Q3 2024 Altimmune Inc Earnings Call
Speaker Change: Lee Roth, Richard Eisenstadt, Andrew Shutterly, Lee Roth, Lee Roth, Andrew Shutterly, Lee Roth, Lee Roth
Thank you. Thank you.
Thank you.
Thank you very much. Thank you.
Speaker Change: Good day, ladies and gentlemen, and welcome to Altamune Inc.'s third quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.
To withdraw your question, please press star 11 again.
Speaker Change: As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Lee Roth of Burns McClellan, Investor Relations Advisor to Altamune. Lee, you may begin.
Lee Roth: Thanks, operator. Good morning, everyone. And once again, thank you for participating in Altimune's third quarter 2024 financial results and business update conference call.
Lee Roth: On today's call, you'll hear from Dr. Vipin Garg, our Chief Executive Officer.
Lee Roth: Dr. Scott Harris, our Chief Medical Officer, and Andrew Shutterly, our Acting Chief Financial Officer.
Lee Roth: Dr. Scott Roberts, our Chief Scientific Officer, and Greg Weaver, our newly appointed Chief Financial Officer, are on the line as well and will join us for the Q&A session.
Lee Roth: A press release covering our third quarter 2024 financial results and corporate update was issued earlier this morning and can be found on the investor relations section of the company's website.
Lee Roth: Before we begin, I'd like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995.
Lee Roth: Ultimian cautions that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated.
Lee Roth: For a full review of the risk factors that could affect the company's future results and operations, we refer you to our filings with the SEC.
Speaker Change: I'll also direct you to read the forward-looking statements disclaimer in our press release issued this morning which is now available on our website.
Speaker Change: Any statements made on this call speak only as of today's date, November 12th, 2024, and the company does not undertake any obligation to update any of these forward-looking statements.
Speaker Change: to reflect events or circumstances that occur on or after today. As a reminder, this call is being recorded and will be available for audio replay on the All Communion website.
Speaker Change: With that, it's my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altamian. Vipin?
Speaker Change: Thank you, Lee. Good morning, everyone, and thank you for joining us for our third quarter corporate update.
Speaker Change: In the three months since our last conference call, we have achieved several important milestones.
Speaker Change: These recent accomplishments coupled with other upcoming catalysts give us a high degree of confidence that we are in position for 2025 to be a transformational year for Altiummune.
Speaker Change: First, our Phase IIb impact trial of panleidotide in MASH is now fully enrolled, and top-line efficacy data is expected in Q2 2025.
Speaker Change: With a successful readout from IMPACT, PAMIDUTIDE would be the first MASH therapy to achieve both fibrosis improvement and significant weight loss at 24 weeks of treatment.
Speaker Change: Following this readout, we expect to hold an end-of-Phase II meeting for MASH with FDA in Q4 2025.
Speaker Change: For our obesity program, as announced last week, we achieved alignment with the FDA at our recent end of phase 2 meeting on a comprehensive phase 3 registrational program designed to leverage the key attributes of PEMBEDU type.
Speaker Change: The important strategic takeaway here is that we now have a differentiated, phase-three
that we believe has the potential to benefit.
Speaker Change: obese and overweight patients and fill gaps in the treatment of the comorbidities of obesity left by existing treatments currently on the market.
Speaker Change: To realize the full potential of Pemidutide, we have made the strategic decision to expand our R&D investments.
Speaker Change: into development of up to three additional indications that leverage the enhanced glucagon activity and other attributes of PEMI-DU type.
Thank you.
Speaker Change: We plan to submit an IND for the first of these indications by the end of 2024.
Speaker Change: and preparations are underway for the initiation of that phase 2 clinical trial in H1 2025, in the first half of 2025.
Speaker Change: We believe each of these indications represents a substantial commercial opportunity that will create value for our shareholders.
Speaker Change: Importantly, these indications were chosen as we believe we can develop these indications ourselves and we expect to provide more details in the coming months.
Thank you.
To summarize
Speaker Change: Our overarching development strategy continues to focus on securing a partnership centered around obesity.
Speaker Change: while moving full speed ahead to advance PEMI-DUTIDE and MASH and launch development efforts in these additional indications.
Speaker Change: Upon a positive data readout from phase 2b impact trial in the second quarter of 2025, we expect to be ready to start a phase 3 program in MASH by the end of next year.
Thank you.
Speaker Change: We continue to believe that family duty is a highly differentiated
agent from others.
Speaker Change: and in strategically important ways relative to the current metabolic disease landscape.
Speaker Change: With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our clinical plans in more detail. Scott? Thank you, Vipin.
Speaker Change: As noted, we completed enrollment in the Phase IIb Impact Trial of PEMP, DUTIDE, and MASH in late September and are on track to report top-line efficacy data in the second quarter of next year.
Speaker Change: Recall, the trial is evaluating approximately 190 subjects with and without diabetes, randomized 1-2-2 to receive either 1.2mg, 1.8mg P2T or placebo for 48 weeks.
Speaker Change: The key efficacy endpoints are MASH resolution or fibrosis improvement at 24 weeks of treatment, with subjects followed for an additional 24 weeks to a total of 48 weeks for safety in biomarker responses.
Speaker Change: Pemp-Duterte has the potential to be the first Incretin agent to achieve statistical significance in mass resolution and fibrosis improvement rates at only 24 weeks.
Thank you.
Speaker Change: Combined with the weight loss achieved with Pempidutide therapy, these results could position Pempidutide to become the standard of care in the treatment of MASH at the completion of the Phase III Registrational Program.
Speaker Change: As we continue to analyze the data from our completed clinical trials.
Speaker Change: It is increasingly clear that pembedutide not only has a meaningful impact on body weight, but also the co-morbidities associated with obesity.
Speaker Change: We're particularly excited about the results from our Phase 2 MRI based body composition sub study reported at the recent European Association for the Study of Diabetes Conference in September of this year.
Speaker Change: That study demonstrated class-leading preservation of lean mass of only 21.9% in subjects treated with pemidutide as well as a preferential reduction in visceral adipose tissue.
This type of hat has been associated with cardiovascular risk.
Speaker Change: The preservation of lean mass is a key factor in both the quantity, quality, and sustainability of weight loss and will be the focus of one of our four phase three studies.
Speaker Change: As Vipin discussed, we completed our End of Phase II meeting with the FDA last week.
Speaker Change: This interaction resulted in an alignment with the agency on an innovative registrational program encompassing four pivotal Phase III studies.
Speaker Change: each designed to leverage a specific attribute of pan-vegetitide in the setting of weight reduction. Let me recap the plan designed of the four trials that we outlined in last week's press release.
Velocity 1
Speaker Change: This trial will assess the effects of penvidutide on body weight in patients with obesity or overweight without diabetes. Other endpoints will include reductions in waist circumference, lipids, and blood pressure.
Speaker Change: Velocity 2. This trial will assess the effects of panthagutide on body weight and serum lipids in subjects with obesity or overweight and elevated LDL cholesterol levels.
Speaker Change: The study population will include a subset of subjects with elevated LDL cholesterol despite concomitant statin therapy.
Speaker Change: A large proportion of patients taking statins fail to achieve target LDL levels and in a previous phase 2 clinical trial in subjects with overweight or obesity, panfidutide appeared to enhance LDL lowering effects in these subjects.
Velocity 3
Speaker Change: This trial will assess the effects of PEMDASidotide on body weight in subjects with obesity or overweight and elevated liver fat.
Speaker Change: Excess liver fat is highly prevalent in patients with obesity and it's associated with an increased risk of cardiovascular disease.
Velocity 4
Speaker Change: This trial will assess the effects of Pemvidutide on body weight and body composition with emphasis on elderly individuals and individuals with sarcopenia at baseline.
Speaker Change: Functional measures and activities of daily living will also be assessed in this patient population.
Thank you.
Speaker Change: The Phase III Registration of Velocity Program will evaluate three doses of Pemvidutide, 1.2mg, 1.8mg, and 2.4mg, administered one weekly via subcutaneous injection over a 60-week treatment period.
Speaker Change: Collectively, the four trials are expected to enroll approximately 5,000 subjects, similar to past registrational programs in obesity.
Speaker Change: Our intention is to obtain regulatory approval for each of these doses, allowing patients to start on therapy on a Pembidutide dose with demonstrated efficacy for weight loss.
Speaker Change: The successful completion of the FDA End-of-Phase II Meeting for Obesity
represents an important milestone in the development of
The Regulatory Path for Approval on Obesity
Speaker Change: but also positively impacting the development of PEMP, DUTIDE, and MASH and the additional indications we are pursuing.
Speaker Change: We believe that panfazutide has broad therapeutic potential beyond obesity and MASH.
Speaker Change: We are exploring up to three additional indications for which penfidutized profile as a balanced GLP-1-glucagon dual agonist may be ideally suited.
Speaker Change: We expect to submit an IND application for a Phase II clinical trial in the first indication by year-end.
Speaker Change: with the study expected to initiate in the first half of 2025.
Speaker Change: We will provide further information about these indications as regulatory discussions are completed.
Speaker Change: With that, I'll now hand over the call to our Acting Chief Financial Officer, Andrew Shutterly, to review our financial results for the third quarter. Andrew?
Andrew Shutterly: Thank you, Scott, and good morning. For today's call, I will be providing a brief overview of Baltimore's third quarter 2024 financial and operating results. More comprehensive information will be available in our form 10-Q to be filed with the SEC later today.
Speaker Change: Altamune ended a third quarter of 2024 with approximately $139.4 million of cash, cash equivalents, and short-term investments, compared to $198 million at the end of 2023.
Speaker Change: We project that our existing cash will fund us well into the first half of 2026.
Speaker Change: which fully funds our IMPACT trial in MASH including the expected readout of top-line biopsy data in the second quarter of 2025.
Speaker Change: Research and development expenses were 19.8 million dollars in the third quarter of 2024 compared to 18.4 million dollars in the same period in 2023.
Speaker Change: Our R&D expenses for the third quarter of 2024 included approximately $12.4 million in direct costs related to development activities for FEMVI-DUTIDE and $0.8 million in direct costs related to additional research and discovery projects.
Thank you.
Speaker Change: General and administrative expenses were $5 million in the third quarter of 2024 versus four and a half million dollars in the third quarter of 2023. The increase was due primarily to a 0.4 million dollar increase in professional services costs.
Speaker Change: Included in the R&D and G&A costs for the third quarter of 2024 are approximately 3.1 million dollars of non-cash stock-based compensation expense.
Speaker Change: compared to 2.7 million dollars in the same period in 2023.
Speaker Change: Net loss for the three months ended September 30, 2024 was $22.8 million, or a $0.32 net loss per share, compared to a net loss of $20.7 million, or a $0.39 net loss per share for the third quarter of 2023.
Speaker Change: I will now turn it back over to Vipin for his closing remarks. Vipin?
Thank you, Andrew.
Vipin Garg: and thank you for everything you've done serving as our acting CFO over the last several months.
Vipin Garg: As Lee mentioned at the start of the call, Greg Beaver, who joined our team yesterday as Chief Financial Officer, is with us for the Q&A session.
Welcome, Greg.
Vipin Garg: Over a distinguished 25-year career, Greg has led the finance function at a number of public and private life sciences companies.
Vipin Garg: We are excited to have him on board and look forward to benefiting from his deep expertise.
Thank you.
Vipin Garg: We are encouraged by the significant strides we have made over the last several months. While we are in a fast-moving and highly competitive space, we are more confident than ever that Pemmidiutide has the potential to stand out from the crowd, and we believe that we are well-equipped to seize the opportunities that lie ahead.
Vipin Garg: That concludes our formal remarks. We would now like to open the lines to take questions. Operator?
Speaker Change: Thank you. As a reminder to ask a question please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 1 again.
Please stand by while we compile the Q&A roster.
Thank you.
Thank you. Thank you.
Speaker Change: Our first question comes from the line of Yasmin Rahimi from Piper Sandler.
Speaker Change: Good morning team, congrats on all the updates and congrats Greg for joining a wonderful company and look very much forward to working closely with you.
Speaker Change: team, really exciting that you got the Velocity Studies aligned with the agency and kicking it off. I guess the question that we have for you is...
Speaker Change: Now that you have the alignment, how important was the alignment in terms of strategic discussion and partnership? That's sort of question one.
Speaker Change: at the same time. And then the third question is, if you could shed some light on what are these additional indications you're potentially considering for which you're filing INDs, that would be helpful. And I'll jump back into the queue. Thank you.
Speaker Change: In terms of how important it is, this is really a significant and very important milestone for development of Pembidu Tide.
Speaker Change: I mean, this was a comprehensive review of our package so far, all of the studies that we have conducted.
Speaker Change: Very importantly, PAMI-DUTA has a clean bill of safety, and Scott can talk more about that.
Speaker Change: and we have clear understanding as to what needs to be done, what are the full registrational trials that would lead to approval of the drug. So we think this is a very important milestone for family dutide, for Alt-Immune, and for our potential partners.
Speaker Change: Our strategy is to continue to look for a partnership centered around obesity and we're moving full speed ahead with MASH and other indications.
Speaker Change: In terms of studies, the sequencing of them, you know, ideally they would all be run in parallel, but Scott can comment more about that, as well as additional indications.
Speaker Change: We haven't really disclosed the details of additional indications at this point, but what I can say is that these are all designed to leverage the advantages of glucagon and pambiduotides. It's really focused around the properties of glucagon and some of the liver defatting and serum lipid improvement that we have seen from our MOMENTUM trial.
Speaker Change: We'll talk more about these indications once we have had regulatory alignment. We are planning to file our first IND later this year, and hopefully we'll talk more about this 30 days after the IND clears the FDA.
Scott, can you provide some more color on the...
Scott: on the FDA interactions as well as on the sequencing of the three indications, sorry, the four velocity trials. Sure. So the meeting was extremely successful. A lot of compliments were passed on the line during the meeting and...
Scott: We have now exposed over 500 subjects to Pemba Jewtide in completed trials and based on that, the FDA looked at our safety profile and gave us a thumbs up on that exposure.
Scott: Obviously the final consideration is what you have at NDA, but no safety signals were identified from that interaction.
They also confirmed our plan.
for the four studies.
Scott: which did not include a diabetes trial, although we are including diabetics in our program. We'll have an ample number.
Scott: to evaluate, but they felt this was a reasonable approach and really liked the idea of targeting the effects most likely to be impacted by glucagon, including the body composition study.
Scott: Regarding the launching of the studies, the sequence is still to be determined as we look to operationalize that and hope to have more details for you in the near future.
Thank you. Thank you.
Thank you so much. I'll jump back in the queue.
Thank you. One moment for our next question.
Speaker Change: Our next question comes from the line of Ellie Murrell from UBS.
Speaker Change: Hi, this is Jasmine on for LE. Thanks so much for taking our question and congratulations on all your progress.
Speaker Change: So, thinking about the recent Kaplan GLP-1 essence trial data we saw in NASH,
Speaker Change: and what we saw there on fibrosis. How are you thinking now about what you'd like to see from IMPACT in QQ and what is really competitive now for incretins in the NASH space? Thanks.
Speaker Change: Scott. Hi, Jasmine. I think I heard you ask the question about the recently completed essence trial. Is that correct?
Speaker Change: Am I correct on that? Yes, yes. And just how you're, how kind of that's impacted your thinking now about, you know, what's competitive for Inkertons and MASH.
Right. Well, the trial results were as we expected.
You know you have to recognize that
Speaker Change: The trial went for 72 weeks. It was longer than other trials, so a longer opportunity to see an effect because of the longer treatment. As well, the study power was increased by going over and aboard what was done in another Phase III program, so a large number of subjects in order to show that statistical significance.
The treatment effect was modest.
Speaker Change: This is what we would expect from an agent like semaglutide that exerts its effects on liver fat indirectly through weight loss rather than direct effects on the liver.
Speaker Change: And as we've seen, when glucagon has been in the mix, or when there's a liver-targeted effect like FGF21, the liver fat and the endpoints move up considerably with more robust effects.
So, moving forward to Pemba-Dewtide.
Speaker Change: The liver fat is what drives the mass resolution and the fibrosis improvement that should have been shown repeatedly in trials.
We have class leading liver fat reduction.
Speaker Change: The FGF-21 showed meaningful and statistically significant effects in mass resolution and fibrosis improvement at 24 weeks. Their liver fat reduction was about 65%. We're at the 76% level.
Speaker Change: We have preclinical studies demonstrating a direct effect of penta-dutide on fibrosis that's independent of defatting, and we've done a number of other analyses suggesting success at 24 weeks. So where do we stand in comparison to essence?
Thank you very much.
Speaker Change: If we are successful, and I believe we will, we will be the first Incretin-based agent to show statistical significance, that is, success, on mass resolution and fibrosis improvement at only 24 weeks.
Speaker Change: combined with the weight loss associated with PEVDUTIDE, the only agent at 24 weeks to offer weight loss because, as you are aware, the current compounds that have shown efficacy at 24 weeks have either been associated with no weight loss or actually even weight gain. And we believe that these combined effects
Speaker Change: will really put us at the front of the class in terms of the mass drugs going toward approval.
Thank you.
Speaker Change: Awesome, thank you so much. Yeah, I just wanted to add that.
Speaker Change: I just want to add that really combining these two effects provides a complete solution for treating MASH. Not only are we going to show direct effect on the liver,
Speaker Change: But at the same time, it's a good thing in this patient population for patients to lose weight. So this combination, there's a lot of discussion already about combination therapy. That's basically what we are doing with Pamidutide is providing a combination of direct liver acting effect with weight loss.
Thank you. Thank you.
Wonderful, thank you.
Thank you.
Thank you. One moment for our next question.
Our next question comes from the line of Lisa Baco.
From Evercore, your line is now open.
Speaker Change: Hi, thanks for taking my question and congrats on all the progress. Sort of two line of questions for me. First of all, I guess as it relates to cardiac safety, do you think FDA views this as a class effect and it might be something that, you know, sort of comes up?
Speaker Change: as you go back to FDA and discuss the Fuller Phase III program, including MASH, which I think is what you intend to sort of prioritize yourselves.
Speaker Change: I'm just curious about that, or is this something where they've seen something specific in the Servo-DUTAI data? It just seems to me with the ratio that they have versus...
Speaker Change: the ratio you have and the fact that you do have quite a bit of glucagon. I'm wondering if that's something that kind of gets revisited. And then curious about the timing of the additional indications. Really interesting concept. Are you going to wait, you know, for
Speaker Change: data from, you know, in MASH before initiating those and really taking off, or when should we expect to learn more about that? Thanks.
Speaker Change: Thanks, Lisa. Thanks for the questions. Let's take your first question first. Scott, you want to get started? Yeah, Lisa. That's a great question. It's a great question.
This is not a class effect.
repeatedly in all of our trials.
Speaker Change: We've seen no evidence of arrhythmias, no evidence of any effects.
on coronary disease, cardiovascular disease, no MACE effects.
Speaker Change: and we've also seen no evidence of any changes on EKG intervals or the like.
Speaker Change: and we've seen this repeatedly in all of our studies and we laid out all of the data for the FDA and the FDA came to the same conclusion.
Speaker Change: So our conclusion would be that what's been described in the Cervidute type program is probably specific to the compound.
and we
Speaker Change: received confirmation at the FDA that they agree on that opinion.
Speaker Change: Regarding the timing of the studies, we'll launch the study in the first half of next year.
Speaker Change: We'll have to see whether that actual launch goes before or comes after the mass readout and we'll have more information for you as we get into next year.
Okay, great. One quick follow-up.
Speaker Change: Just can you remind us for Servidutide, were those signals that they saw, the
Speaker Change: increase in heart rate and all those things. Were they early events or late events? In other words, do they happen after six months or earlier in the study? Thanks.
You know, Lisa, we don't know what we know.
Speaker Change: When we went to the FDA, we presented our whole program, and they did a comprehensive evaluation of the program. And again, they indicated no safety signals, and like
all of the other sponsors that have preceded in obesity
Speaker Change: allowed us to design a program with purely efficacy trials. As you are aware, you need about 5,000 subjects in total to go to NDN obesity that is exposed for a year.
Speaker Change: and we and other sponsors have usually achieved that by filling it up with efficacy trials and that's what full velocity 1, 2, 3 and 4 is.
With the Serve-A-Due-Type program they've elected to conduct
Too Smaller [inaudible]
efficacy trials and a very large safety trial.
which is actually designed
to show no harm versus placebo specifically to cardiac events.
Thank you. Thank you.
one would imagine that that could be
Speaker Change: suggestive of a discussion that the company had with FDA, we don't know.
Speaker Change: So, really can't comment about this signal. What we can say is that the design of their program is unusual.
and is oriented towards showing safety.
more than it is to show efficacy.
Okay, thank you.
Speaker Change: And I think to be very clear, you asked a question about the phase 3 program. This was a comprehensive interaction with the FDA and there is no requirement for PEMI-DUTA to do additional safety studies.
Got it. Thanks.
[inaudible]
Thank you. One moment for our next question.
Speaker Change: Our next question comes from the line of Xiaotong Jia from Jeffreys.
Hi team, this is Fiona for Roger from Jeffries.
Speaker Change: My question is, I have two questions regarding the three additional indications. First is, I think I remember that you mentioned in the call that these indications, you're gonna carry forward independently, or is it part of the ongoing conversation regarding like partnerships? Thank you. And I have a follow-up.
Speaker Change: And we believe they will not only create value for PEMI-DUTA, these are indications we can pursue on our own, and they will be attractive to potential partners as well. So it's really.
Speaker Change: designed to continue those discussions and if a partnership can be built around these indications, we'll be very, very keen to do so, but we can also develop these on our own. So it really gives us a lot of flexibility, a lot of optionality as to how we move forward with these indications.
Speaker Change: You got it. Thank you. That's very helpful. And my second question is, does the cash runway to one half on 26 cover these three indications? Thank you.
Speaker Change: Yes, the initial plans, the initial IND filings as well as the initial phase 2 type of trials that we would conduct around them that the current cash will be sufficient for us to conduct these.
Awesome. Thank you. Congrats on the quarter.
Thank you.
Thank you.
Speaker Change: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Speaker Change: Our next question comes from the line of Corin Johnson from Goldman Sachs.
Thank you. Thank you. Thank you.
Speaker Change: Hi, this is Omari for Corinne. Also, I have a couple of questions on the re-education. How are you thinking about
which indications you'll select to move forward.
What are the size of these trials that you anticipate?
at the beginning in the first half of 25.
Scott
and others. Thank you. Thank you.
Speaker Change: The three indications are based on targets which would benefit from glucagon. These are all indications that involve subjects with obesity and overweight.
and consequently, it is not only demonstrated in effect.
Speaker Change: on these three specific targets, but also the effects of Pembidutide on body weight. So it has also implications for the obesity program as well.
Speaker Change: We'll provide further details about the invocations once we have complete regulatory discussions. Hope to have that in the very near future.
regarding the launching of the studies.
That's good.
Speaker Change: And the size of the studies, we'll provide more information again about that next year. We do expect.
Speaker Change: to file the first IND by the end of this year and to commence activities to launch that trial in the very near future. But I want to emphasize that these will not be Phase I studies. These will all be Phase II proof-of-concept studies.
Speaker Change: So we're really moving ahead into mid-stage development into all of these indications once the IND is clear.
Thank you.
All right, thank you.
Thank you. One moment for our next question.
Speaker Change: Our next question comes to the line of Mayank Mamtani from B. Reilly Securities.
and many more. Thank you. Thank you.
Speaker Change: Hi, good morning team. This is William Ong from ION. Thanks for taking our questions and.
Speaker Change: Congratulations on a great quarter and and congratulations on the recently hiring of Greg.
Speaker Change: We have a couple questions digging a little bit deeper. Just kind of curious about the phase 3 essence.
data that we will be expecting at ASLD coming up.
Speaker Change: I guess maybe what are you looking for specifically in that data that really could help provide or inform your confidence in your ongoing phase two impact study any any extra insight there could be could be helpful and then I have a follow-up
Speaker Change: Yeah, William, again, there were a lot of details that were not included in that initial readout.
Speaker Change: Some of the questions about the statistical approaches, completers, and the like.
Speaker Change: I don't think that really changes the way we view the study. We think the effects were predictable.
We think the effects were modest.
Speaker Change: and represented the long duration of treatment and the supersizing of the study power.
Speaker Change: So, it would be of interest to see the details of that study. We certainly will watch the presentation with everyone else.
Speaker Change: But we really think the effects of the study are modest.
Speaker Change: and that they speak to our having an even better readout to the effects at a much earlier time point showing enhanced efficacy at a time point that could not be hit by semi-glutide. It would just be too soon to see those effects.
Thank you. Thank you.
Speaker Change: Got it. And then an additional question on your strategic partnerships.
Speaker Change: These have been going on for a little while now, beginning around the end of your Phase II momentum readout. I'm just kind of curious how your discussions with potential partnerships have evolved over time, now that we're getting closer to Phase II impact, obviously essence readout, and now your three additional indications.
Speaker Change: Any color on, you know, the evolving conversation and if they're now starting to expand across multiple, you know, the broader potential of the V-2 type, any color on that would be helpful. Thank you.
Speaker Change: Yeah, absolutely. Ray, do you want to take that question? Our Chief Business Officer Ray is here, so Ray George.
Ray George: Yeah, thank you for the question. As you mentioned, you know, the strategic partner discussions, you know, we've been engaged with for the, you know, throughout the period of 2024.
Ray George: What's interesting, I think, is, and our approach has always been to, you know, continue to generate data and advance the programs. And why I say that is...
Ray George: Because the feedback I think we received generally has been from these companies that they're still trying to figure out their own strategic initiatives.
Ray George: You know, how do they leverage their capabilities? What's their strategy to jump into obesity? And I think that feedback is fairly accurate because there have been no other deals that have been executed for now, about 12 months now.
Ray George: keep generating value for everyone and I think things are starting to resonate so again the preservation of leaden mass I think that's a very unique attribute for Pemba dutide and that's been a hot topic in this space.
Ray George: The MASH indication, I think, is gaining even more traction, I think, with the Res Difra launch. I think more attention is being focused there. And again, Scott and Vipin have talked about how we believe we'll be positioned there with the combination of direct efficacy.
24 weeks and weight loss is going to be differentiating.
Ray George: And I think the additional indications is going to be something that will even create more value, broaden the offering. So at a high level, I think these are the things that benefit our strategic partnering discussions as well as Altamune in general.
Speaker Change: Thanks, Ray, and I would just add that the the conclusion of the end of phase two meeting, successful conclusion of the end of phase two meeting, is a very important milestone in moving these discussions forward. The path is clear now. We know, you know, how the program looks and
Speaker Change: what are the trial designs and how much it's going to cost really to take this to the finish line. So I think all that being in place, we continue to seek a partnership centered around obesity.
and others. Thank you.
Speaker Change: Got it. Very helpful. I'll hop back in the queue and congrats again on a very nice quarter.
[inaudible]
Speaker Change: Thank you. At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks.
Vipin Garg: Thank you everyone for joining our call today. As always, we sincerely appreciate your continued support and interest in Altiummune as we work diligently to advance PEMI-Dewtide. Thank you again for your time. We look forward to updating you on our progress in the near future. Have a great rest of your day.
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.