  • Secured U.S.-based GMP-compliant manufacturing partnership for lead drug candidate
  • Manufacturing agreement supports advancement to Phase IIb clinical trials
  • Addresses unmet medical need with no current FDA-approved pharmacological treatments
  • Strengthens domestic production capabilities for clinical development
Negative
  • Phase IIb trials not expected to start until 2026
  • Early-stage drug development carries inherent clinical trial risks

Insights

Oragenics secures US manufacturing for lead concussion drug ONP-002, advancing toward Phase IIb trials in an untapped market.

This manufacturing agreement with Sterling Pharma Solutions represents a significant operational milestone in Oragenics' clinical development roadmap. Securing GMP-compliant manufacturing capabilities is a critical prerequisite for advancing ONP-002 through clinical trials and regulatory review. The partnership specifically supports their Phase IIb clinical trials planned for next year, which will evaluate early efficacy in mild traumatic brain injury patients.

The selection of a US-based CDMO is strategically sound, potentially offering advantages in regulatory coordination, supply chain security, and operational oversight. Sterling's expertise in CNS therapies aligns well with Oragenics' focus on intranasal therapeutics for brain-related conditions.

What's particularly noteworthy is that Oragenics is targeting concussion treatment, a condition with no FDA-approved pharmacological therapies currently available. This represents a substantial unmet medical need and potential first-mover advantage if ONP-002 demonstrates efficacy. The upcoming Phase IIb trial will be a critical proof-of-concept study that could significantly impact Oragenics' clinical and commercial trajectory.

This manufacturing agreement indicates Oragenics is methodically building the infrastructure necessary to support late-stage clinical development. For a small biotechnology company, securing reliable manufacturing capabilities reduces execution risk and strengthens their position for potential future partnerships or commercialization efforts.

SARASOTA, Fla., July 16, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company developing intranasal therapeutics for brain-related conditions, today announced it has entered into a manufacturing agreement with Sterling Pharma Solutions, an industry leading CDMO with multiple US-based development and manufacturing facilities. Oragenics has partnered with Sterling Pharma Solutions for the GMP production of its lead drug candidate, ONP-002, for the treatment of concussion.

This agreement is expected to ensure Good Manufacturing Practice (GMP)-compliant drug product supply ahead of the planned Phase IIb clinical trials which the Company expects to start next year. The collaboration marks an important milestone for Oragenics as it secures domestic production capabilities to support its upcoming clinical and regulatory efforts.

“We are excited to partner with Sterling’s facility in Cary, North Carolina, to support the production of ONP-002,� said Janet Huffman, Chief Executive Officer of Oragenics. “This partnership is a critical milestone in our path forward for Phase IIb clinical trials.  This partnership reinforces our commitment to quality, efficiency, and U.S.-based innovation and we believe this step will help streamline our clinical development strategy.�

Sterling will produce ONP-002 under strict cGMP conditions for use in Oragenics� planned Phase IIb trials, a proof-of-concept study which will evaluate early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI).

Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, said: “We are pleased to be partnering with Oragenics for the GMP production of its lead molecule for clinical trials. Our scientific expertise in CNS therapies and our ability to meet critical timelines will support the continued path to market for this transformative drug candidate.�

This U.S.-based manufacturing agreement builds upon Oragenics� broader strategy to develop scalable, accessible, and fast-acting treatments for neurological trauma, beginning with concussion, a condition that currently has no FDA-approved pharmacological therapies.

About Oragenics, Inc.
Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders. Its lead candidate, ONP-002, is being developed for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion. The Company’s intranasal delivery technology is designed to deliver fast, targeted, and non-invasive therapy to the brain. For more information, please visit .

About Sterling Pharma Solutions
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years� experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specializing in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services.

Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Cramlington, UK and a site in Newcastle upon Tyne, UK; a European presence in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more at .

Forward-Looking Statements

This communication contains “forward-looking statements� within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,� “expect,� “anticipate,� “intend,� “estimate,� “project� and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Oragenics, Inc.
Janet Huffman
Chief Executive Officer
813-286-7900
[email protected]

Investor Contact:
Rich Cockrell
CG Capital
866.889.1972
[email protected]


FAQ

What is the purpose of Oragenics' (OGEN) manufacturing agreement with Sterling Pharma Solutions?

The agreement is for GMP production of ONP-002, Oragenics' lead drug candidate for concussion treatment, to support upcoming Phase IIb clinical trials.

When will Oragenics (OGEN) begin Phase IIb clinical trials for ONP-002?

Oragenics expects to start Phase IIb clinical trials for ONP-002 in 2026.

What condition does Oragenics' ONP-002 drug candidate treat?

ONP-002 is being developed to treat concussion/mild traumatic brain injury (mTBI), a condition that currently has no FDA-approved pharmacological therapies.

Where will Sterling Pharma Solutions manufacture ONP-002 for Oragenics?

Sterling Pharma Solutions will manufacture ONP-002 at their facility in Cary, North Carolina, ensuring U.S.-based production.

What is the significance of GMP manufacturing for Oragenics' ONP-002?

GMP (Good Manufacturing Practice) compliance ensures the drug meets strict quality standards required for clinical trials and regulatory approval.
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