MacroGenics Provides Update On Corporate Progress And 1st Quarter 2017 Financial Results

ROCKVILLE, Md., May 03, 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 March 31, 2017.

“MacroGenics’ broad pipeline of clinical compounds continues to make encouraging progress. In addition to advancing our HER2 and B7-H3-based franchises, our PD-1-targeted franchise has matured with the submission of an IND related to MGD013, the first of our next-generation PD-1-based bispecific molecules with the potential for enhanced anti-tumor activity. By targeting the two different checkpoint molecules, PD-1 and LAG-3, MGD013 has demonstrated enhanced T-cell response in vitro versus what has been observed with targeting PD-1 or LAG-3 alone or in combination,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “I look forward to sharing updates on our other clinical programs and further defining our future development strategies over the course 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:

• Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics remains on track for completing enrollment of this study by late 2018.
• Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. MacroGenics expects to complete enrollment of this study in 2017.

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:

• Enoblituzumab: The Company continues to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a monotherapy study expanded to include additional bladder and prostate cancer cohorts and a combination study with an anti-PD-1 antibody.
• MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate expansion cohorts in multiple tumor types in 2017.
• MGC018: The Company is conducting activities to support an Investigational New Drug (IND) application for this anti-B7-H3 antibody drug conjugate in 2018. The Company’s poster on MGC018 at the recent American Association for Cancer Research (AACR) Annual Meeting showed that this molecule had potent in vivo antitumor activity.

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:

• MGA012. The Company’s proprietary anti-PD-1 monoclonal antibody is enrolling patients in the dose escalation segment of its Phase 1 clinical study and expects to define a target dose and schedule in 2017. With anti-PD-1 therapy becoming a mainstay of cancer treatment across multiple tumor types, MacroGenics believes MGA012 will be the basis for potential combination therapy with several of the molecules in its pipeline.
• MGD013. MacroGenics is developing MGD013, a DART molecule, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company recently submitted an IND for MGD013.
• PD-1 x CTLA-4. At the recent AACR meeting, MacroGenics featured a poster showing preclinical bispecific DART and trispecific TRIDENT™ molecules that bind to and inhibit ligand interaction with PD-1 and CTLA-4, resulting in enhanced T-cell activation. Combinatorial blockade of PD-1 and CTLA-4 has shown improved anti-tumor activity in the clinic. By targeting these clinically validated checkpoint molecules simultaneously, MacroGenics’ DART and TRIDENT proteins hold the promise of enhanced anti-tumor activity.

Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development include flotetuzumab (CD123 x CD3, also known as MGD006 and S80880); MGD007 (gpA33 x CD3); MGD010 (CD32B x CD79B); duvortuxizumab (CD19 x CD3, also known as MGD011), which is being developed by Janssen; and PF-06671008 (P-cadherin x CD3), which is being developed by Pfizer. Updates on three of these programs for which MacroGenics leads development include:

• Flotetuzumab. MacroGenics continues to recruit patients with acute myeloid leukemia or myelodysplastic syndrome in the U.S. and Europe in the Phase 1 study of flotetuzumab. The Company expects to establish a recommended dose and schedule as well as initiate expansion cohorts for this study in 2017.
• MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study. The Company expects to establish a recommended dose and schedule for MGD007 in 2017.
• MGD010. MacroGenics expects to present updated pharmacodynamic activity results from the completed Phase 1 study of MGD010 in June.

First Quarter 2017 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2017, were $248.1 million, compared to $285.0 million as of December 31, 2016. On May 2, 2017, the Company completed the sale of 1,100,000 shares of its common stock at a purchase price of $21.50 per share to an institutional healthcare investor in a registered direct offering. Gross proceeds to the Company, before deducting estimated offering expenses, were $23.7 million.
• Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.1 million for the quarter ended March 31, 2017, compared to $2.8 million for the quarter ended March 31, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the period.
• R&D Expenses: Research and development expenses were $32.8 million for the quarter ended March 31, 2017, compared to $27.3 million for the quarter ended March 31, 2016. This increase was primarily due to the initiation of a Phase 1 clinical trial of MGA012 in late 2016, continued enrollment in the margetuximab SOPHIA study and increased activity in the Company’s other preclinical and clinical programs. These increases were partially offset by a decrease in duvortuxizumab manufacturing costs, which are reimbursed by our collaborator.
• G&A Expenses: General and administrative expenses were $7.5 million for the quarter ended March 31, 2017, compared to $6.1 million for the quarter ended March 31, 2016. This increase was primarily due to increased professional fees, including consulting expenses, and increased employee compensation and benefit expense to support our overall growth.
• Net Loss: Net loss was $37.7 million for the quarter ended March 31, 2017, compared to net loss of $30.4 million for the quarter ended March 31, 2016.
• Shares Outstanding: Shares outstanding as of March 31, 2017 were 34,980,433.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (EDT) to discuss financial results for the quarter ended March 31, 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: 9279413.

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.