MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on developing and commercializing innovative monoclonal
antibody-based therapeutics for the treatment of cancer, today
provided an update on its recent corporate progress and reported
financial results for the year ended December 31, 2020.
“Following the approval in late 2020 of our first
drug with the U.S. Food and Drug Administration (FDA), 2021 has the
potential to be another transformative year for MacroGenics. We
expect to launch MARGENZA in the coming weeks and will continue to
advance our deep pipeline of promising product candidates in
multiple clinical trials," said Scott Koenig, M.D., Ph.D.,
President and CEO of MacroGenics. “We are particularly excited
about our ongoing, potentially registration-enabling studies,
including flotetuzumab in acute myeloid leukemia (AML) and
margetuximab in gastric cancer, as well as two Prescription Drug
User Fee Act (PDUFA) target action dates in July related to
retifanlimab and teplizumab. And finally, we look forward to
providing clinical updates on multiple, ongoing dose expansion
studies this year.”
Key Updates on Proprietary
Programs
Recent progress and anticipated events in 2021
related to MacroGenics’ approved and investigational product
candidates in clinical development, as well as an advanced
preclinical program, are highlighted below.
-
Margetuximab is an Fc-engineered, monoclonal
antibody (mAb) that targets the HER2 oncoprotein, which is
expressed by certain breast, gastroesophageal and other solid tumor
cells.
- MARGENZA
(margetuximab-cmkb) approval and commercial launch. In
December 2020, the FDA approved MARGENZA in combination with
chemotherapy for the treatment of adult patients with metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2 regimens, at least one of which was for metastatic
disease. The launch, which is being coordinated with MacroGenics’
commercial partner, EVERSANA, is expected in March.
- Phase 2/3 MAHOGANY
study in advanced gastric (GC) and gastroesophageal junction (GEJ)
cancer. The MAHOGANY clinical program contains two modules
designed to evaluate margetuximab as an investigational agent in
combination with a checkpoint inhibitor, with or without
chemotherapy, as a potential first-line treatment for patients with
advanced or metastatic HER2-positive GC/GEJ. Initial safety and
efficacy data from among the first 40 patients enrolled in Module
A, which is evaluating margetuximab in combination with
retifanlimab (an anti-PD-1 therapy), are expected in the first half
of 2021. Enrollment in Module B, which is evaluating margetuximab
plus MacroGenics’ checkpoint inhibitor molecules in combination
with chemotherapy compared to standard of care therapy of
trastuzumab with chemotherapy in patients with HER2-positive tumors
irrespective of PD-L1 expression, is currently ongoing in
coordination with the Company's regional partner in Greater China,
Zai Lab.
-
Flotetuzumab is a bispecific CD123
× CD3 DART® molecule being evaluated in patients
with primary induction failure (PIF) and early relapsed (less than
six months, or ER6) AML. Six clinical and preclinical
abstracts related to AML and flotetuzumab were presented at the
American Society of Hematology (ASH) Annual Meeting &
Exposition in December 2020. MacroGenics is conducting a
single-arm, registration-enabling clinical study to evaluate
flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete
remission (CR) and CR with partial hematological recovery (CRh) as
the composite primary endpoint. The Company anticipates providing
further updates on the clinical development of flotetuzumab in the
second half of 2021, and completing full enrollment of this study
in 2022.
-
MGC018 is an antibody-drug conjugate that targets
B7-H3. MacroGenics continues to enroll patients with metastatic
castration-resistant prostate cancer (mCRPC), triple negative
breast cancer (TNBC) and non-small cell lung cancer (NSCLC) in the
dose expansion portion of the Phase 1 clinical study. The Company
expects to provide an update on this study in mid-2021.
-
Enoblituzumab is an Fc‐engineered, anti‐B7‐H3
mAb. In the coming weeks, MacroGenics expects to initiate a
Phase 2 study of enoblituzumab in a chemo-free regimen in
combination with retifanlimab in front-line patients with squamous
cell carcinoma of the head and neck (SCCHN) who are PD-L1 positive
and with tebotelimab in SCCHN patients who are PD-L1 negative.
-
Tebotelimab is a bispecific, tetravalent DART
molecule targeting PD-1 and LAG-3. Tebotelimab is being evaluated
in a Phase 1 dose expansion study as monotherapy in several tumor
types. An oral presentation of tebotelimab Phase 1 data in patients
with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) was
made at ASH in December 2020. In addition, data from the
combination study of tebotelimab and margetuximab in patients with
advanced HER2+ neoplasms were presented at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting in November 2020.
MacroGenics’ regional partner in Greater China, Zai Lab, is also
evaluating tebotelimab in Phase 1 combination studies with
niraparib and brivanib for the study of advanced gastric cancer and
hepatocellular carcinoma, respectively, as well as a monotherapy
study in patients with melanoma. MacroGenics expects to provide
clinical updates on tebotelimab in 2021, including future
development plans.
-
MGD019 is a bispecific, tetravalent DART molecule
targeting PD-1 and CTLA-4. The Company is enrolling Phase 1 dose
expansion cohorts, initially in patients with microsatellite stable
colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC at the
recommended Phase 2 dose. The Company expects to provide a clinical
update on this study in mid-2021.
-
IMGC936 is an antibody-drug conjugate that targets
ADAM9, a cell surface protein over-expressed in several solid tumor
types. IMGC936 is being advanced under a co-development agreement
with ImmunoGen, Inc. Under the 50/50 collaboration, ImmunoGen is
leading clinical development and the Phase 1 dose escalation study
is currently enrolling patients with select advanced solid
tumors.
-
MGD024 is a next-generation, bispecific CD123 ×
CD3 DART molecule in preclinical development. The molecule
incorporates a CD3 component designed to minimize cytokine-release
syndrome, while maintaining anti-tumor cytolytic activity, along
with an Fc domain to permit intermittent dosing through a longer
half-life. The Company anticipates submitting an Investigational
New Drug (IND) application to the FDA by the end of 2021.
Key Partnered Programs Update
Recent progress and disclosed priorities for
MacroGenics’ partnerered investigational molecules are highlighted
below.
-
Retifanlimab is an anti-PD-1 mAb that has
been exclusively licensed to Incyte Corporation. To date,
MacroGenics has earned $65 million in milestones related to
retifanlimab, triggered by advancement of the molecule through
various clinical and regulatory activities. In January 2021, Incyte
announced that the FDA had accepted for Priority Review its
Biologics License Application (BLA) for retifanlimab as a potential
treatment for adult patients with locally advanced or metastatic
squamous cell carcinoma of the anal canal. The PDUFA target action
date for retifanlimab is July 25, 2021. MacroGenics is eligible to
receive up to a total of $685 million in potential remaining
development, regulatory and commercial milestones. If retifanlimab
is approved and commercialized, MacroGenics would be eligible to
receive royalties, tiered from 15 to 24 percent, on future
worldwide net sales of the drug.
-
Teplizumab is a mAb being developed by Provention
Bio, Inc. for the treatment of type 1 diabetes. In January 2021,
Provention announced the FDA filing of a BLA and Priority Review
for this molecule, with a PDUFA target action date of July 2, 2021.
In 2018, MacroGenics sold its interest in teplizumab to Provention
and is eligible to receive up to $170 million upon the achievement
of certain regulatory approval milestones, including $60 million
upon approval of a BLA in the U.S., additional milestone payments
totaling $225 million upon the achievement of certain sales
milestones and single-digit royalties on net sales of the
molecule.
Corporate Updates
-
Janssen Collaboration. In December 2020,
MacroGenics announced a research collaboration and global license
agreement to develop a preclinical bispecific molecule
with Janssen Biotech, Inc. The research collaboration
will incorporate MacroGenics' proprietary DART platform
to enable simultaneous targeting of two undisclosed targets in a
therapeutic area outside oncology. Under the terms of the
agreement, Janssen paid MacroGenics an upfront payment
of $20 million and will be responsible for funding all
expenses. MacroGenics will also be eligible to receive up
to $312 million in potential milestone payments and
tiered royalties on worldwide product sales.
- Ms.
Federica O’Brien Added to Board. MacroGenics recently
announced the appointment of Federica “Freddi” O’Brien, a veteran
executive with 25 years of financial and operational leadership in
biopharmaceutical, medical device, and technology companies, to its
Board of Directors.
2020 Financial Results
- Cash
Position: Cash, cash equivalents and marketable securities
as of December 31, 2020 were $272.5 million, compared to
$215.8 million as of December 31, 2019.
-
Revenue: Total revenue, consisting primarily of
revenue from collaborative agreements, was $104.9 million for the
year ended December 31, 2020, compared to $64.2 million for
the year ended December 31, 2019. This increase was primarily
due to the recognition of milestones, partially offset by timing of
revenue recognition under the Company's collaborative
agreements.
- R&D
Expenses: Research and development expenses were $193.2
million for the year ended December 31, 2020, compared to
$195.3 million for the year ended December 31, 2019.
- G&A
Expenses: General and administrative expenses were $42.7
million for the year ended December 31, 2020, compared to
$46.1 million for the year ended December 31, 2019. This
decrease was primarily due to a decrease in external costs,
including consulting.
- Net
Loss: Net loss was $129.7 million for the year ended
December 31, 2020, compared to net loss of $151.8 million for
the year ended December 31, 2019.
- Shares
Outstanding: Shares outstanding as of December 31,
2020 were 56,244,771.
- Cash Runway
Guidance: MacroGenics anticipates that its cash, cash
equivalents and marketable securities as of December 31, 2020,
as well as anticipated and potential collaboration payments, should
enable it to fund its operations into 2023, assuming the Company’s
programs and collaborations advance as currently contemplated.
Conference Call Information
MacroGenics will host a conference call today
at 4:30 pm (ET) to discuss financial results for the year
ended December 31, 2020 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: 6094343.
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.
MACROGENICS,
INC.SELECTED CONSOLIDATED BALANCE SHEET
DATA(Amounts in thousands)
|
As of December 31, |
|
2020 |
|
2019 |
Cash, cash equivalents and marketable securities |
$ |
272,531 |
|
|
$ |
215,756 |
|
Total assets |
378,743 |
|
|
312,501 |
|
Deferred revenue |
11,382 |
|
|
19,853 |
|
Total stockholders' equity |
295,884 |
|
|
230,628 |
|
MACROGENICS,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Amounts in thousands, except
share and per share data)
|
Year Ended December 31, |
|
2020 |
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
Revenue from collaborative and other agreements |
$ |
97,764 |
|
|
$ |
62,024 |
|
|
$ |
58,644 |
|
Revenue from government agreements |
7,119 |
|
|
2,164 |
|
|
1,477 |
|
Total revenues |
104,883 |
|
|
64,188 |
|
|
60,121 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Research and development |
193,201 |
|
|
195,309 |
|
|
190,827 |
|
General and administrative |
42,742 |
|
|
46,064 |
|
|
40,500 |
|
Total costs and expenses |
235,943 |
|
|
241,373 |
|
|
231,327 |
|
|
|
|
|
|
|
Loss from operations |
(131,060 |
) |
|
(177,185 |
) |
|
(171,206 |
) |
|
|
|
|
|
|
Other income (expense) |
1,321 |
|
|
25,374 |
|
|
(247 |
) |
Net loss |
(129,739 |
) |
|
(151,811 |
) |
|
(171,453 |
) |
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
Unrealized gain (loss) on investments |
(23 |
) |
|
19 |
|
|
58 |
|
Comprehensive loss |
$ |
(129,762 |
) |
|
$ |
(151,792 |
) |
|
$ |
(171,395 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(2.47 |
) |
|
$ |
(3.16 |
) |
|
$ |
(4.19 |
) |
Basic and diluted weighted average number of common shares |
52,442,389 |
|
|
48,082,728 |
|
|
40,925,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
IMPORTANT SAFETY INFORMATION -
MARGENZABOXED WARNING: LEFT VENTRICULAR
DYSFUNCTION AND EMBRYO-FETAL TOXICITY
- Left
Ventricular Dysfunction: MARGENZA may lead to reductions
in left ventricular ejection fraction (LVEF). Evaluate cardiac
function prior to and during treatment. Discontinue MARGENZA
treatment for a confirmed clinically significant decrease in left
ventricular function.
-
Embryo-Fetal Toxicity: Exposure to MARGENZA during
pregnancy can cause embryo-fetal harm. Advise patients of the risk
and need for effective contraception.
WARNINGS & PRECAUTIONS:
Left Ventricular Dysfunction
- Left ventricular
cardiac dysfunction can occur with MARGENZA.
- MARGENZA has not
been studied in patients with a pretreatment LVEF value of <50%,
a prior history of myocardial infarction or unstable angina within
6 months, or congestive heart failure NYHA class II-IV.
- Withhold MARGENZA
for ≥16% absolute decrease in LVEF from pre-treatment values or
LVEF below institutional limits of normal (or 50% if no limits
available) and ≥10% absolute decrease in LVEF from pretreatment
values.
- Permanently
discontinue MARGENZA if LVEF decline persists greater than 8 weeks,
or dosing is interrupted more than 3 times due to LVEF
decline.
- Evaluate cardiac
function within 4 weeks prior to and every 3 months during and upon
completion of treatment. Conduct thorough cardiac assessment,
including history, physical examination, and determination of LVEF
by echocardiogram or MUGA scan.
- Monitor cardiac
function every 4 weeks if MARGENZA is withheld for significant left
ventricular cardiac dysfunction.
Embryo-Fetal Toxicity
- Based on findings
in animals and mechanism of action, MARGENZA can cause fetal harm
when administered to a pregnant woman. Post-marketing studies of
other HER-2 directed antibodies during pregnancy resulted in cases
of oligohydramnios and oligohydramnios sequence manifesting as
pulmonary hypoplasia, skeletal abnormalities, and neonatal
death.
- Verify pregnancy
status of women of reproductive potential prior to initiation of
MARGENZA.
- Advise pregnant
women and women of reproductive potential that exposure to MARGENZA
during pregnancy or within 4 months prior to conception can result
in fetal harm.
- Advise women of
reproductive potential to use effective contraception during
treatment and for 4 months following the last dose of
MARGENZA.
Infusion-Related Reactions
(IRRs)
- MARGENZA can cause
IRRs. Symptoms may include fever, chills, arthralgia, cough,
dizziness, fatigue, nausea, vomiting, headache, diaphoresis,
tachycardia, hypotension, pruritus, rash, urticaria, and
dyspnea.
- Monitor patients
during and after MARGENZA infusion. Have medications and emergency
equipment to treat IRRs available for immediate use.
- In patients
experiencing mild or moderate IRRs, decrease rate of infusion and
consider premedications, including antihistamines, corticosteroids,
and antipyretics. Monitor patients until symptoms completely
resolve.
- Interrupt MARGENZA
infusion in patients experiencing dyspnea or clinically significant
hypotension and intervene with supportive medical therapy as
needed. Permanently discontinue MARGENZA in all patients with
severe or life-threatening IRRs.
MOST COMMON ADVERSE REACTIONS:
The most common adverse drug reactions (≥10%) with
MARGENZA in combination with chemotherapy are fatigue/asthenia,
nausea, diarrhea, vomiting, constipation, headache, pyrexia,
alopecia, abdominal pain, peripheral neuropathy,
arthralgia/myalgia, cough, decreased appetite, dyspnea,
infusion-related reactions, palmar-plantar erythrodysesthesia, and
extremity pain.
You may report side effects to the FDA at (800)
FDA-1088 or www.fda.gov/medwatch or to MacroGenics at
(844)-MED-MGNX (844-633-6469).
Link to full Prescribing Information, including
Boxed Warning.
About MacroGenics, Inc.
MacroGenics is a biopharmaceutical company focused
on developing and commercializing innovative monoclonal
antibody-based therapeutics for the treatment of cancer. The
Company generates its pipeline of product candidates primarily from
its proprietary suite of next-generation antibody-based technology
platforms, which have applicability across broad therapeutic
domains. 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 and DART
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,
commercial prospects of or product revenues from MARGENZA,
milestone or opt-in payments from the Company's collaborators, the
Company's anticipated milestones 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: risks that MARGENZA revenue, expenses
and costs may not be as expected, risks relating to MARGENZA’s
market acceptance, competition, reimbursement and regulatory
actions, 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,
CFO1-301-251-5172info@macrogenics.com
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