Merrimack Reports Second Quarter 2023 Financial Results
August 03 2023 - 4:30PM
Business Wire
Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or
the “Company”)] today announced its second quarter 2023 financial
results for the period ended June 30, 2023.
“We were excited to see the announcement from Ipsen that the
U.S. Food and Drug Administration (FDA) had accepted its
supplemental new drug application (sNDA) Onivyde® (irinotecan
liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin
(NALIRIFOX regimen) as a potential first-line treatment for
metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the
FDA had provided a Prescription Drug User Fee Act goal date of 13
February 2024 for review of the application” said Gary Crocker,
Chairman of Merrimack's Board of Directors. “We will continue to
monitor the progress of this program which, if approved, would
entitle Merrimack to a $225 million milestone payment from
Ipsen.”
Second Quarter 2023 Financial Results
Merrimack reported a net loss of $391 thousand for the second
quarter ended June 30, 2023, or $0.03 per basic and diluted share
on a fully diluted basis, compared to a net loss of $478 thousand,
or $0.04 per basic and diluted share on a fully diluted basis, for
the same period in 2022.
Interest income in the second quarter ended June 30, 2023, was
$178 thousand compared to $8 thousand for the same period in
2022.
General and administrative expenses for the second quarter ended
June 30, 2023, were $569 thousand, compared to $486 thousand for
the same period in 2022.
As of June 30, 2023, Merrimack had cash, cash equivalents and
short term investments of $19.0 million, compared to $19.4 million
as of December 31, 2022.
As of June 30, 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 June 2023, Ipsen announced that the U.S. Food and Drug
Administration (FDA) had accepted its supplemental new drug
application (sNDA) Onivyde® (irinotecan liposome injection) plus 5
fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a
potential first-line treatment for metastatic pancreatic ductal
adenocarcinoma (mPDAC) and that the FDA had provided a Prescription
Drug User Fee Act goal date of 13 February 2024 for review of the
application.
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803597427/en/
Tim Surgenor ir@merrimack.com
Merrimack Pharmaceuticals (NASDAQ:MACK)
Historical Stock Chart
From Apr 2024 to May 2024
Merrimack Pharmaceuticals (NASDAQ:MACK)
Historical Stock Chart
From May 2023 to May 2024