CARGO Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
21 März 2024 - 9:05PM
CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage
biotechnology company positioned to advance next generation,
potentially curative cell therapies for cancer patients, today
provided a business update and reported financial results for the
quarter and year ending December 31, 2023.
To date, 20 sites have been initiated and are enrolling for the
potentially pivotal Phase 2 clinical study, FIRCE-1. The Phase 2
trial (NCT05972720) is an open-label, multicenter Phase 2 clinical
study evaluating the efficacy and safety of firicabtagene
autoleucel (firi-cel) (CRG-022) in patients with relapse or
refractory (R/R) large B-cell lymphoma (LBCL) whose disease has
progressed after CD19-directed CAR T-cell therapy, an area of high
unmet need. Interim results are anticipated in the first half of
2025.
“2023 was a transformative year for CARGO as we built our
leadership team and attracted top talent, initiated FIRCE-1, a
potentially pivotal Phase 2 clinical study of CRG-022, which we are
now calling firi-cel, and executed a successful private financing
and IPO, fortifying a strong financial position," said Gina
Chapman, President and Chief Executive Officer of CARGO. “Our team
has the expertise and experience to engineer, develop and deliver a
next generation of potentially curative therapies to patients with
high unmet need in cancer with a commercial-ready manufacturing
process.”
In December 2023, CARGO summarized results regarding an ongoing
Phase 1 clinical study (being conducted by Stanford University
(Stanford)) (NCT04088890) in patients with LBCL that were R/R to
CD19 CAR T-cell therapy. At Dose Level 1 (n=29), the dose CARGO is
using for its Phase 2 clinical trial, firi-cel (CRG-022) was
well-tolerated and complete response (CR) rate was 52%, with 73% of
patients who achieved a CR maintaining CR for at least 12 months,
as of the November 4, 2023 cut-off date.
Other Corporate Highlights
- Completed an initial public offering
(IPO) raising approximately $291.0 million in net proceeds.
- Added to the Russell 2000® Index on
March 15, 2024.
Fourth Quarter and Year-End Financial
Results
- CARGO had $405.7 million in cash
and cash equivalents as of December 31, 2023, which it expects will
fund operations through 2025.
- Research and development (R&D)
expenses were $27.1 million for the fourth quarter of 2023, which
includes $0.7 million of non-cash stock-based compensation expense.
For 2023, R&D expenses were $75.8 million, which includes $1.3
million of non-cash stock-based compensation expense.
- General and administrative (G&A)
expenses were $7.9 million for the fourth quarter of 2023, which
includes $1.0 million of non-cash stock-based compensation expense.
For 2023, G&A expenses were $20.9 million, which includes $2.0
million of non-cash stock-based compensation expense.
- Net loss for the fourth quarter of 2023
was $32.1 million, or $1.49 per share, including non-cash
stock-based compensation and depreciation expenses of $1.7 million
and $0.5 million, respectively. For 2023, net loss was $98.1
million, or $16.53 per share, including non-cash stock-based
compensation and depreciation expenses of $3.3 million and $1.5
million, respectively.
About CARGO Therapeutics
CARGO Therapeutics, Inc. is a clinical-stage biotechnology
company positioned to advance next generation, potentially curative
cell therapies for cancer patients. CARGO’s programs, platform
technologies, and manufacturing strategy are designed to directly
address the limitations of approved cell therapies, including
limited durability of effect, safety concerns and unreliable
supply. CARGO is currently evaluating its lead program,
firicabtagene autoleucel (firi-cel) (CRG-022), an autologous CD22
chimeric antigen receptor (CAR) T-cell therapy candidate, in a
potentially pivotal Phase 2 clinical study in patients with large
B-cell lymphoma (LBCL) whose disease relapsed or was refractory
(R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate
firi-cel (CRG-022) in patients at earlier stages of disease,
including LBCL and other hematologic malignancies. Beyond its lead
program, CARGO is leveraging its proprietary cell engineering
platform technologies to develop a pipeline of programs that
incorporate multiple transgene therapeutic “cargo” designed to
enhance CAR T-cell persistence and trafficking to tumor lesions, as
well as to help safeguard against tumor resistance and T-cell
exhaustion. CARGO’s founders are pioneers and world-class experts
in CAR T-cell therapy, and its team has significant experience and
success developing, manufacturing, launching and commercializing
oncology and cell therapy products. For more information, please
visit the CARGO Therapeutics website at
https://cargo-tx.com/.Follow us on LinkedIn: CARGO
TherapeuticsFollow us on X (Twitter): @CARGOTx
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. In some cases, you can identify
forward-looking statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “positioned,” “potential,” “predict,”
“seek,” “should,” “target,” “will,” “would” and other similar
expressions that are predictions of or indicate future events and
future trends, or the negative of these terms or other comparable
terminology. All statements other than statements of historical
facts contained in this press release are forward-looking
statements. These forward-looking statements include, but are not
limited to, statements about: advancement of CARGO’s clinical
programs; the potential benefits from treatment with CD19 CAR
T-cell therapies; timing of data reports, including the release of
interim data from the Company’s ongoing Phase 2 clinical trial of
CRG-022; the implementation of CARGO’s strategic plans for
its business and product candidates; and whether the Company’s cash
and cash equivalents will be able to fund operations through 2025.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results and events to differ materially from those anticipated,
including, but not limited to, risks and uncertainties related to:
the company’s ability to obtain necessary capital to fund its
clinical programs; the early stages of clinical development of the
company’s product candidates; the company’s ability to obtain
regulatory approval of and successfully commercialize its product
candidates; any undesirable side effects or other properties of the
company’s product candidates; the company’s reliance on third-party
suppliers and manufacturers, including CROs; the outcomes of any
future collaboration agreements; and the company’s ability to
adequately maintain intellectual property rights for its product
candidates. These and other risks are described in greater detail
under the section titled “Risk Factors” contained in the company’s
prospectus filed with the Securities and Exchange Commission (SEC)
on November 13, 2023 pursuant to Rule 424(b) under the Securities
Act and the company’s other filings with the SEC. Any
forward-looking statements that the company makes in this press
release are made pursuant to the Private Securities Litigation
Reform Act of 1995, as amended, and speak only as of the date of
this press release. Except as required by law, the company
undertakes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
CARGO Therapeutics, Inc.Condensed Statements of
Operations and Comprehensive Loss (in thousands, except
share and per share data) |
|
|
Three months endedDecember
31, |
|
|
Year endedDecember 31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
27,067 |
|
|
$ |
9,231 |
|
|
$ |
75,791 |
|
|
$ |
29,373 |
|
General and administrative |
|
7,889 |
|
|
|
1,774 |
|
|
|
20,919 |
|
|
|
5,398 |
|
Total operating expenses |
|
34,956 |
|
|
|
11,005 |
|
|
|
96,710 |
|
|
|
34,771 |
|
Loss from operations |
|
(34,956 |
) |
|
|
(11,005 |
) |
|
|
(96,710 |
) |
|
|
(34,771 |
) |
Other income (expense), net |
|
2,879 |
|
|
|
(2,744 |
) |
|
|
(1,437 |
) |
|
|
(6,180 |
) |
Net loss and
comprehensive loss |
$ |
(32,077 |
) |
|
$ |
(13,749 |
) |
|
$ |
(98,147 |
) |
|
$ |
(40,951 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(1.49 |
) |
|
$ |
(25.62 |
) |
|
$ |
(16.53 |
) |
|
$ |
(104.40 |
) |
Weighted-average shares used in
computing net loss per share attributable to common stockholders,
basic and diluted |
|
21,563,893 |
|
|
|
536,579 |
|
|
|
5,938,782 |
|
|
|
392,268 |
|
CARGO Therapeutics, Inc.Condensed Balance
Sheet Data(in thousands) |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
405,732 |
|
|
$ |
1,872 |
|
Other assets |
|
47,304 |
|
|
|
8,371 |
|
Total assets |
$ |
453,036 |
|
|
$ |
10,243 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’Equity
(Deficit) |
|
|
|
|
|
Liabilities |
$ |
47,650 |
|
|
$ |
45,479 |
|
Stockholders’ equity
(deficit) |
|
405,386 |
|
|
|
(35,236 |
) |
Total liabilities, convertible preferred stock
and stockholders’ equity
(deficit) |
$ |
453,036 |
|
|
$ |
10,243 |
|
|
|
Find more information at
cargo-tx.comFollow us on
LinkedIn: CARGO
TherapeuticsFollow us on X (Twitter):
@CARGOTx
Media Contact:Maura
Gavaghanmaura@redhousecomms.com
Investor Contact:Laurence
Wattslaurence@gilmartinir.com
CARGO Therapeutics (NASDAQ:CRGX)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
CARGO Therapeutics (NASDAQ:CRGX)
Historical Stock Chart
Von Jun 2023 bis Jun 2024