“MacroGenics’ most advanced programs are positioned to initiate or complete registration-directed studies over the next year,” said
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
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
MGA012 (INCMGA0012): is an investigational, anti-PD-1 mAb exclusively licensed to
MGD013: is an investigational, first-in-class bispecific PD-1 x LAG-3 DART molecule being evaluated in Phase 1 studies.
Enoblituzumab: is an investigational, Fc-optimized mAb that targets B7-H3, an antigen broadly expressed across many solid tumors.
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 millionas of December 31, 2018.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$18.7 millionfor the quarter ended September 30, 2019, compared to $20.8 millionfor the quarter ended September 30, 2018.
- R&D Expenses: Research and development expenses were
$44.9 millionfor the quarter ended September 30, 2019, compared to $46.2 millionfor the quarter ended September 30, 2018.
- G&A Expenses: General and administrative expenses were
$11.8 millionfor the quarter ended September 30, 2019, compared to $9.6 millionfor the quarter ended September 30, 2018.
- Net Loss: Net loss was
$44.6 millionfor 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 $34.0 millionfor the quarter ended September 30, 2018.
- Shares Outstanding: Shares outstanding as of September 30, 2019 were 48,914,284.
Conference Call Information
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
|September 30, 2019||December 31, 2018
|Cash, cash equivalents and marketable securities||$||254,416||$||232,863|
|Total stockholders' equity||255,198||242,877|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Revenue from collaborative and other agreements||$||17,984||$||20,617||$||37,468||$||43,670|
|Revenue from government agreements||757||181||1,528||657|
|Costs and expenses:|
|Research and development||44,852||46,218||143,352||143,902|
|General and administrative||11,833||9,584||34,174||29,953|
|Total costs and expenses||56,685||55,802||177,526||173,855|
|Loss from operations||(37,944||)||(35,004||)||(138,530||)||(129,528||)|
|Other income (expense)||(6,687||)||975||17,115||2,719|
|Other comprehensive income:|
|Unrealized gain (loss) on investments||(11||)||(18||)||26||61|
|Basic and diluted net loss per common share||$||(0.91||)||$||(0.81||)||$||(2.54||)||$||(3.13||)|
|Basic and diluted weighted average common shares outstanding||48,902,766||42,239,327||47,796,957||40,462,658|
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
Source: MacroGenics, Inc.