Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| We see this drug extremely well positioned in the obesity marketplace, especially fitting the segment of patients who need to get further reduction in their serum lipids, reduction in their liver fat content, both important risk factors for cardiovascular disease, but most importantly, achieving it safely |
| We're very pleased with it and the comments reading from patients and investigators is that you've got the drug out there |
| We feel that we're going to be able to generate a very robust response with surface antigen and other measures of HBV replication |
| We are excited about the continued advancement of our lead product candidate, pemvidutide, a GLP-1/glucagon dual receptor agonist, in development for both obesity and NASH |
| We've demonstrated in our Phase 1 studies that it's very safe and that it's able to significantly increase the T cell response to HBV antigens |
| And we think that's a very important differentiator |
| We think this sights feel and patients feel as well based on the reactions that this is going to be a very successful product |
| Pemvidutide may also provide the opportunity to initiate or established therapy without dose titration, which we believe may be a highly attractive option to primary care physicians as the obesity market grows beyond specialty clinical settings |
| That's something we're obviously taking a very, very good look at |
| Significant improvements are positive trends in cardiometabolic risk factors were observed |
| It is general to believe that an effective therapy for chronic hepatitis B will require both direct-acting antivirals and immunotherapy and we believe that HepT cell is highly differentiated and may provide a functional cure of chronic hepatitis B infection when combined with novel direct-acting antivirals |
| Importantly, weight loss will also be assessed as a key endpoint as we believe this will be an important differentiator with respect to the majority of NASH therapeutics in development |
| So we're obviously optimistic about that |
| Chronic hepatitis B continues to represent a serious unmet need in the United States and worldwide and represents a significant commercial opportunity |
| We also achieved significant reduction in serum ALT in MRI-based corrected T1 imaging, both important markers of NASH improvement |
| We're optimistic about the pending results and look forward to ongoing discussions with FDA about the design of our Phase 3 program, which we hope to commence with a partner in the second half of 2024 |
| And with combination with the adjuvant that we are using IC31, which is preclinically looked very encouraging |
| It should also be pointed out that at the 24-week time point, the magnitude of LDL cholesterol reduction on pemvidutide treatment with several fall better than that achieved by semaglutide or tirzepatide in a similar population at the conclusion of their trials, but at 68 and 72 weeks, respectively |
| I would emphasize there's been a great deal of enthusiasm from not only patients, but also sites and in particular, Dr |
| This gives us confidence that the weight loss beyond the -- that weight loss beyond the mid-teens could be achieved, the subjects were to be treated for longer durations |
| So we think the safety profile, the good solid weight loss, the effects on serum and hepatic lipids, and especially in primary care, which we believe is going to dominate the obesity marketplace in the future, the convenience of not having a dose titration, at least at the 1.8-milligram dose |
| Given the compelling trade data on our Phase 1b trials, we expect to achieve significant rates of NASH resolution and fibrosis improvement and data readout, which is anticipated in Q1 2025 |
| So that's really what we are executing to, we feel that with the data that we are expecting at 48-week read out that would give us the best opportunity to line up a partner to move forward into Phase 3 |
| We appreciate the opportunity to share our results and outlook with you, and thank you for your continued interest |
| We believe that it is the action of the glucagon receptor agonism present in pemvidutide, but not in semaglutide or tirzepatide that leads to the improved effects on lipids and differentiates pemvidutide |
| The important reductions in lipid-based cardiovascular risk factors suggest that pemvidutide has the potential to achieve even greater reductions in cardiovascular risk than those observed in the recently completed select cardiovascular outcomes trial |
| And we felt that, that would represent a population that has received direct acting antivirals, has had the surface antigen reduced by the mechanisms that I referred to earlier and then created a better environment for the immunotherapeutic to work and boost the T-cell response |
| Obviously, there is a lot of opportunity to tweak the dosing any way we wish in order to get that profile down even better than it is right now |
| Fast Track Designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical needs |
| So, Omari, we -- as we've said, we feel comfortable that we could achieve weight loss in the mid-teens, which as Dr |
| Statement |
|---|
| As you mentioned, there was a higher than we expected adverse event discontinuation rate at the 2.4 milligram dose |
| NASH is a growing public health concern, and there are currently two or two treatments |
| Net loss for the three months ended September 30, 2023, was $20.7 million or $0.39 net loss per share compared to a net loss of $23.5 million or $0.48 net loss per share for the third quarter of 2022 |
| Now we'll continue to see weight loss, or would have continued to see weight loss beyond the 48 week time point |
| So if you recall, the weight loss achieved by tirzepatide and semaglutide at 48 weeks was less than it achieved at 48 weeks, at 72 weeks, or 68 and 72 weeks |
| And that also we'll continue to see weight loss beyond that |
| This may prove to be an important differentiator as cardiac effects may be -- may not be tolerated in a population with higher cardiovascular risk, such as elderly individuals or individuals with pre-existing cardiovascular disease |
| And so they're unlikely to mutate in response to the immune pressure that will be generated |
| Recall, the MOMENTUM interim data showed weight loss of 10.7% at the 2.4 milligram dose after only 24 weeks of treatment |
| Remember that at the 1.2 milligram and 1.8 milligram doses, the adverse event rates leading to discontinuation were low |
| For a discussion of some of the risks and factors that could affect the company's future results and operations, please see the risk factors and other cautionary statements contained in the company's filings with the SEC |
| A few questions from us |
Please consider a small donation if you think this website provides you with relevant information