ROCKVILLE, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended September 30, 2020.
“MacroGenics continued the advancement of its portfolio of multiple clinical molecules during the third quarter of 2020, with three investigational programs currently in pivotal studies: margetuximab, flotetuzumab and retifanlimab. The PDUFA action date for margetuximab in breast cancer is December 18. Just prior, we look forward to our next presentation of flotetuzumab clinical data at ASH in December, following the publication of data in three separate journals this year highlighting the medical and scientific interest in this DART® molecule,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "At ESMO in September, we and our partner, Incyte, presented clinical data on MGD019 and retifanlimab, respectively. And on the heels of MGC018 data presented at ASCO, we recently commenced the enrollment of patients with mCRPC, TNBC and NSCLC. More near-term, we look forward to providing an update on tebotelimab plus margetuximab in HER2-positive patients at the upcoming SITC Annual Meeting this month. Finally, we look forward to updating you on continued progress through the rest of 2020 and into 2021.”
Key Highlights from Investigational Product Candidates in Pivotal Studies:
Key Highlights from Other Investigational Product Candidates:
Third Quarter 2020 Financial Results
Conference Call Information
MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended September 30, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 5986584.
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
September 30, 2020 | December 31, 2019 | ||||||
(unaudited) | |||||||
Cash, cash equivalents and marketable securities | $ | 280,659 | $ | 215,756 | |||
Total assets | 374,380 | 312,501 | |||||
Deferred revenue | 15,037 | 19,853 | |||||
Total stockholders' equity | 291,585 | 230,628 |
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, | ||||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||||
Revenues: | |||||||||||||||||||
Revenue from collaborative and other agreements | $ | 17,415 | $ | 17,984 | $ | 46,018 | $ | 37,468 | |||||||||||
Revenue from government agreements | 838 | 757 | 6,174 | 1,528 | |||||||||||||||
Total revenues | 18,253 | 18,741 | 52,192 | 38,996 | |||||||||||||||
Costs and expenses: | |||||||||||||||||||
Research and development | 44,656 | 44,852 | 150,901 | 143,352 | |||||||||||||||
General and administrative | 9,732 | 11,833 | 30,181 | 34,174 | |||||||||||||||
Total costs and expenses | 54,388 | 56,685 | 181,082 | 177,526 | |||||||||||||||
Loss from operations | (36,135 | ) | (37,944 | ) | (128,890 | ) | (138,530 | ) | |||||||||||
Other income (expense) | 92 | (6,687 | ) | 1,238 | 17,115 | ||||||||||||||
Net loss | (36,043 | ) | (44,631 | ) | (127,652 | ) | (121,415 | ) | |||||||||||
Other comprehensive loss: | |||||||||||||||||||
Unrealized gain (loss) on investments | (15 | ) | (11 | ) | (14 | ) | 26 | ||||||||||||
Comprehensive loss | $ | (36,058 | ) | $ | (44,642 | ) | $ | (127,666 | ) | $ | (121,389 | ) | |||||||
Basic and diluted net loss per common share | $ | (0.66 | ) | $ | (0.91 | ) | $ | (2.49 | ) | $ | (2.54 | ) | |||||||
Basic and diluted weighted average common shares outstanding | 54,463,412 | 48,902,766 | 51,176,884 | 47,796,957 |
About MacroGenics, Inc.
MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing 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 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 the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, 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", "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: the uncertainties inherent in the initiation and enrollment of future clinical trials, 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, 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 disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), 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