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Merrimack Pharmaceuticals Reports First Quarter 2014 Financial Results

CAMBRIDGE, Mass., May 1, 2014 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK), a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, today announced its first quarter 2014 financial results. Merrimack will host a live conference call and webcast today, Thursday, May 1 at 8:30 a.m., Eastern Time, to provide a summary of first quarter 2014 financial results as well as discuss the positive top line results of the combination arm of MM-398's Phase 3 NAPOLI-1 study in post-gemcitabine metastatic pancreatic cancer announced this morning.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 37032608. A listen-only webcast of the call can be accessed in the Investors section of Merrimack's website, http://investors.merrimackpharma.com, and a replay of the call will be archived there for six weeks following the call.

Key Recent Events

  • Merrimack announced in a separate release this morning that in a Phase 3 study in patients with metastatic pancreatic cancer, the combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin. The NAPOLI-1 study was completed in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. The primary log-rank analysis of overall survival was statistically significant (p=0.012) with a corresponding hazard ratio of 0.67. A statistically significant advantage for progression free survival was also observed in the combination arm. The most common Grade 3 or higher adverse events in the combination arm were neutropenia, fatigue, diarrhea and vomiting. The arm evaluating MM-398 as a monotherapy did not meet the statistical endpoint. The hazard ratio for overall survival in the monotherapy arm was 0.99 with a corresponding p-value of 0.942. The study has been accepted for oral presentation at the European Society for Medical Oncology (ESMO) World Conference on Gastrointestinal Cancer being held in Barcelona, Spain on June 25-28, 2014.  
  • Merrimack also recently announced Phase 1 results from a clinical pilot study demonstrating that ferumoxytol*, an iron oxide nanoparticle, was well tolerated when used as a tumor contrast agent prior to MM-398 treatment. Data from the first cohort of patients in this study, which was completed in conjunction with the Virginia G. Piper Cancer Center and Imaging Endpoints, were presented at the American Association of Cancer Research Annual Meeting, April 5-9, 2014, in San Diego, California.

Upcoming Milestones

Merrimack anticipates the following upcoming milestones:

  • Presentation of MM-121 Phase 2 data at the 2014 Annual Meeting of the American Society of Clinical Oncology in Chicago;
  • Presentation of MM-398 Phase 3 NAPOLI-1 results at the ESMO World Congress on Gastrointestinal Cancer 2014 in Barcelona;
  • Announcement of top line data for the Phase 2 triple negative breast cancer cohort of MM-121 in the neoadjuvant setting in the second quarter of 2014;
  • Continued enrollment in the Phase 2 program for MM-111 in gastric, esophageal and gastroesophageal cancers;
  • Initiation of a Phase 2 clinical study for MM-302 in 2014;
  • Initiation of a Phase 2 clinical study for MM-151 in 2014; and
  • Initiation of a Phase 2 clinical study for MM-141 in 2014.

Conferences

Merrimack expects to attend a number of investor conferences in the months ahead, including:

  • Bank of America Merrill Lynch 2014 Health Care Conference, May 14 in Las Vegas; and
  • UBS 2014 Global Healthcare Conference, May 19-21 in New York City.

First Quarter 2014 Financial Results

Net loss for the first quarter of 2014 was $27.8 million, or basic and diluted net loss per share available to common stockholders of $0.27, compared with net loss for the first quarter of 2013 of $28.3 million, or basic and diluted net loss per share available to common stockholders of $0.29. This decrease in net loss was primarily attributable to four factors:

  • A $9.0 million non-recurring decrease in net loss related to the MM-121 program – $5.8 million of this decrease relates to an increase in revenue in the first quarter of 2014 due to Merrimack receiving budget approval from Sanofi during the quarter for the funding of expenses recognized in 2013, and $3.2 million of this decrease relates to a reduction in MM-121 expenses during the first quarter of 2014 due to a credit received from an agreement with a contract research organization;
  • $3.8 million of increased research and development expense not associated with MM-121, which was primarily due to increased spending on Merrimack's other clinical stage product candidates;
  • $3.3 million of increased interest expense from Merrimack's 4.50% convertible senior notes, which were issued in July 2013, of which $1.9 million is imputed non-cash expense primarily related to the conversion feature of the convertible senior notes; and
  • $1.3 million of increased general and administrative expense primarily associated with increased headcount costs to support clinical development, increased rent expense and increased costs to support preliminary commercialization efforts on MM-398.

Financial Outlook

Merrimack expects its existing unrestricted cash and cash equivalents and available-for-sale securities as of March 31, 2014 of $124.2 million, anticipated interest income and reimbursement of expenses under its license and collaboration agreement with Sanofi related to MM-121 to be sufficient to fund operations and pre-commercial efforts into 2015.

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