Full Press Release Details
Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Highlights
Sub-Study of CT-0508 in combination with KEYTRUDA (pembrolizumab) in patients with HER2-overexpressing solid tumors
manufacturing capacity through successful technology transfer of CT-0508
Closed merger with Sesen Bio and commenced trading on Nasdaq under ticker symbol "CARM"
PHILADELPHIA, PA - May 11, 2023
- 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.
"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."
Anticipated Upcoming Milestones
First Quarter 2023 Financial Results(1)
(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.
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
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
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 | ) |