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Oragenics Inc. (NYSE American: OGEN) is a publicly-traded biopharmaceutical company specializing in innovative, proprietary technologies aimed at improving human health. Based in Sarasota, Florida, Oragenics is renowned for its cutting-edge research and development in the fields of neurology and infectious diseases. The company’s core business revolves around the development of novel pharmaceutical treatments, including nasal delivery medications, which promise significant advancements in therapeutic efficacy and patient outcomes.
Oragenics’ flagship product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid. Designed to cross the blood-brain barrier effectively, ONP-002 targets mild Traumatic Brain Injury (mTBI), commonly known as concussion. The drug reduces swelling, oxidative stress, and inflammation while restoring proper blood flow through gene amplification. This revolutionary approach positions ONP-002 as a potential game-changer in treating brain injuries.
In addition to ONP-002, Oragenics boasts a diverse product pipeline, including therapies targeting Niemann-Pick Disease Type C (NPC) and other infectious diseases. The company is also recognized for its ProBiora3 technology, which is the foundation of products like evoraplus™—a unique probiotic mint that promotes oral health by supporting gums, freshening breath, and whitening teeth.
Recent achievements highlight Oragenics' relentless pursuit of excellence. The company is preparing to initiate a Phase II clinical trial for ONP-002, with advancements in drug formulation aimed at optimizing intranasal delivery. Collaborating with Avance Clinical Pty Ltd, Oragenics is focused on conducting this trial in emergency departments at level one trauma centers, ensuring robust and well-structured studies.
The leadership team at Oragenics, led by President Michael Redmond and Chief Medical Officer Dr. James Kelly, emphasizes the importance of partnerships and advanced research. Their dedication is reflected in Oragenics' preclinical studies, which have shown significant improvements in molecular and behavioral outcomes following brain injury. The company's innovative approach to intranasal delivery as nanoparticles has further enhanced brain exposure and metabolism.
Oragenics' commitment to addressing unmet medical needs, such as concussions—which affect millions globally each year—has positioned the company as a pivotal player in the biopharmaceutical industry. Through continuous innovation and strategic collaborations, Oragenics aims to provide effective treatments for neurological disorders and improve patient outcomes worldwide.
For more information, visit www.oragenics.com.
Oragenics, Inc. (NYSE American: OGEN) has entered a licensing agreement with the National Research Council of Canada to develop next-generation vaccines against SARS-CoV-2 and its variants. The collaboration leverages NRC technologies, enhancing the speed of cell line production for spike protein antigens from six months to six to eight weeks. The company has initiated preclinical studies and aims to advance vaccine candidates rapidly. This strategy may position Oragenics competitively against existing vaccines, particularly with additional options like intranasal administration.
Oragenics, Inc. (NYSE American: OGEN) has announced that its annual shareholder meeting, convened on June 30, 2021, was adjourned due to a lack of quorum. The meeting is rescheduled for August 23, 2021, at 4:00 p.m. The Company continues to solicit votes to meet the quorum requirement of a majority of shares. Currently, only 40% of the shares are represented by proxy. Shareholders of record as of May 5, 2021, are urged to vote by August 22, 2021. If quorum is not reached, further adjournment may incur additional costs.
Oragenics (NYSE American: OGEN) affirms its commitment to advancing its business strategy following the resignation of CEO Alan Joslyn. Executive Chairman Frederick W. Telling will take a more active management role. The company is focused on developing the Terra CoV-2 vaccine to combat COVID-19 and antibiotic resistance through its lantibiotics program. Oragenics has a strong leadership team and has recently raised nearly $22 million to support its initiatives, which positions it to continue operations well into 2022.
Oragenics, Inc. (NYSE American: OGEN) announced the resignation of Dr. Alan Joslyn as CEO and President, effective May 2, 2021. Dr. Frederick Telling transitions to Executive Chairman, while CFO Mr. Sullivan takes on the role of interim principal executive officer. The Board will guide the company in the interim as they seek a new CEO to lead the Terra CoV-2 vaccine development. Oragenics focuses on creating a vaccine to combat COVID-19 and developing new antibiotics. The company expresses gratitude for Dr. Joslyn's contributions and remains committed to future growth.
Oragenics, Inc. (NYSE American: OGEN) has entered into a material transfer agreement with Biodextris Inc. regarding the use of three intranasal mucosal adjuvants for its Terra CoV-2 vaccine against COVID-19. The adjuvants—BDX100, BDX300, and BDX301—aim to enhance immune response and manufacturing efficiency. This collaboration will facilitate preclinical studies essential for FDA Investigational New Drug applications and potential clinical trials. Oragenics' vaccine offers advantages like refrigerated storage, aiming to address ongoing COVID-19 vaccination needs.
Oragenics, Inc. (NYSE American: OGEN) announced that its CEO, Alan Joslyn, Ph.D., will participate in two virtual investment conferences in March 2021. The events are the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10 and the Roth Conference on March 15-17. A prerecorded presentation for the Roth Conference will be available on the Company's website starting March 9. Oragenics focuses on developing a vaccine for COVID-19 and novel antibiotics, leveraging research from the National Institutes of Health.
Oragenics, Inc. (NYSE American: OGEN) announced a successful capital raise of approximately $20 million through a sales agreement with A.G.P./Alliance Global Partners. The firm also gained around $1.9 million from exercising common stock warrants. Furthermore, Oragenics will redeem all shares of its Series C Preferred Stock, valued at $5.6 million, which eliminates a 20% preferred dividend. These funds will support the Phase 2 clinical trial of its SARS CoV-2 vaccine, Terra CoV-2, and advance its lantibiotics program.
Oragenics, Inc. (NYSE American: OGEN) has announced positive results for its COVID-19 vaccine candidate, Terra CoV-2. Research from the NIH indicates that the spike protein S-2P, licensed by Oragenics, induced protective immunity in mice infected with SARS-CoV-2. The study showed complete inhibition of virus growth in treated mice, with significant immune responses measured. The results support the ongoing development of Terra CoV-2, a candidate positioned to address the estimated 12-14 billion doses needed globally for COVID-19 vaccination. The company aims to file an Investigational New Drug application soon.
Oragenics, Inc. (NYSE American: OGEN) issued a letter to stockholders from CEO Alan Joslyn, updating on the COVID-19 vaccine Terra CoV-2. The firm has gained confidence from recent vaccine developments and has a nonexclusive license from the NIH for a prefusion stabilized spike protein vaccine candidate. Oragenics held a pre-IND meeting with the FDA, streamlining its timelines. The company raised $12.5 million in recent financing, aiming to advance vaccine studies. Despite financial hurdles, Oragenics believes in market demand for multiple vaccines against COVID-19.
Oragenics, Inc. (NYSE American: OGEN) announced a material transfer agreement with Adjuvance Technologies for the use of the adjuvant TQL1055 in its Terra CoV-2 vaccine against COVID-19. TQL1055 is designed to enhance immunogenicity, with initial studies planned to support the FDA Investigational New Drug application in Q1 2021. The vaccine aims for a robust immune response with lower antigen doses, and will be assessed in various animal studies. The vaccine's stable storage conditions may improve distribution.
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