Closed merger with Sesen Bio and commenced
trading on Nasdaq under ticker symbol "CARM"
Cash position as of the closing of the merger
with Sesen Bio provides anticipated operating runway through
2024
PHILADELPHIA, April 4,
2023 /PRNewswire/ -- Carisma Therapeutics Inc.
(Nasdaq: CARM), a clinical-stage biopharmaceutical company focused
on discovering and developing innovative immunotherapies, today
reported financial results for the year ended December 31, 2022 and highlighted recent business
updates.
![(PRNewsfoto/CARISMA Therapeutics Inc.) (PRNewsfoto/CARISMA Therapeutics Inc.)](https://mma.prnewswire.com/media/1219543/Carisma_Therapeutics_Logo.jpg)
"2022 was a transformational year for Carisma as we made
meaningful progress across all areas of our business, including
entering a development collaboration with Moderna, advancing our
lead program CT-0508 in HER2+ solid tumors, and announcing our
merger with Sesen Bio," said Steven
Kelly, President and Chief Executive Officer of Carisma.
"The successful close of the merger and concurrent financing has
further strengthened our foundation, enabling us to continue to
advance our pipeline of important therapies. We look forward to the
multiple potential value inflection points over the next 18 months,
including the completion of our Phase 1 study of CT-0508, as well
as data from clinical trial sub-study of CT-0508 in combination
with pembrolizumab."
Recent Business Highlights
- Completed merger transaction with Sesen Bio in March 2023. Carisma Therapeutics and Sesen
Bio closed the previously announced merger, 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." The combined company will focus on the development of
Carisma's chimeric antigen receptor macrophage (CAR-M) therapies,
which are believed to be the only therapies of their kind with
demonstrated proof of mechanism and safety data in clinical trials.
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.
- Received $105.3 million of
proceeds as a result of completing the merger transaction, which
includes $74.7 million from Sesen Bio
and $30.6 million from a concurrent
financing. The $30.6 million
financing was from a syndicate of investors, including HealthCap,
AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech,
MRL Ventures Fund, the therapeutics-focused corporate venture arm
of Merck & Co., Agent Capital, Solasta, Livzon, Pictet
Alternative Advisors and 4Bio.
- Expanded Scientific Advisory Board (SAB) with additional
expertise in solid tumor immunotherapy development
capabilities. The Company appointed leading solid tumor
immunotherapy expert Padmanee Sharma, MD, PhD 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 VP 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 CSO of External
Research Ventures, Lin Guey, PhD to
Carisma's SAB in February 2023. Dr.
Guey is a leading expert in mRNA therapeutics and oversees
Moderna's partnership with Carisma to develop in vivo CAR-M
therapies.
- Presented new data from Phase 1 clinical trial of CT-0508 at
the Society for Immunotherapy of Cancer (SITC) Annual Meeting in
November 2022. Additional
findings from the CT-0508 CAR-M clinical trial for patients with
advanced metastatic human epidermal growth factor receptor 2 (HER2)
overexpressing solid tumors, supported a favorable safety profile
and demonstrate that CT-0508 has been successfully manufactured
using macrophages obtained from heavily pre-treated, advanced solid
tumor patients and has shown high CAR expression, viability, and
purity.
Anticipated Upcoming Milestones
- Additional data from Group 2 of Carisma's Phase 1 CT-0508 study
expected in the second half of 2023
- Initial data from clinical trial sub-study of CT-0508 in
combination with KEYTRUDA® (pembrolizumab) expected in
the second half of 2023
- Submission of IND application to the FDA for CT-0525, Carisma's
first anti-HER2 CAR-Mono product candidate, expected in the second
half of 2023
- Nomination of additional targets(s) under the Moderna
development collaboration expected in 2023
Fiscal 2022 Financial Results
- Cash, cash equivalents and marketable securities as of
December 31, 2022 were $52.0 million, compared to $28.6 million as of December 31, 2021, and is not inclusive of
proceeds from the merger transaction with Sesen Bio and concurrent
financing, which were completed in March of 2023.
- Moderna collaboration revenues were $9.8
million for the year ended December
31, 2022. The Company began its collaboration with Moderna
in January 2022 and deferred
$47.5 million in revenue from the
Moderna collaboration agreement, which will be recognized in future
periods.
- Research & development expenses were $56.6 million for the year ended December 31, 2022, compared to $34.4 million in 2021. The increase was primarily
due to costs associated with growth and expansion of Carisma's
clinical and pre-clinical activities to support advancing CT-0508
in clinical development and expand research for the Company's
Moderna in vivo research.
- General & administrative expenses were $9.4 million for the year ended December 31, 2022, compared to $6.4 million in 2021, primarily due to costs
associated with the expanded patent portfolio and preparing to
operate as a public company.
- Net loss was $61.2 million for
the year ended December 31, 2022,
compared to net loss of $40.8 million
in 2021, primarily due to increased research and development
expenses, which was partially offset by Moderna collaboration
revenue.
Outlook
Carisma believes that its cash, cash equivalents and marketable
securities of $52.0 million as of
December 31, 2022, in combination
with the net proceeds of $105.3
million from the completion of the merger with Sesen Bio and
concurrent financing, 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. 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
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 biopharmaceutical company
dedicated to developing a differentiated and proprietary cell
therapy platform focused on engineered macrophages, 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, the sufficiency of its cash
resources, 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) the effect of the completion of the merger on
Carisma's business relationships, operating results and business
generally; (iii) the outcome of any legal proceedings related to
the merger agreement or the transactions contemplated thereby; (iv)
Carisma's ability to obtain, maintain and protect its intellectual
property rights related to its product candidates; (v) Carisma's
ability to advance the development of its product candidates under
the timelines it anticipates in planned and future clinical trials;
(vi) Carisma's ability to replicate in later clinical trials
positive results found in preclinical studies and early-stage
clinical trials of its product candidates; (vii) 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; (viii) 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; (ix) changes to
clinical trial designs and regulatory pathways; (x) risks
associated with Carisma's ability to manage expenses; (xii) 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 the Company'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 on March 8, 2023, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company'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.
|
Consolidated Balance
Sheets
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
December 31,
|
Assets
|
2022
|
|
2021
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
24,194
|
|
$
|
28,551
|
|
Marketable
securities
|
|
27,802
|
|
|
—
|
|
Prepaid expenses and
other assets
|
|
2,596
|
|
|
1,235
|
|
|
|
|
|
Total current
assets
|
|
54,592
|
|
|
29,786
|
Property and equipment,
net
|
|
8,628
|
|
|
3,084
|
Right of use assets –
operating leases
|
|
4,822
|
|
|
2,579
|
Deferred financing
costs
|
|
4,111
|
|
|
—
|
|
|
|
|
|
Total assets
|
$
|
72,153
|
|
$
|
35,449
|
|
|
Liabilities, Convertible Preferred Stock and
Stockholders' Deficit
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
$
|
1,728
|
|
$
|
2,322
|
|
Accrued
expenses
|
|
10,361
|
|
|
4,471
|
|
Deferred
revenue
|
|
2,459
|
|
|
—
|
|
Operating lease
liabilities
|
|
3,437
|
|
|
898
|
|
Finance lease
liabilities
|
|
1,162
|
|
|
—
|
|
Other current
liabilities
|
|
523
|
|
|
—
|
|
|
|
|
|
Total current
liabilities
|
|
19,670
|
|
|
7,691
|
Deferred
revenues
|
|
45,000
|
|
|
—
|
Convertible promissory
note
|
|
33,717
|
|
|
—
|
Derivative
liability
|
|
5,739
|
|
|
—
|
Operating lease
liabilities
|
|
976
|
|
|
1,734
|
Finance lease
liabilities
|
|
872
|
|
|
—
|
Other long-term
liabilities
|
|
1,041
|
|
|
—
|
|
|
|
|
|
Total
liabilities
|
|
107,015
|
|
|
9,425
|
|
|
|
|
|
Total convertible
preferred stock
|
|
|
107,808
|
|
|
107,808
|
Stockholders'
deficit:
|
|
|
|
|
|
|
Common stock $0.0001
par value, 14,910,158 shares authorized, 1,167,602
and 1,084,082 shares issued and outstanding at December 31, 2022
and 2021,
respectively
|
|
—
|
|
|
—
|
|
Additional paid-in
capital
|
|
1,199
|
|
|
818
|
|
Accumulated other
comprehensive loss
|
|
(41)
|
|
|
—
|
|
Accumulated
deficit
|
|
(158,223)
|
|
|
(96,997)
|
|
|
|
|
|
Total Carisma
Therapeutics Inc. stockholders' deficit
|
|
(157,065)
|
|
|
(96,179)
|
|
Noncontrolling
interests
|
|
14,395
|
|
|
14,395
|
|
|
|
|
|
Total stockholders'
deficit
|
|
(142,670)
|
|
|
(81,784)
|
|
|
|
|
|
Total liabilities,
convertible preferred stock and stockholders' deficit
|
$
|
72,153
|
|
$
|
35,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CARISMA THERAPEUTICS INC.
|
Consolidated
Statements of Operations
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
|
|
|
|
2022
|
|
2021
|
Collaboration
revenues
|
$
|
9,834
|
$
|
—
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
|
56,618
|
|
34,387
|
|
General and
administrative
|
|
9,378
|
|
6,407
|
|
|
|
Total operating
expenses
|
|
65,996
|
|
40,794
|
|
|
|
Operating
loss
|
|
(56,162)
|
|
(40,794)
|
Change in fair value of
derivative liability
|
|
(1,919)
|
|
—
|
Interest (expense)
income, net
|
|
|
(3,145)
|
|
10
|
Net loss
|
|
|
|
$
|
(61,226)
|
$
|
(40,784)
|
|
|
|
|
|
|
|
|
|
|
|
Share
information:
|
|
|
|
|
Net loss per share of
common stock, basic and diluted
|
$
|
(54.65)
|
$
|
(37.62)
|
Weighted-average shares
of common stock outstanding, basic and diluted
|
|
1,120,390
|
|
1,084,082
|
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SOURCE Carisma Therapeutics Inc.