Oragenics, Inc. Provides Q1 2025 Shareholder Update on Strategic and Financial Progress
Oragenics (NYSE American: OGEN) provided a Q1 2025 shareholder update highlighting progress on ONP-002, its intranasal therapy for concussion treatment. The company raised approximately $5 million through combined financing, including $2.6 million via ATM equity and $2.25 million in non-dilutive debt funding.
Key Q1 achievements include: submission of Investigator's Brochure for Phase IIa clinical trial in Australia, partnership with BRAINBox Solutions for diagnostic biomarkers integration, and participation in the Brain Health Summit. The company completed Phase I human study showing ONP-002 was well-tolerated with no serious adverse events.
Financial updates include conversion of all Series A and B preferred shares to common stock in Q4 2024, and implementation of executive leadership changes to reduce overhead costs. The 2025 Annual Shareholder Meeting is scheduled for May 2, 2025.
Oragenics (NYSE American: OGEN) ha fornito un aggiornamento per gli azionisti del primo trimestre 2025 evidenziando i progressi su ONP-002, la sua terapia intranasale per il trattamento delle commozioni cerebrali. L'azienda ha raccolto circa 5 milioni di dollari attraverso finanziamenti combinati, inclusi 2,6 milioni tramite equity ATM e 2,25 milioni in finanziamenti a debito non diluitivi.
Tra i principali risultati del primo trimestre ci sono: la presentazione del Brochure dell'Investigatore per la sperimentazione clinica di Fase IIa in Australia, la partnership con BRAINBox Solutions per l'integrazione di biomarcatori diagnostici e la partecipazione al Brain Health Summit. L'azienda ha completato uno studio umano di Fase I dimostrando che ONP-002 è stato ben tollerato senza eventi avversi gravi.
Gli aggiornamenti finanziari includono la conversione di tutte le azioni privilegiate di Serie A e B in azioni ordinarie nel quarto trimestre del 2024 e l'implementazione di cambiamenti nella leadership esecutiva per ridurre i costi generali. L'Assemblea Annuale degli Azionisti 2025 è programmata per il 2 maggio 2025.
Oragenics (NYSE American: OGEN) proporcionó una actualización para los accionistas del primer trimestre de 2025 destacando los avances en ONP-002, su terapia intranasal para el tratamiento de conmociones cerebrales. La compañía recaudó aproximadamente 5 millones de dólares a través de financiamiento combinado, incluyendo 2.6 millones a través de acciones ATM y 2.25 millones en financiamiento de deuda no dilutiva.
Los logros clave del primer trimestre incluyen: la presentación del Folleto del Investigador para el ensayo clínico de Fase IIa en Australia, una asociación con BRAINBox Solutions para la integración de biomarcadores diagnósticos y la participación en la Cumbre de Salud Cerebral. La compañía completó un estudio humano de Fase I que mostró que ONP-002 fue bien tolerado sin eventos adversos graves.
Las actualizaciones financieras incluyen la conversión de todas las acciones preferentes de la Serie A y B a acciones ordinarias en el cuarto trimestre de 2024, y la implementación de cambios en el liderazgo ejecutivo para reducir costos generales. La Junta Anual de Accionistas de 2025 está programada para el 2 de mayo de 2025.
Oragenics (NYSE American: OGEN)는 2025년 1분기 주주 업데이트를 제공하며 뇌진탕 치료를 위한 비강 내 치료제 ONP-002의 진행 상황을 강조했습니다. 이 회사는 ATM 주식을 통한 260만 달러와 비희석 채무 자금 225만 달러를 포함하여 약 500만 달러를 조달했습니다.
1분기의 주요 성과로는 호주에서의 2상 임상 시험을 위한 연구자 안내서 제출, 진단 바이오마커 통합을 위한 BRAINBox Solutions와의 파트너십, 그리고 뇌 건강 정상 회의에 참여한 것이 있습니다. 이 회사는 ONP-002가 심각한 부작용 없이 잘 견딜 수 있음을 보여주는 1상 인간 연구를 완료했습니다.
재무 업데이트에는 2024년 4분기에 모든 A 및 B 시리즈 우선주를 보통주로 전환하고, 간접비를 줄이기 위한 경영진 리더십 변경이 포함됩니다. 2025년 연례 주주 총회는 2025년 5월 2일로 예정되어 있습니다.
Oragenics (NYSE American: OGEN) a fourni une mise à jour pour les actionnaires du premier trimestre 2025 mettant en avant les progrès réalisés sur ONP-002, sa thérapie intranasale pour le traitement des commotions cérébrales. L'entreprise a levé environ 5 millions de dollars grâce à un financement combiné, dont 2,6 millions via des actions ATM et 2,25 millions en financement par dette non dilutive.
Les réalisations clés du premier trimestre incluent : la soumission de la brochure de l'investigateur pour l'essai clinique de phase IIa en Australie, un partenariat avec BRAINBox Solutions pour l'intégration de biomarqueurs diagnostiques, et la participation au Brain Health Summit. L'entreprise a complété une étude humaine de phase I montrant qu'ONP-002 était bien toléré sans événements indésirables graves.
Les mises à jour financières incluent la conversion de toutes les actions privilégiées de série A et B en actions ordinaires au quatrième trimestre 2024, ainsi que la mise en œuvre de changements dans la direction exécutive pour réduire les coûts généraux. L'assemblée générale annuelle des actionnaires 2025 est prévue pour le 2 mai 2025.
Oragenics (NYSE American: OGEN) hat ein Update für die Aktionäre des ersten Quartals 2025 bereitgestellt, in dem die Fortschritte bei ONP-002, seiner intranasalen Therapie zur Behandlung von Gehirnerschütterungen, hervorgehoben werden. Das Unternehmen hat etwa 5 Millionen Dollar durch kombinierte Finanzierungen gesammelt, darunter 2,6 Millionen über ATM-Aktien und 2,25 Millionen in nicht verwässernder Fremdfinanzierung.
Wichtige Erfolge im ersten Quartal umfassen: die Einreichung des Investigator's Brochure für die klinische Studie der Phase IIa in Australien, eine Partnerschaft mit BRAINBox Solutions zur Integration diagnostischer Biomarker und die Teilnahme am Brain Health Summit. Das Unternehmen hat eine Phase-I-Studie am Menschen abgeschlossen, die zeigt, dass ONP-002 gut vertragen wurde und keine schwerwiegenden unerwünschten Ereignisse auftraten.
Finanzielle Updates umfassen die Umwandlung aller Vorzugsaktien der Serien A und B in Stammaktien im vierten Quartal 2024 sowie die Implementierung von Änderungen in der Unternehmensführung zur Senkung der Gemeinkosten. Die jährliche Hauptversammlung der Aktionäre 2025 ist für den 2. Mai 2025 angesetzt.
- Successful completion of Phase I human study with positive safety profile
- Strategic partnership established with BRAINBox Solutions
- Secured $5 million in new funding through mixed financing
- Reduced overhead costs through executive leadership restructuring
- Capital structure simplified through preferred shares conversion
- Continued reliance on dilutive ATM equity financing ($2.6M)
- Still awaiting regulatory approval for Phase IIa trial
- No current revenue generation from products
Insights
Oragenics has made meaningful progress in Q1 2025 that strengthens the clinical pathway for ONP-002, their intranasal concussion treatment candidate. The submission of the Investigator's Brochure for their Phase IIa trial in Australia represents significant regulatory advancement, with the trial now listed on ClinicalTrials.gov.
The company has secured approximately
The strategic partnership with BRAINBox Solutions creates a compelling diagnostic-therapeutic combination that could accelerate the clinical adoption pathway - pairing BRAINBox's biomarker diagnostics with ONP-002's treatment delivery system enhances their competitive positioning in the concussion space.
From a development standpoint, ONP-002 has been substantially de-risked through extensive preclinical studies and a successful Phase I human trial showing favorable tolerability. With drug production finalized and a commercial-ready delivery device, Oragenics has eliminated several common clinical development hurdles.
Most notably, Oragenics is targeting a condition with zero FDA-approved treatments, potentially giving ONP-002 first-mover advantage in an untapped therapeutic market. The operational efficiencies implemented through leadership changes have also reduced overhead costs, directing more capital toward value-driving clinical programs.
ONP-002 Advances Toward Phase IIa Concussion Trial with Strengthened Financial Foundation and Industry Momentum
SARASOTA, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treating concussion.
“We believe ONP-002 is one of the most undervalued clinical assets in biotechnology today,” said Janet Huffman, Interim CEO of Oragenics. “With strong preclinical validation and clinical safety data, a scalable ONP-002 intranasal delivery system, and no current FDA-approved treatments for concussion, ONP-002 could redefine the standard of concussion care. Our Q1 progress — from regulatory submissions to our landmark partnership with BRAINBox — reflects a sharpened strategic focus and operational momentum. We’re energized by what’s ahead and remain committed to delivering long-term value for our shareholders.”
Key Accomplishments in Q1 2025
In the first quarter of 2025, Oragenics achieved several strategic and operational milestones:
- Industry Engagement & Awareness: Participated in the 12th Annual Brain Health Summit at Leigh Steinberg’s Super Bowl Party 2025, helping raise visibility for traumatic brain injury (TBI) and ONP-002’s potential therapeutic impact.
- Strategic Partnership: Established a collaboration with BRAINBox Solutions to combine diagnostic biomarkers with ONP-002’s intranasal delivery system, aiming to transform concussion treatment by enabling faster, more targeted care.
- Clinical Trial Advancements: Submitted the Investigator’s Brochure (IB) for the Phase IIa clinical trial in Australia, marking a key regulatory step. The trial is now publicly listed on ClinicalTrials.gov.
- Strengthened Financial Position: Raised approximately
$5 million through a combination of dilutive and non-dilutive capital, including approximately$2.6 million via At-the-Market (ATM) equity financing and approximately$2.25 million through non-dilutive debt funding. - Shareholder Communications: Announced that the 2025 Annual Shareholder Meeting will be held on May 2, 2025, with the preliminary proxy filed with the SEC on March 19, 2025.
ONP-002: An Undervalued Asset with First-Mover Advantage
Oragenics’ lead drug candidate, ONP-002, is a neuroprotective, anti-inflammatory compound administered intranasally for the treatment of concussion, classified as a mild traumatic brain injury (mTBI). ONP-002 is an intranasal therapeutic being developed for concussion and is designed to interrupt key biological pathways involved in inflammation, oxidative stress, and swelling following head trauma.
Although still in clinical development, ONP-002 represents a “silent asset” that has been significantly de-risked through extensive preclinical studies. These include cardiotoxicity, genotoxicity, and dose-ranging evaluations. In addition ONP-002 successfully completed a Phase I human study that was well-tolerated with no serious adverse events. With a novel formulation and scalable ONP-002 intranasal delivery system already in place, ONP-002 is ready for rapid and cost-effective progression through clinical phases.
Clinical and Regulatory Milestones Build Momentum
In late 2024 and early 2025, Oragenics finalized drug production for the Phase IIa clinical trial and submitted the Investigator’s Brochure to regulatory authorities in Australia. The trial has been officially listed on ClinicalTrials.gov, and the Company is now awaiting approval from the Human Research Ethics Committee (HREC), with first patient enrollment expected shortly thereafter.
“Reaching this stage of clinical preparation—especially with a commercial-ready delivery device and finalized drug product—positions us for rapid execution once regulatory clearance is received,” added Huffman.
Strategic Partnership with BRAINBox Solutions
In February, Oragenics formed a pivotal collaboration with BRAINBox Solutions, a diagnostics company pioneering biomarker-based concussion testing. This partnership pairs Oragenics’ intranasal therapeutic with BRAINBox’s diagnostic tools to create a smarter, faster, and more personalized approach to concussion care.
“This collaboration unites two emerging leaders in brain health—Oragenics in therapeutic innovation and BRAINBox in diagnostic excellence,” said Huffman. “Together, we are designing a smarter, faster approach to treating concussion that could set a new benchmark for the field.”
Increased Visibility and Market Awareness
Beyond industry events, Oragenics has made a concerted effort in recent months to engage investors, clinicians, and thought leaders through media, podcasts, and speaking opportunities. The Company’s outreach has focused on raising awareness around the scale of untreated concussion, the science behind ONP-002, and the lack of approved pharmacological options.
“We’ve worked diligently to educate the market—both the investment community and clinical stakeholders—about the game-changing potential of ONP-002,” said Huffman. “The response has been highly encouraging. It’s clear there is an unmet need, and the concept of a fast-acting, intranasal treatment resonates with physicians, patients, and investors alike.”
Financial Foundation and Capital Structure Improvements
In Q1 2025, Oragenics raised approximately
“This funding underscores our ability to secure capital through multiple channels and at critical moments,” Huffman stated. “It reflects growing confidence in our strategy and allows us to continue executing with discipline and focus.”
Operational Efficiencies and Governance Updates
As part of its disciplined approach to resource management, Oragenics implemented executive leadership changes in late 2024 that have meaningfully reduced fixed overhead costs. These moves ensure that capital is directed toward value-driving programs like ONP-002. The Company also confirmed that its 2025 Annual Shareholder Meeting will be held on May 2, 2025, with preliminary proxy materials filed in March.
Key Milestones Ahead
With strong positioning across clinical, operational, and financial fronts, Oragenics is preparing to advance ONP-002 through the next stage of development. The Company’s upcoming projected milestones include:
| Milestone | Expected Timing |
| HREC approval in Australia | Q2 2025 |
| First patient enrolled in Phase IIa trial | Q2 2025 |
| Completion of Phase IIa enrollment | Q4 2025 |
| Interim safety and biomarker readout | Q4 2025 – Q1 2026 |
| Initiation of Phase IIb (Part B) | Q1 2026 |
| Topline Phase IIb results | Q2 2026 |
| FDA End-of-Phase 2 Meeting | Q3 2026 |
| FDA Accelerated Approval Filing (if eligible) | Q3 2026 |
| First revenues from licensing or early access | 2027 (projected) |
Our Commitment to Long-Term Value Creation
As Oragenics enters a pivotal execution phase, the Company remains committed to advancing ONP-002 with urgency and precision. Its goal is to deliver a meaningful clinical breakthrough in concussion care and to generate long-term value for its shareholders.
“We are committed to seeing ONP-002 through to its full potential,” said Huffman. “With each milestone we reach, our conviction only grows stronger. This is more than a drug program—it’s an opportunity to change the standard of care for millions of patients. Our team is fully aligned, fully engaged, and determined to deliver results that matter for shareholders and society alike.”
Investor Contact
Rich Cockrell
866.889.1972
ogen@cg.capital
About Oragenics, Inc.
Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, including its lead candidate, ONP-002, for the treatment of mild traumatic brain injury (mTBI) or concussion. The Company is also advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration. For more information, 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.
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