CARGO Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
CARGO Therapeutics (NASDAQ: CRGX) reported Q3 2024 financial results and business updates. The company has dosed 57 patients in its Phase 2 FIRCE-1 study of firi-cel, with interim analysis expected in 1H25. Their cash position stands at $404.8 million, projected to fund operations through 2026. Q3 financial results show R&D expenses of $35.9 million and G&A expenses of $11.2 million, with a net loss of $41.9 million ($0.88 per share). The company plans to submit an IND for CRG-023 in Q1'25 and will present pre-clinical data at ASH 2024. CFO Anup Radhakrishnan has been appointed as COO while retaining his CFO role.
CARGO Therapeutics (NASDAQ: CRGX) ha pubblicato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali. L'azienda ha trattato 57 pazienti nello studio di fase 2 FIRCE-1 con firi-cel, con un'analisi intermedia prevista per la prima metà del 2025. La loro posizione di liquidità ammonta a 404,8 milioni di dollari, prevista per finanziare le operazioni fino al 2026. I risultati finanziari del terzo trimestre mostrano spese in R&D di 35,9 milioni di dollari e spese generali e amministrative di 11,2 milioni di dollari, con una perdita netta di 41,9 milioni di dollari (0,88 dollari per azione). L'azienda prevede di presentare un IND per CRG-023 nel primo trimestre del 2025 e presenterà dati preclinici all'ASH 2024. Il CFO Anup Radhakrishnan è stato nominato COO mantenendo anche il suo ruolo di CFO.
CARGO Therapeutics (NASDAQ: CRGX) ha informado sobre los resultados financieros del tercer trimestre de 2024 y novedades comerciales. La compañía ha tratado a 57 pacientes en su estudio de fase 2 FIRCE-1 con firi-cel, con un análisis intermedio esperado para la primera mitad de 2025. Su posición de efectivo asciende a 404,8 millones de dólares, proyectada para financiar operaciones hasta 2026. Los resultados financieros del tercer trimestre muestran gastos en I+D de 35,9 millones de dólares y gastos generales de 11,2 millones de dólares, con una pérdida neta de 41,9 millones de dólares (0,88 dólares por acción). La compañía planea presentar un IND para CRG-023 en el primer trimestre de 2025 y presentará datos preclínicos en ASH 2024. El CFO Anup Radhakrishnan ha sido nombrado COO, manteniendo su papel como CFO.
CARGO Therapeutics (NASDAQ: CRGX)는 2024년 3분기 재무 결과 및 비즈니스 업데이트를 발표했습니다. 이 회사는 firi-cel의 2상 FIRCE-1 연구에서 57명의 환자를 투여했으며, 중간 분석은 2025년 상반기에 예상됩니다. 그들의 현금 상태는 4억 4백만 달러로, 2026년까지 운영 자금을 지원할 것으로 예상됩니다. 3분기 재무 결과는 R&D 비용이 3천590만 달러, 일반 관리 비용이 1천120만 달러로 나타났으며, 순손실은 4천190만 달러(주당 0.88달러)입니다. 이 회사는 2025년 1분기에 CRG-023에 대한 IND를 제출할 계획이며, ASH 2024에서 전임상 데이터를 발표할 것입니다. CFO Anup Radhakrishnan은 COO로 임명되었으며 CFO로서의 역할도 유지하고 있습니다.
CARGO Therapeutics (NASDAQ: CRGX) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur ses activités. La société a traité 57 patients dans son étude de phase 2 FIRCE-1 sur firi-cel, avec une analyse intérimaire prévue pour la première moitié de 2025. Leur position de liquidités s'élève à 404,8 millions de dollars et est projetée pour financer les opérations jusqu'en 2026. Les résultats financiers du troisième trimestre montrent des dépenses de R&D de 35,9 millions de dollars et des dépenses générales et administratives de 11,2 millions de dollars, avec une perte nette de 41,9 millions de dollars (0,88 dollar par action). La société prévoit de soumettre un IND pour CRG-023 au premier trimestre 2025 et présentera des données précliniques lors de l'ASH 2024. Le CFO Anup Radhakrishnan a été nommé COO tout en conservant son rôle de CFO.
CARGO Therapeutics (NASDAQ: CRGX) hat die Finanzzahlen für das dritte Quartal 2024 und Unternehmensaktualisierungen veröffentlicht. Das Unternehmen hat 57 Patienten in der Phase-2-Studie FIRCE-1 mit firi-cel behandelt, wobei eine Zwischenanalyse für die erste Hälfte von 2025 erwartet wird. Die Liquiditätsposition beträgt 404,8 Millionen Dollar, was voraussichtlich ausreicht, um die Aktivitäten bis 2026 zu finanzieren. Die Finanzzahlen für das dritte Quartal weisen Forschung und Entwicklungskosten von 35,9 Millionen Dollar und allgemeine Verwaltungskosten von 11,2 Millionen Dollar aus, mit einem Nettoverlust von 41,9 Millionen Dollar (0,88 Dollar pro Aktie). Das Unternehmen plant, im ersten Quartal 2025 einen IND für CRG-023 vorzulegen und wird präklinische Daten auf der ASH 2024 präsentieren. CFO Anup Radhakrishnan wurde zum COO ernannt und behält gleichzeitig seine Rolle als CFO.
- Strong cash position of $404.8 million, sufficient through 2026
- Successfully dosed 57 patients in Phase 2 FIRCE-1 study
- IDMC recommended continuation of FIRCE-1 study without modifications
- Successful pre-IND meeting with FDA for CRG-023
- Net loss of $41.9 million in Q3 2024
- Increased R&D expenses to $35.9 million in Q3
- G&A expenses rose to $11.2 million in Q3
Insights
The Q3 results reveal a robust financial position with
The burn rate appears well-managed given the company's clinical stage and multiple programs. Stock-based compensation of
The clinical progress shows strong execution with 57 patients dosed in the FIRCE-1 study for firi-cel, a potential breakthrough in treating relapsed/refractory large B-cell lymphoma. The IDMC's recommendation to continue without modifications signals positive safety profile. The development of CRG-023, their tri-specific CAR T candidate, demonstrates pipeline expansion with promising preclinical data showing durable anti-tumor activity against multiple targets.
The successful pre-IND meeting with FDA for CRG-023 indicates regulatory alignment. The planned presentations at ASH will be important for validating the technology platform. The manufacturing success in the FIRCE-1 study is particularly noteworthy, as manufacturing challenges often plague cell therapy development.
- 57 patients dosed in the potentially pivotal Phase 2 clinical study, FIRCE-1 of firicabtagene autoleucel (firi-cel); on track for interim analysis in 1H25 -
- CRG-023 pre-clinical data to be presented at ASH 2024; IND submission anticipated Q1’25 with Phase 1 initiation planned for 2025 -
- Anup Radhakrishnan, CFO of CARGO Therapeutics, appointed as COO and CFO -
SAN CARLOS, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (NASDAQ: CRGX), a clinical-stage biotechnology company positioned to advance next-generation, potentially curative cell therapies for cancer patients, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.
“We are pleased to report another quarter of strong execution underscored by continued progress in our FIRCE-1, Phase 2 study of firi-cel in addition to meaningful pipeline advancements,” said Gina Chapman, President and Chief Executive Officer of CARGO. “With 57 patients dosed and continued, strong manufacturing success, we remain on track to report our interim analysis in the first half of 2025. We also anticipate a clear path forward to advancing CRG-023, our innovative tri-specific CAR T product candidate, into the clinic following our successful pre-IND meeting with the FDA and we are excited to share more at the upcoming ASH meeting.”
Chapman continued, “I’d also like to recognize Anup Radhakrishnan on his appointment to Chief Operating Officer in addition to his current role as CFO. Anup has been instrumental in transforming CARGO from a private to public company, including establishing and scaling our corporate infrastructure, achieving operational excellence, leading our successful IPO, and overseeing our corporate and capital formation strategies. His leadership over the years has not only enabled our progress and execution across our programs but also positioned CARGO for future growth.”
Corporate Highlights
- Firi-cel:
- Currently 57 patients have been dosed across all cohorts with strong manufacturing success in the FIRCE-1, Phase 2 clinical study of firi-cel in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy.
- The Independent Data Monitoring Committee (IDMC) completed its safety and futility assessment during the third quarter and recommended the continuation of the FIRCE-1 study without modification.
- CARGO expects to complete its interim analysis and report the results in the first half of 2025.
- CRG-023:
- During the third quarter, CARGO completed a successful pre-Investigational New Drug (IND) meeting with the FDA, obtaining guidance on the development program and the data package to be provided in the IND.
- IND application submission for CRG-023 in Non-Hodgkin’s lymphoma anticipated in the first quarter of 2025; first patient dosed planned for 2025.
- CARGO will present CRG-023 pre-clinical data at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The abstract cites CRG-023 construct design as well as pre-clinical data demonstrating durable anti-tumor activity following repeated challenge from tumor cells expressing all three antigens (CD19, CD20, CD22), sustained tumor clearance when only a single antigen is expressed, and robust in vivo, anti-lymphoma activity in low CAR T dose levels.
- Corporate:
- CARGO today announced the appointment of Anup Radhakrishnan, Chief Financial Officer (CFO), as Chief Operating Officer (COO) and CFO. In this role, Mr. Radhakrishnan will continue to oversee CARGO's financial and business strategy, while also providing operational leadership to drive the execution of CARGO's strategic goals across the enterprise.
Third Quarter 2024 Financial Highlights
- Cash Position: As of September 30, 2024, our cash, cash equivalents and marketable securities were
$404.8 million , which we believe will be sufficient to fund our expected operations through 2026. - Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2024 were
$35.9 million and$103.9 million , respectively, which included$1.9 million and$5.2 million of non-cash stock-based compensation expenses, respectively. - General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2024 were
$11.2 million and$33.3 million , respectively, which included$3.0 million and$7.9 million of non-cash stock-based compensation expenses, respectively. - Net Loss: Net loss for the three and nine months ended September 30, 2024 was
$41.9 million , or$0.88 per share, and$122.1 million , or$2.77 per share, respectively, including non-cash stock-based compensation of$4.9 million and$13.1 million , respectively.
About CARGO Therapeutics
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next- generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating firicabtagene autoleucel (firi-cel), an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical study in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO has developed proprietary cell engineering platform technologies which it leverages to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. This includes the CRG-023 program, which incorporates a novel tri-specific CAR T with CD2 co-stimulation that is designed to provide more patients across a broad range of B-cell malignancies with durable responses by addressing several known causes of relapse, resulting in a potential best-in-class CAR T-cell therapy. CARGO’s leadership and team have significant experience in developing, engineering, manufacturing, and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress, advancement, and results of CARGO’s clinical and preclinical programs; the potential benefits of CARGO’s product candidates; the timing of data reports, including the release of interim data from CARGO’s ongoing Phase 2 clinical trial of firi-cel; CARGO’s strategic plans for its business and product candidates; and CARGO’s expectations that its current cash, cash equivalents and marketable securities will be sufficient to fund its expected operations through 2026. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates and the product candidates involving novel technologies; clinical and preclinical development being a lengthy and expensive process with uncertain outcomes; interim, “topline” and preliminary data from the company’s clinical trials and preclinical studies as well as any favorable data from trials conducted by third-parties, including Stanford University or the NCI, may not be replicated in the company’s clinical trials or predictive of future results; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers, including CROs; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to CARGO’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 to be filed on or about the date hereof. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. CARGO’s results for the three and nine months ended September 30, 2024 are not necessarily indicative of its operating results for any future periods.
| CARGO Therapeutics, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 35,932 | $ | 22,233 | $ | 103,893 | $ | 48,724 | ||||||||
| General and administrative | 11,180 | 6,478 | 33,343 | 13,030 | ||||||||||||
| Total operating expenses | 47,112 | 28,711 | 137,236 | 61,754 | ||||||||||||
| Loss from operations | (47,112 | ) | (28,711 | ) | (137,236 | ) | (61,754 | ) | ||||||||
| Other income (expense), net | 5,204 | (6,760 | ) | 15,169 | (4,316 | ) | ||||||||||
| Net loss | $ | (41,908 | ) | $ | (35,471 | ) | $ | (122,067 | ) | $ | (66,070 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on marketable securities | 958 | — | 635 | — | ||||||||||||
| Comprehensive loss | $ | (40,950 | ) | $ | (35,471 | ) | $ | (121,432 | ) | $ | (66,070 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.88 | ) | $ | (47.37 | ) | $ | (2.77 | ) | $ | (98.15 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 47,664,309 | 748,862 | 44,014,886 | 673,175 | ||||||||||||
| CARGO Therapeutics, Inc. Condensed Balance Sheet Data (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 71,176 | $ | 405,732 | ||||
| Marketable securities | 333,672 | — | ||||||
| Other assets | 46,113 | 47,304 | ||||||
| Total assets | $ | 450,961 | $ | 453,036 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Liabilities | $ | 50,083 | $ | 47,650 | ||||
| Stockholders’ equity | 400,878 | 405,386 | ||||||
| Total liabilities and stockholders’ equity | $ | 450,961 | $ | 453,036 | ||||
Contacts
Media Contact:
Kimberly Muscara
kimberly@redhousecomms.com
Investor Contact:
Jessica Serra
jserra@cargo-tx.com
Laurence Watts
laurence@newstreetir.com
FAQ
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