Astria Therapeutics, Inc.

Good morning and welcome to the Astria therapeutics quarter 3, 2023 corporate update at this time. All attendees are in a listen only mode. A question and answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the Q and a text box at the bottom of the webcast player, or by emailing your questions to questions at lifestyle advisors dot com. As a reminder, this call is being recorded and a repo will be made available on the ASHRAE website following the conclusion of the event. I'd now like to turn the call over to Liz Higgins, Director of Communications and Investor Relations at ASHRAE Therapeutics. Please go ahead, Liz.

Thank you, Tara. Welcome to today's ASHRAE Therapeutics Q3 2023 conference call. With me today are Jill Milne, Chief Executive Officer, Christopher Morabito, Chief Medical Officer, Andrew Pomiani, Chief Commercial Officer, Andrew Matthews, Chief Business Officer and Noah Klauser, Chief Financial Officer. We issued a press release this morning summarizing our corporate update and third quarter financial results, which we will reference on today's call and is available on our website. We are also using slides during today's call that are available within the events and presentation section in the investors part of our website. I would like to note during today's event, as mentioned on slide two, we will be making forward-looking statements related to our business based on current and future expectations. Actual results may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties, including those discussed in our most recent Form 10-K and our subsequent SEC violence. Such statements may represent our judgment as of today, and we undertake no obligation to publicly update any forward-looking statements except as required by law. I will now pass the call over to Jill Mill, Chief Executive Officer. Jill.

Good morning, and thank you for joining our earnings call. We've had an exciting few months at Astraea and are in a strong position to close out the year. Just a few days ago at ACAAI annual meeting, we shared positive phase 1A data for STAR-0215, our lead program, that supports our vision for STAR-215 to be the first choice preventative treatment for hereditary angioedema, or HAE. The data confirmed the potential for STAR-215 to prevent HAE attacks with dosing two or four times per year. We aim to provide patients the option to choose a dosing regimen that works best for their lives, which we will review more on the coming slides. Last month, we also announced the expansion of our pipeline with STAR 310. We plan to present a preclinical profile for this program next year with a planned IND submission by the end of 2024 and Phase 1A initiation expected in Q1 2025. Our focus for Astrea is to develop first choice products that improve the health outcomes of patients with allergic and immunological diseases. First choice to us means patients and treating physicians would choose our products because of their strong competitive efficacy, low treatment burden, and favorable safety and tolerability profile. Our initial pipeline is focused on well-established mechanisms, mechanisms that are clinically validated where we believe we can advance ultimately best-in-class programs. Very much in line with this strategy is our STAR-215 program. We think that STAR-215 is very well positioned to be the first choice preventative treatment to help stabilize the lives of patients living with HAE, a rare, life-changing, and at times, life-threatening disease. STAR-310 is an anti-Ox40 antibody also aligned with this strategy that we plan to develop as a potential best-in-class therapeutic for atopic dermatitis and potentially other indications. The next slide is an overview of our expected milestones for the integrated pipeline with both programs. We just shared additional Phase Ia results at ACAAI this weekend, which further supports STAR215's best-in-class PK profile and the options for Q3 and Q6 month dosing as a potential HAE preventative therapy with robust attack suppression and low treatment burden. Our AlphaStar trial in HAE patients is progressing very well. We are now planning to share meaningful initial proof of concept results in Q1 of 2024. Assuming positive results from this trial, we plan to initiate a pivotal phase three trial In Q1 of 2025 and are looking at ways to accelerate this timeline we're actively working on the design of our phase three trial. With star 310 we expect to submit 90 by year end 2024 and to share the preclinical profile in 2024 at a scientific conference. We anticipate early proof of concept results from a phase one a trial in Q3 of 2025. which we believe will be an important milestone for the program. Next, assuming positive results in the phase 1A trial, we anticipate initiating a phase 1B clinical trial in atopic dermatitis patients in the second half of 2025. I will now turn it over to Chris Morabito, our chief medical officer, who will review the new data we have seen for STAR215. Chris.