This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
8/11/2025
Good day, everyone. My name is Olivia and I will be your conference operator today. At this time, I would like to welcome you to the Chimera Therapeutics second quarter 2025 results call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there'll 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 Bruce Jacobs, Chief Financial Officer.
Good morning. I'm Bruce Jacobs, and I'm kicking off this in place of Justine Konigsberg, our head of IR, who is out today. Joining me this morning are Nella Manolfi, founder, president, and CEO, and Jared Golub, our chief medical officer. Following our prepared remarks, we'll open the call to questions from our publishing analysts. If you'd like to ask a question, please use the raised hand icon, which can be found at the bottom of your meeting window. And to help us move efficiently through the Q&A session, we ask that you're ready to unmute your line when called upon. In addition, we ask that you please limit your question to one and a relevant follow-on to be sure we have enough time to address everyone's questions this morning. Before we begin, I'd 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. The 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 turn the call over to Nello.
Thanks, Bruce, and thank you for joining us this morning. As I mentioned at the beginning of the year, we set ourselves up for a very productive and exciting 2025, and we're delivering on that promise. The updates we've shared in the first half of the year represent a powerful validation of Chimera's innovative and disciplined approach to drug development within the biopharma industry, while paving the way for our future progress across our high-impact immunology pipeline. We're committed to leveraging the unique capabilities we've developed to unlock disease biology and deliver groundbreaking oral degrader medicines for areas not served well by existing technologies. Today's immunology treatment landscape still leaves millions of patients without adequate options, forcing difficult trade-offs between efficacy, safety, cost, and convenience. Millions of patients with life-altering immune inflammatory diseases don't have access to advanced systemic therapies. mostly injectable biologics. This is true if we look across countries with extremely diverse systems on how they prescribe, reimburse, and deliver these highly effective medicines. The issue is really more fundamental than the inefficiencies of the healthcare ecosystems around the world. Simply put, well-tolerated oral drugs that can be as effective as these difficult-to-access injectable biologics have the potential to transform the treatment landscape, and in doing so, impact lives of millions of patients. This is what we're set to do at Chimera. It's an exciting time for the company and I want to take a moment to briefly recap some of the key accomplishments of the first half of 2025. Starting with our first-in-class STAT6 program, we completed the first KT621 trial in healthy volunteers and reported positive results that exceeded even our highest expectations, surpassing our target product profile. Importantly, the data furthered the risks our path forward and highlights the possibility of KT621's dupilumab in a pill profile. As potential first-in-class treatment, we believe KT621 has the ability to be a broadly accessible oral option for many dermatological and respiratory diseases like AD and asthma. In addition, for Japanese regulatory purposes, we recently completed a second small healthy volunteer study in Japanese subjects with results that were consistent with the US study. You can expect that we'll present these findings at a future medical meeting. We also wanted to share a few updates regarding KT621 Phase 1b broadened study in moderate to severe AD patients. As noted in the release, the patient's data we plan to share will include data from two different dose groups. While we initially set out to explore a single dose, the speed at which the trial enrolled allow us to evaluate the translation from healthy volunteers into patients more broadly, which we believe gives us an even richer data set to inform our Phase 2b dose choices. which was an important goal of this study. The phase 1b was designed with a flexible protocol that contemplated this scenario, allowing us to make this choice without impacting timelines and as a result were well positioned to report results in the fourth quarter as planned. I'm also happy to share that we have selected and finalized the three doses that will be included in the two Phase IIb studies, as well as completed long-term toxicity studies. These were really the final important pieces of our planning to start these studies beginning later this year. Given we're moving into data collection and analysis mode soon, we're going to limit our comments around the study to what we have said previously until we're able to share the full results in the fourth quarter. But we can certainly say that we're pleased with the speed at which the trial has enrolled, very excited about the trajectory of the program, and we look forward to sharing the full data set when it's available. The additional piece of news to share is that we have selected a follow-on STAT6 degrader to KT621 with strong potency, selectivity, and safety profile, and have advanced it through all required IND-enabling studies. The degrader is IND-ready should we decide to further advance it into the clinic in the future. More broadly, we're building what we believe is the best in industry oral immunology pipeline. And beyond STAT6, we're also very excited about what's next. Early this year, we've unveiled our oral IRF5 program, which is moving through IND-enabling studies. The compelling preclinical data we've generated showcases that targeting IRF5 can lead to correcting immune dysregulation across multiple disease pathologies while generally sparing normal cells. And it remains our goal to progress our early discovery pipeline of novel immunology programs, unveiling one new program per year to expand access to oral systemic advanced therapies for broad patient populations in the space. We hope to share more about this next year. Additionally, we announced two important partnerships updates in June. First, we're very excited to announce our first oral molecular glue degrader program targeting CDK2 will be developed under our collaboration agreement with Gilead. We have a highly innovative research engine and the CDK2 program is a great example of this given the challenges of existing technologies to address this highly valued target. With our focus in immunology, this program was an ideal candidate for partnering. We in Gilead believe that a highly specific, safe, and effective CDK2 degrader has exciting potential to meaningfully improve treatment for patients living with breast cancer and other solid tumors that are inadequately treated today. Secondly, Sanofi announced that they officially opted in into the IRAC4 program and will assume full responsibility for development activities of KT485, our second generation oral IRAC4 degrader. which we expect to advance into phase one testing next year. Based on our preclinical results, KT485 has greater potency, broader distribution, and a generally improved overall profile than KT474, our first generation degrader. As a result, Sanofi made the decision not to advance 474 into further development as KT485 has the greatest potential benefit for patients. Both these collaborations have the potential to realize significant milestones for Chimera, which Bruce will cover later in the call, and we're happy to collaborate with two industry leaders on these novel programs. Finally, to support all we have ahead of us, we've extended our cash runway into the second half of 2028. We raised approximately $288 million in the full-on offering that we launched at the end of June and received the upfront payment from Gilead, increasing our cash position to $1 billion as of the end of July. Our well-capitalized balance sheet should allow us not only to take KT621 through the planned phase 2b studies in AD and asthma, but also to prepare for and initiate several phase 3 studies across multiple indications, while also progressing our earlier stage pipeline. As you've heard me say before, our strategy centers on combining the unique power of targeted protein degradation with carefully selected targets and pathways to create transformative new class of medicines. By focusing on immunology, we're not only addressing large patient populations, but also meeting a significant need to create effective safe oral therapies. We believe our approach has the potential to deliver, for the first time in our industry, biologics-like efficacy with ease and convenience of an oral pill. Again, I couldn't be more excited about the foundation we built and where we're going. I'm looking forward to the Q&A discussion, but let me pause here for Jared to discuss KT621 and our pipeline. Jared?
You're reading a preview of the KYMR Q2 2025 earnings call.
Free account.
