"We are pleased to already have achieved several of our key corporate goals for 2014, including advancing our first DART molecule into clinical development and clearing the IND for our second DART molecule with the
Development Pipeline Update
Margetuximab is an Fc-optimized monoclonal antibody that targets HER2-expressing tumors, including gastroesophageal, breast and other cancers. Recent highlights include:
Completed Phase 1 Enrollment:
MacroGenicshas completed enrollment of its three intermittent dosing cohorts that explored dosing up to 18 mg/kg every three weeks. Margetuximab continues to exhibit both a favorable safety profile and evidence of single-agent activity in refractory HER-2 positive cancer patients. Enrollment in the Company's Phase 2a metastatic breast cancer study continues and planning for the Phase 3 MAGENTA study for gastroesophageal cancer is ongoing.
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 enrollment of the first three dose-expansion cohorts of its MGA271 Phase 1 clinical trial by the end of 2014. The Company plans to initiate multiple additional monotherapy expansion cohorts across various solid tumor types beginning in the second half of this year. MacroGenicsalso plans to initiate further studies of MGA271 in combination with other therapies in 2015.
MGD006 is a Dual-Affinity Re-Targeting (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. Recent highlights include:
Dosing Initiated in Phase 1 Clinical Study: During the second quarter of 2014,
MacroGenicsannounced that the first patient had received drug in a Phase 1 study of MGD006 for the treatment of acute myeloid leukemia. MGD006 represents the first DART molecule to enter the clinic.
MGD007 is a DART molecule that recognizes both the glycoprotein A33 antigen, or gpA33, and CD3. gpA33 is expressed by approximately 95% of primary and metastatic human colorectal cancers, including cancer stem cells that 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:
IND Cleared by
FDAto Start Enrolling Patients: MacroGenics'investigational new drug (IND) application for MGD007 was cleared by the U.S. Food and Drug Administration(FDA). MacroGenicsintends to commence the Phase 1 clinical trial for MGD007 in patients with colorectal cancer in the second half of 2014.
Milestone Payment by
Servier: MacroGenicswill receive a $5 millionmilestone payment from Servier, France'slargest privately-held pharmaceutical company, triggered by the IND clearance. Servierhas the option to obtain an exclusive license to develop and commercialize this program in all territories outside of North America, Japan, Korea, and India. MacroGenicsretains development and commercialization rights to these territories.
MGD010 is a DART molecule that simultaneously targets CD32B and CD79B, which are two B cell surface proteins. MGD010 is currently in pre-clinical development for the treatment of autoimmune diseases. Recent highlights include:
Strategic Allianceformed with Takeda: During the second quarter of 2014, MacroGenicsentered into an option agreement with Takeda Pharmaceutical Company Limited for the development and commercialization of MGD010. This transaction represents the Company's fifth major corporate collaboration around its DART platform. MacroGenicsreceived a $15 millionupfront payment and is eligible to receive an additional license option fee and an early development milestone that together would total $18 million. Assuming successful development and commercialization of MGD010, MacroGenicscould receive up to an additional $468.5 millionin milestone payments and double-digit royalties on any global net sales. MacroGenicshas the option to co-promote MGD010 in the United Statesand may participate in funding late-stage development of the program in exchange for a share of North American profits.
Pre-Clinical Data Presented at IMMUNOLOGY 2014: At the
American Association of Immunologists'Annual Meeting in May, MacroGenicspresented pre-clinical data on MGD010, demonstrating the molecule's ability to inhibit B-cell activation without B-cell depletion, which could provide a novel treatment option for patients with autoimmune disorders. MGD010 also was shown to inhibit the development of graft-versus-host disease in a humanized mouse model, a system amenable to ascertain the activity of immunomodulatory interventions.
2014 Second Quarter Financial Results
Cash Position: Cash and cash equivalents as of
June 30, 2014were $194.0 million, compared to $116.5 millionas of December 31, 2013.
Revenue: Total revenues, consisting primarily of revenue from collaborative research, were
$9.2 millionfor the quarter ended June 30, 2014, compared to $12.3 millionfor the quarter ended June 30, 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
$17.3 millionfor the quarter ended June 30, 2014, compared to $11.0 millionfor the quarter ended June 30, 2013.
G&A Expenses: General and administrative expenses were
$4.1 millionfor the quarter ended June 30, 2014, compared to $1.5 millionfor the quarter ended June 30, 2013.
Net Loss: Net loss was
$12.3 millionfor the quarter ended June 30, 2014, compared to a net loss of $0.3 millionfor the quarter ended June 30, 2013.
Shares Outstanding: Shares outstanding as of
July 31, 2014were 27.7 million.
Conference Call Information
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
|CONSOLIDATED BALANCE SHEET DATA|
|(Amounts in thousands)|
|Cash and cash equivalents||$ 194,014||$ 116,481|
|Total stockholders' equity||141,979||78,914|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(Amounts in thousands, except share and per share data)|
Three Months Ended
Six Months Ended
|Revenue from collaborative research||$ 9,202||$ 11,838||$ 23,603||$ 21,905|
|Costs and expenses:|
|Research and development||17,335||11,049||31,904||21,146|
|General and administrative||4,145||1,503||7,403||5,336|
|Total costs and expenses||21,480||12,552||39,307||26,482|
|Loss from operations||(12,260)||(254)||(15,368)||(3,586)|
|Other income (expense)||1||(40)||1||(74)|
|Net comprehensive loss||$ (12,259)||$ (294)||$ (15,367)||$ (3,660)|
|Basic and diluted net loss per common share||
|Basic and diluted weighted average number of common shares outstanding||27,651,297||1,219,884||26,960,664||1,184,507|
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, firstname.lastname@example.org Karen Sharma, Vice President MacDougall Biomedical Communications1-781-235-3060, email@example.com
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