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ROCKVILLE, Md., May 09, 2023 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended March 31, 2023.
“The recent U.S. Food and Drug Administration (FDA) approval of Incyte’s ZYNYZ (retifanlimab-dlwr) represents the third U.S. marketing clearance of a product originating from MacroGenics’ pipeline of proprietary or partnered product candidates. We are delighted that the approval of ZYNYZ provides an additional option for treating patients with Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. “With the approval of both ZYNYZ and TZIELD™ (teplizumab-mzwv) by our partners, MacroGenics remains eligible to receive more than $1 billion in milestone payments related to the continued advancement and successful commercialization of these two products. Over the past nine months, these and other programs have allowed us to generate $270 million in non-dilutive capital, extending our cash runway through 2025.”
Updates on Proprietary Investigational Programs
Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.
Other Corporate Updates
First Quarter 2023 Financial Results
Conference Call Information
To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.
The listen-only webcast of the conference call can be accessed under “Events & Presentations” in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|(Amounts in thousands)|
|March 31, 2023||December 31, 2022|
|Cash, cash equivalents and marketable securities||$||241,656||$||154,346|
|Total stockholders’ equity||109,268||142,013|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(Amounts in thousands, except share and per share data)
|Three Months Ended March 31,|
|Collaborative and other agreements||$||16,686||$||7,093|
|Product sales, net||3,490||3,580|
|Costs and expenses:|
|Cost of product sales||113||48|
|Cost of manufacturing services||3,410||—|
|Research and development||45,872||61,438|
|Selling, general and administrative||13,527||16,253|
|Total costs and expenses||62,922||77,739|
|Loss from operations||(38,426||)||(66,638||)|
|Interest and other income, net||1,073||195|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on investments||13||(222||)|
|Basic and diluted net loss per common share||$||(0.61||)||$||(1.08||)|
|Basic and diluted weighted average common shares outstanding||61,809,817||61,324,163|
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical company focused on developing 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, MARGENZA and DART 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; 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.
Jim Karrels, Senior Vice President, CFO
Source: MacroGenics, Inc.