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Oragenics, Inc. develops antibiotics for infectious diseases in the United States. The company engages in the development and commercialization of NT-CoV2-1, an intranasal vaccine candidate that provides immunity from the novel severe acute respiratory syndrome coronavirus; and Terra CoV-2, an intramuscular vaccine candidate that provides immunity from the novel severe acute respiratory syndrome coronavirus. The company's product candidates also comprise LPT3-04, a weight loss candidate; and SMaRT Replacement Therapy, a topical treatment to prevent dental carries. It has a license agreement with Noachis Terra Inc. for licensing of certain specified patent rights and biological materials relating to the use of pre-fusion coronavirus spike proteins; and a collaboration agreement with Precigen, Inc. and ILH Holdings, Inc. for the development and commercialization of MU1140 and related homologs. The company was formerly known as Oragen, Inc. Oragenics, Inc. was incorporated in 1996 and is headquartered in Tampa, Florida.

Oragenics, Inc.

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COMPANY ALSO ADVANCES U.S. REGULATORY PATHWAY FOR ONP-002 WITH FDA TYPE B MEETING REQUEST ALL THREE AUSTRALIAN PHASE IIA TRIAL SITES  MACKAY BASE HOSPITAL, ALFRED HEALTH, AND ROYAL ADELAIDE HOSPITAL  ARE NOW ACTIVE AND ENROLLING, FOLLOWING ROYAL ADELAIDE HOSPITAL'S RESEARCH GOVERNANCE OFFICE (RGO) APPROVAL ALFRED HEALTH ENROLLS FIRST PARTICIPANT IN THE PHASE IIA CLINICAL TRIAL COMPANY SUBMITS TYPE B MEETING REQUEST TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), ADVANCING THE U.S. REGULATORY PATHWAY FOR ONP-002 SARASOTA, FLA., JULY 07, 2026 (GLOBE NEWSWIRE) -- ORAGENICS (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY DEVELOPING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, TODAY ANNOUNCED THAT ALL THREE SITES IN ITS AUSTRALIAN PHASE IIA CLINICAL TRIAL ARE NOW ACTIVE AND ENROLLING  ALONGSIDE CONTINUED PROGRESS ON ITS U.S. REGULATORY PROGRAM FOR ONP-002, BEING EVALUATED FOR THE TREATMENT OF MTBI (CONCUSSION).

ORAGENICS ACHIEVES FULL ACTIVATION OF AUSTRALIAN PHASE IIA TRIAL NETWORK  ALL THREE SITES NOW ENROLLING

SARASOTA, FL, MAY 19, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN) ("ORAGENICS" OR THE "COMPANY"), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY PIONEERING NEUROLOGICAL THERAPEUTICS, WILL PRESENT AND HOST ONE-ON-ONE MEETINGS WITH INVESTORS AT SIDOTI'S MICRO-CAP VIRTUAL INVESTOR CONFERENCE, TAKING PLACE ON MAY 20-21, 2026.

ORAGENICS TO PRESENT AT SIDOTI'S MICRO-CAP VIRTUAL INVESTOR CONFERENCE MAY 20-21

A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER SARASOTA, FL, MAY 18, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN) DEAR FELLOW SHAREHOLDERS, SINCE OUR LAST INVESTOR UPDATE, ORAGENICS HAS CONTINUED TO EXECUTE ACROSS ALL FRONTS - IN THE CLINIC, IN THE REGULATORY PIPELINE, ON OUR BALANCE SHEET, AND STRATEGICALLY.

ORAGENICS PROVIDES INVESTOR UPDATE

THE EXPECTED LICENSE AGREEMENT WOULD POSITION ORAGENICS AS THE ONLY COMPANY WITH THERAPEUTIC STRATEGIES TARGETING TBI-INDUCED INFLAMMATION ON BOTH SIDES OF THE BLOOD-BRAIN BARRIER SARASOTA, FL AND SAN DIEGO, CA, MAY 07, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN) ("ORAGENICS" OR THE "COMPANY"), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY PIONEERING NEUROLOGICAL THERAPEUTICS, AND SIGYN THERAPEUTICS, INC.

ORAGENICS SIGNS LETTER OF INTENT TO LICENSE CARDIODIALYSIS TECHNOLOGY FROM SIGYN THERAPEUTICS TO TARGET TBI-INDUCED SYSTEMIC INFLAMMATION

SARASOTA, FLA., MAY 05, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY DEVELOPING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, TODAY ANNOUNCED THAT ALFRED HOSPITAL IS NOW ACTIVELY ENROLLING PARTICIPANTS IN ITS ONGOING PHASE IIA CLINICAL TRIAL EVALUATING ONP-002, THE COMPANY'S LEAD CANDIDATE FOR THE TREATMENT OF CONCUSSION AND MILD TRAUMATIC BRAIN INJURY (MTBI). TO DATE, FOUR PATIENTS HAVE BEEN ENROLLED AND DOSED AT MACKAY BASE HOSPITAL IN QUEENSLAND, AUSTRALIA, THE FIRST SITE ACTIVATED IN THE TRIAL.

ORAGENICS ACTIVATES SECOND SITE IN PHASE IIA CLINICAL TRIAL OF ONP-002 FOR CONCUSSION AND MILD TRAUMATIC BRAIN INJURY.

 ENROLLMENT UNDERWAY AT MACKAY BASE HOSPITAL IN QUEENSLAND, AUSTRALIA; ADDITIONAL SITES IN FINAL ACTIVATION STAGES SARASOTA, FLA. , APRIL 20, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY DEVELOPING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, TODAY ANNOUNCED THAT 2 PATIENTS AND 8 STUDY DRUG DOSES HAVE BEEN ADMINISTERED IN ITS ONGOING PHASE IIA CLINICAL TRIAL EVALUATING ONP-002, THE COMPANY'S LEAD CANDIDATE FOR THE TREATMENT OF MILD TRAUMATIC BRAIN INJURY (MTBI) A.

ORAGENICS REPORTS 8 STUDY DRUG DOSES IN PHASE IIA CLINICAL TRIAL OF ONP-002 FOR MILD TRAUMATIC BRAIN INJURY

SARASOTA, FLA., APRIL 13, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY DEVELOPING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, TODAY ANNOUNCED THAT THE FIRST PATIENT HAS BEEN DOSED IN ITS ONGOING PHASE IIA CLINICAL TRIAL EVALUATING ONP-002, THE COMPANY'S LEAD CANDIDATE FOR THE TREATMENT OF CONCUSSION AND MILD TRAUMATIC BRAIN INJURY (MTBI). THE MILESTONE WAS ACHIEVED AT MACKAY HOSPITAL IN AUSTRALIA  THE FIRST SITE TO BE ACTIVATED IN THE TRIAL  WITHIN DAYS OF SITE ACTIVATION ON MARCH 31, 2026.

ORAGENICS DOSES FIRST PATIENT IN PHASE IIA CLINICAL TRIAL OF ONP-002 FOR MILD TRAUMATIC BRAIN INJURY

SARASOTA, FLA., MARCH 25, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY PIONEERING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, ANNOUNCED THAT, AS PREVIOUSLY DISCLOSED IN ITS ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2025, WHICH WAS FILED ON MARCH 16, 2026 WITH THE SECURITIES AND EXCHANGE COMMISSION, THE AUDITED CONSOLIDATED FINANCIAL STATEMENTS CONTAINED AN UNQUALIFIED AUDIT OPINION FROM ITS INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM THAT INCLUDED AN EXPLANATORY PARAGRAPH RELATED TO THE COMPANY'S ABILITY TO CONTINUE AS A GOING CONCERN. SEE FURTHER DISCUSSION IN FOOTNOTE 1 TO THE COMPANY'S CONSOLIDATED FINANCIAL STATEMENTS INCLUDED IN THE COMPANY'S ANNUAL REPORT ON FORM 10-K. THIS ANNOUNCEMENT IS MADE PURSUANT TO NYSE AMERICAN LLC COMPANY GUIDE SECTION 610(B), WHICH REQUIRES PUBLIC ANNOUNCEMENT OF THE RECEIPT OF AN AUDIT OPINION CONTAINING A GOING CONCERN PARAGRAPH. THIS ANNOUNCEMENT DOES NOT REPRESENT ANY CHANGE OR AMENDMENT TO THE COMPANY'S FINANCIAL STATEMENTS OR TO ITS ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2025.

ORAGENICS, INC. RECEIVES AUDIT OPINION WITH GOING CONCERN EXPLANATION

FIRST SITE INITIATION VISIT COMPLETED IN AUSTRALIA SARASOTA, FLA., MARCH 12, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY PIONEERING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, TODAY ANNOUNCED IT HAS COMPLETED THE FIRST SITE INITIATION VISIT (SIV) FOR ITS PHASE IIA CLINICAL TRIAL OF ONP-002 IN AUSTRALIA.

ORAGENICS INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATION

SARASOTA, FLA., MARCH 11, 2026 (GLOBE NEWSWIRE) -- ORAGENICS, INC. (NYSE AMERICAN: OGEN), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY PIONEERING BRAIN-TARGETED THERAPEUTICS THROUGH PROPRIETARY INTRANASAL DELIVERY TECHNOLOGY, TODAY ANNOUNCED THAT IT IS EXPLORING DISCUSSIONS WITH THIRD PARTIES REGARDING THE POTENTIAL ACQUISITION OF ADDITIONAL ASSETS IN THE CENTRAL NERVOUS SYSTEM (CNS) SPACE, WITH A SPECIFIC FOCUS ON BRAIN HEALTH AND BRAIN RECOVERY INDICATIONS THAT DEMONSTRATE STRATEGIC SYNERGIES WITH THE COMPANY'S LEAD CANDIDATE ONP-002 AND ITS PROPRIETARY INTRANASAL DRUG DELIVERY PLATFORM.

Oragenics, Inc.

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Oragenics, Inc.

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