Clinical study of first DART, MGD006, to commence in Second Quarter 2014
Phase 3 margetuximab gastroesophageal "MAGENTA" study poised for initiation in second half 2014
"In the first quarter of this year, we continued to build on the success of 2013," said
Development Pipeline Update
Margetuximab is an Fc-optimized monoclonal antibody that targets HER2-expressing tumors, including gastroesophageal, breast and other cancers. Recent highlights include:
Phase 3 Initiation Expected in the Second Half of 2014:
MacroGenicsexpects to initiate the MAGENTA study, a Phase 3 clinical trial of margetuximab in advanced gastroesophageal cancer, in the second half of 2014. This pivotal study will include approximately 425 patients across multiple countries and assess overall survival of patients on margetuximab in combination with chemotherapy versus chemotherapy alone.
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:
Planned Phase 1 Expansion:
MacroGenicsexpects to complete the first three dose-expansion cohorts of its MGA271 Phase 1 clinical trial by the end of 2014. The Company plans to initiate additional monotherapy expansion cohorts across multiple solid tumor types beginning in the second half of this year. In addition, MacroGenicsplans to initiate further studies of MGA271 in combination with other therapies beginning in 2015.
MGD006 is a DART-based 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. Recent highlights include:
Expected to Enter the Clinic:
MacroGenicsis on track to commence a Phase 1 clinical trial for MGD006 in patients with acute myeloid leukemia in the second quarter of 2014.
MacroGenics'Partner Increases Commitment to DART Program: During the first quarter of 2014, MacroGenicsreceived a total of $20 millionfrom Servier, which encompasses both their license grant fee and IND acceptance milestone. MacroGenicsretains the right to develop and commercialize MGD006 in North America, Japan, Koreaand India.
MGD007 is a DART-based molecule that recognizes both the glycoprotein A33 antigen, or gpA33, and CD3. gpA33 is found on over 95% of primary and metastatic human colorectal cancers, including cancer stem cells, which are thought to be responsible for tumor recurrence and metastasis. The primary mechanism of action of MGD007 is its ability to redirect T cells, via their CD3 component, to kill gpA33-expressing colon cancer cells. Recent highlights include:
Pre-Clinical Data Presented at AACR: Key findings from a poster presentation at the recent
American Association for Cancer Research(AACR) Annual Meeting included: (1) MGD007 mediates in vivo tumor growth inhibition at doses as low as 4 µg/kg; and (2) in non-human primates, four weekly doses of up to 200 µg/kg were well-tolerated with prolonged pharmacokinetics, consistent with that of an Fc-containing molecule.
Expected to Enter the Clinic:
MacroGenicsintends to commence a Phase 1 clinical trial for MGD007 in patients with colorectal cancer in the second half of 2014.
Proprietary Pre-Clinical Pipeline Update
Recent Corporate Developments
Completed Follow-on Offering of Common Stock:
MacroGenicscompleted a public offering of common stock and secondary shares in February 2014, raising net proceeds to the Company of $76.7 million.
Strengthened Board of Directors: The Company added
Matt Fustas a Director to its Board, and Chairman of its Audit Committee, in March 2014. Mr. Fustwas the former Executive Vice President and Chief Financial Officer of Onyx Pharmaceuticals, Inc., an oncology-focused biopharmaceutical company that was purchased by Amgen in October 2013.
Expanded Management Team: The Company appointed
Atul Saranas Senior Vice President and General Counselin April 2014. Mr. Saranmost recently held a leadership role at AstraZeneca as Vice President, Corporate Development and Ventures, and also chaired the MedImmune Ventures Investment Committee.
2014 First Quarter Financial Results
Cash Position: Cash and cash equivalents as of
March 31, 2014were $198.7 million, compared to $116.5 millionas of December 31, 2013.
Revenue: Total revenues, consisting primarily of revenue from collaborative research, were
$14.7 millionfor the quarter ended March 31, 2014, compared to $10.6 millionfor the quarter ended March 31, 2013. Collaborative research revenue includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the quarter.
R&D Expenses: Research and development expenses were
$14.6 millionfor the quarter ended March 31, 2014, compared to $10.1 millionfor the quarter ended March 31, 2013.
G&A Expenses: General and administrative expenses were
$3.3 millionfor the quarter ended March 31, 2014, compared to $3.8 millionfor the quarter ended March 31, 2013.
Net Loss: Net loss was
$3.1 millionfor the quarter ended March 31, 2014, compared to a net loss of $3.4 millionfor the quarter ended March 31, 2013.
Shares Outstanding: Shares outstanding as of
April 30, 2014were 27.6 million.
Conference Call Information
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
|Cash and cash equivalents||$ 198,722||$ 116,481|
|Total stockholders' equity (deficit)||153,219||78,914|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Amounts in thousands, except share and per share data)
Three Months Ended
|Revenue from collaborative research||$ 14,401||$ 10,067|
|Costs and expenses:|
|Research and development||14,569||10,097|
|General and administrative||3,259||3,833|
|Total costs and expenses||17,828||13,930|
|Income (loss) from operations||(3,109)||(3,332)|
|Other income (expense)||1||(34)|
|Net comprehensive income (loss)||$ (3,108)||$ (3,366)|
|Basic and diluted net income (loss) per common share||
|Basic and diluted weighted average number of common shares outstanding||26,262,356||1,148,694|
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, Vice President, CFO MacroGenics, Inc.1-301-251-5172, email@example.com Karen Sharma, Vice President MacDougall Biomedical Communications1-781-235-3060, firstname.lastname@example.org
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