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Mar 31, 2021
Phathom Q1 2021 Earnings Report
Phathom Pharmaceuticals reported financial results for the first quarter of 2021 and provided an update on its recent clinical and organizational progress.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $34.8 million for the first quarter of 2021. The company highlighted positive Phase 3 trial results for vonoprazan in H. pylori infection and the initiation of a Phase 2 trial for NERD.
PHALCON-HP trial met all primary and secondary endpoints.
NDAs for vonoprazan-based regimens are targeted for the fourth quarter of 2021.
FDA granted additional QIDP designations to vonoprazan-based regimens with amoxicillin capsules.
Phase 2 trial evaluating vonoprazan on-demand in NERD was initiated.
Phathom
Phathom
Forward Guidance
Phathom expects topline results from the PHALCON-EE Phase 3 clinical trial in the fourth quarter of 2021. They also plan to submit New Drug Applications for the eradication of H. pylori infection and complete enrollment in the Phase 2 NERD study.
Positive Outlook
- Topline results from the PHALCON-EE Phase 3 clinical trial expected in the fourth quarter of 2021.
- New Drug Applications for the eradication of H. pylori infection are expected to be submitted.
- Enrollment in the Phase 2 NERD study is expected to be completed.
- Vonoprazan could represent an important treatment option for acid-related diseases, if approved.
Challenges Ahead
- Potential delays in the commencement, enrollment and completion of clinical trials due to the COVID-19 pandemic and other factors outside of Phathom’s control.
- Patients already enrolled in PHALCON-EE and the Phase 2 NERD study may not complete the clinical trials or public health conditions and governmental restrictions may lead Phathom to stop such trial all together, which may adversely impact its trial results and development plans.
- Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing.
- Unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims.
- QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan.