2/27/2025

speaker
Megan
Conference Operator

Good day, everyone. My name is Megan, and I will be your conference operator today. At this time, I would like to welcome you to the Chimera Therapeutics fourth quarter 2024 results call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time and if you have joined via the webinar, please use the raise hand icon, which can be found at the bottom of your webinar application. If you have joined by phone, please dial star nine on your keypad to raise your hand. At this time, I would like to turn the call over to Justine Konigsberg, Vice President of Investor Relations.

speaker
Justine Konigsberg
Vice President of Investor Relations

Good morning and welcome to Chimera's quarterly update. As you will notice, we have moved to video format, which we hope you will enjoy. Joining me this morning are Nello Manolfi, our founder, president, and CEO, Jared Golub, our chief medical officer, and Bruce Jacobs, our chief financial officer. Following our prepared remarks, we will open the call to questions, where we will take questions from our publishing analysts on video. To be sure we have enough time to address everyone's questions, we ask that you please limit your questions to one and a relevant follow-up. Before we begin, I would like to remind you that today's discussion will include forward-looking statements about our future expectations, plans, and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10-K filed with the SEC. Any forward-looking statements speak only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call. With that, I will now turn the call over to Nello.

speaker
Nello Manolfi
Founder, President & CEO

Thank you, Justine. Welcome, everybody. We're excited to have you with us today as we transition our quarterly financial updates to a video format. I believe this reflects our continued commitment to transparency, open communication, and deeper connections with our stakeholders. We will have lots of data update this year, so it will be productive to have videos and slides. We'll use today's call to briefly reflect on our achievement of 2024, which positions us for what I anticipate will be a very exciting 2025. Stepping back, we started 2024 with our R&D day, where we shared our expanded focus on immunology with the goal of developing therapies that have the potential to deliver biologic-like efficacy with the convenience of a normal daily pill. There, we introduced STAT6 and TIK2, which exemplify programs we believe have the potential to disrupt conventional treatment paradigms and expand access to millions of patients around the world. As we mentioned at the time, the strategic effort was years in the making, but it has materialized rapidly with a recent clinical progress. Our team executed exceptionally over the past year and successfully delivered on all of our key priorities. Here's a quick recap of what we did last year. For STAT6, we completed IND enabling studies for KT621, filed an IND, and initiated the Phase 1 Healthy Volunteer Study. Now we're completing the final MAD cohorts. This is the first STAT6 targeted agent to enter clinical development. While the attractiveness of STAT6 is a target and the strong validation of preclinical work has attracted many others to the space, we believe we are the unquestioned leader, a position in which we intend to build. With TIK2, progress continued as well. Since the first introduction in January again of last year, we named and advanced a novel development candidate, KT295, and are now completing IND enabling studies. Regarding IRAC4, we continue to support our partner Sanofi in their efforts to progress the two ongoing phase 2b studies in HS and AD. Importantly, following an interim analysis in the middle of last year, Sanofi expanded the studies to accelerate the overall development timelines on a path to pivotal trials. Finally, while less visible to investors, we progressed our early pipeline of novel immunology programs to the point where we're poised to soon share our new exciting immunology target. So with all the progress that I just discussed, which reflect really a year of truly outstanding accomplishments, we're positioned to an even more productive 2025. where we'll have several clinical advancement across our immunology pipeline. To summarize, here is what you can expect this year. Starting with STAT6, we're on track to report KT621 phase one data this year for both the healthy volunteer trial, which will happen in June, and the phase 1B trial in AD, which will happen in the fourth quarter of 25. And we also initiate two phase 2B studies. AD will start in the later part of 25, and asthma will start in early 26. For TIK2, we're on track to advance KT295 into the clinic next quarter, with phase 1 healthy volunteer data before year-end. Stay tuned in May as we plan to unveil our next program, a previously undrugged transcription factor that has the potential to be first-in-class agent for multiple rheumatic as well as other autoimmune diseases. Importantly, we will not stop here. Our goal remains to deliver at least one new IND per year, so you should expect more exciting new developments to be disclosed at a consistent pace. I want to finish my comments here where we started this call, which is with our drug development principles and strategy. ChemAir is deeply committed to developing an industry-leading immunology pipeline, featuring innovative oral small molecule therapies. We're determined to ensure that patients won't have to choose or make trade-off between efficacy, safety, convenience, and cost. We believe that if we achieve this, we will expand the choices available to patients and transform how patients are treated in immunology and potentially beyond. Traditional small molecules have always offered convenience benefits, but delivering powerful pharmacology compared with biologics has been elusive. We believe our oral medicines can provide a differentiated and potentially better solution, oral drugs with biologics-like efficacy, and we're dedicated to making this a reality. Our work to deliver on the promise continue. We look forward to delivering on and sharing multiple data readouts in the next 12 to 18 months that we believe will validate our strategy and put us that much closer to addressing many important markets with next generation oral drugs. Before handing the call over to Jared, I'd like to take a moment to thank Lee Morgan, who has been a director at Chimera for the last three years. As you may have seen in the filing today, she's decided not to stand for reelection at our upcoming annual shareholder meeting in June. I would love to personally thank her for all the contributions she's made at Chimera over the last several years, which have been much appreciated. With that, let me pause here so Jared can give you more details on our clinical strategy plans and data. Thanks, Nello.

Disclaimer

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