-- 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
"This past year was critical for advancing our mission to harness the power of the immune system to fight cancer and autoimmune diseases," said
"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
Development Pipeline Update
Margetuximab is an Fc-optimized monoclonal antibody that targets HER2. Recent highlights include:
Phase 3 Metastatic Breast Cancer Study: The Company expects to commence SOPHIA, a Phase 3 pivotal study in approximately 530 subjects, in the third quarter of 2015. This study is planned to evaluate margetuximab plus chemotherapy against trastuzumab plus chemotherapy in third-line metastatic breast cancer patients with HER2 expression at the 3+ level by immunohistochemistry (IHC) or 2+ level by IHC with gene amplification, subject to completion of further regulatory review.
MacroGenicsprojects that it will take approximately three years to complete this study, which will include an interim futility analysis.
Presentation of Phase 1 Data: In mid-2015,
MacroGenicsplans to present margetuximab Phase 1 clinical data for patients with breast cancer in expansion cohorts testing once-every-three-week dosing regimens.
- Gastroesophageal Cancer Opportunity: The Company plans to initiate Phase 1/2 combination studies in gastroesophageal cancer starting in the fourth quarter of 2015.
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:
Recruiting Additional Monotherapy Expansion Cohorts: During the fourth quarter of 2014, the Company initiated recruitment of patients in multiple additional monotherapy expansion cohorts across various tumor types, including triple-negative breast cancer, head and neck cancer, renal cell cancer, melanoma (in patients who have failed a checkpoint inhibitor), and a cohort consisting of non-small cell lung cancer and bladder cancer patients with the highest level of B7-H3 expression.
Presentation of Phase 1 MGA271 Data: In the second half of 2015,
MacroGenicsplans to present Phase 1 clinical data for MGA271.
MacroGenicsplans to initiate studies of MGA271 in combination with other immuno-oncology agents in 2015, including a combination study with ipilimumab in B7-H3 positive melanoma, lung, and head and neck cancers.
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.
MGD010 Nearing Phase 1 Clinical Initiation: MGD010 is a DART molecule for the treatment of autoimmune disorders that simultaneously targets CD32B and CD79B, which are two B-cell surface proteins. MGD010 is designed to inhibit B-cell activation by exploiting the inhibitory function of CD32B, a checkpoint molecule expressed by B cells. MacroGenics expects to initiate a Phase 1a study in normal healthy volunteers in the first half of 2015. This product candidate is subject to a global collaboration with Takeda.
Introducing MGD009: In late 2015,
MacroGenicsanticipates initiating a Phase 1 clinical study of MGD009, a humanized DART molecule that recognizes both CD3 and an undisclosed antigen expressed on many solid tumor types. MacroGenics retains worldwide development and commercialization rights to this molecule.
2014 Partnering Highlights
Janssen Biotech, Inc.: In December 2014, MacroGenicsentered into a global collaboration and license agreement with Janssen Biotech, Inc.for MGD011. Johnson & Johnson Innovation - JJDC, Inc.concurrently agreed to make an equity investment in MacroGenics. Upon closing of these agreements in 2015, MacroGenicsreceived a total of $125 million. MGD011 is a humanized CD19 x CD3 bi-specific DART protein being developed for the treatment of B-cell hematological malignancies. Janssen will be fully responsible for developing MGD011 following submission of the IND, which is planned for 2015. MacroGenics may elect to fund a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada.
May 2014, MacroGenicsannounced that it had entered into an option agreement with Takeda Pharmaceutical Company Limited for the development and commercialization of MGD010. In September 2014, MacroGenicsannounced that it had entered into a second strategic alliance with Takeda. The second collaboration was for the development and commercialization of additional DART molecules.
Servier: In February 2014, MacroGenicsannounced that Servierhad exercised its exclusive option to develop and commercialize MGD006. MacroGenics has retained exclusive development and commercial rights in the U.S., Canada, Mexico, Japan, South Koreaand India. Servierhas rights in all other countries.
2014 Financial Results and 2015 Financial Guidance
Cash Position: Cash and cash equivalents as of
December 31, 2014were $157.6 million, compared to $116.5 millionas of December 31, 2013. In the first quarter of 2015, MacroGenicsclosed a global collaboration and license agreement for MGD011 with Janssen Biotech, Inc.and received a $50 millionupfront license fee, and Johnson & Johnson Innovation - JJDC, Inc.invested $75 millionwith the purchase of new shares of MacroGenicscommon stock at a price of $39.00per share.
Revenue: Total revenues, consisting primarily of revenue from collaborative research, were
$47.8 millionfor the year ended December 31, 2014, compared to $58.0 millionfor the year ended December 31, 2013. Collaborative research revenue includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
R&D Expenses: Research and development expenses were
$70.2 millionfor the year ended December 31, 2014, compared to $46.6 millionfor the year ended December 31, 2013. This increase was primarily due to the initiation of clinical manufacturing activities for two product candidates and the advancement of the Company's clinical and pre-clinical programs.
G&A Expenses: General and administrative expenses were
$15.9 millionfor the year ended December 31, 2014, compared to $11.1 millionfor the year ended December 31, 2013. This increase was primarily due to higher stock-based compensation expense as well as an increase in professional fees and other costs associated with public company operations.
Net Loss: Net loss was
$38.3 millionfor the year ended December 31, 2014, compared to net loss of $0.3 millionfor the year ended December 31, 2013.
Shares Outstanding: Shares outstanding as of
December 31, 2014were 27,995,638 million. This excludes the 1,923,077 shares issued to Johnson & Johnson Innovation - JJDC, Inc., in January 2015.
MacroGenicsexpects that its current cash and cash equivalents, combined with anticipated funding under its strategic collaborations, should fund the Company's operations into 2018.
Conference Call Information
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
|CONSOLIDATED BALANCE SHEET DATA|
|(Amounts in thousands)|
|Cash and cash equivalents||$ 157,591||$ 116,481|
|Total stockholders' equity||121,286||78,914|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|(Amounts in thousands, except share and per share data)|
|Revenue from collaborative research||$ 47,264||$ 56,753||$ 59,646|
|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||
|Basic and diluted weighted average number of common shares||27,384,990||6,847,697||1,083,276|
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
Jim Karrels, Senior Vice President, CFO MacroGenics, Inc.1-301-251-5172, firstname.lastname@example.org Karen Sharma, Vice President MacDougall Biomedical Communications1-781-235-3060, email@example.com
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