MacroGenics Provides Update on Corporate Progress and 2023 Financial Results
07 Março 2024 - 6:01PM
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on discovering, developing, manufacturing 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 year
ended December 31, 2023.
“We expect that 2024 will be an important year for
MacroGenics, with multiple pipeline advancements anticipated," said
Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Late
last year, we completed enrollment of 177 patients in the TAMARACK
Phase 2 study of vobra duo, which was ahead of schedule. We plan to
present the initial TAMARACK clinical data in the second quarter of
this year. Later in the year, we expect to share updated clinical
data from the trial. In addition, we continue to enroll the
LORIKEET Phase 2 study of lorigerlimab in mCRPC and expect to start
enrolling patients in the dose expansion portion of the combination
study of vobra duo and lorigerlimab. Finally, we are excited about
the potential of our topoisomerase I inhibitor-based ADCs,
including MGC026, for which we recently began a Phase 1 study, and
MGC028, for which we anticipate submitting an IND by year end.”
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 tumors and a member of the
B7 family of molecules involved in immune regulation.
- MacroGenics
completed enrollment of the TAMARACK Phase 2 study of vobra duo in
November 2023. A total of 177 patients have been dosed in the
study, exceeding the study design goal of 100 participants.
TAMARACK is being conducted in patients with metastatic
castration-resistant prostate cancer (mCRPC) who were previously
treated with one prior androgen receptor axis-targeted therapy
(ARAT). Participants may have received up to one prior
taxane-containing regimen, but no other chemotherapy agents. The
TAMARACK study is designed to evaluate vobra duo at two different
doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W).In late
January 2024, the TAMARACK independent data safety monitoring
committee (IDSMC) recommended continuing the study. Also, in early
February, MacroGenics submitted an abstract to the American Society
of Clinical Oncology Annual Meeting (ASCO) that included the safety
data reviewed by the IDSMC, based on a January 2024 data cut-off.
The Company anticipates presenting updated safety and preliminary
efficacy data at ASCO.
- MacroGenics intends
to expand the TAMARACK study of vobra duo by enrolling patients
with non-small cell lung cancer (NSCLC), small cell lung cancer
(SCLC), melanoma, squamous cell carcinoma of the head and neck
(SCCHN) and anal cancer. The Company expects to initiate dosing in
these additional cohorts in mid-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. The Company anticipates commencing a dose expansion
study of this combination in mCRPC and at least one additional
indication in 2024.
-
Lorigerlimab is a bispecific, tetravalent PD-1 ×
CTLA-4 DART® molecule. MacroGenics is enrolling LORIKEET, a
randomized Phase 2 study of lorigerlimab in combination with
docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve
mCRPC patients. A total of 150 patients are planned to be treated
in the 2:1 randomized study. The current trial design includes a
primary study endpoint of radiographic progression-free survival
(rPFS). The Company anticipates providing a study update in the
second half of 2024.
-
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.
-
MGC026 is a clinical ADC directed against B7-H3,
incorporating a novel site-specific linker and topoisomerase I
inhibitor-based cytotoxic payload developed by Synaffix (a Lonza
company). With distinct mechanisms of action, vobra duo and MGC026
may address different cancers, tumor stages, or be used in
combination with alternate agents — or potentially with one another
— to enhance their clinical utility. The Company plans to present
MGC026 preclinical data at the upcoming American Association for
Cancer Research (AACR) Annual Meeting in April 2024. MacroGenics
recently initiated a Phase 1 dose escalation study of MGC026 in
patients with advanced solid tumors.
-
MGC028 is a preclinical ADC incorporating an
ADAM9-targeting antibody and represents the second MacroGenics ADC
molecule that incorporates Synaffix’s novel site-specific linker
and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a
disintegrin and metalloprotease domain 9) is a member of the ADAM
family of multifunctional type 1 transmembrane proteins that play a
role in tumorigenesis and cancer progression and is overexpressed
in multiple cancers, making it an attractive target for cancer
treatment. MacroGenics plans to present preclinical data for MGC028
at the upcoming AACR Annual Meeting in April and currently
anticipates submitting an investigational new drug (IND)
application for MGC028 by the end of 2024.MGC028 is the second
ADAM9-targeted ADC that MacroGenics has pursued. The first was
IMGC936, a molecule with a maytansinoid payload that was advanced
under a co-development arrangement with ImmunoGen, Inc. (ImmunoGen,
now part of AbbVie). Under the 50/50 collaboration, ImmunoGen led
clinical development and completed initial Phase 1 dose escalation
and dose expansion studies. Neither MacroGenics nor AbbVie intends
to further pursue development of IMGC936 as the molecule did not
achieve pre-established clinical safety and efficacy benchmarks.
The Company believes ADAM9 remains a promising target for delivery
of an alternative cytotoxic payload.
- Enoblituzumab is an
Fc-optimized monoclonal antibody that targets B7-H3. MacroGenics’
academic collaborators have initiated the HEAT study, an
investigator-sponsored, randomized Phase 2 clinical trial. This
study will evaluate the activity of neoadjuvant enoblituzumab given
prior to radical prostatectomy in up to 219 men with high-risk
localized prostate cancer.
2023 Financial
Results
- Cash
Position: Cash, cash equivalents and marketable securities
balance as of December 31, 2023, was $229.8 million, compared
to $154.3 million as of December 31, 2022.
-
Revenue: Total revenue was $58.7 million for the
year ended December 31, 2023, compared to total revenue of
$151.9 million for the year ended December 31, 2022. The
decrease was primarily due to a decrease in revenue from
collaborative and other agreements.
- R&D
Expenses: Research and development expenses were $166.6
million for the year ended December 31, 2023, compared to
$207.0 million for the year ended December 31, 2022. The
decrease was primarily due to decreased manufacturing-related costs
for vobra duo, decreased development and clinical trial costs
related to margetuximab, and decreased costs related to
discontinued studies, partially offset by increased expenses
related to MGC026 and MGC028 development.
- SG&A
Expenses: Selling, general and administrative expenses
were $52.2 million for the year ended December 31, 2023,
compared to $58.9 million for the year ended December 31,
2022. The decrease was primarily related to decreased selling costs
for MARGENZA®.
- Other
Income: During the year ended December 31, 2023,
MacroGenics received $100.0 million proceeds from the sale of its
single-digit royalty interest on global net sales of TZIELD® to DRI
Healthcare Acquisitions LP. In addition, the Company received a
$50.0 million milestone payment from Sanofi S.A. related to the
achievement of a primary endpoint in a TZIELD clinical study. Under
GAAP guidelines and pursuant to Financial Accounting Standards
Board’s Accounting Standards Codification 470, this combined $150.0
million was included in Other Income as a “Gain on royalty
monetization arrangement” in 2023.
- Net
Loss: Net loss was $9.1 million for the year ended
December 31, 2023, compared to net loss of $119.8 million for
the year ended December 31, 2022.
- Shares
Outstanding: Shares of common stock outstanding as of
December 31, 2023 were 62,070,627.
- Cash Runway
Guidance: MacroGenics anticipates that its cash, cash
equivalents and marketable securities balance of $229.8 million as
of December 31, 2023, in addition to projected and anticipated
future payments from partners and product revenues should extend
its cash runway into 2026. The Company’s expected funding
requirements reflect anticipated expenditures related to the Phase
2 TAMARACK clinical trial, the Phase 2 LORIKEET study 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) |
|
December 31, 2023 |
|
December 31, 2022 |
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
229,805 |
|
$ |
154,346 |
Total assets |
|
298,418 |
|
|
280,468 |
Deferred revenue |
|
80,893 |
|
|
69,468 |
Total stockholders' equity |
|
152,613 |
|
|
142,013 |
MACROGENICS, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Amounts in thousands, except share and per
share data) |
|
|
2023 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
Collaborative and other agreements |
$ |
28,990 |
|
|
$ |
119,303 |
|
|
$ |
63,294 |
|
Product sales, net |
|
17,939 |
|
|
|
16,727 |
|
|
|
12,349 |
|
Contract manufacturing |
|
9,833 |
|
|
|
13,988 |
|
|
|
— |
|
Royalty revenue |
|
431 |
|
|
|
— |
|
|
|
— |
|
Government agreements |
|
1,556 |
|
|
|
1,923 |
|
|
|
1,804 |
|
Total revenues |
|
58,749 |
|
|
|
151,941 |
|
|
|
77,447 |
|
Costs and expenses: |
|
|
|
|
|
Cost of product sales |
|
619 |
|
|
|
3,351 |
|
|
|
2,651 |
|
Cost of manufacturing services |
|
7,603 |
|
|
|
4,033 |
|
|
|
— |
|
Research and development |
|
166,583 |
|
|
|
207,026 |
|
|
|
214,577 |
|
Selling, general and administrative |
|
52,188 |
|
|
|
58,949 |
|
|
|
63,014 |
|
Total costs and expenses |
|
226,993 |
|
|
|
273,359 |
|
|
|
280,242 |
|
Loss from operations |
|
(168,244 |
) |
|
|
(121,418 |
) |
|
|
(202,795 |
) |
Gain on royalty monetization arrangement |
|
150,930 |
|
|
|
— |
|
|
|
— |
|
Interest and other income |
|
9,686 |
|
|
|
1,660 |
|
|
|
680 |
|
Interest expense |
|
(1,430 |
) |
|
|
— |
|
|
|
— |
|
Net loss |
|
(9,058 |
) |
|
|
(119,758 |
) |
|
|
(202,115 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
Unrealized gain (loss) on investments |
|
(1 |
) |
|
|
56 |
|
|
|
(54 |
) |
Comprehensive income (loss) |
$ |
(9,059 |
) |
|
$ |
(119,702 |
) |
|
$ |
(202,169 |
) |
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ |
(0.15 |
) |
|
$ |
(1.95 |
) |
|
$ |
(3.37 |
) |
Basic and diluted weighted average common shares outstanding |
|
61,929,198 |
|
|
|
61,433,124 |
|
|
|
59,944,717 |
|
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical
company focused on discovering, developing, manufacturing 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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