Initiated a Phase 1 Sub-Study of CT-0508 in
combination with KEYTRUDA® (pembrolizumab) in patients
with HER2-overexpressing solid tumors
Expanded clinical manufacturing capacity
through successful technology transfer of CT-0508
Closed merger with Sesen Bio and commenced
trading on Nasdaq under ticker symbol "CARM"
PHILADELPHIA, May 11, 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 first quarter ended
March 31, 2023 and provided business
highlights.
![(PRNewsfoto/CARISMA Therapeutics Inc.) (PRNewsfoto/CARISMA Therapeutics Inc.)](https://mma.prnewswire.com/media/1219543/Carisma_Therapeutics_Logo.jpg)
"In the first quarter, we closed our merger with Sesen Bio,
Inc., which further strengthened our foundation to advance our
pipeline through the end of 2024," said Steven Kelly, President and Chief Executive
Officer of Carisma. "With multiple potential value inflection
points on the horizon, including the completion of our Phase 1
clinical trial of CT-0508 and the upcoming data from the clinical
trial sub-study of CT-0508 in combination with
KEYTRUDA®, we believe we are well positioned to continue
driving innovation and delivering value to our stakeholders. We
remain committed to advancing our pipeline and leveraging our
expertise in chimeric antigen receptor (CAR)-macrophages to bring
transformative therapies to patients in need."
Pipeline Updates
- CT-0508
-
- Initiated a sub-study in the Company's Phase 1 clinical trial
that will test the safety and tolerability of Carisma'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 cancers.
- Presented a trial-in-progress poster at The American
Association for Cancer Research (AACR) Annual Meeting in
April 2023 that provided an overview
of Carisma's Phase 1, first-in-human study of CT-0508.
- Increased clinical manufacturing capacity by successfully
completing a technology transfer of CT-0508 manufacturing to
Novartis, including the first manufacturing run for a clinical
trial patient.
- CT-1119
-
- Presented pre-clinical data at the AACR Annual Meeting
demonstrating that CT-1119, an autologous human anti-mesothelin
CAR-M, can phagocytose, eradicate, and induce an inflammatory
response against mesothelin overexpressing solid tumors. The
results show that CAR-M is potentially a feasible approach for the
treatment of mesothelin overexpressing solid tumors.
Business Highlights
- Completed merger with Sesen Bio and concurrent financing in
March 2023. The Company closed
its previously announced merger with Sesen Bio, Inc. (Sesen Bio),
pursuant to which the combined company changed its name to "Carisma
Therapeutics Inc." and commenced trading on The Nasdaq Global
Market under the symbol "CARM." At the closing of the merger,
taking into account the reverse stock split of shares of common
stock of Sesen Bio prior to the closing, the combined company had
approximately 40.3 million outstanding shares of common stock. The
net assets acquired by the Company in the merger with Sesen Bio was
$80.3 million. In addition, the
Company raised $30.6 million from a
concurrent financing.
- Expanded Scientific Advisory Board (SAB) with additional
expertise in solid tumor immunotherapy development
capabilities. The Company appointed leading solid tumor
immunotherapy expert Padmanee Sharma, M.D., Ph.D. to Carisma's SAB
in January 2023. Dr. Sharma is a
nationally regarded cancer immunologist and professor in the
departments of Genitourinary Medical Oncology and Immunology,
Associate V.P. of Immunobiology and the T.C. and Jeanette D. Hsu
Endowed Chair in Cell Biology at The University of Texas MD Anderson Cancer Center.
Additionally, the Company appointed Moderna Inc. (Moderna) CSO of
External Research Ventures, Lin
Guey, Ph.D. to Carisma's SAB in February 2023. Dr. Guey is a leading expert in
mRNA therapeutics and oversees Moderna's collaboration with Carisma
to develop in vivo CAR-M therapies.
Anticipated Upcoming Milestones
- Additional data from Group 2 of Carisma's Phase 1 clinical
trial of CT-0508 expected in the second half of 2023.
- Initial data from clinical trial sub-study of CT-0508 in
combination with KEYTRUDA® expected in the second half
of 2023.
- Submission of Investigational New Drug 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.
- Nomination of additional target(s) under the Moderna
development collaboration expected in 2023.
First Quarter 2023 Financial Results(1)
- Cash, cash equivalents and marketable securities as of
March 31, 2023 were $139.0 million, compared to $52.0 million as of December 31, 2022.
- Research & development expenses were $16.6 million for the first quarter of 2023,
compared to $8.8 million in 2022. The
increase was primarily due to an increase in lab space and lab
supplies, personnel costs due to growth in employee headcount,
pre-clinical activities towards submission of an IND for CT-0525,
and pre-clinical development expenses associated with the Moderna
collaboration, partially offset by a $0.5
million decrease in direct costs associated with
CT-0508.
- General & administrative expenses were $9.6 million for the first quarter of 2023,
compared to $2.2 million in 2022. The
increase was primarily attributable to severance and payroll costs
associated with the Sesen Bio merger, an increase in headcount,
costs associated with Carisma's patent portfolio, costs associated
with expanding infrastructure in preparation of operating as a
public company and public relation expenditures.
- Net loss was $24.6 million for
the first quarter of 2023, compared to net loss of $11.3 million for the same period in 2022,
primarily due to increased research and development expenses, which
was partially offset by Moderna collaboration revenue.
(1) All prior year comparisons are relative to
CTx Operations, Inc. (formerly CARISMA Therapeutics Inc.), which
merged with and into a subsidiary of the Company in connection with
the closing of the merger with Sesen Bio, surviving as a wholly
owned subsidiary of the Company. Following the completion of the
merger, the business conducted by the Company became primarily the
business conducted by Carisma.
Outlook
Carisma believes that its cash, cash equivalents and marketable
securities of $139.0 million as of
March 31, 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 are not eligible for
treatment with currently available HER2-targeted therapies or who
do not respond to treatment. We are 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 our CAR-M. The Phase 1 clinical trial is
first-of-its-kind, marking the first time that genetically
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 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. The first applications of the platform,
developed in collaboration with the University
of Pennsylvania, are autologous chimeric antigen receptor
(CAR)-macrophages for the treatment of solid tumors. 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 and 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) risks associated with the
possible failure to realize certain anticipated benefits of the
merger, including with respect to future financial and operating
results; (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; (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; (vii) changes to
clinical trial designs and regulatory pathways; (viii) Carisma's
commercialization and manufacturing capabilities and strategy; (ix)
risks associated with Carisma's ability to manage expenses; (x)
Carisma's competitive position; (xi) changes in capital resource
requirements; (xii) risks related to the inability of Carisma to
obtain sufficient additional capital to continue to advance its
product candidates and its preclinical programs; and (xiii)
legislative, regulatory, political and economic developments. For a
discussion of other 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 Exhibit 99.3 to Company's Current
Report on Form 8-K filed with the Securities and Exchange
Commission (SEC) on March 8, 2023,
Carisma's Annual Report on Form 10-K for the year ended
December 31, 2022 filed with the SEC
on February 28, 2023 and Carisma's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 to be filed with the SEC on
May 11, 2023, as well as discussions
of potential risks, uncertainties, and other important factors in
Carisma's most 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)
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
62,777
|
|
|
$
|
24,194
|
|
Marketable
securities
|
|
|
76,190
|
|
|
|
27,802
|
|
Prepaid expenses and
other assets
|
|
|
5,535
|
|
|
|
2,596
|
|
Total current
assets
|
|
|
144,502
|
|
|
|
54,592
|
|
Property and equipment,
net
|
|
|
8,107
|
|
|
|
8,628
|
|
Right of use assets –
operating leases
|
|
|
3,493
|
|
|
|
4,822
|
|
Restricted
cash
|
|
30
|
|
—
|
|
Deferred financing
costs
|
|
|
—
|
|
|
|
4,111
|
|
Total assets
|
|
$
|
156,132
|
|
|
$
|
72,153
|
|
|
|
|
|
|
|
|
|
|
Liabilities,
Convertible Preferred Stock and Stockholders' Equity
(Deficit)
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
4,614
|
|
|
$
|
1,728
|
|
Accrued
expenses
|
|
|
10,187
|
|
|
|
10,361
|
|
Deferred
revenue
|
|
|
2,136
|
|
|
|
2,459
|
|
Operating lease
liabilities
|
|
|
2,597
|
|
|
|
3,437
|
|
Finance lease
liabilities
|
|
|
1,188
|
|
|
|
1,162
|
|
Other current
liabilities
|
|
|
755
|
|
|
|
523
|
|
Total current
liabilities
|
|
|
21,477
|
|
|
|
19,670
|
|
Deferred
revenues
|
|
|
45,000
|
|
|
|
45,000
|
|
Convertible promissory
note
|
|
|
—
|
|
|
|
33,717
|
|
Derivative
liability
|
|
|
—
|
|
|
|
5,739
|
|
Operating lease
liabilities
|
|
|
948
|
|
|
|
976
|
|
Finance lease
liabilities
|
|
|
740
|
|
|
|
872
|
|
Other long-term
liabilities
|
|
|
1,897
|
|
|
|
1,041
|
|
Total
liabilities
|
|
|
70,062
|
|
|
|
107,015
|
|
Convertible preferred
stock
|
|
|
—
|
|
|
|
107,808
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
|
|
|
|
Common stock $0.001 par
value, 100,000,000 shares authorized, 40,254,666 and
2,217,708 shares issued and outstanding at
March 31, 2023 and December 31,
2022, respectively
|
|
|
40
|
|
|
|
2
|
|
Additional paid-in
capital
|
|
|
268,759
|
|
|
|
1,197
|
|
Accumulated other
comprehensive income (loss)
|
|
|
136
|
|
|
|
(41)
|
|
Accumulated
deficit
|
|
|
(182,865)
|
|
|
|
(158,223)
|
|
Total Carisma
Therapeutics Inc. stockholders' equity (deficit)
|
|
|
86,070
|
|
|
|
(157,065)
|
|
Noncontrolling
interests
|
|
|
—
|
|
|
|
14,395
|
|
Total stockholders'
equity deficit
|
|
|
86,070
|
|
|
|
(142,670)
|
|
Total liabilities,
convertible preferred stock and stockholders' equity
(deficit)
|
|
$
|
156,132
|
|
|
$
|
72,153
|
|
CARISMA THERAPEUTICS INC.
|
Unaudited
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands,
except share and per share data)
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Collaboration
revenues
|
|
$
|
3,243
|
|
|
$
|
822
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
16,641
|
|
|
|
8,767
|
|
General and
administrative
|
|
|
9,574
|
|
|
|
2,211
|
|
Total operating
expenses
|
|
|
26,215
|
|
|
|
10,978
|
|
Operating
loss
|
|
|
(22,972)
|
|
|
|
(10,156)
|
|
Change in fair value of
derivative liability
|
|
|
(84)
|
|
|
|
(557)
|
|
Interest (expense)
income, net
|
|
|
(1,477)
|
|
|
|
(599)
|
|
Pre-tax loss
|
|
|
(24,533)
|
|
|
|
(11,312)
|
|
Income tax
expense
|
|
|
(109)
|
|
|
|
-
|
|
Net loss
|
|
$
|
(24,642)
|
|
|
$
|
(11,312)
|
|
|
|
|
|
|
|
|
|
|
Share
information:
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
|
$
|
(1.93)
|
|
|
$
|
(5.49)
|
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
|
|
12,783,523
|
|
|
|
2,059,986
|
|
Comprehensive
loss
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(24,642)
|
|
|
$
|
(11,312)
|
|
Unrealized gain (loss)
on marketable securities
|
|
|
177
|
|
|
|
(158)
|
|
Comprehensive
loss
|
|
$
|
(24,465)
|
|
|
$
|
(11,470)
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Carisma Therapeutics Inc.