SAN CARLOS, Calif., May 28, 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 announced that the company will be participating in the following investor conferences. TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA Gina Chapman, President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat on Tuesda ...

SAN CARLOS, Calif., May 28, 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 announced that the company will be participating in the following investor conferences. TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA Gina Chapman, President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat on Tuesda ...

– Financing includes participation from new and existing investors – – Supports BLA preparation for potentially pivotal Phase 2 study, FIRCE-1 of firicabtagene autoleucel (firi-cel) (CRG-022) and IND-enabling studies for CRG-023 – – Extends cash runway through 2026 – SAN CARLOS, Calif., May 28, 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 announced ...

Investors might want to bet on CARGO Therapeutics, Inc. (CRGX) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Individual ...

CARGO Therapeutics, Inc. (CRGX) closed the last trading session at $20.05, gaining 5.5% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $31.33 indicates a 56.3% upside potential. The average comprises three short-term price targets ranging from a low of $30 to a high of $32, with a standard deviation of $1.15. While the lowest estimate indicates an increase of 49.6% from the curren ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________to ____________ Commission File Number: 001-41859 CARGO Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 84-4 ...

Exhibit 99.1 – 26 sites activated and over 20 patients dosed in the potentially pivotal Phase 2 clinical study, FIRCE-1 of firicabtagene autoleucel (firi-cel) (CRG-022); Currently on-track for interim results expected in 1H25 – - Ongoing follow-up from the Stanford Phase 1 study for firi-cel 1to be presented at the 2024 European Hematology Association (EHA) Congress, highlighting median overall survival of 25.7 months and favorable safety profile at the dose level selected for CARGO's Phase 2 Study - "We're ...

Financial Performance - The company incurred a net loss of $98.1 million for the year ended December 31, 2023, compared to a net loss of $41.0 million for 2022, resulting in an accumulated deficit of $145.1 million as of December 31, 2023[213]. - The company has no products approved for commercial sale and has not generated any revenue from product sales since its inception in December 2019[213]. - The company has incurred significant costs associated with building its organization and platform technologies, which may impact future profitability[214]. - The company anticipates significant commercialization expenses if any product candidates receive regulatory approval, including costs related to manufacturing and supply chain management[222]. - The company will require additional funding to finance operations and may need to seek additional capital sooner than planned due to various factors[220]. Research and Development - The company expects its expenses and operating losses to continue to increase substantially as it expands research and development efforts and conducts clinical trials[215]. - The company’s ability to achieve profitability is uncertain and depends on successful clinical trials and regulatory approvals[217]. - The company focuses its limited resources on specific product candidates and platform technologies, which may lead to missed opportunities for potentially more profitable options[252]. - The development of engineered T cell therapy is a key focus, but the company faces challenges in predicting development timelines and costs due to the novel nature of its technologies[254]. - The company must conduct extensive clinical trials to demonstrate safety and efficacy before obtaining regulatory approval[306]. Regulatory and Compliance Risks - The company has identified material weaknesses in its internal control over financial reporting, which could adversely affect investor confidence[212]. - The regulatory landscape for cell therapy products is complex and subject to change, potentially leading to delays or increased costs in obtaining approvals[300]. - The FDA has established the Office of Therapeutic Products to consolidate the review of cell therapy products, which may lengthen the regulatory review process[301]. - Non-compliance with regulatory requirements could lead to severe penalties, including product recalls or withdrawal from the market[355][358]. - The company must adhere strictly to FDA regulations regarding marketing and promotion, with significant liability risks for off-label promotion[359][360]. Clinical Trials and Development Challenges - The company has not yet completed a clinical trial for any of its product candidates, indicating limited experience in this area[306]. - Delays in clinical trials can arise from various factors, including regulatory approvals, patient enrollment challenges, and the need for additional studies[309]. - Patient enrollment is critical and may be hindered by competition from other companies targeting the same diseases[317]. - Adverse side effects from product candidates could lead to delays in approval or even abandonment of clinical trials[318]. - Interim data from clinical trials may change as more patient data become available, potentially impacting business prospects[328]. Market and Competitive Landscape - The company operates in a highly competitive industry, which may result in competitors developing products more successfully[212]. - The biotechnology and pharmaceutical industries are highly competitive, with significant competition from larger companies and academic institutions[247]. - The company faces challenges in attracting and retaining qualified personnel due to intense competition in the biotechnology sector[245]. - Market opportunity estimates may be overly optimistic, with potential patient populations being smaller than anticipated due to various factors[264]. - Product candidates may not gain market acceptance even if approved, affecting revenue generation and overall business performance[266]. Intellectual Property and Licensing - The company relies on intellectual property licensed from third parties, which is critical for its business operations and product development[402]. - The company has licensed intellectual property from notable institutions such as NCI, Oxford, and Stanford University, which imposes various obligations including milestone payments and royalties[403]. - Failure to comply with licensing agreements could result in significant damages and loss of rights, adversely affecting the company's ability to commercialize its product candidates[404]. - The complexity of licensing agreements may lead to disputes that could materially affect the company's financial condition and operational results[409]. - The company is dependent on licensors to maintain and enforce patents, and any failure in this regard could hinder its ability to develop and commercialize products[410]. Strategic and Operational Risks - The company relies on third parties for clinical trials and manufacturing, and any failure by these parties could delay development programs[212]. - The company does not own manufacturing facilities and depends on third-party manufacturers for the production of its product candidates, increasing the risk of supply disruptions[389]. - There are no noncancellable long-term commitments with third-party manufacturers, which raises the risk of failing to obtain sufficient quantities of product candidates[392]. - The company actively evaluates strategic transactions to acquire technologies and enhance its product pipeline, which involves risks such as unanticipated liabilities and integration difficulties[277]. - Future acquisitions may lead to dilutive equity issuances, incurrence of debt, or impairments that could harm the company's financial condition[280].

Financial Performance - CARGO Therapeutics completed an IPO raising approximately $291.0 million in net proceeds[2] - As of December 31, 2023, CARGO had $405.7 million in cash and cash equivalents, expected to fund operations through 2025[11] - Research and development expenses for Q4 2023 were $27.1 million, totaling $75.8 million for the full year[11] - General and administrative expenses for Q4 2023 were $7.9 million, totaling $20.9 million for the full year[12] - The net loss for Q4 2023 was $32.1 million, or $1.49 per share, with a total net loss of $98.1 million for the year, or $16.53 per share[13] - CARGO's total assets increased to $453.0 million as of December 31, 2023, compared to $10.2 million in 2022[17] Clinical Development - The Phase 2 clinical study FIRCE-1 for firi-cel is currently enrolling at 20 sites, with interim results expected in 1H 2025[1][8] - In a Phase 1 study, firi-cel demonstrated a 52% complete response rate in patients with R/R large B-cell lymphoma[9] - The company plans to evaluate firi-cel in earlier stages of disease, including LBCL and other hematologic malignancies[4] Market Position - CARGO was added to the Russell 2000® Index on March 15, 2024[2]

– Potentially pivotal Phase 2 clinical study FIRCE-1 of firicabtagene autoleucel (CRG-022) is rapidly recruiting with 20 sites open to date; interim results expected 1H 2025 – SAN MATEO, Calif., March 21, 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 provided a business update and reported financial results for the quarter and year ending December 3 ...