Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 145

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1A
Chunk 145
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armaceutical, biotechnological and therapeutics companies. Moreover, we may also compete with universities and other research institutions who may be active in the indications we are targeting and could be in direct competition with us. We also compete with these organizations to recruit management, scientists and clinical development personnel, which could negatively affect our level of expertise and our ability to execute our business plan. 

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We will also face competition in establishing clinical trial sites, enrolling patients for clinical trials and in identifying and in-licensing new product candidates. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

We expect that, for the treatment of H. pylori infection, healing and maintenance of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis and treatment of heartburn associated with Non-Erosive GERD, VOQUEZNA will primarily compete with generic PPIs marketed by multiple pharmaceutical companies in both the prescription and OTC markets. In addition to generic PPI-based triple and quad therapies, we expect VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK will compete with Talicia, a co-formulated capsule comprising generic omeprazole, amoxicillin, and rifabutin for the treatment of H. pylori infection, launched in March 2020 by RedHill Biopharma Ltd.

We are aware of three PCABs in development in U.S. as well as additional PCABs in territories outside the U.S. If approved in our territories, these PCABs may compete with vonoprazan. In the U.S., Daewoong is seeking a partner to advance development of fexuprazan. Outside the U.S., fexuprazan is launched in five countries and under health authority review in nine countries or regions. In the U.S., Sebela initiated three tegoprazan Phase 3 studies in Erosive GERD, Non-Erosive GERD and long-term safety–with expected completion in 2025. Outside the U.S., tegoprazan is launched in 14 countries, registered but not launched in one country and under health authority review in four countries. In the U.S., Cinclus obtained FDA agreement on their linaprazan glurate pediatric plan and plans to initiate two linaprazan glurate Phase 3 studies in patients with severe Erosive GERD in 202