Presented updated data from Phase 1 clinical
trial of CT-0508 at CAR-TCR Summit, further supporting CAR-M
safety, feasibility and mechanism of action
Selected clinical candidate for CT-1119, an
anti-mesothelin CAR-Monocyte
Presented pre-clinical proof of concept data
of in vivo CAR-M, from the Company's collaboration with Moderna, at
SITC
Cash, cash equivalents and marketable
securities of $94.1 million expected
to fund company into the first quarter of 2025
PHILADELPHIA, Nov. 9, 2023 /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 September 30, 2023,
and highlighted recent business updates.
"During the third quarter, Carisma made several key advancements
across our clinical and pre-clinical programs and reported data
from both our Phase 1 clinical study of CT-0508 and our
pre-clinical work with Moderna developing in vivo CAR-M,"
said Steven Kelly, President and
Chief Executive Officer of Carisma. "We continue to progress
CT-0508 and CT-0525, our assets targeting HER2 overexpressing
tumors, as we work to validate our first-in-class engineered
macrophage platform. We believe that we have value-driving,
next-generation cell therapies in our pipeline that have the
potential to improve the treatments available for patients with
cancer and other serious disorders."
Third Quarter 2023 and Recent Business Highlights
- CT-0508
- Announced updated data from the Company's Phase 1 clinical
trial of CT-0508, a human epidermal growth factor receptor 2 (HER2)
targeted chimeric antigen receptor macrophage (CAR-M), which
included data from the first five patients from group 2 (single-day
bolus dosing). Preliminary results from the nine patients in
group 1 (fractionated dosing) were presented in November 2022. The group 2 data, which were
presented at the 8th Annual CAR-TCR Summit, support
primary safety and manufacturing feasibility endpoints of
single-day bolus dosing. The Company believes that translational
analyses on early data from the combined groups 1 and 2 show that
biomarkers of tumor microenvironment activation, T cell activation,
and HER2 status correlate with best overall response of stable
disease, providing further evidence of the CT-0508 mechanism of
action.
- CT-1119
- Selected a clinical candidate for the CT-1119 program,
a CAR-Monocyte for mesothelin overexpressing solid tumors.
CT-1119 will incorporate two key enhancements: a next-generation
CAR that, as demonstrated in pre-clinical studies, leads to a
significant increase in tumor killing and cytokine release, and the
incorporation of SIRPα knockdown to overcome the CD47 immune
checkpoint. SIRPα knockdown is achieved using Carisma's proprietary
intronic shRNA platform, which enables CAR delivery and gene
knockdown using a single vector. The Company is targeting an
Investigational New Drug Application (IND) for CT-1119 in 2025.
- In Vivo CAR-M (Moderna
Collaboration)
- Presented pre-clinical proof of concept data demonstrating
feasibility, tolerability, and early efficacy of mRNA/LNP
in vivo CAR-M therapy at the Society for Immunotherapy of
Cancer (SITC) 38th Annual Meeting. Accepted as a late-breaking
abstract and oral presentation, "In vivo CAR-M: Redirecting
endogenous myeloid cells with mRNA for cancer immunotherapy,"
showcased data that demonstrated CAR-M can be directly produced
in vivo, or within the body, successfully redirecting
endogenous myeloid cells against tumor-associated antigens using
mRNA/LNP. This novel approach to cancer immunotherapy offers an
off-the-shelf solution that has the potential to increase access to
CAR-based therapies and be the basis of up to 12 oncology programs
developed under the Carisma and Moderna collaboration.
Upcoming Milestones
- The Company recently submitted an IND to the U.S. Food and
Drug Administration (FDA) for CT-0525. Subject to regulatory
feedback, the Company expects to treat the first patient in the
first half of 2024.
- The Company expects to present data from the sub-study of its
Phase 1 clinical trial of CT-0508 in combination
with pembrolizumab in the first half of 2024.
- The Company expects pre-clinical proof of concept data for its
initial program outside of oncology, in liver fibrosis, in the
first half of 2024.
- The Company is targeting an IND for CT-1119 in 2025.
Third Quarter 2023 Financial Results
- Cash, cash equivalents and marketable securities as of
September 30, 2023, were $94.1 million, compared to $117.1 million as of June
30, 2023.
- Research & development expenses were $19.6 million for the third quarter of 2023,
compared to $15.6 million for the
same period in 2022. The increase of $4.0
million was primarily due to a $2.9
million increase in direct costs associated with the
pre-clinical development of CT-0525, a $1.2
million increase in personnel costs due to growth in
research and development employee headcount, and a $0.3 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 and a $0.1 million decrease of other clinical and
pre-clinical development expenses associated with tracking CT-0525
and CT-1119 separately.
- General & administrative expenses were $6.6 million for the third quarter of 2023,
compared to $3.8 million for the same
period in 2022. The increase of $2.8
million was primarily due to a $1.4
million increase of higher personnel costs as a result of an
increase in headcount, a $0.4 million
increase in facilities and supplies due to an increase in office
expenditures, a $0.6 million increase
in legal and professional fees in support of our patent portfolio
and expanding infrastructure, as well as a $0.4 million increase in other expenses due to an
increase in travel expenses and subscriptions.
- Net loss was $21.4 million for
the third quarter of 2023, compared to net loss of $18.3 million for the same period in 2022,
primarily due to increased research and development expenses to
support CT-0525 as well as an increase in expanding headcount and
infrastructure, which was partially offset by Moderna
collaboration revenue.
Outlook
Carisma believes that its cash, cash equivalents and marketable
securities of $94.1 million as of
September 30, 2023, are sufficient to
sustain Carisma's planned operations into the first quarter of
2025.
About CT-0508
CT-0508 is a human epidermal growth factor receptor 2 (HER2)
targeted chimeric antigen receptor macrophage (CAR-M). It is being
evaluated in a landmark 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. Carisma
is selecting participants who have tumors of any anatomical origin,
but with the commonality of overexpressing the HER2 receptor on the
cell surface, which is the target for its CAR-M. The Phase 1
clinical trial marks the first time that engineered macrophages are
being studied in humans. The trial continues to enroll patients at
seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center,
(ii) the University of North Carolina
Lineberger Comprehensive Cancer Center, (iii) the City of Hope
National Medical Center, (iv) the MD Anderson Cancer Center, (v)
the Sarah Cannon Cancer Research Institute, (vi) Oregon Health
& Science University and (vii) Fred Hutchinson Cancer
Center.
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; (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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on November 9,
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.
Media Contact:
Julia
Stern
(763) 350-5223
jstern@realchemistry.com
Investor Contact:
investors@carismatx.com
CARISMA THERAPEUTICS
INC.
|
Unaudited
Consolidated Balance Sheets
|
(in thousands,
except share and per share data)
|
|
|
September 30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
83,132
|
|
$
24,194
|
Marketable
securities
|
11,005
|
|
27,802
|
Prepaid expenses and
other assets
|
3,428
|
|
2,596
|
Total current
assets
|
97,565
|
|
54,592
|
Property and equipment,
net
|
7,379
|
|
8,628
|
Right of use assets –
operating leases
|
1,664
|
|
4,822
|
Restricted
cash
|
30
|
|
—
|
Deferred financing
costs
|
146
|
|
4,111
|
Total
assets
|
$
106,784
|
|
$
72,153
|
|
|
|
|
Liabilities,
Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,409
|
|
$
1,728
|
Accrued
expenses
|
7,026
|
|
10,361
|
Deferred
revenue
|
1,185
|
|
2,459
|
Operating lease
liabilities
|
856
|
|
3,437
|
Finance lease
liabilities
|
532
|
|
1,162
|
Other current
liabilities
|
943
|
|
523
|
Total current
liabilities
|
12,951
|
|
19,670
|
Deferred
revenue
|
45,000
|
|
45,000
|
Convertible promissory
note
|
—
|
|
33,717
|
Derivative
liability
|
—
|
|
5,739
|
Operating lease
liabilities
|
891
|
|
976
|
Finance lease
liabilities
|
468
|
|
872
|
Other long-term
liabilities
|
1,176
|
|
1,041
|
Total
liabilities
|
60,486
|
|
107,015
|
|
|
|
|
Convertible preferred
stock
|
—
|
|
107,808
|
Stockholders' equity
(deficit):
|
|
|
|
Common stock $0.001
par value, 350,000,000 shares authorized, 40,304,436 and
2,217,737 shares issued and outstanding at September 30, 2023
and December 31,
2022, respectively
|
40
|
|
2
|
Additional paid-in
capital
|
270,029
|
|
1,197
|
Accumulated other
comprehensive income (loss)
|
373
|
|
(41)
|
Accumulated
deficit
|
(224,144)
|
|
(158,223)
|
Total Carisma
Therapeutics Inc. stockholders' equity (deficit)
|
46,298
|
|
(157,065)
|
Noncontrolling
interests
|
—
|
|
14,395
|
Total stockholders'
equity (deficit)
|
46,298
|
|
(142,670)
|
Total liabilities,
convertible preferred stock and stockholders' equity
(deficit)
|
$
106,784
|
|
$
72,153
|
CARISMA THERAPEUTICS
INC.
|
Unaudited
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands,
except share and per share data)
|
|
|
Three Months
Ended
September 30,
|
|
|
2023
|
|
2022
|
|
Collaboration
revenues
|
$
3,827
|
|
$
2,578
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
19,551
|
|
15,557
|
|
General and
administrative
|
6,620
|
|
3,772
|
|
Total operating
expenses
|
26,171
|
|
19,329
|
|
Operating
loss
|
(22,344)
|
|
(16,751)
|
|
Change in fair value of
derivative liability
|
—
|
|
(668)
|
|
Interest income
(expense), net
|
941
|
|
(908)
|
|
Pre-tax loss
|
(21,403)
|
|
(18,327)
|
|
Income tax
expense
|
—
|
|
—
|
|
Net loss
|
$
(21,403)
|
|
$
(18,327)
|
|
|
|
|
|
|
Share
information:
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
$
(0.53)
|
|
$
(8.37)
|
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
40,285,858
|
|
2,189,265
|
|
Comprehensive
loss
|
|
|
|
|
Net loss
|
$
(21,403)
|
|
$
(18,327)
|
|
Unrealized gain (loss)
on marketable securities
|
108
|
|
37
|
|
Comprehensive
loss
|
$
(21,295)
|
|
$
(18,290)
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/carisma-therapeutics-reports-third-quarter-2023-financial-results-and-recent-business-highlights-301982660.html
SOURCE Carisma Therapeutics Inc.