Merrimack Reports First Quarter 2023 Financial Results
04 Maio 2023 - 6:00PM
Business Wire
Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or
the “Company”)] today announced its first quarter 2023 financial
results for the period ended March 31, 2023.
“During the first quarter of 2023 our operating expenses
remained consistent with prior quarters and were reduced both by
proceeds we received from the receipt of an option fee paid in
connection with the entry into an asset purchase option agreement
on a preclinical asset and increased interest income” said Gary
Crocker, Chairman of Merrimack's Board of Directors. “We continue
to be focused on maintaining cash balances that will allow us to be
in a position to receive potential milestone payments from Ipsen
and Elevation under the programs that we previously sold to
them.”
First Quarter 2023 Financial Results
Merrimack reported a net loss of $271 thousand for the first
quarter ended March 31, 2023, or $0.02 per basic and diluted share
on a fully diluted basis, compared to a net loss of $132 thousand,
or $0.01 per basic and diluted share on a fully diluted basis, for
the same period in 2022.
Merrimack reported a gain on the sale of assets for the first
quarter ended March 31, 2023, of $139 thousand, attributable to an
asset purchase option agreement on a preclinical program, compared
to $445 thousand related to an asset sale in the same period in
2022.
Interest income in the first quarter ended March 31, 2023, was
$176 thousand compared to no interest income for the same period in
2022.
General and administrative expenses for the first quarter ended
March 31, 2023, were $586 thousand, compared to $577 thousand for
the same period in 2022.
As of March 31, 2023, Merrimack had cash and cash equivalents of
$19.4 million, compared to $19.4 million as of December 31,
2022.
As of March 31, 2023, Merrimack had 14.3 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.
On March 14, 2021 Elevation Oncology announced that it would be
presenting two posters on NRG1 fusions, including updated data from
the Phase 2 CRESTONE study evaluating seribantumab in patients with
solid tumors harboring NRG1 fusions at the American Association for
Cancer Research (AACR) Annual Meeting 2023, being held April 14-19,
2023. If Elevation elects not to proceed with seeking regulatory
approval, or if regulatory approval is not obtained, Merrimack
would not be entitled to the $54.5 million in additional potential
development, regulatory approval and commercial-based milestone
payments.
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. 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. 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 Onivyde® and 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. 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. 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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Tim Surgenor ir@merrimack.com
Merrimack Pharmaceuticals (NASDAQ:MACK)
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