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| We also see great potential in our rapid onset hormone-free PHAD nasal spray |
| So I think we're very confident as we continue to see clinical data support the preclinical data and the whole package that says this is a differentiated safety profile because of the MOA |
| Yeah, I think we're very optimistic about our ability to execute a well- controlled study post-pandemic and it's everything that you talked about, but it's also the things that we're able to do in terms of how we work with our CRO |
| We are encouraged that novel, late-stage, neuroscience-derived product candidates with differentiated safety profiles have stimulated renewed interest in large-market neuropsychiatry programs with the potential to change lives |
| So as we wrap up today's call, I want to emphasize that we are very proud and very excited to be focused on reaching another key corporate milestone in the near term |
| We believe each of our clinical neuroactive pherines, led by fasedienol for the acute treatment of social anxiety disorder, is anchored in novel neuroscience and has the potential to produce differentiated product profiles across multiple and diverse large-market therapeutic areas with high need for innovation and high need to transform the standards of care, including anxiety, depression, women's health and other disorders |
| With the positive results from our PALISADE-2 Phase 3 trial reported last year, and a strong balance sheet, we're fully focused on advancing our PALISADE Phase 3 development program in SAD, with preparations to initiate this year all key remaining studies planned for that program |
| We're confident in a go-forward where patients could have the ability to access the drug online on a recurring basis with the drug potentially not being scheduled, no REMS |
| All those things combined have the potential, of course, to improve even on what we've seen in the past in Phase 2 and in PALISADE-2 |
| Its potential is anchored in the previously unreported positive results from two trials in women's health indications that we announced last year |
| We have some additional exclusion criteria to make sure that subjects that are coming into the study have the best chance to have positive results or opportunity to have positive results with fasedienol and even things such as eligibility review, making sure that subjects are appropriate subjects before they're going into the Visit 2 and Visit 3 public speaking challenges |
| We believe either PALISADE-3 or PALISADE-4 if successful, together with the positive results from PALISADE-2 may establish substantial evidence of effectiveness of fasedienol in support of a potential NDA submission for the acute treatment of anxiety in adults with SAD |
| Again our mission in this large and unfortunately increasing neuropsychiatry market is to deliver a differentiated therapy to transform the standard of care without the risk of sexual side effects, weight gain or abuse liability concerns |
| We will progress through the next phases of our core corporate development strategies with confidence in our team's expertise to execute our PALISADE Phase 3 clinical program of fasedienol and SAD, the potential of our robust pipeline for multiple and diverse psychiatric and neurological disorders, and our steadfast commitment to pioneering neuroscience to develop and commercialize truly differentiated treatment solutions |
| It's nice to be knowing we're talking about potential labelling benefits |
| Last year we accomplished something that to our knowledge had never been achieved and that is to demonstrate positive Phase 3 results in an anxiety study with a drug candidate that does not need to be taken up systemically or act directly on neurons in the brain |
| So we already know we have fast-track |
| Have a tremendous day |
| Shelf registration statements on Form S3 are standard in our industry and are intended to provide us with broad flexibility to improve our balance sheet in the future as may be needed |
| So, at the end of the day for us positive study is we either see that there is some indication that it could be a benefit or we don't, but either way, there's benefit from the first dose |
| We appreciate everyone's interest and support |
| Having the ability to have in person investigator meetings, have the ability to do things that ensure rigorous adherence to the protocol, very exacting requirements of that protocol consistently across sites |
| Beyond fasedienol in our Phase 3 program in SAD we are continuing to explore various ways to unlock the significant potential of itruvone asset as a differentiated new therapy for major depressive disorder or MDD |
| So the things that we've done to improve surveillance, improve and further de-risk execution of the program, certainly that's a possibility |
| Here at Vistagen, we are pioneering neuroscience, with an intention to deliver first-in-class therapies for psychiatric and neurological disorders, where there are few, if any, adequate and differentiated FDA-approved treatment options to satisfy the widespread needs of patients whose mental health and whose well-being are adversely affected by their disorders |
| We look forward to getting back into the clinic soon with PALISADE-3 to continue driving on our mission to deliver a first-in-class therapy in a large neuropsychiatry market in need of differentiated fast-acting therapies without the risk of sexual side effects, weight gain, or abuse liability concerns |
| So on behalf of our whole team here at Vistagen, I want to thank you for your continued support |
| While the prevalence of SAD continues to grow, there's still no FDA-approved, patient-tailored, acute treatment option to help individuals with SAD rapidly and safely address their anxiety when their stressors are upon them in their daily life |
| Tim Lugo Thanks for the question and congratulations on the progress |
| Within the last few months, we've seen a renaissance in neuroscience, marked notably by pharma M&A in the neuropsychiatry space, valued at about $23 billion |
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| We know the agency is worried about the potential high abuse of benzodiazepines given their drug safety communication on that during COVID |
| Our net loss attributed to common shareholders was $6.3 million and $9.8 million for the three months ended December 31, 2023 and 2022 respectively |
| Of course forward-looking statements involve risks and uncertainties and our actual results could differ materially from those anticipated by any forward-looking statements we make today |
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