CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage
biotechnology company positioned to advance next generation,
potentially curative cell therapies for cancer patients, today
reported business updates and its financial results for the third
quarter ended September 30, 2023.
“This year has been transformational for our company. We
experienced growth across our business, including expanding our
leadership team, commencing a Phase 2 clinical trial of CRG-022,
and becoming a publicly traded company,” said Gina Chapman,
President and Chief Executive Officer of CARGO. “While CAR
T-cell therapies have changed the treatment landscape for patients
with LBCL, patients whose disease relapses or is refractory to CD19
CAR T-cell therapy face a median survival of less than 6 months. We
continue to believe that CRG-022 has the potential to alter the
treatment paradigm for patients whose disease has relapsed or is
refractory to CD19 CAR T. We are very pleased to have
started our Phase 2 clinical trial which represents a key milestone
as we work toward our goal of developing and delivering potentially
curative therapies to more patients.”
Third Quarter and Subsequent Highlights
Phase 2 Clinical Trial of CRG-022 CAR T-Cell Therapy in
Patients with Relapsed or Refractory (R/R) Large B-cell Lymphoma
(LBCL): CARGO announced that it has dosed the first seven
patients in its potentially pivotal Phase 2 multicenter clinical
trial (NCT05972720) after successfully manufacturing CRG-022, the
Company’s autologous CD22 chimeric antigen receptor (CAR) T-cell
product candidate. CD22 is a common B-cell antigen widely expressed
in the vast majority of B-cell malignancies, including LBCL. The
clinical trial is an open-label, multicenter Phase 2 clinical trial
evaluating the efficacy and safety of CRG-022 in patients with R/R
LBCL whose disease has progressed after CD19-directed CAR T-cell
therapy, an area of high unmet need.
- The Phase 2 clinical trial is
designed to treat up to 123 patients with a single infusion of
CRG-022 across clinical sites in the United States. Clinical trial
sites are opening rapidly, with 12 sites currently recruiting
patients. The primary endpoint is overall response rate (ORR).
Secondary endpoints include additional efficacy, safety,
pharmacology, and manufacturing feasibility measures.
- Prior to starting the clinical
trial, CARGO implemented process and method improvements to
establish the intended commercial manufacturing process in order to
minimize the need for changes post-pivotal trial.
- The Phase 2 clinical trial of
CRG-022 is informed by positive initial results from a Phase 1
clinical trial being conducted by Stanford University (Stanford)
evaluating CRG-022 in patients with LBCL that was R/R to CD19 CAR
T-cell therapy.
- Interim results from CARGO’s Phase 2
trial are anticipated in 2025.
Phase 1 Clinical Trial Updates: During the
American Society of Hematology (ASH) 2023 Annual Meeting in early
December, Stanford shared updated data from its ongoing Phase 1
clinical trial in patients with LBCL that was R/R to CD19 CAR
T-cell therapy (NCT04088890). The update reflects a recent data
cut-off as of November 4, 2023. The previous data cut-off was May
3, 2023. The updated data that was shared included:
- For all patients treated (n=38), the
ORR and CR rates were 68% and 53% respectively.
- The November 2023 data cut-off now
provides a median follow-up of 27.3 months and includes the
following new information from Stanford:
- Since the May 2023 data cut-off, one
additional patient relapsed after a remission duration of 21
months.
- At Dose Level 1 (the dose CARGO is
using for its Phase 2 clinical trial), 73% of patients who achieved
a CR maintained the CR for at least 12 months (29 patients were
treated at Dose Level 1; 15 achieved a CR, 11 of whom maintained a
CR for ≥ 12 months).
- At Dose Level 2, 9 patients were
treated with 5 patients achieving a CR. Four of these 5 patients
have maintained a CR for 12 months or longer.
- With a median follow-up of 27.3
months, for Dose Level 1, the median OS has not been reached
and for Dose Level 2, the median OS is 14.1 months.
- Five patients who died of
non-relapse causes were in CR at the time of death; 2 of 5 patients
were in Dose Level 1 and 3 of 5 patients were in Dose Level 2.
Other Corporate Highlights
- Entered into a lease agreement for
99,557 square feet of lab and office space in San Carlos,
California in December 2023. The lease is expected to commence in
January 2024 with an initial term through March 31, 2031, and
provides options to renew the lease for two additional three-year
terms.
- Successfully completed an initial
public offering (IPO) raising approximately $291 million in net
proceeds.
- Strengthened the leadership team
with the hiring of Ginna Laport, MD, as Chief Medical Officer who
is responsible for providing leadership and direction to guide
clinical development strategy, and Michael Ports, PhD, as Chief
Scientific Officer who is responsible for advancing the Company's
proprietary platform technologies and discovery-stage
programs.
- Announced the formation of a
Scientific Advisory Board comprised of experts in cancer research,
immunology, and CAR T-cell therapy.
Third Quarter 2023 Financial Results
- As of September 30, 2023, CARGO had
cash and cash equivalents of $60.3 million and approximately $438
million, as adjusted for the net proceeds from the third tranche of
the Company’s Series A financing in October and its IPO in November
which it expects will fund operations through 2025.
- Research and development (R&D)
expenses were $22.2 million for the quarter ended September 30,
2023, compared to $8.5 million for the same period in 2022. The
increase was primarily driven by an increase in contract
manufacturing, preclinical, and clinical costs for the CRG-022
program and increased headcount in research and development teams
to support development efforts.
- General and administrative (G&A)
expenses were $6.5 million for the quarter ended September 30,
2023, compared to $1.6 million for the same period in 2022. The
increase was primarily attributable to the expansion of
administrative functions to support business operations and to
prepare CARGO to operate as a public company.
- Net loss was $35.5 million, or
$47.37 per basic and diluted share, for the quarter ended September
30, 2023. This compares with a net loss of $12.3 million, or $28.38
per basic and diluted share for the quarter ended September 30,
2022.
Upcoming Events
CARGO will participate in the 42nd Annual J.P.
Morgan Healthcare Conference, taking place January 8-11, 2024, in
San Francisco, California. Gina Chapman, President and Chief
Executive Officer, is scheduled to present on Monday, January 8, at
9:45 AM PT.
About Large B-Cell Lymphoma (LBCL)
Lymphoma that affects B lymphocytes are called B-cell lymphomas.
B-cells make antibodies to fight infections and are an important
part of the human immune system. B-cell lymphomas account for
approximately 85% of non-Hodgkin lymphomas (NHL) in the United
States. LBCL is an aggressive (fast-growing) lymphoma that occurs
most commonly in people over the age of 60, though it can occur in
childhood.
About CRG-022
CRG-022 is CARGO's investigational cell therapy that is composed
of autologous T-cells transduced with a lentiviral vector
(m971-BBZ) expressing a CD22-targeting CAR. CD22 is a transmembrane
protein expressed on normal B-cells and B-cell malignancies.
Results of an ongoing Phase 1 clinical trial in adults demonstrate
the safety and antitumor activity of CRG-022 in patients with LBCL
whose disease is relapsed or refractory (R/R) to CD19 CAR T-cell
therapy. Based on Phase 1 results, Stanford University was granted
Breakthrough Therapy Designation from the FDA for the treatment of
adult LBCL patients whose disease is R/R after CD19-directed CAR
T-cell therapy. CRG-022 has a unique design which is associated
with efficacy in the clinic that has not been seen with other CD22
CAR Ts. CARGO believes that CRG-022 has the potential to safely and
effectively treat LBCL, including patients for whom prior CD19 CAR
T-cell therapies have failed.
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, CRG-022, an
autologous CD22 chimeric antigen receptor (CAR) T-cell therapy
candidate, in a potentially pivotal Phase 2 clinical trial 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 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 Twitter:
@CARGOTx
Cautionary Note Regarding Forward-Looking
Statements
This 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; and the implementation of CARGO’s
strategic plans for its business and product candidates, including
additional indications which the company may pursue; 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
Consolidated Statement of Operations
(Unaudited) |
|
(in
thousands) |
|
Three months
endedSeptember 30, |
|
Nine months
endedSeptember 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
22,233 |
|
|
$ |
8,469 |
|
|
$ |
48,724 |
|
|
$ |
20,142 |
|
General and administrative |
|
|
6,478 |
|
|
|
1,580 |
|
|
|
13,030 |
|
|
|
3,624 |
|
Total
operating expenses |
|
|
28,711 |
|
|
|
10,049 |
|
|
|
61,754 |
|
|
|
23,766 |
|
Loss
from operations |
|
|
(28,711 |
) |
|
|
(10,049 |
) |
|
|
(61,754 |
) |
|
|
(23,766 |
) |
Interest
expense |
|
|
— |
|
|
|
(1,458 |
) |
|
|
(1,604 |
) |
|
|
(2,234 |
) |
Net
change in fair value of redeemable convertible preferred stock
tranche obligations |
|
|
(7,651 |
) |
|
|
— |
|
|
|
(8,343 |
) |
|
|
— |
|
Change
in fair value of derivative liabilities |
|
|
— |
|
|
|
(779 |
) |
|
|
6,453 |
|
|
|
(1,186 |
) |
Loss on
extinguishment of convertible notes |
|
|
— |
|
|
|
— |
|
|
|
(2,316 |
) |
|
|
— |
|
Other
income (expense), net |
|
|
891 |
|
|
|
1 |
|
|
|
1,494 |
|
|
|
(16 |
) |
Net loss
and comprehensive loss |
|
$ |
(35,471 |
) |
|
$ |
(12,285 |
) |
|
$ |
(66,070 |
) |
|
$ |
(27,202 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(47.37 |
) |
|
$ |
(28.38 |
) |
|
$ |
(98.15 |
) |
|
$ |
(79.16 |
) |
Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted |
|
|
748,862 |
|
|
|
432,835 |
|
|
|
673,175 |
|
|
|
343,635 |
|
|
|
CARGO Therapeutics, Inc.Condensed
Consolidated Balance
Sheets(Unaudited) |
|
(in
thousands) |
|
September 30,2023 |
|
December 31,2022 |
|
|
(Unaudited) |
|
|
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
60,344 |
|
|
$ |
1,872 |
|
Prepaid expenses and other
current assets |
|
|
3,072 |
|
|
|
2,055 |
|
Operating lease right-of-use
assets |
|
|
2,825 |
|
|
|
2,165 |
|
Property and equipment,
net |
|
|
9,150 |
|
|
|
3,368 |
|
Other non-current assets |
|
|
7,021 |
|
|
|
783 |
|
Total assets |
|
$ |
82,412 |
|
|
$ |
10,243 |
|
|
|
|
|
|
Liabilities,
Redeemable Convertible Preferred Stock and Stockholders’
Deficit |
|
|
|
|
Current liabilities |
|
$ |
41,134 |
|
|
$ |
44,137 |
|
Long-term liabilities |
|
|
525 |
|
|
|
1,342 |
|
Redeemable convertible
preferred stock |
|
|
150,088 |
|
|
|
— |
|
Total stockholders’
deficit |
|
|
(109,335 |
) |
|
|
(35,236 |
) |
Total liabilities, redeemable convertible preferred stock and
stockholders’ deficit |
|
$ |
82,412 |
|
|
$ |
10,243 |
|
|
Media Contact:Maura
Gavaghanmaura@redhousecomms.com
Investor Contact:Laurence
Wattslaurence@gilmartinir.com
CARGO Therapeutics (NASDAQ:CRGX)
Historical Stock Chart
From May 2024 to Jun 2024
CARGO Therapeutics (NASDAQ:CRGX)
Historical Stock Chart
From Jun 2023 to Jun 2024