ACELYRIN, INC.

Good afternoon and welcome to the Acelerin Inc. Third Quarter 2024 Financial Results and Company Update Conference Call. This conference call has been recorded today, November 13th, 2024. I would now like to turn the call over to Tyler Marciniak, Vice President of Investor Relations and Corporate Affairs.

Tyler. Thanks Victor. Good afternoon everyone and thank you for joining us for Acelerin's Third Quarter 2024 Conference Call. With me today are Mina Kim, our Chief Executive Officer, Gil Labroucherie, our Chief Financial Officer and Chief Business Officer, and Shep Mpofu, our Chief Medical Officer. We issued a news release earlier detailing our third quarter financial results and important corporate updates. And before we begin today's call, I'd like to remind the audience that our remarks may contain forward-looking statements such as those related to the progress of our clinical trials, our future financial operating results and investments, and our ability to commercialize our product candidates. We urge you to review the risk factors section of our Form 10-Q for the quarter ended September 30, 2024, which was filed today with the SEC and which is also available on our website at acelerin.com, along with today's press release, which identifies certain factors that could cause our actual results, performance, and events to differ materially. Finally, our statements are based on information available to us today, November 13, 2024, and we undertake no obligation to update them as circumstances may change. I would like to now turn the call over to Mina.

Thanks, Tyler, and thanks, everyone, for joining us today. The first nine months of 2024 were transformative for its seller, and we're pleased with the progress we've made refocusing our pipeline and corporate strategy. In August, we announced the strategic reprioritization of our pipeline to focus our efforts on developing our lead product candidate, Monogutamab. for which we are in late-stage development as a treatment for thyroid eye disease, or TAD. Today, we will review our progress with monogutamab, as well as our anticipated upcoming milestones for both that program and our ongoing Phase 2b3 trials of isocibeb in noninfectious non-interior uveitis. First, I'd like to review our progress on monogutamab, our subcutaneously delivered humanized IgG1 monoclonal antibody targeting IGF1R. which is the only approved mechanism of action for the treatment of TAD. TAD is a vision-threatening autoimmune disease in which there is both inflammation as well as expansion of the tissues behind the eye, resulting in eye bulging known as proptosis and the subsequent inability to close the eyelids. Double vision or diplopia can also occur, as well as the potential for compression of the optic nerve, which can lead to blindness. TED is a progressive, chronic, inflammatory disease impacting more than 100,000 people in the U.S. alone. Earlier this year, we shared positive proof-of-concept data for a subcutaneously delivered Lonigutimab in TED patients, a first for the anti-IGF-1R MOA, demonstrating rapid improvements in proptosis and clinical activity scores within three weeks after the first dose. Our adaptive Phase II dose-finding trial now continues with multiple cohorts to establish both a minimum effective dose and optimal dose level and dose regimen for the Phase III registrational program. In selecting a dose, we're focused on maintaining a narrow therapeutic window that stays above a certain cement to drive efficacy of the kind that we have observed with Lonigutimab and which is in line with other anti-IGF-1R agents. and minimizes CMAX in an effort to mitigate the safety liabilities, especially hearing-related events that are evident with these same agents. We've now completed Cohorts 2 and 3 through 12 weeks of dosing and 12 weeks of follow-up. As a reminder, Cohort 2 included a loading dose of 50 mg followed by 25 mg weekly, and Cohort 3 tested 50 mg monthly with no loading dose. We previously announced that we were adding a fourth dosing cohort to our Phase II trial. That dosing cohort was expected to be 70 mg either Q3W or Q4W. We started this cohort at 70 mg Q4W, but have now shifted to 100 mg Q4W. We are using this cohort primarily to confirm PK we've used to model a loading dose. For example, cohort two used a loading dose, and that cohort demonstrated rapid achievement of steady-state semen, which we think could deliver faster patient benefit. Cohort 4 is also the first cohort where we are using MRI assessments to measure proctosis, in addition to Hertel measurements. We think this early experience with MRI assessments will help ensure smooth execution in the Phase III program. We're continuing to enroll cohort four, and this cohort may not be fully enrolled at the time that we announce the full results from the first three cohorts, as well as detailed phase three program design and timelines. Given this last cohort is really being used to confirm a loading dose, we have now largely completed our dosing exploration with the first three cohorts. And with FDA alignment on our dosing strategy, we're confident in our ability to start our phase three program in the first quarter of 2025. The TED patient data presented so far for Lonigutimab has been met with excitement from both the physician and patient communities, and during the third quarter were presented at multiple international medical congresses, including ASOPers, ESOPers, and AAL. We're encouraged by the response from the KOL and patient communities and believe this response demonstrates the need for even better treatment options for TED patients, which deliver the right risk-benefit profiles. one that delivers the efficacy seen with IGF-1R agents, but also with a potentially improved safety profile. This response also gives us confidence in our ability to enroll the phase three trials in a timely manner. We also recently completed a positive end of phase two meeting with the FDA. The goal of the meeting request was to achieve alignment on important elements of the phase three registrational program, including design, size, primary and secondary endpoints, and proposed phase 3 dose. We were pleased with the feedback received, too, and in alignment with our proposed differentiated approach to developing monogutamab in TED. We have also aligned with the agency on our approach to dosing patients beyond 24 weeks and out to 52 weeks in both active and inactive TED patients. We look forward to sharing further details at our upcoming investor event in early 2025. Finally, we recently established a scientific and patient advisory board that brings together world-class clinicians and patient advocates to provide important strategic input, clinical expertise, and patient perspectives as we prepare to advance monogutamab into Phase III clinical development. But before that milestone occurs, we also expect to announce top-line results for our Phase 2b3 trial of isokibab in uveitis in December. As with our earlier decision to discontinue internal development of isokibab in HS and PSA, we will make a decision about the future development plans for uveitis after we see the data. The development path for uveitis as a standalone indication and not one tied to HS and PSA presents a very different opportunity. Importantly, we are now thinking about uveitis as a potential orphan indication in a patient population with very high unmet need. This materially changes the potential opportunity for uveitis, especially if our data demonstrate improved patient outcomes compared to the currently approved treatments. We look forward to providing the uveitis top-line data, along with an update on the entire ISAC-HIVAD program in December. And with that, I'll turn it over to Shep to walk you through the uveitis program in more detail.