Candel Therapeutics, Inc. · NASDAQ:CADL
Candel Therapeutics — Investor Day (December 2025)
80 slides from Candel Therapeutics's investor day presentation, Dec 5, 2025
Slide 1: Research & Development Day
RESEARCH & DEVELOPMENT DAY Virtual Event | December 5, 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 o CAN-2409 (aglitimagene besadenovec): Off-the-shelf pan-solid tumor therapy, individualized anticancer immune response • Positive phase 3 randomized placebo-controlled clinical trial in localized, intermediate- to high-risk prostate cancer • Positive overall survival data from ra
Slide 4: Key achievements and anticipated future milestones in clinical programs
Key achievements and anticipated future milestones in clinical programs 2025-2026 BLA filing Updated OS data, New recurrent HGG biomarker data, Phase 1b (Arm C), prostate cancer CAN-3110 Phase 3, Phase 2 (biomarker/ Initiation phase 3 biodistribution), clinical trial, CAN-2409 Updated NSCLC clinical
Slide 5: Leadership team with decades of experience in oncology, immunology, and drug development
Leadership team with decades of experience in oncology, immunology, and drug development Paul Peter Tak, MD, PhD, FMedSci Charles Schoch, MBA, MSA President & Chief Executive Officer Chief Financial Officer Francesca Barone, MD, PhD Garrett Nichols, MD, MS Chief Scientific Officer Chief Medical Offi
Slide 6: Research Advisory Board of premier thought leaders
Research Advisory Board of premier thought leaders James Allison, PhD Edward Benz, MD Henry Brem, MD Roy Herbst, MD, PhD Elizabeth M. Jaffee, MD Chair of the Department of President and CEO Emeritus Director, Department of Chief of Medical Oncology Deputy Director of the Sidney Immunology, MD Anders
Slide 7: R&D Day 2025: Agenda
R&D Day 2025: Agenda 1 Introduction to Candel Therapeutics 11:00–11:10 AM 2 Immuno-oncology: The Next Wave of Innovation 11:10–11:40 AM 3 CAN-2409 for Newly Diagnosed Localized Prostate Cancer 11:40–12:10 PM 4 Road Map to Biologics License Application (BLA) 12:10–12:30 PM 5 Pre-Commercialization Roa
Slide 8: Immuno-Oncology: The Next Wave of Innovation
IMMUNO-ONCOLOGY: THE NEXT WAVE OF INNOVATION James P. Allison, PhD, Nobel Laureate, Regental Professor and Chair of Immunology, and Founding Director of Scientific Programs for the James P. Allison Institute at the University of Texas MD Anderson Cancer Center Carl H. June, MD, Richard W. Vague Prof
Slide 9: CAN-2409 for Newly Diagnosed Localized Prostate Cancer
CAN-2409 FOR NEWLY DIAGNOSED LOCALIZED PROSTATE CANCER Glen Gejerman, MD, Co-chief of Urologic Oncology, Hackensack University Medical Center Philip Kantoff, MD, FASCO, CEO and Co-Founder, Convergent Therapeutics, Past Chairman of Medicine Memorial Sloan Kettering Cancer Center, Jerome and Nancy Koh
Slide 10: Candel is addressing a clear unmet patient need
Candel is addressing a clear unmet patient need The U.S. prostate cancer opportunity for CAN-2409 Clear Unmet Need for Patients Localized LOW INTERMEDIATE HIGH Prostate Incidence 65K 109K 43K Suboptimal Long-term ADT associated with SoC Options severe side effects Benefits of CAN-2409 in Localized P
Slide 11: Target Product Profile for CAN-2409 in intermediate- to high-risk, localized prostate cancer
Target Product Profile for CAN-2409 in intermediate- to high-risk, localized prostate cancer “Off-the-shelf” viral immunotherapy product designed to elicit a broad, potent immune response against solid tumors o Planned indication in newly diagnosed localized prostate cancer in patients with intermed
Slide 12: 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 Valacyclovir Inflammatory Tumor Dendritic cell B-cell mediators antigens Macrophage Fibroblast CAN-2409 Cytotoxic metabolite Thymidine kinase enzyme Valacyclovir CAN-2
Slide 13: Phase 3 clinical trial of CAN-2409 in newly diagnosed prostate cancer
Phase 3 Clinical trial of CAN-2409 in patients with newly diagnosed, intermediate- to high-risk, localized prostate cancer NCT01436968 CAN-2409 + Valacyclovir Primary endpoints (3 injection courses + radiotherapy o Disease-free survival with or without short-course ADT) (time to cancer recurrence or
Slide 14: CAN-2409 is delivered in a routine and well-tolerated outpatient procedure
CAN-2409 is delivered in a routine and well-tolerated outpatient procedure Standard urologic injection procedure Prostate Bladder Images of fluorescently labeled adenoviral vector in freshly resected prostate, demonstrating homogeneous distribution throughout the organ after 4 injections of virus (0
Slide 15: Most patients tolerate intraprostatic injection the same or better than prostate biopsy
Most patients tolerate intraprostatic injection the same or better than prostate biopsy Patient questionnaire substudy (n=32) In total >2000 intraprostatic injections (40% transperineal; 56% transrectal; 4% not reported) “How did you tolerate the study procedure compared to a prostate biopsy?” Trans
Slide 16: CAN-2409 significantly improved disease-free survival (DFS)
CAN-2409 significantly improved disease-free survival (DFS) in newly diagnosed, intermediate- to high-risk prostate cancer Hazard ratio (95% CI): 0.70 (0.52, 0.94), P=0.0155 Median follow-up: 50.3 months (95% CI 45.37, 51.29) CAN-2409 results in 30% risk reduction in disease recurrence (includes dea
Slide 17: CAN-2409 significantly improved prostate cancer-specific DFS
CAN-2409 significantly improved prostate cancer-specific DFS Hazard ratio (95% CI): 0.62 (0.44, 0.87) P=0.0046 38% reduction in risk for prostate cancer-specific disease recurrence (ITT,* n=745) *Intent to treat population. DeWeese TL et al. 2025 ASCO Annual Meeting; May 28, 2025; Chicago, IL. J Cli
Slide 18: CAN-2409: Other key secondary endpoints
CAN-2409: Other key secondary endpoints o Significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir of <0.2 ng/mL in the treatment arm compared with placebo arm • 67.1% vs 58.6%, respectively (P=0.0164) o As expected1, overall survival was similar by treatm
Slide 19: Improved pathological complete response in 2-year biopsies
CAN-2409 significantly improved the rate of pathological complete response in 2-year biopsies compared with 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 with 63.6% in the placebo arm CAN-2409 Placebo To
Slide 20: Positive biopsies ≥2 years after radiotherapy are predictive of metastases and mortality
Positive biopsies ≥2 years after radiotherapy are predictive of metastases and cancer-related mortality after long-term follow-up Patients with a positive prostate biopsy ≥2 years after radiotherapy because of localized cancer had: o 10-fold higher odds of developing biochemical failure (P < 0.00001
Slide 21: Phase 3 primary endpoint achieved, supported by secondary endpoints
Phase 3 clinical trial of CAN-2409 in intermediate- to high-risk, localized prostate cancer: primary endpoint achieved, supported by secondary endpoints o 745-patient randomized trial with treatment arm + placebo arm, focused on disease-free survival (DFS) primary Trial Design endpoint and multiple
Slide 22: CAN-2409 for Newly Diagnosed Localized Prostate Cancer
CAN-2409 FOR NEWLY DIAGNOSED LOCALIZED PROSTATE CANCER Glen Gejerman, MD, Co-chief of Urologic Oncology, Hackensack University Medical Center Philip Kantoff, MD, FASCO, CEO and Co-Founder, Convergent Therapeutics, Past Chairman of Medicine Memorial Sloan Kettering Cancer Center, Jerome and Nancy Koh
Slide 23: Road Map to Biologics License Application (BLA)
ROAD MAP TO BIOLOGICS LICENSE APPLICATION (BLA) Susan Stewart, JD LLM, Candel’s Chief Regulatory Officer Seshu Tyagarajan, PhD, Candel’s Chief Technical and Development Officer Moderator: Andres Maldonado, PhD, H.C. Wainwright & Co.
Slide 24: BLA strategy
BLA strategy BLA on track for submission to FDA in Q4 2026 o iPSP pediatric waiver granted o Priority Review eligible o Expedited Review: Potential for additional reduced review timeline by 1+ more months o Rolling Review eligible o Small business fee waiver request
Slide 25: FDA interactions 2025
FDA interactions 2025 Prostate Lung o RCA Specification/Assay, Type D o EOP2/pre-Ph3 meeting, Type B o RMAT designation granted o Tox and Biodistribution/Shedding Study Proposal, Type D o Comparability Proposal, Type D
Slide 26: CAN-2409 prostate BLA road map: December 5, 2025
CAN-2409 prostate BLA road map: December 5, 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Q2 2026 Q3 2026 Q4 2026 Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Conduct Planned Nonclinical Studies Nonclinical BLA Module 4–Nonclinical Study Reports BLA Modules 2.4 & 2.6 BL
Slide 27: Interactions with FDA about CAN-2409 in prostate cancer
Interactions with FDA about CAN-2409 in prostate cancer RMAT designation granted, allowing for frequent meetings FDA aligned with approach to setting RCA specification FDA aligned with proposed nonclinical toxicology package and clinical biodistribution/shedding study FDA aligned with the analytical
Slide 28: Interactions with FDA about CAN-2409 in NSCLC
Interactions with FDA about CAN-2409 in NSCLC FDA alignment with: Single preclinical Proposed phase 3 toxicology study: registration study Clinical biodistribution Species (mouse); RoA (IV); and shedding plan Contribution of the agents requirement noted—July 2025 prodrug (ip ganciclovir) FDA Guidanc
Slide 29: Manufacturing Update
¢ MANUFACTURING UPDATE CANDEL 4505 THERAPEUTICS
Slide 30: Technical operations (CMC) critical successes, to date
Technical operations (CMC) critical successes, to date GMP1 run successful Assay qualification and validation on track DP fills successful RCA assay development is complete FDA meeting on RCA and Comparability were GMP2 run ongoing currently productive Master cell bank (MCB) and working cell bank Cl
Slide 31: CAN-2409: Anticipated CMC timelines with FDA interactions
CAN-2409: Anticipated CMC timelines with FDA interactions Completed Planned 2023 2024 2025 2026 Type C - CMC Type C - RCA Type D - Comp Comp Filing PD at SAFC PD Conf Eng Run Clin Run 1 Clin Run 2 PPQ Runs 3L, 10L, 50L BLA filing Run (200L) (200L) (200L) (200L) (200L) Process Lock GMP Space GMP1 GMP
Slide 32: CMC progress
CMC progress o 4 large-scale runs + 2 midscale runs ( 3 × 200L runs completed, 2 × 50L runs completed, 1 × 200L run ongoing) Manufacturing o 2 DP fills completed, 3 DP fills scheduled for December/January o Master cell bank and working cell bank vialed, testing ongoing o Commercial viral bank vialed
Slide 33: CMC scale-up on track to support regulatory filings and anticipated launch
CMC scale-up on track to support regulatory filings and anticipated launch Process development and scale-up from 3L to 50L to 200L 2023 Type C Meeting with FDA re: CMC Key areas of progress Alignment on analytical 2024 200L ENG run comparability plan for BLA No additional clinical/non-clin
Slide 34: SAFC manufacturing update
SAFC (Millipore Sigma/Candel's CDMO) manufacturing update Process All activities Small-scale model characterization on track qualification is complete and PPQ readiness is ongoing Showing a collaborative approach to ensure readiness Candel has for meeting BLA timelines They continue to be a person-i
Slide 35: Road Map to Biologics License Application (BLA)
ROAD MAP TO BIOLOGICS LICENSE APPLICATION (BLA) Susan Stewart, JD LLM, Candel’s Chief Regulatory Officer Seshu Tyagarajan, PhD, Candel’s Chief Technical and Development Officer Moderator: Andres Maldonado, PhD, H.C. Wainwright & Co.
Slide 36: Pre-Commercialization Road Map
PRE-COMMERCIALIZATION ROAD MAP Jonathon Mitchell, MSc, Partner, Globe Life Sciences Jacqueline Poot, President, IDEA Pharma Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and CEO Moderator: Andres Maldonado, PhD, H.C. Wainwright & Co.
Slide 37: Benefits of Candel's pre-commercialization model
Benefits of Candel’s pre-commercialization model 1 EXTENSIVE COMMERCIALIZATION EXPERIENCE IN ONCOLOGY 2 MARKET-LEADING PRICING AND MARKET ACCESS CAPABILITIES TO MAXIMIZE VALUE 3 EXPERTISE TO DEFINE CRITICAL STRATEGIES & OPERATIONAL LEVERS TO ENSURE SUCCESS 4 FLEXIBILITY, SHARED RISK, AND POTENTIAL L
Slide 38: Comprehensive commercial work streams for CAN-2409 in prostate cancer
Comprehensive commercial work streams for CAN-2409 in prostate cancer 12- to 18-month commercial road map At launch Strategic Goals Key Activities o HCP/account engagement Go-to-Market execution Planned pre-launch activities o Speaker medical education Ensure a seamless, data- program driven commerc
Slide 39: For patients electing radical therapy, achieving cure was the primary goal
For patients electing to undergo radical therapy, achieving cure was consistently identified as the primary goal of treatment Goals of Treatment 1 "If you were going to rank these, cure is probably the top, and it’s going to be competing with quality of life … I want to live as long as I can, but I
Slide 40: Significant patient burden associated with recurrence
Significant patient burden associated with recurrence, while unmet need for a novel adjunct therapy to improve outcomes was consistently described by physicians and KOLs as “high” or “very high” Factors Contributing to Burden of Recurrence "The impact is pretty profound. It’s very high. Burden of fu
Slide 41: Substantial addressable market in intermediate- to high-risk localized prostate cancer
Substantial (and growing) addressable market opportunity in intermediate- to high-risk, localized prostate cancer - 65,000 patients undergoing RT each year in the US Incidence ~314k 69%2 Note: Incidence of low-risk prostate cancer is decreasing due to increased use of pre-biopsy MRI, likely driving
Slide 42: CAN-2409 product concept generated enthusiasm among physicians
The CAN-2409 product concept generated enthusiasm and excitement among interviewed physicians–with a consistently positive response across customer segments Physician Interest/Excitement in Product Concept (N=30) 0 0 1 2 3 4 5 6 7 8 9 10 A A A A A A A Avg. Academic A A A A A A A ~8.5 Clear enthusias
Slide 43: 100% of physicians considered DFS data clinically meaningful
100% of interviewed physicians considered the DFS primary endpoint data to be clinically meaningful–and roughly 50% viewed it to be transformative Physician Views on Strength & Clinical Meaningfulness of DFS Primary Endpoint Data (N=30) Minimal Modest benefit Incremental but valuable benefit Transfo
Slide 44: Physician feedback suggests potential for strong uptake of CAN-2409
Physician feedback suggests potential for strong uptake of CAN-2409 across risk groups, and adoption of the product as a standard of care in patients receiving RT Physician Anticipated Uptake of CAN-2409 in Their Practice (in Patients Receiving RT) * (N=30) 0%–10% 10%–30% 30%–50% 50%–70% 70%+ Uptake
Slide 45: Benchmarks and payer feedback support an illustrative pricing range
Benchmarks and payer feedback support an illustrative pricing range for CAN-2409 in localized prostate cancer Annual wholesale acquisition cost (WAC) for selected Payer study findings prostate cancer products ~$290k ~$250k o Phase 3 results resonate with payers and purchasers—30% improvement in Medi
Slide 46: CAN-2409 is positioned to succeed in early localized prostate cancer
CAN-2409 is positioned to succeed in early localized prostate cancer High Unmet Need Significant Market Opportunity Candel’s Unique Value Proposition CAN-2409: Off-the-shelf pan-solid tumor therapy, individualized anticancer immune response o Positive Phase 3 randomized placebo-controlled clinical t
Slide 47: Our commercial strategy is anchored in aligned critical success factors
Our commercial strategy is anchored in aligned critical success factors Critical Success Factor 1 Critical Success Factor 2 Critical Success Factor 3 Establish stakeholder belief Optimize distribution, Maximize pricing by in CAN-2409 as a purchase, and reimbursement communicating strong value transf
Slide 48: Anticipated CAN-2409 cross-functional launch readiness and milestone events
Anticipated CAN-2409 cross-functional launch readiness and milestone events 2025 2026 2027 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Clinical/ Oral Oral Long-Term Prostate- Immunological BLA Expected Regulatory Presentation Presentation Survivors Specific Biomarker Submission PDUFA Milestones (ASCO) (AST
Slide 49: Field sales launch strategy to drive rapid penetration
Field sales launch strategy to drive rapid penetration in both community and hospital urologic oncology practices Key Physician Urologist Groups (N=30) 3% o Ensure strong education and awareness around the product concept—including around its ease of use, excellent safety, and demonstrated clinical
Slide 50: Prostate cancer launch expected to create a scalable commercial platform
CAN-2409 prostate cancer anticipated launch expected to create a scalable commercial platform across the pipeline Anchor Transferrable Enterprise leverage launch infrastructure across pipeline o PCa potential launch (CAN- o Regulatory pathways o CAN-2409 NSCLC 2409) builds core o CMC and quality sys
Slide 51: Pre-Commercialization Road Map
PRE-COMMERCIALIZATION ROAD MAP Jonathon Mitchell, MSc, Partner, Globe Life Sciences Jacqueline Poot, President, IDEA Pharma Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and CEO Moderator: Andres Maldonado, PhD, H.C. Wainwright & Co.
Slide 52: CAN-2409 for Immune Checkpoint Inhibitor Refractory Non-Small Cell Lung Cancer
CAN-2409 FOR IMMUNE CHECKPOINT INHIBITOR REFRACTORY NON-SMALL CELL LUNG CANCER Charu Aggarwal, MD, Professor of Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania Roy Herbst, MD, PhD, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology, Yale Can
Slide 53: Phase 2a clinical trial of CAN-2409 + continued ICI in NSCLC
Phase 2a clinical trial of CAN-2409 + continued ICI in stage III/IV NSCLC patients with an inadequate response to ICI Stage 3/4 Cohort 1 March 2025 data Stable disease (after >18 weeks ICI) CAN-2409 and nonresectable NSCLC valacyclovir o Final overall survival data with inadequate (2 courses) respon
Slide 54: 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% Platinum-based 3.9% with premetrexed 11.8% <1% Platinum-based 26.3% 5.3% Former with taxane 46.0% 1%-49% Platinum-based Current >50% and/or other 57.9% Never 19.7% Unknown Unk
Slide 55: CONSORT diagram
CONSORT diagram AE=adverse event.
Slide 56: 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 Median (range), years 67 (43-88) 69 (43-84) Never 7 (9.2%) 4 (8.7%) Sex Former 60 (78.9
Slide 57: 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% of patients o Most treatment-related AEs (TRAEs) (n=73) grade 1-2 Grade: n (%) 1 2 3 4 Total Gastrointestinal disorders o Grade 3 TRAEs in <5% of patient
Slide 58: mOS of 24.5 months after CAN-2409 treatment in NSCLC
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 59: mOS of 21.5 months in progressive disease (Cohort 2)
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 60: CAN-2409 induced long-term, systemic antitumor activity in progressive NSCLC
CAN-2409 induced long-term, systemic antitumor activity in progressive, metastatic NSCLC Abscopal effect, survival >52 months (ongoing) after CAN-2409 treatment As of 20-Oct-2025 40 CAN-2409 1ST injection 30 Target sum (mm) CAN-2409 2nd injection NY-007 (Cohort 2) 74-year-old male, Stage IV nonsquam
Slide 61: Local injection-induced systemic antitumor activity
Local injection-induced systemic antitumor activity Regression of uninjected lesions in ~two-thirds of patients presenting with multiple lesions Abscopal effect Abscopal effect >5% 40 30 31% Number of responses 40% Not abscopal 20 Abscopal 69% 10 60% 0 Across all injection sites o Systemic or abscop
Slide 62: Long tail of survival: 37% alive >2 years
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) Long tail of CAN-2409 survival Time post treatment No. of patients % survivors* >24 months 15 37% >30 months 9 22% >36 month
Slide 63: mOS of 25.4 months in nonsquamous NSCLC (per protocol)
mOS of 25.4 months after CAN-2409 treatment in nonsquamous NSCLC patients with progressive disease despite ICI (per protocol in Cohort 2) Cohort 2 (per-protocol population, nonsquamous NSCLC): Patients with the greatest unmet medical needs and histologic subset most likely to benefit from CAN-2409 m
Slide 64: mOS of 16.7 months in nonsquamous NSCLC (ITT)
mOS of 16.7 months after CAN-2409 in nonsquamous NSCLC patients with progressive disease despite ICI (ITT* in Cohort 2) Cohort 2 (ITT population,* nonsquamous NSCLC) Historical controls: mOS in PD-1 refractory NSCLC with nonsquamous disease with SoC chemo is 9.9–12.3 mos.1,2 mOS 16.7 months n=53 Ove
Slide 65: Positive overall survival data in phase 2a clinical trial of CAN-2409 in NSCLC
Positive overall survival data in phase 2a clinical trial of CAN-2409 in NSCLC Experimental treatment of We observed mOS of 21.5 months CAN-2409 + valacyclovir in in patients with progressive disease NSCLC patients with an inadequate Long tail of survival with 37% at baseline, markedly exceeding res
Slide 66: CAN-2409 for Immune Checkpoint Inhibitor Refractory Non-Small Cell Lung Cancer
CAN-2409 FOR IMMUNE CHECKPOINT INHIBITOR REFRACTORY NON-SMALL CELL LUNG CANCER Charu Aggarwal, MD, Professor of Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania Roy Herbst, MD, PhD, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology, Yale Can
Slide 67: CAN-3110 for Recurrent Glioblastoma
CAN-3110 FOR RECURRENT GLIOBLASTOMA Francesca Barone, MD, PhD, Candel’s Chief Scientific Officer Henry Brem, MD, Professor of Neurosurgery, Johns Hopkins University Moderator: Kemp Dolliver, Brookline Capital Markets
Slide 68: CAN-3110: High-grade glioma opportunity
CAN-3110: High-grade glioma opportunity Prevalence of glioblastoma in the US1 1st Line 2nd Line 3rd Line 16K 12K 7K o Glioblastoma, the most common form of high-grade glioma, is a rare and often deadly cancer1 o Fewer than 10% of patients survive >5 years past initial diagnosis2 o Median overall sur
Slide 69: CAN-3110: Mechanism of action
Candel’s second investigational medicine, CAN-3110: Mechanism of action Please visit https://vimeo.com/822133681 Nestin Nestin expression in tumor cells Promoter induces ICP34.5 expression, resulting in tumor-specific replication ICP34.5 CAN-3110 Virus expands in Nestin- expressing tumor cells, caus
Slide 70: Durable response for 2 years after single injection of CAN-3110
Durable response for 2 years after single injection of CAN-3110 in recurrent glioblastoma (patient died in an accident) Initial lesion Day—262 Day—259 Day—47 Day—30 Day—14 Initial presentation Initial resection Tumor recurrence 2nd subtotal resection Rapid progression Tumor bed injection site Needle
Slide 71: Prolonged survival associated with HSV1 seropositivity
Prolonged survival after CAN-3110 treatment was associated with HSV1 seropositivity HSV2 serology status is not associated with survival. CO×PH Hazard Ratios Ling AL et al. Nature. 2023;623:157-166.
Slide 72: Changes in T-cell fractions and TCRβ diversity correlate with survival
Changes in T-cell fractions and TCRβ diversity correlate with survival after CAN-3110 treatment Tumor TCRβ PBMC TCR Analysis was performed if > 200 ng of DNA could be extracted in pretreatment or post- treatment sample. Ling AL et al. Nature. 2023;623:157-166.
Slide 73: Survival data after repeated administration of CAN-3110
Survival data after repeated administration of CAN-3110 in recurrent glioblastoma (ongoing), suggesting a long tail of survival At the time of data cutoff (8/15/2025), 2 patients were still alive after single CAN-3110 injection after prolonged follow-up (59.2 and 42.4 months, respectively) Patient A
Slide 74: CAN-3110 induced remodeling of the tumor microenvironment
CAN-3110 induced dynamic spatial and temporal remodeling of the tumor microenvironment, where tumor cells are replaced by immune cells Ling AL et al. Sci Transl Med. 2025;17:eadv2881.
Slide 75: CAN-3110 induced HSV-reactive T-cell clones in rGBM
CAN-3110 induced HSV-reactive T-cell clones in rGBM 192 TCRα/β pairs from 169 clonotypes, were reconstructed and screened for antigen specificity Up to 30% of identified TCRs were reactive to CAN-3110. o CD8+ HSV/CAN-3110-reactive TILs enriched in IFNG+LAG3+ T effector cells (FDR <0.2) and displayed
Slide 76: CAN-3110 enhanced HLA-immunopeptidome expression
CAN-3110 treatment enhanced HLA-immunopeptidome expression, including glioma-associated CTAs and tumor-associated antigens o HLA-A, HLA-B, HLA-C, and HLA-DR levels were increased in nearly all post-treatment biopsies o HLA-I–bound immunopeptides were elevated post-treatment o Several upregulated imm
Slide 77: Encouraging safety data, clinical activity, and immunological changes after CAN-3110
Encouraging safety data, clinical activity, and immunological changes after CAN-3110 in recurrent high-grade glioma (glioblastoma) Monotherapy treatment with CAN-3110 in rHGG is well tolerated and associated with doubling of expected median overall survival Immunological changes in the tumor microen
Slide 78: CAN-3110 for Recurrent Glioblastoma
CAN-3110 FOR RECURRENT GLIOBLASTOMA Francesca Barone, MD, PhD, Candel’s Chief Scientific Officer Henry Brem, MD, Professor of Neurosurgery, Johns Hopkins University Moderator: Kemp Dolliver, Brookline Capital Markets
Slide 79: Candel Therapeutics R&D Day 2025: Q&A
CANDEL THERAPEUTICS RESEARCH & DEVELOPMENT DAY 2025: Q&A Kemp Dolliver, Brookline Capital Markets Sudan Loganathan, PhD, Stephens Andres Maldonado, PhD, H.C. Wainwright & Co. Imogen Mansfield, MA, MBA, Cantor Fitzgerald Oliver McCammon, LifeSci Capital John Newman, PhD, Canaccord Genuity Yigal Nocho
Slide 80: Thank You
THANK YOU Candel Research & Development Day December 5, 2025 NASDAQ: CADL