MacroGenics Announces Achievement of $100 Million in Milestones Related to Retifanlimab Collaboration with Incyte

Rhea-AI Summary

MacroGenics (NASDAQ: MGNX) has achieved $100 million in milestones from Incyte related to the development of ZYNYZ® (retifanlimab-dlwr), a PD-1 inhibitor for treating Merkel cell carcinoma. This milestone is part of a 2017 collaboration agreement, under which MacroGenics has now received $215 million in total milestones. The company remains eligible for up to $540 million in additional milestones and tiered royalties of 15-24% on ZYNYZ's worldwide net sales. MacroGenics expects its current cash balance, including the recent $100 million, along with projected future payments and revenues, to support its operations into 2026.

Positive

• Achieved $100 million in milestones from Incyte
• Total milestones received under the collaboration agreement reached $215 million
• Eligible for up to $540 million in additional potential milestones
• Receives tiered royalties of 15-24% on ZYNYZ worldwide net sales
• Cash runway extended into 2026

Negative

• None.

Financial Analyst

The achievement of $100 million in milestones by MacroGenics (NASDAQ: MGNX) marks a significant financial boost for the company. This influx of capital, stemming from their collaboration with Incyte on ZYNYZ® (retifanlimab-dlwr), substantially strengthens MacroGenics' financial position. The company has now received a total of $215 million in milestone payments from this partnership, on top of the initial $150 million upfront payment.

What's particularly noteworthy is the impact on MacroGenics' cash runway. The company now projects its cash reserves will last into 2026, a considerable extension that provides important breathing room for its ongoing R&D efforts. This extended runway is vital in the capital-intensive biotech sector, where cash burn is a constant concern.

Moreover, the potential for additional milestone payments - up to $210 million in development and regulatory milestones and $330 million in commercial milestones - presents significant upside. The tiered royalty structure of 15% to 24% on ZYNYZ's global net sales could become a substantial revenue stream if the drug gains traction in the market.

From an investor's perspective, this news reduces near-term financing risks and potentially delays the need for dilutive equity raises. However, it's important to monitor the progress of ZYNYZ in other indications and its commercial performance, as these will ultimately determine the long-term value of this collaboration for MacroGenics.

Oncology Expert

The FDA approval of ZYNYZ® (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma represents a significant advancement in the treatment landscape for this rare and aggressive skin cancer. As a PD-1 inhibitor, ZYNYZ harnesses the power of immunotherapy, a approach that has shown remarkable efficacy in various cancers.

What's particularly intriguing is Incyte's pursuit of retifanlimab's development in other indications, both as a monotherapy and in combination regimens. This broad development strategy could potentially expand the drug's utility across multiple cancer types, significantly increasing its market potential.

However, it's important to note that the PD-1/PD-L1 inhibitor market is highly competitive, with established players like Merck's Keytruda and Bristol Myers Squibb's Opdivo dominating the field. ZYNYZ will need to demonstrate superior efficacy or a better safety profile in its ongoing trials to carve out a significant market share.

The success of ZYNYZ in Merkel cell carcinoma and its potential in other indications could have far-reaching implications for cancer treatment. Investors should closely monitor the results of ongoing clinical trials, as positive outcomes could significantly boost both Incyte's and MacroGenics' market positions in the oncology space.

Confirming cash runway guidance into 2026

ROCKVILLE, MD, July 30, 2024 (GLOBE NEWSWIRE) --  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.

###

FAQ

What milestone did MacroGenics (MGNX) achieve in July 2024?

MacroGenics achieved $100 million in milestones from Incyte related to the development progress of ZYNYZ® (retifanlimab-dlwr).

How much has MacroGenics (MGNX) received in total milestones from the Incyte collaboration?

MacroGenics has received a total of $215 million in milestones from the Incyte collaboration, including the recent $100 million.

What is ZYNYZ® and what is it used for?

ZYNYZ® (retifanlimab-dlwr) 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.

How long does MacroGenics (MGNX) expect its cash runway to last?

MacroGenics anticipates that its current cash balance, including the $100 million milestone payment, along with projected future payments and revenues, will support its operations into 2026.