Kymera Therapeutics, Inc.

Good day and welcome to the Chimera Therapeutics second quarter 2024 results 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 telephone keypad. To withdraw your questions, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Justine Konigsberg, Head of Investor Relations. Please go ahead.

Good morning and welcome to Chimera's quarterly update call. Joining me this morning are Nella Manolfi, 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. In order to have enough time to address everyone's questions, 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 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'll now turn the call over to Nello.

Thank you, Justine, and good morning. Every day we take important steps towards our goal of building a fully integrated global biotechnology company, demonstrating our ability to consistently deliver first-and-best-in-class programs that target validated pathways with the potential to address large underserved disease areas. The progress we've made over the past quarter highlights our novel approach to drug development that emphasizes innovative molecular design, fidelity of translation from preclinical settings to the clinic, data-driven development strategies, and the commitment to maximize the impact of our science to improve patients' lives. Our unique approach has led to the development of a pipeline of exciting degrader medicines with the potential to change treatment paradigms for multiple diseases, as evident in our recent updates and presentations at major medical congresses and publication in peer-reviewed journals over the past few months. Our STAT6 program, for example, was featured at both ATS and DDW, MDM2 at ASCO, and STAT3 at AACR and EHA. In addition, we published data from our non-interventional trial evaluating IREC4 expression in patients with HS in the Journal of Investigative Dermatology. The findings we've shared across these forums highlight the differentiated profiles of our programs. Before handing the call over to Jared for a more detailed overview, I wanted to highlight two important updates in our immunology pipelines. I will start with our IRAC4 program. As a reminder, KC474, our IRAC4 degrader partnered with Sanofi, the first hetero-bifunctional molecule to have been dosed in healthy volunteers and then HS and AD patients. We have shown in our phase one studies deep degradation of IRAC4 in blood and skin, resulting in impact on biomarkers of inflammation, both systemically and in the skin of HS and AD patients. This robust PD profile has resulted in clinical benefits measured by easy and prorated scores in AD and high score and pain in HS. KT474 has likely been the most studied degrader in a Phase I setting. Last month, we announced, after an interim review of safety and efficacy of the ongoing HS and AD Phase II trials, that Sanofi intends to expand both of these trials with a goal to accelerate the path to registrational Phase III studies for both HS and AD. The impact of these expansions effectively allows us to transition seamlessly into more expansive dose range-finding Phase II studies. As a result, while the modified Phase II trials will be larger and extended, the expectation is that this will enable a direct transition into Phase III more quickly than anticipated. Staying with immunology, we've been talking about the concept of oral degraders with biologics-like activity, a unique value proposition for Canera's platform in this attractive therapeutic area. Our STAT6 program best exemplifies this concept. Dupilumab is the drug that has transformed the lives of almost a million patients with Th2 diseases, and in doing so has become, with sales that are projected to reach $20 billion, a mega blockbuster and one of the largest drugs in this industry. At Canera, we've developed an oral degrader that, by targeting STAT6, the selective transcription factor of the IL-413 pathway, is able to block the pathway in a similar or superior way. In fact, we've shown in preclinical studies that an orally active picomolar STAT6 degrader, KT621, is more potent than dupilumab at blocking Th2 signaling in cell systems and equal or superior at blocking Th2 inflammation in preclinical disease models. Overall, the preclinical data generated to date demonstrate the opportunity for KT621 with best impact with potential given its dupilumab-like activity and the convenience of an oral pill. We believe that a paradigm-shifting oral drug with this profile has the potential to change how Th2 diseases such as AD, asthma, COPD, and others can be treated. Our mission is not only to target the patients that are currently on biologic that the more than 100 million patients that are not currently on biologics, and by doing so, we have the potential to change millions of lives around the globe. We're excited to start our KT621 Phase I trial soon. We usually don't comment on the status or results of ongoing IND enabling studies, but since one of the most frequently asked questions we receive is the current status of the program, I wanted to provide a brief update. Very happy to say that we have completed all of the IND enabling studies with no safety findings of any kind. Case in point, in our GLP toxicology studies, at all doses tested, we did not see any adverse events of any type. This is an important milestone for the program, for KMR, and hopefully for millions of patients in the future. With those activities behind us, the next update you should expect will be when we dose our first subject. And importantly, We look forward to sharing the Phase I results in the first half of 2025. I will let Jared share more details on our programs, and then I'll be happy to do questions. Jared?