Dosed first patient in Phase 1 clinical trial
of CT-0508 in combination with KEYTRUDA® (pembrolizumab) in
patients with HER2-overexpressing solid tumors
Nominated additional oncology target as part
of the Company's collaboration with Moderna to develop in-vivo
targeted CAR-M therapies
Cash, cash equivalents and marketable
securities of $117.1 million expected
to fund company through 2024
PHILADELPHIA, Aug. 10,
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 June 30, 2023, and
highlighted recent business updates.
"In the second quarter, the Carisma team successfully achieved
the important clinical milestone of dosing the first patient in the
Phase 1 clinical trial of CT-0508 in combination with KEYTRUDA,
which represents the next step in our progression of engineering
macrophages for the treatment of solid tumors," said Steven Kelly, President and Chief Executive
Officer of Carisma. "We continue to execute on our overall
strategic plan and we are excited to use this momentum to reach our
upcoming potential value inflection points within our HER2
franchise and across our pipeline. We believe we are
well-positioned to drive innovation as the leader in engineered
macrophages and deliver value to our stakeholders."
Pipeline Updates
- CT-0508
-
- Announced the first patient has been dosed in the Company's
Phase I clinical trial that will test the safety and tolerability
of the Company's lead candidate, CT-0508, a human epidermal growth
factor receptor 2 (HER2) targeted chimeric antigen receptor
macrophage (CAR-M) in combination with Merck's anti-PD1 therapy
KEYTRUDA® (pembrolizumab) for the treatment of HER2 overexpressing
solid tumors.
- In Vivo Oncology Program (Moderna Collaboration)
-
- Nominated and initiated research on an additional oncology
target under the Moderna research collaboration to develop
in-vivo targeted CAR-M therapies. The goal of the program, which
now has five nominated targets, is to create novel in vivo CAR-M
therapies with an approach that uses Moderna's mRNA/LNP technology
together with Carisma's CAR-M platform technology.
Recent Business Highlights
- Expanded Leadership Team to support legal and human
resources functions. The Company appointed Eric Siegel as General Counsel and Corporate
Secretary and Terry Shields as
Senior Vice President of Human Resources. Mr. Siegel and Ms.
Shields each bring to Carisma more than 25 years of experience in
their respective fields.
- Added to the Russell 2000, Russell 3000, and Russell
Microcap Indexes. Following the conclusion of the 2023 Russell
indexes annual reconstitution, the Company joined three Russell
indexes that capture the 4,000 largest U.S. stocks as of
April 28, 2023, ranked by total
market capitalization.
Anticipated Upcoming Milestones
- Data from Group 2 of Phase 1 clinical trial of CT-0508 expected
in the second half of 2023
- Initial data from Phase 1 clinical trial of CT-0508 in
combination with KEYTRUDA® (pembrolizumab) expected in
the second half of 2023
- Submission of Investigational New Drug (IND) application to the
U.S. Food and Drug Administration for CT-0525, Carisma's first
anti-HER2 CAR-Monocyte product candidate, expected in the second
half of 2023
- Selection of next-generation candidate for CT-1119 expected in
the first half of 2024
- Proof-of-concept data for the Company's initial non-oncology
program expected in the first half of 2024
Second Quarter 2023 Financial Results
- Cash, cash equivalents and marketable securities as of
June 30, 2023 were $117.1 million, compared to $139.0 million as of March
31, 2023.
- Research & development expenses were $18.5 million for the second quarter of 2023,
compared to $14.2 million for the
same period in 2022. The increase of $4.3
million was primarily due to a $1.5
million increase in direct costs associated with the
preclinical development of CT-0525, a $1.3
million increase in direct costs associated with CT-0508, a
$1.0 million increase in personnel
costs due to growth in research and development employee headcount,
a $0.5 million increase in direct
costs related to CT-1119, and a $0.2
million increase in facilities and other expenses due to an
increase in rent expense, partially offset by a $0.2 million decrease of other clinical and
pre-clinical development expenses associated with tracking CT-0525
and CT-1119 separately.
- General & administrative expenses were $6.0 million for the second quarter of 2023,
compared to $2.4 million for the same
period in 2022. The increase of $3.6
million was attributable to $1.9
million increase in legal and professional fees in support
of our expanding infrastructure and patent portfolio, a
$1.5 million increase of higher
personnel costs as a result of an increase in headcount, as well as
a $0.3 million increase in other
expenses due to an increase in travel and other administrative
costs, partially offset by a $0.1
million decrease in facilities and supplies due to a decline
in office expenditures.
- Net loss was $19.9 million for
the second quarter of 2023, compared to net loss of $14.8 million for the same period in 2022,
primarily due to increased research and development expenses to
support CT-0508 and CT-0525 as well as 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 $117.1 million as of
June 30, 2023, are sufficient to
sustain Carisma's planned operations through the end of 2024.
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 is first-of-its-kind, marking 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
Therapeutics' 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 August 10,
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)
|
|
|
June 30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
76,353
|
|
$
24,194
|
Marketable
securities
|
40,725
|
|
27,802
|
Prepaid expenses and
other assets
|
5,122
|
|
2,596
|
Total current
assets
|
122,200
|
|
54,592
|
Property and equipment,
net
|
7,590
|
|
8,628
|
Right of use assets –
operating leases
|
3,047
|
|
4,822
|
Restricted
cash
|
30
|
|
—
|
Deferred financing
costs
|
146
|
|
4,111
|
Total
assets
|
$
133,013
|
|
$
72,153
|
|
|
|
|
Liabilities,
Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
2,487
|
|
$
1,728
|
Accrued
expenses
|
9,614
|
|
10,361
|
Deferred
revenue
|
1,416
|
|
2,459
|
Operating lease
liabilities
|
2,486
|
|
3,437
|
Finance lease
liabilities
|
1,215
|
|
1,162
|
Other current
liabilities
|
755
|
|
523
|
Total current
liabilities
|
17,973
|
|
19,670
|
Deferred
revenue
|
45,000
|
|
45,000
|
Convertible promissory
note
|
—
|
|
33,717
|
Derivative
liability
|
—
|
|
5,739
|
Operating lease
liabilities
|
920
|
|
976
|
Finance lease
liabilities
|
606
|
|
872
|
Other long-term
liabilities
|
1,809
|
|
1,041
|
Total
liabilities
|
66,308
|
|
107,015
|
Convertible preferred
stock
|
—
|
|
107,808
|
Stockholders' equity
(deficit):
|
|
|
|
Common stock $0.001
par value, 350,000,000 shares authorized, 40,269,576 and
2,217,737 shares issued and outstanding at June 30, 2023 and
December 31, 2022,
respectively
|
40
|
|
2
|
Additional paid-in
capital
|
269,141
|
|
1,197
|
Accumulated other
comprehensive income (loss)
|
265
|
|
(41)
|
Accumulated
deficit
|
(202,741)
|
|
(158,223)
|
Total Carisma
Therapeutics Inc. stockholders' equity (deficit)
|
66,705
|
|
(157,065)
|
Noncontrolling
interests
|
—
|
|
14,395
|
Total stockholders'
equity (deficit)
|
66,705
|
|
(142,670)
|
Total liabilities,
convertible preferred stock and stockholders' equity
(deficit)
|
$
133,013
|
|
$
72,153
|
CARISMA THERAPEUTICS
INC.
|
Unaudited
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands,
except share and per share data)
|
|
|
Three Months
Ended
June 30,
|
|
|
2023
|
|
2022
|
|
Collaboration
revenues
|
$
3,560
|
|
$
2,703
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
18,518
|
|
14,212
|
|
General and
administrative
|
6,007
|
|
2,424
|
|
Total operating
expenses
|
24,525
|
|
16,636
|
|
Operating
loss
|
(20,965)
|
|
(13,933)
|
|
Change in fair value of
derivative liability
|
—
|
|
(144)
|
|
Interest income
(expense), net
|
1,177
|
|
(771)
|
|
Pre-tax loss
|
(19,788)
|
|
(14,848)
|
|
Income tax
expense
|
(88)
|
|
—
|
|
Net loss
|
$
(19,876)
|
|
$
(14,848)
|
|
|
|
|
|
|
Share
information:
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
$
(0.49)
|
|
$
(7.20)
|
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
40,258,107
|
|
2,061,643
|
|
Comprehensive
loss
|
|
|
|
|
Net loss
|
$
(19,876)
|
|
$
(14,848)
|
|
Unrealized gain (loss)
on marketable securities
|
129
|
|
(39)
|
|
Comprehensive
loss
|
$
(19,747)
|
|
$
(14,887)
|
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/carisma-therapeutics-reports-second-quarter-2023-financial-results-and-recent-business-highlights-301897403.html
SOURCE Carisma Therapeutics Inc.