MacroGenics Provides Update on Corporate Progress and Second Quarter 2017 Financial Results
August 02 2017 - 4:01PM
MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical
company focused on discovering and developing innovative monoclonal
antibody-based therapeutics for the treatment of cancer, as well as
autoimmune disorders and infectious diseases, today provided a
corporate progress update and reported financial results for the
quarter ended June 30, 2017.
“MacroGenics’ broad portfolio of product candidates continues to
advance. We are very encouraged by the data we’ve seen to date in
our Phase 1 study of flotetuzumab, a CD123 x CD3 bispecific DART®
molecule, and we look forward to presenting the updated interim
results from this trial in an oral presentation at ESMO in
September,” said Scott Koenig, M.D., Ph.D., President and CEO of
MacroGenics. “In addition, we continue to make progress with
margetuximab, our B7-H3-based franchise and our PD-1-targeted
franchise. During the second quarter, our IND for MGD013,
which targets PD-1 and LAG-3, was cleared by FDA and we expect to
dose the first patients in the coming weeks. I look forward to
sharing updates on our pipeline and further defining our future
development strategies over the remainder of the year.” Key
Pipeline Highlights
Margetuximab. Recent highlights
related to the Company’s Fc-optimized monoclonal antibody 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. MacroGenics remains on track for completing
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 this study in 2017.
B7-H3 Franchise. MacroGenics is developing a
portfolio of therapeutics that target B7-H3, a member of the B7
family of molecules involved in immune regulation. The Company is
advancing multiple programs that target B7-H3 through complementary
mechanisms of action that take advantage of this antigen's broad
expression across multiple solid tumor types. These molecules
include:
- Enoblituzumab: The Company continues to
recruit patients in multiple ongoing studies of enoblituzumab, an
Fc-optimized monoclonal antibody that targets B7-H3. These studies
include a monotherapy study that includes patients with bladder or
prostate cancer and a combination study with an anti-PD-1
antibody.
- MGD009: This DART molecule targeting B7-H3 and
CD3 is being evaluated in a Phase 1 study across multiple solid
tumor types. The Company expects to establish the dose and schedule
for MGD009 administration as well as initiate expansion cohorts in
multiple tumor types in 2017.
- MGC018: The Company is conducting activities
to support the submission of an Investigational New Drug (IND)
application for this anti-B7-H3 antibody drug conjugate in
2018.
PD-1-Directed Immuno-Oncology Franchise.
MacroGenics is advancing several PD-1-directed programs, which will
enable both a broad set of combination opportunities across the
Company’s portfolio and provide further differentiation from
existing PD-1-based treatment options. The first of these are:
- MGA012. The Company’s proprietary anti-PD-1
monoclonal antibody is enrolling patients in the dose escalation
segment of its Phase 1 clinical study and expects to define a
target dose and schedule soon. To date, the antibody has been well
tolerated up to 10 mg/kg. With anti-PD-1 therapy becoming a
mainstay of cancer treatment across multiple tumor types,
MacroGenics believes MGA012 will be the basis for potential
combination therapy with several of the molecules in its pipeline.
The Company plans to initiate the first such study of MGA012 in
combination with another internal program by year end 2017, subject
to regulatory feedback.
- 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’s IND submitted
for MGD013 was cleared by FDA in May and commencement of enrollment
is expected imminently.
- PD-1 x CTLA-4. MacroGenics continues to
advance its preclinical bispecific DART and trispecific TRIDENT™
molecules that bind to and inhibit ligand interaction with PD-1 and
CTLA-4, resulting in enhanced T-cell activation. By targeting these
clinically validated checkpoint molecules simultaneously,
MacroGenics’ DART and TRIDENT proteins hold the promise of enhanced
anti-tumor activity together with a simplified development
path.
Additional DART Clinical Programs. Other DART
molecules being led by MacroGenics in Phase 1 clinical development
include flotetuzumab (CD123 x CD3, also known as MGD006 and
S80880), MGD007 (gpA33 x CD3) and MGD010 (CD32B x CD79B). Updates
on these programs include:
- Flotetuzumab. In July, MacroGenics was
notified that its abstract titled “Interim Results from a Phase 1
First-in-Human study of flotetuzumab, a CD123 x CD3 bispecific DART
molecule, in AML/MDS” had been accepted for oral presentation at
the European Society for Medical Oncology Annual Congress, ESMO
2017. The Company continues to recruit patients with acute myeloid
leukemia or myelodysplastic syndrome in the U.S. and Europe and has
established a recommended dose and schedule and has initiated
expansion cohorts for this study.
- MGD007. MacroGenics continues to recruit
patients with colorectal cancer in a Phase 1 study. The Company has
initiated various expansion cohorts to define a recommended dose
and schedule.
- MGD010. In June, MacroGenics presented updated
data from its Phase 1 study of MGD010 at the EULAR Annual European
Congress of Rheumatology. The Company highlighted data
demonstrating that a single dose administration of MGD010 at either
3 or 10 mg/kg delivers an immunomodulatory effect that counters
B-cell function.
Second Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities as of June 30, 2017, were $243.7 million,
compared to $285.0 million as of December 31, 2016.
- Revenue: Total revenue, consisting primarily
of revenue from collaborative agreements, was $1.7 million for the
quarter ended June 30, 2017, compared to $80.7 million for the
quarter ended June 30, 2016. This decrease was primarily due to the
receipt of $75.0 million in 2016 as an upfront payment under a
collaboration and license agreement with Janssen for MGD015.
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 $34.5 million for the quarter ended June 30, 2017,
compared to $33.3 million for the quarter ended June 30, 2016.
- G&A Expenses: General and administrative
expenses were $8.4 million for the quarter ended June 30, 2017,
compared to $7.2 million for the quarter ended June 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 $40.7 million for the
quarter ended June 30, 2017, compared to net income of $40.5
million for the quarter ended June 30, 2016.
- Shares Outstanding: Shares outstanding as of
June 30, 2017 were 36,680,522.
Conference Call Information
MacroGenics will host a conference call today at
4:30 pm (EDT) to discuss financial results for the quarter ended
June 30, 2017 and provide a corporate update. To participate in the
conference call, please dial (877) 303-6253 (domestic) or (973)
409-9610 (international) five minutes prior to the start of the
call and provide the Conference ID: 50966747.
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.
|
MACROGENICS, INC. |
SELECTED CONSOLIDATED BALANCE SHEET
DATA |
|
(Amounts in thousands) |
|
|
June 30, 2017 |
|
December 31, 2016 |
|
(unaudited) |
|
|
|
Cash, cash equivalents
and investments |
$ |
243,660 |
|
$ |
284,982 |
Total assets |
|
274,846 |
|
|
311,263 |
Deferred revenue |
|
12,440 |
|
|
14,306 |
Total stockholders'
equity |
|
231,348 |
|
|
268,751 |
MACROGENICS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS) |
(Unaudited) |
|
(Amounts in thousands, except share and per
share data) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2017 |
|
|
|
2016 |
|
|
2017 |
|
|
|
2016 |
Revenues: |
|
|
|
|
|
|
|
Revenue
from collaborative agreements |
$ |
1,081 |
|
|
$ |
78,497 |
|
$ |
2,359 |
|
|
$ |
80,390 |
Revenue
from government agreements |
|
585 |
|
|
|
2,176 |
|
|
1,361 |
|
|
|
3,129 |
Total revenues |
|
1,666 |
|
|
|
80,673 |
|
|
3,720 |
|
|
|
83,519 |
|
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
34,461 |
|
|
|
33,340 |
|
|
67,262 |
|
|
|
60,686 |
General
and administrative |
|
8,384 |
|
|
|
7,239 |
|
|
15,846 |
|
|
|
13,372 |
Total costs and
expenses |
|
42,845 |
|
|
|
40,579 |
|
|
83,108 |
|
|
|
74,058 |
|
|
|
|
|
|
|
|
Income (loss) from
operations |
|
(41,179 |
) |
|
|
40,094 |
|
|
(79,388 |
) |
|
|
9,461 |
|
|
|
|
|
|
|
|
Other income |
|
525 |
|
|
|
370 |
|
|
1,078 |
|
|
|
640 |
Net income (loss) |
|
(40,654 |
) |
|
|
40,464 |
|
|
(78,310 |
) |
|
|
10,101 |
|
|
|
|
|
|
|
|
Other comprehensive
income (loss): |
|
|
|
|
|
|
|
Unrealized gain (loss)
on investments |
|
25 |
|
|
|
7 |
|
|
(1 |
) |
|
|
64 |
Comprehensive income
(loss) |
$ |
(40,629 |
) |
|
$ |
40,471 |
|
$ |
(78,311 |
) |
|
$ |
10,165 |
|
|
|
|
|
|
|
|
Basic net income (loss)
per common share |
($1.14 |
) |
|
$1.17 |
|
($2.21 |
) |
|
$0.29 |
Diluted net income
(loss) per common share |
($1.14 |
) |
|
$1.12 |
|
($2.21 |
) |
|
$0.28 |
Basic weighted average
number of common shares outstanding |
|
35,784,804 |
|
|
|
34,616,197 |
|
|
35,373,799 |
|
|
|
34,560,021 |
Diluted weighted
average number of common shares outstanding |
|
35,784,804 |
|
|
|
36,017,411 |
|
|
35,373,799 |
|
|
|
35,966,987 |
About MacroGenics, Inc.
MacroGenics is a clinical-stage biopharmaceutical company
focused on discovering and developing innovative monoclonal
antibody-based therapeutics for the treatment of cancer, as well as
autoimmune disorders and infectious diseases. The Company generates
its pipeline of product candidates primarily from its proprietary
suite of next-generation antibody-based technology platforms. The
combination of MacroGenics' technology platforms and protein
engineering expertise has allowed the Company to generate promising
product candidates and enter into several strategic collaborations
with global pharmaceutical and biotechnology companies. For more
information, please see the Company's website at
www.macrogenics.com. MacroGenics, the MacroGenics logo, DART and
TRIDENT are trademarks or registered trademarks of MacroGenics,
Inc.
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 Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release
represent the Company's views only as of the date hereof. The
Company anticipates that subsequent events and developments will
cause the Company's views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so, except as may be required by law. These forward-looking
statements should not be relied upon as representing the Company's
views as of any date subsequent to the date hereof.
Contacts:
Jim Karrels, Senior Vice President, CFO
MacroGenics, Inc.
1-301-251-5172, info@macrogenics.com
Karen Sharma, Senior Vice President
MacDougall Biomedical Communications
1-781-235-3060, ksharma@macbiocom.com
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