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Bionomics CEO believes company has 'significant, unrealized value'


Bionomics CEO believes company has 'significant, unrealized value'

Bionomics announced that Spyridon "Spyros" Papapetropoulos M.D., Ph.D., President and Chief Executive Officer of Bionomics, issued a letter to Bionomics shareholders, which read in part, "This year continues to be a pivotal year for Bionomics, characterized by numerous wins and essential changes that have enhanced the Company and furthered our goal of creating therapies for the countless individuals suffering from anxiety and stress disorders...Additionally, we are in the final stages of redomiciling the Company to the U.S. and launching Neuphoria Inc, a company with new vision, strategy and CNS pipeline focus to fully leverage the strong U.S. biotechnology ecosystem, while maintaining our Australian presence and potential future tax benefits. During the ordinary course of this process, we plan to consolidate our issued shares of our trading securities and remain compliant with the NASDAQ Stock Market listing rules. Thanks to these efforts, we believe the company is and will be fundamentally in a much stronger position today and moving forward. As shareholders ourselves, we remain disappointed in Bionomics' stock performance, particularly following our Annual Report filling on September 30, 2024. Yet, we believe that Bionomics is significantly undervalued, given our lead asset BNC210 is essentially a novel, "pipeline in a pill", small molecule with unique anxiolytic and antidepressant properties that can bring tremendous benefits to patients suffering from anxiety and stress disorders globally. Following the recent unfavorable industry developments with psychedelics in post-traumatic stress disorder, unrelated to our product pipeline, Bionomics' BNC210 is the only promising registrational stage program with a novel mechanism of action having demonstrated the best clinical study outcomes in decades, with a clear path for an NDA submission, and with one successful registrational quality study already competed, requiring one additional successful Phase 3 trial for potential registration. Of note, BNC210 also has two FDA fast track designations for SAD and PTSD programs, a sizable and favorable safety database supporting a differentiated non-sedating, non-addicting profile and positive datasets in four separate anxiety and stress-related indications. These clinical datasets and designations give us the ability to leverage regulatory privileges that can potentially accelerate review and approval. Moreover, we are also considering submitting a rebuttal in the future regarding the FDA decision to not grant a Breakthrough Designation in PTSD. It should also be noted that not being granted this designation does not in any way derail our progress or pathway in our clinical trials or intended operational success. As we continue executing the Phase 3 program in SAD with anticipated readout in Q3 2025, we are also working diligently on exploring ways to enhance efficiencies and foster potential partnerships that will ensure our ability to drive the Phase 3 trial of BNC210 in PTSD to a successful NDA submission with a single trial. This would be a major achievement for the Company following our successful End-of-Phase 2 meeting with the FDA in June 2024. We have begun trial initiation activities, and we are on track to commence the Phase 3trial in PTSD in the second half of 2025 or sooner, contingent upon successful financing. Our long-standing strategic partnership with MSD on the development of alpha7 receptor PAMs targeting cognitive dysfunction associated with Alzheimer's disease and other central nervous system conditions valued ~$500M is quickly advancing and is anticipated to enter Phase 2 in the near future, triggering a sizable milestone payment for the Company. Along with you, we believe Bionomics has significant, unrealized value that is not yet reflected in the current stock price."

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