MacroGenics Announces Achievement of $100 Million in Milestones Related to Retifanlimab Collaboration with Incyte
July 30 2024 - 3:01PM
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on discovering, developing, manufacturing and
commercializing innovative antibody-based therapeutics for the
treatment of cancer, today announced the achievement of $100
million in milestones from Incyte Corporation related to
development progress of ZYNYZ® (retifanlimab-dlwr), following an
agreement on July 24, 2024, pursuant to which certain milestones
were deemed to have been met. ZYNYZ is an intravenous PD-1
inhibitor indicated in the U.S. for the treatment of adult patients
with metastatic or recurrent locally advanced Merkel cell
carcinoma. ZYNYZ is a monoclonal antibody initially developed by
MacroGenics and licensed to Incyte under a 2017 exclusive global
collaboration and license agreement. Incyte and its collaborators
continue to pursue development of retifanlimab in other
indications, which include both monotherapy and combination
regimens.
Under the 2017 collaboration agreement with Incyte, MacroGenics
received an upfront payment of $150 million and has achieved a
total of $215 million in milestones, including the recent $100
million described above. MacroGenics remains eligible to receive up
to a total of $210 million in potential development and regulatory
milestones and up to $330 million in potential commercial
milestones. MacroGenics receives tiered royalties, which range from
15 to 24 percent, on worldwide net sales of ZYNYZ.
MacroGenics expects to provide its June 30, 2024 cash, cash
equivalents and marketable securities balance in its second quarter
earnings announcement on or around August 6, 2024. The Company
currently anticipates that its June 30, 2024 cash balance plus the
$100 million in milestones achieved from Incyte, in addition to
projected and anticipated future payments from partners and product
revenues should support its cash runway into 2026. The Company’s
expected funding requirements reflect anticipated expenditures
related to its ongoing clinical and preclinical studies.
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical company focused
on discovering, developing, manufacturing and commercializing
innovative monoclonal antibody-based therapeutics for the treatment
of cancer. The Company generates its pipeline of product candidates
primarily from its proprietary suite of next-generation
antibody-based technology platforms, which have applicability
across broad therapeutic domains. The combination of MacroGenics'
technology platforms and protein engineering expertise has allowed
the Company to generate promising product candidates and enter into
several strategic collaborations with global pharmaceutical and
biotechnology companies. For more information, please see the
Company's website at www.macrogenics.com. MacroGenics, the
MacroGenics logo, and MARGENZA are trademarks or registered
trademarks of MacroGenics, Inc.
Cautionary Note on Forward-Looking
Statements
Any statements in this press release about future expectations,
plans and prospects for MacroGenics (“Company”), including
statements about the Company’s strategy, future operations,
clinical development of the Company’s therapeutic candidates,
including initiation and enrollment in clinical trials, expected
timing of results from clinical trials, discussions with regulatory
agencies, commercial prospects of or product revenues from MARGENZA
and the Company’s product candidates, if approved, manufacturing
services revenue, milestone or opt-in payments from the Company’s
collaborators, the Company’s anticipated milestones and future
expectations and plans and prospects for the Company, as well as
future global net sales of TZIELD and the Company’s ability to
achieve the milestone payments set forth under the terms of the
agreement with DRI (or its successors or assigns with respect to
such agreement), and other statements containing the words “subject
to”, "believe", “anticipate”, “plan”, “expect”, “intend”,
“estimate”, “potential,” “project”, “may”, “will”, “should”,
“would”, “could”, “can”, the negatives thereof, variations thereon
and similar expressions, or by discussions of strategy constitute
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: risks that TZIELD, vobramitamab
duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product
candidate’s revenue, expenses and costs may not be as expected,
risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab,
ZYNYZ, MARGENZA or any other product candidate’s market acceptance,
competition, reimbursement and regulatory actions; future data
updates, especially with respect to vobramitamab duocarmazine; our
ability to provide manufacturing services to our customers; the
uncertainties inherent in the initiation and enrollment of future
clinical trials; the availability of financing to fund the internal
development of our product candidates; expectations of expanding
ongoing clinical trials; availability and timing of data from
ongoing clinical trials; expectations for the timing and steps
required in the regulatory review process; expectations for
regulatory approvals; expectations of future milestone payments;
the impact of competitive products; our ability to enter into
agreements with strategic partners and other matters that could
affect the availability or commercial potential of the Company's
product candidates; business, economic or political disruptions due
to catastrophes or other events, including natural disasters,
terrorist attacks, civil unrest and actual or threatened armed
conflict, or public health crises such as the novel coronavirus
(referred to as COVID-19 pandemic); and other risks described in
the Company's filings with the Securities and Exchange Commission.
In addition, the forward-looking statements included in this press
release represent the Company's views only as of the date hereof.
The Company anticipates that subsequent events and developments
will cause the Company's views to change. However, while the
Company may elect to update these forward-looking statements at
some point in the future, the Company specifically disclaims any
obligation to do so, except as may be required by law. These
forward-looking statements should not be relied upon as
representing the Company's views as of any date subsequent to the
date hereof.
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CONTACTS:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com
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