Announced CT-0525 as lead product candidate
for anti-HER2 program; initial data expected by year-end
2024
Presented preclinical proof of concept data in
liver fibrosis at ASGCT; expects to nominate a development
candidate in the first quarter of 2025
Presented Regimen Level 1 data from Phase 1
sub-study utilizing CT-0508 in combination with pembrolizumab at
AACR; expects to report Regimen Level 2 data in second quarter of
2024
Cash and cash equivalents of $56.5 million expected to fund the Company into
the third quarter of 2025
PHILADELPHIA, May 9, 2024
/PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM)
("Carisma" or the "Company"), a clinical-stage biopharmaceutical
company focused on discovering and developing innovative
immunotherapies, today reported financial results for the quarter
ended March 31, 2024, and highlighted
recent business updates.
"We enter the second quarter with a renewed focus on our
programs that we believe exhibit the greatest potential and
meaningful near-term milestones," said Steven Kelly, President and Chief Executive
Officer of Carisma. "We are pleased by the continued clinical
validation of our anti-HER2 CAR-M program as evidenced by the
initial data from CT-0508 and are excited to shift our attention to
the development of CT-0525, which we believe has the potential to
significantly increase anti-tumor activity. The preclinical proof
of concept data in liver fibrosis fuels our momentum to explore the
potential of engineered macrophages beyond oncology. Carisma
remains committed to advancing next-generation cell therapies that
hold the potential to enhance treatment options for patients
grappling with cancer and other serious disorders."
First Quarter 2024 Highlights and Upcoming Milestones
Ex Vivo Oncology
- CT-0525 (Anti-HER2 chimeric antigen receptor monocyte
(CAR-Monocyte))
- In late March 2024, Carisma made the decision to
prioritize CT-0525 due to the potential for a CAR-Monocyte to have
an approximately 2,000-fold increase in total exposure compared to
a CAR-Macrophage. As a result, the Company believes that CT-0525
will be able to build on clinical anti-tumor activity observed in
CT-0508, the Company's anti-HER2 CAR-Macrophage. CT-0525 is now
Carisma's lead product candidate.
- Carisma expects to treat the first patient in the CT-0525 Phase
1 clinical study in the second quarter of 2024 and to report
initial data from the study by year-end 2024.
- CT-0508 (Anti-HER2 CAR-Macrophage)
- Due to the prioritization of CT-0525, Carisma has ceased
recruitment of new patients into Study 101 and its sub-studies.
However, the Company will continue all study operations for
enrolled subjects.
- On April 10, 2024, during its
presentation at the American Association for Cancer Research (AACR)
2024 Annual Meeting, Carisma reported Regimen Level 1 data (n=3
patients) from the open label Phase 1 (Study 101) sub-study
utilizing CT-0508 in combination with pembrolizumab, a programmed
cell death protein 1 (PD-1) checkpoint inhibitor. Based on
preliminary results from these three patients, the combination
therapy has been generally well-tolerated after infusion with no
dose-limiting toxicities. Carisma observed a best overall response
of progressive disease in the first two patients and stable disease
in the third patient, per RECIST 1.1 criteria. The patient who
achieved stable disease presented the greatest increase in
peripheral blood T cell clonality seen across all 17 patients
treated to date in Study 101 and had one out of two target lesions
reduced by approximately 46%.
- Carisma expects to report data from Regimen Level 2 in the
Study 101 sub-study evaluating the co-administration of CT-0508 and
pembrolizumab in the second quarter of 2024.
- CT-1119 (Anti-Mesothelin CAR-Monocyte)
- In late March 2024, Carisma made the decision to pause
further development of CT-1119, pending additional financing.
Fibrosis and Immunology
- Fibrosis
- On May 8, 2024, during its
presentation at the American Society of Gene and Cell Therapy
(ASGCT) 2024 Annual Meeting, Carisma reported preclinical proof of
concept data of its engineered macrophages for the treatment of
liver fibrosis.
- In the presentation titled "Genetically Engineered Macrophage
Cell Therapy Reverses Liver and Lung Fibrosis in Preclinical
Models," Carisma presented preclinical proof of concept data
for engineered macrophage cell therapy in liver fibrosis. In a
CCL4-induced liver fibrosis model, the data showed that a single
dose of macrophages co-expressing the anti-fibrotic factor relaxin
and the anti-inflammatory cytokine IL10 significantly improved
established fibrosis with a 116% reduction in fibrosis relative to
untreated control. In addition, systemic administration of
engineered macrophages co-expressing relaxin and IL10 significantly
reduced liver fibrosis in a high fat diet metabolic
dysfunction-associated steatohepatitis (MASH) model, with a 45%
reduction in fibrosis relative to untreated control. In both
models, the relaxin-IL10 macrophage treatment also resulted in a
greater reduction in liver fibrosis compared to non-engineered
macrophages.
- The presentation also included initial preclinical data for the
use of engineered macrophages in pulmonary fibrosis. The data
showed that a single dose of macrophages expressing a dominant
negative TGFβ receptor, which nullified pro-fibrotic TGFβ
signaling in the lung, prevented fibrosis in a bleomycin mouse
model of pulmonary fibrosis, with a 90% reduction in fibrosis
relative to untreated control.
- Carisma expects to nominate a development candidate for its
liver fibrosis program in the first quarter of 2025.
Corporate Updates
- On May 2, 2024, Carisma announced
the appointment of Eugene P.
Kennedy, M.D., F.A.C.S. as the Company's Chief Medical
Officer. Dr. Kennedy brings over 15 years of clinical and industry
experience, including cross-functional leadership driving clinical
development and regulatory strategies for oncology and
immuno-oncology focused organizations.
- On April 1, 2024, Carisma
announced a pipeline reprioritization and corporate restructuring.
The pipeline reprioritization includes stopping recruitment of new
patients in the Phase 1 clinical study of CT-0508 (Study 101) to
focus the Company's efforts and resources on CT-0525 as its lead
anti-HER2 product candidate, as well as pausing development of
CT-1119 pending additional financing. As a result of the pipeline
reprioritization and corporate restructuring, Carisma reduced its
workforce by approximately 37% in the second quarter of 2024.
- On April 1, 2024, Carisma
announced the appointment of John
Hohneker, M.D. to the Board of Directors of the Company,
effective April 1, 2024. Dr. Hohneker
brings over 30 years of extensive experience in drug development
and leadership across the biotech and pharmaceutical sectors. The
Company concurrently announced the resignation of Chidozie Ugwumba
from Carisma's Board of Directors, also effective April 1, 2024.
First Quarter 2024 Financial Results
- Cash and cash equivalents as of March
31, 2024 were $56.5 million,
compared to $77.6 million as of
December 31, 2023.
- Research and development expenses for the three months ended
March 31, 2024 were $17.5 million, compared to $16.6 million for the three months ended
March 31, 2023. The increase of
$0.8 million was primarily due to a
$0.9 million increase in personnel
costs due to increased stock-based compensation and payroll,
$0.7 million increase in direct costs
associated with pre-clinical development of CT-0525, a $0.4 million increase in direct costs associated
with the pre-clinical development related to CT-1119, partially
offset by a $0.7 million decrease in
direct costs associated with CT-0508, a $0.4
million decrease in our facilities and other expenses
associated with a decrease in sponsored research agreement fees,
and a $0.1 million decrease in costs
associated with a reduction in pass through studies.
- General and administrative expenses for the three months ended
March 31, 2024 were $5.4 million, compared to $9.6 million for the three months ended
March 31, 2023. The decrease of
$4.1 million was attributable to a
$3.5 million decrease in personnel
costs including severance and related costs resulting from the
Merger offset by an increase in salaries and stock-based
compensation, and a $0.7 million
decrease in professional fees as a result of non-recurring legal
costs associated with the Merger.
- Net loss was $19.0 million for
the first quarter of 2024, compared to a $24.6 million net loss for the same period in
2023.
Outlook
Carisma anticipates that its cash and cash equivalents of
$56.5 million as of March 31, 2024, combined with the expected cost
savings from implementing the revised operating plan, are
sufficient to sustain its planned operations into the third quarter
of 2025.
About CT-0525
CT-0525 is a first-in-class, ex
vivo gene-modified autologous chimeric antigen
receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat
solid tumors that overexpress human epidermal growth factor
receptor 2 (HER2). It is being studied in a multi-center, open
label, Phase 1 clinical trial for patients with advanced/metastatic
HER2-overexpressing solid tumors that have progressed on available
therapies. The CAR-Monocyte approach has the potential to address
some of the challenges of treating solid tumors with cell
therapies, including tumor infiltration, immunosuppression within
the tumor microenvironment, and antigen heterogeneity. CT-0525 has
the potential to enable significant dose escalation, enhance tumor
infiltration, increase persistence, and reduce manufacturing time
compared to CT-0508.
About CT-0508
CT-0508 is an ex vivo gene-modified autologous
chimeric antigen receptor-macrophage (CAR-Macrophage) cellular
therapy intended to treat solid tumors that overexpress HER2. It is
being evaluated in a Phase 1 multi-center clinical trial that
focuses on patients with recurrent or metastatic
HER2-overexpressing solid tumors whose cancers do not have approved
HER2-targeted therapies or who do not respond to treatment. The
Phase 1 clinical trial marks the first time that engineered
macrophages are being studied in humans.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical
company focused on utilizing our proprietary macrophage and
monocyte cell engineering platform to develop transformative
immunotherapies to treat cancer and other serious diseases. We have
created a comprehensive, differentiated proprietary cell therapy
platform focused on engineered macrophages and monocytes, cells
that play a crucial role in both the innate and adaptive immune
response. Carisma is headquartered in Philadelphia, PA. For more information, please
visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
"forward-looking statements" within the meaning of The Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, statements relating to Carisma's business,
strategy, future operations, cash runway, the advancement of
Carisma's product candidates and product pipeline, and clinical
development of Carisma's product candidates, including expectations
regarding timing of initiation and results of clinical trials. The
words "anticipate," "believe," "contemplate," "continue," "could,"
"estimate," "expect," "goals," "intend," "may," "might," "outlook,"
"plan," "project," "potential," "predict," "target," "possible,"
"will," "would," "could," "should," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements are based on management's current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in, or implied by,
such forward-looking statements. These risks and uncertainties
include, but are not limited to, (i) Carisma's ability to realize
the anticipated benefits of its pipeline reprioritization and
corporate restructuring, (ii) Carisma's ability to obtain,
maintain and protect its intellectual property rights related to
its product candidates; (iii) Carisma's ability to advance the
development of its product candidates under the timelines it
anticipates in planned and future clinical trials and with its
current financial and human resources; (iv) Carisma's ability to
replicate in later clinical trials positive results found in
preclinical studies and early-stage clinical trials of its product
candidates; (v) Carisma's ability to realize the anticipated
benefits of its research and development programs, strategic
partnerships, research and licensing programs and academic and
other collaborations; (vi) regulatory requirements or developments
and Carisma's ability to obtain and maintain necessary approvals
from the U.S. Food and Drug Administration and other regulatory
authorities related to its product candidates; (vii) changes to
clinical trial designs and regulatory pathways; (viii) risks
associated with Carisma's ability to manage expenses; (ix) changes
in capital resource requirements; (x) risks related to the
inability of Carisma to obtain sufficient additional capital to
continue to advance its product candidates and its preclinical
programs; and (xi) legislative, regulatory, political and economic
developments.
For a discussion of these risks and uncertainties, and other
important factors, any of which could cause Carisma's actual
results to differ from those contained in the forward-looking
statements, see the "Risk Factors" set forth in the Company's
Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of
potential risks, uncertainties, and other important factors in
Carisma's other recent filings with the Securities and Exchange
Commission. Any forward-looking statements that are made in this
press release speak as of the date of this press release. Carisma
undertakes no obligation to revise the forward-looking statements
or to update them to reflect events or circumstances occurring
after the date of this press release, whether as a result of new
information, future developments or otherwise, except as required
by the federal securities laws.
Investors:
Shveta
Dighe
Head of Investor Relations
investors@carismatx.com
Media Contact:
Julia
Stern
(763) 350-5223
jstern@realchemistry.com
CARISMA THERAPEUTICS
INC.
|
Unaudited
Consolidated Balance Sheets
|
(in thousands,
except share and per share data)
|
|
|
March 31,
2024
|
|
December
31, 2023
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
56,515
|
|
$
77,605
|
Prepaid expenses and
other assets
|
4,438
|
|
2,866
|
Total current
assets
|
60,953
|
|
80,471
|
Property and equipment,
net
|
7,550
|
|
6,764
|
Right of use assets –
operating leases
|
5,150
|
|
2,173
|
Deferred financing
costs
|
142
|
|
146
|
Total
assets
|
$
73,795
|
|
$
89,554
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,166
|
|
$
3,933
|
Accrued
expenses
|
4,729
|
|
7,662
|
Deferred
revenue
|
1,189
|
|
1,413
|
Operating lease
liabilities
|
2,474
|
|
1,391
|
Finance lease
liabilities
|
1,390
|
|
544
|
Other current
liabilities
|
1,193
|
|
965
|
Total current
liabilities
|
13,141
|
|
15,908
|
Deferred
revenue
|
45,000
|
|
45,000
|
Operating lease
liabilities
|
2,759
|
|
860
|
Finance lease
liabilities
|
869
|
|
328
|
Other long-term
liabilities
|
1,131
|
|
926
|
Total
liabilities
|
62,900
|
|
63,022
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock $0.001
par value, 5,000,000 shares authorized, none issued or
outstanding
|
—
|
|
—
|
Common stock $0.001
par value, 350,000,000 shares authorized, 41,542,744 and
40,609,915
shares issued and outstanding at March 31, 2024 and
December 31, 2023, respectively
|
41
|
|
40
|
Additional paid-in
capital
|
274,934
|
|
271,594
|
Accumulated
deficit
|
(264,080)
|
|
(245,102)
|
Total stockholders'
equity
|
10,895
|
|
26,532
|
Total liabilities and
stockholders' equity
|
$
73,795
|
|
$
89,554
|
CARISMA THERAPEUTICS
INC.
|
Unaudited
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands,
except share and per share data)
|
|
|
Three Months
Ended
March 31,
|
|
2024
|
|
2023
|
Collaboration
revenues
|
$
3,397
|
|
$
3,243
|
Operating
expenses:
|
|
|
|
Research and
development
|
17,462
|
|
16,641
|
General and
administrative
|
5,445
|
|
9,574
|
Total operating
expenses
|
22,907
|
|
26,215
|
Operating
loss
|
(19,510)
|
|
(22,972)
|
Change in fair value of
derivative liability
|
—
|
|
(84)
|
Interest income
(expense), net
|
532
|
|
(1,477)
|
Pre-tax loss
|
(18,978)
|
|
(24,533)
|
Income tax
expense
|
—
|
|
(109)
|
Net loss
|
$
(18,978)
|
|
$
(24,642)
|
|
|
|
|
Share
information:
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
$
(0.46)
|
|
$
(1.93)
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
40,938,464
|
|
12,783,523
|
Comprehensive
loss
|
|
|
|
Net loss
|
$
(18,978)
|
|
$
(24,642)
|
Unrealized gain on
marketable securities
|
—
|
|
177
|
Comprehensive
loss
|
$
(18,978)
|
|
$
(24,465)
|
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SOURCE Carisma Therapeutics Inc.