Loading...
•
Jun 30, 2021
Phathom Q2 2021 Earnings Report
Phathom Pharmaceuticals reported financial results for the second quarter of 2021 and provided an update on expected clinical and regulatory milestones.
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $36.6 million for the second quarter of 2021. The company is progressing with its GERD development programs and expects to submit NDAs to the FDA for H. pylori infection treatments in September 2021.
Topline data from the pivotal Phase 3 PHALCON-EE trial for erosive esophagitis is expected in October 2021.
Topline data from the Phase 2 PHALCON-NERD on-demand trial for non-erosive reflux disease is now expected in the first quarter of 2022.
NDAs for dual and triple vonoprazan-based regimens for H. pylori infection treatment are expected to be submitted in September 2021.
Cash and cash equivalents were $209.7 million as of June 30, 2021, expected to be sufficient into the fourth quarter of 2022.
Phathom
Phathom
Forward Guidance
Phathom anticipates key milestones including topline data from clinical trials and NDA submissions.
Positive Outlook
- Topline results from PHALCON-EE trial expected in October 2021.
- Topline results from PHALCON-NERD trial expected in Q1 2022.
- NDA submissions for H. pylori treatments expected in September 2021.
Challenges Ahead
- Potential delays in clinical trials due to the COVID-19 pandemic.
- Dependence on third parties for manufacturing and testing.
- Unexpected adverse side effects or inadequate efficacy of vonoprazan.
- Risk of withdrawal of QIDP and Fast Track designations.
- Ability to maintain undisrupted business operations due to COVID-19.