Oragenics, Inc. Provides Shareholder Update on Strategic Progress and Announces Janet Huffman as Interim CEO
Oragenics (NYSE American: OGEN) provided updates on its strategic progress since its $4 million capital raise in September 2024 and announced Janet Huffman as interim CEO. Key developments include improvements to ONP-002's formulation and intranasal delivery device, advancement of Phase II trial preparations in Australia, and completion of spray-dry campaign for drug-device units.
The company aims to dose the first patient in Australian Phase II trials by end of Q1 2025 or early Q2. Regulatory milestones, including Phase I trial closure and IND submission, remain on track. Ms. Huffman, previously CFO at TRxADE HEALTH, brings experience in capital raising and M&A. The company plans to submit the IB package by Q1 2025, formalize Australian partnerships, and submit the IND package for US phase IIb trials in Q3 2025.
Oragenics (NYSE American: OGEN) ha fornito aggiornamenti sui suoi progressi strategici a partire dalla raccolta di 4 milioni di dollari avvenuta nel settembre 2024 e ha annunciato Janet Huffman come CEO ad interim. Tra gli sviluppi principali ci sono miglioramenti nella formulazione e nel dispositivo di somministrazione intranasale di ONP-002, avanzamenti nei preparativi per le sperimentazioni di fase II in Australia, e completamento della campagna di spray-drying per le unità farmaco-dispositivo.
L'azienda punta a dosare il primo paziente negli studi di fase II in Australia entro la fine del primo trimestre del 2025 o all'inizio del secondo. I traguardi regolatori, inclusa la chiusura della fase I e la presentazione dell'IND, rimangono nella giusta direzione. La signora Huffman, precedentemente CFO di TRxADE HEALTH, porta con sé esperienza nella raccolta di capitali e nelle fusioni e acquisizioni. L'azienda prevede di presentare il pacchetto IB entro il primo trimestre del 2025, formalizzare le partnership australiane e presentare il pacchetto IND per gli studi di fase IIb negli Stati Uniti nel terzo trimestre del 2025.
Oragenics (NYSE American: OGEN) proporcionó actualizaciones sobre su progreso estratégico desde su recaudación de capital de 4 millones de dólares en septiembre de 2024 y anunció a Janet Huffman como CEO interina. Los desarrollos clave incluyen mejoras en la formulación y el dispositivo de entrega intranasal de ONP-002, avances en los preparativos para los ensayos de Fase II en Australia y la finalización de la campaña de spray-dry para las unidades de fármaco-dispositivo.
La compañía tiene como objetivo dosificar al primer paciente en los ensayos de Fase II en Australia para finales del primer trimestre de 2025 o principios del segundo. Los hitos regulatorios, que incluyen el cierre del ensayo de Fase I y la presentación del IND, están en buen camino. La Sra. Huffman, que fue CFO en TRxADE HEALTH, aporta experiencia en la recaudación de capital y fusiones y adquisiciones. La empresa planea presentar el paquete IB para el primer trimestre de 2025, formalizar asociaciones australianas y presentar el paquete IND para los ensayos de fase IIb en EE. UU. en el tercer trimestre de 2025.
오라제닉스 (NYSE American: OGEN)는 2024년 9월 400만 달러 자본 조달 이후 전략적 진척 상황을 업데이트하고 자넷 허프먼을 권한대행 CEO로 발표했습니다. 주요 개발 사항으로는 ONP-002의 제형 및 비강 전달 장치 개선, 호주에서의 2상 시험 준비 진행 상황, 약물-장치 유닛에 대한 스프레이 드라이 캠페인 완료가 포함됩니다.
회사는 2025년 1분기 말 또는 2분기 초에 호주 2상 시험에서 첫 환자를 투여하는 것을 목표로 하고 있습니다. 1상 시험 종료 및 IND 제출을 포함한 규제 이정표는 순조롭게 진행되고 있습니다. 허프먼 씨는 TRxADE HEALTH의 CFO로 이전 경험을 보유하고 있으며 자본 조달 및 인수 합병에 대한 경험이 있습니다. 회사는 2025년 1분기까지 IB 패키지를 제출하고 호주 파트너십을 공식화하며 2025년 3분기에 미국 2b상 시험을 위한 IND 패키지를 제출할 계획입니다.
Oragenics (NYSE American: OGEN) a fourni des mises à jour sur ses progrès stratégiques depuis sa levée de fonds de 4 millions de dollars en septembre 2024 et a annoncé Janet Huffman comme PDG par intérim. Les développements clés comprennent des améliorations de la formulation et du dispositif d'administration intranasale d'ONP-002, l'avancement des préparatifs pour les essais de phase II en Australie, et l'achèvement de la campagne de spray-dry pour les unités de médicaments-dispositifs.
L'entreprise vise à administrer le premier patient dans les essais de phase II en Australie d'ici la fin du premier trimestre 2025 ou au début du deuxième trimestre. Les jalons réglementaires, y compris la clôture de l'essai de phase I et la soumission de l'IND, restent sur la bonne voie. Mme Huffman, ancien CFO de TRxADE HEALTH, apporte une expérience en levée de fonds et en fusions-acquisitions. L'entreprise prévoit de soumettre le paquet IB d'ici le premier trimestre 2025, de formaliser des partenariats australiens et de soumettre le paquet IND pour les essais de phase IIb aux États-Unis au troisième trimestre 2025.
Oragenics (NYSE American: OGEN) hat Updates zu seinen strategischen Fortschritten seit der Kapitalerhöhung von 4 Millionen Dollar im September 2024 bereitgestellt und Janet Huffman als Interims-CEO bekannt gegeben. Zu den wichtigsten Entwicklungen gehören Verbesserungen der Formulierung und des intranasalen Liefergeräts von ONP-002, Fortschritte bei den Vorbereitungen für die Phase-II-Studien in Australien und der Abschluss der Spray-Dry-Kampagne für Arzneimittel-Geräte-Einheiten.
Das Unternehmen beabsichtigt, bis Ende des ersten Quartals 2025 oder Anfang des zweiten Quartals den ersten Patienten in den australischen Phase-II-Studien zu behandeln. Die regulatorischen Meilensteine, einschließlich des Abschlusses der Phase-I-Studie und der IND-Einreichung, liegen im Zeitplan. Frau Huffman, zuvor CFO bei TRxADE HEALTH, bringt Erfahrung in der Kapitalbeschaffung und M&A mit. Das Unternehmen plant, das IB-Paket bis zum ersten Quartal 2025 einzureichen, australische Partnerschaften zu formalisiere und das IND-Paket für die US-Phase-IIb-Studien im dritten Quartal 2025 einzureichen.
- Secured $4 million in capital raise (September 2024)
- Advanced ONP-002 formulation and delivery device development
- Completed prototyping for automated intranasal device
- On track for Phase II trials in Australia (Q1/Q2 2025)
- Completed spray-dry campaign ensuring sufficient drug-device units
- Operating with capital from recent $4M raise
- Dependent on successful completion of regulatory milestones
- Leadership transition period with interim CEO appointment
Insights
The appointment of Janet Huffman as interim CEO, while notable, is overshadowed by the more substantial developments in OGEN's clinical progress and strategic initiatives. The $4 million capital raise from September 2024 has been strategically deployed across several critical areas that strengthen the company's market position.
The company's focus on formulation improvements and device enhancements for ONP-002, coupled with securing intellectual property rights, demonstrates a robust commercialization strategy. The planned Phase II trials in Australia, targeted for Q1/Q2 2025, represent a significant milestone in the clinical development pathway. The selection of Australia for clinical trials is particularly strategic, as the country offers a favorable regulatory environment and potential cost advantages compared to US-based trials.
The completion of the spray-dry campaign and device prototyping indicates strong operational execution and readiness for clinical trials. With a market cap of just $3.55 million, the company appears significantly undervalued relative to its clinical progress and intellectual property portfolio. However, the small market cap also suggests substantial execution risks and potential need for additional capital raises to fund future development phases.
The development of an automated intranasal device for patients with altered states of consciousness represents a significant technical advancement in drug delivery systems. This innovation addresses a important clinical need, as traditional drug administration methods can be challenging in patients with impaired consciousness.
The completion of the spray-dry campaign is a critical technical milestone that ensures product stability and consistency for clinical trials. The focus on both drug formulation and delivery device optimization demonstrates a comprehensive approach to product development that could enhance therapeutic efficacy and patient compliance.
However, the relatively small market capitalization raises concerns about the company's ability to fully commercialize these innovations without significant additional funding. The planned progression to Phase II trials, while positive, will require substantial resources for successful execution and subsequent development phases.
The timeline for clinical development appears aggressive but achievable. The planned submission of the Investigator's Brochure (IB) in Q1 2025 and targeting first patient dosing by early Q2 2025 in Australia demonstrates efficient clinical planning. The parallel preparation for US IND submission in Q3 2025 suggests a well-structured global development strategy.
However, several critical factors warrant attention. The company's cash position following the $4 million raise may be insufficient to complete the planned Phase II trials, potentially necessitating additional funding that could dilute existing shareholders. The choice of Australia for initial Phase II trials is strategically sound due to lower costs and faster regulatory pathways, but success in Australian trials doesn't guarantee FDA acceptance for US studies.
The completion of Phase I and preparation of regulatory submissions indicates positive safety data, but the company will need to demonstrate compelling efficacy in Phase II to justify its valuation and attract potential strategic partners.
SARASOTA, Fla., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company advancing innovative treatments for brain-related health conditions, today provided an update on its strategic progress since its last capital raise in September 2024. The Company also announced the appointment of Janet Huffman as its new interim Chief Executive Officer.
Strategic Progress Since Capital Raise
Following the Company’s
- Formulation and Device Enhancements: The Company has improved the formulation and intranasal delivery device for ONP-002 and in connection therewith has taken significant steps with the goal of securing its intellectual property for such formulations and devices.
- Advancing Phase II Preparations: The Company has vetted clinical research organizations (CROs) and hospital partners in Australia and is in the process of finalizing site agreements for its Phase II clinical trials in Australia. The goal remains to dose the first patient in Australia by the end of Q1 2025, or early Q2.
- Supply Chain Preparedness: Completion of the spray-dry campaign is expected to ensure sufficient drug-device units for the upcoming trials, with all units validated and prepared for shipment.
- Prototyping for Enhanced Accessibility: Prototyping for an automated intranasal device, designed for patients with altered states of consciousness, has been completed.
- Regulatory Milestones: Closure of the Phase I clinical trial and submission of data for investigational new drug (IND) and investigator’s brochure (IB) approval remain on track.
Leadership Transition
The Company is also pleased to announce the appointment of Janet Huffman as interim Chief Executive Officer. Since joining Oragenics, Ms. Huffman has played a pivotal role in driving the Company’s strategy, leveraging her extensive experience in capital raising, mergers and acquisitions, and financial planning.
Before her tenure at Oragenics, she served as Chief Financial Officer for TRxADE HEALTH, Inc. (NASDAQ:MEDS), a company focused on health services IT for retail pharmacies. In 2019, Ms. Huffman was a founding member of Banyan Pediatric Care Centers, where she served as CFO and played a critical role in its merger with Assisted 4 Living, Inc., later renamed Arboreta Healthcare Inc. She also held financial leadership roles at Signature HomeNow, Infinity Homecare, and Family Home Health Services.
“I am honored to take on this role, and am deeply committed to Oragenics’ mission of addressing unmet medical needs through innovation,” said Ms. Huffman. “As we work to advance ONP-002 and prepare for the next phase of clinical development, I look forward to collaborating with our dedicated team and stakeholders to build on the momentum we’ve created. Together, we are charting an exciting course that prioritizes both patient outcomes and shareholder value.”
The Oragenics Board of Directors expressed confidence in Ms. Huffman’s leadership during this pivotal time for the Company. “Janet’s proven track record as a strategic leader and her deep understanding of Oragenics’ operations make her an excellent choice to guide the Company during this transition,” said Charles Pope, Chairman of the Board of Directors at Oragenics. “Her expertise in financial stewardship and her commitment to advancing our development plans position Oragenics to maintain its momentum and continue creating value for patients and shareholders alike.”
Financial Overview
Since the September 2024 capital raise, the Company has strategically allocated resources with the goal of delivering operational efficiency:
- Additional investments were made in improved drug and device formulation, device prototyping, and clinical trial preparations for phase II.
- Additional investments were made to continue the Company’s efforts in protecting existing patents and securing new patents for the Company’s improved drug formulation and device prototype.
Next Steps and Upcoming Milestones
The Company remains focused on executing its clinical and regulatory plans, with the following goals:
- Submission of the IB package by Q1 2025 for Australia phase II clinical trials.
- Formalizing the Company’s strategic partnerships in Australia for clinical trial site selections and clinical research leadership to lead the Australia clinical trials.
- Dosing of the first patient in Australia in the Phase II clinical trial by the end of Q1 2025 or early Q2 2025.
- Submission of the IND package for phase IIb clinical trials in the US targeted for Q3 of 2025.
“I am thrilled about the opportunities ahead in 2025 as we position Oragenics for a transformative year,” said Ms. Huffman. “I am filled with optimism about what this year holds as we advance ONP-002 and lay the groundwork for future growth. With ONP-002 advancing into its next phase of development, we are at a critical juncture that holds tremendous promise for both patients and stakeholders. Leading the way is our innovative science, strategic focus, and unwavering commitment to our mission, I believe this positions us well to continue to make meaningful progress that will shape our future and create lasting value.”
Investor Contact
Rich Cockrell
404.736.3838
ogen@cg.capital
About Oragenics, Inc.
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.
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, circumstances should change, except as otherwise required by law.
FAQ
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