Phathom Q3 2022 Earnings Report
Key Takeaways
Phathom Pharmaceuticals reported a net loss of $51.1 million for the third quarter of 2022. The company completed enrollment in its Phase 3 NERD daily dosing trial and secured a commitment for up to an additional $40 million under a revenue interest financing agreement.
Patient enrollment completed for Phase 3 non-erosive gastroesophageal reflux disease (NERD) daily dosing trial with topline data for primary endpoint expected in Q1 2023.
Obtained commitment for up to an additional $40 million under revenue interest financing agreement, increasing total financing potentially available to $300 million.
Commercial launches in H. pylori and Erosive Esophagitis (EE), if approved, are anticipated in Q1 2023.
Phathom is in discussions with the FDA on control limits for nitrosamine impurity in drug product.
Phathom
Phathom
Forward Guidance
Phathom anticipates potential approval of their EE NDA and plans to launch vonoprazan for H. pylori and EE indications. Topline data for the NERD daily dosing Phase 3 trial is expected. The company plans to address the nitrosamine impurity observed in vonoprazan drug product and obtain FDA approval for commercial launch.
Positive Outlook
- Potential approval of EE NDA.
- Planned launch of vonoprazan for H. pylori and EE indications.
- Expected topline data for NERD daily dosing Phase 3 trial.
- Plans to address nitrosamine impurity in vonoprazan drug product.
- Aim to obtain FDA approval for commercial launch.
Challenges Ahead
- FDA may disagree that existing safety and efficacy data is sufficient to approve the EE NDA due to nitrosamine impurity.
- Potential for FDA to delay the PDUFA target action date related to the EE NDA due to internal resource constraints.
- Inherent risks of clinical development of vonoprazan.
- Dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing.
- Unexpected adverse side effects or inadequate efficacy of vonoprazan may limit its development, regulatory approval and/or commercialization.