Castor Maritime Q3 2024 Earnings Call Transcript

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Provided by Quartr
November 12, 2024

There are 8 speakers on the call.

Operator

Good afternoon, and welcome to Fractal Health's Third Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. I will now turn the call over to Steven Jasper. Steven, you may now begin.

Speaker 1

Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today. The release is available at www.fractal.com under the Investors tab. Joining us on the call today are Doctor. Harith Rajagopalan, Chief Executive Officer and Lisa Davidson, Chief Financial Officer.

Speaker 1

Before we begin, I would like to remind everyone that statements made during this conference call that do not relate to matters of historical fact, including statements about our objectives and anticipated clinical milestones, preclinical or clinical trial data, the impact of any of our product candidates, the design initiation, timing and results of clinical enrollment in any clinical trial or readouts, the potential launch or commercialization of any of our product candidates or products, the sufficiency of our cash, cash equivalents and investments to fund our operating activities for any specific period of time should be considered forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are intended to be subject to the Safe Harbor protection provided by the Reform Act. Actual results could differ materially from those indicated by the forward looking statements due to the impact of risks, uncertainties and other important factors. Participants are directed to the risk factors set forth in Fractal's quarterly report on Form 10 Q filed with the Securities and Exchange Commission on November 12, 2024, and the company's other filings with the SEC. Any forward looking statements made today speak only to Frackel's operations as of today.

Speaker 1

Frackel disclaims any duty to provide updates to its forward looking statements even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Fareed.

Speaker 2

Thank you, Stephen, and good afternoon, everyone. Thank you for joining us on today's call. This is an exciting time for Fractal as we approach multiple critical milestones over the next few quarters. I'm immensely proud of the progress we have made across both of our platforms, Revita and REJUVA, as we develop transformative therapies that can prevent and reverse metabolic disease. Q3 was another quarter of excellent performance and accomplishment.

Speaker 2

A few key highlights. First, we began enrollment in our REMAIN-one pivotal study for weight maintenance after GLP-one discontinuation and this study is progressing rapidly. 2nd, we anticipate reporting data from the REVEAL 1 open label cohort of this study beginning in Q4 2024. 3rd, we began enrollment under the expanded protocol for the REVEALIZE 1 pivotal study for Rubida in type 2 diabetes, and we expect to report top line data in mid-twenty 25. And 4th, we continue to present compelling weight maintenance and blood sugar data from Revita and REJUVA at multiple medical meetings.

Speaker 2

We are confident in our ability to continue to execute against our upcoming major value drivers and we continue to be laser focused on demonstrating the potential for our therapies to transform the treatment landscape in obesity and diabetes. To begin, let's talk about the rapidly evolving landscape of obesity and GLP-one drugs. These drugs have clearly had a positive impact on treatment options for people with obesity and diabetes, but they also carry significant challenges that affect both patients and healthcare systems. There are 3 main concerns that have emerged in the past year and they are all intertwined. First, the durability of weight loss effects over time with GLP-one drugs is beginning to be a major problem as discontinuation rates and weight rebound are major challenges for the class.

Speaker 2

2nd, there is an obvious and growing gap between the impressive Phase III results from these drugs versus their substantially less impressive real world performance. And 3rd, despite their expense, these drugs are not delivering discernible clinical benefit to payers, leading to fundamental and crucial questions about value. No one doubts the importance of durable, clinically meaningful weight loss, but the question is, why are these drugs not delivering on their promise in the real world and what will. We've spoken before about poor persistence or durability of therapy from GLP-one drugs. It's essentially the same issue that has already been seen with other drugs for every other chronic non acute disease including hypertension, high cholesterol and diabetes.

Speaker 2

Investors were assured that in obesity unlike in other chronic diseases, patients will want to stay on therapy because they can see the benefits. But this is not the case. Discontinuation rates from GLP-1s are high even when controlling for cost, access and side effects. In addition, the real world effectiveness of GLP-one drugs is not matching data shown in Phase 3 trials. A study from the Cleveland Clinic published in the JAMA Open Network Journal in September 2024 showed that in nearly 2,000 patients who were prescribed semaglutide in their Ohio and Florida hospital networks, mean weight loss at 1 year was only 5.1% or roughly 1 third of the amount of weight loss that was seen from their registrational clinical studies.

Speaker 2

In addition, a Reuters article from October 24, 2024 highlighted data from pharmacy benefits manager Prime Therapeutics. Key highlights from the analysis, only 1 in 4 patients are still taking their GLP-one drug at 2 years and drug switching rates are extremely low. Despite the drop off in utilization, the insurance costs for patients who are using Wegovy rose significantly, leading to a nearly 50% increase in the total cost of care for these individuals. Critically, this analysis found no decrease in obesity related medical events in the patients who were prescribed GLP-1s, such as heart attacks, strokes or new diagnoses of type 2 diabetes. So in summary, what the data are beginning to show are poor durability, higher cost and absence of real world clinical benefit.

Speaker 2

In conversations with key payer stakeholders, a recurring theme has emerged. The primary concern is finding a way to deprescribe GLP-1s because of the disparity between increased pharmacy costs and lack of consequent medical benefit. There are many drugs in development for obesity today, but if they all lack durability like today's GLP-1s, they will all have the same essential weaknesses as the drugs that already exist. And all of this underscores the biggest unmet need in obesity today, finding a pathway to durable, reliable weight loss maintenance. This is precisely what our therapies aim to accomplish.

Speaker 2

And we do this by offering patients therapies that are designed to provide them a durable metabolic reset. Let's move on to discuss our progress across our platforms, starting with Revita, an outpatient endoscopic procedural therapy targeting the duodenum. We recently presented compelling weight maintenance data from Revita at 2 medical meetings, DGVS in Germany and Obesity Week in San Antonio, Texas. At DGVS, we presented clinical results from our German real world registry showing that Rubida can deliver sustainable weight loss and metabolic benefits to patients for up to 1 year post procedure. These results confirm earlier observations from Revita clinical trials of the potential for a one time Revita treatment to have real world results that can actually match or exceed clinical trial results.

Speaker 2

In addition, in the presentation, we highlighted some new information on patient reported outcomes and quality of life, which were remarkably favorable for Revita even 1 year post procedure. Last week at the Obesity Week Medical Meeting, we presented a new analysis of pool data from 5 Rubida clinical studies tracking participants for 1 year after a Rubida procedure. These patients who had poorly controlled type 2 diabetes and advanced age typically face significant challenges in losing weight. The pooled data post Rubida show that 90% of participants lost weight 1 month after the procedure with 84% maintaining weight loss for a full year even in the absence of any prescribed diet or lifestyle changes over the course of the year. Compare this to the only 16% of patients who maintained at least 80% of their lost body weight 1 year after stopping tirzepatide in the SURMOUN-four study sponsored by Eli Lilly even when all of the patients were prescribed a diet and lifestyle change.

Speaker 2

The data we presented at Obesity Week in addition to the data from our German discontinuation of GLP-one based drugs. RAVITA is the only device or drug to our knowledge to have obtained breakthrough device designation from the FDA for a broad obesity indication. Our pivotal weight maintenance study, REMAIN-one is moving rapidly. As a reminder, REMAIN-one is our randomized, double blind, sham controlled study testing Revita against a sham procedure. This is the 1st pivotal study of an intervention that aims to demonstrate durable weight maintenance after discontinuation of GLP-one based drugs.

Speaker 2

People with obesity and a BMI between 30 45 kilograms per meter squared who have not been on GLP-one drugs will be started on tirzepatide to achieve 15% total body weight loss. Once they have achieved that weight loss, they will discontinue tirzepatide and be randomized to either Revita or sham in a 2:one treatment allocation. All patients will be prescribed a diet and lifestyle program. And we believe that if the pivotal study is successful, the data from this study can support a PMA application for approval in the United States. We are announcing today that we have already completed enrollment of a sufficient number of patients for the midpoint analysis of the study and we continue to expect to report this midpoint analysis in Q2 2025.

Speaker 2

We believe this will be a crucial catalyst for the program, marking the 1st demonstration of randomized data in this patient population. In addition, our enrollment rate in RIMAIN1 is on par with those for GLP-one drug studies in obesity, demonstrating the substantial interest from patients and clinicians in this much needed weight maintenance therapeutic option. In the REMAIN-one study, we are implementing a comprehensive approach to handling the patient experience, providing GLP-one drug to clinical trial sites, referring patients to Revita Centers of Excellence for the endoscopic procedure and offering a diet and lifestyle counseling program. This integrated obesity solution entails the use of 1, best in class pharmacology 2, a Revita Metabolic Reset and 3, a diet and lifestyle program on the heels of Revita. The combination of these elements for obesity is quite unique and it positions us as experts in the implementation of an integrated care solution for people with obesity and related diseases.

Speaker 2

It also creates for us an exciting opportunity for a unique and compelling commercial model that can replicate the clinical pathway for REMAIN-one in a real world setting post approval. More on this potential commercial model later. Moving to the REVEAL 1 open label cohort of the REMAIN-one study. REVEAL 1 is an open label study that aims to enroll patients who have already lost at least 15% total body weight on GLP-1s, but who need to stop taking these drugs. Patients will discontinue their GLP-1 drug, undergo Revita and subsequently begin a diet and lifestyle program.

Speaker 2

The response to this study has exceeded our expectations. What we are hearing from clinical trial sites and from obesity KOLs at Obesity Week is that there is a large and growing pool of patients on GLP-1s who are looking for an off ramp for a variety of reasons. And this is a population that REVEAL 1 aims to target. We anticipate that we will begin sharing the 1st tranche of REVEAL 1 data at year end. As mentioned above, we believe that 1 month data, while early, will be a key leading indicator of longer term results.

Speaker 2

After this initial tranche of data, we plan to provide incremental updates in this open label cohort as longer term follow-up accrues over the course of 2025. Moving from weight maintenance to type 2 diabetes with Rubida. In our REVITALIZE I study for type 2 diabetes, we've expanded our study criteria to include patients who are not yet on insulin. There are a large pool of patients who would rather live with poorly controlled type 2 diabetes than start on insulin and that's who Revita aims to target. In fact, patients with type 2 diabetes who are on 2 or 3 agents to lower their blood sugar often avoid insulin therapy for an average of 5 years and have an HbA1c of nearly 9% before initiating insulin, despite the high risks associated with their condition.

Speaker 2

What this means is that in the type 2 diabetes market, there is a huge prevalence pool of patients who have high blood sugar and are needing alternatives to insulin, alternatives that do not exist today. And we estimate this prevalence pool to be approximately 10,000,000 people in the United States. Revitalize 1 is positioned to address this critical unmet need by offering a viable and compelling treatment alternative to medication escalation and in particular to insulin initiation. The choice is simple. 1, start insulin, gain weight, constantly manage your diabetes or 2, try Revita and potentially improve your blood sugar, lower your body weight and prevent the need for insulin.

Speaker 2

We are enrolling under the expanded version of our protocol and expect to report top line data in mid-twenty 25. Moving to our Rubida German commercialization plans. The past quarter has been focused on setting ourselves up for controlled expansion in Germany in 2025. The first step is to obtain German government reimbursement approval to offer Revita at additional centers around the country. We have seen encouraging interest in Revita from numerous hospitals and have worked with GI endoscopy clinical leaders considerable amount of data we have accumulated in our registry, and are looking forward to next steps in the German market, and we will provide and are looking forward to next steps in the German market and we will provide further updates when we are able.

Speaker 2

Many people ask who would be a candidate for a procedure like Revita. You can think of Revita as like LASIK, but for obesity. People with poor eyesight can wear glasses or contact lenses, which are easy and necessary for proper vision and yet nearly a 1000000 people a year undergo a one time procedure that targets a laser to their eye in order to free themselves from the burden of managing their poor eyesight. A substantial fraction of the population simply wants freedom from ongoing disease management burden, even if that burden is simply wearing glasses. Now think about obesity.

Speaker 2

There are 10,000,000 people in the United States with obesity who will be on a GLP-one this year. Roughly eight percent of these individuals or 800,000 people will also undergo an endoscopy this year for other reasons. Before their procedure, an endoscopy nurse will call the patient to help them prepare for their visit and part of that preparation would be to ask them if they are already on a GLP-one drug in order to advise them to stop taking that drug at least 1 week prior to endoscopy. What fraction of these 800,000 patients can be converted to Revita to offer them an off ramp to their GLP-1s as they are being scheduled for their otherwise already planned endoscopy? Revita is purpose built and developed over the past decade precisely to fit seamlessly into this high volume, highly scalable GI endoscopy workflow.

Speaker 2

Given that Ruvita has breakthrough device designation from the FDA, given the desire for patients for persistent and effortless weight loss without drug therapy and given the favorable economic model for GI endoscopy practices to perform Ruvita, we believe that a substantial fraction of patients and GI physicians would choose Revita. Now let's shift our focus to REJUVA, our innovative pancreatic gene therapy platform. As a reminder, REJUVA is enabled by a proprietary endoscopic device that can precisely deliver AAV gene therapy vectors directly to the pancreas and opens the door to gene therapy medicines for the pancreas for the very first time. At the beginning of the year, we nominated REJUVA001 for type 2 diabetes, an AAV9 vector containing the human insulin promoter driving a human GLP-one transgene. We presented data over the past several quarters showcasing the drug candidate's innovative smart GLP-one mechanism.

Speaker 2

The candidate is designed to auto regulate GLP-one levels, amplifying normal GLP-one signaling rather than mimicking drug action. Think of it as you but better, making enough GLP-one to be able to survive and thrive in our modern world. Our work to support the submission of a clinical trial application or CTA for REJUVA-one is progressing well. There are 3 key in vivo experiments in the pipeline, all of which have been substantially derisked already. The first study is durability in wild type mice through 12 weeks.

Speaker 2

The second is dose ranging efficacy in the DBDB mouse model of type 2 diabetes. And the third is safety and biodistribution in Yucatan pigs. During Obesity Week, we presented new REJUVA 1 data on sustained weight maintenance and lowering of blood sugar levels in the diet induced mouse model. The data from Doctor. Randy Siegel's lab at the University of Michigan demonstrated significant durability in DIO mice over 13 weeks, marking the longest evidence of durability with REJUVA 1 we've recorded in an obesity model to date.

Speaker 2

These data are incredibly exciting because they show how to translate the promise of GLP-1s to the real world. This is a one time therapy that potentially has efficacy that can exceed that as semaglutide and also offer benefit that lasts long enough to actually see effects on cardiovascular disease, kidney disease and diabetes prevention in the real world. And this is something that we are not seeing with GLP-one drugs today because of their high rates of discontinuation and lack of durable effect as we discussed before. We plan to communicate more data on the execution of these studies at upcoming scientific meetings, but what we are seeing so far gives us confidence that we are successfully checking off key boxes for our regulatory filing. We anticipate completing these key CTA enabling studies by the end of the year.

Speaker 2

And if the CTA is approved, we plan to initiate a first in human study for RIGUVA-one in the first half of twenty twenty five. Last week at Obesity Week, we also announced the nomination of RIGUVA-two as our first smart GIP GLP-one dual agonist gene therapy lead candidate designed for the treatment of obesity. RIGUVA-two is a locally administered AAV9 viral vector that expresses human GLP-one and GIP hormones from a human insulin promoter. RIGUVA-two is designed to activate both GIP and GLP-one receptors, which both play crucial roles in regulating blood sugar and body weight when combined, as we have seen with many of the injectable dual agonists that are in the market or under development. The nomination of RIGUVA-two represents a significant milestone in the development of the RIGUVA platform as it reflects the ability to combine multiple therapeutic modalities within the same construct.

Speaker 2

And with that, I will now turn the call to Lisa to provide an update on our Q3 financials. Lisa?

Speaker 3

Thank you, Harith. In the Q3 of 2024, revenue was generated from our commercial pilot in Germany and enabled patients to enroll in the German Real World Registry study. Turning to operating expenses. Research and development expense in the Q3 of 2024 was $19,000,000 compared to $9,400,000 for the same period in 2023. The increase during the quarter was primarily due to the progress made in our REMAIN-one and REVITALIZE-one clinical studies, continued development of the REJUVA program and increased personnel related expenses, including stock based compensation.

Speaker 3

Selling, general and administrative expenses in the Q3 2024 was $4,800,000 compared to $4,500,000 in the same period in 2023. The increase during the quarter was primarily due to the professional service expenses and other costs associated with operating as a publicly traded company and increased personnel related expenses, including stock based compensation. For the Q3 of 2024, we reported a net loss of $23,200,000 compared to a net loss of $15,700,000 for the same period in 2023. The increase in net loss was primarily attributed to the increase in operating expenses discussed above and the non cash loss from changes in fair value of notes payable, offset by a non cash gain from changes in fair value of warrant liabilities as well as an increase in net interest income. As of September 30, 2024, Fractal had approximately $84,700,000 in cash and cash equivalents.

Speaker 3

Based on our current development plans, we believe that our existing cash and cash equivalents will be sufficient to fund our operations through expected key company milestones into the Q4 of 2025. I will now turn the call back to Harish.

Speaker 2

Thank you, Lisa. As the obesity market continues to evolve, we have found that losing weight and maintaining weight loss are 2 very different problems. The market has now largely solved the problem of short term weight loss, but there remains an incredible need for durable weight maintenance and an off ramp to GLP-one drugs. Obesity is a chronic disease, but it's only a chronic disease because we do not have therapies today that can truly have durable effect on the condition. And unless we are able to address the root cause, we will never break the pattern of chronic maintenance therapy in obesity.

Speaker 2

While most next generation GLP-one therapies face fierce competition to improve on existing drugs, Revita and REJUVA standalone as we pioneer a new weight maintenance category. Since Fractal Health began to focus on weight maintenance in the Q1 of this year, there has been a very interesting dynamic with both Revita and REJUVA. The size of the problem that we are addressing is coming into focus and the size of the opportunity is becoming clearer as major players are beginning to see how differentiated the profile of Revita and REJUVA are. It's been encouraging to see large companies intrigued by the unique value proposition these therapies will represent in the market. Fractal is reaching a critical inflection point.

Speaker 2

Over the next several quarters, we look forward to sharing data from our 2 pivotal studies of Revita in weight maintenance and type 2 diabetes, in addition to advancing our REJUVA001 pancreatic gene therapy candidate into the clinic. We are grateful for the continued support of our employees, our physician partners, our patients and our shareholders as we aim to free people from the relentless pattern of metabolic disease progression. And with that, we will now open the call up for questions. Thank you very much.

Operator

Our first question comes from the line of Jason Gerberry of BofA. Your question please, Jason.

Speaker 4

Hey, hello everyone. This is Chi on for Jason. Thanks for taking our questions and congrats on all the progress. And I have 3 if I may. The first question is regarding the main one.

Speaker 4

You have mentioned the enrollment for the midpoint analysis has been completed. Can you remind us the sample size enroll and also the duration of follow-up for the midpoint analysis? If I recall correctly, correct me if I'm wrong, I think the last time we spoke, we could be looking at around 45 subjects at 2:one randomization between Vervida and sham with a 12 week follow-up. And along the same line, can you also talk about expectation for the midpoint analysis?

Speaker 2

Sure, Chi. Very good to speak with you. You're correct. The sample size is 45 subjects with a 2:one treatment allocation of Revita to sham. And we will follow these patients for 12 weeks after the discontinuation of tirzepatide and randomization to either Revita or sham.

Speaker 2

We expect that based on prior data from surmount 4 and from step 1 extension of tirzepatide and somaglutide respectively that the sham arm should be regaining roughly 3% body weight over the course of that 12 week period of time. And we would expect that Revita would hold weight steady over that 12 week period of time. And the objective would be to begin to demonstrate a treatment difference that is emergent between the two arms that we believe will be predictive of the likelihood of success of the full data set, which was which has a 6 month primary endpoint.

Speaker 4

Got it. Just a quick follow-up on that. You have already completed enrollment. It's a 12 week follow-up. Should we expect some level update early in the Q2?

Speaker 2

Well, remember, Chi, you have the way that the study is designed, we're taking people who are de novo not on tirzepatide yet. We are actually starting them on tirzepatide ourselves, getting them to 15% total body weight loss and then we will be randomizing them. And so what we are accounting for is that we have to enroll enough patients that we know that we're going to have 45 of them to who will have achieved 15% body weight loss by Q1 in order to be able to randomize them and then see the data in Q2. So the weight maintenance trials, because you got to get the weight loss in the 1st place, do have that added time at the beginning, which is what explains the difference between your understanding of completing of enrollment and when the data will actually be available.

Speaker 4

Got it. Thanks for the clarification. And my second question is on REVEAL 1. What's the current thinking on the venue for the initial data at year end? I'm curious, can you also talk about your latest expectation for the initial REVEAL 1 data?

Speaker 4

I think in terms of the size and the makeup of the data, I think last time we spoke, you may be we may be looking at initial data in the range around maybe 10 patients after 4 to 8 weeks of follow-up. Can you talk about that? Thanks.

Speaker 2

Yes, that's right. So we will have initial 10 patients at least 4 weeks of follow-up and we're going to be showing you what's happening to their weight. And our aim is to demonstrate that we're able to hold weight steady. As you may know from prior studies of Revita in type 2 diabetes, 1 month results are actually pretty predictive of what happens at 3, 6 12 months afterwards. And so we feel like the 1 month time point can be quite informative for us here as well.

Speaker 2

And we think that the REVEAL 1 data in general, given open label view on what the remain randomized data might look like. And so it does help from that perspective as well.

Speaker 4

Got it. And last one for me. Just want to quickly touch upon on REJUVA. How does the program tracking towards CTA filing by year end? Are you close to wrapping up all the in vivo studies needed for the filing?

Speaker 4

And if we were to assume CTA approval by year end, what's the typical turnaround time for CTA review and approval and setting up clinical trial size subsequently? Curious what level of human data can we expect from MERJUVA in 2025? Thanks so much.

Speaker 2

Yes. So the key point here, Chi, is the key CTA enabling studies will be completed by year end. And then we aim to file for that CTA in the first half of twenty twenty five, just for clarification. And what I was what we shared earlier was that there are 3 key CTA enabling studies. One of them is durable demonstration of REJUVA activity in a wild type mouse out to 12 weeks.

Speaker 2

A second one is dose dependent efficacy in the DBDB mouse model of type 2 diabetes. And then the third one is safety and biodistribution studies through with our proprietary needle catheter with our route of administration in the Yucatan pigs. And what we're seeing so for all of these studies are underway or various stages of completion, but what we are seeing so far gives us a lot of encouragement that we're heading in the right direction. And we feel confident in our ability to complete these 3 key studies by the end of the year. And we'll be giving further updates as we enter into the first half of twenty twenty five on timelines.

Speaker 4

Got it. Thanks so much.

Speaker 2

Thank you.

Operator

Thank you. Our next question comes from the line of Mike Ulz of Morgan Stanley. Your question please, Mike.

Speaker 5

Good afternoon. Thanks for taking the question. Maybe just a follow-up on the REVEAL 1 open label update expected by the end of the year. You mentioned about 10 patients, at least 4 weeks of follow-up. I guess, what are you expecting for the what would you expect for sort of a control arm at 4 weeks?

Speaker 5

Would you expect to see any difference at that point or not?

Speaker 2

Yes. I mean, looking at what you know from surmount 4 and step 1 extension, as I mentioned with tirzepatide and semaglutide respectively, you would expect 3% body weight gain by the end of that 4 week period of time. And so and importantly, the trajectory of weight will also be important. And so what we're hoping to be able to show is that we're holding weight constant. You'll be able to see the trajectory of that weight from baseline out to 4 weeks versus what you would expect from a control.

Speaker 2

And we can walk you through that as the date comes up on what prior studies have shown as a point of comparison. Of course, it's always hard to do cross trial comparisons, but we've endeavored to do everything we can to mimic what those trials have done for those patients when they stop GLP-1s. Yes, makes sense. That's helpful. Thanks.

Speaker 5

And then maybe just on the controlled expansion in Germany, maybe talk a little bit more about the rationale there. Is it to generate more data or just get more experience at more centers prior to a potential launch?

Speaker 2

Obviously, you can satisfy both and we are excited about the opportunity to satisfy both. We're going to be why we say it's controlled is because we're going to be careful about our spend going into 2025, but we have a list of hospitals that are eager to offer Revita for their patients, some of whom have patients who they would like to be able to offer this for already. And we see an opportunity to be able to ensure that the stuff that we're seeing in Dusseldorf and our clinical trials, we can expand that commercial model and footprint in order to be able to penetrate the German market. And we feel optimistic about our ability to prove out the commercial model of driving patients into Revita Centers of Excellence in order to be able to give them a treatment alternative to medication escalation in diabetes. And in the process, we're obviously going to be able to generate revenue and additional clinical data.

Speaker 2

Got it. Thank you. Thanks.

Operator

Thank you. Our next question comes from the line of Michael DiFiori of Evercore ISI. Please go ahead, Michael.

Speaker 6

Hey guys, thanks so much for taking my question and congrats on all the progress. Three questions for me on REJUVA. The first one regarding the presentation at Obesity Week. I noticed that a slightly lower dose was used in the 12 week analysis compared to the 8 week analysis. I think in the 12 week analysis it was 7.5 E to the 12th, whereas in the 8 week analysis was 1 times E to the 13th.

Speaker 6

I was wondering why that was done. And similar question is that I noticed that the mean body weight reduction is maintained, but the error bar start to get really wide by 18 weeks. And curious to see if this was due to expiration of the mice over time or weeding of effect? And then I have one more follow-up. Thank you.

Speaker 2

Great. So this is a study conducted by Randy Seeley, a collaborator in at the University of Michigan. And he selected the dose based on what we had seen from the work that we had done before, which you highlighted. And he's doing a bunch of other mechanistic work that we'll be publishing next we're looking to present and or publish next year. So it was his selection of dose, but I think it proves the point that we've been making, which is a low dose of virus can deliver a very meaningful clinical effect.

Speaker 2

You're right to point out that the error bars get wide. I was confident that you would ask the question about that actually. The wild type DIO mice really begin to gain like really begin to have pretty variable weight when they're fed effectively a McDonald's diet for over 90 days. And so what you're seeing there is a reflection of just the dispersion that's happening as DIO mice are seeing that weight gain over time. And what we showed was placebo adjusted weight.

Speaker 2

And that's the reason for the error bars there.

Speaker 6

Got it. Very helpful. And my last question is regarding the RIGUVA 2 candidate that you just nominated for obesity. At this point in the game, Haritha, are you able to comment on the relative affinities for GLP-1 versus GIP relative to the native ligands as well as any comments on beta arrestin recruitment?

Speaker 2

At this point in the game, I'm not able to comment on any of that, but of course, we're looking at these things and we'll be able to share that with you as we get further along in development.

Speaker 6

Got it. Thanks so much.

Speaker 2

Thank you, Mike.

Operator

Thank you. Our next question comes from the line of William Wood of B. Riley Securities. Your line is open, William.

Speaker 7

Thanks so much for taking my questions and congratulations on the very nice quarter. Just maybe one from us to start. I was just kind of curious in terms of your RGV A002, in terms of how closely it mimics in design 1 just in terms of the machinery used, the overall design, essentially the 1 derisk, 2 in a term that it's essentially just a plug and play now with a GLP added in with a GIP added in?

Speaker 2

It's the same delivery catheter. It's the same AAV9, and it's the same insulin promoter. So yes, RIGUVA 1 does de risk RIGUVA 2. And it has the same smart mechanism, which is to leverage the fact that the insulin promoter allows the proportionate release of the hormones in response to the body's needs, which we think is a clear differentiator for the strategy compared to the drugs that are out there today or the other drugs that are in development. And I think that what you'll see as the data mature and as we reveal them publicly over the course of the next several quarters is that you're able to leverage both the GIP and the GLP-one mechanism simultaneously with RIGUVA-two.

Speaker 2

And we have conviction that based on what you see with tirzepatide and with the dual GIP GLP-one agonists that are in development that you can achieve superior potency with better tolerability compared to GLP-one alone at higher doses. And I think that that's a good reason for why we went there with obesity.

Speaker 7

Got it. I appreciate that. And then one secondary, you've obviously got your post market registry ongoing in Germany and maybe I've missed this in the past. Are there any additional plans to try to expand into other EU countries or has there been any interest in doing that? Or is this sort of a focused target with Germany and then sort of moving back into the States with your ongoing FDA studies?

Speaker 2

Well, we are doing work to be ready to have a global launch, at the time that we're ready to launch in the United States. There's this unique opportunity in Germany to be able to generate real world data earlier in a market that has many similarities to the U. S. Market and to do so under a reimbursement scheme that the German government has set up called the NUB, but we are actively working to make sure that we're set up to be able to launch in other countries in key geographies as well, but that will be more in line with the U. S.

Speaker 2

Launch.

Speaker 7

Got it. Makes sense. I appreciate you taking on questions and now back in the queue. Thank you.

Speaker 2

Thank you. Appreciate it.

Operator

Thank you. I would now like to turn the conference back to Doctor. Rajagopalan for closing remarks. Sir?

Speaker 2

Well, thanks everyone for your time. You've been patient with us and very happy to continue to share the progress that we're making every quarter here through our earnings calls and look forward to continuing to show some very exciting results that are going to be coming in the next several months. Look forward to following up with you all then.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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