Oragenics, Inc. (NYSE American: OGEN), a biopharmaceutical company
committed to developing novel therapies for neurological disorders,
today provided a corporate update reflecting on the company’s
progress throughout 2024, including key milestones in the
development of ONP-002, its lead candidate for the treatment of
concussions.
Company Overview: A Vision for Innovation in
NeurologyOragenics is focused on revolutionizing drug
delivery for neurological disorders using innovative intranasal
technology. The company’s lead program, ONP-002, is a
first-in-class neurosteroid being developed to treat moderate to
severe concussions. Intranasal delivery provides numerous
advantages over traditional systemic methods, including faster
brain delivery, reduced systemic exposure, and a non-invasive
approach.
“Our mission is to address significant unmet medical needs by
developing cutting-edge therapies,” stated Michael Redmond,
President of Oragenics. “There are over 3 million annual concussion
occurrences in the U.S. and an estimated 69 million globally,
however it is believed that a substantial number, up to 50%, of
cases go unreported. Given that there is still no FDA approval, and
patients in need continue to face limited treatment options, the
urgency to advance our efforts is greater than ever.
Key Milestones in Concussion Drug
DevelopmentOragenics has made significant advancements in
the development of ONP-002 during 2024, including:
Strengthened Clinical Leadership: In 2024, the
company appointed two renowned experts—Dr. James “Jim” Kelly as
Chief Medical Officer and Dr. William “Frank” Peacock as Chief
Clinical Officer—bringing deep expertise in brain health and
emergency medicine to oversee the clinical development of
ONP-002.
Phase II Clinical Trial Preparation: Building
on successful Phase I trials, which demonstrated the safety and
tolerability of ONP-002, the company is preparing to initiate Phase
II clinical trials, which will evaluate the drug’s efficacy based
on patient outcomes.
Successful Cardiotoxicity Testing: In July
2024, ONP-002 demonstrated a strong cardiac safety margin, clearing
FDA-required cardiotoxicity tests. These results suggest that the
treatment is unlikely to cause cardiac arrhythmias, a crucial
milestone that derisks the program as it moves forward into the
Phase II clinical trial.
FDA-Required Genotoxicity Studies: In August
2024, ONP-002 successfully completed the necessary studies
regarding FDA-required genotoxicity testing, confirming that the
drug does not cause DNA damage, further strengthening its safety
profile as it advances towards Phase II.
Partnership with Avance Clinical: In May 2024,
the company entered into a partnership with Avance Clinical, a
leading CRO, strengthening the company’s ability to execute its
Phase II trial for ONP-002 and leveraging Avance's expertise in
clinical trial management and regulatory pathways.
Temperature Stability Achieved: ONP-002
demonstrated stability across a wide temperature range, eliminating
the need for cold-chain storage. This milestone is especially
important for field delivery, where concussions frequently occur,
such as in sports or military environments.
Spray-Dry Manufacturing and Device Completion:
The company completed the spray-dry formulation of ONP-002 and
filled intranasal delivery devices needed for upcoming Phase II
trial. These ready-to-use devices should enable fast, targeted
treatment to patients following a concussion.
Improved Drug Percentage in Final Formulation:
A novel nanoparticle spray dried powder formulation was created
that should enhance intranasal absorption and increase the amount
of ONP-002 per dose by 4-fold. This new formulation is expected to
allow for more drug to enter the brain at each treatment increasing
the chance for reaching therapeutic levels and patient
improvement.
Completion of FDA-Recognized Study for Concussion Drug,
ONP-002: Intranasal casting studies are critical for FDA
approval of pharmaceuticals delivered via the nasal passage. The
study results demonstrated the drug successfully targets the
interior nose that is made from cast metal (AINI), making it more
likely to reach and treat the brain after a concussion. This model
is standard for intranasal drug delivery and is accepted by the FDA
as a surrogate for the actual nasal.
Recent Financing and Strategic GrowthIn
September 2024, Oragenics closed a public offering, raising
approximately $4.45 million, contributing to a total of over $6
million raised throughout the year, including previous financing
efforts. These funds will support the continued development of
ONP-002, allowing the company to advance toward Phase II clinical
trials and further address the unmet medical need for concussion
treatments.
“We are grateful for the confidence that our investors have
placed in our vision,” added Redmond. “This financing allows us to
continue advancing ONP-002, which we believe has the potential to
be the first approved drug for concussion treatment.”
Looking Ahead: Key MilestonesOragenics
anticipates several key milestones in the coming months,
including:
Initiation of Phase II Clinical Trials: The
company plans to begin Phase II trials later this year, initially
in Australia, followed by U.S. trials. These trials will evaluate
safety and efficacy - evaluating the effects of ONP-002 on
concussion patient symptom reduction and functional recovery.
Clinical Site Selection The company is
currently working with Avance Clinical, a clinical CRO along with
major neurotrauma centers in Australia on Phase II clinical
protocols. A key feature of the Phase II trial is to develop
emergency department protocols for patient inclusion/exclusion with
the goal of having the first dose occur within 8 hours of the
injury. Efficacy evaluations during this 10-day trial include
testing of visual-motor and neurocognitive functional performance
while also assessing patient symptoms relative to drug
treatment.
Australian Regulatory Submission Brochure
In preparation for its upcoming Phase II clinical trials,
Oragenics plans to submit the Australian Regulatory Submission
Brochure during the fourth quarter of 2024. This submission is a
critical component for the regulatory approval of the trial in
Australia and outlines the clinical trial safety and efficacy
protocols, informed consent protocols, and data collection
methods.
Continued Development of Intranasal Delivery
System: Oragenics’ intranasal system is a breakthrough in
brain injury drug delivery, designed to provide rapid, targeted
brain delivery with minimal side effects. This system will continue
to be a key focus as the company advances ONP-002. This includes
the breath-propelled and automated device technologies.
Commitment to ShareholdersOragenics remains
committed to maintaining transparency and open communication with
its shareholders. The company will continue to provide updates on
its progress as it advances toward key milestones and works to
commercialize ONP-002.
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.
Investor Relations:Rich Cockrell404.736.3838achv@cg.capital
Oragenics (AMEX:OGEN)
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