CAMBRIDGE, Mass., May 10, 2019 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (Nasdaq: MACK), an oncology company focused
on biomarker-defined cancers, today announced its first quarter
2019 financial results for the period ended March 31, 2019.
"We continue to focus our efforts on completing the review of
our strategic alternatives through which we are committed to
optimizing value for our stockholders, including the
preservation of potential contractual milestone
payments Merrimack is eligible to receive," said Richard Peters, M.D., Ph.D., President and Chief
Executive Officer of Merrimack. "To that end, we have recently
implemented a series of measures to scale back operations and
strengthen our balance sheet."
Corporate Update
As previously announced, Merrimack has engaged external advisors
to explore the Company's strategic alternatives. In the first
quarter and more recently, Merrimack has implemented a series of
measures designed to preserve its current resources as part of
this ongoing process:
- In April 2019, Merrimack
terminated its Phase 1 study of MM-310 and discontinued the
program, following a comprehensive review of available safety data
indicating that the drug would not achieve an optimal therapeutic
index. In parallel, the Company announced it would close out all
remaining clinical activities;
- In April 2019, Merrimack
initiated a workforce reduction in connection with the Company's
decision to close out clinical activities and in line with prior
cost-cutting measures. Merrimack estimates that it will incur
approximately $1.5 million to
$1.7 million in one-time charges in
connection with this workforce reduction, which is expected to be
substantially completed by May 31,
2019;
- In April 2019, Merrimack retired
its outstanding debt with Hercules Capital ahead of schedule, which
totaled $16.0 million with interest
and fees; and
- In May 2019, Merrimack monetized
certain assets to strengthen its cash position. This includes the
sale of its equity position in Silver Creek Pharmaceuticals,
resulting in $7.8 million in cash,
and the auction of laboratory equipment from the Company's research
and development operations, resulting in approximately $1.3 million in cash.
Merrimack continues to operate with a narrow research footprint,
focused on two 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. Merrimack plans to prudently advance
these programs, with deference to the Company's ongoing strategic
process.
- At the American Association for Cancer Research (AACR) Annual
Meeting, held March 29 – April 3, 2019 in Atlanta, Georgia, Merrimack presented six
posters highlighting its preclinical work, of which three featured
MM-401 and two featured MM-201.
First Quarter 2019 Financial Results
The following summarizes Merrimack's financial results for the
three months ended March 31,
2019:
- Research and development expenses for the three months ended
March 31, 2019 were $6.4 million, compared to $13.1 million for the three months ended
March 31, 2018. Research and
development spending for the first quarter of 2019 was lower versus
the comparable period in 2018, primarily due to phasing and close
out of several clinical development programs;
- General and administrative expenses for the three months ended
March 31, 2019 were $3.7 million, compared to $4.3 million for the three months ended
March 31, 2018. General and
administrative spending for the first quarter of 2019 was less than
expenditures over the comparable period in 2018, primarily due to a
decrease in corporate expenses related to reduced headcount levels
and stock-based compensation;
- Net loss for the three months ended March 31, 2019 was $10.5
million, or $0.78 per share,
compared to a net loss attributable to Merrimack's continuing
operations of $17.8 million, or
$1.33 per share, for the three months
ended March 31, 2018; and
- As of March 31, 2019, Merrimack
had 13.3 million shares of common stock, $0.01 par value per share, outstanding.
Financial Outlook
As of March 31, 2019, Merrimack had cash, cash equivalents
and marketable securities of $58.5 million. Accounting for
events subsequent to the quarter close, together with possible
additional restructuring and cost-cutting measures that Merrimack
could implement in the future, but excluding any potential
contractual milestone payments, Merrimack continues to believe that
its cash position has the potential to fund
operations into at least the second half of 2022.
Merrimack remains eligible to receive additional milestone
payments from Servier and Ipsen, resulting from Merrimack's asset
sale to Ipsen in 2017:
- Merrimack is entitled to receive up to $5 million in milestones from Servier, triggered
by Ipsen and Servier's decision to progress their ongoing
multi-part clinical trial evaluating ONIVYDE in small-cell lung
cancer (SCLC) into the second randomized portion of the trial
focused on efficacy; and
- Merrimack is also entitled to receive up to an aggregate of
$450 million in regulatory-based
milestones from Ipsen, which Merrimack has said it expects to pass
through to its stockholders, net of any taxes owed and subject to
there being sufficient surplus at that time, consisting of:
-
- $225 million upon approval by the
FDA of ONIVYDE for the first-line treatment of metastatic
adenocarcinoma of the pancreas, subject to certain conditions;
- $150 million upon approval by the
FDA of ONIVYDE for the treatment of SCLC after failure of
first-line chemotherapy; and
- $75 million upon approval by the
FDA of ONIVYDE for an additional indication unrelated to those
described above.
About Merrimack
Merrimack is a biopharmaceutical company based
in Cambridge, Massachusetts focused on 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. For more information,
please visit Merrimack's 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 Merrimack's
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, Merrimack's forward-looking statements include,
among others, statements about expectations regarding Merrimack's
exploration of strategic alternatives and associated potential
outcomes, preservation of potential contractual milestone payments
and other resources, cash runway, anticipated achievement, receipt
and distribution of milestones, and ongoing research activities.
Such forward-looking statements involve substantial risks and
uncertainties that could cause Merrimack's 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 strategic review process,
expectations for achievement of contractual milestones,
availability of funding sufficient for Merrimack's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements, results from preclinical research, and other matters
that could affect the availability or commercial potential of
Merrimack's product candidates. Merrimack undertakes no
obligation to update or revise any forward-looking statements.
Forward-looking statements should not be relied upon as
representing Merrimack's 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 Merrimack's business in general, see the "Risk Factors"
section of Merrimack's Annual Report on Form 10-K filed
with the SEC on March 6,
2019 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,
|
|
(in thousands,
except per share amounts)
|
|
2019
|
|
2018
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development expenses
|
|
$
6,361
|
|
$
13,106
|
|
General and
administrative expenses
|
|
3,683
|
|
4,270
|
|
Total operating
expenses
|
|
10,044
|
|
17,376
|
|
Loss from
operations
|
|
(10,044)
|
|
(17,376)
|
|
Other income and
expenses:
|
|
|
|
|
|
Interest
income
|
|
365
|
|
275
|
|
Interest
expense
|
|
(478)
|
|
—
|
|
Other (expense)
income, net
|
|
(301)
|
|
(681)
|
|
Total other income
and expenses
|
|
(414)
|
|
(406)
|
|
Net loss
|
|
$
(10,458)
|
|
$
(17,782)
|
|
Net loss per common
share - basic and diluted
|
|
$
(0.78)
|
|
$
(1.33)
|
|
Weighted-average
common shares used to compute basic and
diluted net loss per common share
|
|
13,343
|
|
13,343
|
|
Comprehensive
loss:
|
|
|
|
|
|
Net loss
|
|
$
(10,458)
|
|
$
(17,782)
|
|
Unrealized gain
(loss) on marketable securities
|
|
9
|
|
(12)
|
|
Comprehensive
loss
|
|
$
(10,449)
|
|
$
(17,794)
|
Merrimack
Pharmaceuticals, Inc.
|
Selected Balance
Sheet Data (unaudited)
|
|
|
|
|
|
|
|
(in
thousands)
|
|
March 31,
2019
|
|
December 31,
2018
|
|
Cash, cash
equivalents and marketable securities
|
|
$
58,466
|
|
$
71,278
|
|
Working
capital
|
|
51,880
|
|
61,307
|
|
Total
assets
|
|
74,353
|
|
88,543
|
|
Total
liabilities
|
|
25,389
|
|
29,724
|
|
Total stockholders'
equity
|
|
48,964
|
|
58,819
|
CONTACT:
Josh Rappaport
212-362-1200
josh.rappaport@sternir.com
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SOURCE Merrimack Pharmaceuticals, Inc.