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Exhibit 99.1
Merrimack Reports Fourth Quarter and Full Year 2018 Financial Results
Cambridge, Mass., March 6, 2019 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, today announced its fourth quarter and full year 2018 financial results for the period ended December 31, 2018.
Last quarter, we engaged external advisors and initiated a process to explore Merrimacks strategic alternatives. This is an active process that we are working expeditiously to bring to conclusion, with a range of potential outcomes under consideration. We are also committed to preserving the value of the potential milestones that Merrimack remains eligible to receive from Ipsen, said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. In light of this ongoing process, we are also prudently advancing our pipeline and are pleased to report today an update from our ongoing Phase 1 study of MM-310 and that six posters have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting, five of which highlight our prioritized preclinical programs, MM-401 and MM-201.
Program Update:
MM-310:
In November 2018, Merrimack amended its Phase 1 study of MM-310 in patients with solid tumors to extend the dosing interval of MM-310 from every three weeks to every four weeks. To date, three patients have been enrolled in the 360 mg every four weeks dose cohort under the amended protocol, which matches the highest dose level reached during the prior version of the protocol at every three weeks.
As of March 4, 2019, all three patients in the 360 mg every four weeks dose cohort continue to be treated in the study: one patient has completed 98 days of treatment and received four cycles of MM-310, reaching stable disease as a best response to date; the second patient has completed 56 days of treatment and received two cycles of MM-310; and the third patient received the first dose 21 days prior. Importantly, there have been no instances of grade 3 peripheral neuropathy reported in this cohort.
If all three patients in the 360 mg every four weeks dose cohort successfully complete the observation period for dose-limiting toxicities, which is expected to occur in mid-March, Merrimack would plan to begin enrolling the next dose-escalation cohort at 420 mg of MM-310 every four weeks.
Preclinical Programs:
In November 2018, in connection with its corporate restructuring and exploration of strategic alternatives, Merrimack narrowed the scope of its preclinical efforts to its two most promising preclinical programs: MM-401, an agonistic antibody targeting a novel immuno-oncology target, TNFR2; and MM-201, a highly stabilized agonist-Fc fusion protein targeting death receptors 4 and 5.
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This decrease was offset by non-cash adjustments including $7.7 million benefit from intraperiod tax allocation, $4.1 million in depreciation and amortization, $3.1 million of stock-based compensation expense, $3.1 million in loss on equity method investment, and $0.2 million non-cash activity related to discontinued operations.
The non-cash adjustments to net loss of $11.5 million resulted in a decrease in cash used, including a $25.3 million non-cash loss on extinguishment, $17.3 million of non-cash activity related to discontinued operations, $12.8 million of stock-based compensation expense, $5.2 million of depreciation and amortization expense and $3.7 million in non-cash interest expense offset by removal of a $42.4 million income tax benefit and $10.8 million gain on deconsolidation of Silver Creek Pharmaceuticals, Inc.
On April 3, 2017, pursuant to the asset sale agreement with Ipsen, we retained the right to receive net milestone payments that may become payable for the ex-U.S. development and commercialization of ONIVYDE for up to $33.0 million pursuant to the Servier agreement.
We retained the rights to receive net milestone payments that may become payable pursuant to the Servier agreement for the ex-U.S. development and commercialization of ONIVYDE for up to $33.0 million, which is comprised of potential payments of $18.0 million from the sale of ONIVYDE in two additional major European countries, $5.0 million related to the sale of ONIVYDE in the first major non-European, non-Asian country and $10.0 million for the first patient dosed in a pivotal clinical trial in an indication other than pancreatic cancer.
Our research and development expenses consist of: employee salaries and related expenses, which include stock-based compensation and benefits for the personnel involved in our drug discovery and development activities; external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites; manufacturing material expense for third-party manufacturing organizations and consultants, including costs associated with manufacturing product prior to product approval; license fees for and milestone payments related to in-licensed products and technologies; and facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, and laboratory and other supplies.
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Financial Statements, Disclosures and Schedules
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Merrimack Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits
Ticker: MACK
CIK: 1274792
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-006385
Submitted to the SEC: Wed Mar 06 2019 2:32:36 AM EST
Accepted by the SEC: Wed Mar 06 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations