On November 6, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2019 (Press release, MacroGenics, NOV 6, 2019, View Source [SID1234550477]).
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"MacroGenics’ most advanced programs are positioned to initiate or complete registration-directed studies over the next year," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We look forward to presenting detailed data from the second interim OS analysis of SOPHIA, the Phase 3 study comparing margetuximab to trastuzumab in patients with metastatic HER2-positive breast cancer at the San Antonio Breast Cancer Symposium in December. We believe that our molecule, if approved, will address an important unmet need for patients. We continue our activities in preparation for a BLA submission before the end of the year."
Advances in Key Portfolio Programs
Margetuximab: is an investigational, Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2) being developed for metastatic breast and gastric cancer.
Breast Cancer: MacroGenics reported topline results from the second interim analysis of overall survival (OS) from SOPHIA, the Phase 3 clinical trial of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. Detailed results are scheduled for an oral presentation at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2019. MacroGenics expects to submit a Biologics License Application (BLA) to the U.S. FDA before the end of 2019.
Gastric Cancer: MacroGenics recently initiated MAHOGANY, a Phase 2/3 registration-directed clinical trial of margetuximab in combination with either MGA012 (anti-PD-1 mAb) or MGD013 (bispecific PD-1 x LAG-3 DART molecule) in first-line patients with HER2-positive gastroesophageal adenocarcinoma (GEA). The MAHOGANY study is based on results from an ongoing Phase 2 study of margetuximab plus pembrolizumab, an anti-PD-1 mAb, for patients with advanced HER2-positive GEA who have previously been treated with chemotherapy and trastuzumab. These data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in September 2019.
Flotetuzumab: is an investigational, bispecific CD123 x CD3 DART molecule being evaluated in acute myeloid leukemia (AML). A Phase 1 monotherapy study enrolled 50 patients with relapsed or refractory AML at the recommended Phase 2 dose. Data from a subset of 30 patients with refractory AML are scheduled for an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 9, 2019. MacroGenics continues to develop flotetuzumab in this refractory patient population. The Company also recently initiated a clinical study with flotetuzumab in combination with MGA012 in relapsed or refractory AML.
Exhibit 99.1
MGA012 (INCMGA0012): is an investigational, anti-PD-1 mAb exclusively licensed to Incyte Corporation on a worldwide basis. Incyte is pursuing development of MGA012 monotherapy in three ongoing, potentially registration-directed trials with initial data expected in 2020. In addition, Incyte and MacroGenics are each conducting studies of MGA012 in combination with other product candidates.
MGD013: is an investigational, first-in-class bispecific PD-1 x LAG-3 DART molecule being evaluated in Phase 1 studies. MacroGenics has enrolled approximately 150 patients as part of a Phase 1 dose expansion study in nine tumor types. The Company expects to submit data from the study for presentation at a scientific conference in the first half of 2020.
Enoblituzumab: is an investigational, Fc-optimized mAb that targets B7-H3, an antigen broadly expressed across many solid tumors. MacroGenics plans to initiate a Phase 2/3 study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of the head and neck (SCCHN) before the end of 2019.
Third Quarter 2019 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2019, were $254.4 million, compared to $232.9 million as of December 31, 2018.
•Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $18.7 million for the quarter ended September 30, 2019, compared to $20.8 million for the quarter ended September 30, 2018.
•R&D Expenses: Research and development expenses were $44.9 million for the quarter ended September 30, 2019, compared to $46.2 million for the quarter ended September 30, 2018.
•G&A Expenses: General and administrative expenses were $11.8 million for the quarter ended September 30, 2019, compared to $9.6 million for the quarter ended September 30, 2018.
•Net Loss: Net loss was $44.6 million for the quarter ended September 30, 2019, which included $7.6 million in net unrealized losses recognized on equity securities held, compared to net loss of $34.0 million for the quarter ended September 30, 2018.
•Shares Outstanding: Shares outstanding as of September 30, 2019 were 48,914,284.
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, 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: 9298813.
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 View Source 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.