Empower the Immune System to Fight Cancer

Ultimovacs Company Presentation May 07, 2024

Disclaimer

This presentation has been prepared by Ultimovacs ASA ("Ultimovacs" or the "Company") for information purposes only and does not constitute an offer to sell common shares of the Company or a recommendation in relation to the shares of the Company. Neither shall the presentation or any part of it, nor the fact of its distribution or communication, form the basis of, or be relied on in connection with any contract, commitment or investment decision in relation thereto.

This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation are forward-looking statements and as such, are based on management's current expectations and beliefs about future events at the date of this presentation. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "hope," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual events, results or achievements to differ materially from the events, results or achievements

expressed or implied by the forward-looking statements contained in this presentation. Given these risks, uncertainties and other factors, recipients of this presentation are cautioned not to place undue reliance on these forward-looking statements.

The information included in this presentation may be subject to updating, completion, revision and amendment, and such information may change materially. Except as required by law, we are under no duty to update any of these forward-looking statements after the date of this presentation to conform our prior statements to actual results or revised expectations.

No representation or warranty (express or implied) is made as to, and no reliance should be placed on, the accuracy, completeness or fairness of the information and opinions contained in this presentation, no reliance should be placed on such information. Neither Ultimovacs nor any of its owners, affiliates advisors or representatives accept any responsibility, liability or loss whatsoever arising directly or indirectly from the use of this presentation.

By accepting this presentation, you acknowledge that you are solely responsible for your own assessment of the market and the market position of the Company and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the Company's business.

Non-Confidential2

Contents

  1. UV1: therapeutic cancer vaccine
  2. Phase I results
  3. Phase II strategy and clinical trials
  4. Discovery: TET technology
  5. Outlook and opportunities

3

INTRODUCTION

UV1: An off-the-shelf cancer vaccine in a broad clinical program

  • Immune checkpoint inhibitors (CPI) have transformed cancer treatment, but the success rate varies
    • Cancer vaccines can enhance the activation and infiltration of T cells into the tumor
    • UV1 target telomerase is expressed in 85-90% of cancer types across stages; represent a potential add-on treatment to CPI in multiple solid tumors
  • Clinical strategy objective: Assessing UV1 efficacy across different types of cancers expressing telomerase, and where CPI therapy are (or likely to be) approved as standard-of-care
  • Phase I studies with UV1 showed good safety profile and promising long-term overall survival
  • UV1 + pembrolizumab in advanced melanoma: 33% complete response, ~ 70% overall survival after 4 years; similar results for PD-L1 +/- tumors
  • Phase II program: Data-driven approach with five randomized controlled trials (RCT) in various indications

First randomized Phase II data in advanced mesothelioma and melanoma

  • NIPU: ipi/nivo +/- UV1 in second-line treatment of malignant mesothelioma: Primary endpoint PSF not met, clinically meaningful survival improvement
  • INITIUM: ipi/nivo +/- UV1, in first-line treatment of advanced melanoma: Primary/secondary endpoint not met

Near-term topline results expected from Phase II trials

  • FOCUS: pembro +/- UV1 in head and neck squamous cell carcinoma: Enrollment complete, readout expected Q3 2024
  • DOVACC: Second-linetreatment of ovarian cancer with UV1 added to olaparib/durvalumab: Enrolling, readout expected H1 2025

Non-Confidential4

INTRODUCTION

Investigating UV1 across cancer indications and combinations

Indication

Combination

Phase I

Phase II

Contributors

Randomized

Single-arm trials

controlled trials

Malignant

Ipilimumab

INITIUM (N=156)

melanoma

Nivolumab

Ultimovacs

Malignant

Pembrolizumab

sponsored

UV1-103(N=30)

melanoma

trials

Malignant

Ipilimumab

UV1-ipi(N=12)

melanoma

Pleural

Ipilimumab

NIPU (N=118)

mesothelioma

Nivolumab

Head and neck

Pembrolizumab

FOCUS (N=75)

Investigator

cancer

initiated trials

Ovarian cancer

Durvalumab

DOVACC (N=184) *

Olaparib

Non-small cell

Cemiplimab

LUNGVAC (N=138) *

lung cancer

DRAMMEN HOSPITAL

* DOVACC and LUNGVAC Phase II trials still enrolling patients

Non-Confidential5

INTRODUCTION

Newsflow and milestones

UV1 VACCINE

Malignant melanoma Phase I: UV1-103

Phase II: INITIUM

Malignant pleural mesothelioma Phase II: NIPU

Head and neck cancer Phase II: FOCUS

Ovarian cancer

Phase II: DOVACC

Non-small cell lung cancer Phase II: LUNGVAC

TET TECHNOLOGY

Prostate cancer

Phase I: TENDU

2H 2023

2024

Q4: 4-yr OS Cohort 1

Q2: 4-yr OS Total

Topline result

March 2024

Data presented at

ESMO, Oct 21, 2023

Exp. topline result

Q3 2024

Data Readout Dec 2023

2025 / 2026

Exp. topline result

H1 2025

Exp. topline result

H1 2026

Non-Confidential6

01

UV1 therapeutic cancer vaccine

UV1

The rationale for therapeutic cancer vaccination

Checkpoint inhibitor (CPI) efficacy relies on spontaneous T cell responses against cancer1

Non-responding (cold) tumors

Responding (hot) tumors

Low PD-L1

Vaccinate to increase the

High PD-L1

Few TILs

magnitude and durability of

Many TILs

Low IFNγ

relevant T cell responses

High IFNγ

Scarce anti-tumor

Abundant anti-tumor

T cell responses

T cell responses

1. Tumeh, P., Harview, C., Yearley, J. et al. PD-1 blockade induces responses by inhibiting

Non-Confidential

8

adaptive immune resistance. Nature 515, 568-571 (2014)

UV1

The UV1 vaccine induces T cell responses against telomerase

Hallmarks of cancer1

Telomerase

UV1 vaccine

Characteristics

Qualities

Universal

85-90% of tumor types express

Applicable to a broad range of

telomerase2,3

cancer types

Essential

Tumor cells depend on expressing

High relevance in heterogenous

tumor environments

telomerase

Enduring

Present throughout tumor evolution:

Enduring and relevant immune

response over time

primary to metastatic cancer

1. Hanahan D et al. Cell (2011) - Figure created with Biorender.

2.

Kim et al. Science (1994)

Non-Confidential

9

3.

Shay et al. European Journal of Cancer (1997)

4. Hornsby PJ. (2007)

UV1

UV1 leverages the unique features of CD4 T cells

CD8 T cells

  • "Soldiers" of the immune response
  • Identifies target antigen on HLA class I
  • Directly kill cancer cells

UV1 vaccination

Anti-neoantigen CD8 response

Anti-TERT CD4 response

CD4 T cells

  • "Orchestrators" of the immune response
  • Identifies target antigen on HLA class II
  • Promotes anti-tumor immune response through activation of:
    • CD8 T cells
    • Macrophages
    • NK cells

CD4+ T cell response towards a

continuously present target maintains

anti-tumor immune responses

over time

Non-Confidential10

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Ultimovacs ASA published this content on 21 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 May 2024 08:44:05 UTC.