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spk00: Ladies and gentlemen, thank you for standing by. Welcome to Abibag's conference call to discuss 2023 financial results and business update. My name is Sandra and I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, we will conduct a Q&A question and answer session and instructions will follow at that time. As a reminder, this call is being recorded at Abibag's request. Now, I would like to introduce your host for today's call, Patrick Malloy, Senior Vice President, Investor Relations. Pat, please go ahead.
spk04: Thank you, Operator, and good morning and good afternoon to everyone. Welcome to today's call, during which we'll provide an update on our financial results for the full year ended December 31st, 2023, as well as key program updates across business. On April 2nd, we issued a press release summarizing our financial results, and on April 5th, we filed our 20F and universal registration document, all of which can be found on the ABVAC's website. Before we get started, I'd like to remind everyone that during today's discussion, we'll make statements about our future expectations, plans, and prospects that constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Security and Litigations Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements are a result of important factors, including those risk factors discussed in our SEC filings, and we are not under any obligation to update these forward-looking statements. In just a few moments, I'll be handing the call over to our CEO, Mark DeGaradell, who will provide the financial results and business up to date. Following the prepared remarks, we'll move to a question and answer session where we'll be joined by members of the management team, including our CFO, Didier Blondel, our Chief Medical Officer, Sheldon Sloan, Chief Scientific Officer, Didier Scherer, and Chief Commercial Officer, Michael Ferguson. Now, I'd like to hand the call over to Marc de Garadel. Marc, please go ahead.
spk02: Thanks, Pat. Good morning and good afternoon, ladies and gentlemen. And thank you for joining the first Abivax Earnings webcast. that we are holding as a dual listed company on NASDAQ and Euronext. Last year was very exciting for Abivex, one that has set us up to accomplish important milestones that are crucial for the future as we continue to develop Obifazimol to be a potential preferred oral option for inflammatory bowel disease patients. First of all, let's focus on the financial aspects. In 2023, Abivax raised over 500 million euros. This consisted of first 130 million euro crossover financing in February, followed in August by two structured debt financing transactions, allowing Abivax to draw up to 150 million euros, and finally, our initial public offering on the NASDAQ global market in October of last year, which raised 223.3 million euros. Abivac's NASDAQ IPO was the largest ever completed by a French-listed biotech company. This record capital raise will support our overall financial and development strategy for our lead drug candidate, Obifazimod, for the treatment of inflammatory bowel disease. With a cash position of 261 million euros as of December of 23, we have sufficient funds to finance our operation into Q4 of 25, based on current business plan. This means that we are financed beyond the announcement of our major milestone for next year, the top-line data from the Phase III APTEC induction trial of Obifazimod in ulcerative colitis. expected in Q1 2025. Let's move now to our clinical and preclinical development progress. Over the course of last year, we implemented a strategy that would allow us to seize the potential of Obifacimab's unique and differentiated profile for the treatment of IBD. The execution of this approach is underway and well advanced. The Phase III APTEC program investigating the efficacy and safety of Obesifacimab in adults with moderate to severely active ulcerative colitis is progressing according to plan. The recruitment into both induction trials is currently ongoing in all designated areas around the world, unlike the Phase IIb, which was only conducted in Europe. Further, we plan to initiate patient recruitment in our Phase IIb trials for the treatment of Crohn's disease in Q3 of this year with top-line data expected during the second half of 2026. As already announced in September of 23, the preclinical efforts intended to identify different options to strengthen our pipeline are also progressing. Among the options being evaluated is a potential combination therapy of all and injectable candidates with obfetimide in ulcerative colitis. Experiments in preclinical models are ongoing and the data to support our decision are expected in the second half of this year. Research and development work to identify potential follow-on drug candidates from Abduvak's compound library is also advancing. We expect the selection of the first follow-on drug candidate later this year in Q3 to evaluate its usefulness for IBD or potential other inflammatory conditions. To enable us to successfully execute on all R&D and clinical development programs and plans, Abivacs made significant efforts in the past months to build the necessary operational infrastructure in the US as well as in Europe. We know how a very seasoned global team in place that we believe has the required market specific competencies and expertise to conduct the ongoing programs and prepare for the respective market authorization applications. starting with Obesazimod for the treatment of ulcerative colitis. In addition, not only did we reinforce the operational team, but we also made notable changes within our board of directors in the past year. June Lee and Troy Nelsey joined in July of 23, and I'm glad that we can also now welcome Camille Sonderby as a new member of the board. We believe Camille's expertise in driving portfolio, strategy, and commercialization will be very valuable for us. We will continue to bring the best expertise on the board to strengthen our path forward with a focus on the U.S. market, representing a significant opportunity in inflammatory bowel disease. In the past year, in addition to attracting new renowned colleagues and board members, we also experienced increasing interest among the scientific community and the industry. Abivac's scientific excellence has been highlighted by several abstract presented by leading U.S. and European KOLs, at the major scientific IBD congresses in 2023 and the first quarter of 2024. We'll continue to scientifically underpin Obifatimo's potential as a safe and effective long-term treatment option in IBD and its novel mechanism of action at upcoming conferences and through publication in relevant scientific journals. IBDACS can look back at a very successful 2023. while also looking forward to achieving implementation of our financial, clinical, scientific, and operational strategy in the course of this year. We believe 2024 will lead us toward major milestones with the data readouts of our UC program in early 2025, initiation of the CE trial in Q3 2024, and the decisions on how to strengthen our pipeline in the future with new preclinical results. That concludes our prepared remarks. Now we will move to the Q&A session. Operator, please.
spk00: 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 answer your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. We will now take the first question from the line of Thomas Smith from LeanRig Partners. Please go ahead.
spk05: Hey, guys. Good morning. Thanks for taking the questions, and congrats on the progress. Just on the ongoing phase three App Tech program, I was wondering if you could elaborate a little bit on how enrollment's progressing there. Are you seeing any region-specific enrollment trends that are worth calling out, and can you comment at all on how patient retention has been in the study so far?
spk04: Thanks, Tom. Sheldon, do you want to take that one?
spk07: Yes, I will. Okay. Hi, Tom. Thank you for your question. I think Mark laid it out where we are with the study. Let me just give you a little bit of a highlight. with our regional expectations. I think we already talked about no more than 25 percent of the subjects enrolled in the study will be from any specific region, which Mark already pointed out. In contrast to Phase 2b, two-thirds are from Eastern Europe. And the good news is we are now actually deployed in all our targeted geographic regions. We're already enrolling in China and Brazil. And obviously, we've been in Japan for a while. North America obviously has been up and running the longest. And even though we had what I would say at the beginning, a little bit of a delay with the CDIS, primarily European countries, we're all fully engaged in those countries now. I think the second thing, which you were talking about retention, I think you're talking about the dropout rate, although right now it's blinded, so we really don't know, but that's something we're actively looking at. Discontinuations, as you know, we had a little over 12%, I believe, in the Phase IIb study, and we're really tracking that carefully. One of the things that drove discontinuations was headaches in the Phase IIb study, and we know that the headaches is more about managing expectations at this point, making sure that the investigators and patients know that it's something that occurs early on in the start of therapy, generally almost always treated with over-the-counter either acetaminophen or non-steroidals, and does not last for more than a few days to a week. And the bottom line is once the patients are on the medication, the headaches actually do not return, and that was apparent in our second year of our open-label extension where headaches were not an adverse event. Just to kind of wrap that up, We're managing that by actually instructing the sites that headaches, again, there are reasons why patients need to discontinue, but generally should not be a reason to discontinue in the study. So we're actually aggressively and actively, proactively actually managing that discontinuation event. Thank you.
spk05: Got it. That's helpful. And then with respect to the long-term extension trial readout for with Avimod in UC that you're expecting in Q3, Can you just talk about your expectations and what are you hoping to learn from this data set?
spk07: So I think that's, as you know, we announced, we actually presented the first cut at this past ECHO, and we are planning actually a similar data cut, and then we'll have patients on for more than actually from the 2A study, probably six years exposure and up to four years exposure from the 2B study. What we found in the first year for those patients who were well-controlled, those patients, this is an enriched population, so they need to have endoscopic improvement, meaning an endoscopic subscore, myoendoscopic subscore of zero or one. They needed to have a zero or one at that point. where many of them, over 70%, started with a three at the start of the study. So it's a very impressive improvement. And we saw the durability over that one year, starting the entry into that 25 milligram open label extension, 100% were obviously an endoscopic improvement. And there was very few that dropped to without endoscopic improvement. 95% were still an endoscopic improvement. So What we hope to show, Tom, is continued durability, even with 25 milligrams, in a well-controlled population. We're testing, obviously, the one-year durability for the first time in our Phase III program, but this will give us some long-term data on that durability in patients well-controlled.
spk05: That's super helpful. Thanks for taking the questions, guys. You bet. Thanks, Tom.
spk04: I'll very welcome you to the next call.
spk00: Thank you. We will now take the next question from the line of Vikram Purohit from Morgan Stanley. Please go ahead.
spk01: Hi, everyone. Good morning. Thanks for taking our questions. So we had two. First, on the Aptek readout that you're guiding to for 1Q25, I know it's a little bit early, but would you have any initial sense on which parameters of data and how extensive of a readout you might expect the induction readout in 1Q to be. And kind of as you progress through the study and as you presumably get more KOL feedback on the program over time, how are you seeing the hurdle for a win on efficacy evolve there? And then secondly, on follow-on compounds, I would just love to get a bit of color on how you're prioritizing and thinking about choosing the best follow-on compounds to add to the pipeline. Thank you.
spk04: All right, great. Thanks, Vikram. Sheldon, you want to take the first part, and then maybe Didier Scherrer and Mark can weigh in on the approach to combination.
spk07: Yeah, so Vikram, to ask you what data we're going to present first quarter 2025, we're still in discussion internally as to how extensive, because we have to manage, obviously, a maintenance study that's concurrently running. So we're going to get some clarity on that as we go a little further down And I think the second question that you had was about the KOLs. Again, it's – and I wasn't clear on winning on efficacy. Can you just clarify that question? I apologize. I didn't quite catch it.
spk01: Yeah, I was just wondering, you know, as you speak with more KOLs in the space and as the Phase III program progresses, how is your view on what a win on efficacy from the induction readout, what that could look like in 1Q?
spk07: Yeah, so that – Boy, I'll tell you, I wish I had the crystal ball for that one. Again, we're blinded to the data currently. The only thing I can tell you that is really more of an anecdotal is when we meet with key opinion leaders or investigators who participated in our 2B program who continue to have patients enrolled, they tend to be very enthusiastic about the opportunity for OB-FASMA because many of these, many of these patients were at the point of going to surgery. And we hear these stories, now they're anecdotal, so I don't want to give any kind of over-promise, under-deliver expectations, but this is coming from investigators who really have had, who have patients who've gone through just about every other therapy. So when it comes to our expectations, we modeled the Phase IIIb study to be very competitive induction results with the current offerings on the market. And that's as best as I could tell you right now. Thank you. I'll hand it over to Didier Chirure.
spk06: Sure. So I can tackle the follow-on compound question. So basically, yes, so we're working on the follow-on compound. Unfortunately, I cannot disclose the exact, you know, criteria we're trying to optimize. But in general, I mean, we're looking at two sides of the coin. I mean, looking at the Those compounds are based on the same MOA, so we're trying to play around, you know, physical, chemical, chemistry properties of the compound, but also in terms of adduction and efficacy. So, sorry, I cannot go into too much detail, obviously, for competitive reasons, but that's what we're doing right now.
spk01: Fair enough. All right. Thank you. Very helpful.
spk00: Thank you. As a reminder, if you wish to ask a question, please press star 1 and 1 on your telephone. We will now take the next question. It comes from the line of Julian Harrison from BTIG. Please go ahead.
spk03: Hi. Congrats on all the recent progress, and thank you for taking my questions. Regarding your follow-on program to albifosamide, I know it's early, but I'm curious if you have a good sense now of how you plan to prioritize IBD versus other INI indications, given how broadly relevant the mechanism likely is. And then regarding combination regimens down the road, I'm curious if there are any external data events that could inform your future decisions there, or will that be based mainly on internally generated data?
spk04: Hey, Julien. Thanks for your question. Maybe turn it to Didier Schreier with regards to the combination, and then if Geraldine and Marc want to weigh in relative to the competitive events that might inform our decisions.
spk06: Yeah, so the way, I mean, combination, the way we're looking at combination is in different way. I mean, obviously, we can look at combination based on a complementary MOA that could make sense. So that's one. We can look at it in terms of what can we improve with a combo based on the profile of the two compounds we want to combine. But also we can look at it from a payer perspective and looking at some compounds that example can go generic and is the combo a good approach with those type of compounds so this different approach we're looking at right now you know we're looking at the preclinical data running preclinical experiments uh i don't know if the decision will be fully based on preclinical data but uh right now we're waiting to see what we're going to get from those experiments yeah maybe i can jump in just uh you know further consideration i think
spk02: You know, obviously beyond the preclinical experiments, you know, we are attentive to, you know, a number of things. In general, first, you know, many of the large companies are developing their own combo programs. So that's obviously one thing we have to think about. But we took advantage of, you know, our presence at ECHO, where we met, I think, about 30, you know, investigators from different nationalities to ask them about, you know, what do you think about where combination therapy is going? What are you looking for? You know, what is the kind of thing that would attract you? And especially as you think about, you know, profile from the face to be. And we heard actually, I think, different sort of thoughts. The first one, by the way, that was also in conjunction with another presentation at ECHO, was the fact that some doctors believe that it would be highly valuable to eat hard with a strong combination in terms of efficacy for induction so that you can reduce the inflammation to the maximum and therefore increase, obviously, the response. And then actually potentially a drug like Obifazimod in maintenance even again, the strong early profile we have in that setting. So that's sort of, you know, the first school of thought. The second school of thought was actually, you know, sort of on the other side of the spectrum where some doctors told us we'd rather use combination really more toward, you know, when there is less and less options available to us, and certainly because of safety considerations. So we would want to, you know, you know, employ combination therapy for more advanced patients and certainly before, you know, potential surgery. And then the third one, so the school of thought was, well, you should combine bifazimod with also with a safe drug because safety ultimately is paramount to this young population. We don't want to hurt them, obviously, as we try to control their disease. And you should really consider safety as a key criteria if you want to combine. So I think this is why in the current preclinical program, we are going to have a vast array of experiments so that we better understand for different type of drugs that could be combined, what's happening. And then, you know, finally, the last thing that the doctors could not comment upon is, you know, is a reimbursement payer's environment. You know, that's going to evolve over time as the drugs, some of the drugs get genericized, you know, or get into biosimilar land. So we'd have to bear that in mind, you know, I would think through the combination therapy. And then in the end, I would say, you know, for us, we would have probably to make a choice on, you know, one combo development because it's going to be very hard, as you know, to finance, you know, multiple combination human trials. I think it's going to be very difficult. So we'll have, you know, probably by year end or next year, you know, we'll have to reflect on all those parameters and figure out, you know, where we would advance, you know, combination therapies of betazimol.
spk03: Very helpful. Thank you.
spk00: Thank you. There are no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.
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