Initial data for CT-0525, lead product
candidate for anti-HER2 program, expected by year-end 2024
Nomination of a development candidate for
liver fibrosis program expected in the first quarter of
2025
Nominated first in vivo CAR-M development
candidate targeting Glypican-3 to treat hepatocellular carcinoma
under the Moderna Collaboration in the second quarter of
2024
Cash and cash equivalents of $40.4 million and $2.0
million received in July under the Moderna Collaboration
expected to fund the Company into the third quarter of 2025
PHILADELPHIA, Aug. 8, 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 June 30, 2024, and highlighted
recent business updates.
![(PRNewsfoto/CARISMA Therapeutics Inc.) (PRNewsfoto/CARISMA Therapeutics Inc.)](https://mma.prnewswire.com/media/1219543/Carisma_Therapeutics_Logo.jpg)
"We've achieved considerable clinical and research advancements
this year, and I'm excited about our strong momentum and clear
focus for the next 12 months," said Steven
Kelly, President and Chief Executive Officer of Carisma.
"The CT-0508 program has provided us with invaluable insights.
Looking ahead, we are dedicating our efforts to our lead asset,
CT-0525, which is actively enrolling patients with initial data
expected by the end of 2024. We have also made significant progress
in our in vivo oncology and fibrosis programs. The
nomination of a development candidate in collaboration with Moderna
marks a significant step forward. We believe our robust development
pipeline offers multiple potential value drivers in both the near
and long term."
Second Quarter 2024 Highlights and Upcoming
Milestones
Ex Vivo Oncology
- CT-0525 (Anti-HER2 chimeric antigen receptor monocyte
(CAR-Monocyte))
- On May 16, 2024, Carisma
announced that the first patient was dosed in its Phase 1 clinical
trial evaluating CT-0525, an ex vivo gene-modified
autologous CAR-Monocyte cellular therapy, for the treatment of
patients with solid tumors that overexpress human epidermal growth
factor receptor 2 (HER2).
- On June 25, 2024, Carisma
announced the U.S. Food and Drug Administration granted Fast Track
designation for CT-0525.
- Carisma expects to report initial data from its Phase 1
clinical trial by year-end 2024.
- CT-0508 (Anti-HER2 chimeric antigen receptor macrophage
(CAR-Macrophage))
- As of July 2024, all clinical
activities related to the clinical trial of CT-0508 and its
sub-study utilizing CT-0508 in combination with pembrolizumab,
have been completed.
- On July 9, 2024, the Company
announced a new analysis of circulating tumor DNA (ctDNA) from 13
patients enrolled in Groups 1 and 2 of the Phase 1 clinical trial
of CT-0508. Although preliminary and limited, the data showed that
75% (n=6/8) of evaluable HER2 3+ patients experienced a decrease in
ctDNA, indicating anti-tumor activity.
- On August 8, 2024, Carisma
updated the results of the open label Phase 1 sub-study evaluating
the co-administration of CT-0508 and pembrolizumab, a programmed
cell death protein 1 checkpoint inhibitor to include data from
Regimen Level 2 (RL2) (n=3 patients). The study met its primary
endpoints of safety, tolerability and manufacturing feasibility of
CT-0508. The pembrolizumab sub-study data from Regimen Level 1 and
RL2 (n=6 patients) demonstrate that the combination therapy was
generally well-tolerated with no dose-limiting toxicities. The best
overall response was stable disease (n=1/6 patients), with
corticosteroid administration and / or loss of human leukocyte
antigens (HLA) expression being key limitations to potential
efficacy in three of the patients who experienced progressive
disease. The correlative data concerning immune activation suggest
a synergistic potential for the combination of CT-0508 with
pembrolizumab based on increased peripheral blood T cell clonality,
T cell activation, and frequency of effector memory CD8 T cells
compared to CT-0508 alone. Supported by these safety and
translational findings, as well as other results from the clinical
trial of CT-0508, Carisma intends to explore the strategy of
combining CAR-Monocyte with pembrolizumab or another checkpoint
inhibitor in the CT-0525 program.
In Vivo Oncology
- GPC3+ solid tumors (CAR-M + mRNA/LNP; Moderna
Collaboration)
- On June 27, 2024, Carisma
announced the nomination of the first development candidate under
its collaboration with ModernaTX Inc. ("Moderna"). The development
candidate is an in vivo chimeric antigen receptor macrophage
and monocyte, or CAR-M, targeting Glypican-3 and is designed to
treat solid tumors, including hepatocellular carcinoma, the most
prevalent type of liver cancer and the fastest-rising cause of
cancer-related death in the United
States. On July 3, 2024, the
Company received the associated $2.0
million milestone payment from Moderna.
- The Company expects to present preclinical data from the
development candidate at an upcoming medical meeting.
Fibrosis and Immunology
- Fibrosis
- On August 6, 2024, Carisma
announced that additional preclinical data for liver fibrosis will
be highlighted in a poster presentation at the American Association
for the Study of Liver Diseases The Liver Meeting 2024, being held
November 15-19, 2024, in San Diego, CA.
- Carisma expects to nominate a development candidate for its
liver fibrosis program in the first quarter of 2025.
Corporate Updates
- On July 1, 2024, Carisma
announced the appointment of David
Scadden, M.D., and Marella
Thorell to the Company's Board of Directors, effective
June 30, 2024. David Scadden, M.D., is a renowned physician and
medical researcher with extensive clinical and medical research
experience. Marella Thorell brings
more than 25 years of extensive experience in finance and
operations across both public and private biotech companies. The
Company concurrently announced the resignation of Regina Hodits and Björn Odlander from Carisma's
Board of Directors, also effective June 30,
2024.
- On August 6, 2024, Carisma
announced the appointment of Scott
Friedman, M.D. and Ira Tabas,
M.D., Ph.D. to its Scientific Advisory Board. Dr. Friedman and Dr.
Tabas bring extensive expertise and pioneering contributions in
liver fibrosis, which will be instrumental as Carisma continues its
program to develop transformative treatments for patients.
Second Quarter 2024 Financial Results
- Cash and cash equivalents as of June 30,
2024, were $40.4 million,
compared to $56.5 million as of
March 31, 2024.
- Research and development expenses for the three months ended
June 30, 2024 were $15.3 million, compared to $18.5 million for the three months ended
June 30, 2023. The decrease of
$3.2 million was primarily due to a
$2.9 million decrease in our
facilities and other expenses associated with a decrease in
sponsored research agreement fees, a $1.7
million decrease in direct costs associated with CT-0508, a
$0.2 million decrease in direct costs
associated with the pre-clinical development related to CT-1119, a
$0.1 million decrease in costs
associated with a reduction in pass through studies, partially
offset by a $1.2 million increase in
direct costs associated with pre-clinical development of CT-0525
and a $0.5 million increase in
personnel costs due to severance costs related to the revised
operating plan.
- General and administrative expenses for the three months ended
June 30, 2024 were $5.6 million, compared to $6.0 million for the three months ended
June 30, 2023. The decrease of
$0.4 million was attributable to a
$1.2 million decrease in professional
fees as a result of non-recurring legal costs associated with the
merger with Sesen Bio, Inc. in 2023, and a $0.4 million decrease in insurance costs,
partially offset by a $0.7 million
increase in facilities and supplies due to a rise in office
expenditures, and a $0.5 million
increase in personnel costs which includes an increase in personnel
costs which includes a raise in salaries and headcount, stock-based
compensation, and severance costs related to the revised operating
plan.
- Net loss was $11.2 million for
the second quarter of 2024, compared to a $19.9 million net loss for the same period in
2023.
Outlook
Carisma anticipates that its cash and cash equivalents of
$40.4 million as of June 30, 2024 are sufficient to sustain its
planned operations into the third quarter of 2025. The Company's
cash forecast contains estimates and assumptions, and management
cannot predict the timing of all cash receipts and expenditures
with certainty. Variances from management's estimates and
assumptions could impact the Company's liquidity prior to 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 macrophage
therapy.
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, its Quarterly Report on Form
10-Q for the quarter ended June 30,
2024, 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 par value)
|
|
|
June 30,
2024
|
|
December 31,
2023
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
40,362
|
|
$
77,605
|
Prepaid expenses and
other assets
|
10,359
|
|
2,866
|
Total current
assets
|
50,721
|
|
80,471
|
Property and equipment,
net
|
6,531
|
|
6,764
|
Right of use assets –
operating leases
|
1,945
|
|
2,173
|
Deferred financing
costs
|
142
|
|
146
|
Total
assets
|
$
59,339
|
|
$
89,554
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,033
|
|
$
3,933
|
Accrued
expenses
|
9,241
|
|
7,662
|
Deferred
revenue
|
659
|
|
1,413
|
Operating lease
liabilities
|
1,179
|
|
1,391
|
Finance lease
liabilities
|
1,283
|
|
544
|
Other current
liabilities
|
1,222
|
|
965
|
Total current
liabilities
|
15,617
|
|
15,908
|
Deferred
revenue
|
41,250
|
|
45,000
|
Operating lease
liabilities
|
795
|
|
860
|
Finance lease
liabilities
|
502
|
|
328
|
Other long-term
liabilities
|
815
|
|
926
|
Total
liabilities
|
58,979
|
|
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, 41,544,975 and
40,609,915 shares issued and outstanding at June 30, 2024 and
December 31, 2023,
respectively
|
41
|
|
40
|
Additional paid-in
capital
|
275,561
|
|
271,594
|
Accumulated
deficit
|
(275,242)
|
|
(245,102)
|
Total stockholders'
equity
|
360
|
|
26,532
|
Total liabilities and
stockholders' equity
|
$
59,339
|
|
$
89,554
|
CARISMA THERAPEUTICS
INC. Unaudited Consolidated Statements of Operations and
Comprehensive Loss (in thousands, except share and per
share data)
|
|
|
Three Months
Ended
June 30,
|
|
2024
|
|
2023
|
Collaboration
revenues
|
$
9,197
|
|
$
3,560
|
Operating
expenses:
|
|
|
|
Research and
development
|
15,307
|
|
18,518
|
General and
administrative
|
5,560
|
|
6,007
|
Total operating
expenses
|
20,867
|
|
24,525
|
Operating
loss
|
(11,670)
|
|
(20,965)
|
Interest income
(expense), net
|
508
|
|
1,177
|
Pre-tax loss
|
(11,162)
|
|
(19,788)
|
Income tax
expense
|
—
|
|
(88)
|
Net loss
|
$
(11,162)
|
|
$
(19,876)
|
|
|
|
|
Share
information:
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
$
(0.27)
|
|
$
(0.49)
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
41,543,553
|
|
40,258,107
|
Comprehensive
loss
|
|
|
|
Net loss
|
$
(11,162)
|
|
$
(19,876)
|
Unrealized gain on
marketable securities
|
—
|
|
129
|
Comprehensive
loss
|
$
(11,162)
|
|
$
(19,747)
|
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SOURCE Carisma Therapeutics Inc.