“MacroGenics continues to advance its portfolio of oncology product candidates toward multiple data read-outs,” said
Key Pipeline Updates
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:
- 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.
MacroGenicsremains on track to complete enrollment of the study in the next few months, with anticipated disclosure of topline PFS data in the first quarter of 2019.
- Phase 2 Gastric Cancer Study. At the 2018 ASCO Annual Meeting in June,
MacroGenicspresented updated interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with HER2-positive gastroesophageal adenocarcinoma. This chemotherapy-free combination, designed to coordinately engage innate and adaptive immunity, demonstrated that margetuximab plus an anti-PD-1 antibody may have enhanced antitumor activity in patients with advanced gastric cancer. The Company expects to complete enrollment of 25 additional gastric cancer patients in the next few months and present data in the first quarter of 2019.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
- Monotherapy Study.
MacroGenicshas completed the enrollment of its AML dose expansion cohort and plans to present updated clinical data and disclose further development plans in late 2018. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Koreaand Indiafor flotetuzumab, also known as S80880.
- Combination Study with MGA012.
MacroGenicshas previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab. MacroGenicsintends to commence enrollment of a combination study with MGA012, an anti-PD-1 mAb also known as INCMGA0012, later this year.
PD-1-Directed Immuno-Oncology Franchise.
- MGA012. This humanized, proprietary anti-PD-1 mAb is being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. MGA012 was licensed to
Incyte Corporationin 2017 under a global collaboration and license agreement. MacroGenicsretains the rights to develop MGA012 in combination with its pipeline assets, and has already initiated clinical combination studies with two separate DART molecules. In June 2018, Incyteannounced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies, with data anticipated in 2020-2021.
- MGD013. This first-in-class DART molecule provides co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MGD013 is currently being evaluated in a Phase 1 study.
MacroGenicsexpects to establish the dose and schedule for MGD013 administration as well as initiate dose expansion cohorts by year end 2018.
- MGD019. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4 on T cells. The Company anticipates submitting the IND application for MGD019 by year end 2018.
- Enoblituzumab: The Company completed the recruitment of patients in an ongoing study of this Fc-optimized mAb that targets B7-H3, in combination with an anti-PD-1 mAb and expects to present clinical data from this study as well as disclose further development plans in the fourth quarter of 2018.
- Orlotamab (formerly known as MGD009): This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study. The Company recently established the dose and schedule for orlotamab administration and initiated monotherapy dose expansion cohorts in six different tumor types. In addition, a combination study of orlotamab and MGA012 was initiated in the first quarter of 2018 and is ongoing.
- MGC018: The Company has submitted an IND for this anti-B7-H3 ADC and anticipates initiation of a Phase 1 study in the coming months. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.
Second Quarter 2018 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
June 30, 2018, were $300.9 million, compared to $305.1 millionas of December 31, 2017.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$18.8 millionfor the quarter ended June 30, 2018, compared to $1.7 millionfor the quarter ended June 30, 2017. Revenue from collaborative agreements 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
$52.0 millionfor the quarter ended June 30, 2018, compared to $34.5 millionfor the quarter ended June 30, 2017. This increase was primarily due to the continued enrollment in the Company’s two margetuximab studies, flotetuzumab study and increased headcount to support expanded manufacturing and development activities.
- G&A Expenses: General and administrative expenses were
$11.1 millionfor the quarter ended June 30, 2018, compared to $8.4 millionfor the quarter ended June 30, 2017. This increase was primarily due to consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system and increased patent expenses.
- Net Loss: Net loss was
$43.2 millionfor the quarter ended June 30, 2018, compared to net loss of $40.7 millionfor the quarter ended June 30, 2017.
- Shares Outstanding: Shares outstanding as of
June 30, 2018were 42,229,011.
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.
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|(Amounts in thousands)|
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents and investments||$300,894||$305,121|
|Total stockholders' equity||312,036||299,238|
|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 agreements||$18,552||$1,081||$23,053||$2,359|
|Revenue from government agreements||282||585||476||1,361|
|Costs and expenses:|
|Research and development||52,014||34,461||97,684||67,262|
|General and administrative||11,134||8,384||20,369||15,846|
|Total costs and expenses||63,148||42,845||118,053||83,108|
|Loss from operations||(44,314||)||(41,179||)||(94,524||)||(79,388||)|
|Other comprehensive loss:|
|Unrealized gain (loss) on investments||40||25||79||(1||)|
|Basic and diluted net loss per common share||($1.03||)||($1.14||)||($2.35||)||($2.21||)|
|Basic and diluted weighted average number of common shares outstanding||42,153,813||35,784,804||39,559,599||35,373,799|
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.