Merrimack Reports Full Year 2022 Financial Results
09 Mars 2023 - 10:40PM
Business Wire
Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) (“Merrimack” or
the “Company”) today announced its full year 2022 financial results
for the period ended December 31, 2022.
“We are encouraged by the results of the NAPOLI 3 trial as
reported by Ipsen in November 2022 and the guidance that Ipsen has
subsequently provided regarding its intention to file a
supplemental New Drug Application with the U.S. Food and Drug
Administration for Onivyde® in previously untreated patients with
metastatic pancreatic ductal adenocarcinoma (“mPDAC”), which could
lead to a potential future milestone payment from Ipsen” said Gary
Crocker, CEO and Chairman of Merrimack’s Board of Directors. “As a
result of the exercise of stock options during the fourth quarter
of 2022 and continued reductions in our operating expenses during
2022 we expect that our cash and cash equivalents as of December
31, 2022, will be sufficient to continue our operations beyond
2027, which we estimate to be the latest date when the longest-term
potential Ipsen milestone may be achieved.”
Full Year 2022 Financial Results
Merrimack reported net loss of $1.5 million for the year ended
December 31, 2022, or $0.11 per basic share, compared to a net loss
of $2.5 million, or $0.18 per basic share, for the same period in
2021.
Merrimack reported a gain on sale of assets for the year ended
December 31, 2022, of $0.4 million compared to $0.1 million for the
same period in 2021.
General and administrative expenses for the year ended December
31, 2022 were $2.2 million, compared to $2.6 million for the same
period in 2021.
As of December 31, 2022, Merrimack had cash and cash equivalents
of $19.4 million, compared to $14.2 million as of December 31, 2021
The increase in cash was primarily a result of $6.5 million of
proceeds from the exercise of stock options.
As of December 31, 2022, Merrimack had 14.2 million shares of
common stock outstanding.
Updates on Programs Underlying Potential Milestone
Payments
Ipsen
Metastatic Pancreatic Ductal
Adenocarcinoma
- In November 2022, Ipsen announced the Phase III NAPOLI 3 trial
of Onivyde (irinotecan liposome injection) plus
5-fluorouracil/leucovorin and oxaliplatin (the “NALIRIFOX regimen”)
met its primary endpoint demonstrating clinically meaningful and
statistically significant improvement in overall survival compared
to nab-paclitaxel plus gemcitabine in 770 previously untreated
patients with mPDAC and key secondary efficacy outcome of
progression-free survival (PFS) also showed significant improvement
over the comparator arm. Ipsen also announced that the safety
profile of Onivyde in the NAPOLI 3 trial was consistent with those
observed in the previous phase I/II mPDAC study.
- In January 2023, Ipsen presented clinical trial results at the
2023 American Society of Clinical Oncology (ASCO) Gastrointestinal
Cancers Symposium.
- In February 2023 Ipsen provided guidance to investors that it
intends to file a supplemental New Drug Application with the U.S.
Food and Drug Administration during the first half of 2023
following the Fast Track Designation granted in 2020 for the use of
Onivyde in combination with oxaliplatin plus
5-fluorouracil/leucovorin for the treatment of patients with
previously untreated mPDAC.
Small Cell Lung Cancer
- In August 2022, Ipsen announced that the Phase III RESILIENT
trial did not meet its primary endpoint of overall survival
compared to topotecan. The trial is evaluating Onivyde versus
topotecan in patients with small cell lung cancer, who have
progressed on or after platinum-based first-line therapy treatment.
In the announcement, Ipsen indicated that detailed results from the
RESILIENT trial would be presented at an upcoming medical
conference. The analysis concluded that the primary endpoint
overall survival was not met in patients treated with Onivyde
versus topotecan. However, a doubling of the secondary endpoint of
objective response rate in favor of Onivyde was observed. In the
August 2022 announcement, Ipsen reported that the clinical study
results would be communicated with the regulatory agency. Ipsen
indicated that while the results from the analysis of the RESILIENT
trial have not demonstrated an overall survival benefit with
Onivyde in patients in second-line small cell lung cancer, Ipsen
intends to analyze the data further before decisions regarding next
steps are made.
- To date, there have been no further announcements by Ipsen
regarding these matters and it remains unclear as to whether Ipsen
will continue to seek approval for the use of Onivyde in the small
cell lung cancer application. If Ipsen elects not to proceed with
seeking regulatory approval, or if regulatory approval is not
obtained, Merrimack would not be entitled to the $150 million
milestone payment tied to FDA approval of Onivyde for treatment of
small cell lung cancer.
Elevation Oncology
- In January 2023, Elevation announced it is pausing further
investment in the clinical development of seribantumab and intends
to pursue further development only in collaboration with a partner.
Elevation also announced that it intends to present additional
interim data from its study of seribantumab in the first half of
2023.
About Merrimack
Merrimack Pharmaceuticals, Inc. is a biopharmaceutical company
based in Cambridge, Massachusetts that is entitled to receive up to
$450.0 million in contingent milestone payments related to its sale
of Onivyde® to Ipsen S.A. in April 2017. $225 million of these
potential milestone payments are tied to the first line metastatic
pancreatic ductal adenocarcinoma potential indication, $150 million
of these potential milestone payments are tied to the small cell
lung cancer potential indication, and $75 million is tied to other
potential applications Ipsen may elect to pursue. These milestone
payments would be payable by Ipsen upon approval by the U.S. Food
and Drug Administration (“FDA”) of Onivyde for certain additional
clinical indications. Onivyde® is already approved by the FDA in
combination with fluorouracil (5-FU) and leucovorin (LV) for the
treatment of patients with metastatic adenocarcinoma of the
pancreas after disease progression following gemcitabine-based
therapy. This existing approval is unrelated to any future
potential milestone payments. Merrimack’s agreement with Ipsen does
not require Ipsen to provide Merrimack with any information on the
progress of Onivyde clinical trials that is not publicly available.
Merrimack is also entitled to receive up to $54.5 million in
contingent milestone payments related to its sale of anti-HER3
programs to Elevation Oncology (formerly 14ner Oncology, Inc.) in
July 2019.
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, Merrimack’s rights to receive payments related to
certain milestone events or whether such milestones will be
achieved, if at all, the sufficiency of Merrimack’s cash resources
and Merrimack’s strategic plan, including any potential
distribution of additional cash to Merrimack’s shareholders. Such
forward-looking statements involve substantial risks and
uncertainties that could cause Merrimack’s 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: Positive information about
pre-clinical and early stage clinical trial results does not ensure
that later stage or larger scale clinical trials will be
successful. For example, Onivyde® may not demonstrate promising
therapeutic effect or appropriate safety profiles in current or
later stage or larger scale clinical trials as a result of known or
as yet unanticipated side effects. The results achieved in later
stage trials may not be sufficient to meet applicable regulatory
standards or to justify further development. Problems or delays may
arise prior to the initiation of planned clinical trials, during
clinical trials or in the course of developing, testing or
manufacturing that could lead Ipsen and Elevation Oncology and
their partners and collaborators to fail to initiate or to
discontinue development. Even if later stage clinical trials are
successful, unexpected concerns may arise from subsequent analysis
of data or from additional data. Obstacles may arise or issues may
be identified in connection with review of clinical data with
regulatory authorities. Regulatory authorities may disagree with
Ipsen and Elevation Oncology’s view of the data or require
additional data or information or additional studies. In addition,
the planned timing of initiation and completion of clinical trials
based upon Onivydeand the anti-HER Program are subject to the
ability of each of Ipsen and Elevation Oncology, respectively, to
enroll patients, enter into agreements with clinical trial sites
and investigators, and overcome technical hurdles and other issues
related to the conduct of the trials for which each of them is
responsible and, with regard to Elevation Technology, access to
adequate capital to conduct such trials. Additionally, each of
Ipsen and Elevation Oncology are subject to the risk that they may
not successfully commercialize these development programs.
Merrimack is also subject to the risk that it may not have funding
sufficient for its foreseeable and unforeseeable operating expenses
and capital expenditure requirements. In addition, press releases
and other public statements by Ipsen and Elevation Oncology may
contain forward-looking statements which may later prove to be
inaccurate. 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 9, 2023, any subsequent quarterly report on
Form 10-Q filed by Merrimack and the other reports Merrimack files
with the Securities and Exchange Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20230309005633/en/
Tim Surgenor ir@merrimack.com
Merrimack Pharmaceuticals (NASDAQ:MACK)
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