- Margetuximab: Phase 3 SOPHIA study enrollment completed; topline results 1Q 2019
- PD-1 franchise: MGD013 cohort expansions initiated;
$15 millionin MGA012 milestones triggered; MGD019 IND cleared
- B7-H3 franchise: enoblituzumab oral presentation at
SITC; MGC018 Phase 1 study initiating
- Flotetuzumab: two oral presentations at ASH
“During the third quarter,
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:
- Fully Enrolled Phase 3 Metastatic Breast Cancer Study. The Company has completed enrollment of 530 relapsed/refractory HER2-positive metastatic breast cancer patients in its pivotal SOPHIA study.
MacroGenicsanticipates disclosure of topline PFS data in the first quarter of 2019. In anticipation of a potential future product launch, MacroGenicsis progressing its U.S. commercial planning and actively exploring ex-U.S. development and commercialization partnership opportunities.
- Phase 2 Gastric Cancer Study Demonstrated Antitumor Activity. At the 2018
European Society of Medical Oncology (ESMO) Congressin October, 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 antitumor activity in patients with advanced gastric cancer. The Company recently completed enrollment of 25 additional gastric cancer patients and expects to present data from this ongoing portion of the study in the first quarter of 2019.
- MGA012 Achieves Development Milestones. This anti-PD-1 mAb, also known as INCMGA0012, 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. MGA012 met certain clinical proof-of-concept criteria, triggering a total of $15 millionin milestones from Incyte, $10 millionof which has been recognized in the third quarter and $5 millionof which is expected to be recognized in the fourth quarter. Incyteplans to present updated data from the cohort expansion portion of the Phase 1 study of MGA012 in a poster session at the upcoming Society for Immunotherapy for Cancer( SITC) Annual Meeting. Incytehas announced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies with initial data anticipated in 2020. In addition, across both Incyteand MacroGenics, multiple studies have been initiated which will feature various combination regimens with MGA012.
- MGD013 Dose Expansion Initiated. 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.
MacroGenicsrecently established the dose and schedule for MGD013 administration and has initiated dose expansion in up to nine tumor types in a Phase 1 study.
- MGD019 IND Cleared. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4, two immune checkpoint inhibitors, on T cells. MacroGenics’ Investigational New Drug (IND) application for MGD019 was cleared by the
FDAand the Company is currently engaged in Phase 1 study startup.
- Enoblituzumab Oral Presentation at
SITC: Clinical data from MacroGenics’ study of this Fc-optimized mAb that targets B7-H3 combined with an anti-PD-1 mAb was selected for oral presentation at the upcoming SITC Annual Meeting. Like the combination of margetuximab and anti-PD-1, enoblituzumab and anti-PD-1 is designed to leverage Fc-optimization and checkpoint blockade to coordinately engage innate and adaptive immunity, the two major components of the immune response. As an update of the recently released abstract, the combination of enoblituzumab and anti-PD-1 demonstrated antitumor activity in checkpoint inhibitor-naïve patients who had squamous cell carcinoma of the head and neck (SCCHN) and in checkpoint inhibitor-naïve patients with non-small cell lung cancer (NSCLC) with tumor PD-L1 expression of <1%. In these two cohorts, objective responses occurred in 6/18 (33%) response-evaluable SCCHN patients and in 5/14 (36%) response-evaluable NSCLC patients. Additional details will be provided at SITC.
- Orlotamab Studies Ongoing: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 monotherapy study in multiple tumor types. In addition, a combination study of orlotamab and MGA012 is ongoing.
- MGC018 Phase 1 Startup Initiated: MacroGenics’ IND submission for this anti-B7-H3 antibody-drug conjugate (ADC) was cleared by the
FDAand the Company is initiating a Phase 1 study. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
- Oral Presentations at ASH.
MacroGenicsplans to present both updated clinical data as well as gene signature data from its completed acute myeloid leukemia (AML) dose expansion cohort in two oral presentations at the American Society of Hematology(ASH) Annual Meeting next month. 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 Planned.
MacroGenicshas previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab and plans to commence a combination study with MGA012.
Third Quarter 2018 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities as of
September 30, 2018, were $260.1 million, compared to $305.1 millionas of December 31, 2017.
- Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was
$20.8 millionfor the quarter ended September 30, 2018, compared to $1.7 millionfor the quarter ended September 30, 2017. This increase was primarily due to revenue recognized under the Incyte MGA012 collaboration. 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
$46.2 millionfor the quarter ended September 30, 2018, compared to $41.0 millionfor the quarter ended September 30, 2017. This increase was primarily due to the initiation of combination studies of MGA012, continued enrollment in multiple ongoing studies, increased development/manufacturing costs related to MGA012, which were partially reimbursed by Incyte, and increased headcount to support expanded manufacturing and development activities.
- G&A Expenses: General and administrative expenses were
$9.6 millionfor the quarter ended September 30, 2018, compared to $8.4 millionfor the quarter ended September 30, 2017. This increase was primarily due to increased patent-related expenses and consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
- Net Loss: Net loss was
$34.0 millionfor the quarter ended September 30, 2018, compared to net loss of $47.0 millionfor the quarter ended September 30, 2017.
- Shares Outstanding: Shares outstanding as of
September 30, 2018were 42,248,075.
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)
|September 30, 2018||December 31, 2017|
|Cash, cash equivalents and investments||$260,143||$305,121|
|Total stockholders' equity||282,644||299,238|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Revenue from collaborative agreements||$20,617||$1,076||$43,670||$3,435|
|Revenue from government agreements||181||587||657||1,948|
|Costs and expenses:|
|Research and development||46,218||40,984||143,902||108,246|
|General and administrative||9,584||8,403||29,953||24,249|
|Total costs and expenses||55,802||49,387||173,855||132,495|
|Loss from operations||(35,004||)||(47,724||)||(129,528||)||(127,112||)|
|Other comprehensive loss:|
|Unrealized gain (loss) on investments||(18||)||56||61||55|
|Basic and diluted net loss per common share||($0.81||)||($1.28||)||($3.13||)||($3.50||)|
|Basic and diluted weighted average number of common shares outstanding||42,239,327||36,779,305||40,462,658||35,847,449|
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.