=Merrimack Pharma (MACK) : trial of pancreatic cancer treatment fails to meet main goals

Merrimack Pharma announces top-line results from the CARRIE study -- did not meet primary or secondary endpoints  

The co announced top-line results from the CARRIE study, a randomized Phase 2 trial evaluating the addition of MM-141 (istiratumab) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1). The study did not meet its primary or secondary efficacy endpoints in patients who received MM-141 in combination with nab-paclitaxel and gemcitabine, compared to nab-paclitaxel and gemcitabine alone. These results were consistent in all subgroups analyzed. Based on these results, Merrimack will not devote additional resources to the development of MM-141.

• Merrimack plans to present the complete data from this Phase 2 study at an upcoming medical oncology meeting.

The company said it would now focus on developing other programs in its pipeline, which includes a drug for breast cancer and lung cancer.

=Merrimack Pharmaceuticals (MACK) : CFO resigns

Dr. Yasir Al-Wakeel said he will resign as Merrimack's chief financial officer and head of corporate development effective June 9, 2017.

Merrimack's shares have been in free fall ever since management decided to sell pancreatic-cancer drug Onivyde and the generic version of the anti-cancer medicine Doxil to the French drugmaker Ipsen SA in January. In a nutshell, Merrimack has reverted back to being a high-risk clinical-stage biotech since this deal, and the unexpected departure of its CFO adds yet another layer of uncertainty regarding the company's ability to create value for shareholders moving forward.

Merrimack's future now squarely depends on the fate of its trio of anti-cancer clinical candidates: MM-121, MM-141, and MM-310. The glaring problem is that experimental cancer drugs in general have an absurdly poor track record, with over 95% of these drugs failing to ever reach the market. In fact, prospective cancer drugs are the least likely to get a green light from the FDA.

=Merrimack Pharma (MACK) reported earnings on Wed 1 March 17 (b/o)

Merrimack Pharma misses by $0.03, misses on revs :

• Reports Q4 (Dec) loss of $0.25 per share, $0.03 worse than the Capital IQ Consensus of ($0.22); revenues rose 186.0% year/year to $61.2 mln vs the $62.66 mln two analyst estimate.
• As announced on January 8, 2017, Merrimack entered into an asset purchase and sale agreement with Ipsen S.A. under which Merrimack will sell ONIVYDE and its generic version of doxorubicin hydrochloride (HCI) liposome injection to Ipsen for up to $1.025 billion, plus up to $33.0 million in net milestone payments retained by Merrimack pursuant to Merrimack's license and collaboration agreement with Shire. A special meeting of Merrimack's stockholders is scheduled for March 30, 2017 to consider and vote on the asset sale. Merrimack anticipates completing the asset sale shortly after approval of the asset sale at the special meeting.
• Upon the closing of the asset sale, Merrimack will receive a $575.0 million upfront cash payment from Ipsen (subject to a working capital adjustment as provided in the asset purchase and sale agreement). Merrimack expects to use these proceeds to declare and pay a special cash dividend of at least $200.0 million to stockholders and use an additional $195.1 million to redeem its senior secured notes. Additionally, if the asset sale is consummated and certain milestones are met with Shire, Merrimack expects to receive up to an aggregate of $33.0 million in net milestone payments in 2017. Merrimack believes that these potential cash inflows, along with the completion of the headcount reduction and refocused research and development efforts that were announced in January 2017, will provide financial resources sufficient to fund its operations into the second half of 2019.

=Merrimack Pharma (MACK) stops the Phase 2 HERMIONE study

Merrimack Pharma stops the Phase 2 HERMIONE study of MM-302 in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab, pertuzumab and ado-trastuzumab emtansine:

• The decision to stop the trial was made following the Data and Safety Monitoring Board's opinion that continuing would be unlikely to demonstrate benefit over the comparator treatments. Subsequent to this recommendation, a futility assessment was performed that confirmed the DSMB's opinion. Both the treatment and control arms were found to have shorter than expected median progression free survival.
• Importantly, there were no new or unexpected safety concerns. Patients currently enrolled in the trial may choose to continue on their assigned treatment based upon discussion with their study physician.
• In light of this development, Merrimack now expects to provide further details about MM-302, as well as the results of its full pipeline review, in January.

Merrimack Pharma (MACK) : trading halted amid FDA news

Shares of drugmaker Merrimack Pharmaceuticals Inc (NASDAQ:MACK) were halted on Thu, Oct 22, after the company announced its pancreatic cancer treatment has received Food and Drug Administration (FDA) approval. When trading resumed, the shares were sharply lower due to a black box warning, dropping 20% to $7.21.

 

weekly

Short interest has been gradually rising on the stock, and now accounts for roughly one-fifth of its total float. At the equity's average trading level, it would take more than two weeks to repurchase these bearish positions.

On the other hand, analysts are extremely bullish, seemingly dismissing its nearly 30% year-to-date retreat. In fact, 100% of covering brokerage firms have handed out a "strong buy" endorsement on the security, and its consensus 12-month price target of $15 sits at levels never before seen.