Delaware | 001-36112 | 06-1591613 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
9704 Medical Center Drive, Rockville, Maryland | 20850 |
(Address of Principal Executive Offices) | (Zip Code) |
Item 2.02 | Results of Operations and Financial Condition |
Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits. |
99.1 | Press Release issued by the Company on May 3, 2017 |
Date: May 3, 2017 | MACROGENICS, INC. | |
By: | /s/ Atul Saran Atul Saran Senior Vice President and General Counsel |
Exhibit Number | Description of Exhibit |
99.1 | Press Release dated May 3, 2017 |
• | Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. MacroGenics remains on track for completing enrollment of this study by late 2018. |
• | Phase 2 Gastric Cancer Study. The Company continues to enroll advanced HER2-positive gastric and gastroesophageal junction cancer patients in its combination study of margetuximab with an anti-PD-1 antibody. MacroGenics expects to complete enrollment of this study in 2017. |
• | Enoblituzumab: The Company continues to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a monotherapy study expanded to include additional bladder and prostate cancer cohorts and a combination study with an anti-PD-1 antibody. |
• | MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate expansion cohorts in multiple tumor types in 2017. |
• | MGC018: The Company is conducting activities to support an Investigational New Drug (IND) application for this anti-B7-H3 antibody drug conjugate in 2018. The Company’s poster on MGC018 at the recent American Association for Cancer Research (AACR) Annual Meeting showed that this molecule had potent in vivo antitumor activity. |
• | MGA012. The Company’s proprietary anti-PD-1 monoclonal antibody is enrolling patients in the dose escalation segment of its Phase 1 clinical study and expects to define a target dose and schedule in 2017. With anti-PD-1 therapy becoming a mainstay of cancer treatment across multiple tumor types, MacroGenics believes MGA012 will be the basis for potential combination therapy with several of the molecules in its pipeline. |
• | MGD013. MacroGenics is developing MGD013, a DART molecule, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of malignancies. The Company recently submitted an IND for MGD013. |
• | PD-1 x CTLA-4. At the recent AACR meeting, MacroGenics featured a poster showing preclinical bispecific DART and trispecific TRIDENT™ molecules that bind to and inhibit ligand interaction with PD-1 and CTLA-4, resulting in enhanced T-cell activation. Combinatorial blockade of PD-1 and CTLA-4 has shown improved anti-tumor activity in the clinic. By targeting these clinically validated checkpoint molecules simultaneously, MacroGenics’ DART and TRIDENT proteins hold the promise of enhanced anti-tumor activity. |
• | Flotetuzumab. MacroGenics continues to recruit patients with acute myeloid leukemia or myelodysplastic syndrome in the U.S. and Europe in the Phase 1 study of flotetuzumab. The Company expects to establish a recommended dose and schedule as well as initiate expansion cohorts for this study in 2017. |
• | MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study. The Company expects to establish a recommended dose and schedule for MGD007 in 2017. |
• | MGD010. MacroGenics expects to present updated pharmacodynamic activity results from the completed Phase 1 study of MGD010 in June. |
• | Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2017, were $248.1 million, compared to $285.0 million as of December 31, 2016. On May 2, 2017, the Company completed the sale of 1,100,000 shares of its common stock at a purchase price of $21.50 per share to an institutional healthcare investor in a registered direct offering. Gross proceeds to the Company, before deducting estimated offering expenses, were $23.7 million. |
• | Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.1 million for the quarter ended March 31, 2017, compared to $2.8 million for the quarter ended March 31, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the period. |
• | R&D Expenses: Research and development expenses were $32.8 million for the quarter ended March 31, 2017, compared to $27.3 million for the quarter ended March 31, 2016. This increase was primarily due to the initiation of a Phase 1 clinical trial of MGA012 in late 2016, continued enrollment in the margetuximab SOPHIA study and increased activity in the Company’s other preclinical and clinical programs. These increases were partially offset by a decrease in duvortuxizumab manufacturing costs, which are reimbursed by our collaborator. |
• | G&A Expenses: General and administrative expenses were $7.5 million for the quarter ended March 31, 2017, compared to $6.1 million for the quarter ended March 31, 2016. This increase was primarily due to increased professional fees, including consulting expenses, and increased employee compensation and benefit expense to support our overall growth. |
• | Net Loss: Net loss was $37.7 million for the quarter ended March 31, 2017, compared to net loss of $30.4 million for the quarter ended March 31, 2016. |
• | Shares Outstanding: Shares outstanding as of March 31, 2017 were 34,980,433. |
March 31, 2017 | December 31, 2016 | ||
Cash, cash equivalents and marketable securities | $ 248,081 | $ 284,982 | |
Total assets | 274,721 | 311,263 | |
Deferred revenue | 13,250 | 14,306 | |
Total stockholders' equity | 234,638 | 268,751 |
Three Months Ended March 31, | |||||
2017 | 2016 | ||||
Revenues: | |||||
Revenue from collaborative agreements | $ | 1,278 | $ 1,893 | ||
Revenue from government agreements | 777 | 953 | |||
Total revenues | 2,055 | 2,846 | |||
Costs and expenses: | |||||
Research and development | 32,801 | 27,346 | |||
General and administrative | 7,462 | 6,133 | |||
Total costs and expenses | 40,263 | 33,479 | |||
Loss from operations | (38,208 | ) | (30,633) | ||
Other income | 553 | 270 | |||
Net loss | (37,655 | ) | (30,363) | ||
Other comprehensive income (loss): | |||||
Unrealized gain (loss) on investments | (26 | ) | 57 | ||
Comprehensive loss | $ | (37,681 | ) | $ (30,306) | |
Basic and diluted net loss per common share | $ | (1.08 | ) | ($0.88) | |
Basic and diluted weighted average number of common shares | 34,958,228 | 34,503,845 |