CAMBRIDGE, Mass.–(BUSINESS THREAD)–Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] today announced its second quarter 2022 financial results for the period ended June 30, 2022.
“We are pleased to report continued reductions in operating expenses as we continue to focus on cash conservation to ensure we have sufficient financial resources to capture potential future payouts from Ipsen Pharmacology and Elevation Oncology,” he said. said Gary Crocker, Chairman of the Merrimack Board of Directors. “We will continue to monitor the progress of Ipsen’s Onivyde® (irinotecan liposomal injection) program and Elevation’s seribantumab program.”
Financial results for the second quarter of 2022
Merrimack reported a net loss of $478,000 for the second quarter ended June 30, 2022, or $0.04 per basic and fully diluted share, compared to a net loss of $759,000, or $0.06 dollars per basic and fully diluted share. diluted basis, for the same period of 2021.
General and administrative expenses for the second quarter ended June 30, 2022 were $486,000, compared to $778,000 for the same period in 2021.
As of June 30, 2022, Merrimack had cash and cash equivalents of $13.4 million, compared to $14.2 million as of December 31, 2021.
As of June 30, 2022, Merrimack had 13.4 million shares of common stock outstanding.
Updates on programs underlying potential milestone payments
– On August 3, 2022, Ipsen announced results from its phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer. The announcement stated that “the primary endpoint of OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) was observed in favor of of Onivyde. The safety and tolerability of Onivyde were consistent with its known safety profile and no safety concerns emerged. The results of the clinical study will be reported to the regulatory agency.” Ipsen indicated in its update that it will analyze the data further before making decisions on next steps.
– On July 28, 2022, Ipsen provided a public update on its sales performance for the first half of 2022 and indicated that baseline data from its ongoing phase 3 study of ONIVYDE® in l ‘front-line pancreatic ductal adenocarcinoma were available during the second half of 2022.
– On May 26, 2022, Elevation Oncology released initial proof-of-concept data from its phase 2 CRESTONE study evaluating the HER3 monoclonal antibody seribantumab in patients with tumors containing NRG1 fusions at ASCO 2022. The corporate presentation more Elevation’s recent release indicates that top-line data from this trial is expected in 2024.
Merrimack Pharmaceuticals, Inc. is a Cambridge, Massachusetts-based biopharmaceutical company entitled to receive up to $450.0 million in contingent milestone payments related to the sale of ONIVYDE® to Ipsen SA in April 2017. These milestone payments would be paid by Ipsen upon approval of ONIVYDE by the US Food and Drug Administration (FDA) for certain additional clinical indications. ONIVYDE® is already FDA approved in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. This current approval is not related to any potential future milestone payments. Merrimack’s agreement with Ipsen does not require Ipsen to provide Merrimack with any information about the progress of the ONIVYDE clinical trials that is not publicly available. Merrimack is also entitled to receive up to $54.5 million in contingent milestone payments related to its sale of anti-HER3 programs to Elevation Oncology (formerly 14ner Oncology, Inc.) in July 2019.
To the extent that the statements contained in this press release are not descriptions of historical facts, they are forward-looking statements that reflect management’s current beliefs and expectations made pursuant to the safe harbor provisions of the Litigation Reform Act. private securities of 1995, amended. . Forward-looking statements include any statements about Merrimack’s strategy, future operations, future financial position, future earnings and Merrimack’s future expectations and plans and prospects, and any other statements that contain the words “anticipate,” “believe “, “estimate”, “expect”, “try”, “could”, “plan”, “predict”, “project”, “goal”, “potential”, “will fly”, “could”, “could”, “should”, “continue” and similar expressions. Merrimack’s forward-looking statements in this press release include, but are not limited to, Merrimack’s rights to receive payments related to certain milestones from Ipsen and/or Elevation Oncology or whether such milestones will be achieved, if any, the sufficiency of Merrimack’s cash resources. and Merrimack’s strategic plan, including any potential distribution of additional cash. These forward-looking statements involve substantial risks and uncertainties that could cause Merrimack’s future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to: Positive information about the results of pre-clinical and early-stage clinical trials does not guarantee that later-stage or large-scale clinical trials will be successful. For example, Onivyde® may not demonstrate promising therapeutic effects or adequate safety profiles in current or later phase or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results obtained in subsequent tests may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise prior to the initiation of planned clinical trials, during clinical trials, or in the course of development, testing, or manufacturing that may cause Ipsen and Elevation Oncology and their partners and collaborators not to initiate or discontinue the development Even if later-stage clinical trials are successful, unexpected concerns may arise from subsequent data analysis or from additional data. Obstacles may arise or problems may be identified related to the review of clinical data with regulatory authorities. Regulatory authorities may disagree with Ipsen’s and Elevation Oncology’s view of the data or require additional data or information or additional studies. In addition, the anticipated timing of initiation and completion of clinical trials based on Onivyde® and the anti-HER program is subject to the ability of each of Ipsen and Elevation Oncology, respectively, to enroll patients, enter into agreements with centers of clinical and research trials, and overcome technical obstacles and other issues related to the conduct of the trials for which each of them is responsible. In addition, each of Ipsen and Elevation Oncology is subject to the risk that they may not successfully commercialize these development programs. Merrimack is also subject to the risk that it will not have sufficient funding for its predictable and unpredictable operating expenses and capital expenditure requirements. In addition, Ipsen’s and Elevation Oncology’s press releases and other public statements may contain forward-looking statements. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be deemed to represent Merrimack’s views as of any date after the date hereof. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks related to Merrimack’s business generally, see the “Risk Factors” section of Merrimack annual report in form. 10-K filed with the SEC on March 9, 2022, any subsequent quarterly report on Form 10-Q filed by Merrimack and the other reports Merrimack files with the Securities and Exchange Commission.