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1. Astria Therapeutics is like a specialized Vertex Pharmaceuticals, developing innovative treatments for rare diseases, with an initial focus on hereditary angioedema.

2. Astria Therapeutics is like a smaller Alexion Pharmaceuticals (now part of AstraZeneca), focused on creating new, long-acting therapies for rare inflammatory conditions.

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• STAR-0215: An investigational monoclonal antibody inhibitor of kallikrein currently in Phase 2 clinical trials for the treatment of hereditary angioedema (HAE).

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Astria Therapeutics (ATXS) is a clinical-stage biopharmaceutical company focused on developing therapies for rare and allergic diseases. As of its current status, the company does not have any commercialized products generating revenue from sales. Therefore, Astria Therapeutics does not currently have major customers in the traditional sense of entities purchasing its products.

If and when Astria Therapeutics successfully develops, gains regulatory approval for, and commercializes its product candidates (such as STAR-0215 for hereditary angioedema), its major customers would primarily be other companies within the healthcare supply chain. These would typically include:

• Pharmaceutical Wholesalers and Distributors: These companies purchase pharmaceutical products directly from manufacturers and distribute them to pharmacies, hospitals, and clinics. They serve as the primary direct customers for many biopharmaceutical companies.
  • Cardinal Health (CAH)
  • McKesson Corporation (MCK)
  • AmerisourceBergen Corporation (ABC)
• Integrated Healthcare Networks and Large Hospital Systems: While often procuring through distributors, very large healthcare systems can sometimes have direct purchasing agreements for certain specialized or high-volume drugs.
• Specialty Pharmacies: These pharmacies specialize in dispensing complex, high-cost, or rare disease medications, often working closely with manufacturers and patients. They typically purchase from distributors or sometimes directly from manufacturers.

Pharmacy Benefit Managers (PBMs) are also crucial stakeholders, as they manage prescription drug benefits for health plans and influence formulary placement and patient access, but they do not directly "purchase" the product from the manufacturer for resale.

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• Lonza Ltd. (SIX: LONN)

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Jill Adler, Chief Executive Officer

Jill Adler previously served as CEO of X4 Pharmaceuticals and Chief Commercial Officer at Kiniksa Pharmaceuticals. She also held various leadership positions at Biogen, including Vice President, U.S. Neurology, and General Manager, Benelux.

William White, Chief Financial Officer

William White previously held the position of Chief Financial Officer at AMAG Pharmaceuticals and also served as Chief Financial Officer and Treasurer of Inotek Pharmaceuticals. Earlier in his career, he held several financial and strategic leadership roles at Biogen, including Vice President, Finance, and Head of Investor Relations.

Jeremy Goldberg, Chief Medical Officer

Prior to joining Astria, Dr. Goldberg served as Senior Vice President and Head of Clinical Development at Sanofi Genzyme, and before that, he spent over 10 years at Amgen.

Ben Harshbarger, Chief Operating Officer

Ben Harshbarger most recently served as Chief Operating Officer at Aura Biosciences and previously as Chief Business Officer at Aerpio Therapeutics. He also held leadership roles at Shire (now Takeda) and Cubist Pharmaceuticals (now Merck).

Amy Nolan, Chief People Officer

Prior to joining Astria, Amy Nolan served as Chief People Officer at Wave Life Sciences. She also held leadership roles in human resources at Biogen.

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1. Clinical Development and Regulatory Risks: Astria's business success is entirely dependent on the successful discovery, development, and commercialization of its product candidates, navenibart and STAR-0310. The company faces significant uncertainties in clinical trials, including potential delays, safety concerns, and the need for additional studies, which could impede progress and increase costs. Obtaining marketing approvals from regulatory bodies like the FDA is a lengthy and uncertain process, with no guarantee of success for Astria's drug candidates.
2. Financial Risks and Dependence on Additional Funding: Astria Therapeutics has consistently incurred significant losses since its inception and does not generate revenue from product sales. The company anticipates continued substantial losses and will require significant additional capital to fund its ongoing research and development programs and potential commercialization efforts. There is no assurance that such funding will be available on acceptable terms or at all, which could force the company to delay, reduce, or even terminate its development programs.
3. Intense Competition: Astria Therapeutics operates in highly competitive therapeutic areas, particularly for hereditary angioedema (HAE) and atopic dermatitis (AD). The company faces substantial competition from other pharmaceutical and biotechnology companies, many of which have greater financial resources, more extensive research and development capabilities, and more established products already on the market. If competitors develop more effective or cheaper alternatives, Astria's potential market share and profitability could be significantly impacted.

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The addressable market for Astria Therapeutics' main product, STAR-0215 for hereditary angioedema (HAE), is global. The hereditary angioedema market size was valued at USD 3.6 billion in 2022 and is projected to grow from USD 4.0 billion in 2023 to USD 8.7 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 9.9% during the forecast period (2023-2032). Another projection estimates the global market for HAE treatments to reach approximately $6.2 billion by 2032.

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• Successful Commercialization and Market Penetration of STAR-0215 for Hereditary Angioedema (HAE): The primary driver of future revenue growth is anticipated to be the successful launch and subsequent market penetration of STAR-0215, Astria's lead product candidate for hereditary angioedema. With topline data from its pivotal Phase 3 ALPHA-STAR study expected in mid-2025 and a potential Biologics License Application (BLA) filing in 2026, STAR-0215 is positioned to enter the market within the 2-3 year timeframe. Its differentiated profile, particularly a potential once-quarterly or once-biannually dosing regimen, is expected to drive uptake in the multi-billion dollar HAE market by offering improved convenience and reduced treatment burden compared to existing therapies.
• Expansion of STAR-0215 into Broader HAE Patient Populations: Beyond its initial indication, Astria may seek to expand STAR-0215's label to include broader HAE patient populations, such as younger patients or those with specific disease characteristics. This expansion would increase the addressable market for STAR-0215, thereby contributing to sustained revenue growth beyond the initial launch phase.
• Strategic Pricing and Reimbursement for STAR-0215: The company's ability to achieve favorable pricing and broad reimbursement for STAR-0215 will be crucial for revenue maximization. Given the high unmet need and the specialized nature of the HAE market, a strategic pricing approach, coupled with effective market access initiatives, is expected to contribute significantly to revenue growth.

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