MacroGenics Provides Update on Corporate Progress and Third Quarter 2023 Financial Results
06 Novembro 2023 - 6:01PM
MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company
focused on 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 quarter ended September 30, 2023.
“Since mid-2022, we have received $335 million
in non-dilutive capital from our collaboration partners and reduced
our quarterly cash burn, enabling us to extend our cash runway into
2026. Over the next two years, we anticipate having multiple data
read-outs, the first of which we expect during the first half of
2024 related to the now fully-enrolled TAMARACK study of vobra duo
in metastatic castration-resistant prostate cancer,” said Scott
Koenig, M.D., Ph.D., President and CEO of MacroGenics. “During this
two-year period, we also expect data from the LORIKEET Phase 2
study of lorigerlimab in prostate cancer, results from the dose
escalation study of MGD024 and results from a planned vobra duo
plus lorigerlimab dose expansion cohort. Also during this time, we
anticipate advancing multiple new ADC molecules from our
preclinical portfolio, the first of which (MGC026) recently
progressed to IND submission.”
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 recently completed enrollment of the TAMARACK Phase
2 study of vobra duo ahead of schedule. This study 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, across a total of approximately 100 patients. MacroGenics
anticipates providing a clinical update in the first half of
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 2024.
- Lorigerlimab is a
bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. MacroGenics
commenced enrollment of 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).
- 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 an ADC
with a topoisomerase inhibitor-based cytotoxic mechanism directed
against an undisclosed solid tumor target. The Company recently
submitted an investigational new drug (IND) application to the U.S.
Food and Drug Administration and, assuming acceptance, anticipates
commencing a Phase 1 dose escalation study beginning in the first
quarter of 2024. More details on this program will be provided in
early 2024.
- Enoblituzumab is
an Fc-optimized monoclonal antibody that targets B7-H3.
MacroGenics’ academic collaborators plan to initiate the HEAT
study, an investigator-sponsored, randomized Phase 2 clinical
trial. This study is expected to commence enrollment in early 2024
and will evaluate the activity of neoadjuvant enoblituzumab given
prior to radical prostatectomy in men with high-risk localized
prostate cancer.
Other Corporate Updates
- $15.7 Million Milestone
Related to Gilead’s Nomination of a Bispecific Research
Program. On September 5, 2023,
MacroGenics announced that its partner, Gilead Sciences, Inc.,
nominated the first of two potential research programs, leveraging
MacroGenics’ DART and TRIDENT® platforms for generating bispecific
antibodies. This nomination grants Gilead an exclusive option, upon
achievement of a pre-defined preclinical milestone, to license
worldwide rights to the research program. MacroGenics received
$15.7 million related to this nomination subsequent to September
30, 2023.
Third Quarter
2023 Financial Results
- Cash Position:
Cash, cash equivalents and marketable securities balance as of
September 30, 2023, was $256.4 million, compared to $154.3
million as of December 31, 2022. The Company’s cash balance as
of September 30, 2023, did not include the $15.7 million milestone
from Gilead subsequently received.
- Revenue: Total
revenue was $10.4 million for the quarter ended September 30,
2023, compared to total revenue of $41.7 million for the quarter
ended September 30, 2022.
- R&D Expenses:
Research and development expenses were $30.1 million for the
quarter ended September 30, 2023, compared to $48.2 million
for the quarter ended September 30, 2022. The decrease was
primarily related to decreased costs related to discontinued
studies, partially offset by increased expenses related to
preclinical ADC molecules and increased clinical expenses related
to lorigerlimab.
- SG&A Expenses:
Selling, general and administrative expenses were $12.4 million for
the quarter ended September 30, 2023, compared to $15.4
million for the quarter ended September 30, 2022. The decrease
was primarily related to decreased selling costs for MARGENZA.
- Other Income:
During the quarter ended September 30, 2023, MacroGenics received a
$50.0 million milestone payment from Sanofi S.A. related to the
previously disclosed achievement of a primary endpoint in a TZIELD®
clinical study. The accounting treatment for this milestone is
consistent with that for the $100.0 million proceeds received from
the sale of the Company's single-digit royalty interest on global
net sales of TZIELD to DRI Healthcare Acquisitions LP in March
2023. Accordingly, $50.0 million was included in Other Income (as
Gain on Royalty Monetization Arrangement) for the quarter ended
September 30, 2023.
- Net Income (Loss):
Net income was $17.6 million for the quarter ended
September 30, 2023, compared to net loss of $24.8 million for
the quarter ended September 30, 2022.
- Shares
Outstanding: Shares of common stock outstanding as of
September 30, 2023 were 62,028,904.
- Cash Runway
Guidance: MacroGenics anticipates that its cash, cash
equivalents and marketable securities balance of $256.4 million as
of September 30, 2023, plus the $15.7 million milestone
subsequently received, 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) |
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
Cash, cash equivalents and marketable securities |
$ |
256,432 |
|
|
$ |
154,346 |
|
Total assets |
|
339,972 |
|
|
|
280,468 |
|
Deferred revenue |
|
82,844 |
|
|
|
69,468 |
|
Total stockholders' equity |
|
193,980 |
|
|
|
142,013 |
|
|
|
|
|
|
|
|
|
|
MACROGENICS, INC.CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited) |
|
(Amounts in thousands, except share and per share
data) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
Collaborative and other agreements |
$ |
885 |
|
|
$ |
35,674 |
|
|
$ |
23,593 |
|
|
$ |
59,630 |
|
Product sales, net |
|
4,695 |
|
|
|
4,371 |
|
|
|
13,247 |
|
|
|
12,623 |
|
Contract manufacturing |
|
4,462 |
|
|
|
1,142 |
|
|
|
9,664 |
|
|
|
5,134 |
|
Royalty revenue |
|
10 |
|
|
|
— |
|
|
|
431 |
|
|
|
— |
|
Government agreements |
|
345 |
|
|
|
547 |
|
|
|
1,094 |
|
|
|
1,455 |
|
Total revenues |
|
10,397 |
|
|
|
41,734 |
|
|
|
48,029 |
|
|
|
78,842 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Cost of product sales |
|
85 |
|
|
|
3,007 |
|
|
|
456 |
|
|
|
3,235 |
|
Cost of manufacturing services |
|
3,274 |
|
|
|
136 |
|
|
|
7,603 |
|
|
|
2,358 |
|
Research and development |
|
30,131 |
|
|
|
48,191 |
|
|
|
119,232 |
|
|
|
161,372 |
|
Selling, general and administrative |
|
12,409 |
|
|
|
15,355 |
|
|
|
39,628 |
|
|
|
45,277 |
|
Total costs and expenses |
|
45,899 |
|
|
|
66,689 |
|
|
|
166,919 |
|
|
|
212,243 |
|
Loss from operations |
|
(35,502 |
) |
|
|
(24,955 |
) |
|
|
(118,890 |
) |
|
|
(133,401 |
) |
Gain on royalty monetization
arrangement |
|
50,000 |
|
|
|
— |
|
|
|
150,930 |
|
|
|
— |
|
Interest and other income |
|
3,056 |
|
|
|
142 |
|
|
|
6,404 |
|
|
|
841 |
|
Interest expense |
|
— |
|
|
|
— |
|
|
|
(1,430 |
) |
|
|
— |
|
Net Income (loss) |
|
17,554 |
|
|
|
(24,813 |
) |
|
|
37,014 |
|
|
|
(132,560 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
38 |
|
|
|
213 |
|
|
|
(30 |
) |
|
|
(52 |
) |
Comprehensive income (loss) |
$ |
17,592 |
|
|
$ |
(24,600 |
) |
|
$ |
36,984 |
|
|
$ |
(132,612 |
) |
|
|
|
|
|
|
|
|
Net income (loss) per common
share: |
|
|
|
|
|
|
|
Basic |
$ |
0.28 |
|
|
$ |
(0.40 |
) |
|
$ |
0.60 |
|
|
$ |
(2.16 |
) |
Diluted |
$ |
0.28 |
|
|
$ |
(0.40 |
) |
|
$ |
0.60 |
|
|
$ |
(2.16 |
) |
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
61,980,680 |
|
|
|
61,459,831 |
|
|
|
61,890,824 |
|
|
|
61,390,143 |
|
Diluted |
|
62,244,602 |
|
|
|
61,459,831 |
|
|
|
62,090,343 |
|
|
|
61,390,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About MacroGenics, Inc.
MacroGenics (the Company) is a biopharmaceutical
company focused on 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, 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 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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