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ROCKVILLE, Md., Nov. 08, 2017 (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, as well as autoimmune disorders and infectious diseases, today provided a corporate progress update and reported financial results for the quarter ended September 30, 2017.
“We continue to be encouraged by data we’ve seen across multiple product candidates in our diverse pipeline. At the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting later this week, we will have five posters relating to our various PD-1-based programs, including MGA012 (anti-PD-1) and our two PD-1-based DART® molecules,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Also, in addition to the Phase 1 flotetuzumab data presented recently at the European Society for Medical Oncology Annual Congress (ESMO), we look forward to having two posters and an oral presentation with updated clinical data, at the 59th Annual Meeting of the American Society of Hematology (ASH) in December. Finally, we are thrilled to work with our new collaboration partner, Incyte, to expand the current development efforts for MGA012 and accelerate our own efforts to investigate combinations of MGA012 with multiple molecules in MacroGenics’ portfolio.”
Key Pipeline Highlights
Flotetuzumab. Enrollment of the Phase 1 dose expansion study of flotetuzumab, a bispecific DART molecule that recognizes both CD123 and CD3, is ongoing in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Recent highlights include:
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which are designed to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are:
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen's broad expression across multiple solid tumor types. These molecules include:
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:
Additional DART Clinical Programs. Other DART molecules being led by MacroGenics in Phase 1 clinical development include MGD007 (gpA33 x CD3) for colorectal cancer and MGD014 (HIV x CD3) for HIV. Updates on these programs include:
Third Quarter 2017 Financial Results
Conference Call Information
MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 2017 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (+1) (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 5477659.
The recorded, 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)
|September 30, 2017||December 31, 2016|
|Cash, cash equivalents and investments||$||203,647||$||284,982|
|Total stockholders' equity||189,465||268,751|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Revenue from collaborative agreements||$1,076||$2,014||$3,435||$82,404|
|Revenue from government agreements||587||1,241||1,948||4,370|
|Costs and expenses:|
|Research and development||40,984||30,296||108,246||90,982|
|General and administrative||8,403||7,224||24,249||20,596|
|Total costs and expenses||49,387||37,520||132,495||111,578|
|Loss from operations||(47,724||)||(34,265||)||(127,112||)||(24,804||)|
|Other comprehensive loss:|
|Unrealized gain (loss) on investments||56||(41||)||55||23|
|Basic and diluted net loss per common share||($1.28||)||($0.97||)||($3.50||)||($0.69||)|
|Basic and diluted weighted average common shares outstanding||36,779,305||34,766,440||35,847,449||34,629,330|
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, as well as autoimmune disorders and infectious diseases. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. 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
Karen Sharma, Senior Vice President
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