Q3 2024 Zealand Pharma A/S Earnings Call
Speaker Change: Michael Carboni Meeting... Hello, I am Paul Madiver. And this is my brother. Now, unlike other people, The world doesn't mean what we seem. In fact, it means what murderers call a riot. Yeah, I got it right there. He said, He said, How do we fight back? How do we fight back? Yeah, I know you ready to cute.
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Speaker Change: Good day and thank you for standing by. Welcome to the Zeeland Pharma results for Q3 2024 conference call.
Speaker Change: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session.
Speaker Change: To ask a question during the session you will need to press star 1 1 on your telephone You will then hear an automated message advising your hand is raised to withdraw your question. Please press star 1 1 again
Speaker Change: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Anna Krassowska
Vice President Investor Relations and Corporate Communications. Please go ahead.
Speaker Change: You can also find the related company announcements and interim report on our website at Zealand pharma Dot com.
Speaker Change: As described on slide two our caution listeners that we will be making forward looking statements that are subject to risks and uncertainties.
Speaker Change: Moving to slide three I will turn the call over to Adam <unk>, President and CEO Adam.
Speaker Change: Okay.
Speaker Change: Thank you Adam.
Speaker Change: Thanks, everyone for joining today.
Speaker Change: I'm extremely pleased with the achievements that we have made in the first half.
Speaker Change: In the first part of 2024.
Speaker Change: At a pace of two eight week and choose T. We presented detailed data from the 16 week phase one trials with Keytruda inside our don't actually that making that a dog, which we I think the other thing as an alternative to JD, one based therapies for the management.
Speaker Change: And obesity.
Speaker Change: We believe that these results strongly support that the train side, it's a very well tolerated and could provide a better patient experience and increasing based therapies, while providing similar degrees of where it goes.
Speaker Change: We expect the first participant in the phase II B trials with between touch to be dosed very soon.
Speaker Change: And we are also now exploring collaboration opportunities with large pharma companies with.
Speaker Change: With the right partnership we believe we have an opportunity to not only develop the train side as an alternative.
Speaker Change: One page therapies, but also a potential future foundational a first line therapy for weight management.
Speaker Change: In that regard.
Speaker Change: Pleased that with us on the call today for the first time is Eric cooks.
Speaker Change: Who recently joined our management team in the role as Chief Commercial Officer.
Speaker Change: Eric brings 25 years of commercial and business development experience from biotech and BV local biopharma companies.
Speaker Change: There'll be a very important contributor.
Speaker Change: As we explore co development and co commercialization opportunities priority.
Speaker Change: Brent stated our PDP programs.
Speaker Change: We are also very pleased to have reported positive and encouraging top line data from part one of the phase <unk> trial with our tier one tier two dual agonist that'd be good time.
Speaker Change: We believe that this candidate holds the potential to be a first in class therapies for obesity.
Speaker Change: And information related co morbidities.
Speaker Change: We have reported data it gives us the confidence needed to progress typically tied into a comprehensive phase II B trial.
Speaker Change: Which is planned to be initiated in the first half of 2025.
Speaker Change: On the back Okay impressive phase II data, which showed that the tightened mess presented earlier this year, our patent up anytime recently announced the initiation of a large global phase III program per se tied in mesh.
Speaker Change: They also announced that service has received U S. FDA breakthrough therapy designation for the treatment of adults with Nacho biotic mesh and moderate or advanced fibrosis.
Speaker Change: There's a significant overlap between obesity and Nash.
Speaker Change: And with the clinical data reported to date, the ambitious phase III program and the recognition by regulators.
Speaker Change: We believe that distributor type holds potential as a leading encrypted based therapy for PBC and Nash.
Speaker Change: Turning to slide four.
Speaker Change: I would like to emphasize the reasons why we are so excited about the potential of the trading side.
Speaker Change: We have seen the impact of the first to once weekly <unk>, one based therapies to be approved.
Speaker Change: And phase III clinical trials of longer duration. They have demonstrated potential for 15 to 21, new weight loss in patients with obesity.
Speaker Change: And positive outcomes on several obesity related comorbidities.
Speaker Change: On the flip side get the web based therapies are associated with a number of gastrointestinal adverse events, including no scan.
Speaker Change: Emitting diarrhea and constipation.
Speaker Change: Real World data suggests that up to 30% of patients with a PBT of GBP, one treatment stuck with them in London before reaching the target dose.
Speaker Change: Within one year.
Speaker Change: Only 60 or.
Speaker Change: 60% to 70% of patients withdraw from treatment.
Speaker Change: We could transact targeting tier one like weight loss of 15% to 20% and don't get to.
Speaker Change: See chart.
Speaker Change: With potential for higher quality vehicles, and a different and better patient experience.
Speaker Change: As evidenced by recent data with the <unk> presented at <unk>, we are confident that Katrina.
Speaker Change: Thank you.
Speaker Change: The improved.
Speaker Change: Beauty profile compared to what.
Speaker Change: We set the acronym, suggesting both lower frequency and severity of Gi adverse events.
Speaker Change: And with that let's move to slide five.
Speaker Change: As I turn it over the course of our Chief Medical Officer, David Kendall to discuss our R&D pipeline David.
David Kendall: Thank you Adam.
David Kendall: I would like to focus my remarks on the continued advancement of our obesity programs and provide a brief update on our other development activities.
David Kendall: Beginning with our novel long acting amylin analogue controlling tied let's move to slide six and the trial design of the recently presented detailed data part two of our phase one B trial.
David Kendall: This was a randomized double blind placebo controlled phase one b trial enrolling a total of 48 adults with overweight and obesity.
David Kendall: Participants were randomized into one of three dose cohorts assessing multiple ascending doses of patrolling side using a dose titration titration scheme or to match placebo stead.
David Kendall: Steady medication was administered weekly for 16 weeks in an outpatient setting followed by a nine week safety follow up period.
Speaker Change: I would also like to highlight that in this trial, we evaluated doses of controlling tied up to nine milligrams and note that the two higher dose cohorts received the maximum assigned maintenance dose for a period of only six and eight weeks respectively.
David Kendall: Turning to slide seven.
David Kendall: Shown here are the mean weight loss curves across each of the individual dose cohorts and placebo.
David Kendall: Drilling type treatments resulted in reduction in mean body weight of $4 886, and eight 3% from baseline after 16 weeks of treatment across the three dose cohorts, while placebo treatment resulted in a mean body weight loss of one 7%.
David Kendall: We find these data to be even more compelling given that the study population was predominantly male with a relatively low BMI and these results were achieved in the absence of any background lifestyle modification, suggesting that the responses observed to me have been muted in participants included in this study.
David Kendall: Moving to slide eight.
David Kendall: Shown here are the individual study participant data on both the adherence to study medication and to the dose escalation and maintenance scheme over the 16 week treatment period.
David Kendall: These data demonstrate that there was both a high degree of compliance with dose escalation and adherence to and completion of study treatment for the vast majority of participants.
David Kendall: Only a single trial participant.
David Kendall: Discontinued therapy.
David Kendall: Due to treatment.
David Kendall: Related or patrolling tide related aes, which occurred after the third dose while also starting at a higher one milligram initial dose. In addition, one participant in the nine milligram arm was maintained for an additional week on the seven milligram dose due to reported tolerability issues.
David Kendall: Two other participants who discontinued therapy, so for other reasons unrelated to study medication.
David Kendall: Notably all other subjects followed both the dose escalation steps defined in the protocol and completed Potomac Petroleum died treatment as planned.
David Kendall: We believe that the ease with which participants achieved their target dose and the proportion of those treated who remained on petroleum type treatment over the course of this trial support our conclusion that treatment with petroleum tightest, both well tolerated and readily dose escalated further differentiating this treatment from encryption based therapies.
David Kendall: <unk>.
David Kendall: Turning now to slide nine and the Tolerability profile.
David Kendall: Additionally, the vast majority of treatment emergent adverse events reported including those related to GI Tolerability were reported as mild and only a single participant in the highest dose cohort discontinued treatment due to treatment emergent adverse events.
David Kendall: Moving to slide 10.
David Kendall: The data reported in this will phase one b trial further demonstrated that all gastrointestinal related treatment emergent adverse events were mild except for the single events or moderate nausea, and vomiting, both of which were experienced by a single study participants the same subjects that discontinued treatment.
David Kendall: Notably no other participants reported vomiting, and there were only two reports of diarrhea, both of which were mild nausea was reported in up to 33% of the petroleum type treated participants as compared to 17% reported by participants in the placebo group.
David Kendall: Additionally, three participants in the highest dose cohort reported constipation, all episodes of which were reported as mild.
David Kendall: These data support the observation from earlier trials with patrolling tied and further support our conclusion that patrolling tied offers the opportunity to limit issues of Gi tolerability.
David Kendall: Overall these data support and further our ambition for petroleum tied to supporting that this novel treatment offers the potential for GOP, one like weight loss and an improved patient experience as compared to that reported in both clinical trials and the clinical use of <unk> based therapies.
David Kendall: Moving to slide 11 in the phase <unk> design.
David Kendall: As mentioned in the last call. We will continue to progress our development of patrolling tied as a standalone therapy in a large and comprehensive phase <unk> program.
David Kendall: The first phase <unk> trial in persons with obesity or overweight related.
David Kendall: Related comorbidities hypertension, or Dyslipidemia will initiate in the coming days.
David Kendall: This larger trial with longer treatment exposure will enroll up to 480 adults and we'll compare multiple doses of controlling tied or placebo over 42 weeks of treatment with five dosing arms the highest being nine milligrams is in the phase <unk> multiple ascending dose part two trial.
David Kendall: Participants will be continuing blinded treatment for 42 weeks with a primary endpoint of percentage change in body weight from baseline at 28 weeks. The primary completion is set for November 2025, and will enable us to more fully assess both the efficacy and safety of patrolling tied across a wide dose.
David Kendall: Range to inform the doses to be used in longer term phase III studies.
David Kendall: Note that the primary endpoint at 28 weeks will be solely used for regulatory interactions about registrational trials with unblinded data readout only after completion of the 42 week treatment period.
David Kendall: Key secondary and exploratory endpoints in this phase <unk> study will include an assessment of body composition by magnetic resonance imaging or MRI change in HBA, one C change in vesting lipids and change and high sensitivity C reactive protein or HFC ERP.
David Kendall: In addition to this phase <unk> study, we expect to initiate a second phase <unk> study in the first half of 2025 exploring weight loss in a population with type two diabetes and pre diabetes, where data support that amylin agonism can potentially deliver weight loss comparable to that observed in non <unk>.
David Kendall: IBD population further differentiating patrolling tied treatment from GOP one receptor based treatments were muting of the weight loss response has been observed in those with diabetes.
David Kendall: Moving to slide 12, and turning our attention to our other wholly owned obesity asset Duffy Glu tied a potential first and best in class GOP, one GOP two receptor dual agonist.
David Kendall: <unk> is designed as a potent <unk> agonist targeting significant weight reduction and offers the potential to leverage <unk> pharmacology to improve gut barrier function and directly address the low grade inflammation associated with meta metabolic disease, representing a truly differentiated inquiry.
David Kendall: Asset.
David Kendall: As we have recently reported <unk> was evaluated in a single center randomized double blind placebo controlled phase one b trial in participants with overweight or obesity.
David Kendall: In part one of this trial a total of 54 participants approximately 85% of whom were male with the median baseline BMI of 30 were randomized to receive 13 weekly doses of either <unk> or placebo within three dose cohorts.
David Kendall: At week 13, the estimated mean placebo adjusted body weight decreased by up to eight 3% that would be blue tide treatment.
David Kendall: Duffy good tech doses of up to 13 milligrams were assessed to be both safe and well tolerated with Gi adverse events consistent with the frequency and intensity reported in studies of other anchor tune based therapies.
David Kendall: We are both excited and encouraged by these data and we look forward to presenting detailed results at a future scientific Congress.
David Kendall: In addition in part two of this trial, we are evaluating even higher doses of Debbie Glu tied up to 26 milligrams over 28 weeks of treatment.
David Kendall: We expect to report top line results of this part in the first half of 2025 and note that this added component of the phase <unk> study will not impact the timing for initiation of a phase II b trial in people with overweight or obesity, which we expect to initiate in the first half of 2025.
David Kendall: We will obtain valuable additional insights on the optimal dose and dose escalation scheme to inform both the phase II <unk> trial, and additional studies investing the potential of that be glued tied in obesity and selected inflammation related comorbidities, including liver disease cardiovascular disease inflammatory.
David Kendall: <unk> disease, and neuro degenerative diseases.
David Kendall: Moving now to slide 13 as conservative.
David Kendall: Along with our Beringer Ingelheim colleagues, we believe that the data from the <unk> phase III trial in metabolic dysfunction associated Seattle, hepatitis or Nash is the strongest clinical dataset on improvements in match and liver fibrosis reported to date positioning <unk> as a potential leading incretin base.
David Kendall: <unk> therapy for the treatment of obesity and Nash.
David Kendall: This leads me to slide 14, we are very excited that our partner Barrick during the lime has initiated a large phase III program for server do tied in match. In addition to the ongoing studies in obesity.
David Kendall: Leverage and leverage cirrhosis, our global phase III clinical trials investigating the efficacy and safety of <unk> in adults with Nash and moderate or advanced fibrosis and in those with compensated mesh cirrhosis, respectively.
David Kendall: Turning to slide 15, and a few remarks on our rare disease franchise.
David Kendall: <unk> without the glucagon for the treatment of congenital hyperinsulinism.
David Kendall: Following the complete response letter issued by the FDA last month, which was due to the timing of findings and conclusions from the re inspection the third party manufacturing facility, we eagerly await the new inspection classification.
David Kendall: We remain confident in the approve ability of this therapy for the sustained substantial unmet clinical needs in <unk> and are committed to working with the FDA.
David Kendall: Our third party manufacturing partner to bring Desi glucagon to patients living with this devastating disease in the months ahead.
David Kendall: We still expect to submit the requested and detailed analysis from existing continuous glucose monitoring data sets supporting use of Deicing glucagon beyond three weeks by the end of the year.
David Kendall: In addition, the U S. FDA has set a regulatory decision goal date of December 22nd for our long acting <unk> two analog.
David Kendall: <unk> died which possesses potential best in class.
David Kendall: Characteristics for the treatment of short bowel syndrome with intestinal failure.
Speaker Change: And with that I would like to move to slide 16, and turn the call over to Eric Cox Chief Commercial Officer at Zealand Pharma to review, our near term and future commercial opportunities for our rare disease franchise and obesity portfolio Eric.
Eric Cox: Thank you, David and Hello to everyone I'd like to start briefly talking about our near term commercial opportunities through our rare disease franchise, our Daphne glucagon product is under evaluation for the treatment of congenital hyperinsulinism.
Speaker Change: Rare and devastating disease, primarily in neonates in children. Our focus is on bringing this product to patients as quickly as possible.
Speaker Change: As there are few existing treatment.
Speaker Change: There are a few existing effective treatment options. Our prelaunch activities are in full swing and we're ensuring that our capabilities across our commercialization spectrum are in place. So that we're ready for a U S launch in the first half of 2025 contingent on regulatory approval.
Speaker Change: Our goal is to serve the patients and all effort has been focused on setting up the necessary structure and resources to accomplish this.
Speaker Change: For our <unk> product, which is currently under evaluation for short term bowel syndrome.
Speaker Change: We are currently undertaking pre commercial activities to enable a launch once approved by the FDA.
Speaker Change: As Glenn glue tide is expected to be launched in markets with a large commercial footprint. We're focused on finding a commercial partner for the product to reach as many patients who need these alternatives and ensure commercial maximization.
Speaker Change: Turning to slide 17.
Speaker Change: Focusing on the future commercial opportunities of the obesity programs.
Speaker Change: In particular I want to talk about why we strongly believe that <unk> has the potential to become a future foundational therapy, including a first line option for weight management.
Speaker Change: With the magnitude of obesity in obesity related Comorbidities, we believe that we are facing the biggest healthcare challenge of our time.
Speaker Change: Not only is it the pandemic associated with tremendous direct medical costs.
Speaker Change: Particularly to the health care systems. It's also the cause of too many preventable deaths.
Speaker Change: Turning to slide 19, and the income statement.
Speaker Change: Revenue for the first first nine months of 2020, Paul was 54 million DKK.
Speaker Change: This was mainly driven by the license and development agreement with Novo Nordisk, let's take a loss.
Speaker Change: Operating expenses for the period were $919 million DKK, driven by research and development. This represented 72% of the Companys operating expenses.
Speaker Change: The increase in R&D expenses compared to the same period last year is due to the clinical advancements of the obesity pipeline.
Speaker Change: The activity is supporting the regulatory view on the U S. FDA of the late stage Radisson sentence.
Speaker Change: Selling and marketing expenses of 50 million DKK, primarily to the pre commercial activities associated with all of our entities.
Speaker Change: The increase in admin expenses is a result of the additional legal expenses related to our patent portfolio as well as the strengthening of our organizational capabilities at lunch.
Speaker Change: The net financial items for the period of 81 million DKK are mainly driven by the interest income from liquidity as investors and market.
Speaker Change: <unk>, which is significantly higher compared to the same period last year as a result of RBC capital increases.
Speaker Change: And that takes me to slide 20, and the cash position.
Speaker Change: In the first nine months of 'twenty plentiful.
Speaker Change: Very pleased with the fact that we have secured eight 6 billion DKK two capital raises and disbursements are part of the loan facility provided by the European investment Bank.
Speaker Change: As of September 32020 for cash cash equivalent and marketable securities were $9 2 billion DKK and our strong cash position truly enable us to make significant investments in our into our PCT programs.
Speaker Change: And this takes me to slide 21, and the financial guidance.
Speaker Change: I'll keep this brief as our guidance is unchanged. We continue to guide for net operating expenses of between one <unk> and 135 billion DKK.
Speaker Change: And with that I'll move to slide 22, and turn to call back to Adam for concluding remarks.
Adam: Thank you.
Adam: I'm extremely satisfied with our progress in the first nine months I think yes.
Speaker Change: We have created very strong platform.
Speaker Change: And to accelerate our growth and pursue our vision of becoming a key player in the growing up you could say.
Speaker Change: And does play our part in that.
Speaker Change: What we believe is the ticket took care of all the time.
Speaker Change: Based on the strong performance in 2004, we are also building momentum into 'twenty side with additional clinical progress anticipated our preparatory activities.
Speaker Change: Upper trans side.
Speaker Change: The first half of 'twenty five expect to initiate the second phase III lead time wise.
Speaker Change: Are we in that.
Speaker Change: And later in 'twenty five also plan to initiate a phase <unk> combination trial with <unk> one receptor agonism.
Speaker Change: In the first half.
Speaker Change: Next year we.
Speaker Change: Also we will initiate a phase <unk> trial.
Speaker Change: Power potential first in class tier one tier two tool accurately ethical tied.
Speaker Change: In the same timeframe. We also expect to announce top line results from a cohort of the phase <unk> trial evaluating even higher doses of debt at the site.
Speaker Change: Don.
Don: Treatment for Lincoln.
Speaker Change: Thank you all and I will now turn over the call to the operator for questions.
Speaker Change: Thank you as a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again.
Speaker Change: We will take our first question.
Speaker Change: Our first question comes from the line of Lucy Codrington from Jefferies. Please go ahead. Your line is open.
Lucy Codrington: Hi, there thanks for taking my questions.
Lucy Codrington: Couple from me just firstly on the <unk>.
Lucy Codrington: TV design.
Lucy Codrington: Bye.
Speaker Change: Can I just confirm I'm sorry, this has already been said.
Lucy Codrington: Is that five different doses of <unk>.
Speaker Change: You bet.
Speaker Change: Fewer days is built with different titration regime being evaluated to the question.
Speaker Change: Current cohorts.
Lucy Codrington: He said they don't.
Lucy Codrington: For the phase III is the intention to take more than one.
Lucy Codrington: Three to two phase III trials.
Lucy Codrington: Secondly.
Lucy Codrington: And one of the competitive with showcasing our initial data.
Lucy Codrington: And then asset.
Lucy Codrington: Weak as well.
Lucy Codrington: Not only necessary, but it has been demonstrated with both tegra and petroleum side too, but not only.
Lucy Codrington: <unk>.
Lucy Codrington: Fewer Gi tolerability issues, but.
Lucy Codrington: Clearly as part of the benefit in terms of the metabolic effects on body weight. So.
Harrison from PBT-IG, please go ahead your line is open.
Speaker Change: Hi, good morning. This is RaeAnn for Julie and congrats on the progress so far and thanks for taking our question. You mentioned earlier on a partnership for both Petrolintide and Glopiglutide. We were just wondering what an ideal partnership term or deal would look like.
and others. Thank you.
Speaker Change: Thank you for that question and I'll hand it over to you Eric to just give some flavors on our thinking there.
Eric Cox: Yeah, and so thanks for the question. I think from a partnership perspective, I think we're exploring...
Eric Cox: All partners, I think at the end of the day, we do know that there are some opportunities.
Eric Cox: on the Galapagos side that are a little bit larger of opportunities.
Eric Cox: So we would want to look at a commercialization partnership as we move forward on that one. I think they would also then explore if there's other opportunities for life cycle management, but it would definitely be a strong
Eric Cox: commercialization partner on the CHI or the DASI glucagon. I think it is a new market and I think people are still trying to assess the opportunity that exists so we are still looking for commercial partners and potential partners that would be willing to consider both.
Speaker Change: options and to commercialize and build more of a full rare disease franchise. So we are looking for commercialization partners for the most part.
Thank you very much.
Speaker Change: Got it, thank you, very helpful. And just a follow-up if I may, do you expect any residual allegiance to Gatix or are you planning for most of the short bowel syndrome market to convert to less frequent treatment options?
Speaker Change: I think there's two components on the short bowel syndrome side of things.
Speaker Change: I think you have the GAVX patients, we know that they're not...
Speaker Change: They're not really well controlled, so there's one option I think as we look at some of the GADACS patients as well, as well as the more convenience, but we still recognize there's a significant portion of patients that are not being treated, and that is still an opportunity for us. So we do look at it as across the entire spectrum of all those customer segments, both the GADACS side of it, those people that are not well controlled, those people that are looking for better convenience, and then those that are currently not being treated.
Speaker Change: And that is still an opportunity for us. So we do look at it is across the entire spectrum of all of those customer segments. Both the <unk> side of it those people that are not well controlled.
Speaker Change: Those people are looking for better convenience and then those that are currently not being treated.
Speaker Change: Thank you very helpful. Thanks again sure. Thank you for the question.
Speaker Change: Thank you. Very helpful. Thanks again. Sure. Thank you for the question. Thank you. We will take our next question. And the question comes from the line of Prakha Agraal from Kanta. Please go ahead. Your line is open.
Speaker Change: We will take our next question and the question comes from the line of Prakash Agarwal from <unk>.
Speaker Change: Hunter. Please go ahead your line is open.
Speaker Change: Hi, Thank you for taking my questions and great presentation that obesity week, one thing that maybe we are still hoping to get more clarity on is on the dose response, the weight loss trajectory looks fairly similar for the $4 eight and nine milligram dose even in the nation titration period, but we clearly believe that based on individual patient data there should be.
Speaker Change: Hi, thank you for taking my questions and a great presentation at Obesity Week. One thing that maybe we are still hoping to get more clarity on is on the dose response. The weight loss trajectory looks fairly similar for the 4.8 and 9 milligram dose.
Speaker Change: Even in the initial titration period, but you clearly believe that based on individual patient data, there should be dose response and longer duration.
Speaker Change: Doses once on longer duration, so anything that you would note based on the data that drives this conviction and.
Speaker Change: So, anything that you would note based on the data that drives this conviction. And a couple more, if I may. On partnership discussions for petrolentide, what would be some of the important factors for you in the deal structure? Is having a co-commercial structure in the U.S. important?
Speaker Change: Couple more if I may on <unk>.
Speaker Change: Partnership discussions for petrol then tied what would it be some of the important factors for you in the deal structure is having a commercial structure in the U S. Important and then lastly, just quickly you talked about the coverage that data coming in for Q, maybe just talk about the implications for petrol and tight from the government that monotherapy arm in the trial.
Speaker Change: And then lastly, just quickly on, you talked about the Kaggle SEMR data coming in for Q. Maybe just talk about the implications for petrol lintide from the Kaggle lintide monotherapy arm in the trial. Just wanted to understand what you're hoping to see on that from an efficacy and safety standpoint. And thank you so much.
Speaker Change: Just wanted to understand what you're hoping to see on that from an efficacy and safety standpoint, and thank you so much.
Speaker Change: Thank you.
Thank you.
Speaker Change: This guy is perhaps a little bit more on the partnership front.
Speaker Change: discuss perhaps a little bit more on the partnership front before handing over to David.
Speaker Change: Before handing over to David.
Speaker Change: It is very important cause and the partnership.
David Kendall: Wherever we partner up with will share their vision and ambition circuitry inside.
Speaker Change: Developed future foundational and first line therapy and that also of course means.
Lucy Codrington: Yes.
Lucy Codrington: Committing to the associated investments into clinical conduct.
Lucy Codrington: committing to the associated investments into clinical conduct and positioning and of course also manufacturing. What we would be looking for is a true partnership where we will continue to contribute and develop, soon and along, you can say, the development of this molecule towards.
Lucy Codrington: Positioning and of course also manufacturing what we would be looking for is a true partnership where we will continue to contribute and to see them at all we can say the development of this molecule towards.
Lucy Codrington: I think it posted the market, where we would also ought to have a co commercialization right.
Lucy Codrington: Well, how these are going to play out specifically is something we will discuss through these partnership discussions But it will be extremely important for us to stay involved in the program we will focus as I said before on the US and potentially other major markets and
Lucy Codrington: How things are going to play out specifically is something that we will discuss today.
Lucy Codrington: Through these partnership discussions, but it will be extremely important for us to stay involved in the program. We will focus as I said before on data.
Lucy Codrington: And potentially other major markets.
Lucy Codrington: <unk>.
Lucy Codrington: And and so it will be important for us.
Lucy Codrington: And so it will be important for us to maintain rights on also the commercial end, but operate alongside a partner.
Lucy Codrington: Maintain rights and also the commercial and.
Lucy Codrington: Operate alongside our partner.
Lucy Codrington: And.
Lucy Codrington: And then maybe just one favorite cut granitite calculus, they buy data that read out to be of course as anyone else extremely excited.
Lucy Codrington: To see how these data reads out and of course, you can say as David Devault, who she had several times on the call today, we have a quite stable over sits about it.
Lucy Codrington: Maybe a different molecule with regard to formulation and other aspects, but but it will be interesting to see also.
Lucy Codrington: But one of his report on the cutaway type model.
Lucy Codrington: But the two four milligram will complete and Todd can deliver of course win.
Lucy Codrington: what the 2.4 milligram of the gradient type can deliver. Of course, when
Lucy Codrington: Looking into that cost it will be important to recognize that.
Lucy Codrington: Looking into that for us, it will be important to recognize that.
Lucy Codrington: We think if we had a significant high back then.
Lucy Codrington: And also we know we will be dosing much higher in our studies David Katz.
Lucy Codrington: While the temperature.
Lucy Codrington: Can't provide us with some guidance and insight. We also recognize that we need to conduct that will need to fully understand that.
Speaker Change: Potential upside same time, David will do ethanol.
Speaker Change: Yes happy to higher per car.
Speaker Change: Dose response, I think to your point there.
Speaker Change: This is obviously a limited dataset 12 participants exposed in.
Speaker Change: The two dose groups for eight and nine.
Lucy Codrington: But.
Lucy Codrington: As we have alluded to it was really that early response with a lower starting dose and the $4 eight group they have.
Lucy Codrington: A fairly robust early response, and then relatively linear mean response after those first few weeks of the titration scheme.
Lucy Codrington: Based on these data and others say that the lines will cross at nine we will continue to decline.
Lucy Codrington: More rapid rate exceeds $4 eight no, but I think.
Lucy Codrington: Both those observations.
Lucy Codrington: The fact that in both groups, we have very limited number of female participants who tend to lose more.
Lucy Codrington: But to that.
Lucy Codrington: Obviously, the phase to be that we've described will allow us between that what I call mid to high dose in the higher dose of nine milligrams allow us to explore if separation as possible. So I don't want to overstate what <unk>.
Lucy Codrington: Give us the confidence that we may see a continued decline in the nine milligram dose.
Lucy Codrington: I can say is that obviously.
Lucy Codrington: We believe we've got at least twice and potentially up to three to Forex the potential dose exposure to get maximal response.
Lucy Codrington: But like you im going to await phase to be to finalize that statement on dose separation, but given that we have tox coverage.
Lucy Codrington: The evidence in road and suggest that higher exposure.
Lucy Codrington: Will permit greater effects on body weight and.
Lucy Codrington: At least some suggestions from each individual data that youll see at a future Congress.
Lucy Codrington: Give us confidence that at least looking in phase II B can help elucidate.
Lucy Codrington: The dose at or above.
Lucy Codrington: The four eight to five milligram range that can maximize the response nothing more to add to Adam's comments on CAGR I think the mono arm will.
Lucy Codrington: Hopefully give us even greater competence.
Lucy Codrington: Double digit we had lost 15% to 20% potential of controlling type.
Lucy Codrington: And if.
Lucy Codrington: Maybe just one other note on day four.
Lucy Codrington: For data in the 90 milligram dose I think it's also perhaps equality to recognize that these are still quite low BMI.
Lucy Codrington: Yeah.
Lucy Codrington: Participants in the phase II.
Lucy Codrington: <unk> studies of course they stayed.
Lucy Codrington: Even with higher BMI, so for us it will be extremely important to carry you can say the full dose opportunity into phase III.
Lucy Codrington: And then.
Lucy Codrington: Yeah.
Lucy Codrington: Right there was to bring forward into phase III.
Speaker Change: Thank you.
Speaker Change: Thank you we will take our final question.
Speaker Change: Final question comes from the line of Thomas Bowers from Thanks Gabor. Please go ahead. Your line is open.
Thomas Bowers: Yes. Thank you very much just a couple of questions for me to have on my side. So just on the <unk> side.
Thomas Bowers: Do you actually have any CRP reduction data from from that phase one I'm not sure whether you actually tested for that and also <unk> tight is that something that we could expect from the phase one as well and then just on the on that you'd be one combination with epogen to Todd is this going to be a combination with <unk>.
Speaker Change: You can say commercially available once weekly approved.
Speaker Change: Everyone at obesity or is it something that you also have internally and the pipeline and then my last question.
Speaker Change: So looking at the slides from from obesity week. So so when I assuming on are these PVC curves.
Speaker Change: Would it be faster sort of make a conclusion that we at least see an indication of the weight loss effect tailing off a bit after after 12 13 weeks for Pfizer to the both the both of the high dose.
Speaker Change: Cohort. So I don't know of course, it's a very small sample size things to the Devil's advocate, but is there anything that we should.
Speaker Change: Should be a little bit concerned about at least arguing for the 20% rate of production that you are targeting.
Speaker Change: Could this maybe be also an effect of baseline APM PMI for these patients in the study. Thank you.
Speaker Change: Yes, thanks for those questions.
Speaker Change: Just a thought.
Speaker Change: CRP you should not expect that from a smaller study like this.
Speaker Change: We of course know from the phase II, starting some noise with <unk> that you see with us once again at least cyclically and tightened therapies. So we would also expect that with this molecule.
Speaker Change: When it comes to combination therapy.
Speaker Change: The train side and get the one I think at least our thinking is potentially quite different from the approach that our competitors have taken.
Speaker Change: We wanted to do.
Speaker Change: <unk> is the future foundational therapy.
Speaker Change: It will be extremely important for us to number one identify as you can see the effect at doses and again and then currency at Adobe appear to one on top of that instead.
Speaker Change: Instead of using what is considered the most effective those buckets you have two one for weight management, adding a little bit of Amazon I think it's a more patients potentially more patient friendly approach.
Speaker Change: It <unk> until the maximum effective dose of Amazon.
Speaker Change: Which could further you can say contributed limiting side effects.
Speaker Change: But those patients who would potentially combination therapies, which we believe will be the most multi year diesel only a smaller fraction of their lots.
Lucy Codrington: Gotcha.
Lucy Codrington: Opportunity.
Lucy Codrington: On the slope of the weight loss.
Lucy Codrington: Maybe not something we see.
Lucy Codrington: What I.
Lucy Codrington: I know you brought this up a few times it's not.
Speaker Change: We read the data I think you are right. If you have no PMI population that is of course the limit to how much weight you can.
Lucy Codrington: And it's most studies you also have to be everything that we can face study phase one study, where you don't apply to diet and exercise. So I would say all data, including data from competing programs that we have looked into suggests.
Lucy Codrington: But the weight loss will continue also called an imaging analog.
Lucy Codrington: So it's not a concern we scan.
Speaker Change: I hope that.
Speaker Change: Alright, Thank you Christiane.
Lucy Codrington: That's great. Thank you very much.
Speaker Change: Thank you.
Speaker Change: This concludes today's question and answer session I will now hand, the call back to Adam Steinberg for closing remarks.
Lucy Codrington: Yes.
Adam Steinberg: I would now.
Speaker Change: Like to thank everyone for your participation today, and we look forward to future updates and interactions. Thank you so much.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Lucy Codrington: [music].