Good morning, and welcome to the Astria Therapeutics Webinar. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentations. If you would like to submit a question, you may do so at any time throughout the webinar by using the Q&A function at the bottom of the webcast player. To our analysts, if you would like to ask a question via Zoom, please raise your hand to indicate you would like to join the queue. As a reminder, this call is being recorded, and a replay will be made available on the Astria Therapeutics website following the conclusion of the event. I would now like to turn the call over to your host, Elizabeth Higgins, with Astria Therapeutics. Please go ahead. Thank you, Sarah. Welcome to today's Astria Therapeutics STAR-0310 Conference Call. With me today are Jill Milne, Chief Executive Officer; Christopher Morabito, Chief Medical Officer; Andrea Matthews, Chief Business Officer; Andrew Komjathy, Chief Commercial Officer, and available for questions, Noah Clauser, Chief Financial Officer. We issued a press release yesterday announcing that we have entered into an exclusive worldwide license agreement with Ichnos Sciences for an OX40 portfolio to be developed for the treatment of atopic dermatitis. The press release 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 that during today's event, as mentioned on Slide 2, 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 filings. Such statements 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, Chief Executive Officer. Jill? Thank you for joining our update call today. We're excited to tell you about our licensing deal with Ichnos Sciences, which we believe transforms our pipeline at Astria, a pipeline which now includes both STAR-0215 for the potential treatment of HAE and STAR-0310 for the potential treatment of atopic dermatitis. Let's dive in to understand the journey of how we got to where we are today and why we're so excited about the future. Astria was formally launched two years ago when we acquired a private biotechnology company and their stealth program in HAE, which I think will transform the treatment landscape for people living with this rare disease. As you well know, finding great assets is challenging, but I think we've done it again. In deep diligence with Ichnos Sciences on its Telazorlimab program, we uncovered a backup program they had in the OX40 space. Ichnos was an innovator in the OX40 space, being the first to get to the clinic with their lead Telazorlimab anti-OX40 antibody. They showed the OX40 pathway works in atopic dermatitis in two Phase 2 clinical trials. But this is an example of the challenges of being a first mover. Telazorlimab demonstrated favorable clinical results, but its efficacy was not competitive in atopic dermatitis, likely due to its low affinity for the OX40 receptor. What we are excited about and why we are here with you today is their preclinical backup program, which we are calling STAR-0310, that has been shown in preclinical studies to have greater than tenfold increase in binding affinity for the OX40 receptor, which importantly, has translated into a greater than tenfold higher potency in primary T-cell assays. We believe this profile will translate to a potential best-in-class OX40 therapeutic. Chris will tell you more about the differentiated profile and how it stacks up in this space in a few slides. Our focus for Astria 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 will continue to be 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-0215 program. We think that STAR-0215 is very well-positioned to be the first-choice preventative treatment to help normalize the lives of patients living with HAE, a rare, life-changing, and at times, life-threatening disease. STAR-0310, the reason we're here today, is an anti-OX40 antibody that we have in-license from Ichnos Sciences and plan to develop as a potential best-in-class therapeutic for atopic dermatitis and potentially other indications. Let's move on to Slide 5, and I can introduce our pipeline. We believe that our focus and approach can be applied to both STAR-0215 and now STAR-0310, in order to improve patient experience and become potential first-choice treatments. STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein, a clinically and commercially validated target in HAE. Our antibody was designed with YTE half-life extension technology, which translated to a half-life that we believe will support every three-month and every six-month dosing intervals. We see this as a potentially significant benefit for patients. Monoclonal antibodies are a trusted modality in HAE, favored for their safety and tolerability, and they have an efficient regulatory path to BLA. In our healthy subject data with STAR-0215, we saw a potential best-in-class PK profile with a half-life of up to 117 days and sustained inhibition of plasma kallikrein during that time. We think there's a strong commercial opportunity for a first-choice preventative in this space. The HAE market is large and growing, estimated to be over $4 billion by 2028. The STAR-0215 program is moving forward with great momentum. We have hit the milestones that give us conviction that we have an important program here, and we believe provides a strong foundation for us to build the pipeline. That brings us to today. We have in-licensed an OX40 portfolio. This portfolio fits with our corporate strategy. It has the potential to make a real difference for patients. It is based on a clinically validated mechanism, and we believe it can be potentially best in class among the OX40 programs. OX40 has become an exciting space in immunology. It is a key immune regulator that regulates T cell functions. Recent acquisitions of OX40 programs by Amgen and Sanofi were each over $1 billion. We believe that STAR-0310 has the potential to be favorably differentiated from these programs. Targeting this pathway has the potential to treat a range of immune-mediated diseases and inflammatory disorders. We have also applied YTE half-life extension technology to STAR-0310. STAR-0310 has a potential best-in-class profile with high affinity, potential for favorable safety and tolerability profile with low T cell depletion from ADCC, or possibly on target cellular toxicity, and importantly, we believe less frequent dosing. There is commercial opportunity for STAR-0310 to be potential first-choice OX40 treatment for moderate to severe atopic dermatitis, a market that's estimated to reach $26 billion by 2030 in the U.S. alone. The next slide is an overview of our expected milestones for the integrated pipeline with both programs. With STAR-0215, we are anticipating sharing additional Phase 1a healthy subject results at ACAAI in November. These data are expected to further support the profile of Q3 and Q6-month dosing with STAR-0215. Our ALPHA-STAR trial in HAE patients is also on track and progressing well. We are currently enrolling patients in the third and final cohort, and we are on track to share results mid-next year. Assuming positive results from this trial, we plan to initiate a single pivotal Phase 3 in Q1 2025. We are actively working on the design of our Phase 3 trial. As we bring STAR-0310 into our pipeline, we expect to submit the IND by year-end 2024 and to share the preclinical profile of STAR-0310 in 2024 at a scientific conference. We anticipate early proof Phase 1a trial in q3 2025, which will be an important milestone for the program. Our goal of this trial will be to establish the target profile we have for STAR-0310 in terms of long half-life, initial PD, as well as safety and tolerability. Half-life extension technology has a great track record, and we expect the data from this trial will be able to demonstrate whether it works with STAR-0310 in healthy patients. Next, phase 1a trial, we anticipate initiating a Phase 1b clinical trial in atopic dermatitis patients in the second half of 2025 and reporting results in Q2 of 2026, with a goal to demonstrate proof of concept in patients. We think STAR-0310 is a great addition to our pipeline, and together with STAR-0215, fits well with our corporate strategy and makes us a stronger and more attractive company with a regular cadence of anticipated clinical milestones over the coming years. I will now turn it over to Andrea Matthews, our Chief Business Officer, who will introduce the potential opportunity for STAR-0310. Andrea? Thanks, Jill. Here's an introduction to atopic dermatitis, a chronic disease where current treatment options are not sufficient to address the needs of patients. Atopic dermatitis is an immune disorder associated with loss of skin barrier function and itching, and it's caused by diverse T cell-driven mechanisms that include Th2, Th1, and Th17/Th22 pathology. Approximately 16 million adults in the U.S. are affected, and half of these are reported to have moderate or severe disease. Standard of care treatments are steroids and topical medications, which can treat symptoms but do not address the underlying disease. Our goals with STAR-0310 are to reduce disease activity, relapse rate, and treatment burden for moderate and severe patients to help normalize their lives. There's a lot of excitement about the atopic dermatitis market. Here's an overview of the U.S. moderate-to-severe treatment market, which is large and anticipated to expand rapidly to $26 billion by 2030. This expansion is expected to be due to an increase in drug treatment rates, especially as new therapies become available. We also anticipate that there will be more patients treated with biologics as dermatologists grow increasingly more familiar and comfortable with them. Overall, this market growth in the U.S. creates a lot of opportunity for a product with a profile like we anticipate for STAR-0310. Here we take a closer look at the approved and under FDA review biologics for atopic dermatitis. Currently, the market is dominated by dupilumab, also known as Dupixent, which was launched in 2017 in the U.S. and has since established a new standard of care for patients that are not adequately controlled with topical prescription treatments. Dupilumab sales in atopic dermatitis for 2022 in the U.S. are estimated at more than $4.5 billion. Dupilumab is an IL-4 receptor alpha monoclonal antibody, and that inhibits both IL-4 and IL-13, and it's co-marketed by Sanofi and Regeneron. There are also two IL-13 biologics listed here, tralokinumab, which is also approved, and lebrikizumab, which is under FDA review. All three of these therapies target Th2. They're typically administered subcutaneously every two to four weeks, and based on their efficacy profiles, may not be able to fully address the needs of atopic dermatitis patients. For example, up to 40% of atopic dermatitis patients that try dupilumab are non-responders or have an inadequate response. We believe that by targeting OX40, STAR-0310 can address a broader set of T cells. This could provide the potential for better efficacy and a broader addressable patient population, including those with an inadequate response to dupilumab. The use of half-life extension technology also sets STAR-0310 apart due to its potential to provide durable efficacy with less frequent dosing every two-three months. There are two OX40 pathway inhibitors in the clinic, and we'll touch on those on the next slide. As a potential long-acting OX40 inhibitor with activity both in and beyond type two inflammatory pathways, STAR-0310 is well-positioned to potentially address the needs for a safe, effective, and infrequently administered atopic dermatitis treatment, particularly for those with suboptimal response to dupilumab, as well as more broadly. The significant potential of treatments that target the OX40 pathway has been appreciated in two recent transactions shown here. In 2021, Amgen entered into a $1.2 billion deal with Kyowa Kirin for the OX40 antagonist rocatinlimab for rights outside of Japan, and this included a $400 million upfront payment. Rocatinlimab is currently in Phase 3 trials for atopic dermatitis. There's a second clinical stage OX40 pathway program, amlitelimab, which targets the ligand and is currently completing a Phase 2b trial in atopic dermatitis. This program was acquired in 2021 by Sanofi in a $1.4 billion acquisition of Kymab. Sanofi also sees the potential of the OX40 pathway beyond atopic dermatitis, and they are currently recruiting an asthma trial. We believe that STAR-0310 could potentially have the best profile for an OX40 pathway treatment and are excited to begin work on the program and potentially bring this treatment forward to patients. I'll now turn it over to Chris Morabito, our Chief Medical Officer, who will review STAR-0310's potential in more detail. Chris? Thanks, Andrea. As I go through the rationale for STAR-0310 being the potential best-in-class and a potential first-choice OX40 pathway inhibitor, I'll make three major points. First, inhibiting OX40 pathway has advantages in atopic dermatitis, and STAR-0310 has potential for competitive efficacy. Second, STAR-0310 has potentially the best-in-class dosing and administration profile. And third, because of its approach to OX40 pathway inhibition, STAR-0310 may have a favorably differentiated safety and tolerability profile. OX40 is a T cell regulatory protein that modulates T cell functions. OX40 has important roles in atopic dermatitis because it impacts inflammatory pathways that cause disease, including effector T cell cytokine release, such as IL-4 and IL-13. But OX40 does much more than regulate cells that produce IL-4 and IL-13, which are called Th2 cells. By inhibiting the OX40 pathway, effector Th1 and Th17/Th22 can be silenced, as well as memory T cells, while sparing regulatory T cells. As atopic dermatitis is driven by a broad range of T cell mechanisms, not limited to Th2, which is what anti-cytokine biologics like dupilumab target, inhibiting OX40 in AD could potentially lead to more clinical responses and being effective in a broad population of atopic dermatitis patients. So far, proof of concept that OX40 pathway inhibition may be a safe and effective approach in AD has been shown by Telazorlimab from Ichnos, rocatinlimab from Amgen, and amlitelimab from Sanofi. We have in-licensed the OX40 antibody portfolio from Ichnos, which started with their first-generation OX40 program called Telazorlimab. Telazorlimab demonstrated a proof of concept in a large Phase 2b trial, showing efficacy across a broad range of endpoints and a favorable safety profile. As a first-generation OX40 inhibitor, Telazorlimab had low affinity for OX40, and we believe the efficacy results, while favorable, are limited by its low affinity. We believe we can do better with STAR-0310, which is an affinity-matured version of Telazorlimab, with a YTE modification to prolong its half-life. The 0310 candidate, minus the YTE, is engineered with 99% sequence identity to improve potency without changing the potential for a favorable safety profile. We have engineered 0310 to include the YTE modification of the Fc region in order to increase its half-life. Our initial experiments have shown that STAR-0310 has properties that we think will permit us to administer STAR-0310 once every two to three months or with less frequent dosing compared to other therapies in clinical development. So now we've established that inhibiting OX40 may be an effective approach to treat atopic dermatitis. Our intention is to develop STAR-0310 as a potential first-choice OX40 pathway inhibitor. Amlitelimab, currently in Phase 2b, is a monoclonal antibody against the OX40 ligand called OX40L. OX40L is present on an array of cells, including epithelial, endothelial, smooth muscle, mast, and B cells. In contrast, OX40 is present only on activated T cells or T cells involved in active inflammation. Rocatinlimab is another OX40 antagonist, and it is in Phase 3. Rocatinlimab is an afucosylated monoclonal antibody, which means that it is designed to be cytotoxic in order to silence effector T cells. We'll see later how Amlitelimab's non-T cell OX40 ligand binding and Rocatinlimab's afucosylation impact safety and tolerability findings. We anticipate both Amlitelimab and Rocatinlimab will be administered once every four weeks or once monthly, while STAR-0310, with its YTE half-life extension, has the potential to be administered once every two to three months sub-Q. In vitro and preclinical data support potential for competitive efficacy of STAR-0310. In this graph, we show that the STAR-0310 candidate, which is STAR-0310 minus the YTE modification, matches best-in-class potency based on preclinical and in vitro data generated to date. STAR-0310 candidate inhibited donor T cell proliferation in vitro, and the results are similar to Rocatinlimab, with at least tenfold better than Telazorlimab. On the right, we are showing that Telazorlimab, the first generation of the STAR-0310 candidate, showed durable inhibition of Th2, Th1, and Th17/Th22 PD markers in atopic dermatitis patients in a Phase 2 trial. These data show multiple fold impacts on effector T cell activities that lasted for at least six weeks after the last dose, which was given on day 29 in this trial. Histopathologic results from the same trial are shown at the bottom right. Here, Telazorlimab-treated participants showed resolving AD pathology that also persisted well beyond the last dose administered. The improved affinity of the STAR-0310 candidate is expected to potentiate the impact on AD compared to Telazorlimab, and adding YTE is expected to to extend the durable inhibition of T cell pathogenic AD responses, which goes beyond targeting Th2. Now, let's move into data that demonstrate the potential for favorable safety with STAR-0310. Beyond the YTE modification, another major difference between STAR-0310 and rocatinlimab is that the STAR-0310 candidate has lower antibody-dependent cellular cytotoxicity, or ADCC, particularly sparing regulatory T cells. ADCC is described on the right, in this slide. It is a process that involves immune-mediated killing of cells expressing the target antigen. It is associated with cytokine release reactions such as fever, called pyrexia, chills, and a flu-like illness. Rocatinlimab has enhanced ADCC, and therefore the potential to deplete a range of activated T cells, leading to adverse events and limiting the therapeutic window. As we'll see later, rocatinlimab is associated with pyrexia, chills, and infection-related side effects. Shown in these graphs, the STAR-0310 candidate has low ADCC when a population of donor T cells are tested. Additionally, STAR-0310 further protects regulatory T cells compared to rocatinlimab. This finding may translate to positively differentiated impacts on immunomodulation in disease. Finally, the YTE modification may further reduce ADCC, allowing for the potential for a favorable safety profile. These data, plus the potency data on the previous slide, suggest that STAR-0310 may impact efficacy while potentially sparing T cells. As I said earlier, the OX40 pathway is clinically validated in atopic dermatitis. On this slide, we look at amlitelimab and rocatinlimab efficacy results from Phase 2 trials. Placebo-subtracted efficacy endpoints are shown here for amlitelimab and rocatinlimab. While clinical trial conditions are different, it appears that rocatinlimab, assessed in Phase 2b, has more positive impacts on AD compared to amlitelimab, assessed in Phase 2a, when we look at endpoints that were measured in common, such as change from baseline EASI, 46% versus 31%, EASI-75, 43% versus 34%, and EASI-90, 33% versus 20%. Sanofi just recently announced positive Phase 2b results for amlitelimab, which used change from baseline EASI as a primary endpoint. So far, we know that the IIb results seem in line with the Phase 2a results, and we look forward to more data from this trial as they become available. A core element of the attractiveness of this mechanism in atopic dermatitis is that it regulates Th1, Th2, and Th17/Th22 effector T cell pathways. The added impacts create the potential for broader and more clinically significant efficacy compared to Th2-specific antibodies, such as dupilumab. In clinical trials, inhibiting OX40 chronically appears to have a more significant impact on AD responses than inhibiting downstream cytokines. After 36 weeks of treatment, rocatinlimab achieved higher IgE responder rates than those achieved by 52 weeks with dupilumab in a separate clinical trial. Our goal with STAR-0310 is to have at least rocatinlimab-like efficacy with less frequent administration.... We think there is potential for high responder rates with STAR-0310 due to more continuous target engagement, and also, as mentioned previously, STAR-0310 is expected to be T-cell preserving, which gives the potential for a wider therapeutic window. Our goal is to ensure that STAR-0310 has a favorably differentiated safety profile when compared to other OX40s in development. When we look at rocatinlimab, T-cell destruction leads to cytokine release, which can cause pyrexia and chills, increased risk of infection, and aphthous ulcers. Additionally, amlitelimab, an OX40 ligand inhibitor, is expressed in a wider array of cell types, and it may increase the risk for upper respiratory infection, esophagitis, respiratory, and vascular adverse events. Because STAR-0310 has the potential to preserve T-cells, it also has the potential to be more favorably, have a more favorable safety profile than rocatinlimab. As we turn to the future, let's review our clinical plans for STAR-0310. We are planning a Phase 1a clinical trial on healthy adult subjects, which we expect to initiate in early 2025. Our goal for this would be to establish early proof of concept for STAR-0310 as a long-acting inhibitor of OX40. The trial is planned to have three single ascending doses and will assess safety and durability of PK and PD. We expect initial proof of concept results in this early trial in Q3 of 2025. We are also planning a proof of concept trial with multiple doses in atopic dermatitis patients to assess clinical impact for EASI of 310. We are expecting two subcutaneous dosing regimens and endpoints that will assess safety, PK, PD, and clinical endpoints in patients. The goal is to demonstrate initial efficacy in atopic dermatitis, as well as differentiation on ADCC-related safety and tolerability compared to rocatinlimab and on-target OX40 ligand binding AEs with amlitelimab. We expect initial proof of concept results in Q2 of 2026. Based on what we have seen so far and our confidence in STAR-0310's profile, we believe that STAR-0310 could be a best-in-class and first-choice treatment for atopic dermatitis. Starting first with common factors for OX40 pathway monoclonal antibodies, targeting this pathway has the ability to have disease-modifying impacts. The OX40 pathway has potential effectiveness across AD, driven by multiple effector T cell types, not just Th2. The potential benefit here is robust and sustained responses across a broad range of AD. We also believe that due to the YTE modification, long-acting STAR-0310 has the potential to be administered four-six times per year, compared to the anticipated 12 times per year from amlitelimab and rocatinlimab. We believe the safety profile of STAR-0310 will differentiate from both rocatinlimab and amlitelimab, as STAR-0310 has the potential for reduced T cell depletion due to ADCC and limited potential for AEs due to off-target binding. Beyond atopic dermatitis, we believe that targeting OX40 has strong potential in a broad range of additional indications, where there remains need to normalize patients' lives with new therapies that are long-acting, effective, and safe. We are also planning on exploring the potential for STAR-0310 in asthma, chronic urticaria, and/or other autoimmune indications, and we look forward to sharing preclinical results in additional indications in the second half of 2024. We would now like to turn to our HAE program, and our Chief Business Officer, Andrew Komjathy, will provide an introduction to STAR-0215. Thanks, Chris. So our STAR-0215 program is a potential first-choice treatment for the prevention of attacks in hereditary angioedema. HAE is a rare life-threatening and life-changing disease characterized by severe, unpredictable, painful, and sometimes life-threatening edema in the skin, abdomen, and airway. For 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. Patients with HAE live in fear of having an attack that could be immensely painful or leave them disfigured for several days, or worse, prove to be fatal. There are approximately 8,000 people affected in the U.S. and approximately 15,000 in the E.U. The standard of care for HAE has evolved from only on-demand treatments in response to attacks to include both on-demand and preventative treatments. Our market research shows that there's a strong interest in a product with the potential profile of STAR-0215 in the HAE market from both a patient and physician perspective, and let's turn to more details on this. The HAE treatment market is substantial, and it's growing. The market was greater than $2 billion in 2022 and is expected to grow to over $4 billion by 2028. This predicted growth is based on patients being diagnosed earlier, more patients taking preventative treatments, as well as the expansion of available therapies in more geographic regions. We conducted market research with essential stakeholders, both healthcare providers and HAE patients.... In the middle of the slide, we show results from a survey we conducted with U.S. physicians, where we shared a blinded product profile of a monoclonal antibody inhibitor of plasma kallikrein, with an efficacy, with efficacy comparable to market leader TAKHZYRO, but with a dosing regimen of every three months. The physicians rated on a seven-point scale how likely they would be to prescribe a product with this profile, and the average rating was a 6.5, indicating a high motivation to prescribe. On the far right-hand side, we see the results of a survey of 101 patients where we shared the same blinded product profile. All the patients surveyed were willing to try a product in this profile, with close to 70% being very willing to either start or switch to a product with this profile. I'll now hand it back to Chris, who will review the clinical results that we've seen up- to- date, to date. Chris? Thanks, Andrew. As we've discussed, we are developing therapies that have the potential to be first-choice treatments with validated mechanisms and differentiated profiles. STAR-0215 inhibits plasma kallikrein, which is a validated mechanism in HAE, leveraging the same mechanism as market leader TAKHZYRO. Our goal with STAR-0215 is to reduce disease and treatment burden to normalize patients' lives, as currently available therapies have high burden of administration or limited efficacy. STAR-0215's profile is also differentiated as the YTE extended half-life supports self-administered dosing once every three or six months, and it has also been formulated without citric acid to reduce painful administration for patients. We have seen encouraging clinical results to date with a potential best-in-class PK profile, long plasma half-life, and sustained inhibition of plasma kallikrein, which I will review more on the next slide. We shared initial results from our Phase 1a healthy subject clinical trial. These results show that STAR-0215 was well tolerated with a favorable safety profile. We also saw rapid and sustained achievement of STAR-0215 concentrations consistent with clinical benefit after single subcutaneous doses. The estimated half-life of STAR-0215 is up to 117 days, or five times longer than lanadelumab. We also saw that STAR-0215 achieved sustained inhibition of plasma kallikrein. Later this year, we are planning to share additional results from this trial that are expected to provide more information on our plans for dosing STAR-0215 every three or six months. Here we look at what those three and six months dose regimens could look like in more detail. This is a pharmacokinetic model, which is based on initial human pharmacokinetic Phase 1a trial in healthy subjects. The left graph shows a model that simulates a potential Q 3-month dosing regimen, beginning with a 600-milligram loading dose, followed by a 300-milligram maintenance dose every three months thereafter. As you can see, the model predicts that STAR-0215 could maintain concentrations above the target threshold associated with clinical benefit, and we believe will prevent HAE attacks. This approach to drug administration is being assessed in Cohort 2 of the ALPHA-STAR trial. The right-hand graph shows a simulated Q 6-month dosing regimen, which begins with a 600-milligram loading dose, then 600 mg every six months, beginning at day 28. Once again, these results show that STAR-0215 can sustain exposure above the target threshold of 12 micrograms per mL with both Q3 and Q6-month dosing regimens. This approach to drug administration is being assessed in Cohort 3 of the ALPHA-STAR trial. ALPHA-STAR is a dose-ranging proof-of-concept trial in HAE patients, and it remains on track, and it is currently enrolling and dosing patients. The cohorts are enrolling sequentially, and we are currently enrolling Cohort 3. We anticipate initial proof-of-concept results on schedule in mid-2024. As shown here, we have three cohorts in ALPHA-STAR, and the target enrollment is 16 patients. All cohorts begin with an 8-week run-in period to assess baseline attack rate. Cohort 1 is a single-dose cohort administering 450 mg once and following for clinical effects out through 6 months. Cohort 2, as we reviewed on the last slide, is a multiple-dose cohort simulating a potential Q3-month regimen, starting with a 600-milligram loading dose and followed by a 300-milligram dose three months later. Cohort 3 simulates a potential six-month dosing regimen and begins with a 600-milligram dose, followed by a second 600-milligram dose one month later. For each cohort, efficacy will be assessed at three-month and six-month intervals after the last STAR-0215 dose was administered. We recently initiated our long-term open-label trial called ALPHA-SOLAR in the fourth quarter of this year for patients that have completed the ALPHA-STAR trial. Pending positive results from ALPHA-STAR, we expect to quickly initiate a single pivotal Phase 3 trial for STAR-0215 in the first quarter of 2025. I will now hand it back to Jill. Thank you, Chris. Here you can see the cadence of anticipated milestones, as well as our future development goals for our combined pipeline, with at least one clinical milestone each year in the coming years. For STAR-0215 w e expect to report HAE patient proof of concept results from our ALPHA-STAR trial mid-year 2024. If results are positive from this trial, we plan to initiate a single pivotal Phase 3 trial in Q1 of 2025. We are actively working on the design of our Phase 3 trial. For STAR-0310, we plan to submit an IND by year-end 2024. In 2025, we expect to have early proof of concept results for STAR-0310, which we think will teach us a great deal about the PK and PD of this program, as well as give us an early read on safety and tolerability. We expect this to be an important readout. In 2026, we anticipate proof of concept results in atopic dermatitis patients for STAR-0310 in the second quarter. Our ultimate goal is to bring first choice therapies to patients with our programs, and we are looking forward to executing on that goal in the years to come. We, as a company, want to become a leader in the allergy and immunology space, a company that makes a meaningful difference for patients. STAR-0215 and STAR-0310 fit our corporate strategy of leveraging established mechanisms and advancing programs that we believe can make a meaningful difference for patients. Importantly, the combined pipeline makes us a stronger company and gives us a regular cadence of clinical milestones. With that, I will ask the operator to open the question, the call for your questions. Thank you. Thank you. At this time, we will begin conducting our Q&A session. As a reminder to the audience, you may submit your questions through the Q&A portal at the bottom of the webcast player. And to our analysts, you must raise your hand to indicate you would like to join the queue. So please hold for a brief moment while we pull for questions. Okay, great. The first question comes from Eun Yang at Jefferies. Thank you. Can you hear me okay? We can. Thank you. So, question is at 3:10, it's a very interesting product for a wide range of indications, but the indications that you are looking at are pretty large. So I want to ask you about your medium to long-term plan with the product, how you are thinking about developing the product to market. Is there something that you would be interested in partnering at some point? And the second question is, given that there are two same mechanism of action drugs in late stage of development, how important it is for you to see improved or better efficacy aside from less frequent dosing? And the last question is, it's just more of a housekeeping question. $15 million upfront payment, is that gonna be booked at once in R&D in the fourth quarter? A clinical development milestone seems to be minimal, about $20 million, but can you kind of comment on your R&D spending for this year as well as the next year? Thank you. Thanks for the question, Eun. I'll have Andrea address your first question. Sure. In terms of a future commercialization strategy for STAR-0310, right now it's too early to tell. We intend to commercialize STAR-0215 ourselves, certainly at least in the U.S., and we could possibly leverage some of those resources for commercializing STAR-0310, either on our own or with a partner, and we'll refine our plans as we learn more about the market. I believe your second question was around differentiation from the two programs that are more advanced than STAR-0310, the Sanofi and the Amgen, and the areas where we think it's important to differentiate. Maybe Chris can speak to the potential for differentiation across the three axes we've been talking about. Yeah, great. It's an important question, and as Jill points out, there are three axes that we think are important here. Number one is establishing competitive efficacy. Number two is normalizing the dosing and administration burden on patients by decreasing the frequency of giving this drug. And three is favorably differentiating on safety. So yes, efficacy absolutely is important, and we need to be in the ballpark to be in the game. And we think, just based on the data we have on hand, targeting OX40 and having roughly ten amount, like, potency in vitro, gives us the potential to be in the game on efficacy. And potentially, just because of best-in-class PK characteristics, could further differentiate positively on efficacy. Second, the YTE modification is well-established and known to prolong half-life, and we'd expect to see two-five fold increases, potentially with half-life, based on YTE modifications, just based on literature that's been publicly produced. And we're based on our hands the YTE modification, in our experience, has the potential to prolong half-life, which would therefore decrease dose frequency. And then finally, I went through a lot of reasons why we think that we could differentiate favorably on safety, including T cell preservation through a non-enhanced ADCC mechanism with STAR-0310, and by limiting activity to the OX40 receptor, instead of the OX40 ligand. So I think, again, all three things need to be in play for us to be competitive. Great. Thanks, Chris. And then the third question I'll hand to Noah, to talk about the $15 million upfront and also a little bit about R&D spending. Yeah. Hi, Eun. We haven't completed a technical accounting memo for the transactions that were just completed, but my preliminary expectation about that upfront is that it would hit R&D expense in Q4. So more to come on that later, but I, I think that your instinct there is probably correct. And then if I remember correctly, your other question was about the influence on R&D spending over the next couple of years for the new STAR-0310 program. I guess that the way I would characterize that is that through the IND enabling process next year and then into the 1A study in healthy volunteers the following year, that expense is going to stay relatively modest. I would characterize the split as about 85/15 between the existing STAR-0215 program and the new STAR-0310 program. Thank you. Thanks, Eun. Thank you. And the next question comes from Farhana Sakloth at Ladenburg. Hey, guys. Good morning and congratulations. A few questions from us. Will you provide any updates on the preclinical activity of STAR-0310 over the next year or so? Also, how many other compounds are there in the OX40 portfolio? And kind of following on the first question was the preclinical data that you showed us today was without the YTE modification. So when might we see additional data with YTE? And just another question on the deal terms is, what are the specified circumstances under which there can be a reduction in royalties? Great. Thank you. I will start. We do intend to share preclinical data for the STAR-0310 program next year at a scientific conference, and our intention would be to share data that supports the target product profile that Chris described for the program. In terms of the OX40 portfolio that we in-licensed from Ichnos, it includes STAR-0310, it includes Telazorlimab, and it includes some other preclinical, I'll call them, lead stage antibodies. In our assessment and analysis of that portfolio, we believe that STAR-0310 has the most favorable characteristics that we think give it the potential to be a best-in-class OX40 program. In terms of the royalties question, we'll be disclosing more of the details of this agreement in upcoming SEC filings. Then I think you had a fourth question, which is around when we will share the data with the STAR-0310 containing the YTE. So we have preliminary data that supports the binding affinity for STAR-0310 for the OX40 receptor, as well as data to support the importance of the YTE in its potential for accepting half-life. And that data we would anticipate sharing at an upcoming scientific conference in 2024. Great. Thank you so much. You're welcome. Thank you. Thanks for the questions. The next question comes from Hartaj Singh at Oppenheimer. Great. Can you hear me? Yes. Great. Thank you. Hey, congratulations, everyone, and good morning. Thanks for keeping our slow, or moving our slow October to a fast October. Really nice in-license here. Just a couple of quick questions. Most of my questions have actually been answered. On STAR-0310, you know, Chris, you've kind of outlined sort of what you're thinking, you know, and Jill, the milestones. Can we just talk a little bit about over the next year and a half, as you're getting the preclinical data, you're preparing or, you know, for an IND by the end of next year, how are you thinking specifically of your clinical strategy? I mean, would it be sort of target, you know, patients that are hard to treat, maybe smaller Phase 2s and 3s, and then try to get to market that way? Is that possible in this market, atopic dermatitis? Would you need larger trials, you know, or is this all to be determined? And then I have a quick follow-up question on 215, after this one. Great. Chris? Yeah. Thanks, Hartaj. It's an important question, and we're learning much more about atopic dermatitis endotypes, and we're learning about what, you know, are the potential patient types that would respond to various mechanisms, and we'll continue to learn more. And while I think it is possible to focus development on specific endotypes, the beauty of this mechanism is that so far it doesn't look like we need to. And I think that this opens up the possibility of there being a broad population of people that could respond to OX40 pathway inhibition. Now, having said that, we'll certainly take advantage of the advances in clinical science to hone our clinical development strategy to be the most efficient possible. Just as you know, case in point, you know, we've already outlined an early development strategy that sets us up for potential success there. The Phase 1a in healthies is relatively agnostic and would set us up for the potential of developing this not just in AD, but also in other then Phase 1b we'll be able to start to explore the potential of focused development in future trials. Yep, Chris, that helps a lot. Thank you so much. And then just on STAR-0215, I know it's a STAR-0310 call, but just had to ask this question. Chris, you mentioned that, you know, you'll start one Phase 3. Is that the expectation right now? That between your early to mid-stage programs, one Phase 3 and the open-label extension, ALPHA-SOLAR, that you could have, you know, enough of a database to file with the FDA, assuming everything is positive? Precisely, Hartaj. We anticipate that the ALPHA-SOLAR study, plus the single pivotal Phase 3, will provide what we think will be of substantial evidence of effectiveness for 215 and HAE. Great. Thank you for the questions. Thanks for the questions, Hartaj. The next question comes from Ingrid at Wedbush. Hi. Thanks. This is Ingrid on for Laura Chico. Just one question from us. Can you speak further in terms of the timing of the licensing deal and why it makes sense ahead of potential pivotal STAR-0215 efforts? Yeah, for sure, Ingrid. Yes, so we think this is good timing for us as a company. We certainly, when we formed Astria just over two years ago now, we had a vision of building the pipeline in the allergy and immunology space. But at that time, it was very important for us to launch the STAR-0215 program and to ensure that we got that program through some critical clinical milestones. We believe we've now done that with our Phase 1a healthy volunteer trial in that we reported on at the end of last year, where we established the potential for STAR-0215 to be dosed every three or six months. In addition to that milestone, the other important milestone for that program was to get the ALPHA-STAR Phase 1b trial up and running and have these sites on data from that trial as well. We've now achieved those important milestones for the STAR-0215 program, and so we think this presents an opportunity for us to begin to think about building the pipeline. We have been looking for assets in the immunology space broadly. We were quite interested in the OX40 pathway generally and identified this program from Ichnos Sciences as having great potential, and think that our hope that we can now build off the success we've had with STAR-0215 with this new program. Thank you. Thanks for the question, Ingrid. The next question comes from Rami Katkhuda at LifeSci Capital. Hey, guys. This is Rami on for Sam Slutsky. Thanks for taking our questions. I guess, given the validation of both the antibody technology for STAR-0310 and OX40 antagonism in atopic dermatitis in general, is there a potential to accelerate the development timelines here versus a traditional kind of Phase 2, 3? Yeah, good question. Chris? It's... Wow, you know, it's I love that question because I always feel like there's potential. We haven't fully mapped out the development plan yet, Rami, and we're certainly in the process of doing so. Already you see that we've set up early development to establish proof of concept. So our plan would be then to proceed as quickly as we can towards what could be pivotal studies to accelerate the overall development time, and we're continuously looking at opportunities based on evolutions in clinical trials which have become more streamlined and statistically I think better to be much more efficient with the patients to establish the data set needed for approvals. So we'll continue our work and look forward to sharing that with you. Got it. And then really quickly, given what we know about the YTE half-life extension tech, are there specific nuances to consider on OX40 as a target for whether STAR-0310 would be administered as every two months versus every three months? I think important to that will be collecting the clinical data. Chris, do you want to comment on? Yeah, it's another really interesting question about this particular pathway. You know, we already see in the clinical data that it appears as though we could dose, not from, not from STAR-0310, but from omalizumab and rocatinlimab. It appears that through this mechanism, we could dose less frequently than the half-life may imply, and that's because of the impacts on the OX40 pathway affecting multiple effector T-cell types, memory T-cells, and so on. So it's possible that, you know, we get indications that the half-life doubles compared to native IgE, but then the dosing frequency could be less frequently than just once every two months. As Jill said, the Phase 1b data will inform that. We'll look for impacts on efficacy, PK, and pharmacodynamic biomarkers that will inform whether we could dose this even less frequently than the half-life may imply. Got it. Thank you, guys, and congrats again. Thank you. Thanks for the questions, Rami. The last question from our analyst comes from Liisa Bayko at Evercore. Hi, congratulations on the deal. And, my first question is on your new program. I was just wondering, why targeting OX40 ligand versus OX40 receptor? Why is there a difference in potential safety? Could you just explain that? Chris, do you want to take that? Yeah. So, the receptor is expressed only on activated T-cells, and those are T-cells that are involved in the active process of inflammation, in this case, atopic dermatitis. The ligand is expressed on multiple cell types, not on T-cells, and respiratory, vascular, a wide range of cells may express the ligand itself. And then just based on where the ligand is expressed, we think that there is a possibility, just a priority, that there would be respiratory and vascular adverse events. And And in fact, in Phase 2a, the data that we have so far with amlitelimab, which targets specifically the ligand, there are respiratory and vascular adverse events. So we wouldn't expect to see those kinds of side effects with targeting the receptor, which is expressed only on the T-cells. I think, Lisa, that's the core reason why we think there's a differentiation on safety. Okay, great. And for STAR-0215, can you maybe just highlight what you're hoping to learn, and share with the street, when the next phase I data results come out later in the fourth quarter? Thanks. Sure. Yes. So we anticipate sharing confirmatory data that supports the conclusions that we made with the original Phase 1a healthy volunteer data that we released last year supporting the potential for dosing every three or six months. So this will be additional PK and PD and safety and tolerability Phase 1a trial. and now we know we'll be presenting that at the ACAAI in November, and titles for those abstracts are now out. Okay, great. And that'll show... Will, will that be kind of like, highlight, the potential for every six months dosing? Is that, is that part of that? We expect that data that we'll be presenting to further provide support for the potential for the every six-month dosing. Okay. When you think about those two dosing strategies, like, how confident you are in the every six-month dosing versus every three? Kind of where does your... I know base case is every three months, but just curious on the potential for every six months. Yeah. Chris, do you wanna take that? Yeah. So, we know already from the initial data that we presented last year that it looks good for every three and every six months dosing. And, you know, one important point as we think about the 215 development is that we aim to give both regimens to patients without compromising efficacy or increasing any safety concerns or increasing the tolerability burden. We wanna be able to give a drug every three months or every six months that has a similar efficacy and safety profile. And I think that's important for patients. And, Andrew, you can talk about what patients seem to prefer regarding dose frequency. Yeah. I mean, we've done a lot of work, obviously, at looking at three-month dosing relative to what's currently available, but also emerging. And what I can conclude is that at three months, STAR-0215 is a profile that is clearly something that both HCPs as well as patients prefer relative to what's available and what's potentially emerging. We need to do, you know, some additional work on six months in terms of market research, but what I will say is we've spoken to the community, both HCPs and physicians, about the possibility of a six-month dose, that enthusiasm continues. So as Chris mentioned, we wanna make sure that it's not only reducing the burden of treatment but also continues to be to provide the efficacy needed to make sure that we can control this disease for patients. Okay, great. Thank you. Thanks, Lisa. I believe we have actually one more question coming from Michael Higgins at Ladenburg. I think we lost Michael, so I think that concludes the Q&A session with analysts, and I'll now turn it back to the host. We're thrilled to have added STAR-0310 to our pipeline and believe it has the potential to be developed as a best-in-class treatment for atopic dermatitis. STAR-0310 is a strong fit for our focus of developing first-choice products that improve the health and outcomes of patients with allergic and immunological diseases. Thank you very much for joining us today. We look forward to keeping you all updated as we progress STAR-0310 through development. Liz? That concludes today's call. A webcast replay will be available for 90 days via the Investor Relations page on our website at www.astriatx.com. Thank you.