ROCKVILLE, Md., Aug. 02, 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 June 30, 2017.
"MacroGenics' broad portfolio of product candidates continues to advance. We are very encouraged by the data we've seen to date in our Phase 1 study of flotetuzumab, a CD123 x CD3 bispecific DART® molecule, and we look forward to presenting the updated interim results from this trial in an oral presentation at ESMO in September," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In addition, we continue to make progress with margetuximab, our B7-H3-based franchise and our PD-1-targeted franchise. During the second quarter, our IND for MGD013, which targets PD-1 and LAG-3, was cleared by FDA and we expect to dose the first patients in the coming weeks. I look forward to sharing updates on our pipeline and further defining our future development strategies over the remainder of the year."
Key Pipeline Highlights
Margetuximab. Recent highlights related to the Company's Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:
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:
PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which will 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:
Additional DART Clinical Programs. Other DART molecules being led by MacroGenics in Phase 1 clinical development include flotetuzumab (CD123 x CD3, also known as MGD006 and S80880), MGD007 (gpA33 x CD3) and MGD010 (CD32B x CD79B). Updates on these programs include:
Second Quarter 2017 Financial Results
Conference Call Information
MacroGenics will host a conference call today at 4:30 pm (EDT) to discuss financial results for the quarter ended June 30, 2017 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: 50966747.
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)|
|June 30, 2017||December 31, 2016|
|Cash, cash equivalents and investments||$||243,660||$||284,982|
|Total stockholders' equity||231,348||268,751|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|(Amounts in thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Revenue from collaborative agreements||$||1,081||$||78,497||$||2,359||$||80,390|
|Revenue from government agreements||585||2,176||1,361||3,129|
|Costs and expenses:|
|Research and development||34,461||33,340||67,262||60,686|
|General and administrative||8,384||7,239||15,846||13,372|
|Total costs and expenses||42,845||40,579||83,108||74,058|
|Income (loss) from operations||(41,179||)||40,094||(79,388||)||9,461|
|Net income (loss)||(40,654||)||40,464||(78,310||)||10,101|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on investments||25||7||(1||)||64|
|Comprehensive income (loss)||$||(40,629||)||$||40,471||$||(78,311||)||$||10,165|
|Basic net income (loss) per common share||($1.14||)||$1.17||($2.21||)||$0.29|
|Diluted net income (loss) per common share||($1.14||)||$1.12||($2.21||)||$0.28|
|Basic weighted average number of common shares outstanding||35,784,804||34,616,197||35,373,799||34,560,021|
|Diluted weighted average number of common shares outstanding||35,784,804||36,017,411||35,373,799||35,966,987|
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.
Contacts: Jim Karrels, Senior Vice President, CFO MacroGenics, Inc. 1-301-251-5172, firstname.lastname@example.org Karen Sharma, Senior Vice President MacDougall Biomedical Communications 1-781-235-3060, email@example.com