FREDERICK, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the third quarter of 2024, and provided business and corporate updates.
“As we approach the end of what has been a year of tremendous progress for Cartesian, we remain focused on advancing our innovative pipeline as we strive toward our mission to extend the potential of cell therapy to patients with autoimmune diseases,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Notably, for our lead Descartes-08 program in MG, we expect to share additional data from our Phase 2b trial and the design of our upcoming Phase 3 trial by the end of the year. With a growing body of clinical evidence supporting the potential for Descartes-08 to serve as a meaningful addition to the MG treatment landscape, we are encouraged by our recent interaction with FDA regarding our plans for a Phase 3 program in MG and plan to initiate the trial in the first half of 2025.”
Dr. Brunn continued, “In addition to our MG development program, enrollment remains ongoing in our Phase 2 trial of Descartes-08 in patients with SLE, and we also remain on track to file an IND application for a pediatric basket study of Descartes-08 by year-end. Beyond Descartes-08, enrollment also continues in our first-in-human Phase 1 trial of Descartes-15, our next-generation autologous anti-BCMA mRNA CAR-T product candidate.”
Recent Pipeline Progress and Anticipated Milestones
Descartes-08 in Generalized Myasthenia Gravis (MG)
Descartes-08 in Systemic Lupus Erythematosus (SLE)
Descartes-08 in Additional Indications
Descartes-15 Program
Corporate Updates
Third Quarter 2024 Financial Results
About Descartes-08
Descartes-08, Cartesian’s lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, mRNA CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.
About Cartesian Therapeutics
Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is an mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and Phase 2 development for systematic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter.
Forward Looking Statements
Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expectation to initiate a Phase 3 trial in myasthenia gravis in 2025, the Company’s plan to release the myasthenia gravis Phase 3 trial design by the end of 2024, observations and data from the myasthenia gravis Phase 2b trial, the Company’s expectation to share additional data from the Descartes-08 myasthenia gravis Phase 2b trial by the end of 2024, the Company’s plan to file an IND application for a pediatric basket trial of Descartes-08 by the end of 2024, the ability of Descartes-08 or Descartes-15 to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the ability of Descartes-15 to have predictable and controllable pharmacokinetics, the likelihood of the Company qualifying for a priority review voucher and receiving priority review, the potential of the Company’s technology to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, Juvenile Dermatomyositis, multiple myeloma, or any other disease, the amount and occurrence of any payments to holders of the Company’s contingent value rights, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to consummate any expected agreements and licenses and to realize the anticipated benefits thereof, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law.
| Cartesian Therapeutics, Inc. and Subsidiaries Consolidated Balance Sheets (Amounts in thousands, except share data and par value) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 219,198 | $ | 76,911 | |||
| Accounts receivable | 4,829 | 5,870 | |||||
| Unbilled receivables | 980 | 2,981 | |||||
| Prepaid expenses and other current assets | 4,129 | 4,967 | |||||
| Total current assets | 229,136 | 90,729 | |||||
| Non-current assets: | |||||||
| Property and equipment, net | 10,225 | 2,113 | |||||
| Right-of-use asset, net | 13,523 | 10,068 | |||||
| In-process research and development assets | 150,600 | 150,600 | |||||
| Goodwill | 48,163 | 48,163 | |||||
| Long-term restricted cash | 1,669 | 1,377 | |||||
| Investments | 2,000 | 2,000 | |||||
| Total assets | $ | 455,316 | $ | 305,050 | |||
| Liabilities, convertible preferred stock, and stockholders’ deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 517 | $ | 3,150 | |||
| Accrued expenses and other current liabilities | 9,452 | 15,572 | |||||
| Lease liability | 2,770 | 2,166 | |||||
| Deferred revenue | — | 2,311 | |||||
| Warrant liabilities | 5 | 720 | |||||
| Contingent value right liability | 8,661 | 15,983 | |||||
| Forward contract liabilities | — | 28,307 | |||||
| Total current liabilities | 21,405 | 68,209 | |||||
| Non-current liabilities: | |||||||
| Lease liability, net of current portion | 11,881 | 8,789 | |||||
| Deferred revenue, net of current portion | — | 3,538 | |||||
| Warrant liabilities, net of current portion | 3,586 | 5,674 | |||||
| Contingent value right liability, net of current portion | 401,839 | 342,617 | |||||
| Deferred tax liabilities, net | 15,853 | 15,853 | |||||
| Total liabilities | 454,564 | 444,680 | |||||
| Series A Preferred Stock, $0.0001 par value; no and 548,375 shares authorized as of September 30, 2024 and December 31, 2023, respectively; no and 435,120.513 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | — | 296,851 | |||||
| Options for Series A Preferred Stock | — | 3,703 | |||||
| Stockholders’ deficit: | |||||||
| Series A Preferred Stock, $0.0001 par value; 180,455.753 and no shares authorized as of September 30, 2024 and December 31, 2023, respectively; 166,341.592 and no shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | — | — | |||||
| Series B Preferred Stock, $0.0001 par value; 437,927 and no shares authorized as of September 30, 2024 and December 31, 2023, respectively; 437,927 and no shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | — | — | |||||
| Preferred stock, $0.0001 par value; 9,381,617.247 and 9,451,625 shares authorized as of September 30, 2024 and December 31, 2023, respectively; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 | — | — | |||||
| Common stock, $0.0001 par value; 350,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 23,896,525 and 5,397,597 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | 2 | 1 | |||||
| Additional paid-in capital | 687,174 | 179,062 | |||||
| Accumulated deficit | (681,818 | ) | (614,647 | ) | |||
| Accumulated other comprehensive loss | (4,606 | ) | (4,600 | ) | |||
| Total stockholders’ equity (deficit) | 752 | (440,184 | ) | ||||
| Total liabilities, convertible preferred stock, and stockholders’ deficit | $ | 455,316 | $ | 305,050 | |||
| Cartesian Therapeutics, Inc. and Subsidiaries Consolidated Statements of Operations and Comprehensive Income (Loss) (Amounts in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (Unaudited) | |||||||||||||||
| Revenue: | |||||||||||||||
| Collaboration and license revenue | $ | — | $ | 6,551 | $ | 39,111 | $ | 17,738 | |||||||
| Grant revenue | 387 | — | 561 | — | |||||||||||
| Total revenue | 387 | 6,551 | 39,672 | 17,738 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,400 | 13,002 | 33,799 | 49,408 | |||||||||||
| General and administrative | 6,562 | 6,614 | 23,039 | 18,414 | |||||||||||
| Total operating expenses | 17,962 | 19,616 | 56,838 | 67,822 | |||||||||||
| Operating loss | (17,575 | ) | (13,065 | ) | (17,166 | ) | (50,084 | ) | |||||||
| Investment income | 2,573 | 1,299 | 4,932 | 4,024 | |||||||||||
| Foreign currency transaction, net | — | (3 | ) | — | 39 | ||||||||||
| Interest expense | — | (1,273 | ) | — | (2,833 | ) | |||||||||
| Change in fair value of warrant liabilities | 5,669 | 3,787 | 2,803 | 6,049 | |||||||||||
| Change in fair value of contingent value right liability | (15,100 | ) | — | (51,900 | ) | — | |||||||||
| Change in fair value of forward contract liabilities | — | — | (6,890 | ) | — | ||||||||||
| Other income, net | 250 | 253 | 1,050 | 753 | |||||||||||
| Net loss | $ | (24,183 | ) | $ | (9,002 | ) | $ | (67,171 | ) | $ | (42,052 | ) | |||
| Other comprehensive income (loss): | |||||||||||||||
| Foreign currency translation adjustment | (15 | ) | (20 | ) | (6 | ) | (69 | ) | |||||||
| Unrealized gain on marketable securities | — | — | — | 11 | |||||||||||
| Total comprehensive income (loss) | $ | (24,198 | ) | $ | (9,022 | ) | $ | (67,177 | ) | $ | (42,110 | ) | |||
| Net loss per share: | |||||||||||||||
| Basic and diluted | $ | (1.13 | ) | $ | (1.74 | ) | $ | (4.61 | ) | $ | (8.20 | ) | |||
| Weighted-average common shares outstanding: | |||||||||||||||
| Basic and diluted | 21,471,408 | 5,160,150 | 14,561,613 | 5,129,030 | |||||||||||
Investor Contact
Blaine Davis
Chief Financial Officer
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Media Contact
David Rosen
Argot Partners
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| Last Trade: | US$18.76 |
| Daily Change: | -1.03 -5.20 |
| Daily Volume: | 60,534 |
| Market Cap: | US$476.690M |
November 05, 2024 September 09, 2024 | |
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