Carisma Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Highlights
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
"In the first quarter, we closed our merger with
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 inApril 2023 that provided an overview ofCarisma'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 inMarch 2023 . The Company closed its previously announced merger withSesen 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 ofSesen 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 withSesen 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. toCarisma's SAB inJanuary 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 atThe University of Texas MD Anderson Cancer Center . Additionally, the Company appointed Moderna Inc. (Moderna) CSO ofExternal Research Ventures ,Lin Guey , Ph.D. toCarisma's SAB inFebruary 2023 .Dr. Guey is a leading expert in mRNA therapeutics and oversees Moderna's collaboration withCarisma 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 ofDecember 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 theSesen Bio merger, an increase in headcount, costs associated withCarisma'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
Outlook
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
About Carisma Therapeutics
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
Media Contact:
(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) |
||||||||
|
|
|||||||
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 |
40 |
2 |
||||||
Additional paid-in capital |
268,759 |
1,197 |
||||||
Accumulated other comprehensive income (loss) |
136 |
(41) |
||||||
Accumulated deficit |
(182,865) |
(158,223) |
||||||
|
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 |
||||||||
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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