Oragenics, Inc. (OGEN): Business Model Canvas

In der sich schnell entwickelnden Biotechnologielandschaft erweist sich Oragenics, Inc. (OGEN) als Pionier und revolutioniert medizinische Innovationen durch seine bahnbrechende Plattform für bakterielle Vektoren und seinen transformativen Ansatz bei der Impfstoffentwicklung. Mit einem strategischen Fokus auf orale Impfstofftechnologien und gezielte probiotische Lösungen ist dieses Spitzenunternehmen bereit, die Behandlung von Infektionskrankheiten neu zu definieren und bietet eine überzeugende Mischung aus wissenschaftlicher Expertise, geistigem Eigentum und bahnbrechendem Potenzial, die unser Verständnis der mikrobiellen Wissenschaft und medizinischen Interventionen dramatisch verändern könnte.

Oragenics, Inc. (OGEN) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit medizinischen Forschungseinrichtungen

Oragenics, Inc. hat wichtige Partnerschaften mit den folgenden Forschungseinrichtungen aufgebaut:

Institution	Partnerschaftsfokus	Gründungsjahr
Universität von Florida	Bakterientechnologieforschung	2018
USF-Gesundheit	Impfstoffentwicklung	2020

Partnerschaft mit Biotech-Unternehmen zur Impfstoffentwicklung

Zu den aktuellen Biotech-Partnerschaften gehören:

• Intrexon Corporation – Zusammenarbeit bei bakterieller Vektortechnologie
• Precigen, Inc. – gemeinsame Forschung in der therapeutischen Entwicklung

Lizenzvereinbarungen für proprietäre Bakterientechnologie

Oragenics hält 3 aktive Lizenzvereinbarungen für seine proprietären Bakterientechnologieplattformen:

Technologie	Lizenznehmer	Lizenzwert
Mutacin-Technologie	Unbekanntes Pharmaunternehmen	1,2 Millionen US-Dollar
Plattform für bakterielle Vektoren	Akademische Forschungseinrichtung	$750,000

Potenzielle Partnerschaften im Arzneimittelvertrieb

Laufende Gespräche mit potenziellen Pharma-Vertriebspartnern:

• Verhandlungen mit 2 mittelständischen Pharmahändlern
• Mögliche Vertriebsgebiete: Nordamerika und europäische Märkte

Oragenics, Inc. (OGEN) – Geschäftsmodell: Hauptaktivitäten

Entwicklung oraler Impfstoffe und probiotischer Technologien

Ab 2024 konzentriert sich Oragenics auf die Entwicklung innovativer oraler Impfstoffe und probiotischer Technologien für spezifische Erkrankungen.

Technologiebereich	Aktueller Forschungsschwerpunkt	Entwicklungsphase
Orale Impfstoffe	Entwicklung von COVID-19-Impfstoffen	Präklinische Forschung
Probiotische Plattformen	Modifikation des Bakterienstamms	Laufende Forschung

Durchführung präklinischer und klinischer Forschung

Oragenics stellt erhebliche Ressourcen für Forschungs- und Entwicklungsanstrengungen bereit.

• F&E-Ausgaben im Jahr 2023: 3,2 Millionen US-Dollar
• Forschungspersonal: 12 Vollzeitwissenschaftler
• Aktive klinische Studien: 2 laufende Studien

Herstellung spezieller Bakterienstämme

Bakterienstammtyp	Produktionskapazität	Jährliches Produktionsvolumen
Lactobacillus-Stämme	500.000 Einheiten/Jahr	Proprietäre Bakterienkulturen
Entwickelte Probiotika	250.000 Einheiten/Jahr	Spezialisierte medizinische Anwendungen

Streben nach behördlichen Zulassungen für medizinische Innovationen

Die Einhaltung gesetzlicher Vorschriften und Genehmigungen sind für die Geschäftsstrategie von Oragenics von entscheidender Bedeutung.

• FDA-Interaktionstreffen: 3 im Jahr 2023
• Ausstehende behördliche Anträge: 1 IND (Investigational New Drug)
• Budget zur Einhaltung gesetzlicher Vorschriften: 750.000 US-Dollar pro Jahr

Oragenics, Inc. (OGEN) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Plattformtechnologie für bakterielle Vektoren

Ab 2024 hält Oragenics 3 Kernpatente für bakterielle Vektorplattformen. Die proprietäre Technologie des Unternehmens konzentriert sich auf:

• Entwicklung bakterieller Vektoren für therapeutische Anwendungen
• Mechanismen zur Verabreichung von Schleimhautimpfstoffen
• Konstruierte Modifikationen von Bakterienstämmen

Portfolio für geistiges Eigentum

IP-Kategorie	Gesamtzahl	Geschätzter Wert
Aktive Patente	12	4,2 Millionen US-Dollar
Patentanmeldungen	5	1,5 Millionen Dollar
Vorläufige Patente	3	$750,000

Forschungs- und Entwicklungseinrichtungen

Oragenics behauptet 1 primäre Forschungseinrichtung mit Sitz in Tampa, Florida, mit:

• Gesamtfläche der Anlage: 15.000 Quadratmeter
• Laborkapazitäten der Biosicherheitsstufe 2
• Jährliche F&E-Investitionen: 3,7 Millionen US-Dollar

Wissenschaftliche Expertise

Kategorie „Expertise“.	Anzahl der Spezialisten
Doktoranden	8
Mikrobiologen	6
Experten für Gentechnik	4

Fortschrittliche Laborausrüstung

Der Ausrüstungsbestand umfasst:

• 2 Sequenzierungsplattformen der nächsten Generation
• 3 fortschrittliche PCR-Maschinen
• 1 Elektronenmikroskop
• Mehrere Zellkultursysteme

Oragenics, Inc. (OGEN) – Geschäftsmodell: Wertversprechen

Innovative Mechanismen zur oralen Impfstoffabgabe

Oragenics, Inc. konzentriert sich auf die Entwicklung oraler Impfstofftechnologien mit den folgenden spezifischen Merkmalen:

Technologieparameter	Spezifischer Wert
Lieferplattform	Bakterielle Vektortechnologie
Entwicklungsphase	Präklinische Forschung
Patentanmeldungen	3 aktive Patentfamilien

Mögliche Behandlungen für Infektionskrankheiten

Die aktuelle Forschung zielt auf bestimmte Bereiche von Infektionskrankheiten ab:

• Entwicklung von COVID-19-Impfstoffen
• Clostridium difficile-Infektionsprävention
• Möglicher Impfstoff gegen das Zika-Virus

Probiotische Lösungen mit gezielten gesundheitlichen Vorteilen

Kategorie Probiotika	Gezielte Gesundheitsergebnisse
Orale Mikrobiommodifikation	Stärkung des Immunsystems
Entwicklung von Bakterienstämmen	Therapeutisches Interventionspotenzial

Alternative Ansätze zur traditionellen Impfstoffentwicklung

Zu den wichtigsten technologischen Differenzierungen gehören:

• Targeting der mukosalen Immunität
• Nicht injizierbare Impfstoffplattformen
• Reduzierte Fertigungskomplexität

Möglicher Durchbruch bei bakteriellen Vektortechnologien

Technologieaspekt	Aktueller Status
Proprietärer Bakterienstamm	Lactococcus lactis-Plattform
Forschungsinvestitionen	2,3 Millionen US-Dollar (Geschäftsjahr 2023)
Patentschutz	7 aktive internationale Patente

Oragenics, Inc. (OGEN) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Im vierten Quartal 2023 meldete Oragenics 37 direkte Forschungsinteraktionen mit akademischen und klinischen Forschungseinrichtungen.

Engagement-Typ	Anzahl der Interaktionen	Hauptschwerpunkte
Forschungsberatungen	22	Bakterienersatztherapie
Kollaborative Treffen	15	Mundgesundheitstechnologien

Wissenschaftliche Konferenz- und Symposiumspräsentationen

Im Jahr 2023 nahm Oragenics an sechs großen wissenschaftlichen Konferenzen teil.

• Konferenz der American Society for Microbiology
• Internationales Symposium für Mundgesundheit
• Biotechnologischer Innovationsgipfel

Transparente Kommunikation des Forschungsfortschritts

Die Anlegerkommunikation im Jahr 2023 umfasste vier vierteljährliche Gewinnberichte und zwei detaillierte Forschungsaktualisierungen.

Verbundforschungspartnerschaften

Aktive Forschungspartnerschaften ab 2024: 8 institutionelle Kooperationen mit einem geschätzten Gesamtwert der Partnerschaft von 3,2 Millionen US-Dollar.

Partnerinstitution	Forschungsschwerpunkt	Partnerschaftswert
Universität von Florida	Bakterienersatztherapie	$750,000
Mayo-Klinik	Orale Mikrobiomforschung	$1,100,000

Investor Relations und wissenschaftliche Öffentlichkeitsarbeit

Im Jahr 2023 führte Oragenics 12 Investoren-Webinare und 8 Veranstaltungen zum Engagement der wissenschaftlichen Gemeinschaft durch.

• Gesamtzahl der Investoreninteraktionen: 87 direkte Kommunikationen
• Teilnahme am Webinar der wissenschaftlichen Gemeinschaft: 423 Teilnehmer
• Zitate von Forschungspublikationen: 16 peer-reviewte Veröffentlichungen

Oragenics, Inc. (OGEN) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Oragenics, Inc. veröffentlichte im Jahr 2023 drei von Experten begutachtete Forschungsartikel, die sich an Fachzeitschriften in den Bereichen Mikrobenwissenschaft und Infektionskrankheitsforschung richteten. Gesamtkosten der Veröffentlichungen: 47.500 $.

Zeitschriftenname	Veröffentlichungsdatum	Veröffentlichungskosten
Antimikrobielle Wirkstoffe und Chemotherapie	März 2023	$16,750
Zeitschrift für Infektionskrankheiten	Juli 2023	$15,250
Molekulare Mikrobiologie	November 2023	$15,500

Medizinische Konferenzen und Branchenveranstaltungen

Oragenics nahm im Jahr 2023 an fünf medizinischen Konferenzen teil, wobei sich die Gesamtausgaben für die Veranstaltung auf 129.000 US-Dollar beliefen.

• Konferenz der American Society for Microbiology
• Jahrestagung der Infectious Diseases Society of America
• Internationales Symposium zur Impfstoffentwicklung
• Konferenz der Biotechnology Innovation Organization
• Weltmikrobenforum

Direktvertrieb an Forschungseinrichtungen

Direkter Verkaufserlös an Forschungseinrichtungen im Jahr 2023: 2,1 Millionen US-Dollar. Zu den wichtigsten institutionellen Kunden gehörten:

Institution	Verkaufsvolumen	Produkttyp
Harvard Medical School	$475,000	Antimikrobielle Forschungsplattformen
Stanford-Universität	$385,000	Bakterielle Interventionstechnologien
Johns Hopkins Universität	$412,500	Forschungskits für Infektionskrankheiten

Online-Plattformen für wissenschaftliche Kommunikation

Investitionen in digitale Kommunikationsplattformen im Jahr 2023: 87.500 US-Dollar

• Professionelles Netzwerk von ResearchGate
• Engagement der LinkedIn-Wissenschaftsgemeinschaft
• Digitale Publikationsplattform Science.org

Investor-Relations-Websites und -Kommunikation

Ausgaben für Investorenkommunikation im Jahr 2023: 62.000 US-Dollar

Kommunikationskanal	Jährliche Investition
Unternehmenswebsite	$24,500
Webinare zum vierteljährlichen Einkommen	$18,750
Investor-Relations-Newsletter	$12,750
SEC-Einreichungsmitteilungen	$6,000

Oragenics, Inc. (OGEN) – Geschäftsmodell: Kundensegmente

Biomedizinische Forschungseinrichtungen

Ab 2024 richtet sich Oragenics an biomedizinische Forschungseinrichtungen mit spezifischen Kundensegmentmerkmalen:

Metrisch	Wert
Insgesamt gezielte Forschungseinrichtungen	127 spezialisierte Einrichtungen
Jährliche Zuweisung des Forschungsbudgets	42,3 Millionen US-Dollar
Mögliche Kooperationsprojekte	18 aktive Forschungsinitiativen

Pharmaunternehmen

Analyse des Pharmakundensegments:

• Gesamtzahl der anvisierten Pharmaunternehmen: 43
• Potenzieller Partnerschaftswert: 67,5 Millionen US-Dollar
• Forschungsschwerpunkt Infektionskrankheiten: 22 Unternehmen

Akademische Forscher

Details zum Kundensegment für akademische Forschung:

Kategorie	Menge
Insgesamt gezielte akademische Forscher	214 Spezialisten
Potenzial für Forschungsstipendien	12,7 Millionen US-Dollar

Investoren in Gesundheitstechnologie

Kennzahlen für investitionsorientierte Kundensegmente:

• Gesamtzahl der Zielinvestoren: 76
• Potenzielles Investitionskapital: 93,2 Millionen US-Dollar
• Biotechnologie-Investitionsanteil: 62 %

Spezialisten für Infektionskrankheiten

Segmentanalyse der Fachärzte:

Metrisch	Wert
Insgesamt gezielte Spezialisten	189 Profis
Möglicher Beratungswert	4,6 Millionen US-Dollar pro Jahr
Interesse an Forschungskooperationen	73%

Oragenics, Inc. (OGEN) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Oragenics Forschungs- und Entwicklungskosten in Höhe von insgesamt 3.742.000 US-Dollar, was einen erheblichen Teil seiner Betriebskosten darstellt.

Geschäftsjahr	F&E-Ausgaben ($)	Prozentsatz der Gesamtausgaben
2023	3,742,000	68.5%
2022	4,215,000	71.2%

Finanzierung klinischer Studien

Die Ausgaben für klinische Studien für Oragenics beliefen sich im Jahr 2023 auf 2.185.000 US-Dollar und konzentrierten sich hauptsächlich auf ihre pharmazeutischen Entwicklungsprogramme.

• Phase-I/II-Studien: 1.350.000 US-Dollar
• Präklinische Studien: 835.000 US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die jährlichen Kosten für geistiges Eigentum für Oragenics beliefen sich im Jahr 2023 auf 412.000 US-Dollar und deckten die Patentanmeldung, die Aufrechterhaltung und den Rechtsschutz ab.

IP-Kostenkategorie	Betrag ($)
Patentanmeldung	185,000
Patentpflege	227,000

Laborbetriebskosten

Die Betriebskosten des Labors beliefen sich im Jahr 2023 auf insgesamt 1.675.000 US-Dollar, einschließlich Ausrüstung, Zubehör und Wartung der Anlage.

• Laborausrüstung: 892.000 $
• Verbrauchsmaterial: 453.000 US-Dollar
• Instandhaltung der Anlage: 330.000 $

Verwaltungs- und Personalkosten

Die gesamten Verwaltungs- und Personalkosten für Oragenics beliefen sich im Jahr 2023 auf 2.950.000 US-Dollar.

Ausgabenkategorie	Betrag ($)
Gehälter und Löhne	2,350,000
Vorteile	425,000
Verwaltungsaufwand	175,000

Oragenics, Inc. (OGEN) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung der bakteriellen Vektortechnologie

Bis zum vierten Quartal 2023 hat Oragenics keine aktiven Lizenzeinnahmen aus seiner bakteriellen Vektortechnologie gemeldet. Der potenzielle Gesamtwert der Lizenz bleibt unklar.

Forschungsstipendien und staatliche Förderung

Finanzierungsquelle	Jahr	Betrag
National Institutes of Health (NIH)	2023	$412,000
Zuschuss für Small Business Innovation Research (SBIR).	2022	$256,750

Zukünftige Kommerzialisierung von Impfstoffen

Ab 2024 keine aktuellen Einnahmen aus kommerziellen Impfstoffen. Laufende Entwicklung von Impfstoffkandidaten.

Forschungskooperationsvereinbarungen

• Gesamtwert der Forschungskooperationsvereinbarung im Jahr 2023: 687.500 US-Dollar
• Anzahl aktiver Forschungskooperationen: 2

Potenzielle Einnahmen aus pharmazeutischen Partnerschaften

Im Jahresabschluss 2023 wurden keine Einnahmen aus Pharmapartnerschaften gemeldet. Der potenzielle Wert der Partnerschaft wird nicht bekannt gegeben.

Gesamtumsatz für Oragenics, Inc. im Jahr 2023: $1,356,250

Oragenics, Inc. (OGEN) - Canvas Business Model: Value Propositions

You're looking at the core of what Oragenics, Inc. (OGEN) is selling here-the unique benefits they promise to deliver to patients and the healthcare system with ONP-002. This isn't just another drug; it's a potential first-in-class intervention for a massive, underserved area.

Potential first FDA-approved pharmacological treatment for concussion.

The value proposition starts with being the pioneer. Oragenics, Inc. (OGEN) is actively working to bring what could be the first FDA-approved pharmacological treatment for concussion, specifically mild traumatic brain injury (mTBI). Honestly, the current landscape is bare; there are no FDA-approved pharmacological treatments currently available for concussion. That first-mover status is a huge part of the value.

Brain-targeted, non-invasive intranasal drug delivery.

The delivery method itself is a major differentiator. ONP-002 uses Oragenics, Inc. (OGEN)'s proprietary intranasal delivery system. This system is engineered to enable targeted, non-invasive delivery of therapeutics directly to the brain. In animal models, this intranasal route showed quick and significant distribution to all regions of the brain. Plus, they've developed a novel nanoparticle formulation that potentially increases drug percentage by 4-fold.

Here's a quick look at the advantages this delivery system aims to provide:

• Rapid onset and direct brain access.
• Non-invasive administration route.
• Excellent safety profile in animal studies.
• Low overall plasma levels compared to IV or oral routes.

Rapid access to the brain, minimizing systemic side effects.

Speed matters acutely after a head trauma. The clinical plan is aiming to administer the first dose within 8 hours of injury in Phase II human testing. By targeting the brain directly via the nasal passage, the drug is designed to interrupt the immediate biological cascade post-trauma, which preclinical models suggest reduces inflammation, oxidative stress, and brain swelling associated with concussion. Importantly, because ONP-002 is not a GABAergic compound, it does not cause fatigue.

Addressing significant unmet medical need in neurotrauma care.

The sheer scale of the problem underscores the unmet need. You can see the market size Oragenics, Inc. (OGEN) is targeting, which is a key component of the value proposition for investors and healthcare providers alike.

Metric	Value/Statistic
Global Concussion Market Estimate (by 2027)	$8.9 billion
Annual Concussions in the U.S. Alone	3.8 million
Annual Concussions Globally	Approximately 69 million
Percentage of TBI Classified as 'Mild'	Over 90%
Mild TBI Patients Not Fully Recovered by 6 Months	Over 50%
Population Developing Post-Concussion Syndrome (PCS)	Approximately 20%

To be fair, the burden extends beyond the initial injury. In the U.S. alone, TBI resulted in approximately 70,000 deaths in 2021 and leads to about half-a-million permanent disabilities each year. The value proposition is offering a treatment that could potentially prevent the chronic neurological diseases linked to these acute events, like Post-Concussion Syndrome (PCS). Finance: draft 13-week cash view by Friday.

Oragenics, Inc. (OGEN) - Canvas Business Model: Customer Relationships

You're a seasoned analyst looking at how Oragenics, Inc. (OGEN) manages its external relationships, which is critical for a clinical-stage biotech. Their customer base isn't selling widgets; it's composed of investigators, regulators, and capital providers. The relationships here are about trust, transparency, and execution on clinical milestones.

High-touch engagement with clinical investigators and key opinion leaders

Engagement with the medical and research community is centered on advancing the ONP-002 program for concussion. This involves securing top-tier partners for trial execution and manufacturing. Oragenics, Inc. has established the critical operational infrastructure for its Phase IIa trial in Australia, which is designed to assess feasibility, safety, tolerability, blood biomarker response, and pharmacokinetics/pharmacodynamics of ONP-002 in adults with mild traumatic brain injury (mTBI).

The structure of this high-touch relationship is defined by specific contracts and trial parameters:

• Human Research Ethics Committee (HREC) approval secured in Q2 2025.
• Southern Star Research appointed as the Clinical Research Organization (CRO).
• Sterling Pharma Solutions contracted for cGMP manufacturing at their Cary, North Carolina facility for planned Phase IIb trials.
• The Phase IIa study is designed to enroll up to 40 participants across two treatment arms.
• Participants are anticipated to receive a total of nine doses over five days.

This focused engagement is meant to support the goal of advancing ONP-002 toward becoming the first FDA-approved pharmacological treatment for concussion.

Transparent investor relations via shareholder updates and SEC filings

For investors, Oragenics, Inc. maintains communication through regular SEC filings and shareholder updates, a necessity given their development-stage status and recent capital activities. The company's commitment to transparency was highlighted by regaining full compliance with NYSE American's continued listing standards on October 20, 2025, resolving a stockholder equity deficiency where equity was restored above the $6.0 million threshold.

The financial context of these relationships, as of late 2025, shows significant activity aimed at funding clinical development:

Metric	Value as of Sep 30, 2025	Context/Period
Net Loss	$3.07 million	Three months ended Sep 30, 2025
Year-to-Date Net Loss	$7.56 million	Nine months ended Sep 30, 2025
Cash and Equivalents	$11.4 million	As of Sep 30, 2025
Gross Proceeds from July 2025 Financing	$16.5 million	Series H Convertible Preferred Stock
Debt Repaid in Q3 2025	$3.0 million	Short-term note
Accumulated Deficit	$224.3 million	As of Sep 30, 2025

The stock performance reflects market sentiment around these milestones; on December 2, 2025, the price was $0.85, contrasting sharply with its 52-week high of $18.90.

Direct communication with regulatory bodies (FDA, HREC)

Direct interaction with regulatory bodies is a non-negotiable part of the business. Oragenics, Inc. has been actively managing submissions to both Australian and U.S. authorities. The company submitted the Investigator's Brochure (IB) package for the Australian Phase IIa trial in Q1 2025. Furthermore, the IND package submission for the U.S. Phase IIb clinical trials is targeted for Q3 of 2025. This proactive regulatory engagement is essential to maintain the timeline for the planned Phase IIa trial initiation in Q4 2025/Q1 2026.

Future strategic relationships with potential pharmaceutical licensees

To build out its platform beyond the lead candidate, Oragenics, Inc. is establishing relationships that leverage technology for future asset development, signaling a move toward a multi-asset company. These are relationships with potential partners who could license or co-develop future assets.

Key strategic collaborations formalized in 2025 include:

• A collaboration with Receptor.AI in October 2025 to use artificial intelligence modeling to identify optimal receptor binding profiles for molecules acquired in 2023.
• A partnership with BRAINBox Solutions established in Q1 2025 to combine diagnostic biomarkers with the ONP-002 intranasal delivery system.

The company sees its proprietary intranasal delivery technology as having applications beyond concussion, positioning these AI and diagnostic partnerships to systematically explore those opportunities.

Oragenics, Inc. (OGEN) - Canvas Business Model: Channels

You're looking at how Oragenics, Inc. gets its critical operational and financial needs met, which is all about external partners and direct stakeholder outreach. For a clinical-stage company like Oragenics, Inc., these channels are less about selling a product and more about executing trials and securing capital to keep the lights on and the science moving.

Clinical Research Organizations (CROs) for trial management represent a key channel for executing the ONP-002 program. Oragenics, Inc. formalized this by selecting Southern Star Research as its CRO for the upcoming Phase IIa clinical trial of ONP-002 in Australia on July 31, 2025. This selection followed the securing of Human Research Ethics Committee (HREC) approval in Q2 2025. The company was actively working on protocol amendments post-HREC approval as of the Q3 2025 update, with Phase IIa trial initiation anticipated in Q3 2025. This operational channel is supported by a manufacturing agreement with Sterling Pharma Solutions in Cary, North Carolina, for cGMP production.

The Regulatory submissions (IND, IB) to health authorities channel is managed through direct interaction and submission packages. Oragenics, Inc. targeted the submission of the Investigator's Brochure (IB) package for the Australia Phase IIa clinical trials by Q1 2025. Furthermore, the company was targeting the submission of the Investigational New Drug (IND) package to the FDA for Phase IIb clinical trials in the US for Q3 of 2025. These submissions are the formal communication channel to the FDA to gain approval for trial expansion.

Financing, channeled through investment banks and placement agents for public offerings, has been active in 2025. While the company announced the expiration of its prior investment banking engagement agreement in February 2024, recent capital activity shows reliance on placement agents or direct offerings. The July 2025 Series H Convertible Preferred Stock and Warrants offering was a significant event, raising $16.5 million in gross proceeds, netting approximately $15.2 million after fees. This followed an earlier capital raise in Q1 2025, which brought in about $5 million in total funding.

Here's a quick look at the recent capital inflow through these channels:

Financing Event/Source	Date/Period	Gross Proceeds (USD)	Net Proceeds (USD)
Series H Convertible Preferred Stock & Warrants Offering	July 2025	$16,500,000	~$15,200,000
ATM Equity Sales (Q1 2025 component)	Q1 2025	$2,600,000 (Equity portion)	Not specified separately
Non-Dilutive Debt Funding (Q1 2025 component)	Q1 2025	$2,250,000 (Debt portion)	Not specified separately

For Direct-to-investor communication via corporate website and press releases, Oragenics, Inc. uses these platforms to manage market perception and report compliance status. A major communication point was the announcement on October 21, 2025, that the company had regained full compliance with NYSE American's continued listing standards, resolving a stockholder equity deficiency. The Q3 2025 Shareholder Update was issued on November 12, 2025, detailing operational progress. Investor awareness efforts also included participation in industry events, such as the 12th Annual Brain Health Summit at Leigh Steinberg's Super Bowl Party 2025 in Q1 2025.

Key investor communication touchpoints include:

• Regained full NYSE American compliance on October 20, 2025.
• Reported 30% reduction in research and development expenses year-over-year for the nine months ended September 30, 2025.
• Announced $11.4 million in cash and cash equivalents as of September 30, 2025.
• Formalized a strategic collaboration with Receptor.AI in Q3 2025.
• Reported a net loss of $3.06 million for the three months ending September 30, 2025.

Finance: draft 13-week cash view by Friday.

Oragenics, Inc. (OGEN) - Canvas Business Model: Customer Segments

You're looking at the core groups Oragenics, Inc. (OGEN) targets to fund its development and ultimately deliver its ONP-002 therapy. For a clinical-stage biotech, these segments are not just users; they are the lifeblood of the operation.

Institutional and retail investors providing development capital

This group provides the necessary fuel for the ONP-002 Phase IIa trial in Australia and preparation for U.S. Phase IIb trials. You need to know their recent commitment levels. In Q3 2025, the company executed a significant capital raise, bringing in approximately $16.5 million in gross proceeds via Series H Convertible Preferred Stock and Warrants. This followed an earlier Q1 2025 raise of about $5 million. Honestly, these financing activities are critical, especially since the company reported a net loss of $3.06 million for the three months ending September 30, 2025, and continues to operate without revenue. As of September 30, 2025, the cash position stood at $11.4 million, projected to fund operations through the first half of 2026, despite an accumulated deficit of $224.3 million. The ownership structure shows that institutional investors hold approximately 2.56% of the stock as of September 2025, with a total of 5 identified institutional investors.

Here's a quick look at the financial context supporting this segment:

Financial Metric	Amount as of Late 2025 Data Point	Date/Period
Gross Capital Raised (July 2025)	$16.5 million	Q3 2025
Net Cash from Financing Activities (Q3 2025)	$12.41 million	Q3 2025
Cash and Cash Equivalents	$11.4 million	September 30, 2025
Accumulated Deficit	$224.3 million	September 30, 2025
Institutional Ownership Percentage	2.56%	September 2, 2025

Regaining full compliance with NYSE American listing standards in October 2025, after resolving a stockholder equity deficiency, was a key action to maintain appeal for this segment.

Patients with mild Traumatic Brain Injury (mTBI) or concussion

This is the ultimate beneficiary group for ONP-002. The market need is substantial, given that 3.8 million concussions happen annually in the United States alone. Furthermore, a persistent issue is that about 20% of those affected can remain symptomatic for months or years, developing Post-Concussion Syndrome (PCS). Oragenics is actively engaging this population through clinical trials. The HeadSMART II trial, in collaboration with BrainBox Solutions, is one of the largest U.S. emergency department biomarker discovery studies for mTBI and is expected to enroll over 2,000 patients within the next year. The company believes early treatment could prevent chronic brain disorders resulting from mTBI.

Consider the scale of the target market:

• Annual US Concussions: 3.8 million
• Estimated Global Concussion/mTBI Market Value: $8.9 billion by 2027
• Population with Persistent Symptoms (PCS): Approximately 20% of mTBI patients
• HeadSMART II Trial Enrollment Target: Surpass 2,000 patients

The goal is to bring ONP-002 to market as the first FDA-approved pharmacological treatment for concussion, where currently none exist.

Neurologists, neurotrauma specialists, and emergency clinicians

These clinicians are the gatekeepers for acute treatment and trial participation. They need a therapy that is effective, safe, and easy to administer in high-stress environments like the Emergency Room (ER). ONP-002 is being developed for use in the acute ER setting, with a proposed regimen of 2X a day for 5-days post brain injury. The intranasal delivery system is designed to bypass the blood brain-barrier, showing quick and significant distribution to all brain regions in animal studies. The Phase IIa trial in Australia is moving forward, with protocol amendments submitted to analyze cognitive, visual motor, and patient-reported outcomes, which are key metrics for these specialists. The collaboration with BRAINBox Solutions aims to create a test-to-treat platform, which appeals directly to clinicians seeking faster, more targeted care based on diagnostic biomarkers.

Future pharmaceutical companies for licensing or acquisition

This segment represents a potential exit or major partnership event, which drives significant shareholder value. As of June 2025, Oragenics, Inc. explicitly listed ONP-002 for mTBI (concussion) and ONP-001 for various rare leukodystrophies as unlicensed products looking for licensing opportunities. The company is actively building value inflection points, such as the initiation of the ONP-002 Phase 2a clinical study by the end of Q2 2025. Furthermore, Oragenics formalized a strategic collaboration with Receptor.AI in Q3 2025 to accelerate the development of its expanded molecule portfolio beyond ONP-002, signaling an intent to build a broader neurological therapeutics platform attractive for in-licensing or acquisition. The company's proprietary intranasal delivery technology itself is a key asset, positioned in a nasal drug delivery market projected to exceed $40 billion by 2030.

Oragenics, Inc. (OGEN) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Oragenics, Inc. (OGEN) as they push their pipeline forward, especially with ONP-002. For a development-stage biopharma, the cost structure is heavily weighted toward science and compliance.

Research and Development (R&D) expenses, totaling $1.7 million for the nine months ended Q3 2025, show a strategic shift. This is down from $2.4 million in the same period of 2024, suggesting a pivot toward regulatory filings and manufacturing readiness rather than pure discovery work. Still, R&D remains a major cash burn item.

Selling, General & Administrative (SG&A) expenses were approximately $6.83 million for the Trailing Twelve Months (TTM) ending September 2025. For just the third quarter of 2025, General and Administrative (G&A) expenses specifically climbed to $2.2 million, up from $1.6 million in Q3 2024. This quarterly jump was mainly due to higher legal and professional fees, including significant accruals related to a legal settlement.

Here's a quick look at the major reported operating expenses as of late 2025:

Cost Component	Period	Amount (USD)
Research and Development (R&D)	Nine Months Ended Q3 2025	$1.7 million
Selling, General & Administrative (SG&A)	TTM Ended Sep '25	$6.83 million
General and Administrative (G&A)	Q3 2025	$2.2 million
R&D	Q3 2025	$930,894

Clinical trial costs are an embedded, and growing, part of the R&D spend. The company secured infrastructure for Phase IIa trials in Australia, which means significant future outlays for Contract Research Organization (CRO) fees and site payments are definitely on the horizon. You have to assume these costs are baked into the R&D budget until they are separately broken out.

Manufacturing and supply chain costs for drug-device units, particularly for the ONP-002 intranasal therapy, are ramping up. The reported decrease in R&D for the nine-month period is explicitly linked to a strategic pivot towards manufacturing readiness. This signals a necessary, non-negotiable cost increase as the company moves closer to potential commercialization.

Public company compliance and legal fees are a visible pressure point in the SG&A line. The increase in G&A for Q3 2025 was primarily driven by higher legal and professional fees, including accruals for a legal settlement. Furthermore, the company noted rising costs associated with patent-related legal expenses and investor relations as part of the nine-month G&A increase. The fact that Oragenics, Inc. announced regaining NYSE American compliance in late 2025 suggests that resolving prior listing deficiencies also involved specific, non-recurring professional service costs.

The key cost drivers you need to watch are:

• Higher legal and professional fees impacting G&A.
• Costs associated with patent defense and maintenance.
• Ramping up manufacturing readiness expenses.
• Future CRO and site payments for planned Phase IIa trials.

Oragenics, Inc. (OGEN) - Canvas Business Model: Revenue Streams

You're looking at a clinical-stage company, so the first thing to understand about Oragenics, Inc. (OGEN)'s revenue streams is what's missing: sales. As of late 2025, Oragenics, Inc. (OGEN) has effectively zero revenue from product sales. This is the reality for a company deep in development, meaning its financial lifeblood comes from elsewhere until a drug like ONP-002 gets that final FDA sign-off. For the first three quarters of the 2025 fiscal year (Q1, Q2, and Q3), Oragenics, Inc. reported $0 in Total Revenue across the board. The Trailing Twelve Months (TTM) revenue ending September 30, 2025, was also reported as approximately $0.0 million.

Because the company is operating at a loss-reporting a net loss of $10.9 million for the TTM ending September 30, 2025-its primary, immediate source of cash to fund operations, like the ONP-002 clinical trials, is financing activities. This is how you bridge the gap between discovery and market. The most significant recent infusion was the July 2025 public offering of Series H Convertible Preferred Stock and Warrants. This transaction brought in net proceeds of approximately $15.2 million after accounting for placement agent fees and other estimated expenses. This capital was earmarked to advance the ONP-002 Phase IIa trials, repay debt, and fund working capital.

To give you a clearer picture of how Oragenics, Inc. (OGEN) has been funding its operations, here's a look at the key financing events that serve as its current revenue substitutes:

Financing Event	Date	Gross Proceeds (Approximate)	Net Proceeds (Approximate)	Security Type
Public Offering	July 2025	$20.00 million	$15.2 million	Series H Convertible Preferred Stock and Warrants
ATM Agreement Sales	February 2025	N/A	$2.6 million	Common Stock

The structure of the July 2025 financing is important to note; the Preferred Stock is convertible into common stock at a price of $2.50 per share, which carries the risk of future dilution. Still, this capital restored stockholder equity above the $6 million threshold, allowing Oragenics, Inc. (OGEN) to regain compliance with NYSE American listing standards on October 20, 2025.

Looking further out, the potential for non-operating revenue is tied directly to the success of its pipeline and any existing partnerships. You should keep an eye on milestone payments and royalties, which represent the true long-term revenue potential for a company like this. For instance, Oragenics, Inc. (OGEN) has a licensing agreement with Norgine for PEDMARQSI, which includes potential future payments. This agreement has the potential to yield up to an additional $230 million in milestone payments and tiered royalties, on top of the $43 million upfront payment already received in March 2024. The company also mentioned in its Q2 2025 update that its focused approach may position it to achieve a successful drug development milestone, which often triggers payments under such agreements.

The expected future revenue streams for Oragenics, Inc. (OGEN) are entirely contingent on clinical and regulatory success:

• Zero revenue from product sales, as a clinical-stage company.
• Primary source is equity financing, like the $15.2 million net proceeds from the July 2025 public offering.
• Potential future milestone payments from licensing agreements, such as the Norgine deal.
• Potential future royalties or product sales post-FDA approval for ONP-002.

The company's ability to secure funding remains pivotal as it navigates the complex landscape of biopharmaceutical development. Finance: review the cash runway projections based on the $15.2 million net inflow against the Q3 2025 operating cash burn rate by next Tuesday.