“We have made significant progress in the first half of the year, during which we reported positive results from the Phase 3 SOPHIA study of margetuximab in metastatic HER2-positive breast cancer and enrolled patients into our Phase 1 studies. We believe this progress positions us favorably to achieve several important milestones for our Company during the remainder of 2019,” said
Key Pipeline Updates
- SOPHIA Phase 3 Data Presented at
ASCO; Second Interim OS Data Expected in 4Q2019; Plans to Submit BLA in 4Q2019: At the American Society of Clinical Oncology( ASCO) Annual Meeting in June 2019, MacroGenicspresented data from SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer. The trial met the first sequential primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. The Company expects to present the results from a pre-specified interim OS analysis and submit a Biologics License Application (BLA) to the U.S. FDAin the fourth quarter of 2019.
- MAHOGANY Phase 2/3 Study Advancing in Front-line Gastric Cancer:
MacroGenicsand Zai Lab, the Company’s partner in Greater China, plan to initiate a Phase 2/3 registration-directed clinical trial of margetuximab in combination with checkpoint inhibitor molecules, including MGA012 (anti-PD-1 mAb) and MGD013 (bispecific PD-1 x LAG-3 DART® molecule) in patients with HER2-positive gastric or gastroesophageal junction cancer in the third quarter of 2019.
- Advancing Enoblituzumab Study in Head and Neck Cancer: Enoblituzumab is an investigational, Fc-optimized mAb that targets B7-H3.
MacroGenicsrecently met with FDAto discuss its plans regarding a Phase 2/3 registration-directed study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of the head and neck (SCCHN) and anticipates initiating the trial in the fourth quarter of 2019.
- MGD009 Program Prioritization: MGD009 is an investigational, bispecific DART molecule designed to target B7-H3 expressed on tumor cells and CD3 expressed on normal T cells. The company is prioritizing the development of the combination of MGD009 with MGA012, including plans to add a new dose expansion cohort in patients with melanoma who have previously been treated with a checkpoint inhibitor.
MacroGenicshas closed patient enrollment in the MGD009 monotherapy study.
- Continued MGC018 Dose Escalation: MGC018 is an investigational, antibody-drug conjugate (ADC) designed to target solid tumors expressing B7-H3 and has advanced through multiple dose levels in the Phase 1 monotherapy dose escalation.
- Completed Enrollment of Monotherapy Study in Acute Myeloid Leukemia (AML); Data Expected 2H2019; Requested End of Phase 1 Meeting with
FDA: MacroGenicshas completed enrollment of 50 patients at the recommended Phase 2 dose in the Phase 1 monotherapy study, including 30 patients with primary refractory AML. The Company plans to submit updated data from the trial for presentation at the 2019 American Society for Hematology(ASH) Annual Meeting. MacroGenicsplans to meet with the FDAin the third quarter to discuss the flotetuzumab program, and to define a potential registration path for this molecule.
- Plans to Initiate MGA012 Combination Study:
MacroGenicsplans to initiate a Phase 1 study in combination with MGA012 in relapsed or refractory AML in the third quarter.
- Regaining Full Global Rights:
MacroGenicswill regain full global rights to develop and commercialize flotetuzumab following Servier’s notification of its intent to terminate the collaboration and license agreement with the Company.
- MGA012 Registration-directed Studies: MGA012 (INCMGA0012) is an anti-PD-1 mAb exclusively licensed to
Incyte Corporationon a worldwide basis. Incyteis pursuing development of MGA012 monotherapy in three ongoing potentially registration-directed trials. Incyteand MacroGenicsare each conducting multiple studies of MGA012 in combination with other agents.
- MGD013 Dose Expansion; Data Expected 2H2019: MGD013 is a first-in-class bispecific DART molecule designed to provide co-blockade of PD-1 and LAG-3, two immune checkpoint molecules expressed on T cells.
MacroGenicshas enrolled approximately 100 patients in the Phase 1 dose expansion study in up to nine tumor types and expects to submit data from this monotherapy trial for presentation at a scientific conference in the second half of 2019.
- MGD019 Dose Escalation: MGD019 is a bispecific DART molecule designed to provide co-blockade of PD-1 and CTLA-4, two immune checkpoint inhibitors expressed on T cells. MGD019 has advanced through multiple dose levels in a Phase 1 dose escalation study.
Recent Corporate Developments
- Collaboration with I-Mab Biopharma: In
July 2019, MacroGenicsentered into an exclusive collaboration and license agreement with I-Mab Biopharma (I-Mab) to develop and commercialize enoblituzumab. I-Mab obtains rights in mainland China, Hong Kong, Macauand Taiwan. MacroGenicswill receive an upfront payment of $15 millionand will also be eligible to receive milestone payments of up to $135 million. In addition, I-Mab will pay tiered royalties ranging from mid-teens to twenty percent based on annual net sales in its territories.
Second Quarter 2019 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
June 30, 2019were $272.1 million, compared to $232.9 millionas of December 31, 2018.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$10.6 millionfor the quarter ended June 30, 2019, compared to $18.8 millionfor the quarter ended June 30, 2018. The decrease was primarily due to decreased revenue recognized under the collaboration and license agreement with Incyte, as well as revenue recognized during the three months ended June 30, 2018under the license agreement and asset purchase agreement with Provention Bio. The decrease was partially offset by the revenue recognized from the deferred upfront payment under the collaboration and license agreement with Zai Lab.
- R&D Expenses: Research and development expenses were
$51.4 millionfor the quarter ended June 30, 2019, compared to $52.0 millionfor the quarter ended June 30, 2018.
- G&A Expenses: General and administrative expenses were
$12.1 millionfor the quarter ended June 30, 2019, compared to $11.1 millionfor the quarter ended June 30, 2018. This increase was primarily due to consulting expenses and other professional service fees.
- Net Loss: Net loss was
$31.8 millionfor the quarter ended June 30, 2019, which included Other Income of $19.6 millionrelated to the revaluation of the warrants received from Provention Bio, compared to net loss of $43.2 millionfor the quarter ended June 30, 2018.
- Shares Outstanding: Shares outstanding as of
June 30, 2019were 48,893,451.
Conference Call Information
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
SELECTED CONSOLIDATED BALANCE SHEET DATA
|(Amounts in thousands)|
|June 30, 2019|
|(unaudited)||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||272,136||$||232,863|
|Total stockholders' equity||294,451||242,877|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|(Amounts in thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Revenue from collaborative and other agreements||$||9,987||$||18,552||$||19,484||$||23,053|
|Revenue from government agreements||606||282||771||476|
|Costs and expenses:|
|Research and development||51,440||52,014||98,500||97,684|
|General and administrative||12,122||11,134||22,341||20,369|
|Total costs and expenses||63,562||63,148||120,841||118,053|
|Loss from operations||(52,969||)||(44,314||)||(100,586||)||(94,524||)|
|Other comprehensive income:|
|Unrealized gain on investments||34||40||37||79|
|Basic and diluted net loss per common share||$||(0.65||)||$||(1.03||)||$||(1.63||)||$||(2.35||)|
|Basic and diluted weighted average number of common shares||48,845,234||42,153,813||47,234,889||39,559,599|
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 "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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 risks described in the Company's filings with the
Source: MacroGenics, Inc.