Kymera Therapeutics, Inc.

Good day and welcome to the Chimera Therapeutics third quarter 2024 results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would like now to turn the conference over to Justine Konigsberg, Head of Investor Relations. Please go ahead.

Thank you. Good morning, and welcome to Chimera's quarterly update call. Joining me this morning are Nello Manolfi, Founder, President, and CEO, Jared Golub, our Chief Medical Officer, and Bruce Jacobs, our Chief Financial Officer. Please note that during Jared's remarks, we intend to reference data from slides in our corporate presentation, which is available within the IR section of our website at chimeratx.com. Following our prepared remarks, we will open the call to questions. We ask that you please limit your questions to one and a relevant follow-up to assure we have enough time to address everyone's questions. 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 10Q 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.

Thank you, Justine, and good morning, everybody. We have a lot of important updates today. So let's jump right in. First and foremost, we're extremely excited that we've started the phase one study of KT621, a first-in-class oral STAT6 degrader and the first STAT6 medicine to ever enter clinical development. It's important to highlight that we were able to accelerate the path to the clinic given our recent increased focus of resources and capital that we're directing towards our growing immunology pipeline. I believe this is also an important moment for the whole industry. We have shown in preclinical species that a stat6 degrader like KT621 can block IL4N13 similarly or even more importantly than in upstream biologics like dupilumab in both cellular and in vivo models. We've also shown that KT621 was well tolerated in all safety studies that we have run in a wide variety of preclinical species. In summary, we have an investigational drug that has the potential to have a dupilumab-like profile in a daily oral tilt. Many of you know there are more than 150 million patients just in the U.S., Europe, and Japan who suffer from diseases associated with Th2 inflammation. And according to market data, less than a million of those patients receive dupilumab. While one could focus on the roughly million of patients currently on dupilumab, Chimera is focused on expanding access across the tens of millions of patients that are waiting for a convenient, safe, and effective oral pill. one that doesn't require needles, refrigeration, syringes, and frequent trips to the doctor's office. We believe KT621 is a medicine that has the potential to transform treatment paradigms in many diseases that affect millions of patients, such as atopic dermatitis, asthma, COPD, EOE, just to name a few. In addition, given that Th2 diseases are highly prevalent in children, we believe this has the potential to be a drug that will change quality of life for many families in the future. Our next DAT6 update is expected to be upon completion of the Healthy Volunteer Study in the first half of 2025, at which point we will share the full results. Following the completion of the Phase 1 study, our plan is to move quickly into patients. We have those plans well established, and we expect to provide guidance on the next stage of 6-to-1 clinical development next year. Jared will share more details around the ongoing Phase I study later in the call. I also wanted to briefly highlight another important update on KT474, our first-in-class IREC IV degrader. This is another program where Chimera was first to clinic, and its success has influenced the industry, with several companies following our lead with other IREC IV directed assets. We're finally able to share more information on the expanded Phase II studies that are being run by our partner Sanofi. As I'm sure you have read in a press release earlier today, the program is transitioning from proof-of-concept-like Phase II studies to fully-powered Phase IIb studies with dose ranging as a means of accelerating our path to registration of Phase III studies right at the conclusion of the ongoing studies. In terms of the specific trial changes, we have basically added one dose group to each study who have enough information to being able to select the dose for the subsequent registration of Phase III studies. We're thankful to our partner Sanofi for the increased confidence in and commitment to this important program. Turning to TIK2, we have exciting progress to report as well. At our R&D day in January of this year, we introduced our TIK2 program in our lead molecule, KT294. Similar to all of our programs, as KT294 was being advanced through preclinical development, we had parallel work ongoing on other promising compounds, One of the compounds we were evaluating demonstrated an even more compelling profile than KT294, highlighted by greater in-view activity and with a similar selectivity and safety profile. As a result, we've decided to advance the new compound, KT295, as our lead clinical candidate. Importantly, we believe we can do that without impacting our previously stated TIK2 development timelines. which assumed the phase one trial start in the first half of 25. Finally, I just wanted to provide everyone with a broader strategic update, and specifically as it pertains to our oncology programs. As many of you recall, it was around this time last year we first shared that we had increased our focus in immunology. The rationale was driven by the profoundly impactful profiles we believe we could generate an immunology with oral degraders that could compete with injectable biologics in terms of efficacy and safety. As shown with KT474 in the clinic and with our STAT6 and TIK2 efforts preclinically, we think we're positioned to develop a potential best-in-industry portfolio of oral immunology assets with opportunities to impact millions of patients. Even more today, with KT474 in multiple phase 2b trials, KT621 in the clinic, and KT295 close to the clinic, and other exciting immunology programs that we will be unveiling starting from next year, we believe that now is the time to focus even more of our resources into this space where we believe we can create outsized value. As a result, while we made some encouraging progress with our clinical oncology pipeline, demonstrating promising clinical activity in a variety of tumor types, As we have completed Phase 1 enrollment, we have made the decision that we will only advance KT333, our STAT3 degrader, and KT253, our MDM2 degrader, beyond Phase 1 with a partner. You can expect that we'll share more on this. If and when it makes sense to do so. While there are many considerations that contributed to this decision, ultimately, we believe our internal resources, both capital and people, are best focused on our expanding immunology pipeline. It should be noted that we did not take this decision lightly or made it without thinking about the potential impact on patients. We're in fact grateful to patients, families, and investigators, and the Chimera team who support their studies and these programs. In conclusion, as we approach year-end, it is quite exciting to see the trajectory that Chimera has had in 2024, especially within our immunology pipeline. We've advanced in the clinic KT621, with what could become one of the biggest programs in our industry. We have supported Sanofi to advance KT474 in expanding the Phase II studies. We've developed a TIC2D grader with a compelling profile and are closer to the clinic. And we have raised a total of approximately $600 million in just 2024. That has enabled us to have cash into mid-2027 and through several inflection points across our pipelines. I will pause here and let Jared share more details on our programs, and Bruce will walk you through the third quarter financial results. I'm looking forward to the Q&A session at the end of our prepared remarks. Jared?