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. |
Exhibit Number | Description of Exhibit |
99.1 |
Date: November 8, 2017 | MACROGENICS, INC. | |
By: | /s/ Jeffrey Peters Jeffrey Peters Vice President and Acting General Counsel |
• | In September, MacroGenics presented clinical data from its ongoing Phase 1 study of flotetuzumab in an oral session at ESMO. Flotetuzumab demonstrated acceptable tolerability in the dose escalation portion of the study with encouraging initial anti-leukemic activity observed in AML patients. As of the data cut-off date of August 1, of the 14 response-evaluable patients treated at the threshold dose, six (43%) experienced an objective response. This included four (28%) patients who achieved a CR/CRi, with one patient who had a molecular CR. |
• | MacroGenics will present updated clinical data in an oral presentation at ASH in December 2017. |
• | MGA012. Enrollment in the dose escalation portion of the Phase 1 study of this anti-PD-1 antibody has been completed and the data have been accepted for poster presentation at the upcoming SITC meeting. MGA012 is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the Phase 1 study. In October 2017, MacroGenics entered into an exclusive global collaboration and license agreement with Incyte Corporation for MGA012, in which Incyte obtained exclusive worldwide rights for the development and commercialization of MGA012. MacroGenics retains the right to pursue its core strategy to develop its pipeline assets in combination with MGA012. The Company plans to initiate the first study of MGA012 in combination with another internal program by year end 2017. |
• | 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 is enrolling the dose escalation portion of the Phase 1 study and will present a preclinical data poster as well as a Trials-in-Progress poster describing the Phase 1 study at SITC. |
• | MGD019. MacroGenics continues to advance a preclinical bispecific DART molecule that provides co-blockade of PD-1 and CTLA-4, resulting in enhanced T-cell activation. The Company is conducting activities to support the potential submission of an Investigational New Drug (IND) application for MGD019 in 2018 and will present a preclinical data poster at SITC. |
• | Enoblituzumab: The Company and collaborators continue to recruit patients in multiple ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include a combination study with an anti-PD-1 antibody and a neoadjuvant prostate cancer study. |
• | MGD009: This DART molecule targets B7-H3 and CD3 and is being evaluated in a Phase 1 study across multiple solid tumor types. The Company continues to explore the dose and schedule for MGD009 administration. |
• | MGC018: The Company is conducting activities to support the potential submission of an IND application for this anti-B7-H3 antibody drug conjugate in 2018. |
• | 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 believes it is on track to complete and announce the results of an interim futility analysis by year-end 2017 or early 2018 and to complete 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 two 30 patient expansion cohorts in 2017 and present clinical data during the first half of 2018. |
• | MGD007. MacroGenics continues to recruit patients with colorectal cancer in a Phase 1 study and is evaluating various expansion cohorts to define a recommended dose and schedule. |
• | MGD014. MacroGenics’ IND submission for MGD014 was cleared by FDA and the Company anticipates that a first patient will be dosed in early 2018. |
• | Incyte Collaboration. In October 2017, MacroGenics and Incyte Corporation entered into an exclusive global collaboration and license agreement for MGA012. Under this agreement, MacroGenics will receive an upfront payment of $150 million and could receive up to $750 million in potential development, regulatory and commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte. The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions. |
• | GMP Manufacturing. Construction progress on MacroGenics’ GMP manufacturing suite remains on track. The Company anticipates that the 5 x 2,000 liter single-use bioreactor facility will be operational in 2018. As part of the MGA012 collaboration with Incyte, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012. |
• | Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2017, were $203.6 million, compared to $285.0 million as of December 31, 2016. MacroGenics anticipates receipt of the $150 million upfront payment from Incyte upon closing of the transaction in the fourth quarter of 2017. |
• | Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $1.7 million for the quarter ended September 30, 2017, compared to $3.3 million for the quarter ended September 30, 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 $41.0 million for the quarter ended September 30, 2017, compared to $30.3 million for the quarter ended September 30, 2016. This increase was primarily due to the initiation of the MGA012 Phase 1 study and continued enrollment in multiple ongoing clinical trials. |
• | G&A Expenses: General and administrative expenses were $8.4 million for the quarter ended September 30, 2017, compared to $7.2 million for the quarter ended September 30, 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 $47.0 million for the quarter ended September 30, 2017, compared to net loss of $33.8 million for the quarter ended September 30, 2016. |
• | Shares Outstanding: Shares outstanding as of September 30, 2017 were 36,807,112. |
September 30, 2017 | December 31, 2016 | ||||||
Cash, cash equivalents and investments | $203,647 | $284,982 | |||||
Total assets | 241,845 | 311,263 | |||||
Deferred revenue | 11,640 | 14,306 | |||||
Total stockholders' equity | 189,465 | 268,751 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenues: | |||||||||||||||
Revenue from collaborative agreements | $ | 1,076 | $ | 2,014 | $ | 3,435 | $ | 82,404 | |||||||
Revenue from government agreements | 587 | 1,241 | 1,948 | 4,370 | |||||||||||
Total revenues | 1,663 | 3,255 | 5,383 | 86,774 | |||||||||||
Costs and expenses: | |||||||||||||||
Research and development | 40,984 | 30,296 | 108,246 | 90,982 | |||||||||||
General and administrative | 8,403 | 7,224 | 24,249 | 20,596 | |||||||||||
Total costs and expenses | 49,387 | 37,520 | 132,495 | 111,578 | |||||||||||
Loss from operations | (47,724 | ) | (34,265 | ) | (127,112 | ) | (24,804 | ) | |||||||
Other income | 681 | 419 | 1,759 | 1,059 | |||||||||||
Net loss | (47,043 | ) | (33,846 | ) | (125,353 | ) | (23,745 | ) | |||||||
Other comprehensive loss: | |||||||||||||||
Unrealized gain (loss) on investments | 56 | (41 | ) | 55 | 23 | ||||||||||
Comprehensive loss | $ | (46,987 | ) | $ | (33,887 | ) | $ | (125,298 | ) | $ | (23,722 | ) | |||
Basic and diluted net loss per common share | $ | (1.28 | ) | $ | (0.97 | ) | $ | (3.50 | ) | $ | (0.69 | ) | |||
Basic and diluted weighted average common shares outstanding | 36,779,305 | 34,766,440 | 35,847,449 | 34,629,330 |