Astria Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the Q3 2021 Astrea Therapeutics Earnings Conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would like to hand the conference over to your speaker today, Andrea Matthews, Senior Vice President, Corporate Affairs. Please go ahead.

Thank you, Alyssa. Welcome to today's Astria Therapeutics conference call, where we will provide a corporate update and review our third quarter 2021 financial results. With me today are Jill Milne, Chief Executive Officer, Andy Nichols, Chief Scientific Officer, Andrew Comiati, Chief Commercial Officer, and Noah Clauser, Chief Financial Officer. We issued a press release this morning summarizing our corporate update and our Q3 2021 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 of presentation section in the investors part of our website. I would like to note that during today's call, as mentioned on slide two, we will make statements related to our business based on current and future expectations that may be considered forward-looking statements under applicable securities laws and regulations. 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 annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in the subsequent SEC filings, which are available on our website. Such statements represent our judgment as of today, and Astra undertakes no obligation to publicly update any forward-looking statements except as required by law. With that, let me pass the call over to Jill, who will provide our corporate update. Andy will share recent preclinical data on STAR-215. Andrew will provide an overview of the need for new HAE treatments, and Noah will follow with the financial update. Jill will then wrap things up.

Jill? Thank you, Andrea. Good morning, everyone, and thank you for joining us on today's call. Turning to slide three, I'm excited to introduce Astrea Therapeutics. Our company name embodies our commitment to put patients first in all that we do. Astrea comes from the Greek word for star, reflecting that patients are the stars that guide us and give us our purpose. Our mission is to bring hope with life-changing therapies to patients and families that are affected by rare and niched allergic and immunological diseases. On slide four, you will see an overview of the Astrea investment opportunity. Our lead program, STAR-215, is a monoclonal antibody inhibitor of plasmacalocrine that we are developing to treat patients living with hereditary angioedema, or HAE. We see STAR-215 as an exciting opportunity to develop a product with the potential to be the most patient-friendly preventative therapy for HAE. For important upcoming milestones, we are on track for an IND filing in mid-2022 and expect initial clinical trial results by year-end 2022. This first clinical trial has the potential to demonstrate clinical proof of concept for the differentiated profile of STAR-215. We are also evaluating opportunities to expand our pipeline, with the broader goal of addressing the unmet needs of patients with rare and niche allergic and immunological diseases. We have an experienced team and board of directors backed by leading life sciences investors. At the close of Q3, we were in a strong position with cash equivalents of $131.8 million, which is expected to fund the current operating plan through 2023. We have 18.3 million common shares outstanding on an as basis and we trade under the symbol ATXS on NASDAQ. Slide five provides an overview of today's Astria corporate updates and Star 215 program highlights. We are making very good progress with the program and are on track for initial phase one clinical results expected by year end 2022. Our chief scientific officer, Andy Nichols, presented new preclinical data last week at the American College of Allergy, Asthma, and Immunology annual scientific meeting regarding STAR-215's binding affinity, potency, binding site, and use of YTE modifications to enable a long duration of action. And he will review these results shortly. Next, Andrew Kamyadi, Our chief commercial officer will highlight the potential market opportunity for STAR-215 and our findings on the burdens of disease and treatment in HAE, which we presented at the National Organization for Rare Disorders Summit last month, supporting the substantial need to decrease patient disease and treatment burden. Subsequently, Noah Clouser, our chief financial officer, will give an update on our financials. For those that may be less familiar with HAE, slide six provides an introduction. HAE is a rare, debilitating, and life-changing disease. It is characterized by severe, unpredictable, painful, and sometimes life-threatening edema. The edema can occur in the skin, the abdomen, and airway. In most patients, it's caused by a deficiency in a protein called C1 inhibitor. which is an important component of the body's contact pathway. There are approximately 8,000 people affected in the United States. Patients have a significant burden of disease and live with the fear of an attack. HAE is treated with preventative therapies to reduce the frequency of attacks and on-demand therapies when an attack occurs. Unmet need exists for effective preventative treatments with lower treatment burden. The global market for HAE treatments is large and estimated to grow from $2 billion in 2020 to more than $4.5 billion by 2026. Slide 7 illustrates the differences between a healthy blood vessel and a blood vessel impacted by HAE and shows how STAR-215 aims to prevent attacks in HAE by inhibiting plasma calocrine. In a healthy individual, external triggers such as pressure from holding a tool, tissue stress, or damage results in the production of plasma calocrine. This system in healthy individuals is kept in check by a protein called C1 inhibitor, which blocks the function of plasma calocrine. In most patients with HAE, C1 inhibitor is either absent or defective. In an HAE patient without active C1 inhibitor, there is no break for plasma calocrine, and what you get is a runaway contact pathway, whereby plasma calocrine continues to produce bradykinin, which leads to pathological swelling. With STAR215, our goal in HAE patients is for plasma calocrine to be inhibited, even in the absence of C1 inhibitor. thereby reducing bradykinin production and preventing edema and pain. Over the years, the therapeutic landscape for HAE has evolved immensely. On slide 8, you will see that recently the landscape changed in a positive direction with the entrance of plasma calocrine inhibitors. However, there remains unmet need as more than 50% of HAE patients on approved plasma calocrine inhibitors still experience attacks We've heard from both patients and physicians that there is high interest in an effective preventative treatment option within frequent dosing. We are aiming to deliver that profile with STAR-215. On slide nine, you will see an overview of our lead program. STAR-215 is a monoclonal antibody inhibitor of plasmacalocrine that we are developing to treat patients living with HAE. We see STAR-215 as an exciting opportunity to develop what could be the most patient-friendly preventative treatment option for HAE based on our data generated to date and the existing HAE treatment landscape. We think of efficacy and dosing frequency as the key aspects that determine an HAE patient's experience with a treatment. And STAR-215 was designed with a clear vision aimed at addressing the needs of HAE patients. What's exciting is its potential to provide long-acting, effective protection from the painful, recurrent, and sometimes life-threatening attacks that are caused by HAE. I'll now hand it over to Andy to give a more in-depth look at STAR-215 and present our recent findings. Andy?