-- Six Immuno-Oncology Clinical Programs Projected by End of 2015 --
-- Cash Runway Extends Into 2017 --
"2013 was a transformative year for
"Looking forward, in 2014, we will continue to invest in our pipeline through the significant expansion of our clinical development programs. We plan to initiate a Phase 3 study of margetuximab in patients with gastroesophageal cancer in the second half of the year and are advancing a Phase 2a study of margetuximab in patients with metastatic breast cancer. By the end of 2014, we expect to complete the first three dose expansion cohorts of a Phase 1 clinical trial of MGA271. In addition, 2014 should be an important year for our Dual-Affinity Re-Targeting (DART®), or bi-specific, antibody platform as we intend to begin the clinical evaluation of two DART candidates, including MGD006 for acute myeloid leukemia and MGD007 for colorectal cancer," concluded Dr. Koenig.
Development Pipeline Update
Margetuximab is an Fc-optimized monoclonal antibody that targets HER2-expressing tumors, including breast, gastroesophageal and other cancers. Highlights include:
Phase 3 Initiation Expected in the Second Half of 2014:
MacroGenicshas selected a contract research organization and is preparing to initiate a Phase 3 study of margetuximab in advanced gastroesophageal cancer.
Enrolling Phase 2a Metastatic Breast Cancer Study:
MacroGenicscontinues to enroll patients in a Phase 2a clinical study in metastatic breast cancer.
MGA271 is an Fc-optimized monoclonal antibody that targets B7-H3, which is over-expressed on a wide variety of solid tumor types and is a member of the B7 family of molecules involved in immune regulation. Recent highlights include:
Continued Phase 1 Enrollment:
MacroGenicscompleted the dose escalation portion of a Phase 1 clinical trial and expects to complete the first three dose expansion cohorts by the end of 2014. The Company plans to initiate additional expansion cohorts using MGA271 as monotherapy in other tumor types in 2014, as well as combining MGA271 with other therapies for certain tumor types.
Additional Study Initiated by
Servier: Servierrecently initiated a study in Europein which it intends to evaluate MGA271 in up to 75 patients representing additional types of cancers.
MGD006 is a humanized 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:
First DART Poised to
Enter Clinic: MGD006 is expected to enter the clinic in the second quarter of 2014 in patients with acute myeloid leukemia (AML).
Servier Exercised Exclusive Option to Develop and Commercialize MGD006 in its Territories: During the first quarter of 2014,
MacroGenicsreceived a total of $20million from Servier, which included exercise of their program option and an IND milestone payment. MacroGenics retains the right to develop and commercialize MGD006 in North America, Japan, Koreaand India.
Pre-Clinical Data Presented at ASH: Pre-clinical MGD006 data demonstrating activity in the clearance of AML blasts in vitro and in vivo was presented at the 55th
American Society of Hematology(ASH) Annual Meeting in New Orleans.
Proprietary Pre-Clinical Pipeline Update
Recent Corporate Developments
Completed Follow-on Offering of Common Stock: In
February 2014, MacroGenicscompleted a public offering of common stock and secondary shares, raising net proceeds to the Company of $76.7 million, net of underwriting discounts and commissions and estimated offering expenses. This included $15.4 millionof additional net proceeds following the full exercise of the over-allotment option by the underwriters.
Strengthened Board of Directors: The Company added
Matt Fustas a Director to its Board, and Chairman of its Audit Committee, in March 2014. Mr. Fust was 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. Prior to joining Onyx Pharmaceuticals, Mr. Fustserved as Chief Financial Officer of Jazz Pharmaceuticals, Inc.
2013 Financial Results and Financial Guidance
Cash Position: Cash and cash equivalents as of
December 31, 2013were $116.5 million, compared to $47.7 millionas of December 31, 2012. In February 2014, MacroGenicscompleted a follow-on offering, issuing 2,250,000 shares of its common stock for net proceeds to the Company of $76.7 million, net of underwriting discounts and commissions and other estimated offering expenses and including the underwriters' exercise of their over-allotment option in full.
Revenue: Total revenues, consisting primarily of revenue from collaborative research, were
$58.0 millionfor the year ended December 31, 2013, compared to $63.8 millionfor the year ended December 31, 2012. 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
$46.6 millionfor the year ended December 31, 2013, compared to $45.4 millionfor the year ended December 31, 2012.
G&A Expenses: General and administrative expenses were
$11.1 millionfor the year ended December 31, 2013, compared to $10.2 millionfor the year ended December 31, 2012.
Net Loss: Net loss was
$0.3 millionfor the year ended December 31, 2013, compared to net income of $8.4 millionfor the year ended December 31, 2012.
Shares Outstanding: Shares outstanding as of
December 31, 2013were 25.2 million. Including the shares issued in the February 2014follow-on offering, the Company had 27.5 million shares outstanding as of February 28, 2014.
MacroGenicsexpects that its current cash and cash equivalents, combined with anticipated non-equity funding under its various strategic collaborations, should fund the Company's operations into 2017.
Conference Call Information
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
|CONSOLIDATED BALANCE SHEET DATA|
|(Amounts in thousands)|
|Cash and cash equivalents||$ 116,481||$ 47,743|
|Convertible preferred stock||--||2,947|
|Total stockholders' equity (deficit)||78,914||(8,237)|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|(Amounts in thousands, except share and per share data)|
|Revenue from collaborative research||$ 56,753||$ 59,646||$ 47,054|
|Costs and expenses:|
|Research and development||46,582||45,433||41,089|
|General and administrative||11,087||10,188||10,869|
|Total costs and expenses||57,669||55,621||51,958|
|Income (loss) from operations||366||8,205||5,250|
|Other income (expense)||(627)||156||1,467|
|Net comprehensive income (loss)||$ (261)||$ 8,362||$ 6,717|
|Basic net income (loss) per common share||
|Diluted net income (loss) per common share||
|Basic weighted average number of common shares||6,847,697||1,083,276||1,025,602|
|Diluted weighted average number of common shares||6,847,697||1,083,276||1,025,602|
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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