Candel Therapeutics : CADL AUA Investor Call final deck 3PM 5.14.26 IR

Published: 2026-05-15 11:47:11 ET CADL

Published on 05/15/2026 at 11:47 am EDT

Extended Data from Phase 3 Trial of Aglatimagene Besadenovec in Localized Prostate Cancer

May 15, 2026 NASDAQ: CADL

Introduction G Welcome

Dr. Paul Peter Tak, CEO | 5 mins

Data Presentation

Dr. Garrett Nichols, CMO | 10 mins

Panel Discussion

Moderated by Dr. Paul Peter Tak, CEO | 20 mins

Panelists: Dr. Steven Finkelstein, Dr. Daniel George, Dr. Neal Shore

Live ǪGA

Financial analyst community | 25 mins

Extended follow-up shows accumulating benefit for patients treated with aglatimagene besadenovec (CAN-2409) + prodrug in combination with standard-of-care external beam radiation (EBRT) in men with localized prostate cancer: update from a randomized placebo-controlled phase 3 clinical trial

Mark Garzotto, John Sylvester, Thomas Wheeler, Thomas Schroeder, Glen Gejerman, Gregory Chesnut, Thomas Facelle, Ronald Tutrone, Christopher Pieczonka, Michael A. Liss, Stephen J. Savage, Bryan Mehlhaff, Steven Sukin, Maximiliano Sorbellini, Jenessa Vogt, Shangbang Rao, Maria Lucia Silva Polanco, Andrea Manzanera, Francesca Barone, Garrett Nichols, Theodore L. DeWeese, Paul P. Tak

Presented by: Mark Garzotto, MD

Professor of Urology and Radiation Medicine Oregon Health & Science University Portland VAMC

DATA CUTOFF: MAR 15, 2026

Disclosures

Dr. Garzotto has served as a clinical trial investigator for Astellas Pharma, Candel Therapeutics, Merck & Co., and Pfizer. He also served as a consultant to Candel Therapeutics

Unmet need in localized prostate cancer

INTERMEDIATE RISK

109K

HIGH RISK

43K

Incidence in US2

LOW RISK

65K

Patients Currently Receiving Radiotherapy

~65K (~43%)

Ultimate goal of curative treatment is prevention of cancer recurrence

while minimizing treatment related side effects and maintaining quality of life3

1 WHO cancer fact sheet. February 3, 2022

2 Siegel RL et al., CA Cancer J Clin. 2025 Jan: 75:10-45

3 Eastham JA et al. J Urol. 2026;22:101097JU0000000000005060

Mark Garzotto, MD | AUA 2026, Washington DC.

Intratumoral gene

delivery

Aglatimagene is a replication-defective adenoviral vector

delivering HSV-TK to tumor cells, minimizing systemic toxicity

It is administered with an oral prodrug for local activation

Prodrug activation

HSV-TK converts prodrug

into cytotoxic metabolites that are incorporated into DNA in tumor cells undergoing proliferation or repair

Radiotherapy synergy

Radiation synergizes with

aglatimagene through induction of DNA damage and activation of the tumor microenvironment (TME)

Anti-tumor

immune priming

Tumor cell death releases

antigens and danger signals, while viral particles promote activation of local and recruited immune cells

Local and systemic

disease control

Tumor-specific T cells

maintain local disease control and establish a new state of immunosurveillance

Aglatimagene plus prodrug combined with radiotherapy enhances immune priming, culminating in local disease control and a new state of immunosurveillance

Mark Garzotto, MD | AUA 2026, Washington DC.

Aglatimagene besadenovec injection procedure

PR O C ED UR E S T EPS

Patient Position

Position: knee-chest (lateral) or lithotomy, as in standard TRUS-

guided biopsy

Approach: transrectal or transperineal - both acceptable

Setting: in-office or ASC; local block or IV sedation typically sufficient

Aglatimagene Prep

Drug: 2 mL drawn

Needle: 20-22G 5" spinal

4-Quadrant Injection

Injections: 1 injection per quadrant

Volume: 2 mL total (0.5 mL × 4 sites)

Pass 1 (Left): basal (L) + apical (L)

Pass 2 (Right): basal (R) + apical (R)

Valacyclovir (oral prodrug)

Start: day 1 post-injection

Dose: 2 g TID × 14 days (adjust for renal function)

ASC= ambulatory surgical centers

A gl a t i m a ge n e

Injection and radiation sequencing schedule

t -14d

14 days prior to radiotherapy

t=0d

Start of RT

t +14d

14 days after prior injection

14-day course valacyclovir

INJECTION SCHEDULE

RT Modality

INJECTION #1 (t−14d)

INJECTION #2 (t=0)

INJECTION #3 (t+14d)

RT Start

Conventional EBRT / Mod Hypofractionated

Fiducial ± spacer

Day 1 of RT

Wk 3 of RT (mid-course)

Phase 3 clinical trial of aglatimagene in patients with newly diagnosed, intermediate- to high-risk, localized prostate cancer

n=745

Newly diagnosed, intermediate/high risk, localized prostate cancer

2:1

Randomized

Aglatimagene + valacyclovir

(3 injection courses + radiotherapy with or without short-course ADT)

Primary endpoints

Disease-free survival (time to cancer recurrence or death due to any cause)

Key secondary endpoints

PSA freedom from biochemical failure

Prostate cancer - specific outcomes

Overall survival

NCT01436968

Conducted under agreement with FDA under Special Protocol Assessment

Placebo + valacyclovir

(3 injection courses + radiotherapy with or without short-course ADT)

Randomization stratified by NCCN risk group and planned short-course (<6 months) of ADT (androgen deprivation therapy)

DeWeese TL et al. Lancet Oncol (In press)

Disease-free survival in localized prostate cancer treated with curative intent

DFS: time from randomization to prostate cancer recurrence (biopsy, clinical, or radiographic evidence), metastasis, or death from any cause

Prostate cancer-specific DFS: time from randomization to prostate cancer recurrence, metastasis, or prostate cancer-specific death

DFS

Disease Free Survival

Local Failure

Tumor growth in prostate

Regional Failure

Spread within pelvis

Distant Metastases Spread

beyond pelvis

Death

All-cause mortality

First DFS Event

Clinical Relevance

Extensive market research confirms clinical relevance with payers and key external experts

Randomization

Regulatory Validation

Endpoint included in the Special Protocol Assessment agreed with the FDA

Mark Garzotto, MD | AUA 2026, Washington DC

Demographic and baseline characteristics of randomized patients

ITT population (N=745)

Aglatimagene + prodrug (N=496)

Placebo + prodrug (N=249)

Total (N=745)

Median age (yrs)

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 (0.6)

1 (0.4)

4 (0.5)

Native Hawaiian or Pacific Islander

0 (0)

2 (0.8)

2 (0.3)

American Indian or Alaskan Native

1 (0.2)

1 (0.4)

2 (0.3)

Not reported

14 (2.8)

11 (4.4)

25 (3.4)

Ethnicity, n (%)

Hispanic or Latino

37 (7.5)

34 (13.7)

71 (9.5)

Not Hispanic or Latino

377 (76.0)

175 (70.3)

552 (74.1)

Not reported

82 (16.5)

40 (16.1)

122 (16.4)

NCCN risk group, n (%)

Intermediate

422 (85.1)

213 (85.5)

635 (85.2)

High

74 (14.9)

36 (14.5)

110 (14.8)

PSA ng/ml

Median

6.8

6.5

6.7

Range

1.0-52.9

0.8-63.3

Gleason score, n (%)

19 (3.8)

5 (2.0)

24 (3.2)

417 (84.1)

217 (87.1)

634 (85.1)

60 (12.1)

27 (10.8)

87 (11.7)

ADT stratification, n (%)

Planned ADT

244 (49.2)

122 (49.0)

366 (49.1)

No planned ADT

252 (50.8)

127 (51.0)

379 (50.9)

Mark Garzotto, MD | AUA 2026, Washington DC. DeWeese TL et al. Lancet Oncol (In press)

Aglatimagene significantly improved prostate cancer-specific disease-free survival after extended follow-up (ITT, N = 745)

HR=0.61; 95% CI 0.44 - 0.85 p=0.0031

Aglatimagene + SoC resulted in

39% improvement in prostate cancer-specific DFS

compared to PBO + SoC

Only 2 deaths due to prostate cancer (1 each arm) after median followup of 58.0 mos

(95% CI, 56.6 - 60.2)

DATA CUTOFF: MAR 15, 2026

Longer time to salvage anticancer therapy and biochemical failure observed in aglatimagene arm (ITT, N=745)

Time to new anticancer therapy Time to biochemical failure (nadir+2)

HR=0.72; 95% CI 0.39 - 1.31 HR=0.72; 95% CI 0.40 - 1.31

Mark Garzotto, MD | AUA 2026, Washington DC. DATA CUTOFF: MAR 15, 2026

Lower incidence of and increased time to metastasis observed in aglatimagene arm (ITT, N = 745)

HR=0.58; 95% CI 0.21 - 1.59

Time to metastasis

Aglatimagene + SoC cohort experienced a lower rate of metastases

Agla 8/496 (1.6%),

PBO 7/249 (2.8%)

Aglatimagene significantly improved prostate cancer-specific disease-free survival in intermediate-risk prostate cancer (n = 635)

HR=0.59; 95% CI 0.41 - 0.84 p=0.0034

Aglatimagene + SoC resulted in

41% improvement in prostate cancer-specific DFS

compared to PBO + SoC

Longer time to salvage anticancer therapy and biochemical failure

observed in aglatimagene arm in intermediate-risk prostate cancer (n = 635)

Time to new anticancer therapy Time to biochemical failure (nadir+2)

HR=0.51; 95% CI 0.24 - 1.1 HR=0.48; 95% CI 0.22 - 1.03

Lower incidence of and increased time to metastases observed in aglatimagene arm in intermediate-risk prostate cancer (n = 635)

HR=0.1; 95% CI 0.01 - 0.85

Time to metastasis

Aglatimagene + SoC cohort experienced lower rate of metastatic disease

Agla 1/422 (0.24%),

PBO 5/213 (2.35%)

DATA CUTOFF: MAR 15, 2026

Grade ≥4 TRAEs

No serious treatment-related events

5.8% vs 7.3%

SAE incidence

Aglatimagene + SOC vs placebo + SOC

5.4% vs 6.0%

Discontinuation due to AEs

Aglatimagene + SOC vs placebo + SOC

Treatment related AEs >5% in either arm

Chills, fever and flu-like symptoms commonly mild to moderate and self-limited

>90% of fever, flu-like symptoms, chills and fatigue resolved within 24-72 hrs

Most TRAEs were grade 1-2

Grade 3 TRAEs in <5% of patients

No grade ≥4 TRAEs reported

Treatment-related SAEs comparable to placebo

1.7% (aglatimagene + SOC) vs 2.2% (placebo + SOC)

Preferred term

Aglatimagene

+prodrug (N=479)

Placebo+ prodrug (N=232)

Total (N=711)

Chills

160 (33.4)

20 (8.6)

180 (25.3)

Influenza-like

illness

146 (30.5)

32 (13.8)

178 (25.0)

Fever

120 (25.1)

9 (3.9)

129 (18.1)

Fatigue

87 (18.2)

35 (15.1)

122 (17.2)

Urinary frequency

58 (12.1)

34 (14.7)

92 (12.9)

Nausea

53 (11.1)

19 (8.2)

72 (10.1)

Headache

45 (9.4)

12 (5.2)

57 (8.0)

Diarrhea

30 (6.3)

18 (7.8)

48 (6.8)

Malaise

28 (5.8)

5 (2.2)

33 (4.6)

Vomiting

26 (5.4)

3 (1.3)

29 (4.1)

Urinary urgency

19 (4.0)

16 (6.9)

35 (4.9)

Urinary tract pain

18 (3.8)

14 (6.0)

32 (4.5)

Accumulating clinical benefit for patients treated with aglatimagene in combination with EBRT after extended follow-up

Previously presented primary endpoint demonstrated statistically significant improvement in DFS as well as increased pathological complete response in 2-year biopsies1, known to be predictive of subsequent biochemical failure and metastasis after 10+ years of follow-up2

Consistent with these earlier findings, extended follow up demonstrated delayed biochemical failure, metastatic disease, and salvage anticancer therapy in the aglatimagene arm versus placebo

Clinical outcome associated with acceptable tolerability profile to date (low discontinuation and SAE rates)

If approved, aglatimagene could offer a new treatment option that may extend the time men live free from prostate cancer recurrence

Mark Garzotto, MD | AUA 2026, Washington DC.

1 DeWeese TL et al. Lancet Oncol (In press)

2 Singh S et al. Prostate Cancer Prostatic Dis 2021;24:612-622

Disclaimer

Candel Therapeutics Inc. published this content on May 15, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 15, 2026 at 15:46 UTC.