Candel Therapeutics : Website Candel April 2026 Corporate Presentation 230PM 041426 IR

Published: 2026-04-14 15:14:09 ET CADL

Published on 04/14/2026 at 03:14 pm EDT

Corporate Presentation | April 2026 NASDAQ: CADL

Aglatimagene besadenovec (CAN-2409): 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 randomized phase 2a clinical trial of aglatimagene in borderline resectable pancreatic cancer

Positive overall survival data from randomized phase 2a clinical trial of aglatimagene in therapy-resistant non-small cell lung cancer

FDA Regenerative Medicine Advanced Therapy (RMAT) Designation in prostate cancer, Fast Track Designation in NSCLC, pancreatic cancer, and prostate cancer. Orphan Drug Designation in pancreatic cancer

"Pipeline in a product" strategy advancing multiple programs in several large indications

Linoserpaturev (CAN-3110): Oncolytic HSV-1 designed for tumor-specific replication

Proof of concept in patients with recurrent high-grade glioma, published in Nature and Science Translational Medicine

Fast Track Designation, Orphan Drug Designation

Opportunity for creation of "pipeline in a product" by expansion into indications beyond brain cancers

Corporate highlights

Experienced Executive Team and strong scientific support from high-profile Research Advisory Board

Entered into a term loan facility with Trinity Capital of up to $130 million in October 2025

Entered into $100 million royalty funding agreement with RTW Investments, subject to approval of aglatimagene in intermediate- to high-risk, localized prostate cancer in February 2026

Cash and cash equivalents of $119.7 million as of December 31, 2025; together with funds from February 2026 follow-on equity offering, provides expected runway into Q1 2028

IP protection: aglatimagene (2034, method of use); linoserpaturev (2036, composition of matter); 12 years data exclusivity

Low-cost manufacturing

Precommercialization activities underway to support potential post approval commercial launch of aglatimagene

2

Please visit https://vimeo.com/822135123

Aglatimagene locally administered combined with oral prodrug 3. Aglatimagene induces CD8+ cytotoxic T cells

Valacyclovir

Inflammatory mediators

Tumor antigens

Macrophage

Dendritic cell

B-cell

Fibroblast

aglatimagene

Cytotoxic metabolite

aglatimagene Valacyclovir

T-cell

Localized cytolytic mechanism combined with proinflammatory viral particles

4. Local immunization yields systemic CD8+ T cell mediated

3 response against injected tumor and uninjected metastases

Aglatimagene is an investigational product and its mechanism of action in humans has not been definitively established. This depiction of the aglatimagene

mechanism of action and the MoA video linked above are based on preclinical data and observations in clinical studies to date

> 1,000 patients dosed

Fast Track Designation in prostate cancer, non-small cell lung cancer (NSCLC), and pancreatic ductal adenocarcinoma (PDAC)

Randomized controlled phase 3 clinical trial (n=745) in localized, intermediate-to-high-risk prostate cancer achieved primary

Conducted under Special Protocol

Monotherapy activity of aglatimagene in NSCLC patient: Nearly 50% decrease in tumor volume in 3 weeks

Assessment (SPA)

Regenerative Medicine Advanced Therapy Designation (RMAT)

Proof of concept in patients with NSCLC and PDAC

Day 0

Tumor Dimensions: 148 x 40 x 82 mm

(1012 vp dose)

Day 22

Tumor Dimensions: 100 x 34 x 75 mm

4

Please visit https://vimeo.com/822133681

Nestin Promoter

ICP34.5

linoserpaturev

Nestin expression in tumor cells induces ICP34.5 expression, resulting in tumor-specific replication

Virus expands in Nestin expressing tumor cells, causing oncolytic activity

5

Linoserpaturev is an investigational product and its mechanism of action in humans has not been definitively established. This depiction of the linoserpaturev

mechanism of action and the MoA video linked above are based on preclinical data and observations in clinical studies to date

Proof of concept in patients with recurrent-high grade glioma (mostly glioblastoma)

> 60 patients dosed

Published in Nature and Science Translational Medicine

Fast Track Designation and Orphan Drug

Encouraging survival data for

Monotherapy activity of linoserpaturev in recurrent high-grade glioma: Clinical effect on injected tumor and uninjected tumor

Antitumor activity of linoserpaturev in preclinical models of melanoma (SITC, Nov 2024)

Day 0

Day 111 Patient back to work

Day 280

Ling AL et al. Nature 2023;623:157-166

PROGRAM INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 BLA Readiness

Adenovirus Platform

Aglatimagene

Pancreatic Cancer

Lung Cancer

Prostate Cancer

Linoserpaturev

Brain Cancer

enLIGHTEN

Discovery Programs

Borderline Resectable Pancreatic Adenocarcinoma, Fast Track Designation (FDA)

NSCLC + PD-1/PD-(L)1,

Fast Track Designation (FDA)

Localized, Intermediate/High Risk, Fast Track Designation (FDA), Special Protocol Assessment (FDA)

Recurrent High-Grade Glioma, Fast Track Designation (FDA)

Solid Tumors

Additional

Phase 3,

2025

Interim OS data, biomarker data, recurrent HGG Phase 1b (Arm C), linoserpaturev

Updated clinical data, NSCLC

Phase 2, aglatimagene besadenovec

2026

Updated clinical data, prostate cancer Phase 3, aglatimagene besadenovec

Initiation phase 3 clinical trial, NSCLC

Phase 3, aglatimagene besadenovec

New biomarker data, prostate cancer Phase 3, Phase 2

(biomarker/ biodistribution), aglatimagene besadenovec

Updated OS data,

recurrent HGG Phase 1b (Arm C), linoserpaturev

BLA filing

Paul Peter Tak, MD, PhD, FMedSci

President & Chief Executive Officer

Francesca Barone, MD, PhD

Chief Scientific Officer

Seshu Tyagarajan, PhD, RAC

Chief Technical and Development Officer

Charles Schoch, MBA, MSA

Chief Financial Officer

Garrett Nichols, MD, MS

Chief Medical Officer

Susan Stewart, JD

Chief Regulatory Officer

James Allison, PhD

Chair of the Department of Immunology, MD Anderson Cancer Center

2018 Nobel Recipient

Carl H. June, MD

Richard W. Vaque Professor in Immunotherapy, Perelman School of Medicine, University of Pennsylvania

Edward Benz, MD

President and CEO Emeritus Dana-Farber Cancer Institute

Philip Kantoff, MD, FASCO

CEO and Co-Founder, Convergent Therapeutics

Past Chairman of Medicine Memorial Sloan Kettering Cancer Center

Jerome and Nancy Kohlberg Emeritus Chair in Medicine

Harvard Medical School

Henry Brem, MD

Director, Department of Neurosurgery

Professor of Neurosurgery Johns Hopkins University

Gary Nabel, MD, PhD

Chief Innovation Officer of OPKO and President/CEO of ModeX Therapeutics

Former CSO Sanofi

Roy Herbst, MD, PhD

Chief of Medical Oncology Yale Cancer Center

Bali Pulendran, PhD

Violetta L. Horton Professor at Stanford University School of Medicine and Director of the Institute for Immunity, Transplantation and Infection at Stanford University

Elizabeth M. Jaffee, MD

Deputy Director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and

Co-Director of the Gastrointestinal Cancers Program

Padmanee Sharma, MD, PhD

Professor of Genitourinary Medical Oncology and Immunology , MD Anderson Cancer Center

Off-the-shelf therapy, individualized cancer response

11

INTERMEDIATE

109K

HIGH

43K

LOW

65K

Localized Prostate Incidence

Clear Unmet Need for Patients

~$10 - 16bn

U.S. Addressable Market Opportunity

Illustrative Range of Existing Prostate Approved Therapies

Source: Globe Life Sciences (May 2025).

~65K (~43%)

~$150-250K

Sub-optimal SoC Options

Long-term ADT associated with severe side effects

Patients' Recurrence

Benefits of Aglatimagene in Localized Prostate

Future

A

voidan

Cost

ce

Recurrence in ~30% of patients post-radiotherapy, with ~50% high-risk patients

Use of ADT or chemotherapy

12

Costs of side effects related to ADT

Planned indication in newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease in conjunction with radiotherapy to prevent prostate cancer recurrence

NCCN* defined intermediate (at least one of: PSA 10-20 ng/mL, Gleason score of 7, stage T2b/T2c) or patients with a single high-risk characteristic (one of: PSA >20 ng/mL, Gleason score 8-10, stage T3a)

Planned Indication

"Off-the-shelf" viral immunotherapy product designed to elicit a broad, potent immune response against solid tumors

Administered in combination with SoC external beam radiotherapy (EBRT) ± short course of ADT (<6 months)

3 courses of intraprostatic injections: 2 mL total volume (2-6 weeks apart)

Each administration is performed in outpatient clinic (~20 minutes)

14 days of valacyclovir orally following each injection course

Administration

13 *National Comprehensive Cancer Network.

Standard urologic injection procedure

Prostate

Bladder

Prodrug (14 days of valacyclovir)

Images of fluorescently labeled adenoviral vector in freshly resected prostate, demonstrating homogeneous distribution throughout the organ after 4 injections of virus (0.5 mL) in each prostate quadrant2

Pre-radiotherapy

Radiotherapy

Post-radiotherapy

Ultrasound-guided injection (transrectal or transperineal)1

Performed by urologists or radiation oncologists in outpatient clinic

A total volume of 2 mL, 0.5 mL in each of 4 quadrants of the prostate using a 20-G to 22-G needle

± Short-term androgen deprivation therapy

Course 1: 15 days-8 weeks prior to radiotherapy

Course 2: 0-3 days prior to radiotherapy

Course 3: 15-22 days after prior injection

1. Aguilar L. 28th Annual Prostate Cancer Foundation, Scientific Retreat, October 2021;

14 2. Rojas-Martínez A et al. Cancer Gene Ther. 2013;20:642-9.

In total >2000 intraprostatic injections

(40% transperineal; 56% transrectal; 4% not reported)

"How did you tolerate the study procedure compared to a prostate biopsy?"

Transperineal Transrectal

Much harder to tolerate 4%

Little harder to tolerate

30%

Much harder to tolerate

Little harder to tolerate

0%

11%

Same or better tolerated

65%

Same or better tolerated

89%

0% 10% 20% 30% 40% 50% 60% 70% 0% 20% 40% 60% 80% 100%

Aguilar L. 28th Annual Prostate Cancer Foundation Scientific Retreat, October 2021

n=745

Newly diagnosed, intermediate/high-risk, localized prostate cancer

2:1

Randomized

Placebo + 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

aglatimagene +

Valacyclovir

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

NCT01436968

Conducted under agreement with FDA under Special Protocol Assessment

Randomized stratified by the National Comprehensive Cancer Network (NCCN) guideline risk group and planned short-course ADT (androgen deprivation therapy). *Defined as local (biopsy), regional or metastatic disease, or death due to any cause.

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

Local failure: includes increase in tumor size by 50%, reappearance of palpable tumor or biopsy revealing adenocarcinoma of the prostate at least 2 years after randomization

Regional failure: clinical recurrence with radiographic evidence of tumor in the pelvis

Distant metastases: clinical recurrence with radiographic evidence of disease beyond the pelvis

Endpoint validated by FDA with Special Protocol Assessment confirmed in 2019

Extensive market research with payers and key external experts confirmed that estimated DFS improvements would be clinically relevant

ITT population (N=745)

aglatimagene + prodrug (N=496)

Placebo + prodrug (N=249)

Total (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 (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

6.815

6.500

6.700

Range

0.99 - 52.90

0.83 -63.30

0.83-63.30

Gleason score, n(%)

< 7

19 (3.8)

5 (2.0)

24 (3.2)

7

417 (84.1)

217 (87.1)

634 (85.1)

> 7

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)

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)

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

Incidence of treatment related SAEs lower on aglatimagene

1.7% on aglatimagene + SoC

2.2% on placebo + SoC

Incidence of SAEs lower on aglatimagene arm

5.8% on aglatimagene + SoC

7.3% on placebo + SoC

Incidence of treatment discontinuation due to AEs lower on aglatimagene arm

5.4% on aglatimagene + SoC

6.0% on placebo + SoC

Disclaimer

Candel Therapeutics Inc. published this content on April 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 14, 2026 at 19:13 UTC.