Item 2.02 | Results of Operations and Financial Condition. |
As described in Item 8.01 below, on October 18, 2021, Phathom Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the topline data from the Company’s Phase 3 clinical trial of vonoprazan for the healing of all grades of erosive esophagitis (“EE”) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. In this press release, the Company disclosed that as of September 30, 2021, Phathom had approximately $225 million in cash and cash equivalents. The Company’s cash and cash equivalents as of September 30, 2021, reflects the Company’s drawdown of $100 million pursuant to its previously announced Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. and the payment of approximately $54 million to satisfy in full and retire the indebtedness under the Company’s previous credit facility with Silicon Valley Bank. The announcement of the positive PHALCON-EE data, as described in Item 8.01 below, provides the Company with access to an additional $50 million from the Loan Agreement.
The Company’s estimated cash and cash equivalents at September 30, 2021, is preliminary, has not been audited and is subject to change upon completion of the preparation of the Company’s financial statements as of and for the three and nine months ended September 30, 2021. In addition, the Company’s independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this unaudited preliminary financial information and does not express an opinion or any other form of assurance with respect thereto. These results could change as a result of further review. Additional information and disclosures would be required for a more complete understanding of the Company’s financial condition, liquidity and results of operations as of and for the three and nine months ended September 30, 2021.
Accordingly, undue reliance should not be placed on such preliminary estimates. The information contained in this Item 2.02 shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information in this Item 2.02 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.
On October 18, 2021, the Company announced that vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal Phase 3 trial evaluating vonoprazan versus lansoprazole for the treatment of EE. Based on the positive PHALCON-EE data, the Company plans to submit a new drug application (“NDA”) in the first half of 2022 to the U.S. Food and Drug Administration (the “FDA”) seeking the following indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. We expect a decision on the NDA in 2023 and, if approved, we expect a commercial launch of vonoprazan for the treatment of EE in 2023.
Study Design
PHALCON-EE was a trial with two phases. In the first phase, vonoprazan 20 mg was compared to lansoprazole 30 mg in the healing of EE after up to 8 weeks of treatment (“Healing Phase”). In the Healing Phase, patients were assessed via endoscopy to determine complete healing following 2 weeks of treatment and, if complete healing was not achieved, a second endoscopy occurred at 8 weeks of treatment. Patients who achieved complete healing were re-randomized into the second phase of the trial, where vonoprazan 10 mg and 20 mg were compared to lansoprazole 15 mg to assess maintenance of healing via endoscopy following 24 weeks of treatment (“Maintenance Phase���). Heartburn symptom relief was assessed via secondary endpoints in both the Healing and Maintenance Phases of the study based on twice daily e-diary data collection.
Study Results
Healing Phase
The primary endpoint of the Healing Phase was non-inferiority of vonoprazan 20 mg compared to lansoprazole 30 mg in the percentage of all patients who have complete healing of EE by Week 8. Vonoprazan met the Healing Phase primary endpoint with a healing rate of 93% compared to 85% for lansoprazole (p<0.0001). In a preplanned exploratory superiority test, the difference between vonoprazan and lansoprazole was also significant (p<0.0001).1
1 | Exploratory superiority comparison, nominal p value presented. |