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ROCKVILLE, Md., Nov. 03, 2022 (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 September 30, 2022.
“Over the past few months, we have strengthened our financial position by generating non-dilutive capital through our partnering efforts. We have achieved this through the receipt of $30 million in milestone payments from Incyte during the quarter and the subsequent receipt of a $60 million upfront payment from Gilead for our recently announced MGD024 collaboration. In addition, over the next few weeks, we await the U.S. Food and Drug Administration (FDA) decision regarding Provention Bio’s teplizumab biologics license application (BLA), which would generate an additional $60 million milestone payment obligation to MacroGenics, if approved,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Moreover, we are focused on advancing our pipeline of clinical and preclinical product candidates. We look forward to initiating the MGC018 TAMARACK study later this year, continuing to enroll the MGC018 combination study with lorigerlimab and the MGD024 dose-escalation study, as well as reporting data from the lorigerlimab monotherapy expansion cohorts in early 2023.”
Updates on Proprietary Investigational Programs
Recent progress and anticipated events related to MacroGenics’ investigational product candidates in clinical development are highlighted below.
Other Program Updates:
Gilead Collaboration
On October 14, 2022, MacroGenics and Gilead Sciences, Inc. entered into an exclusive option and collaboration agreement to develop MGD024 and up to two additional bispecific research programs. The agreement grants Gilead the option to license MGD024. As part of the agreement, Gilead paid MacroGenics an upfront payment of $60 million and MacroGenics will be eligible to receive up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones. MacroGenics will also be eligible to receive tiered, low double-digit royalties on worldwide net sales of MGD024 and a flat royalty on worldwide net sales of products resulting from the two additional research programs.
MacroGenics will be responsible for the ongoing Phase 1 study of MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points. The Phase 1 study includes a dose escalation segment and an expansion segment that is intended to evaluate MGD024 as monotherapy and in combination with other therapies across multiple indications.
Third Quarter 2022 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.
MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands) September 30, 2022 December 31, 2021Cash, cash equivalents and marketable securities$123,616 $243,616Total assets 195,347 335,245Deferred revenue 12,169 20,646Total stockholders' equity 122,958 239,618
MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Revenues: Collaborative and other agreements$35,674 $11,986 $59,630 $54,338 Product sales, net 4,371 3,591 12,623 7,681 Contract manufacturing 1,142 — 5,134 — Government agreements 547 85 1,455 1,281 Total revenues 41,734 15,662 78,842 63,300 Costs and expenses: Cost of product sales 3,007 1,665 3,235 1,704 Cost of manufacturing services 136 — 2,358 — Research and development 48,191 49,823 161,373 158,724 Selling, general and administrative 15,355 17,161 45,277 47,431 Total costs and expenses 66,689 68,649 212,243 207,859 Loss from operations (24,955) (52,987) (133,401) (144,559)Other income 142 101 841 466 Net loss (24,813) (52,886) (132,560) (144,093)Other comprehensive income (loss): Unrealized gain (loss) on investments 213 (4) (52) 4 Comprehensive income (loss)$(24,600) $(52,890) $(132,612) $(144,089) Basic and diluted net loss per common share$(0.40) $(0.86) $(2.16) $(2.42)Basic and diluted weighted average common shares outstanding 61,459,831 61,169,754 61,390,143 59,494,836
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, 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 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 MGC018, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to MGC018, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, the availability of financing to fund the 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, or 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.
CONTACTS:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com