- Continued expansion and advancement of product candidates
- Portfolio update planned for upcoming R&D Day on December 13, 2016
- SOPHIA Study: MacroGenics' Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is ongoing, as the Company continues to initiate sites and enroll patients. This study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory patients. Approximately 90% of the anticipated study sites have been activated as of September 30, 2016.
- Phase 1b/2 Gastric Cancer Study: MacroGenics continues to recruit and dose patients in a clinical trial of margetuximab in combination with pembrolizumab, an anti-PD-1 therapy, in patients with advanced HER2-positive gastric cancer. Treatment options for these patients are limited and the combination regimen being explored avoids chemotherapy while exploiting the potential for enhancing the antitumor immune response. This trial is being conducted in collaboration with Merck and is currently recruiting patients in North America. We anticipate the start of this study in Asia by year-end.
- Enoblituzumab: The Company continues to recruit patients in three ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include one monotherapy study and two combination studies with each of ipilimumab and pembrolizumab. As previously reported, the monotherapy study was expanded to include additional prostate and bladder cancer cohorts. An additional monotherapy study is planned for children with neuroblastoma and other tumors, and we also anticipate an investigator-sponsored monotherapy study in neo-adjuvant prostate cancer.
- MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types.
An Investigational New Drug (IND) application for MGA012, a monoclonal antibody, recently cleared the FDA and the Company plans to submit INDs for two DART molecules in 2017. These two DART molecules are:
- MGD013: MacroGenics is developing MGD013 to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3.
- MGD014: MGD014 is a DART molecule that is being developed to eliminate latent HIV infection.
- R&D Day: MacroGenics plans to host an R&D Day in New York on Tuesday, December 13, 2016. At this meeting, the Company plans to both provide an update on its clinical pipeline as well as preview its next set of development candidates.
- Universal Shelf Registration Statement Filing: MacroGenics has filed a shelf registration statement with the SEC and believes that this filing provides the Company with the flexibility to access the equity or debt capital markets most efficiently should the need arise. However, the Company has no immediate plan to undertake an offering.
- Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2016, were $314.1 million, compared to $339.0 million as of December 31, 2015.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $3.3 million for the quarter ended September 30, 2016, compared to $14.7 million for the quarter ended September 30, 2015. This decrease was primarily due to recognition of a one-time milestone received from Janssen Biotech, Inc. in 2015.
- R&D Expenses: Research and development expenses were $30.3 million for the quarter ended September 30, 2016, compared to $24.1 million for the quarter ended September 30, 2015. This increase was due primarily to increased activity in the Company's preclinical immune checkpoint programs, including MGD013, MGD014 (funded by NIAID/NIH) and the initiation of two Phase 1 clinical trials combining enoblituzumab with other compounds.
- G&A Expenses: General and administrative expenses were $7.2 million for the quarter ended September 30, 2016, compared to $6.0 million for the quarter ended September 30, 2015. This increase was primarily due to increased staff, recruiting costs and stock-based compensation expense.
- Net Income/Loss: Net loss was $33.9 million for the quarter ended September 30, 2016, compared to net loss of $15.4 million for the quarter ended September 30, 2015.
- Shares Outstanding: Shares outstanding as of September 30, 2016 were 34,813,334.
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.
| MACROGENICS, INC. | ||||||||||
| SELECTED CONSOLIDATED BALANCE SHEET DATA | ||||||||||
| (Amounts in thousands) | ||||||||||
| September 30, 2016 | December 31, 2015 | |||||||||
| Cash, cash equivalents and investments | $ | 314,124 | $ | 339,049 | ||||||
| Total assets | 339,864 | 359,269 | ||||||||
| Deferred revenue | 13,577 | 18,497 | ||||||||
| Total stockholders' equity | 300,102 | 313,337 | ||||||||
| MACROGENICS, INC. | |||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | |||||||||||||||
| (Amounts in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||
| Revenues: | |||||||||||||||
| Revenue from collaborative agreements | $ | 2,014 | $ | 14,681 | $ | 82,404 | $ | 91,444 | |||||||
| Revenue from government agreements | 1,241 | - | 4,370 | 1,232 | |||||||||||
| Total revenues | 3,255 | 14,681 | 86,774 | 92,676 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Research and development | 30,296 | 24,103 | 90,982 | 68,227 | |||||||||||
| General and administrative | 7,224 | 6,021 | 20,596 | 16,050 | |||||||||||
| Total costs and expenses | 37,520 | 30,124 | 111,578 | 84,277 | |||||||||||
| Income (loss) from operations | (34,265 | ) | (15,443 | ) | (24,804 | ) | 8,399 | ||||||||
| Other income (expense) | 419 | 1 | 1,059 | (88 | ) | ||||||||||
| Net income (loss) | (33,846 | ) | (15,442 | ) | (23,745 | ) | 8,311 | ||||||||
| Other comprehensive income (loss): | |||||||||||||||
| Unrealized gain (loss) on investments | (41 | ) | - | 23 | - | ||||||||||
| Comprehensive income (loss) | $ | (33,887 | ) | $ | (15,442 | ) | $ | (23,722 | ) | $ | 8,311 | ||||
| Basic net income (loss) per common share | $ | (0.97 | ) | $ | (0.46 | ) | (0.69 | ) | 0.27 | ||||||
| Diluted net income (loss) per common share | $ | (0.97 | ) | $ | (0.46 | ) | (0.69 | ) | 0.25 | ||||||
| Basic weighted average number of common shares | 34,766,440 | 33,339,163 | 34,629,330 | 30,952,458 | |||||||||||
| Diluted weighted average number of common shares | 34,766,440 | 33,339,163 | 34,629,330 | 32,960,233 | |||||||||||
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, CFOMacroGenics, Inc.1-301-251-5172, info@macrogenics.comKaren Sharma, Senior Vice PresidentMacDougall Biomedical Communications1-781-235-3060, ksharma@macbiocom.com