MacroGenics, Inc.
Mar 3, 2015

MacroGenics Provides Update on Corporate Progress and 2014 Financial Results

-- Four oncology molecules in clinical development, including two bi-specific DART® molecules
-- Margetuximab Phase 3 SOPHIA study in metastatic breast cancer to initiate 3Q 2015
-- Cash runway extends into 2018

ROCKVILLE, Md., March 3, 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 year ended December 31, 2014.

"This past year was critical for advancing our mission to harness the power of the immune system to fight cancer and autoimmune diseases," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We achieved significant traction with our bi-specific Dual-Affinity Re-Targeting, or DART, antibody platform with the initiation of clinical testing of our first two DART product candidates in both hematological malignancies and solid tumors. In addition, we entered into three DART collaborations during the year that, combined with the completion of our February 2014 follow-on offering, further strengthened our financial position to enable us to advance our proprietary pipeline of immuno-therapeutics."

"Looking forward, in 2015, we will continue to invest in our immuno-oncology pipeline through the expansion of our growing portfolio of clinical development programs. We plan to initiate SOPHIA, a Phase 3 study of margetuximab in patients with metastatic breast cancer, in the third quarter. In addition, we expect to add to the growing body of MGA271 clinical data by enrolling monotherapy expansion cohorts representing six different tumor types and commencing studies in combination with other immuno-oncology agents. By the end of the year, we expect that a total of five DART molecules will be in the clinic, including those we've recently partnered," concluded Dr. Koenig.

Development Pipeline Update

Margetuximab is an Fc-optimized monoclonal antibody that targets HER2. Recent highlights include:

MGA271 is an Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules involved in immune regulation. Recent highlights include:

MGD006 is a humanized DART molecule that recognizes both CD123 and CD3. CD123, the Interleukin-3 receptor alpha chain, is expressed on leukemia and leukemic stem cells. The primary mechanism of action of MGD006 is its ability to redirect T cells, via their CD3 component, to kill CD123-expressing cells. MacroGenics continues to enroll patients in the dose escalation portion of a Phase 1 study of MGD006 for the treatment of acute myeloid leukemia.

MGD007 is a humanized DART molecule that recognizes both the glycoprotein A33 antigen, or gpA33, and CD3. The primary mechanism of action of MGD007 is its ability to redirect T cells, via their CD3 component, to kill gpA33-expressing cells. MacroGenics continues to enroll patients in the dose escalation portion of a Phase 1 study of MGD007 for the treatment of colorectal cancer.

MacroGenics' pipeline of earlier DART candidates continues to progress. In addition to MGD011, which was recently licensed to Janssen Biotech, Inc., the Company expects that both MGD010 and MGD009 will start in Phase 1 clinical studies in 2015. Details of these programs include:

2014 Partnering Highlights

2014 Financial Results and 2015 Financial Guidance

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (EST) to discuss the year 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: 92691132.

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)
 
  As of December 31,
  2014 2013
Cash and cash equivalents  $ 157,591  $ 116,481
Total assets  173,886  125,782
Deferred revenue  30,720  27,403
Total stockholders' equity  121,286  78,914
 
 
MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Amounts in thousands, except share and per share data)
       
  Year Ended December 31,
  2014 2013 2012
Revenues:       
Revenue from collaborative research  $ 47,264  $ 56,753  $ 59,646
Grant revenue  533  1,282  4,180
Total revenues  47,797  58,035  63,826
       
Costs and expenses:       
Research and development  70,186  46,582  45,433
General and administrative  15,926  11,087  10,188
Total costs and expenses  86,112  57,669  55,621
       
Income (loss) from operations  (38,315)  366  8,205
       
Other income (expense)  2  (627)  157
Net comprehensive income (loss)  $ (38,313)  $ (261)  $ 8,362
       
       
Basic and diluted net income (loss) per common share ($1.40) ($0.04) $0.00
Basic and diluted weighted average number of common shares  27,384,990  6,847,697  1,083,276

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. MacroGenics is a registered trademark of MacroGenics, 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.

CONTACT: Jim Karrels, Senior Vice President, CFO

         MacroGenics, Inc.

         1-301-251-5172, info@macrogenics.com



         Karen Sharma, Vice President

         MacDougall Biomedical Communications

         1-781-235-3060, ksharma@macbiocom.com

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Source: MacroGenics, Inc.

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