Full Press Release Details
MacroGenics Provides Update on Corporate Progress and Third Quarter 2015 Financial Results
Bi-specific antibody leadership - fifth DART molecule (MGD009) enters clinical testing
B7-H3 franchise advances - Encouraging initial clinical results from ongoing enoblituzumab (MGA271) Phase 1 trial and regional rights regained
Recent collaboration with Merck on immuno-oncology study evaluating margetuximab in combination with KEYTRUDA (pembrolizumab)
Balance sheet strengthened with $141M net proceeds from July equity offering
ROCKVILLE, Md., Nov. 04, 2015 (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 third quarter ended September 30, 2015.
"As we strive to create breakthrough biologics and life-changing medicines, the team at MacroGenics was proud to share our progress at our recent R&D Day in New York," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We reported encouraging initial clinical trial results from an ongoing Phase 1 study of enoblituzumab, our Fc-optimized monoclonal antibody that targets B7-H3. We also extended our B7-H3 franchise by advancing MGD009, a DART molecule directed against B7-H3 and CD3, into a Phase 1 study. Furthermore, we recently announced a collaboration with Merck to evaluate margetuximab in combination with Merck's anti-PD-1 therapy, KEYTRUDA, in patients with advanced gastric cancer. This combination of therapeutics could exploit complementary immune-based mechanisms for targeting tumors and provide an important alternative for patients who do not respond to currently available regimens."
Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2. Recent highlights 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's three programs target B7-H3 through complementary mechanisms of action and take advantage of this target's broad expression across multiple solid tumor types. Recent highlights include:
DART Product Candidates-There are currently five DART molecules in clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD011 (CD19 x CD3, also known as JNJ-64052781), MGD010 (CD32B x CD79B) and MGD009 (B7-H3 x CD3). Each of these DART molecules is being evaluated in a Phase 1 clinical study. At its R&D Day, the Company disclosed for the first time two DART molecules that it expects to advance into clinical development in the first half of 2017. These two product candidates include:
Third Quarter 2015 Financial Results
Conference Call Information
MacroGenics will host a conference call today at 4:30 pm (EST) to discuss the third quarter 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: 67542492.
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. | ||||||||
| CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (Amounts in thousands) | ||||||||
| September 30, 2015 | December 31, 2014 | |||||||
| Cash and cash equivalents | $ | 365,767 | $ | 157,591 | ||||
| Total assets | 384,089 | 173,886 | ||||||
| Deferred revenue | 19,052 | 30,720 | ||||||
| Total stockholders' equity | 339,326 | 121,286 |
| MACROGENICS, INC. | ||||||||||||||||
| CONSOLIDATED STATEMENT 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, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenues: | ||||||||||||||||
| Revenue from collaborative research | $ | 14,681 | $ | 18,283 | $ | 91,444 | $ | 41,886 | ||||||||
| Grant revenue | - | 99 | 1,232 | 435 | ||||||||||||
| Total revenues | 14,681 | 18,382 | 92,676 | 42,321 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 24,103 | 18,632 | 68,227 | 50,536 | ||||||||||||
| General and administrative | 6,021 | 3,678 | 16,050 | 11,081 | ||||||||||||
| Total costs and expenses | 30,124 | 22,310 | 84,277 | 61,617 | ||||||||||||
| Income (loss) from operations | (15,443 | ) | (3,928 | ) | 8,399 | (19,296 | ) | |||||||||
| Other income (expense) | 1 | - | (88 | ) | 1 | |||||||||||
| Net comprehensive income (loss) | $ | (15,442 | ) | $ | (3,928 | ) | $ | 8,311 | $ | (19,295 | ) | |||||
| Basic net income (loss) per common share | $ | (0.46 | ) | $ | (0.14 | ) | $ | 0.27 | $ | (0.71 | ) | |||||
| Diluted net income (loss) per common share | $ | (0.46 | ) | $ | (0.14 | ) | $ | 0.25 | $ | (0.71 | ) | |||||
| Basic weighted average number of common shares | 33,339,163 | 27,751,437 | 30,952,458 | 27,227,151 | ||||||||||||
| Diluted weighted average number of common shares | 33,339,163 | 27,751,437 | 32,960,233 | 27,227,151 |
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 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. DART, Trident, MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.
The development of a DART molecule targeting HIV is funded in part by NIAID under contract no. HHSN272201500032C.
KEYTRUDA is a registered trademark of Merck & Co., 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 "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. 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 risk factors 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 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. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
Jim Karrels, Senior Vice President, CFO
1-301-251-5172, info@macrogenics.com
Karen Sharma, Vice President
MacDougall Biomedical Communications
1-781-235-3060, ksharma@macbiocom.com