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ROCKVILLE, Md., May 01, 2019 (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 March 31, 2019.
“In February, we reported topline results from SOPHIA showing that in the Phase 3 trial, progression-free survival was prolonged following treatment with margetuximab and chemotherapy compared to trastuzumab with chemotherapy. We look forward to presenting detailed results at ASCO. In addition, we anticipate submitting a BLA for this program to the FDA in the second half of 2019. If approved by regulators, margetuximab could offer the potential of a new treatment option for patients living with HER2-positive metastatic breast cancer in a third line and beyond setting where there are currently no FDA-approved therapies. In seeking to address unmet needs of patients with HER2-postive cancers beyond breast cancer, we plan to initiate in the second half of 2019 a registration-directed trial to evaluate margetuximab for treating gastric cancer patients in the frontline setting,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.
“Mechanistically, we believe the results achieved in the SOPHIA study have validated our Fc-optimization technology, also used in enoblituzumab, our investigational monoclonal antibody targeting B7-H3,” continued Dr. Koenig. “To date, we have made tremendous progress with our immuno-oncology pipeline of nine clinical product candidates with multiple molecules demonstrating clinical proof of concept to support ongoing and/or planned registration studies.”
Key Pipeline Updates
Margetuximab. Recent updates related to the Company’s investigational Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2) include:
B7-H3 Franchise. MacroGenics is developing a portfolio of investigational antibody-based therapeutics that target B7-H3 through complementary mechanisms of action taking advantage of this antigen's broad expression across multiple solid tumor types. Recent program highlights include:
PD-1 Franchise. MacroGenics is advancing multiple investigational PD-1-directed programs to provide differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:
Flotetuzumab. A recent update related to the Company’s investigational, bispecific DART molecule that recognizes both CD123 and CD3, includes:
First Quarter 2019 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 March 31, 2019 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 8788605.
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.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
March 31, 2019
|December 31, 2018|
|Cash, cash equivalents and marketable securities||$||320,391||$||232,863|
|Total stockholders' equity||320,617||242,877|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended March 31,|
|Revenue from collaborative agreements||$||9,497||$||4,501|
|Revenue from government agreements||165||194|
|Costs and expenses:|
|Research and development||47,060||45,670|
|General and administrative||10,219||9,235|
|Total costs and expenses||57,279||54,905|
|Loss from operations||(47,617||)||(50,210||)|
|Other comprehensive loss:|
|Unrealized gain on investments||3||39|
|Basic and diluted net loss per common share||$||(0.99||)||$||(1.34||)|
|Basic and diluted weighted average number of common shares||45,606,651||36,936,560|
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, DART® and TRIDENT 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 regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates 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
Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
MacDougall Biomedical Communications
Karen Sharma, Senior Vice President