On March 9, 2023 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its full year 2022 financial results for the period ended December 31, 2022 (Press release, Merrimack, MAR 9, 2023, View Source [SID1234628420]).
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"We are encouraged by the results of the NAPOLI 3 trial as reported by Ipsen in November 2022 and the guidance that Ipsen has subsequently provided regarding its intention to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Onivyde in previously untreated patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"), which could lead to a potential future milestone payment from Ipsen" said Gary Crocker, CEO and Chairman of Merrimack’s Board of Directors. "As a result of the exercise of stock options during the fourth quarter of 2022 and continued reductions in our operating expenses during 2022 we expect that our cash and cash equivalents as of December 31, 2022, will be sufficient to continue our operations beyond 2027, which we estimate to be the latest date when the longest-term potential Ipsen milestone may be achieved."
Full Year 2022 Financial Results
Merrimack reported net loss of $1.5 million for the year ended December 31, 2022, or $0.11 per basic share, compared to a net loss of $2.5 million, or $0.18 per basic share, for the same period in 2021.
Merrimack reported a gain on sale of assets for the year ended December 31, 2022, of $0.4 million compared to $0.1 million for the same period in 2021.
General and administrative expenses for the year ended December 31, 2022 were $2.2 million, compared to $2.6 million for the same period in 2021.
As of December 31, 2022, Merrimack had cash and cash equivalents of $19.4 million, compared to $14.2 million as of December 31, 2021 The increase in cash was primarily a result of $6.5 million of proceeds from the exercise of stock options.
As of December 31, 2022, Merrimack had 14.2 million shares of common stock outstanding.
Updates on Programs Underlying Potential Milestone Payments
Ipsen
Metastatic Pancreatic Ductal Adenocarcinoma
In November 2022, Ipsen announced the Phase III NAPOLI 3 trial of Onivyde (irinotecan liposome injection) plus 5-fluorouracil/leucovorin and oxaliplatin (the "NALIRIFOX regimen") met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with mPDAC and key secondary efficacy outcome of progression-free survival (PFS) also showed significant improvement over the comparator arm. Ipsen also announced that the safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase I/II mPDAC study
In January 2023, Ipsen presented clinical trial results at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium
In February 2023 Ipsen provided guidance to investors that it intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration during the first half of 2023 following the Fast Track Designation granted in 2020 for the use of Onivyde in combination with oxaliplatin plus 5-fluorouracil/leucovorin for the treatment of patients with previously untreated mPDAC.
Small Cell Lung Cancer
In August 2022, Ipsen announced that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival compared to topotecan. The trial is evaluating Onivyde versus topotecan in patients with small cell lung cancer, who have progressed on or after platinum-based first-line therapy treatment. In the announcement, Ipsen indicated that detailed results from the RESILIENT trial would be presented at an upcoming medical conference. The analysis concluded that the primary endpoint overall survival was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate in favor of Onivyde was observed. In the August 2022 announcement, Ipsen reported that the clinical study results would be communicated with the regulatory agency. Ipsen indicated that while the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, Ipsen intends to analyze the data further before decisions regarding next steps are made
To date, there have been no further announcements by Ipsen regarding these matters and it remains unclear as to whether Ipsen will continue to seek approval for the use of Onivyde in the small cell lung cancer application. If Ipsen elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $150 million milestone payment tied to FDA approval of Onivyde for treatment of small cell lung cancer.
Elevation Oncology
In January 2023, Elevation announced it is pausing further investment in the clinical development of seribantumab and intends to pursue further development only in collaboration with a partner. Elevation also announced that it intends to present additional interim data from its study of seribantumab in the first half of 2023.