MacroGenics Provides Update on Corporate Progress and First Quarter 2023 Financial Results
09 Maio 2023 - 5:01PM
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on developing and commercializing innovative antibody-based
therapeutics for the treatment of cancer, today provided an update
on its recent corporate progress and reported financial results for
the quarter ended March 31, 2023.
“The recent U.S. Food and Drug Administration
(FDA) approval of Incyte’s ZYNYZ (retifanlimab-dlwr) represents the
third U.S. marketing clearance of a product originating from
MacroGenics’ pipeline of proprietary or partnered product
candidates. We are delighted that the approval of ZYNYZ provides an
additional option for treating patients with Merkel cell carcinoma
(MCC), a rare and aggressive type of skin cancer,” said Scott
Koenig, M.D., Ph.D., President and Chief Executive Officer of
MacroGenics. “With the approval of both ZYNYZ and TZIELD™
(teplizumab-mzwv) by our partners, MacroGenics remains eligible to
receive more than $1 billion in milestone payments related to the
continued advancement and successful commercialization of these two
products. Over the past nine months, these and other programs have
allowed us to generate $270 million in non-dilutive capital,
extending our cash runway through 2025.”
Updates on Proprietary Investigational
Programs
Recent progress and anticipated events related
to MacroGenics’ investigational product candidates are highlighted
below.
- Vobramitamab duocarmazine
(vobra duo) is an antibody-drug conjugate (ADC) that
targets B7-H3, an antigen with broad expression across multiple
solid tumor types and a member of the B7 family of molecules
involved in immune regulation.
- MacroGenics initiated the Phase 2
portion of the TAMARACK study of vobra duo in patients with mCRPC
in late 2022. This study is designed to evaluate vobra duo at two
different doses, 2.0 mg/kg or 2.7 mg/kg every four weeks, in two
experimental arms comprising a total of 100 patients. Regulatory
approval of a modified protocol, primarily reflecting removal of a
control arm, has been obtained in the U.S. and all countries
targeted for study enrollment in the E.U. MacroGenics anticipates
commencement of enrollment under the revised protocol beginning in
the second quarter of 2023 and expects to provide a clinical update
in 2024.
- MacroGenics continues to enroll a
Phase 1/2 dose escalation study of vobra duo in combination with
lorigerlimab in patients with various advanced solid tumors.
- Lorigerlimab is a
bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. The Company
presented encouraging preliminary clinical results from a single
arm, dose-expansion study of lorigerlimab in patients with advanced
solid tumors in a poster session at the ASCO Genitourinary Cancers
Symposium in February 2023. Based on the strength of the mCRPC data
presented, MacroGenics plans to commence enrollment of a randomized
Phase 2 study of lorigerlimab in combination with docetaxel vs.
docetaxel in second-line, chemotherapy-naïve mCRPC patients in the
second half of 2023. A total of 150 patients are planned to be
randomized 2:1. The current study design includes a primary study
endpoint of radiographic progression-free survival (rPFS).
- MGD024 is a
next-generation, humanized CD123 × CD3 DART molecule designed to
minimize cytokine-release syndrome, while maintaining anti-tumor
cytolytic activity, and permitting intermittent dosing through a
longer half-life. MacroGenics continues to enroll patients in a
Phase 1 dose-escalation study of MGD024 in patients with
CD123-positive neoplasms, including acute myeloid leukemia and
myelodysplastic syndromes.
- Enoblituzumab is an
Fc-optimized monoclonal antibody that targets B7-H3. In April 2023,
results from a Phase 2 investigator-sponsored study at the Johns
Hopkins Kimmel Cancer Center was published in Nature Medicine. In
the clinical study, 32 men with high-risk or very high-risk
prostate cancer who were scheduled for prostate cancer surgery were
treated with six weekly infusions of enoblituzumab prior to surgery
and were followed for an average of 30 months thereafter.
Twenty-one patients (66%) had an undetectable prostate-specific
antigen (PSA) level 12 months following surgery, suggesting to the
authors that there was no sign of residual disease. Additionally,
the investigators reported the drug was well-tolerated overall; no
patients had any surgical delays or medical complications during or
after the operation.
Other Corporate Updates
- Sale of TZIELD royalty
interest. As announced in March 2023, MacroGenics received
a $100 million upfront payment from a wholly-owned subsidiary of
DRI Healthcare Trust (DRI) for the sale to DRI of its single-digit
royalty on global net sales of TZIELD, while retaining the right to
receive a 50% share of the royalty on global net sales above a
certain annual threshold. Sanofi, S.A. (Sanofi)’s acquisitions of
both Provention Bio and DRI’s royalty interest in TZIELD in April
2023 have not changed MacroGenics’ economic interests, and
MacroGenics is eligible to receive from Sanofi a total of up to
$430 million in milestone payments, including $105 million upon the
achievement of certain regulatory approval milestones, $225 million
upon the achievement of certain sales milestones and $100 million
in potential payments that Sanofi assumed from DRI.
- ZYNYZ
approval. As announced in March 2023, the
FDA approved ZYNYZ, a humanized monoclonal antibody targeting PD-1,
for the treatment of adults with metastatic or recurrent locally
advanced MCC. Incyte continues to conduct global registrational
studies of retifanlimab across multiple indications, including
lung, anal and endometrial cancer. This molecule was initially
developed by MacroGenics and licensed by Incyte in October 2017,
pursuant to an exclusive global collaboration and license agreement
that includes the following provisions:
- MacroGenics received a $15 million
milestone payment from Incyte based on the approval of ZYNYZ in MCC
and is eligible to receive up to a total of $320 million in
potential remaining development and regulatory milestones and up to
$330 million in potential commercial milestones from Incyte.
- MacroGenics is eligible to receive
tiered royalties of 15% to 24% from Incyte on any global net sales
of the product.
- MacroGenics will manufacture a portion of Incyte’s global
commercial supply of retifanlimab.
First Quarter
2023 Financial Results
- Cash Position:
Cash, cash equivalents and marketable securities as of
March 31, 2023, were $241.7 million, compared to $154.3
million as of December 31, 2022. This cash balance did not
include a $30 million payment received after March 31, 2023 related
to the TZIELD approval milestone.
- Revenue: Total
revenue, consisting primarily of revenue from collaborative
agreements, was $24.5 million for the quarter ended March 31,
2023, compared to total revenue of $11.1 million for the quarter
ended March 31, 2022.
- R&D Expenses:
Research and development expenses were $45.9 million for the
quarter ended March 31, 2023, compared to $61.4 million for
the quarter ended March 31, 2022. The decrease was primarily
related to decreased vobramitamab duocarmazine development costs
and decreased costs related to discontinued studies. These
decreases were partially offset by increased expenses related to
discovery projects and preclinical molecules, and increased
clinical expenses related to lorigerlimab.
- SG&A Expenses: Selling, general and
administrative expenses were $13.5 million for the quarter ended
March 31, 2023, compared to $16.3 million for the quarter
ended March 31, 2022. The decrease was primarily related to
decreased legal and consulting expenses.
- Net
Loss: Net loss was $38.0 million for the quarter ended
March 31, 2023, compared to net loss of $66.4 million for the
quarter ended March 31, 2022.
-
Shares Outstanding: Shares of common stock
outstanding as of March 31, 2023 were 61,838,565.
- Cash Runway Guidance: MacroGenics anticipates
that its cash, cash equivalents and marketable securities balance
of $241.7 million as of March 31, 2023, plus projected and
anticipated future payments from partners and product revenues
should extend its cash runway through 2025. The Company’s expected
funding requirements reflect anticipated expenditures related to
the Phase 2 TAMARACK clinical trial, the planned Phase 2 study of
lorigerlimab in mCRPC as well as MacroGenics’ other ongoing
clinical and preclinical studies.
Conference Call Information
To participate via telephone, please register in
advance at this link. Upon registration, all telephone participants
will receive a confirmation email detailing how to join the
conference call, including the dial-in number along with a unique
passcode and registrant ID that can be used to access the call.
The listen-only webcast of the conference call
can be accessed under "Events & Presentations" in the Investor
Relations section of MacroGenics’ website at
http://ir.macrogenics.com/events.cfm. A recorded replay of the
webcast will be available shortly after the conclusion of the call
and archived on MacroGenics’ website for 30 days following the
call.
MACROGENICS, INC. |
SELECTED CONSOLIDATED BALANCE SHEET DATA |
(Amounts in thousands) |
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
Cash, cash equivalents and marketable securities |
$ |
241,656 |
|
$ |
154,346 |
Total assets |
|
343,498 |
|
|
280,468 |
Deferred revenue |
|
67,255 |
|
|
69,468 |
Total stockholders' equity |
|
109,268 |
|
|
142,013 |
MACROGENICS,
INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
(Unaudited) |
|
(Amounts in
thousands, except share and per share data) |
|
Three Months Ended March 31, |
|
2023 |
|
2022 |
Revenues: |
|
|
|
Collaborative and other agreements |
$ |
16,686 |
|
|
$ |
7,093 |
|
Product sales, net |
|
3,490 |
|
|
|
3,580 |
|
Contract manufacturing |
|
3,615 |
|
|
|
— |
|
Royalty revenue |
|
422 |
|
|
|
— |
|
Government agreements |
|
283 |
|
|
|
428 |
|
Total revenues |
|
24,496 |
|
|
|
11,101 |
|
Costs and expenses: |
|
|
|
Cost of product sales |
|
113 |
|
|
|
48 |
|
Cost of manufacturing services |
|
3,410 |
|
|
|
— |
|
Research and development |
|
45,872 |
|
|
|
61,438 |
|
Selling, general and administrative |
|
13,527 |
|
|
|
16,253 |
|
Total costs and expenses |
|
62,922 |
|
|
|
77,739 |
|
Loss from operations |
|
(38,426 |
) |
|
|
(66,638 |
) |
Interest and other income,
net |
|
1,073 |
|
|
|
195 |
|
Interest expense |
|
(656 |
) |
|
|
— |
|
Net loss |
|
(38,009 |
) |
|
|
(66,443 |
) |
Other comprehensive income
(loss): |
|
|
|
Unrealized gain (loss) on investments |
|
13 |
|
|
|
(222 |
) |
Comprehensive loss |
$ |
(37,996 |
) |
|
$ |
(66,665 |
) |
|
|
|
|
Basic and diluted net loss per
common share |
$ |
(0.61 |
) |
|
$ |
(1.08 |
) |
Basic and diluted weighted
average common shares outstanding |
|
61,809,817 |
|
|
|
61,324,163 |
|
About MacroGenics, Inc.
MacroGenics (the Company) 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, MARGENZA 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 MacroGenics
(“Company”), including statements about the Company’s strategy,
future operations, clinical development of the Company’s
therapeutic candidates, including initiation and enrollment in
clinical trials, expected timing of results from clinical trials,
discussions with regulatory agencies, commercial prospects of or
product revenues from MARGENZA and the Company’s product
candidates, if approved, manufacturing services revenue, 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, as well as future global net sales of
TZIELD and the Company’s ability to achieve the milestone payments
set forth under the terms of the agreement with DRI (or its
successors or assigns with respect to such agreement), and other
statements containing the words “subject to”, "believe",
“anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,”
“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 TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ,
MARGENZA or any other product candidate’s revenue, expenses and
costs may not be as expected, risks relating to TZIELD,
vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any
other product candidate’s market acceptance, competition,
reimbursement and regulatory actions; our ability to provide
manufacturing services to our customers; the uncertainties inherent
in the initiation and enrollment of future clinical trials; the
availability of financing to fund the internal development of our
product candidates; expectations of expanding ongoing clinical
trials; availability and timing of data from ongoing clinical
trials; expectations for the timing and steps required in the
regulatory review process; expectations for regulatory approvals;
expectations of future milestone payments; the impact of
competitive products; our ability to enter into agreements with
strategic partners and other matters that could affect the
availability or commercial potential of the Company's product
candidates; business, economic or political disruptions due to
catastrophes or other events, including natural disasters,
terrorist attacks, civil unrest and actual or threatened armed
conflict, or public health crises such as the novel coronavirus
(referred to as COVID-19 pandemic); 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 1-301-251-5172
info@macrogenics.com
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