8-K
false 0001966494 0001966494 2024-01-08 2024-01-08

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 8, 2024

 

 

CARGO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41859   84-4080422

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

1900 Alameda De Las Pulgas, Suite 350

San Mateo, California 94403

(Address of principal executive offices) (Zip Code)

(650) 379-6143

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value per share   CRGX   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 


Item 7.01

Regulation FD Disclosure.

On January 8, 2024, CARGO Therapeutics, Inc. (the “Company”) made available a corporate presentation, which it plans to use for meetings with investors and analysts at the 42nd Annual J.P. Morgan Healthcare Conference. A copy of the presentation is being furnished hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit No.   

Description

99.1    CARGO Therapeutics Corporate Presentation
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    CARGO THERAPEUTICS, INC.
Date: January 8, 2024     By:  

/s/ Gina Chapman

      Gina Chapman
      Chief Executive Officer
EX-99.1

Exhibit 99.1 NASDAQ: CRGX ENGINEERING NEXT GENERATION CAR T-CELL THERAPIES TO DELIVER MORE CURES J.P. MORGAN HEALTHCARE CONFERENCE 2024


FORWARD-LOOKING STATEMENTS/Disclaimers ⚫ This presentation contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include the words “believe”, “expect”, “anticipate”, “intend”, “plan”, “estimate”, “project”, “will”, “may”, “targeting” and similar expressions as well as statements other than statements of historical facts including, without limitation, those regarding business strategy, plans, estimated milestones and objectives of the management of the Company. Such forward-looking statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, econo and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing CRG-022 or CRG-023, future results from the Company's ongoing and planned clinical trials, the Company's ability to obtain adequate financing to fund its planned clinical trials and other expenses, trends in the industry, the legal and regulatory framework for the industry and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in the presentation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given. These and other risks are described more fully in CARGO’s filings with the Securities and Exchange Commission (SEC) including its Registration Statement on Form S-1 filed with the SEC on October 10, 2023 (and as subsequently amended) or in other documents CARGO subsequently files with or furnishes to the SEC. CARGO undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations. ⚫ Information in this presentation (including market data and statistical information) has been obtained from various sources (including third-party sources) and the Company does not guarantee the accuracy or completeness of such information. All projections, valuations and statistical analyses are provided for information purposes only. They may be based on subjective assessments and assumptions and may use one among many alternative methodologies that produce different results and to the extent they are based on historical information, they should not be relied upon as an accurate prediction of future performance, and you are cautioned not to give undue weight to them. ⚫ This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the therapeutic use for which such product candidates are being studied. ⚫ The Phase 1 clinical trial for CRG-022 referenced herein was conducted by Stanford using their formulation of CRG-022. The Company has made additional process and analytical improvements to the Stanford process to create the intended commercial manufacturing process for CRG-022 in an effort to improve manufacturing yields and efficiency. 2


CARGO – developing potentially curative cell therapies ⚫ Autologous CAR T revenue in DLBCL is estimated to reach $3.3B by 2030 Transformative and growing CAR T market⚫ Patient access is broadening as more treatment centers offer CAR T (1) ⚫ CRG-022 may address the ~60% of LBCL patients who do not achieve a durable response with CD19 CAR T-cell therapy Significant unmet need (2) ⚫ By 2030, ~7,600 patients expected to need treatment post CD19 CAR T-cell therapy in US/EU4/UK alone post CD19 CAR T ⚫ Positive Phase 1 results in CD19 CAR T R/R LBCL – 53% CR rate with impressive durability and safety CRG-022: targeting ⚫ 120+ patients dosed across multiple clinical trials and CRG-022 was generally well-tolerated CD22, potentially ⚫ Initiated potentially pivotal Phase 2 clinical trial; multiple patients dosed with successful manufacturing to date, pivotal stage leveraging our intended commercial and readily transferable manufacturing process ⚫ Stanford was granted Breakthrough Therapy Designation by FDA ⚫ Leveraging proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate Platform technologies multiple transgene therapeutic “cargo” designed to address mechanisms of resistance and tri-specific ⚫ CRG-023, an IND-enabling stage tri-specific targeting CD19, CD20 and CD22, incorporates first platform, which program integrates a novel CD2 costimulatory domain to counter downregulation of CD58 ⚫ Co-founded in 2021 by globally recognized pioneers and leaders in oncology and cell therapy World class team and ⚫ Seasoned, strong leadership team with deep cell therapy and oncology experience well capitalized ⚫ November 2023 IPO raised approximately $320M gross proceeds, NASDAQ ticker: CRGX Source: Yi-Jiun Su, et al. ASH 2023, Nov’2023 data cutoff (1) (2) Source: Five-year follow-up of ZUMA-1 trial; N Engl J. Med 2017;377:2531-44 DOI: 10.1056/NEJMoa1707447; Clarivate Disease and Landscape Forecasting (NHL, CLL) 2023; US/EU4/UK and CARGO company analysis 3


Pipeline of transformative CAR T-cell therapies to deliver cures - addressing mechanisms of resistance Resistance mechanism Solutions Antigen escape (e.g., CD19) Target Alt Antigen or Multi-specific CAR designs Loss of costimulation (e.g., CD58) CAR-Engineered, CD2 technology Immune rejection of product Human binders Tumor burden, loss of functional persistence Design, lead selection and MFG Potentially pivotal Phase 2 topline data for lead product candidate CRG-022 expected in 2025 Stage of Development IND- Commercial Program Target(s) Indication(s) Discovery Phase 1 Phase 2 Phase 3 enabling rights R/R LBCL - post CD19 CAR T CRG-022 LBCL - CAR T CD22 (1) (CAR T) naïve Pediatric B-ALL CRG-023 CD19 (tri-specific B-cell CD20 CAR T with malignancies CD2 co- CD22 stimulation) (1) Based on data from the Phase 1 clinical trial conducted by Stanford and our ongoing Phase 2 clinical trial in R/R LBCL - post CD19 CAR T, we intend to discuss with the FDA initiation of a Phase 2 program in LBCL - CAR T naïve without completing earlier clinical trials in LBCL - CAR T naïve patients 4


CD19 CAR T-cell therapy: transformative and growing Projected Autologous CAR T Revenue in DLBCL ⚫ Autologous CD19 CAR T-cell 3.5 $3.3B therapies to potentially become Standard of Care for relapsed / 3 refractory Large B-Cell Lymphoma (R/R LBCL) 2.5 ⚫ Recent approvals in earlier lines of therapy and additional 2 geographies anticipated to continue to fuel growth 1.5 $1.3B ⚫ Patient access broadening as more treatment centers offer CAR T and 1 manufacturing challenges are addressed 0.5 0 2022 2026 2030 (projected) (projected) Source: Clarivate Disease and Landscape Forecasting (NHL, CLL) 2022; US/EU4/UK 5 Revenue ($B)


CRG-022 could address a significant and growing unmet need for patients whose disease is R/R to CD19 CAR T-cell therapy 100 ⚫ ~60% of LBCL patients were observed to not achieve a 80 durable response with CD19 (1) CAR T-cell therapy ⚫ High unmet need with no 60 standard of care for post CD19 CAR T patients and poor survival outcomes 40 ⚫ By 2030, approximately 7,600 patients expected to need treatment post CD19 CAR T-cell 20 (2) therapy in US/EU4/UK alone Median PFS (95% CI), months 5.9 (3.3 – 15.0) 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 Months (1) (2) Source: Five-year follow-up of ZUMA-1 trial; N Engl J. Med 2017;377:2531-44 DOI: 10.1056/NEJMoa1707447; Clarivate Disease and Landscape Forecasting (NHL, CLL) 2023; US/EU4/UK and CARGO company analysis 6 Progression-free survival (%)


CRG-022


Phase 1 design: Stanford study of CRG-022 CAR T in R/R LBCL 6 ⚫ DL1: 1 × 10 CD22 CAR+ cells/kg Baseline Characteristics of ⚫ CD19 CAR T Relapsed/ 6 Treated Patients Refractory LBCL⚫ DL2: 3 × 10 CD22 CAR+ cells/kg (N=38) ⚫ 97% progressed after prior CD19 CAR T ⚫ Median age 65 years old ⚫ Median 4 prior lines of therapy ⚫ 76% had DLBCL; 16% double- Key eligibility Conditioning Follow-up hit status CRG-022 dose criteria chemotherapy period ⚫ 84% had elevated lactate dehydrogenase (high tumor burden) Primary Endpoints ⚫ Safety and toxicity (TEAEs) ⚫ Recommended Phase 2 dose ⚫ Fludarabine 30 mg/m² IV⚫ Initial response ⚫ Manufacturing feasibility + assessment: Day +28 Cyclophosphamide 500 mg/m² IV ⚫ Subsequent Key Secondary Endpoints ⚫ Days -5, -4, -3 assessments at Day 90 ⚫ ORR* (investigator-assessed) then every 3 months ⚫ DOR/PFS/OS Abbreviations: CAR19 = anti-CD19 CAR T-cell therapy; R/R = relapsed or refractory; CRG-022 = anti-CD22 CAR T-cell therapy; DL = dose level; RP2D = recommended phase 2 dose; ⚫ Pharmacokinetics TEAE = treatment-emergent adverse events; ORR = overall response rate; DOR = duration of response; PFS = progression free survival; OS = overall survival; ULN = upper limit of normal; Note: Response was classified according to Lugano criteria for LBCL Source: Cheson BD, et al. J Clin Oncol. 2014; 32(27):3059-67; Lee DW, et al. Biol Blood Marrow Transplant. 2019; 25(4):625-38; Frank MJ et al. EHA 2023 8


Phase 1 results: CRG-022 demonstrated potential to be an effective therapy for LBCL patients whose disease is R/R to CD19 CAR T-cell therapy Progression free survival (PFS) Overall survival (OS) Key Takeaways • CR rate: 53% • ORR rate: 68% • CRs typically durable with only 4 of 20 pts who achieved a CR have relapsed LBCL DL1 (n=29) DL2 (n=9) Total (n=38)• Manufacturing success rate: 95% • Dose Level 1 Median follow up, months [range] 27.3 [12.0 – 48.9] 39.8 [35.1 – 43.9] 28.9 [12.0 – 48.9] • 1 million CAR+ cells/kg Overall Response Rate (ORR)*, n (%) 19 (66%) 7 (78%) 26 (68%) • Dose Level 2 CR rate 15 (52%) 5 (56%) 20 (53%) • 3 million CAR+ cells/kg 1 12-mon duration of CR 11/15 (73%) 4/5 (80%) 15/20 (75%) Median OS, months [95% CI] NR (8.4 – NR) 14.1 (1.2 – NR) 14.1 (8.4 – NR) Source: Stanford Phase 1 data presentation at ASH Investigator meeting; Yi-Jiun Su, et al. ASH 2023; Nov’2023 data cutoff Five patients who died of non-relapse causes were in CR at the time of death; 2 of 5 patients were in Dose Level 1 and 3 of 5 patients were in Dose Level 2. 1) 2 patients relapsed. 3 patients died (1 related, 2 unrelated); NR: Not reached 9


Phase 1 results: CRG-022 was generally well-tolerated DLBCL DLBCL Total Parameter Grade 3+ rates DL1 (n=29) DL2 (n=9) n=38 (3) Cytokine Release Syndrome, n (%) Approved CD19 CAR T-cell therapies IEC-HS incidence None 2 (7%) 0 (0%) 2 (5%) • DL1: 7% ZUMA-1 JULIET TRANSCEND Grade 1 13 (45%) 1 (11%) 14 (37%) • DL2: 33% (axi-cel) (tisagen) (liso-cel) • Total: 18% Grade 2 14 (48%) 7 (78%) 21 (55%) Grade ≥3 0 (0%) 1 (11%) 1 (3%) 13% 22% 2% Managed with anakinra and steroids Neurologic Events / ICANS, n (%) Real world incidence of None 26 (90%) 7 (78%) 33 (87%) carHLH with CD19 CARs: • Peds B-ALL: 14.8% Grade 1 2 (7%) 1 (11%) 3 (8%) • DLBCL: 6% Grade 2 1 (3%) 1 (11%) 2 (5%) Grade ≥3 0 (0%) 0 (0%) 0 (0%) 28% 12% 10% Abbreviations: IEC-HS = Immune effector cell HLH-like syndrome; carHLH = Chimeric Antigen Receptor T-Cell-Associated Hemophagocytic Lymphohistiocytosis (1) (2) (3) Source: Hines et al. 2021; Ahmed et al. 2020; Data reported from clinical studies for each approved therapy and not from head-to-head studies with CRG-022. Source: Stanford Phase 1 data analysis shared at ASH 2023 Investigator meeting 10


Potentially pivotal Phase 2 clinical trial of CRG-022 in R/R LBCL Currently enrolling Cohort 1 ⚫ Prior CD19 CAR T-cell therapy (n=81) Conditioning Endpoint chemotherapy Key eligibility criteria Cohort 2 ⚫ Fludarabine + Cyclophosphamide ⚫ R/R LBCL Primary endpoint ⚫ Nonconforming product ⚫ Target CRG-022 cell or dose ⚫ CD22 expression at any ⚫ ORR per PET/CT 6 dose: 1 x 10 CAR+ level cells/kg Cohort 3 ⚫ Prior Bispecific Abs (n=20) (including prior CD19 CAR T) Abbreviations: LBCL = large B-cell lymphoma; R/R = relapsed or refractory; PET/CT = positron emission tomography / computed tomography; ORR = overall response rate; 11


CRG-022: Differentiated CAR-mediated activity and commercially suitable manufacturing process Design: Chimeric antigen receptor (CAR) has Manufacturing: Address Commercial Suitability While differentiated functional potential Maintaining Product Comparability Infusion Apheresis collection Automated fill/finish & cryopreservation Apheresis (cryopreservation) T cell enrichment Optimized expansion (optimized cell CD22 Binder and costim seeding density) Unique Target to domain Suspension-based lentiviral transduction address CD19 Beneficial antigen-independent antigen loss signaling & enhanced persistence *Source: Ereno-Orbea J, et al (2021) J Biol Chem 297(2): 100966; Singh N, et al (2021) Nat Med 27(5):842 12 BioRender


Pipeline & platform overview


CARGO’s pipeline: CRG-023, Tri-Specific CAR T targeting CD19, CD20, CD22 In Vivo, Mouse Xenograft Lymphoma Model • 3 distinct CARs. Each with unique co-stimulatory domains, including 1 CAR with novel CD2 co-stim • Expressed from 1 vector • New Hu scFv binders for CD19, 20. • 1000s of constructs screened Model: 14


Seasoned leadership team with significant oncology and cell therapy experience Gina Chapman Anup Radhakrishnan Ginna Laport, MD Shishir Gadam, PhD President & Chief Executive Officer Chief Financial Officer & Chief Medical Officer Chief Technical Officer Chief Business Officer Michael Ports, PhD Kari Leetch Halley Gilbert, JD Bethany Rogers Chief Scientific Officer Chief People Officer Chief Legal Officer SVP, Product Strategy & Commercialization 15


CARGO – focused on developing and delivering potentially curative cell therapies Strong financial position and significant value Key takeaways inflection points ⚫ Raised $320M in gross proceeds November 2023 ⚫ Impressive Phase 1 results of CRG-022 in CD19 CAR T R/R P LBCL following IPO ⚫ Initiation of Phase 2 for CRG-022 August 2023 ⚫ Currently enrolling potentially pivotal Phase 2 clinical trial, P with topline data expected in 2025 in LBCL R/R CD19 ⚫ Interim Phase 2 results for 2025 (expected) ⚫ Developed strong commercial and readily transferable manufacturing process for all clinical trials CRG-022 in LBCL R/R CD19 ⚫ Leveraging proprietary cell engineering platform technologies to develop a pipeline of programs ⚫ Seasoned, strong leadership team ⚫ Total cash at hand (as of 31 Dec 2023): $406M *Includes Series A Tranche 3 Note: As of May 3, 2023 data cutoff date 16


Thank you