Merrimack Pharmaceuticals Inc. (MACK) is actively developing innovative medicines paired with companion diagnostics for the treatment of serious diseases, primarily focusing on cancer. With five therapeutic oncology candidates in clinical development and multiple product candidates in preclinical development, Merrimack is poised for several milestones in the coming months.
MM-398: Targeting Metastatic Pancreatic Cancer
The most advanced drug candidate in Merrimack's pipeline is MM-398, a nano-encapsulated formulation of Irinotecan. Merrimack holds worldwide development and commercialization rights to MM-398, excluding Taiwan. A global phase III study of MM-398 in second-line metastatic pancreatic cancer, for patients who have failed Gemcitabine treatment, was initiated in November. This study is designed to enroll 270 metastatic pancreatic cancer patients and evaluates MM-398 against 5-Fluorouracil and Leucovorin. The final data collection date for the primary outcome measure is expected in December 2013.
Last month, the company expanded the global phase III study of MM-398 to include an additional arm which combines MM-398 with 5-Fluorouracil and Leucovorin. The study is scheduled to begin enrollment on the amended protocol this month. MM-398 has been granted orphan drug status by the FDA and EMA for pancreatic cancer.
MM-398 is also being evaluated in investigator-sponsored trials, including a phase II clinical trial in colorectal cancer, a phase I clinical trial in colorectal cancer, and a phase I clinical trial in glioma.
MM-121: Broad Spectrum Solid Tumor Targeting
Next in the pipeline is MM-121, developed in partnership with Sanofi under a 2009 agreement. MM-121 is being tested across a wide spectrum of solid tumors. Phase II studies of MM-121 in combination with Erlotinib in non-small cell lung cancer patients, with Paclitaxel in HER2-negative breast cancer patients, and with Paclitaxel in platinum-resistant/refractory advanced ovarian cancer patients were initiated in the fourth quarter of 2011. Additionally, one phase I/II clinical trial and four phase I clinical trials of MM-121 in multiple cancer types are underway.
Additional Pipeline Programs
Merrimack's other clinical drug candidates include MM-111, currently in two phase I clinical trials across multiple cancer types; MM-302, in a phase I clinical trial for breast cancer; and MM-151, in a phase I clinical trial for solid tumors. MM-151 was discovered by Adimab LLC and licensed exclusively to Merrimack. The company also plans to initiate a phase I trial for DX-929, an imaging diagnostic for its nanotherapeutics, in the coming months.
Financial Overview
Merrimack, founded in 2002, has incurred significant operating losses since its inception. The company has no marketed products and derives revenue from collaboration agreements. In the first quarter ended March 31, 2012, Merrimack's net loss widened to $23.4 million, or $2.14 per share, from $13.5 million, or $1.35 per share, in the year-ago quarter. The company had an accumulated deficit of $374.1 million at the end of the first quarter of 2012. Collaboration revenues for the first quarter of 2012 increased 77% to $11.3 million due to increases in development, milestone, and manufacturing revenues recognized under the 2009 agreement with Sanofi for the development of MM-121. Merrimack had cash of $30.6 million as of March 31, 2012, and net proceeds from the initial public offering, which closed the following month, were $100.5 million, sufficient to fund operations into the second half of 2013.
