UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 8, 2018
Merrimack Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 001-35409 | 04-3210530 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
One Kendall Square, Suite B7201 Cambridge, MA |
02139 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrants telephone number, including area code: (617) 441-1000
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. | Results of Operations and Financial Condition. |
On May 8, 2018, Merrimack Pharmaceuticals, Inc. announced its financial results for the quarter ended March 31, 2018. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
99.1 | Press release issued by the Registrant on May 8, 2018 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MERRIMACK PHARMACEUTICALS, INC. | ||||||
Date: May 8, 2018 | By: | /s/ Jeffrey A. Munsie | ||||
Jeffrey A. Munsie | ||||||
General Counsel |
Exhibit 99.1
Merrimack Reports First Quarter 2018 Financial Results
Three clinical readouts expected in 2018, including data from two randomized Phase 2 studies
Conference call at 8:30 am ET today
Cambridge, Mass., May 8, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, today announced its first quarter 2018 financial results for the period ended March 31, 2018.
At Merrimack, we set out to design targeted solutions with pharmacological properties to match our teams understanding of cancer pathways and drug metabolism. We have been focused on executing this strategy as we advance the ten wholly-owned programs across our clinical and preclinical pipeline, each addressing biomarker-defined cancers, said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. We look forward to our three upcoming clinical readouts: randomized Phase 2 data for istiratumab (MM-141) in pancreatic cancer and seribantumab (MM-121) in non-small cell lung cancer and Phase 1 data for MM-310 in solid tumors.
First Quarter and Recent Highlights
Key events from the first quarter and more recently include:
| Appointment of Lee Newcomer, M.D., M.H.A., former Senior Vice President for Oncology and Genetics and Chief Medical Officer at UnitedHealthcare and board-certified medical oncologist, to Merrimacks Scientific Advisory Board (SAB). Dr. Newcomer, with his perspective on medical oncology and patient access, joins distinguished experts in precision oncology, bioengineering, drug discovery and clinical development on Merrimacks SAB; and |
| Presentation of preclinical data at the 2018 American Association for Cancer Research (AACR) Annual Meeting. Merrimack hosted four poster sessions, highlighting preclinical data from MM-310 as well as other preclinical programs currently in development. |
Upcoming Milestones
Merrimack anticipates the following upcoming clinical milestones:
| Top-line results in the first half of 2018 from the CARRIE study, an event-driven, randomized Phase 2 clinical trial evaluating istiratumab (MM-141) added to standard of care in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1; |
| Top-line results in the second half of 2018 from the SHERLOC study, an event-driven, randomized Phase 2 clinical trial evaluating seribantumab (MM-121) added to standard of care in patients with heregulin positive non-small cell lung cancer; and |
| Safety data and maximum tolerated dose in the second half of 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors. |
First Quarter 2018 Financial Results
The following summarizes Merrimacks financial results for the three months ended March 31, 2018:
| Research and development expenses for the three months ended March 31, 2018 were $13.1 million, compared to $21.6 million for the three months ended March 31, 2017. Research and development spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to Merrimacks refocused clinical and preclinical pipeline; |
| General and administrative expenses for the three months ended March 31, 2018 were $4.3 million, compared to $5.6 million for the three months ended March 31, 2017. General and administrative spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to a decrease in corporate expenses related to headcount levels following the asset sale to Ipsen S.A.; |
| Net loss from operations for the three months ended March 31, 2018 was $17.8 million, or $1.33 per share, compared to a net loss from continuing operations of $28.7 million, or $2.20 per share, for the three months ended March 31, 2017; |
| As of March 31, 2018, Merrimack had cash and cash equivalents and marketable securities of $76.3 million, compared to $93.4 million as of December 31, 2017; and |
| As of March 31, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding. |
Financial Outlook
Merrimack continues to believe that its cash and cash equivalents and marketable securities of $76.3 million as of March 31, 2018 and certain potential net milestone payments anticipated from Shire will be sufficient to fund its planned operations into the second half of 2019.
Conference Call and Webcast
Merrimack will host a live conference call and webcast today, Tuesday, May 8, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.
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 1596995. A listen-only webcast of the call can be accessed in the Investors section of Merrimacks website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.
About Merrimack
Merrimack is a biopharmaceutical company based in Cambridge, Massachusetts that is outthinking cancer to ensure that patients and their families live fulfilling lives. Its mission is to transform cancer care through the smart design and development of targeted solutions based on a deep understanding of cancer pathways and biological markers. All of Merrimacks development programs, including four clinical studies and six candidates in preclinical development, fit into its strategy of 1) understanding the biological problems it is trying to solve, 2) designing specific solutions and 3) developing those solutions for biomarker-selected patients. This three-pronged strategy seeks to ensure optimal patient outcomes. For more information, please visit Merrimacks website at www.merrimack.com.
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements include any statements about Merrimacks strategy, future operations, future financial position, future revenues and future expectations and plans and prospects for Merrimack, and any other statements containing the words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, continue and similar expressions. In this press release, Merrimacks forward-looking statements include, among others, statements about the timing of availability of clinical trial data, the anticipated achievement of milestones and the availability of funding sufficient to fund Merrimacks operations. Such forward-looking statements involve substantial risks and uncertainties that could cause Merrimacks clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the availability of data from ongoing clinical trials, expectations for regulatory approvals, development progress of Merrimacks companion diagnostics, availability of funding sufficient for Merrimacks foreseeable and unforeseeable operating expenses and capital expenditure requirements, and other matters that could affect the availability or commercial potential of Merrimacks product candidates or companion diagnostics. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing Merrimacks views as of any date subsequent to the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Merrimacks business in general, see the Risk Factors section of Merrimacks Annual Report on Form 10-K filed with the SEC on March 12, 2018 and the other reports Merrimack files with the SEC.
Merrimack Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
Three Months Ended March 31, |
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(in thousands, except per share amounts) | 2018 | 2017 | ||||||
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Operating expenses: |
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Research and development expenses |
$ | 13,106 | $ | 21,605 | ||||
General and administrative expenses |
4,270 | 5,634 | ||||||
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Total operating expenses |
17,376 | 27,239 | ||||||
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Loss from continuing operations |
(17,376 | ) | (27,239 | ) | ||||
Other income and expenses: |
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Interest income |
275 | 14 | ||||||
Interest expense |
| (1,979 | ) | |||||
Other income (expense), net |
(681 | ) | (2 | ) | ||||
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Total other income and expenses |
(406 | ) | (1,967 | ) | ||||
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Net loss from continuing operations |
(17,782 | ) | (29,206 | ) | ||||
Discontinued operations: |
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Loss from discontinued operations, net of tax |
| (947 | ) | |||||
Net loss |
(17,782 | ) | (30,153 | ) | ||||
Net loss attributable to non-controlling interest |
| (467 | ) | |||||
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Net loss attributable to Merrimack Pharmaceuticals, Inc. |
$ | (17,782 | ) | $ | (29,686 | ) | ||
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Other comprehensive loss: |
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Unrealized loss on marketable securities |
(12 | ) | | |||||
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Other comprehensive loss |
(12 | ) | | |||||
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Comprehensive loss |
$ | (17,794 | ) | $ | (29,686 | ) | ||
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Amounts attributable to Merrimack Pharmaceuticals, Inc.: |
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Net loss from continuing operations |
$ | (17,782 | ) | $ | (28,739 | ) | ||
Loss from discontinued operations, net of tax |
| (947 | ) | |||||
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Loss attributable to Merrimack Pharmaceuticals, Inc. |
$ | (17,782 | ) | $ | (29,686 | ) | ||
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Basic and dilutive net loss per common share |
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Net loss from continuing operations |
$ | (1.33 | ) | $ | (2.20 | ) | ||
Net loss from discontinued operations, net of tax |
| (0.07 | ) | |||||
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Net loss per share |
$ | (1.33 | ) | $ | (2.27 | ) | ||
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Weighted-average common shares used per share calculationsbasic and diluted |
13,343 | 13,059 |
Merrimack Pharmaceuticals, Inc.
Selected Balance Sheet Data (unaudited)
March 31, | December 31, | |||||||
(in thousands) | 2018 | 2017 | ||||||
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Cash and cash equivalents and marketable securities |
$ | 76,266 | $ | 93,441 | ||||
Working capital |
$ | 59,576 | $ | 75,269 | ||||
Total assets |
$ | 97,495 | $ | 117,326 | ||||
Total liabilities |
$ | 18,241 | $ | 21,042 | ||||
Total stockholders equity |
$ | 79,254 | $ | 96,284 |
CONTACT:
Geoffrey M. Grande, CFA
617-441-7602
ggrande@merrimack.com