Abivax SA

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.

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.

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.