Slide 1: CAN-2409 in Localized Prostate Cancer: Overview of Phase 3 Top-line Data
Exhibit 99.2 CAN-2409 in Localized Prostate Cancer: Overview of Phase 3 Top-line Data th Wednesday, December 11 , 2024
Slide 2: Disclaimers and forward-looking statements
Disclaimers and forward-looking statements This presentation and the accompanying discussion contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the expectations regardin
Slide 3: Opening Remarks
Opening Remarks Paul Peter Tak CEO, Candel Therapeutics 3
Slide 4: Candel presents statistically significant and clinically meaningful phase 3 data for localized prostate cancer
Candel presents statistically significant and clinically meaningful phase 3 clinical trial data for localized prostate cancer Phase 3 top-line data in intermediate / high risk, localized prostate cancer • 745-patient randomized trial with treatment arm + placebo arm, focused on disease-free survival
Slide 5: Intermediate / High Risk, Localized Prostate Cancer Unmet Need & Candel's Approach
Intermediate / High Risk, Localized Prostate Cancer Unmet Need & Candel’s Approach 5
Slide 6: Candel is addressing a potential $10bn+ market with clear unmet need
Candel is addressing a potential $10bn+ market with clear unmet need The prostate cancer opportunity for CAN-2409 Substantial U.S. Addressable Market Clear Unmet Need for Patients Opportunity Sub-optimal • Long-term ADT associated with SoC Localized LOW INTERMEDIATE HIGH severe side effects Options
Slide 7: CAN-2409: Mechanism of Action
CAN-2409: Mechanism of Action 1. CAN-2409 locally 4. Local immunization yields administered and oral prodrug systemic anti-tumor response Inflammatory Tumor Dendritic cell T-cell Valacyclovir mediators antigens Macrophage Fibroblast Cytotoxic metabolite CAN-2409 Thymidine kinase enzyme Valacyclovir
Slide 8: CAN-2409 synergizes with radiotherapy in a mouse model of prostate cancer
CAN-2409 treatment synergizes with radiotherapy in a mouse model of prostate cancer Uninjected lung metastases Model of prostate cancer: PBS= phosphate buffer (control) RM-1 cells in C57BL/6 mice XRT= radiation therapy ( 5Gy) 10 CAN-2409 = 3x 10 pfu +prodrug Injected flank tumor Decrease in injected
Slide 9: Target product profile for CAN-2409 in intermediate / high risk, localized prostate cancer
Target product profile for CAN-2409 in intermediate / high risk, localized prostate cancer “Off-the-shelf” immunotherapy product designed to elicit a broad, potent immune response against solid tumors • Planned indication in newly diagnosed localized prostate cancer in patients with intermediate- to
Slide 10: CAN-2409 is delivered in a routine and tolerable procedure
CAN-2409 is delivered in a routine and tolerable procedure (1) Patient questionnaire substudy (n=32) Standard urologic injection procedure “How did you tolerate the study procedure as compared to Tolerability of study procedure a prostate biopsy?” compared to prostate biopsy • Routine outpatient pro
Slide 11: Intermediate / High Risk, Localized Prostate Cancer Overview of Top-line Phase 3 Data
Intermediate / High Risk, Localized Prostate Cancer Overview of Top-line Phase 3 Data 11
Slide 12: Phase 3 trial of CAN-2409 in newly diagnosed intermediate / high risk localized prostate cancer
Phase 3 clinical trial of CAN-2409 in patients with newly diagnosed, intermediate / high risk, localized prostate cancer PIs: Dr. T. DeWeese (JHU) and Dr. P. Scardino (MSKCC) NCT01436968 Primary Endpoints o Disease-free survival (time to CAN-2409 + Valacyclovir cancer recurrence or death due (3 inje
Slide 13: Disease-free survival: primary endpoint to capture treatment effect
Disease-free survival: primary endpoint to capture treatment effect in early localized prostate cancer Disease-free survival (DFS) Date of randomization to date of recurrence proven by biopsy, clinical or radiographic evidence of local or regional failure, distant metastases, or death from any cause
Slide 14: CONSORT diagram
CONSORT diagram 2:1 randomized to CAN-2409 vs. placebo Patients screened (N=774 ) Screen failures (N=29) Randomized (N=745) Randomized to CAN-2409 Randomized to placebo + prodrug (N=496 ) + prodrug (N=249) Randomized not treated Randomized not treated (n=17) (n=17) Incomplete treatment Incomplete tr
Slide 15: Demographics/baseline characteristics of randomized patients
Demographics/baseline characteristics of randomized patients Total ITT population (N=745) CAN-2409 + prodrug (N=496) Placebo + prodrug (N=249) (N=745) Median age (yrs) 69 68 69 Race, n(%) White/Caucasian 385 (77.6) 206 (82.7) 591 (79.3) Black/African American 93 (18.8) 28 (11.2) 121 (16.2) Asian 3 (
Slide 16: CAN-2409 top-line readout exceeds KOL expectations
CAN-2409 top-line readout exceeds KOL expectations KOL expectations on DFS ahead of Ph3 Candel Ph3 top-line data top-line data • Ph3 trial 90% powered to detect a 15% relative If you hit a 5 –10% improvement in disease-free difference between active and placebo arms survival, then that’s going to be
Slide 17: CAN-2409 improved DFS in newly diagnosed, intermediate/high-risk prostate cancer
CAN-2409 improved DFS in newly diagnosed, intermediate/high-risk prostate cancer (ITT population, N=745) Estimated DFS rate at 54 months shows a 14.5% relative improvement in the CAN-2409 treatment arm compared to control arm Hazard ratio (95% CI): 0.70 (0.52, 0.94) p=0.0155 17 Note: Disease-free su
Slide 18: CAN-2409 significantly improves pathological complete response in 2 year biopsies
CAN-2409 significantly improves the rate of pathological complete response in 2 year biopsies compared to the placebo control arm Pathological complete response was observed in 80.4% of the biopsies available at 2 years in the CAN-2409 arm CAN-2409 Placebo • 451 post-treatment biopsies centrally rev
Slide 19: CAN-2409 improves DFS in key subgroups
CAN-2409 improves DFS in key subgroups Subgroups Number of patients Hazard Ratio (95% CI) Race Age Ethnicity Severity ADT Usage Severity & ADT Usage ß FAVORS CAN-2409 19
Slide 20: CAN-2409 improves prostate-specific outcomes
CAN-2409 improves prostate-specific outcomes (ITT population, N=745) Highly significant 38% reduction in risk for prostate cancer recurrence or prostate cancer-related death Hazard ratio (95% CI): 0.62 (0.44, 0.87) P=0.0046 20 (1) As per Globe Life Sciences (January 2021). Note: Disease-free surviva
Slide 21: CAN-2409: summary of key secondary endpoints
CAN-2409: summary of key secondary endpoints • Significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir of <0.2 ng/ml in the treatment arm compared to the placebo • 67.1% vs. 58.6%, respectively (p=0.0164) • Freedom from PSA failure numerically lower in CA
Slide 22: CAN-2409 with SoC radiation +/-ADT was generally well tolerated
CAN-2409 in combination with SoC radiation +/-ADT was generally well tolerated Treatment related AEs >5% in either arm Preferred term CAN-2409+prodrug Placebo+prodrug Total Chills, fever, flu-like symptoms were (N=479) (N=232) (N=711) commonly mild to moderate and self Chills 160 (33.4) 20 (8.6) 180
Slide 23: Active Surveillance, Localized Prostate Cancer Candel's Approach and Overview of Phase 2b Results
Active Surveillance, Localized Prostate Cancer Candel’s Approach and Overview of Phase 2b Results 23
Slide 24: Phase 2b of CAN-2409 in low/intermediate risk prostate cancer on active surveillance
Phase 2b of CAN-2409 in low/intermediate risk, localized prostate cancer undergoing active surveillance demonstrated a consistent safety profile, but did not meet statistical significance • 190 patient randomized trial with treatment arm + placebo arm, focused on primary endpoint progression- free s
Slide 25: Closing Remarks
Closing Remarks Paul Peter Tak CEO, Candel Therapeutics 25
Slide 26: Summary of today's announcement
Summary of today’s announcement Phase 3 prostate cancer clinical trial demonstrated statistically significant and clinically meaningful improvement in DFS for CAN-2409 plus SoC radiotherapy CAN-2409 showed a highly significant effect on prostate cancer-specific outcomes (prostate cancer recurrence o
Slide 27: Candel Therapeutics key milestones in 2025
Candel Therapeutics key milestones in 2025 Expected Milestones in 2025 Expected Timing CAN-2409 ✓ Phase 3 readout for intermediate / high risk, localized prostate cancer✓ Q4’24 • Final OS data for non-small cell lung cancer (NSCLC)• Q1’25 • Final OS data for pancreatic ductal adenocarcinoma (PDAC)•
Slide 28: Appendix
Appendix > CANDEL 28
Slide 29: Primary endpoint DFS event summary
Primary endpoint DFS event summary 2:1 randomized to CAN-2409 vs. placebo CAN-2409+ Placebo+ Disease-Free Survival Total prodrug prodrug (DFS) (N=745) (N=496) (N=249) Patients with DFS event (n) 113 (22.8%) 76 (30.5%) 189 (25.4%) Positive biopsies 67 (13.5%) 51 (20.5%) 118 (15.8%) Treatment failure
Slide 30: Prostate-specific DFS event summary
Prostate-specific DFS event summary 2:1 randomized to CAN-2409 vs. placebo CAN-2409+ Placebo+ Summary of Disease-Free Survival Total prodrug prodrug (DFS) (N=745) (N=496) (N=249) Patients with DFS event 82 (16.5%) 62 (24.9%) 144 (19.3%) Positive biopsies 67 (13.5%) 51 (20.5%) 118 (15.8%) Treatment f
Slide 31: CAN-2409 in Non-Small Cell Lung Cancer (NSCLC)
CAN-2409 in Non-Small Cell Lung Cancer (NSCLC) 31
Slide 32: CAN-2409: Non-small cell lung cancer unmet need
CAN-2409: Non-small cell lung cancer unmet need o Lung cancer is the most commonly diagnosed cancer in the US with NSCLC representing over 80% of all lung 1 2 Incident advanced NSCLC in the US cancer diagnoses o Majority of NSCLC patients without actionable mutations st are treated with immune check
Slide 33: mOS of 20.6 months after CAN-2409 treatment in NSCLC patients
mOS of 20.6 months after CAN-2409 treatment in NSCLC patients with progressive disease despite immune checkpoint inhibitor (cohort 2) Cohort 2 Median overall survival: 20.6 mos (13.7, NA) Median follow-up: 20.6 mos mOS in this population is <12 months using SoC Reckamp K et al. J Clin Onc 2022;40:22
Slide 34: Local injection induces systemic anti-tumor activity
Local injection induces systemic anti-tumor activity Evidence of abscopal effect, survival > 30 months (ongoing) after CAN-2409 treatment NY-007 (Cohort 2) 74M, Stage IV non-squamous NSCLC diagnosed Feb’19 PD-L1 <1% Initial therapy: cisplatin/etoposide Feb-Jul’19 Maintenance: nivolumab from Sep’19,
Slide 35: Immune activation after CAN-2409 is associated with prolonged survival
nd Immune activation after 2 CAN-2409 administration is associated with prolonged survival nd Changes in immune cells after 2 CAN-2409 injection ≥24 months <24 months Multiparameter flow cytometry Fold changes between 1st and 2nd injection in short (< 24 months; n=9) and long (> 24 months; n=4) surv
Slide 36: Encouraging safety data, clinical activity and immunological changes in NSCLC
Encouraging safety data, clinical activity and immunological changes demonstrated with CAN-2409 in NSCLC o Experimental treatment of CAN-2409 + valacyclovir in NSCLC patients with an inadequate response to ICI is feasible and well tolerated, and results in median overall survival (mOS) of 22.0 month
Slide 37: CAN-2409 in Pancreatic cancer
CAN-2409 in Pancreatic cancer 37
Slide 38: CAN-2409: Pancreatic ductal adenocarcinoma unmet need
CAN-2409: Pancreatic ductal adenocarcinoma unmet need Incidence of pancreatic ductal o Limited available treatment options for patients 1 adenocarcinoma in the US by risk level suffering from pancreatic cancer beyond resection when possible and chemotherapy o Borderline resectable disease: median ov
Slide 39: Overall survival in borderline resectable PDAC patients
Overall survival in borderline resectable PDAC patients Data as of 3/29/2024 Time since enrollment Alive (A) Surgical pStage Date of last OS mo OS mo PCN Arm / Dead (enrollment) (diagnosis) result # follow-up (D) 71.4% 2022PIN C Unresected IV 6/16/2020 10.6 17.2 D OS rate at 24,months 2072PIN C Unre
Slide 40: CAN-2409 induces lymphocyte aggregates, tumor disruption, and necrosis in PDAC
CAN-2409 induces formation of dense lymphocyte aggregates, disruption of tumor structures, and necrosis in PDAC Baseline biopsies Follow-up resections High magnification of follow-up Control Liver metastasis Cancer cells * * * * Test arm Pancreas resection Immune cells * * * * * Pancreas resection I
Slide 41: Encouraging safety data, clinical activity and immunological changes in pancreatic cancer
Encouraging safety data, clinical activity and immunological changes demonstrated with CAN-2409 in pancreatic cancer o Notable improvements in estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in control group o At 24 months, survival