Recent Corporate Highlights
Completed Initial Public Offering:
MacroGenicscompleted a successful IPO in October, which raised approximately $83.8 million, net of underwriting discounts and commissions and estimated offering expenses.
Increased Non-Dilutive Capital: Subsequent to June 30, 2013, MacroGenicshas received or invoiced $19 millionof milestone and maintenance payments from two of its collaborators.
Strengthened Management Team:
Jon Wigginton, M.D., joined the Company in August as Senior Vice President, Clinical Development. Previously, Jon had been at Bristol-Myers Squibb, where he was most recently the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research.
Augmented Board of Directors: The Company elected
Paulo F. Costaas Chairman and added David C. Stump, M.D., as a Director to its Board. Mr. Costawas the former Chairman of Amylin Pharmaceuticalsand the former President and CEO of Novartis U.S. Corporation. Dr. Stump was most recently Executive Vice President, Research and Development at Human Genome Scienceswhere he joined the company in 1999 from Genentech.
Development Pipeline Update
Margetuximab is an Fc-optimized monoclonal antibody that targets HER2-expressing tumors, including breast, gastroesophageal and other cancers. Recent highlights include:
Phase 3 Initiation Expected in 2014:
MacroGenicsis preparing for a Phase 3 study of margetuximab in advanced gastroesophageal cancer, for which enrollment is expected to begin in the second half of 2014.
- Enrolling Phase 2a Metastatic Breast Cancer Study: MacroGenics continues to enroll patients in a Phase 2a clinical study in metastatic breast cancer. The Company plans to report data in 2014.
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:
$10 millionPayment by Servierfor Initiation of Phase 1 Dose Expansion: The dose expansion phase of the MGA271 Phase 1 clinical study initiated in August triggered a $10 millionpayment to MacroGenicsby its partner, Les Laboratoires Servier, or Servier.
MacroGenicscontinues to enroll patients in the Phase 1 study with prostate cancer, melanoma and other B7-H3 positive tumors.
MGD006 is a humanized DART-based molecule, or DART, 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 to
Enter Clinic: MGD006, MacroGenics'first DART, is poised to enter the clinic in the first half of 2014.
Pre-Clinical Data to be Presented at ASH: On
December 9, an abstract titled "Targeting CD123 In Leukemic Stem Cells Using Dual Affinity Re-Targeting Molecules (DARTs®)" is scheduled for oral presentation by Muneera Al-Hussaini, M.D., an investigator from the Division of Hematology & Oncology, Washington University School of Medicinein St. Louis, at the 55th ASH Annual Meeting in New Orleans, LA.
Other Pre-Clinical Product Candidates
In early November, Boehringer Ingelheim nominated a DART-based therapeutic candidate for pre-clinical development, triggering a
Third Quarter 2013 Financial Highlights
Cash Position: Cash and cash equivalents as of
September 30, 2013were $33.6 million, compared to $47.7 millionas of December 31, 2012. Subsequent to September 30, 2013, the Company raised net proceeds of $83.8 millionfrom its IPO, including the underwriters' exercise of the over-allotment option.
Revenue: Total revenues, consisting primarily of revenue from collaborative research, were
$20.2 millionfor the third quarter of 2013 and $43.1 millionfor the nine months ended September 30, 2013, compared to $16.1 millionand $54.0 millionfor the comparable periods in 2012.
R&D Expenses: Research and development expenses were
$11.1 millionfor the third quarter of 2013 and $32.2 millionfor the nine months ended September 30, 2013, compared to $12.0 millionand $36.9 millionfor the comparable periods in 2012.
G&A Expenses: General and administrative expenses were
$2.0 millionfor the third quarter of 2013 and $7.3 millionfor the nine months ended September 30, 2013, compared to $1.5 millionand $6.6 millionfor the comparable periods in 2012.
Net Income: Net income was
$6.6 millionfor the third quarter of 2013 and $2.9 millionfor the nine months ended September 30, 2013, compared to $2.6 millionand $10.5 millionfor the comparable periods in 2012.
Shares Outstanding: Shares outstanding as of
October 31, 2013were 25.0 million, which includes the sale of 5.75 million shares of common stock in the Company's IPO and the resulting automatic conversion of the Company's convertible preferred stock into common stock.
Conference Call Information
The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.macrogenics.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website following the call.
|CONSOLIDATED BALANCE SHEETS|
|(Amounts in thousands)|
|Cash and cash equivalents||$ 33,569||$ 47,743|
|Convertible preferred stock||2,947||2,947|
|Total stockholders' equity (deficit)||(4,048)||(8,237)|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME|
|(Amounts in thousands, except per share data)|
Three Months Ended
Nine Months Ended
|Revenue from collaborative research||$ 20,111||$ 15,533||$ 42,016||$ 50,284|
|Costs and expenses:|
|Research and development||11,088||11,968||32,234||36,925|
|General and administrative||1,987||1,514||7,323||6,641|
|Total costs and expenses||13,074||13,483||39,557||43,566|
|Income from operations||7,158||2,599||3,571||10,462|
|Other income (expense)||(554)||2||(627)||5|
|Net comprehensive income||$ 6,604||$ 2,601||$ 2,944||$ 10,467|
|Basic net income per common share||
|Diluted net income per common share||
|Basic weighted average number of common shares||1,184,507||1,092,307||1,463,798||1,078,145|
|Diluted weighted average number of common shares||21,242,978||21,502,424||21,908,859||21,412,848|
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, Director MacDougall Biomedical Communications1-781-235-3060, firstname.lastname@example.org
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