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| Statement |
|---|
| We strongly believe that these changes, will significantly enhance the probability, of success of our current studies |
| So, we do believe that the quality is very, very good in this trial |
| So, I'm very confident that despite having some patients enrolled previously, I still think, we're going to be successful overall |
| Enrollment continues to steadily progress, and our ability, to leverage our close relationship, with the study site, is paying dividends |
| I think it's a very reasonable question, but I'm pretty confident, I would say I'm very confident that we should be successful |
| And we are confident that the, we are top line data in the second half of this year |
| Sergio Traversa Well, thank you, and in summary, we remain confident that, we do have an approvable drug in REL-1017, and are excited by the potential of our novel psilocybin, and derivative program |
| So that's another improvement we've made |
| We are continuing, to make solid progress in advancing the ongoing Phase 3 program, for REL-1017 in major depressive disorder, MDD, as well as in the promising preclinical novel psilocybin program, all of which I will briefly cover today |
| These initial promising preclinical results, support the therapeutic potential, of low chronic dose of psilocybin |
| And to close, I'm grateful to the Relmada team, for their continued hard work and dedication to executing on our mission |
| So, the screening process, it's going very, very well |
| Based on our current clinical development plan, our current cash position provides us, with ample runway into 2025 |
| So, we feel confident that with these measures, we won't, what happened in the Study 301, will not happen again |
| As previously communicated, we have made critical changes to RELIANCE II, the ongoing study 302, a Phase 3 two-arm placebo-controlled pivotal study, evaluating REL-1017 25 milligrams, for adjunctive MDD, aimed at controlling placebo response, and improving the enrollment quality |
| That would be the minimum, right? We hope we can do better than that, based on the Phase 2 data, but that's a fair assumption |
| So I hope that helps |
| It's a good proxy, to be sure that the patient, is a real patient |
| But it's on track |
| As we said previously, based on - these data, low dose psilocybin could improve lipids and glucose, with potential fewer side effects, over other investigative treatment approaches such as GLP-1, glucagon, and GIP |
| Moreover, the ongoing initiative we put in place, to drive trial awareness with prospective patients, are also bearing fruit |
| Thanks everyone |
| The previous study, really was very close to being positive |
| And we'll try to do something that is, a reasonable, good way to get the drug approved in a relatively short amount of time |
| What we have noticed with the improvement on the protocol, clearly the screening failure, it went up significantly |
| Thank you very much to everyone |
| Thank you very much |
| Thank you |
| Thank you |
| Thank you |
| Statement |
|---|
| So the FDA, had concerns about that |
| And then if there's a site that has issues, we're actually stopping their enrollment |
| And then, there were a couple of issues there |
| And really the problem, was they didn't have a good story, for how two weeks of treatment, would hold a charge |
| For the fourth quarter ended December 31, 2023, total research and development expense was approximately $14.8 million, as compared to $26.9 million, for the comparable period of 2022, a decrease of approximately $12.1 million |
| Actual results could differ materially, from those stated, or implied by these forward-looking statements, due to risks and uncertainties associated with the company's business |
| Total research and development expense, was approximately $54.8 million, as compared to $113.3 million, for the year ended December 31, 2022, representing a decrease of $58.5 million |
| And the screening failure for legitimate reasons, it's much higher |
| And what we have seen is that, there is a material decrease in body weight with no diet, with continuing the high fat, high glucose diet |
| For the fourth quarter ended December 31, 2023, the net loss was $25.2 million, or $0.84, per basic and diluted share, compared with a net loss of $37.9 million, or $1.28 per basic, and diluted share in the comparable period, of 2022 |
| It just missed |
| So despite like high fat and high glucose diet, the rodent, they lost weight, not as much as a GLP-1, but enough to make it like a valuable drug, to treat obesity |
| Also, because the sites that, where the issue with data, was generated in the previous trials |
| For the year ended December 31, 2023, the net loss was approximately $98.8 million, or $3.28, per basic and diluted share, compared with a net loss of $157 million, or $5.30, per basic and diluted share, for the year ended December 31, 2022 |
| We just have to be better |
| But at the same time, we have seen a material decrease in glucose level, like similarly, probably a little higher than metformin |
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