Company to prioritize CT-0525 as its anti-HER2
CAR-M product candidate and will cease further development
of CT-0508
Other prioritized pipeline programs include
the Company's in vivo CAR-M collaboration with Moderna, and
research programs including fibrosis
Cash and cash equivalents of $77.6 million as of December 31, 2023, combined with a restructuring
of operations, including pausing development of CT-1119, expected
to fund the Company into the third quarter of 2025
PHILADELPHIA, April 1,
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 fourth quarter, and full year ended December 31, 2023, and provided a business
update.
"Clinical data generated with CT-0508 in Study 101 has shown
that CAR-M is well-tolerated, feasible to manufacture and
biologically active in HER2 positive solid tumors. Combining this
data set with the multiple potential advantages we've seen
preclinically around a monocyte-based approach gives us confidence
that CT-0525 may be a significant advancement in CAR-M treatment,"
said Steven Kelly, President and
Chief Executive Officer of Carisma. "We have therefore made the
decision to focus our resources on the clinical development of the
product we believe is best suited to deliver benefit to patients
with significant unmet need."
Mr. Kelly continued, "We have also undertaken a careful review
of our business and prioritized our other pipeline programs on
those with the greatest overall potential and near-term milestones.
This prioritization enables us to reduce expenses and streamline
operations, including a restructuring of our workforce. I want to
express my sincere gratitude to those impacted by the workforce
reduction for their invaluable contributions to our mission and
their dedication to helping patients."
Reprioritization Plan, Pipeline Updates, and Upcoming
Milestones:
Ex Vivo Oncology
- Anti-human epidermal growth factor receptor 2 (Anti-HER2)
Program
- The Company's goal to identify a registrational profile for the
product candidate in its anti-HER2 program in 2025 remains
unchanged.
- In Study 101, CT-0508, a chimeric
antigen receptor macrophage (CAR-Macrophage), was well-tolerated,
remodeled the tumor microenvironment (TME), and induced anti-tumor
T cell immunity in patients with HER2 3+ tumors that achieved
stable disease, despite suboptimal dose and a patient population
with exhausted T cells.
- In late March 2024, Carisma made
the decision to prioritize CT-0525, a chimeric antigen receptor
monocyte (CAR-Monocyte), as the development candidate in its
anti-HER2 program 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 CT-0508's observed clinical
anti-tumor activity.
- CT-0525 (Anti-HER2 CAR-Monocyte)
- In November 2023, Carisma announced the clearance of its
Investigational New Drug application (IND) by the U.S. Food and
Drug Administration (FDA) for CT-0525.
- The Company 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)
- In September 2023, the Company
reported preliminary data from 14 patients in the open label
Phase 1 clinical study of CT-0508 (Study 101) designed to evaluate
the safety, tolerability and manufacturing feasibility of CT-0508
along with several customary secondary endpoints.
- The Company has also enrolled six patients in a Study 101
substudy evaluating the co-administration of CT-0508 and
pembrolizumab, a programmed cell death protein 1 (PD-1) checkpoint
inhibitor, evaluating the safety and tolerability of the
co-administration, along with several customary secondary
endpoints.
- While the Company will continue all study operations for
subjects enrolled in Study 101, it plans to stop recruitment of new
patients into the study and its substudies, and expects to report
data from the substudy evaluating the co-administration of CT-0508
and pembrolizumab in the second quarter of 2024.
- CT-1119 (Anti-Mesothelin CAR-Monocyte)
- The Company has elected to pause further development of CT-1119
as part of its reprioritization plan, pending additional
financing.
In Vivo Oncology
- Oncology (CAR-M + mRNA/LNP; Moderna Collaboration)
- In November 2023, Carisma
presented pre-clinical data from its in vivo program
demonstrating that chimeric antigen receptor macrophages and
monocytes (CAR-M) can be directly produced in vivo,
successfully redirecting endogenous myeloid cells against
tumor-associated antigens using mRNA/LNP. The data demonstrated
feasibility, tolerability, and efficacy of in vivo CAR-M
against metastatic solid tumors.
- In December 2023, the Company
announced the nomination of the first lead candidate in its
collaboration with Moderna Tx, Inc., which will target an antigen
present on a solid tumor with significant unmet medical
need.
Fibrosis and Immunology
- Liver Fibrosis
- Pre-clinical proof of concept data from the fibrosis program is
targeted for the second quarter of 2024.
Corporate Updates
- As a result of the pipeline reprioritization and corporate
restructuring, Carisma plans to reduce 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.
Fourth Quarter and Full Year 2023 Financial Results
- Cash and Cash Equivalents: As of December 31, 2023, Carisma had cash and cash
equivalents of $77.6 million.
- R&D Expenses: Research and development
(R&D) expenses were $19.4 million
and $74.1 million for the fourth
quarter and full year ended December 31, 2023, respectively,
compared to $18.1 million and
$56.6 million for the fourth quarter
and full year ended December 31, 2022, respectively. The
increase of $17.5 million
year-over-year was primarily due to a $8.4 million increase in direct costs
associated with pre-clinical development of CT-0525, a $4.4 million increase in personnel costs due to
growth in research and development employee headcount, a
$2.7 million increase in the
Company's facilities and other expenses resulting from increased
laboratory space and laboratory supplies from expanded clinical and
pre-clinical work, a $1.3 million increase due to costs
associated with growth and expansion of pre-clinical activities
towards submission of an IND for CT-0525, and a $0.9 million increase in direct costs
associated with the pre-clinical development related to CT-1119,
partially offset by a $0.2 million
decrease in direct costs associated with CT-0508. The Company
expects its research and development expenses to decrease in 2024
as it implements the revised operating plan, including a reduction
in workforce, prioritization of CT-0525 and a pause in development
of CT-1119. The Company expects that its expenses will increase
again in future years as it continues to advance its clinical
trials and potentially progress additional product candidates.
- G&A Expenses: General and administrative
(G&A) expenses were $7.3 million
and $29.5 million for the fourth
quarter and full year ended December 31, 2023, respectively,
compared to $1.0 million and
$9.4 million for the fourth quarter
and full year ended December 31, 2022, respectively. The
increase of $20.1 million
year-over-year was primarily attributable to a $9.2 million increase in personnel costs and a
$7.5 million increase in professional
fees. The increase in personnel costs was primarily due to
non-recurring severance and other costs associated with the merger
with Sesen Bio, Inc. on March 7, 2023
("Merger") of $4.6 million, and
higher personnel costs as a result of an increase in headcount to
support operating as a public company of $4.6 million. The increase in professional fees
primarily consisted of $5.3 million
in costs associated with activities to support the transitioning to
and operating as a public company and protecting the Company's IP
portfolio, along with $2.2 million in
legal fees and communication fees associated with the Merger.
Insurance and taxes increased $2.1
million as a result of costs associated with operating as a
public company, such as director and officer insurance. Facilities
and supplies increased $0.8 million
due to office expenditures resulting from an increased footprint,
and other expenses increased $0.5
million. The Company expects that its general and
administrative expenses will decrease in 2024 as its 2023 expenses
included a significant amount of non-recurring costs related to the
Merger and as it implements its revised operating plan, including
reducing its workforce and decreasing expenses related to
non-essential activities.
- Net Loss: Net loss was $86.9
million and $61.2 million for
the years ended December 31, 2023,
and 2022, respectively.
Outlook
Carisma anticipates that its cash and cash equivalents of
$77.6 million as of December 31, 2023, 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
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 obtain,
maintain and protect its intellectual property rights related to
its product candidates; (ii) 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; (iii) Carisma's ability to
replicate in later clinical trials positive results found in
preclinical studies and early-stage clinical trials of its product
candidates; (iv) 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; (v) 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; (vi) changes to
clinical trial designs and regulatory pathways; (vii) risks
associated with Carisma's ability to manage expenses; (viii)
changes in capital resource requirements; (ix) risks related to the
inability of Carisma to obtain sufficient additional capital to
continue to advance its product candidates and its preclinical
programs; and (x) 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:
Julia Stern
(763) 350-5223
jstern@realchemistry.com
CARISMA THERAPEUTICS
INC.
|
Consolidated Balance
Sheets
|
(in thousands,
except share and per share data)
|
|
|
|
December
31,
|
Assets
|
|
2023
|
|
|
2022
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
77,605
|
|
$
|
24,194
|
Marketable
securities
|
|
-
|
|
|
27,802
|
Prepaid expenses and
other assets
|
|
2,866
|
|
|
2,596
|
Total current
assets
|
|
80,471
|
|
|
54,592
|
Property and equipment,
net
|
|
6,764
|
|
|
8,628
|
Right of use assets –
operating leases
|
|
2,173
|
|
|
4,822
|
Deferred financing
costs
|
|
146
|
|
|
4,111
|
Total
assets
|
$
|
89,554
|
|
$
|
72,153
|
|
|
|
|
|
|
Liabilities,
Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
$
|
3,933
|
|
$
|
1,728
|
Accrued
expenses
|
|
7,662
|
|
|
10,361
|
Deferred
revenue
|
|
1,413
|
|
|
2,459
|
Operating lease
liabilities
|
|
1,391
|
|
|
3,437
|
Finance lease
liabilities
|
|
544
|
|
|
1,162
|
Other current
liabilities
|
|
965
|
|
|
523
|
Total current
liabilities
|
|
15,908
|
|
|
19,670
|
Deferred
revenue
|
|
45,000
|
|
|
45,000
|
Convertible promissory
note
|
|
-
|
|
|
33,717
|
Derivative
liability
|
|
-
|
|
|
5,739
|
Operating lease
liabilities
|
|
860
|
|
|
976
|
Finance lease
liabilities
|
|
328
|
|
|
872
|
Other long-term
liabilities
|
|
926
|
|
|
1,041
|
Total
liabilities
|
|
63,022
|
|
|
107,015
|
Convertible preferred
stock
|
|
-
|
|
|
107,808
|
Stockholders' equity
(deficit):
|
|
|
|
|
|
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,
40,609,915 and 2,217,737 shares issued and outstanding at December
31,
2023 and 2022, respectively
|
|
40
|
|
|
2
|
Additional paid-in
capital
|
|
271,594
|
|
|
1,197
|
Accumulated other
comprehensive loss
|
|
-
|
|
|
(41)
|
Accumulated
deficit
|
|
(245,102)
|
|
|
(158,223)
|
Total Carisma
Therapeutics Inc. stockholders' equity (deficit)
|
|
26,532
|
|
|
(157,065)
|
Noncontrolling
interests
|
|
-
|
|
|
14,395
|
Total stockholders'
equity (deficit)
|
|
26,532
|
|
|
(142,670)
|
Total liabilities,
convertible preferred stock and
stockholders' equity (deficit)
|
$
|
89,554
|
|
$
|
72,153
|
CARISMA THERAPEUTICS
INC.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
(in thousands,
except share and per share data)
|
|
|
|
Three Months
Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
2023
|
|
2022
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenues
|
$
|
4,289
|
$
|
3,731
|
|
$
|
14,919
|
$
|
9,834
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
19,415
|
|
18,082
|
|
|
74,125
|
|
56,618
|
General and
administrative
|
|
7,324
|
|
971
|
|
|
29,525
|
|
9,378
|
Total operating
expenses
|
|
26,739
|
|
19,053
|
|
|
103,650
|
|
65,996
|
Operating
loss
|
|
(22,450)
|
|
(15,322)
|
|
|
(88,731)
|
|
(56,162)
|
Change in fair value of
derivative liability
|
|
—
|
|
(550)
|
|
|
(84)
|
|
(1,919)
|
Interest income
(expense), net
|
|
1,295
|
|
(867)
|
|
|
1,936
|
|
(3,145)
|
Pre-tax loss
|
|
(21,155)
|
|
(16,739)
|
|
|
(86,879)
|
|
(61,226)
|
Income tax
provision
|
|
197
|
|
—
|
|
|
—
|
|
—
|
Net loss
|
$
|
(20,958)
|
$
|
(16,739)
|
|
$
|
(86,879)
|
$
|
(61,226)
|
|
|
|
|
|
|
|
|
|
|
Share
information:
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
$
|
(0.52)
|
$
|
(7.61)
|
|
$
|
(2.59)
|
$
|
(28.77)
|
Weighted-average shares
of common stock
outstanding, basic and diluted
|
|
40,391,608
|
|
2,198,748
|
|
|
33,524,197
|
|
2,128,069
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(20,958)
|
$
|
(16,739)
|
|
$
|
(86,879)
|
$
|
(61,226)
|
Unrealized gain (loss)
on marketable securities
|
|
26
|
|
119
|
|
|
440
|
|
(41)
|
Less: reclassification
to net loss of previous
unrealized gain on marketable securities
|
|
(399)
|
|
—
|
|
|
(399)
|
|
—
|
Comprehensive
loss
|
$
|
(21,331)
|
$
|
(16,620)
|
|
$
|
(86,838)
|
$
|
(61,267)
|
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SOURCE Carisma Therapeutics Inc.