“In February, we reported topline results from SOPHIA showing that in the Phase 3 trial, progression-free survival was prolonged following treatment with margetuximab and chemotherapy compared to trastuzumab with chemotherapy. We look forward to presenting detailed results at
“Mechanistically, we believe the results achieved in the SOPHIA study have validated our Fc-optimization technology, also used in enoblituzumab, our investigational monoclonal antibody targeting B7-H3,” continued Dr. Koenig. “To date, we have made tremendous progress with our immuno-oncology pipeline of nine clinical product candidates with multiple molecules demonstrating clinical proof of concept to support ongoing and/or planned registration studies.”
Key Pipeline Updates
Margetuximab. Recent updates related to the Company’s investigational Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2) include:
- Oral Presentation of SOPHIA Data at
ASCO; Plans to Submit BLA in 2H2019: In February 2019, MacroGenicsannounced that SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer, met the trial’s 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. An abstract containing data from SOPHIA was selected for presentation in an oral session to be held on Tuesday, June 4, 2019at the American Society of Clinical Oncology( ASCO) Annual Meeting. MacroGenicsanticipates submitting a Biologics License Application (BLA) to the U.S. FDAfor margetuximab, based on the PFS results, in the second half of 2019.
- Additional Validating Mechanistic Data in Posters at AACR and
ASCO: Data presented at the American Association for Cancer Research(AACR) Annual Meeting in April 2019showed improved Fc-dependent activity of margetuximab compared to trastuzumab in vitro. These preclinical data validate the molecule’s underlying mechanism of action and the Company’s Fc-optimization platform. In addition, an abstract containing data describing HER2-specific immunity observed in patients with HER2-positive cancers treated with margetuximab in the Phase 1 trial was selected for presentation in a poster session at ASCOon Sunday, June 2, 2019.
- Plans to
Initiate Front-line Gastric Cancer Trial in 2H2019: At the ASCO Gastrointestinal Cancers Symposium in January 2019, data were presented demonstrating encouraging anti-tumor activity and acceptable safety and tolerability of margetuximab in combination with an anti-PD-1 mAb in a Phase 2 clinical trial in patients with HER2-positive gastric or gastroesophageal junction cancer. MacroGenicsand its partner in Greater China, Zai Lab, expect 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 the second half of 2019.
- Plans to Advance Enoblituzumab in Head and Neck Cancer Study: Enoblituzumab is an Fc-optimized mAb that targets B7-H3. Encouraging data from the Phase 1 clinical study of enoblituzumab in combination with an anti-PD-1 mAb were presented at the
Society for Immunotherapy of Cancer( SITC) Annual Meeting in November 2018. Based on these data, MacroGenicsis planning to initiate a Phase 2 study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of the head and neck (SCCHN) in the second half of 2019.
- MGD009 Phase 1 Studies Ongoing: MGD009 is a bispecific DART molecule designed to target B7-H3 expressed on tumor cells and CD3 expressed on normal T cells.
MacroGenicsis enrolling patients in two Phase 1 clinical trials of MGD009, one as monotherapy and another in combination with MGA012.
- MGC018 Dose Escalation Ongoing: MGC018 is an antibody-drug conjugate (ADC) designed to target solid tumors expressing B7-H3.
MacroGenicsis evaluating MGC018 in a Phase 1 dose escalation study.
PD-1 Franchise. MacroGenics is advancing multiple investigational PD-1-directed programs to provide differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:
- MGA012 Registration-directed Studies Ongoing: MGA012 (INCMGA0012) is an anti-PD-1 mAb exclusively licensed to
Incyte Corporationon a worldwide basis. Incyteis initially pursuing development of MGA012 monotherapy through three potentially registration-directed trials in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer and Incyteand MacroGenicsare each conducting multiple studies of MGA012 in combination with other agents. MacroGenicsretains the right to develop its pipeline of product candidates in combination with MGA012.
- MGD013 Dose Expansion Ongoing: 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.
MacroGenicsis evaluating MGD013 in a Phase 1 dose expansion study in up to nine tumor types and expects to present data from this trial in the second half of 2019.
- MGD019 Dose Escalation Ongoing: 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.
MacroGenicsis currently evaluating MGD019 in a Phase 1 dose escalation study.
Flotetuzumab. A recent update related to the Company’s investigational, bispecific DART molecule that recognizes both CD123 and CD3, includes:
- Data from Ongoing Study Expected 2H2019: Based on data presented at the
American Society of Hematology(ASH) Annual Meeting in December 2018showing anti-leukemic activity and acceptable tolerability of flotetuzumab in patients with relapsed/refractory AML, MacroGenicsis enrolling additional patients in a dose expansion cohort enriched for primary refractory patients and expects to announce updated data from the trial in the second half of 2019. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Koreaand Indiafor flotetuzumab, also known as S80880.
First Quarter 2019 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
March 31, 2019were $320.4 million, compared to $232.9 millionas of December 31, 2018.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$9.7 millionfor the quarter ended March 31, 2019, compared to $4.7 millionfor the quarter ended March 31, 2018. Revenue from collaborative agreements included revenue received under a clinical supply agreement with Incyte, as well as the recognition of deferred revenue from payments received in previous periods and payments received during the quarter.
- R&D Expenses: Research and development expenses were
$47.1 millionfor the quarter ended March 31, 2019, compared to $45.7 millionfor the quarter ended March 31, 2018. This increase was due to increased clinical trial costs for MGD013, MGC018 and flotetuzumab, as well as increased development/manufacturing costs related to MGA012 (largely offset by revenue from Incyte). These increases were partially offset by decreased expenses related to the SOPHIA and enoblituzumab clinical studies.
- G&A Expenses: General and administrative expenses were
$10.2 millionfor the quarter ended March 31, 2019, compared to $9.2 millionfor the quarter ended March 31, 2018.
- Net Loss: Net loss was
$45.0 millionfor the quarter ended March 31, 2019, compared to net loss of $49.5 millionfor the quarter ended March 31, 2018.
- Shares Outstanding: Shares outstanding as of
March 31, 2019were 48,805,008.
Conference Call Information
The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
|March 31, 2019
|December 31, 2018|
|Cash, cash equivalents and marketable securities||$||320,391||$||232,863|
|Total stockholders' equity||320,617||242,877|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended March 31,|
|Revenue from collaborative agreements||$||9,497||$||4,501|
|Revenue from government agreements||165||194|
|Costs and expenses:|
|Research and development||47,060||45,670|
|General and administrative||10,219||9,235|
|Total costs and expenses||57,279||54,905|
|Loss from operations||(47,617||)||(50,210||)|
|Other comprehensive loss:|
|Unrealized gain on investments||3||39|
|Basic and diluted net loss per common share||$||(0.99||)||$||(1.34||)|
|Basic and diluted weighted average number of common shares||45,606,651||36,936,560|
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.