On May 4, 2023 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its first quarter 2023 financial results for the period ended March 31, 2023 (Press release, Merrimack, MAY 4, 2023, View Source [SID1234631038]).
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"During the first quarter of 2023 our operating expenses remained consistent with prior quarters and were reduced both by proceeds we received from the receipt of an option fee paid in connection with the entry into an asset purchase option agreement on a preclinical asset and increased interest income" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We continue to be focused on maintaining cash balances that will allow us to be in a position to receive potential milestone payments from Ipsen and Elevation under the programs that we previously sold to them."
First Quarter 2023 Financial Results
Merrimack reported a net loss of $271 thousand for the first quarter ended March 31, 2023, or $0.02 per basic and diluted share on a fully diluted basis, compared to a net loss of $132 thousand, or $0.01 per basic and diluted share on a fully diluted basis, for the same period in 2022.
Merrimack reported a gain on the sale of assets for the first quarter ended March 31, 2023, of $139 thousand, attributable to an asset purchase option agreement on a preclinical program, compared to $445 thousand related to an asset sale in the same period in 2022.
Interest income in the first quarter ended March 31, 2023, was $176 thousand compared to no interest income for the same period in 2022.
General and administrative expenses for the first quarter ended March 31, 2023, were $586 thousand, compared to $577 thousand for the same period in 2022.
As of March 31, 2023, Merrimack had cash and cash equivalents of $19.4 million, compared to $19.4 million as of December 31, 2022.
As of March 31, 2023, Merrimack had 14.3 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. On March 14, 2021 Elevation Oncology announced that it would be presenting two posters on NRG1 fusions, including updated data from the Phase 2 CRESTONE study evaluating seribantumab in patients with solid tumors harboring NRG1 fusions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, being held April 14-19, 2023. If Elevation elects not to proceed with seeking regulatory approval, or if regulatory approval is not obtained, Merrimack would not be entitled to the $54.5 million in additional potential development, regulatory approval and commercial-based milestone payments.