Candel Therapeutics, Inc. · NASDAQ:CADL
Candel Therapeutics — Investor Presentation (March 2025)
47 slides from Candel Therapeutics's investor presentation, Mar 27, 2025
Slide 1: Tipping the balance in favor of the immune system to fight cancer
Exhibit 99.2 Tipping the balance in favor of the immune system to fight cancer Corporate Presentation | March 2025 NASDAQ: CADL
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including express or implied statements regarding our
Slide 3: Candel at a glance
Candel at a glance • Positive phase 3 randomized, triple-blinded, placebo-controlled, clinical trial of CAN-2409 in intermediate-to-high-risk, localized prostate cancer • Positive overall survival data from randomized phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal ade
Slide 4: CAN-2409: Mechanism of action
CAN-2409: Mechanism of action 1. CAN-2409 locally administered combined with oral prodrug 3. CAN-2409 induces CD8+ cytotoxic T cells Inflammatory Tumor Dendritic cell B-cell Valacyclovir mediators antigens Macrophage Fibroblast CAN-2409 Cytotoxic metabolite Thymidine kinase enzyme Valacyclovir CAN-2
Slide 5: CAN-2409: Replication-defective adenoviral gene construct for in situ vaccination
CAN-2409: Replication-defective adenoviral gene construct engineered for in situ vaccination against pan-solid tumors o Monotherapy activity of CAN-2409 in NSCLC o > 1,000 patients dosed patient: Nearly 50% decrease in tumor o Fast Track Designation in prostate cancer, volume in 3 weeks non-small ce
Slide 6: CAN-2409 Lung Cancer
CAN-2409 Lung Cancer Phase 2a clinical trial of CAN-2409 + continued immune checkpoint inhibitor (ICI) in stage III/IV NSCLC patients with an inadequate response to ICI Enabling work underway for anticipated phase 3 clinical trial (Protocol development, Scientific and Regulatory Advisory Boards, eng
Slide 7: CAN-2409: Non-small cell lung cancer opportunity
CAN-2409: Non-small cell lung cancer opportunity 1 NSCLC cancer therapy global market was estimated to be $32B in 2023 and is expected to grow to $52B by 2028 2 Incidence of advanced NSCLC in the US o Lung cancer is most common cancer in the US; NSCLC representing over 80% of all lung cancer 3 (70-7
Slide 8: Positive overall survival data in phase 2a NSCLC clinical trial
Positive overall survival data in phase 2a NSCLC clinical trial o Experimental treatment of CAN-2409 + valacyclovir in NSCLC patients with an inadequate response to (1) ICI was well tolerated, with median overall survival (mOS) of 24.5 months after only two administrations o We observed mOS of 21.5
Slide 9: Phase 2a clinical trial of CAN-2409 + continued ICI in stage III/IV NSCLC
Phase 2a clinical trial of CAN-2409 + continued ICI in stage III/IV NSCLC patients with an inadequate response to ICI Stage III/IV Cohort 1 non-resectable CAN-2409 and Stable Disease (after >18 wks ICI) March 2025 data NSCLC with valacyclovir o Final overall survival data inadequate (2 courses) o Lo
Slide 10: Bronchoscopic delivery of CAN-2409 extends existing care for NSCLC patients
Bronchoscopic delivery of CAN-2409 is an extension of existing care for NSCLC patients Most lung and thoracic lymph node lesions are accessible through outpatient bronchoscopic injection o Therapeutic delivery tool based on extensive experience with bronchoscopic biopsy, a routine outpatient procedu
Slide 11: CONSORT diagram
CONSORT diagram 11 AE= Adverse Events
Slide 12: Baseline demographics and characteristics
Baseline demographics and characteristics: Per protocol population is representative of overall study population Enrolled Per protocol Enrolled Per protocol n=76 (%) n=46 (%) n=76 (%) n=46 (%) Age Smoking History Never 7 (9.2%) 4 (8.7%) Median (Range) 67 years (43-88) 69 years (43-84) Former 60 (78.
Slide 13: Study population: unfavorable prognostic factors at baseline
Study population: unfavorable prognostic factors at baseline PDL-1 expression Smoking Prior lines of therapy 5.3% 9.2% 13.2% 3.9% 11.8% 26.3% 5.3% 46.0% 57.9% 19.7% 78.9% 22.4% <1% 1-49% >50% Unknown Former Current Never Platinum-based Platinum-based Platinum-based with pemetrexed with taxane and/or
Slide 14: CAN-2409 demonstrated a generally favorable safety and tolerability profile
CAN-2409 demonstrated a generally favorable safety and tolerability profile Most common treatment-emergent related adverse events occurring in ≥ 5% patients, n=73 Grade: n (%) 1 2 3 4 Total Gastrointestinal disorders Diarrhoea 5 (7) 0 (0) 0 (0) 0 (0) 5 (7) Nausea 11 (15) 4 (5) 0 (0) 0 (0) 15 (21) Vo
Slide 15: mOS of 24.5 months in NSCLC patients with inadequate response to ICI
mOS of 24.5 months after CAN-2409 treatment in NSCLC patients with an inadequate response to immune checkpoint inhibitors (cohort 1 and cohort 2) Cohort 1 + Cohort 2 (per protocol population) mOS 24.5 months n=46 Median f/u: 32.4 mos Per protocol population: patients who received complete treatment
Slide 16: mOS of 21.5 months in NSCLC patients with progressive disease despite ICI
mOS of 21.5 months after CAN-2409 treatment in NSCLC patients with progressive disease despite immune checkpoint inhibitor (cohort 2) Cohort 2 (per protocol population): Patients with the greatest unmet medical needs mOS 21.5 months n=41 Median f/u: 32.4 mos Per protocol population: patients who rec
Slide 17: Durable tumor regression and long-term survival after CAN-2409
Large, growing lung mass with durable post-treatment tumor regression and long-term survival after CAN-2409 treatment (survival > 41 months, ongoing) ST CAN-2409 1 injection PA-003 (Cohort 1) 120 73-year-old male, Stage III non-squamous NSCLC diagnosed nd CAN-2409 2 injection 110 January 2020, PD-L1
Slide 18: Long-term systemic anti-tumor activity in progressive, metastatic NSCLC
CAN-2409 induced long-term, systemic anti-tumor activity in progressive, metastatic NSCLC Abscopal effect, survival > 44 months (ongoing) after CAN-2409 treatment 40 ST CAN-2409 1 injection NY-007 (Cohort 2) 74-year-old male, Stage IV non-squamous NSCLC diagnosed nd 30 CAN-2409 2 injection February
Slide 19: Local injection induced systemic anti-tumor activity
Local injection induced systemic anti-tumor activity Regression of uninjected lesions in ~two-thirds of patients presenting with multiple lesions Abscopal effect Abscopal effect >5% 31% 40% 69% 60% Across all injection sites o Systemic or abscopal effect (decrease of uninjected lesions) was measured
Slide 20: Long tail of survival in progressive NSCLC
Long tail of survival: 37% of patients alive > 2 years after CAN-2409 administration in patients with progressive NSCLC at time of enrollment Cohort 2 (per protocol population) (1) Long tail of CAN-2409 survival Time post treatment N. Patients % survivors >24 months 15 37% >30 months 9 22% >36 month
Slide 21: Towards a precision medicine approach: non-squamous vs squamous NSCLC
Towards a precision medicine approach: Non-squamous (~70-75%) and squamous PD(L)-1 refractory NSCLC (~25- 30%) are distinct disease subsets with a differential response to treatment 1 Survival by histology in TROPION-Lung01 study Survival by histology in CAN-2409 treated patients 16.7 14.6 12.3 HR 0
Slide 22: Non-squamous NSCLC differential immunological response to CAN-2409
Towards a precision medicine approach: Non-squamous NSCLC is characterized by differential immunological response to CAN-2409 nd Changes after 2 CAN-2409 injection Squamous Non-squamous Non-switched memory B cells PDL1+ CD1c+CD14+ DCs Non-switched CD8 T Naive memory B cells Patients with non-squamou
Slide 23: mOS of 25.4 months in non-squamous NSCLC patients
mOS of 25.4 months after CAN-2409 treatment in non-squamous NSCLC patients with progressive disease despite ICI (per protocol in cohort 2) Cohort 2 (per protocol population, non-squamous NSCLC): Patients with the greatest unmet medical needs and histologic subset most likely to benefit from CAN-2409
Slide 24: mOS of 16.7 months in non-squamous NSCLC (ITT)
mOS of 16.7 months after CAN-2409 in non-squamous NSCLC patients with progressive disease despite ICI (ITT* in cohort 2) Cohort 2 (intention to treat population*, non-squamous NSCLC) Historical controls: mOS in PD-1 refractory NSCLC with non-squamous disease 1,2 with SoC chemo is 9.8 – 11.8 mos mOS
Slide 25: CAN-2409 Pancreatic Cancer
CAN-2409 Pancreatic Cancer Off-the-shelf therapy, individualized cancer response Enabling work underway (Protocol development, Scientific and Regulatory Advisory Boards, engagement with FDA) 25
Slide 26: CAN-2409: Pancreatic ductal adenocarcinoma opportunity
CAN-2409: Pancreatic ductal adenocarcinoma opportunity 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 o
Slide 27: Overall survival in borderline resectable PDAC patients
Overall survival in borderline resectable PDAC patients Data as of 2/20/2025 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% OS rate at 2022PIN C Unresected IV 6/16/2020 10.6 17.2 D 24 mo 2072PIN C Unresect
Slide 28: CAN-2409 increased post progression survival in pancreatic cancer
CAN-2409 increased post progression survival in pancreatic cancer Data as of 2/20/2025 Median survival post progression (months) Survival Survival post progression Patient post progression Patient (months) (months) 21.2 2162PLB 1.6 2092POS 0 2102PLB 6.5 2072PIN 3.1 2182PLB 17.9 2052PLB 5.6 2192PIN 2
Slide 29: CAN-2409 Prostate Cancer
CAN-2409 Prostate Cancer Preparatory activities underway for BLA submission and potential commercialization 29
Slide 30: Candel is addressing a potential $10B+ market with a clear unmet need
Candel is addressing a potential $10B+ market with a clear unmet need The potential 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 effec
Slide 31: Phase 3 trial in localized prostate cancer: primary endpoint achieved
Phase 3 clinical trial of CAN-2409 in intermediate-to-high risk, localized prostate cancer: primary endpoint achieved • 745-patient randomized trial with treatment arm + placebo arm, focused on disease-free survival (DFS) primary Trial Design endpoint and multiple secondary endpoints • Statistically
Slide 32: Target product profile for CAN-2409 in 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 33: CAN-2409 is delivered in a routine and well-tolerated procedure
CAN-2409 is delivered in a routine and well-tolerated 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 outpatien
Slide 34: Phase 3 trial design in 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 35: 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 36: CAN-2409 with 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 (1) (N=479) (N=232) (N=711 ) commonly mild to moderate and self limited Chills 160 (33.4)
Slide 37: CAN-2409 significantly improved DFS in prostate cancer
CAN-2409 significantly improved DFS in newly diagnosed, intermediate / high-risk prostate cancer (ITT, N=745): 30% decrease in disease recurrence median follow-up 50.3 months (CI 45.37, 51.29) Hazard ratio (95% CI): 0.70 (0.52, 0.94) p=0.0155 37 Note: Disease-free survival (DFS) represents time to c
Slide 38: CAN-2409 significantly improves prostate-specific outcomes
CAN-2409 significantly improves prostate-specific outcomes (ITT, N=745): 38% risk reduction Hazard ratio (95% CI): 0.62 (0.44, 0.87) P=0.0046 38 (1) As per Globe Life Sciences (January 2021). Note: Disease-free survival (DFS) represents time to cancer recurrence or death due to any cause Disease-Fre
Slide 39: CAN-2409: other key secondary endpoints
CAN-2409: other 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) • Only 2 deaths due to prostate cancer over 10+ years (
Slide 40: Improved 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 compared to 63.6% in the placebo group CAN-2409 Placebo • 45
Slide 41: Positive biopsies after radiotherapy predict metastases and mortality
Positive biopsies ≥ 2 years after radiotherapy are predictive of metastases and cancer-related mortality after long-term follow up Meta-analysis showed that patients with a positive prostate biopsy ≥ 2 years after radiotherapy because of localized cancer had • 10-fold higher odds of developing bioch
Slide 42: Comprehensive commercial workstreams for CAN-2409 in prostate cancer
Comprehensive commercial workstreams for CAN-2409 in prostate cancer 12-18 month commercial roadmap At launch Key Activities Strategic Goals • HCP / account engagement execution Go-To-Market Planned pre-launch • Speaker medical Ensure a seamless, data- education program activities driven commerciali
Slide 43: Payor feedback indicates strong support for reimbursement
Payor feedback indicates strong support for reimbursement for CAN-2409 Key Factors Driving Coverage Pivotal trial design meets standard – delivering on proposed level of efficacy in Disease-Free Survival (while further maintaining a strong U.S. Payor Feedback safety profile) will weigh heavily in CA
Slide 44: Benchmarks support illustrative $150-250k annual pricing range
Benchmarks for currently commercialized prostate cancer drugs support illustrative $150-250k annual pricing range $260k Annual Wholesale Acquisition Cost (WAC) for Prostate Cancer $229k $211k $195k Median: $193k $193k $173k $166k $157k $132k PSMA-targeted Cell-based Microtubule Novel Antiandrogens P
Slide 45: Payor mix and direct feedback support broad market access
Payor mix and direct feedback support broad market access Payor Feedback Other ~5% “ … There are a couple of interesting things with this product that Traditional Commercial set it apart from medications we don’t cover in oncology … the Medicare ~35% avoidance of ADT is great, it could almost be lik
Slide 46: Multiple milestones achieved over just last months
Multiple milestones achieved over just last 3 months Product Indication Recent Milestones Achieved What’s Next ✓ Localized Prostate Cancer Phase 3 – Positive Data BLA submission by Q4 2026 (Dec. 2024) Phase 2a – Positive Biomarker ✓ CAN-2409 Non-Small Cell Lung Cancer (NSCLC) and Final Overall Survi
Slide 47: Candel at a glance
Candel at a glance • Positive phase 3 randomized, triple-blinded, placebo-controlled, clinical trial of CAN-2409 in intermediate-to-high-risk, localized prostate cancer • Positive overall survival data from randomized phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal ade
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