Ultimovacs ASA

2023

Annual Report

FinancialStatements 

Notes 

FinancialStatements 

Notes 

Auditor’sReport 

Contents

Aboutthecompany 

Ultimovacsataglance 

Milestones 

LetterfromtheCEO 

TheUVcancervaccine 

PhaseIIclinicaltrials 

PhaseIclinicaltrials 

Regulatorydesignations 

Manufacturing 

TETvaccineadjuvanttechnology 

Publications 

Intellectualproperty 

BoardofDirectorsStatement 

BoardofDirectors 

Financialoverview 

Environmentandgovernance 

Risksanduncertainties 

Goingconcern 

Outlook 

Responsibilitystatement 

ESGataglance 

ESGinUltimovacs 

CorporateGovernanceReport 

About

Ultimovacs

Governance

Business

overview

Board of

Directors'

Report

Financial

Statements

Ultimovacs ASA

Ultimovacs Group

01 About Ultimovacs

Aboutthecompany 

Ultimovacsataglance 

Milestones 

LetterfromtheCEO 

Chapters

UV1 triggers an immune response against the shared cancer antigen

telomerase, a target present in 85-90% of all cancer indications.

The vaccine does not require testing for eligibility or sophisticated

hospital infrastructure for initiating treatment.

Ultimovacs is investigating the safety and efficacy of UV1 combined

with various checkpoint inhibitors in a broad clinical development

program with currently five Phase II clinical trials and one Phase I

trial ongoing. More than 750 patients in the U.S., Europe, and Aust-

ralia will be enrolled in the current program. More than 300 patients

have already received treatment with UV1 per date with no safety

concerns reported with the use of UV1.

The first three randomized Phase II trials have completed enroll-

ment: INITIUM investigating ipilimumab/nivolumab with or with-

out UV1 vaccination as first-line treatment of unresectable or

metastatic malignant melanoma, NIPU investigating ipilimumab/

nivolumab with or without UV1 vaccination as second-line treat-

ment of malignant mesothelioma, and FOCUS investigating pem-

brolizumab with or without UV1 vaccination as first-line treatment

of metastatic or recurrent head and neck squamous cell carcinoma.

In October 2023, the NIPU trial malignant mesothelioma reported

a clinically meaningful overall survival benefit in patients receiving

UV1 vaccination on top of ipilimumab and nivolumab with no added

toxicities. Confirmed objective response rates showed a significant

benefit of adding the UV1 vaccine. The primary endpoint of progres-

sion-free survival was not met.

In March 2024, the INITIUM trial in advanced melanoma reported

that with 18 months minimum follow-up all the patients, the trial

did not meet the primary endpoint of improved progression-free

survival (PFS). Median PFS was not reached in either arm. The data

did not show a difference in overall survival and objective response

rate. The safety profile of the combination of UV1 plus ipilimumab

and nivolumab was consistent between the two arms, confirming

the good safety profile for UV1.

Ultimovacs remains committed to the development of the UV1 vac-

cine in specific therapeutic combinations and indications. Topline

results for the Phase II FOCUS trial are expected in the third quarter

of 2024.

Ultimovacs is listed on Euronext Oslo Stock Exchange (OSE:ULTI).

Ultimovacs is a clinical-stage biotechnology

company developing novel immunotherapies

against cancer. The lead product candidate,

UV1, is an off-the-shelf therapeutic cancer

vaccine aiming to increase treatment efficacy

and extend the benefits of immunotherapy

to more cancer patients.

About the company

Chapters

Locations

Oslo, Norway & Uppsala, Sweden

Euronext listing

Oslo 2019 (ULTI)

Cash end Q4 2023

MNOK 267 / MUSD 25

Ultimovacs at a glance

26 employees

7 nationalities

54% female

Our mission

Prolong the

life of cancer

patients

Target telomerase

expressed in 85-90%

of cancers

Pipeline: TET

Vaccine adjuvant

technology

Basis for new,

first-in-class

therapeutic

cancer vaccines

Lead product: UV1

Immunotherapeutic cancer vaccine

UV1 Phase II

5 ongoing randomized controlled

clinical trials, combining top five

checkpoint inhibitors

33% complete

response

~70% overall

survival after 4 years

INITIUM

Advanced

melanoma

DOVACC

Ovarian cancer

NIPU

Advanced

mesothelioma

LUNGVAC

Non-Small

cell lung cancer

FOCUS

Head and

neck cancer

33% 70%

UV1 Phase I

1 ongoing trial: UV1-103 in advanced

melanoma

Trials enrolling

> 670 patients

in Europe, USA

and Australia

Chapters

June

Topline results

announced in NIPU:

Primary endpoint

(PFS) not met

3-year update from

UV1-103 (cohort 2):

All patients alive after

2 years remain alive

after 3 years follow up

October

Receives FDA Orphan

Drug Designation for

UV1 in mesothelioma

4-year update from

UV1-103 (cohort 1):

All patients alive after

3 years remain alive

after 4 years follow up

NIPU results present-

ed at ESMO 2023:

Clinically meaningful

improvement in over-

all survival

Protocol amendment

in INITIUM: Data read-

out in first half of 2024

November

Completed patient

enrollment in INITIUM

supplementary study

December

Completion of explor-

atory Phase I TENDU

study: Primary end-

point met

August

Completed patient

enrollment in FOCUS

April

Updated guidance

on timeline for

readout of INITIUM

January

Completed patient

enrollment in NIPU

PHASE I TRIALS:

 UV1 + pembrolizumab in advanced melanoma

PHASE II RANDOMIZED CONTROLLED TRIALS:

INITIUM: Ipilimumab / nivolumab +/- UV1 in advanced melanoma

NIPU: Ipilimumab / nivolumab +/- UV1 in malignant mesothelioma

FOCUS: Pembrolizumab +/- UV1 in head and neck cancer

DOVACC: Olaparib / durvalumab +/- UV1 in ovarian cancer

LUNGVAC: Cempiplimab +/- UV1 in non-small cell lung cancer

Milestones 2023

Chapters

2023 was the year in which Ultimovacs began to gather the data from

the extensive Phase II clinical development program. While the NIPU

study reported encouraging survival data in a hard-to-treat cancer

indication, we were surprised and disappointed by the INITIUM re-

sults, which were not consistent with previous clinical experience.

The Phase II NIPU trial in malignant mesothelioma reported topline

results in June 2023 and the trial’s principal investigator Professor

Åslaug Helland, MD, PhD, presented the results in October at ESMO

2023. While the trial did not meet the primary endpoint of PFS, the

data reported a clinically meaningful improvement in overall survival

for patients receiving UV1. The results have been underpinned by an

Orphan Drug Designation from the European Medicines Agency (EMA)

and the U.S. Food and Drug Administration (FDA), and a Fast Track

Designation from the FDA, for UV1 in the treatment of mesothelioma.

The negative topline results from the Phase II INITIUM trial, evalu-

ating UV1 in advanced melanoma were announced in March 2024.

Unfortunately, the study failed to meet the primary and secondary

endpoints. We knew that the bar was set very high as ipilimumab

and nivolumab currently are considered the most efficacious treat-

ment combination for this patient population. The patients in the

INITIUM study took much longer to progress than expected:

LETTER FROM THE CEO

With an ambitious clinical program in hard-

to-treat cancer indications, we are prepared

for both challenges and accomplishments

along the way.

OUR GOAL

The successful

development of an off-

the-shelf cancer vaccine

that can benefit solid

tumor cancer patients

worldwide.

Carlos de Sousa

A year of data and achievements

Based on published historical references, progression was esti-

mated to occur in 70 patients by the first half of 2023. With the 18

months minimum follow-up of all patients in January 2024, the 70

endpoints were still not reached. The information from the INITIUM

trial will be used to support the ongoing development of UV1.

The UV1 vaccine has shown promising benefits in previous clinical

studies, and we remain committed to support ongoing studies and

to continue investigating the potential of the vaccine to enhance

the efficacy of cancer therapies.

The FOCUS trial completed the enrollment in August 2023, and we

are looking forward to the expected readout in the third quarter of

2024. The study investigates pembrolizumab with or without UV1

vaccination as treatment for patients with head and neck cancer.

I thank the Ultimovacs team for their drive, expertise, and relentless

dedication to improve the treatment options for cancer patients,

and Ultimovacs’ shareholders, collaborators, and stakeholders around

the world. I am confident that together we will continue to make

an impact for cancer patients in the years to come.

Carlos de Sousa,

Chief Executive Officer

Chapters

02 Business overview

TheUVcancervaccine 

PhaseIIclinicaltrials 

PhaseIclinicaltrials 

Regulatorydesignations 

Manufacturing 

TETvaccineadjuvanttechnology 

Publications 

Intellectualproperty 

Chapters

Immunotherapy empowers the body’s immune

system to fight cancer. The discovery of immune

checkpoint inhibitors has significantly transformed

cancer treatment. Their impact includes improved

overall survival rates, and a safer and more tole-

rable alternative to traditional chemotherapies.

However, the success rate of checkpoint inhibitors

in treating different types of cancer varies; some

cancers are less responsive to checkpoint inhibi-

tors than others.

The UV1 cancer vaccine

– Breakthrough science

has given researchers, cli-

nicians, and patients new hope

in the fight against cancer.

With recent discoveries in immuno-

therapy treatments and an increased

understanding of the immune system’s

role in fighting disease, we are closer

than ever before to transforming all

cancers into curable diseases.

Cancer Research Institute

Chapters

THE UV1 CANCER VACCINE

Low PD-L1

Few TILs

Low IFNγ

High PD-L1

Many TILs

High IFNγ

Responding (hot) tumorsNon-Responding (cold) tumors

Vaccinate to increase the

magnitude and durability of

relevant T cell responses

Scarce anti-tumor

T cell responses

Abundant anti-tumor

T cell responses

The efficacy of checkpoint inhibitors is mediated through the T

cells, a specific immune cell able to recognize and attack cancer

cells. The checkpoint inhibitors work by “releasing the brakes” on

these T cells, leading to improved cancer cell killing. However, if

there is a limited T cell response against the tumor, releasing their

brakes is insufficient for robust cancer cell killing. Inflamed (“hot”)

tumors are characterized by a strong anti-tumor T cell response,

and are more likely to respond to checkpoint inhibitors. “Cold” tu-

mors are characterized by insufficient or suppressed anti-tumor T

cell responses, and show little benefit from checkpoint inhibitors.

Cancer vaccines can improve the efficacy of immune checkpoint

inhibitors by enhancing the activation and infiltration of T cells into

the tumor and induce more effective antitumor immune responses.

Much like traditional vaccines against viruses, cancer vaccines work

by training the immune system to attack an antigen (a target for the

immune system). They differ, however, in what type of antigen they

target, where cancer vaccines target antigens specific to the tumor.

The T cell response induced through vaccination can help improve

the limiting factor for checkpoint inhibitor efficacy, i.e. the breadth

and magnitude of anti-tumor T cell responses.

The rationale behind cancer vaccines

Chapters

Combining telomerase-based vaccination with checkpoint inhibi-

tors is an emerging strategy aimed at enhancing the effectiveness

of both treatments.

The telomeres are protective caps at the ends of our chromo-

somes that are crucial to prevent damage to our DNA. In healthy

cells, the telomeres are gradually shortened with each cell division

until they are eroded and the cell eventually dies and is replaced.

A critical feature of cancer, however, is the cells’ ability to divide

indefinitely, so-called replicative immortality. Cancer cells acquire

replicative immortality by activating an enzyme called telomer-

ase that elongates the telomeres thereby preventing their attrition

during cell division. Activation of telomerase allows cancer cells

to replicate and proliferate in an uncontrolled manner, infiltrate

tissues, and metastasize to distant organs. Human telomerase re-

verse transcriptase (hTERT) is the functionally most important part

of telomerase and is seen in 85-90% of cancer types, across all

stages of the disease, making it an attractive therapeutic target.

The UV1 cancer vaccine was developed through a unique approach,

using a biobank of patient blood samples to identify clinically rele-

vant targets within hTERT. Researchers identified three hTERT pep-

tides that elicited strong T cell responses that correlated with pro-

longed survival across different cancer types. These peptides were

chosen because they demonstrated the ability to mount immune

responses irrespective of HLA type, a limitation of previous cancer

vaccines. It is therefore not required to perform HLA screening of

patients since the UV1 vaccine has a broad population coverage.

Healthy cells typically lack telomerase activity, whereas cancer

cells have very high telomerase activity. There is a limited theoret-

ical risk that T cells induced through vaccination will harm healthy

tissue, and the growing body of clinical evidence suggests telomer-

ase-targeting vaccines are safe. In total, more than 300 cancer

patients have received treatment with UV1 in Phase I and Phase II

trials, and no safety concerns have been reported with the use of

UV1 to date.

Amino acid

563

Amino acid

735

Active site of TERT

Peptide fragment

1. Build library of overlapping peptides

2. Identify optimal regions by testing

patient samples for immune responses

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Peptide fragment

Immune responses

2. Identify optimal regions by testing patient

samples for immune responses

1. Build library of overlapping peptides 3. Validate immunogenic peptides

• Assess in vitro HLA binding capacities

• Ensure broad population coverage by in silico

epitope prediction

• Test if peptide-specific T cells can recognize

melanoma cells naturally (in vitro co-culture)

• Correlate immune response presence against

survival data

Telomerase; a safe and clinically relevant target

THE UV1 CANCER VACCINE

Chapters

UV1 is a second-generation, off-the-shelf peptide-based therapeutic

cancer vaccine that induces specific T cell responses against the

pan-tumor antigen, telomerase.

The UV1 vaccine stimulates the immune system to expand T cells

recognizing sequences of the hTERT enzyme leading to a stronger

anti-tumor immune response. The combination of the cancer vac-

cine added to checkpoint inhibitor treatment may result in a more

enhanced and longer-lasting responses due to the improved acti-

vation of the immune system.

CD4+ T cells are recognized as the “generals” and CD8+ T cells the

“soldiers” of the immune system: CD4 T cells direct a broader im-

mune response towards the tumor, whereas the CD8 T cells directly

kill the cancer cells. The vaccine-induced CD4+ T cells secrete

inflammatory cytokines, such as interleukin (IL)-2 and interferon

(IFN)-, which are crucial in the anti-tumor immune response, also

supporting the direct action of the CD8+ T cells. The UV1 vaccine is

therefore designed to induce robust CD4+ T cells that are essential

for a strong and long-lasting anti-tumor immune response. The T

cells induced by UV1 have been shown to persist in patients for

many years after vaccination, and T cell responses against hTERT

correlate with improved survival in human cancer studies.

Treatment with UV1 has been assessed in three Phase I studies

(metastatic prostate cancer, metastatic non-small cell lung cancer,

and metastatic malignant melanoma) in 52 patients at Oslo Uni-

versity Hospital. The observed clinical outcomes from these three

trials, including dose selection, immune response, safety, and sig-

nals clinical efficacy, served as a basis for the transition of the

clinical development of UV1 into Phase II.

In addition, Ultimovacs is the sponsor of the ongoing Phase I clinical

study UV1-103 in the U.S. in 30 patients with inoperable or meta-

static malignant melanoma, with UV1 as add-on to the PD-1 check-

point inhibitor pembrolizumab. Efficacy readout showed that the

UV1 vaccine plus pembrolizumab elicited an overall response rate

(ORR) of 57% with a complete response (CR) rate of 33%. The ORR

in PD-L1–negative patients (n = 14) was 57%, with a CR rate of 36%.

Four-year overall survival rate is ~ 70%.

Features and clinical development

THE UV1 CANCER VACCINE

Chapters

Investigating UV1 in a data-driven approach

across cancer indications

UV1 has the potential to be used broadly across multiple cancer

types, in different stages of the disease, and in combination with

different cancer treatments. Randomized controlled trials (RCTs)

are the most definitive tool for this evaluation. UV1 is currently

being evaluated in five Phase II RCTs in five different cancer types

in combination with different checkpoint inhibitors. The full clinical

program will enroll more than 670 patients at approximately 100

hospitals in Europe, the U.S., and Australia.

The INITIUM trial is sponsored by Ultimovacs. NIPU, FOCUS, DOVACC,

and LUNGVAC, are investigator-initiated trials, supported by Ultimo-

vacs. The NIPU trial is also supported by Bristol Myers Squibb, and

the DOVACC trial is also supported by AstraZeneca.

Considering the evolving immune-oncology and cancer vaccine

landscape, it would be attractive to investigate the use of UV1 in

neo-adjuvant settings.

Phase II clinical trials

EExxtteennssiivvee rraannddoommiizzeedd PPhhaassee IIII cclliinniiccaall pprrooggrraamm

LUNGVACDOVACCFOCUSINITIUMNIPU

First line non-small

cell lung cancer

Second line ovarian

cancer

First line head and

neck cancer

First line malignant

melanoma

Second line

mesothelioma

Indication

Cemiplimab

Durvalumab

Olaparib

Pembrolizumab

Ipilimumab

Nivolumab

Ipilimumab

Nivolumab

Immunotherapy

combination

138 patients

9 sites

Norway

184 patients

35 sites

10 countries

Europe

75 patients

10 sites

Germany

156 patients

39 sites

4 countries

Europe, US

118 patients

6 sites

5 countries

Europe, Australia

Study conduct

>15%> 40%Enrollment status

H1 2026H1 2025H2 2024March 2024

Announced

October 2023

Topline results

Primary endpoint: Progression-free survival

Secondary endpoints: Overall survival, objective response rate, duration of response, safety

Announced

March 2024

Q3 2024

Chapters

About malignant mesothelioma

Malignant mesothelioma is a rare and aggressive

cancer that occurs in the thin layer of tissue that

surrounds the lungs and inside of the chest. It is

considered an aggressive, complex form of cancer

with a high mortality rate and few therapeutic options. Patients

affected have often been occupationally or environmentally ex-

posed to asbestos, and the disease can take several decades to

develop. Despite the banning of asbestos in many countries, meso-

thelioma continues to pose a medical challenge with significant

unmet medical need. Malignant mesothelioma patients have a very

severe prognosis, and the median overall survival is just over one

year. About 3,000 new cases are diagnosed each year in the United

States (Source: American Cancer Society, 2019).

Over the past few decades, substantial efforts have been made to

improve the survival outcomes of patients with malignant pleural

mesothelioma. However, the results of these investigations have

not been very encouraging. There is currently no established stand-

ard of care in second-line treatment. Telomerase (hTERT) is overex-

pressed in 91-100% of the mesothelioma cancers and is a relevant

target for therapeutic vaccination with UV1.

NIPU: A randomized controlled Phase II trial in

malignant pleural mesothelioma

NIPU (NCT04300244) is an investigator-initiated randomized, open-

label, multi-center Phase II trial in malignant pleural mesothelioma

where patients received immunotherapy as a second-line treatment

after first-line treatment with platinum-based chemotherapy. The

study was designed to investigate if UV1 vaccination, on top of the

checkpoint inhibitors ipilimumab and nivolumab from Bristol-Myers

Squibb, would provide a benefit compared to ipilimumab and nivo-

lumab alone. Professor Åslaug Helland, MD PhD, is the principal inves-

tigator for the trial, which is sponsored by Oslo University Hospital.

Bristol-Myers Squibb and Ultimovacs have supported the trial.

The primary endpoint in the study was progression-free survival (PFS).

Secondary endpoints include overall survival (OS), objective response

rate (ORR), duration of response (DOR) and safety. 118 patients were

randomized from June 2020 to January 2023. Six sites in five countries

(Australia, Denmark, Norway, Sweden, and Spain) participated in the

trial. All participating centres were university hospitals, and patients

were referred from other hospitals in the respective countries. The

patients were randomized 1:1 to ipilimumab and nivolumab alone

(arm B) or combined with the UV1 vaccine (arm A).

The results from the trial

The topline results from the NIPU trial were reported in June 2023.

The results were shared in a late-breaking abstract and as an oral

presentation by the Principal Investigator at the ESMO Congress 2023

in Madrid in October. The study, including subtype analyses, was also

published in the European Journal of Cancer in March 2024, “UV1

telomerase vaccine with ipilimumab and nivolumab as second line

treatment for pleural mesothelioma – a phase II randomized trial.”

Based on blinded independent central review (BICR), the study did not

meet its primary endpoint of improved PFS. ORR (by BICR) showed a

significant benefit of adding the UV1 vaccine. Investigator assessment,

a pre-defined supportive analysis of the primary endpoint performed

by specialized radiologists at the study hospitals, indicated an im-

proved PFS among the patients in the vaccine arm for all histologi-

cal subtypes combined, and for the epithelioid subtype especially.

The data showed that UV1 plus ipilimumab and nivolumab improved

overall survival, reducing the risk of death by 27% (HR=0.73 [80% CI,

0.53-1.00]). The median OS was 15.4 months (95% CI, 11.1-22.6) for UV1

plus ipilimumab and nivolumab (treatment arm) versus 11.1 months

(95% CI, 8.8-18.1) for ipilimumab and nivolumab alone (control arm),

with a median observation time of 17.3 months. This degree of improve-

ment met the protocol predefined threshold for statistical significance.

The data further demonstrated a benefit in terms of objective response

rate, as determined by BICR. In the UV1 arm, 31% of the patients ex-

perienced an objective response, as compared to 16% in the control

arm (odds ratio 2.44 [80% CI, 1.35-4.49]).

The safety profile of the combination of UV1 plus ipilimumab and

nivolumab observed in the trial was consistent with the safety pro-

file of ipilimumab and nivolumab alone, confirming the good safety

profile for UV1. The patients will continue to be monitored for effi-

cacy and safety endpoints over the next years.

The positive data reported from the NIPU study are the first demon-

stration of clinically meaningful prolonged survival for the UV1 vac-

cine in a randomized Phase II trial and the first time a comparative

study reports efficacy on a off-the-shelf cancer vaccine targeting

a nearly universal, shared antigen. Updated results from the NIPU

study will be discussed with the regulatory authorities.

In October 2023, Ultimovacs announced that FDA had granted Orphan

Drug designation for UV1 in the treatment of mesothelioma (based

on the NIPU data from June 2023). In February 2024, Ultimovacs

announced that FDA had granted Fast Track designation for UV1 in

combination with ipilimumab and nivolumab for the treatment of

patients with unresectable malignant pleural mesothelioma to im-

prove overall survival.

In February 2024, EMA Orphan Drug Designation was granted to UV1

for treatment of mesothelioma.

Malignant mesothelioma

PHASE II CLINICAL TRIALS

Chapters

About advanced melanoma

Immunotherapy for melanoma has changed the way

this cancer is treated. In particular, checkpoint in-

hibitors has contributed to increased survival rate

and is standard of care in this population. Despite

this, a large proportion of the patient population remains under-

served due to suboptimal responses to monotherapy checkpoint in-

hibitor, underscoring the need for more effective treatment options.

Melanoma comprises less than five percent of all skin cancers, it

accounts for the vast majority of deaths. Instances of melanoma

is on the rise globally. Approximately 290,000 people are diagnosed

each year in addition to about 61,000 deaths. The aggressive nature

of this disease sustains an urgent need for more successful, effec-

tive melanoma immunotherapies (Source: Cancer Research Institute).

INITIUM: A randomized controlled Phase II trial

in advanced melanoma

INITIUM (NCT04382664) is an Ultimovacs-sponsored randomized,

open-label, multi-center Phase II trial in which the off-the-shelf

cancer vaccine UV1 is being evaluated in combination with the

checkpoint inhibitors ipilimumab and nivolumab for first-line treat-

ment of patients with unresectable or metastatic malignant mela-

noma. A total of 156 patients were randomized between June 2020

and July 2022. The study is being conducted at 40 sites in 39

hospitals across the U.S., UK, Belgium, and Norway.

Ipilimumab and nivolumab is considered the most efficacious treat-

ment for these patients. The trial was designed after the registra-

tional trial for ipilimumab and nivolumab, CHECKMATE-067, reporting

a median PFS of 11.5 months. The primary endpoint in the INITIUM

trial is progression-free survival. Secondary endpoints include over-

all survival (OS), objective response rate (ORR), duration of response

(DOR) and safety.

In March 2024, Ultimovacs announced that with the 18 months min-

imum follow-up of all patients, the trial did not meet the primary

endpoint of improved progression-free survival (PFS). Median PFS

was not reached in either arm, and the Hazard Ratio (HR) between

the arms for PFS was 0.95. Evaluation on secondary endpoints did

not show a difference on overall survival, objective response rate

or duration of response. UV1 maintained its positive safety profile

with similar safety and tolerability as observed in the control arm.

In September 2022, Ultimovacs initiated a supplementary single-

arm study to the INITIUM trial. The study was fully enrolled in

October 2023 with a total of 21 patients. The single-arm study was

designed to describe the mechanisms leading to improved clinical

effect in patients treated with UV1 vaccination. The single-arm

study will provide in-depth data on biological activity and mode

of action of the T cells induced by the UV1. All patients will receive

experimental treatment (i.e., the triple combination of UV1, ipili-

mumab, and nivolumab). Data collected from the supplementary

study will not be part of the primary and secondary endpoint

analyses of INITIUM and will not affect the timeline for topline

read-out. Six patients in the INITIUM study will also be part of

the INITIUM supplementary study, for a total of 27 patients.

PHASE II CLINICAL TRIALS

Advanced melanoma

Chapters

About head and neck cancer

“Head and neck cancer” is a collective term that

includes several different types of cancer. The most

common type is squamous cell carcinoma of the

head and neck (HNSCC). HNSCC accounts for about

three to five percent of all cancers in the US. Globally, there were

an estimated 890,000 cases in 2018 along with 450,000 deaths.

The five-year survival rate is about 60%. Pembrolizumab is one of

the approved immunotherapies for patients with advanced head

and neck cancer, including as a first-line therapy. (Source: Cancer

Research Institute).

FOCUS: A randomized controlled Phase II trial

in head and neck cancer

The FOCUS trial (NCT05075122) is an investigator-initiated, rand-

omized Phase II clinical trial. The cancer vaccine UV1 will be evalu-

ated in combination with the checkpoint inhibitor pembrolizumab

as first-line treatment of patients with recurrent or metastatic PD-L1

positive head and neck squamous cell carcinoma. Prof. Mascha

Binder is the principal investigator for the trial, which is sponsored

by University Medicine Halle in Germany.

The first patient received treatment in the FOCUS trial in August

2021, and the last patient was enrolled and received the first dose

of treatment in August 2023. The study is being conducted in ten

hospitals in Germany, and a total of 75 patients have been enrolled.

The patients are randomized 2-to-1 so that 50 patients will receive

UV1 and pembrolizumab, and 25 patients will receive pembroli-

zumab alone.

The FOCUS trial is a landmark study. The primary endpoint of the

study is progression-free survival rate at 6 months after the last

patient has been included. For the secondary endpoints, including

overall survival (OS), objective response rate (ORR), duration of re-

sponse (DOR) and safety, patients will be followed until 12 months

after the last patient has been enrolled. The data, including PFS

and OS, will be analyzed 12 months after inclusion of last patient,

and the results are expected to be reported in the third quarter

of 2024.

Head and neck cancer

PHASE II CLINICAL TRIALS

Chapters

About ovarian cancer

Immunotherapy for ovarian cancer shows a sub-

stantial potential for addressing the unmet need

of the disease. Ovarian cancer often progresses

significantly before a patient is diagnosed. The

symptoms can easily be confused with digestive issues. Roughly

20 percent of ovarian cancers are detected before it spreads be-

yond the ovaries. Women who test positive for the inherited

mutations in the BRCA1 or BRCA2 genes are at greater risk of

developing ovarian cancer.

Globally, ovarian cancer is diagnosed in an estimated 300,000

women each year, and causes roughly 180,000 deaths. The poor

survival in advanced ovarian cancer is due both to late diagnosis

as well as to the lack of effective second-line therapy for patients

who relapse. Many people affected by advanced ovarian cancer

respond to chemotherapy, but effects are not typically long-lasting.

More than 80% of ovarian cancer patients experience recurrent

disease, and more than 50% of these patients die from the disease

in less than five yeards post-diagnosis. There is an urgent need

for new treatments for advanced stage, recurring ovarian cancer.

(Source: Cancer Research Institute)

DOVACC: A randomized controlled Phase II trial

in ovarian cancer

DOVACC (NCT04742075) is an investigator-initiated, randomized,

open-label clinical collaboration trial with the Nordic Society of

Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the

European Network of Gynaecological Oncological Trial Groups

(ENGOT). The trial is supported by AstraZeneca and Ultimovacs.

The cancer vaccine UV1 will be evaluated in combination with

AstraZeneca’s durvalumab, a PD-L1 checkpoint inhibitor, and

olaparib, a PARP inhibitor, which is approved for this patient popu-

lation. This second-line maintenance study will enroll patients

with high-grade BRCA-negative ovarian cancer after partial or

complete response following the second round of chemotherapy.

MD Manzoor Raza Mirza is the principal investigator for the trial,

which is sponsored by NSGO-CTU.

The first patient received treatment in the DOVACC trial in Decem-

ber 2021. Per Q4 2023 reporting date, a total of 75 out of 184 patients

have been enrolled. The trial will be conducted at approximately 35

hospitals in 10 European countries. Ultimovacs will provide the UV1

vaccine, and AstraZeneca will provide durvalumab and olaparib for

the trial.

The study includes three arms treating a total of 184 patients. The

first arm will enroll 46 patients receiving the PARP inhibitor olaparib.

The 46 patients enrolled in the second arm will receive olaparib and

the checkpoint inhibitor durvalumab. The third arm will include 92

patients who will receive Ultimovacs’ UV1 vaccine in combination

with both AstraZeneca drugs.

The primary endpoint is progression-free survival (PFS) in the treat-

ment arm with PARP inhibitor olaparib monotherapy, versus PFS in the

triple combination treatment arm. Secondary endpoints will include

overall survival (OS), objective response rate (ORR), duration of re-

sponse (DOR) and safety. Readout is expected in the first half of 2025.

Ovarian cancer

PHASE II CLINICAL TRIALS

Chapters

About non-small cell lung cancer

Immunotherapy can significantly improve outcomes

for patients fighting lung cancer. As the most com-

mon cancer worldwide, lung cancer causes an esti-

mated 1.7 million deaths each year. Lung cancer

claims more lives every year than do cancers of the breast, prostate,

and colon combined. Non-small cell lung cancer (NSCLC) comprises

approximately 85-90% of all lung cancers cases, which is typically

diagnosed in advanced stages and more challenging to treat. Further

research is needed on immunotherapy combination treatments for

advanced NSCLC.

LUNGVAC: A randomized controlled Phase II trial

in non-small cell lung cancer

The LUNGVAC trial (NCT05344209) is an investigator-initiated, ran-

domized, open-label clinical trial in which the cancer vaccine UV1

will be evaluated in combination with a PD-1 checkpoint inhibitor

as first-line treatment of NSCLC patients with advanced or meta-

static disease. The trial will enroll previously untreated patients

with adenocarcinoma or squamous NSCLC, where tumor biopsies

show a PD-L1-expression score equal to or above 50%. These sub-

groups represent approximately 30% of all advanced and metastatic

NSCLC patients. Professor Odd Terje Brustugun is the principal

investigator for the trial, which is sponsored by Drammen Hospital

in Vestre Viken Hospital Trust, Norway.

The LUNGVAC study will be conducted at approximately 10 clinical

centers in Norway. The first patient received treatment in the

LUNGVAC trial in October 2022. In December 2022, the Norwegian

health authorities changed the reimbursement of checkpoint

inhibitor in the indication from pembrolizumab to cemiplimab.

Following this decision, the LUNGVAC study changed the PD-1 in-

hibitor in the study from pembrolizumab to cemiplimab. The 138

patients will be randomized 1:1 where half of the patients will be

treated with UV1 vaccination on top of the checkpoint inhibitor,

and the other half will be treated with the checkpoint inhibitor

alone. Per Q4 2023 reporting date, 23 patients have received treat-

ment with cemiplimab +/- UV1, and three patients have received

treatment with pembrolizumab +/- UV1.

The primary endpoint of the trial will be progression-free survival.

Secondary endpoints will include overall survival (OS), objective

response rate (ORR), duration of response (DOR) and safety. Read-

out is expected in the first half of 2026.

Non-small cell lung cancer

PHASE II CLINICAL TRIALS

Chapters

Overall Survival (n=30)**

The UV1-103 trial in advanced melanoma

PHASE I CLINICAL TRIALS

ORR = Objective Response Rate

iCR = Complete Response Rate according to iRECIST

iPR = Partial Response Rate according to iRECIST

POPULATION   

PD-L(≥%)(n=) (%) (%) (%)

PD-L(<%)(n=) (%) (%) (%)

StageIIIB/C(n=) (%) (%) (%)

StageIV(n=) (%) (%) (%)

This U.S.-based Phase I clinical trial (NCT03538314) is evaluating UV1

in combination with the PD-1 checkpoint inhibitor pembrolizumab

as a first-line treatment in patients with unresectable or metastatic

malignant melanoma. Thirty patients in the U.S. were treated in the

study in two cohorts that differed only in the concentration of GM-CSF

used as vaccine adjuvant. The 20 patients in the first cohort received

a 37.5 mcg GM-CSF adjuvant dose per UV1 vaccination. The 10 pa-

tients in the second cohort received the standard 75 mcg GM-CSF

adjuvant dose per UV1 vaccination. The study has completed the

enrollment of 30 patients, as announced on August 18, 2020.

UV1 has demonstrated a good safety profile in the study, and no

unexpected safety issues related to UV1 have been observed. The

objective response rate was 57%, with 33% achieving a complete

response (disappearance of the tumors). The median progression-

free survival was 18.9 months, and the median overall survival has

not been reached after a median follow-up of 47.8 months. Com-

bined overall survival rates per year for both cohorts are shown in

the Kaplan-Meier diagram below. In Cohort 1, all patients have been

followed for 4 years, showing an overall survival rate of 73.8%.

After the study ended at two years follow-up, the protocol was

amended to allow extended follow-up of patients for up to five

years to evaluate overall survival. Three patients in Cohort 1 chose

not to be followed up further after two years, changing the num-

ber of participating patients in Cohort 1 from 20 to 17. 12 out of 17

patients were confirmed alive after 4 years.

The target patient population in the UV1-103 trial is similar to the

UV1 Phase II trial INITIUM.

The UV1-103 trial – biomarker analyses

The analyses of five different biomarkers in the UV1-103 trial, pub-

lished in Q3 2023 in Clinical Cancer Research, signal efficacy in

patients treated with UV1 in combination with pembrolizumab.

These results are supportive of the addition of UV1 to checkpoint

inhibitors, with the potential for improving both efficacy in current

target patient populations and extending the use of immunotherapy

to broader patient populations in multiple cancer types that are un-

derserved by existing therapies. The potential value of expanding the

number of patients that can benefit from UV1 could be substantial.

Clinical analyses from the UV1-103 study indicate efficacy of the

UV1-pembrolizumab combination in patients with low levels of

PD-L1 (<1%). Low PD-L1 levels are a key predictive biomarker asso-

ciated with lower efficacy for pembrolizumab and other anti-PD-1

therapies in some tumor types. The analyses showed robust respons-

es in patients treated with the combination of UV1 and pembroli-

zumab, regardless of patients’ PD-L1 status.

In addition to the sub-analysis of PD-L1 status, the study also eval-

uated four other key biomarkers that, in other historical studies,

have indicated how responsive patients may be to pembrolizumab

monotherapy: baseline tumor mutational burden (TMB), predicted

neoantigens, interferon-gamma (IFN-gamma) gene signature, and

levels of tumor-infiltrating lymphocytes (TILs). In the UV1-103 study,

objective responses were also observed in patients with low TMB,

in patients with low neoantigen burden, and in patients with tumors

that were not enriched for IFN-gamma. These are characteristics

of tumors that previous data have shown would be less responsive

to treatment with pembrolizumab monotherapy in various cancer

types. Lastly, the study also showed that clinical responders did

not have higher levels of TILs prior to treatment.

Chapters

In addition to UV1-103, Ultimovacs has conducted three Phase I trials

with UV1: in metastatic prostate cancer (n=22 patients), in meta-

static non-small cell lung cancer (n=18 patients), and in metastatic

malignant melanoma with UV1 in combination with ipilimumab

(named ‘UV1-ipi’, n=12 patients). Enrollment of patients in these

trials took place during 2013-2015.

Data from these clinical trials showed that UV1 was generally well

tolerated, has a good safety profile, and there were no dose-limiting

toxicities. UV1 immune monitoring data from these studies showed

a robust and durable immune response induction with dynamic T

cell responses in 78% of the patients, lasting up to 9.5 years.

The observed clinical outcomes from these three completed trials

served as a strong basis for the further clinical development of UV1

with respect to safety, immune response and signals of clinical

effect.

Earlier UV1 Phase I trials

(in long-term follow-up)

PHASE I CLINICAL TRIALS

Chapters

Mesothelioma

EMA Orphan Drug Designation has been granted to UV1 for

treatment of mesothelioma (February 2024)

FDA Fast Track Designation has been granted for UV1 as

add-on therapy to ipilimumab and nivolumab for treatment

of malignant pleural mesothelioma (February 2024)

FDA Orphan Drug Designation has been granted to UV1 for

treatment of mesothelioma (October 2023)

Melanoma

FDA Orphan Drug Designation has been granted to UV1 for

treatment of stage IIB-IV melanoma (December 2021).

FDA Fast Track Designation has been granted for UV1 as add-

on therapy to ipilimumab or pembrolizumab for treatment of

unresectable or metastatic melanoma (October 2021)

Regulatory designations

Chapters

Manufacturing

UV1 as a pharmaceutical product

UV1 is designed as a convenient off-the-shelf product with a long

shelf life, easy to use with simple intradermal administration. The

use of the vaccine does not require screening of patients or so-

phisticated hospital infrastructure. These features extend accessi-

bility to community centers and in rural and underserved commu-

nities, ensuring broad patient access to therapy.

Ultimovacs is progressing development of chemical manufacturing

and control (CMC) of the UV1 product candidate in preparation for

Phase III clinical trials and Process Performance Qualification with

commercial scale manufacturing processes.

PolyPeptide Group is the contract development and manufacturing

organization (CDMO) for the UV1 Active Pharmaceutical Ingredients.

Corden Pharma is the CDMO for the manufacture of the UV1 Drug

Product (fill and finish). These CDMOs have the required capabili-

ties to manufacture UV1 in a commercial phase.

Active Ingredients

Three highly immunogenic peptides

(one 30-mer and two 15-mers) from

the active site of telomerase reverse

transcriptase (TERT)

Peptide Selection Strategy

Selected based on strong immuno-

genicity and correlation to pro-

longed survival in human trials

Vaccine Adjuvant

Granulocyte-macrophage colony

stimulating factor (GM-CSF /

sargramostim*) administered

separately

Simple Administration

8 intradermal vaccinations over

a 14-week period

Off-the-shelf Treatment

Peptides are promiscuous with

respect to HLA class I and II

alleles

Simple Production + Logistics

Standard peptide synthesis,

stable product with 3 years

shelf life at 5 °C

Commercial Scale Process in place

Chapters

TET vaccines have the tumor antigen and the adjuvanting signals

in one unit. The adjuvanting effect is mediated by the tetanus-

derived sequences. TET harness the immune activation function

of immune complexes that is formed between the tetanus-derived

parts of the vaccine and pre-existing antibodies against tetanus

resulting from standard tetanus vaccination. Immune complex for-

mation is known to be an effective way to initiate and amplify an

immune response.

In Ultimovacs’ TET vaccines, the tetanus sequences and the anti-

gen are linked by use of an innovative conjugation technology. This

conjugation technology allows for flexibility to incorporate a variety

of antigens, and thereby tailoring vaccines to different types of

cancer. The TET vaccine adjuvant technology and the conjugation

technology may be basis for new, first-in-class therapeutic cancer

vaccines.

THE ANTIBODIES

bind to the tetanus

sequences in the

vaccine, forming an

immune complex.



sequences facilitating

the adjuvant function

ANTIGEN that directs the

immune response towards

the intended goal

THIS LEADS TO acti-

vation of vaccine spe-

cific T cells…

… and killing of

the tumor.

TET (Tetanus-Epitope Targeting) is Ultimovacs’

patent protected vaccine adjuvant technology.

TET ensures targeted delivery of both antigen

and adjuvant signals to antigen presenting cells,

and is a novel strategy to effectively activate

tumor specific T cells.

TET vaccine adjuvant technology

VACCINATION.

Anti-tetanus anti-

bodies are already

present in the

circulation.

THE IMMUNE COMPLEX binds

to receptors on dendritic cells.

→ targeting of antigens to den-

dritic cells immune complexes

mediate clustering of receptors

on the dendritic cells.

→ adjuvanting effect

RECEPTORS CLUSTERING

promts the dendritic cell to

inernalize the imune com-

plex anf mature into an

antigen presenting cell.

PIPELINE

Chapters

The study was conducted at Oslo University Hospital and enrolled

a total of 12 patients between Q1 2021 and Q4 2022. Three different

doses of TENDU were investigated: 40mcg (3 patients), 400mcg

(3 patients), and 960mcg (6 patients). All patients were followed up

for 6 months after their last treatment.

Ultimovacs announced results from the TENDU study in Q4 2023.

The trial showed good safety and tolerability across all dose cohorts,

meeting the primary endpoint. The data also included observations

of immune activation with vaccine specific T cell responses, meeting

the secondary endpoint. No dose-limiting toxicities were observed,

indicating a potential for increasing the dose of TET based vaccines

in future clinical studies. Further results from the study will be

presented in a peer-reviewed publication.

TENDU Phase I trial

The TENDU study was the first Phase I trial

exploring the TET technology. In TENDU, TET

is used together with prostate-cancer-specific

antigens. The trial’s objective was to provide

safety and immune activation data to support

the further development of new vaccine solu-

tions utilizing the TET strategy.

PIPELINE

Chapters

Ultimovacs is conducting a series of activities

to further develop and explore the potential

of TET and the conjugation technology. Pre-

clinical experiments support the TET strategy

of targeted delivery of antigens and adjuvant

signals to antigen presenting cells.

PIPELINE

Other CMC and preclinical

development

The combination of exploratory research using Ultimovacs’ conju-

gation technology, significant progress made in the manufacturing

process, and the clinical data, provide a valuable basis for potential

expansion of Ultimovacs’ pipeline.

Ultimovacs’ will continue the ongoing TET nonclinical activities.

Future development of TET based vaccine candidates will take into

consideration the evolution of the therapeutic landscape and medi-

cal needs in different tumor types.

Chapters

Publications

“UV1 telomerase vaccine with ipilimumab and nivolumab

as second line treatment for pleural mesothelioma – a

phase II randomized trial”

European Journal of Cancer, March 1, 2024

https://www.ejcancer.com/article/S0959-8049(24)00129-1/fulltext

“LBA99 – First survival data from the NIPU trial: A rand-

omized, open-label, phase II study evaluating nivolumab

and ipilimumab combined with UV1 vaccination as second-

line treatment in patients with malignant mesothelioma”

ESMO 2023 / Annals of Oncology, October 21 2023

https://oncologypro.esmo.org/meeting-resources/esmo-congress/first-

survival-data-from-the-nipu-trial-a-randomised-open-label-phase-ii-

study-evaluating-nivolumab-and-ipilimumab-combined-with-uv1-vac-

cination

“Clinical Activity of Combined Telomerase Vaccination and

Pembrolizumab in Advanced Melanoma: Results from a

Phase I Trial”

Clinical Cancer Research, August 15 2023

https://aacrjournals.org/clincancerres/article/29/16/3026/728218/Clini-

cal-Activity-of-Combined-Telomerase

“Therapeutic cancer vaccination against telomerase:

clinical developments in melanoma”

Current Opinion in Oncology, March 2023

https://journals.lww.com/co-oncology/fulltext/2023/03000/therapeu-

tic_cancer_vaccination_against_telomerase_.4.aspx

“Durable and dynamic hTERT immune responses following

vaccination with the long-peptide cancer vaccine UV1:

long-term follow-up of three phase I clinical trials”

Journal for ImmunoTherapy of Cancer, May 25, 2022

https://jitc.bmj.com/content/10/5/e004345.info

“Telomerase as Target for Therapeutic Cancer Vaccines

and Considerations for Optimizing Their Clinical Potential”

Frontiers in Immunology, July 5, 2021

https://www.frontiersin.org/journals/immunology/articles/10.3389/fim-

mu.2021.682492/full

Chapters

Ultimovacs is continuously working to obtain and

maintain patent protection for the company’s tech-

nologies and platforms. This will in due time include

seeking to obtain patent term extensions such as

Supplementary Protection Certificates (SPCs) in

Europe and Patent Term Extension (PTE) in the USA.

SPCs and PTE can be applied for after the granting

of market authorization in the respective territories.

Intellectual property

In Europe, patent term extensions via an SPC are up to 5 additional

years provided that this does not result in a total remaining patent

plus SPC term of more than 15 years from the grant of marketing

approval (+ 0.5 years via pediatric extension (PED)) and in the US,

extensions via PTE are up to 5 years, provided that the extension

does not result in a total remaining patent term of more than 14

years from FDA approval (+ 0.5 years via PED).

There are also other mechanisms for protection of pharmaceutical

products in addition to patents. Regulatory data exclusivity blocks

subsequent drug developers from referencing (comparing to) an

innovative drug’s data in order to take a shortcut to get marketing

authorization. European regulations provide eight years of data ex-

clusivity for innovative drugs, starting from the first marketing

authorization date. Data exclusivity is followed by a two-year mar-

ket exclusivity period, which can be extended by a further year if

the product shows significant clinical benefit in a new therapeutic

indication. Competitors will not be able to launch generic or bio-

similar product until the expiry of the data and marketing exclusivity

periods. In the USA the market exclusivity term for innovative bio-

logics is 12 years from the date the reference product was first

licensed with an additional 6 months of exclusivity for use in pedi-

atric populations. For qualifying indications with small patient pop-

ulations Orphan Drug status may be granted to a pharmaceutical

product giving market exclusivity for 10 years (+ 2 years for PED plan)

in Europe and 7 years (+ 0.5 years via PED) in the US. In Europe,

products granted Orphan Drug status are not anymore entitled to

the + 0.5 years via PED to SPC protection.

Chapters

Patent / patent

application

Priority date Status Area Covered Geographic area

Expiry date

(unextended)

Expiry date

(extended)

Assignee

1 EP10250265.5 16 Feb 2010 Granted/pending UV1 composition of matter, the nucleic acid sequences coding

for the vaccine peptides, as well as use of the vaccine for the

treatment of cancer.

Patent granted in: Europe, USA,

Japan, Russia, South-Korea, India,

China and Hong Kong, including

divisionals in USA and Japan.

Divisional applications have been

filed in Europe, USA, Japan, India,

and China.

2031 Up until 15 February 2036

via a Supplementary Pro-

tection Certificate (SPC) in

Europe or via Patent Term

Extension (PTE) in the USA.

 

Ultimovacs

2 EP16172760.7 2 June 2016 Granted/pending UV1 in combination with an immune checkpoint inhibitor of a

certain definition, including combined treatment with UV1 and

anti-CTLA-4 and/or anti-PD(L)-1 antibodies.

Patent granted in USA.

Pending national/regional phase

in Europe, Japan, Australia and

Canada.

Divisional applications have been

filed in USA and Japan.

2037 Maxiumum term could be

until 2042 via a SPC in Eu-

rope or PTE in USA, but it

could be shorter depending

on various factors.  

Ultimovacs

3 EP10156505 15 March 2010 Granted Composition of matter and method of use for an immunogen

comprising a peptide derived from tetanus toxin.

Patent granted in USA, Europe

and Canada.

2031 – Leiden University

Medical Centre

(Ultimovacs license)

4 GB1917699.9 4 December 2019 Pending Composition of matter of TENDU conjugates and vaccine

compositions and use thereof for the prevention or treatment

of cancer, T-cell epitopes of the conjugates and the encoding

nucleic acid molecules.

Pending national/regional phase

in USA, Europe, Japan, China,

Hong Kong, India and Canada.

2031 – Ultimovacs

5 EP21178648.8 9 June 2021 Pending 1. Composition of matter of a TET conjugate comprising a

B-cell epitope (such as an MTTE sequence) and certain

CD4+ T-cell epitopes (such as an hTERT sequence). Also, nu-

cleic acid sequences encoding the conjugate as well as use

of the conjugate for the treatment or prophylaxis of cancer.

2. Compositions of matter of certain hTERT polypeptides and

the nucleic acid sequences encoding these as well as their

use in the treatment or prophylaxis of cancer.

3. Composition of matter of a core molecule.

4. A (biomarker) method for detecting a CD4+ T-cell response

following vaccination by measuring specific B-cell responses.

Pending national/regional phase

in USA, Europe, Japan, China,

India, Canada, Korea, Mexico,

Australia and Israel.

2040 – Ultimovacs

1 In the list of published patents and patent applications the ownerships of patents and patent app-

lications 1 and 2 related to the UV1 platform are held by Ultimovacs. Patents and patent applicat-

ions in group 3,4 and 5 are related to the TET platform. Patents in group 3 are licensed from Leiden

University Medical Centre. Patent applications in group 4 and 5 are held by Ultimovacs.

2 Europe: It is likely that SPCs based on both patents granted, from EP10250265.5 and EP16172760.7,

could be obtained;

3 USA: PTE can generally only be obtained for one patent based on a single marketing authorization

Published patents and patent applications

Chapters

BoardofDirectorsStatement 

BoardofDirectors 

Financialoverview 

Environmentandgovernance 

Risksanduncertainties 

Goingconcern 

Outlook 

Responsibilitystatement 

03 Board of

Directors' Report

Chapters

The negative results from the INITIUM trial in March 2024, were

unexpected and undoubtedly disappointing. Based on encouraging

results from Phase I studies with UV1 and ipilimumab and UV1 and

pembrolizumab, melanoma has been considered a lead indication

for the UV1 vaccine. The study was statistically powered and thought-

fully designed based on discussions with international experts in

the field. The patient enrollment across 40 sites in four countries

– during the pandemic – was impressive. The patients took longer

to progress in this study than in any comparable trial. These sig-

nals gave us reason to be optimistic.

The INITIUM results have important consequences for the company,

and for the shareholders. The Board initiated the implementation

of cash preservation initiatives immediately to ensure that the

available financial resources will sustain the company into 2025.

While the INITIUM trial failed, the company remains committed to

the development of the UV1 vaccine in specific therapeutic combi-

nations and indications.

With the NIPU readout in 2023, the first of the Phase II trial read-

outs, UV1 has showed clinically meaningful data in patients’ overall

survival in second-line malignant mesothelioma, a hard-to-treat

indication. The confirmed objective response rate by the blinded

independent central review almost doubled in the patient group

who received UV1 vaccination on top of ipilimumab and nivolumab.

This milestone is a signal of UV1’s ability to provide therapeutic

value for cancer patients with extremely limited treatment options.

Ultimovacs looks forward to receiving more mature survival data

from the NIPU trial.

The upcoming clinical trial readout in the FOCUS trial will be im-

portant for determining the path forward for UV1 in the field of

cancer vaccines.

Despite the recent challenges, the Ultimovacs team has demon-

strated relentless commitment and we highly appreciate their

excellent work and persistent dedication in the past year.

Board of Directors

The cancer vaccine UV1 is being studied in a

wide-ranging clinical program involving different

cancers and combinations with other immuno-

therapies. Readout from the randomized Phase

II clinical trials, which began in 2023, will guide

the future development of UV1.

Board of Directors Statement

Chapters

Jònas Einarsson has been the Chair of the Board since 2018 and

has served as a Board Member since 2011. Mr. Einarsson has over

30 years of experience in the medical industry and has had and

has several board positions in Norwegian biotech companies. He is

currently the CEO of Radforsk Investment Fund, which position he

has held since 2000. Mr. Einarsson was a general practitioner and

health director of the Lardal municipality from 1991 until 2000 and

was general manager of Oslo Private Hospital from 1984 until 1991.

Mr. Einarsson is educated as a Medical Doctor (MD) from the Rey-

kjavik University, Iceland and the University of Oslo, Norway.

Leiv Askvig has served as a Board Member since 2015 and is cur-

rently also a member of the Audit Committee. Mr. Askvig is an In-

vestment Advisor for Sundt AS and served as their CEO from 2003

to 2020. Mr. Askvig has vast experience within the financial indus-

try. He was CEO/CFO at Opticore AB from 2001 until 2002, CFO at

StudentUniverse, Inc. from 1999 until 2001 and has held various

positions within investment banking at Sundal Collier & Co ASA

(now “ABG Sundal Collier”). Mr. Askvig has significant board experi-

ence from a variety of industries.

Mr. Askvig holds a bachelor’s degree in Business Administration

from BI Norwegian Business School and attended the Advanced

Management course at Harvard Business School.

Ketil Fjerdingen has served as a Board Member since 2012 and

was the Chair of the Board of Directors from 2012 until 2018.

Mr. Fjerdingen has, since 2002, been involved in investments and

property development projects through a range of small single

purpose companies. Prior to this, he held various executive man-

agement roles with companies including VI Partners AS, Mobile

Media, Ernst & Young and Fokus Bank ASA.

Mr. Fjerdingen holds the degree of Certified Public Accountant

from NHH Norwegian School of Economics.

Board of Directors

Kari Grønås has served as a Board Member since 2019. Ms. Grønås

has broad experience from the pharmaceutical/biotech industry.

She has extensive experience in drug development and commer-

cialization within the pharmaceutical industry of new breakthrough

products securing regulatory approvals, i.e. Xofigo, Hexvix. Grønås

also holds significant leadership and management experience in-

cluding leadership of cross functional and governance teams from

Bayer/Algeta ASA, PhotoCure and Nycomed Imaging/Amersham

Health (Now GE Healthcare). Today she is a consultant within the

sector and holds board positions in Spago Nanomedical AB, Arxx

AS and The Norwegian Lung Cancer Society.

Ms. Grønås holds a M. Pharm. degree from the University of Oslo.

Chapters

Board of Directors

Henrik Schüssler has served as a Board Member since 2015.

Mr. Schüssler is the CEO and board member of Gjelsten Holding AS,

which position he has held since 2000. Mr. Schüssler was CEO and

CFO at Norway Seafoods ASA from 1995 until 2000 and accountant/

consultant at Ernst & Young AS from 1987 until 1995. Mr. Schüssler

has significant board experience from several other companies.

Mr. Schüssler holds a Bachelor of Chartered Accounting from

BI Norwegian Business School.

Eva S. Dugstad has served as a Board Member since 2019.

Ms. Dugstad started as Manager for Business and Community Rela-

tions at Faculty of Mathematics and Natural Sciences, University of

Oslo, in February 2022. Her previous appointments include Director

for Business Development in Radforsk, the President and the Exec.

Vice President at the Institute for Energy Technology (IFE), where

she also was the Chair of the Board for IFE Venture. Ms. Dugstad

has been involved in various boards in both public and private sector

and in several public expert panels.

Ms. Dugstad holds a Cand. Pharm. degree from the University of Oslo.

Haakon Stenrød has served as a Board Member since 2020 and is

currently also a member of the Audit Committee. Mr. Stenrød is a

Senior Investment Manager at Watrium. Prior to joining Watrium,

Mr. Stenrød spent 12 years in the Investment Banking department

of ABG Sundal Collier, focusing on M&A, restructurings and capital

markets advisory. He is currently a Board member of DF Capital,

a UK challenger bank listed on AIM London and Vertus Capital, a

specialist capital provider to independent financial advisors.

Mr. Stenrød holds a Master in Industrial Economics and Technology

management from NTNU, studied at London School of Economics

and was an officer in the Royal Norwegian Army.

Aitana Peire served as a Board Member from 2020 until she resig-

ned from the Ultimovacs Board of Directors on the 13th of December

2023 due to her appointment as Director of Investments at The

Johns Hopkins University.

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Financial overview

Financial results

Ultimovacs does not yet generate revenues, as the Company is in a

research and development phase. In FY23, the Company recognized

government grants of MNOK 10.2 compared to MNOK 9.5 in FY22,

which have been deducted from payroll expenses and other operat-

ing expenses in the statement of profit and loss. The cash payments

from the grants are partly received in the calendar year following

the accounting year. The grants received are from Innovation Norway

(MNOK 5.1) for the DOVACC project, Forskningsrådet (MNOK 3.1) for the

FOCUS project, and MNOK 2.0 from the Skattefunn grant scheme.

Total personnel expenses in FY23 were MNOK 75.1 compared to

MNOK 71.5 in FY22. The FY23 increase was primarily due to two more

FTEs employed in the company during FY23 compared to FY22,

explaining approximately MNOK 5.7 of the difference, along with

the general salary increase. This was offset by lower expenses

related to the share option program, MNOK 2.0.

Other operating expenses primarily comprise research and devel-

opment related expenses. These expenses, including IP and ex-

ternal R&D expenses, offset by government grants, amounted to

MNOK 121.2 in FY23 and MNOK 91.0 in FY22. The primary projects

contributing to these expenses in FY23 were the phase II trials IN-

ITIUM, NIPU and DOVACC, CMC development (i.e. Chemistry, Man-

ufacturing, and Controls), and development of the TET platform.

Total other operating expenses in FY23 was MNOK 137.8 compared

to MNOK 109.5 in FY22, where the total increase primarily is de-

rived from the increase in R&D costs.

Net financial income in FY23 of MNOK 26.5 is comprised primarily

of MNOK 14.1 in interest from bank, MNOK 1.8 in currency gain from

cash in EUR bank account and MNOK 12.7 in currency gain from the

EUR currency future contracts.

Total loss in FY23 amounted to MNOK 189.2 compared to a loss of

MNOK 167.8 in FY22.

  

Totalrevenues - -

Totaloperatingexpenses () ()

  

  

Basicanddilutedearnings(loss)pershare(NOKpershare) () ()

Netchangeincashandcashequivalents () ()

  

Financial position

Total assets per 31 December 2023 were MNOK 349.0, a decrease

of MNOK 160.6 from 31 December 2022, primarily as a consequence

of negative operational cashflow.

The book value of Goodwill and Licenses amounted to MNOK 68.2

per 31 December 2023. This value related to the value of the sub-

sidiary Ultimovacs AB in Sweden, has since 31 December 2022

decreased by MNOK 5.6 due to the weakening of NOK against SEK.

Total liabilities as of 31 December 2023 amounted to MNOK 69.6,

of which MNOK 13.5 are non-current. The Company has entered into

EUR swap contracts to mitigate the foreign exchange risk related

to expected future costs in ongoing projects. By the end of the

fiscal year, the EUR swaps amounted to MEUR 7.3, and MNOK 4.9

of ‘Other current liabilities’ are related to the fair value of these

EUR swap contracts by the end of the year.

 equaled MNOK 279.4 as of 31 December 2023. A cap-

ital increase in November 2023 related to the exercise of a total

of 9,600 options granted under Ultimovacs’ share option program,

resulted in gross proceeds of MNOK 0.3. Subsequently, the Com-

pany’s share capital increased during 2023 by NOK 960 by issuing

9,600 new shares, leading to a total of 34,406,061 shares as per

31 December 2023, each share of par value NOK 0.10.

Further, total equity has, since year-end 2022, been decreased by

the period’s operating loss and currency translation, amounting to

MNOK 184.5, and has in addition been increased by the recognition

of share-based payments/stock options of MNOK 14.3.

Cash flow

The total net decrease in cash and cash equivalents in FY23, not

including currency effects, was MNOK 177.6, which is primarily relat-

ed to net negative cash-flow from operations amounting to MNOK

189.8, offset by interest income of MNOK 14.1 and a share issue

related to share option exercises, raising net proceeds of MNOK 0.3.

 per 31 December 2023 amounted

to MNOK 266.6.

Allocation of the Parent Company’s net result

The Board of Directors proposed that the loss of MNOK 183.7 in

Ultimovacs ASA is transferred to accumulated losses.

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Working environment

Ultimovacs aims to provide a safe, secure and positive work envi-

ronment for all employees, free of discrimination or harassment.

Ultimovacs does not accept any kind of discrimination against em-

ployees, shareholders, board members and suppliers on the basis

of ethnicity, nationality, age, gender, or religion. Salary and terms

of employment for comparable positions, as well as recruitment,

promotion and development of the employees, are the same for

women and men.

Absence due to sickness was 1.0% in 2023, compared to 1.1% in 2022.

No work-related accidents were recorded in Ultimovacs in 2023.

As per 31 December 2023, the Group had 27 employees, 21 in Ulti-

movacs ASA in Oslo, and 6 in Ultimovacs AB in Uppsala, Sweden.

Of the 27 employees, three were part time employees with 20-50%

positions. 12 out of the 27 employees were male and 15 were female.

The management team is comprised of six men and four women,

and the Board of Directors is comprised of five men and two wom-

en (three until the 13th of December 2023, as Aitana Peire resigned

from the Board on this date).

A total of 25 full time employee equivalents were employed during

the financial year of 2023.

External Environment

Ultimovacs’ operations do not directly pollute or harm the environ-

ment, and the Company and its employees are committed to behav-

ing responsibly and to minimizing the impact on the environment.

Environment and governance

Corporate Governance

The Board and management of Ultimovacs are committed to main-

taining high ethical standards and promoting good corporate gov-

ernance. Ultimovacs believes that strong corporate governance

builds and maintains confidence among investors and other stake-

holders, and thereby supports maximal value creation over time.

The Board believes that attention to corporate governance is bene-

ficial for companies and investors. Ultimovacs’ corporate govern-

ance principles are based on maintaining a transparent and clear

communication, regulating the division of roles between share-

holders, the Board and Executive Management, and treating all

shareholders equally. In addition, shares in the Company are freely

transferable and all shareholders are to be treated equally.

Ultimovacs’ Corporate Governance Policy (approved by the Board

of Directors on 24 March 2022) and the Report in this annual

statement are based on the Norwegian Code of Practice for Corp-

orate Governance, issued by the Norwegian Corporate Governance

Board (NUES), last revised on 14 October 2021, and the corporate

governance reporting requirements under section 3-3b of the Nor-

wegian Accounting Act.

Corporate Governance is further addressed in a separate statement

in this Annual Report and constitutes an integral part of the Directors

Report. The full Corporate Governance Policy is available on the

company’s website at www.ultimovacs.com/investors/governance

Corporate Social Responsibility

Ultimovacs is committed to develop, manufacture and deliver in-

novative cancer vaccines to address unmet medical needs and ad-

vance cancer care. In its pursuit to reach this goal, Ultimovacs will

work to ensure a socially responsible business operation involving

good business ethics, as well as how employees are treated, the

relationship with the environment and the work to deliver safe

products to patients, among others.

Ultimovacs recognizes that we must integrate our business values

and operations in a way so that we act responsibly in a broader

social context and meet key expectations of our stakeholders. These

stakeholders include employees, patients, regulators, suppliers,

shareholders, the community and the environment. Ultimovacs will

work to ensure a socially responsible business operation involving

good business ethics, as well as how employees are treated, the

relationship with the environment and the work to deliver safe

products to patients, among others.

Key CSR focus areas identified and integrated into the Company’s ESG

Guidelines (Environmental, Social, & Governance), are patient safety,

employee environment, human rights, environment, supply chain

management, anti-corruption and transparent communication. In ad-

dition, separate ethical guidelines apply to all employees in the group.

Corporate Social Responsibility is further addressed in the ESG Report

which also includes the reporting on the Transparency Act (Norwe-

gian: ‘Åpenhetsloven’), included in section #3 in this Annual Report.

The ESG guidelines along with the annual ESG report, are available

on the company’s website at www.ultimovacs.com/investors/ESG

The Board of Directors of Ultimovacs are ultimately responsible for

the ESG governance in the Company, overseeing the ESG topics

and Management’s role in assessing and managing them. All em-

ployees are responsible for adopting and implementing the Com-

pany’s guidelines on ESG.

The ESG Guidelines will be regularly reviewed and any amendment

shall be approved by the Board of Directors.

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certain geographical areas/markets, produce the relevant products,

in-license and out-license products and technology, etc.

Competitive environment

Competitive cancer treatments and new/alternative therapies, either

within immune-oncology or within the broader space of oncology,

may affect the Group’s ability to commence and complete clinical

trials, as well as the opportunity to apply for marketing authoriza-

tion, and may influence future sales if marketing authorization is

obtained. Competing pharmaceuticals can capture market shares

or reach the market faster than Ultimovacs. If competing projects

have a better product profile (e.g. better efficacy and/or less side

effects), the future value of Ultimovacs’ product offerings may be

lower than expected. The amount and magnitude of clinical trials

within different oncology areas in which the Group operates may

influence the access to patients for clinical trials.

Financial risks

The primary financial risks are financing risk and foreign exchange

risks.

Financing

Adequate sources of funding may not be available when needed or

may not be available on favorable terms. The Company’s ability to

obtain such additional capital or financing will depend in part upon

prevailing market conditions as well as conditions of its business

and its operating results, and those factors may affect its efforts

to arrange additional financing on satisfactory terms. The Group

monitors the liquidity risk through monthly rolling consolidated

forecasts for result and cash flow, and the Board of Directors works

Risks and uncertainties

continuously to secure the business operation’s need for financing.

The financing risk is higher after the negative results from the

INITIUM trial.

Foreign exchange rate exposure

Ultimovacs will conduct a large share of its clinical studies and

other R&D activities outside of Norway and is therefore exposed to

fluctuations in the exchange rate between NOK and several cur-

rencies, mainly EUR and USD. Further, production is conducted in

France and Italy, and production costs are, therefore, exposed to

the fluctuations of EUR against NOK. The fluctuation of the above-

mentioned currencies may therefore impact the overall costs for

the clinical studies and production, as well as other costs such as

consultants invoicing in these currencies.

In addition, the Company has investment in foreign operations,

whose net assets are exposed to currency translation risk.

Operational currency exposure is constantly monitored and assessed.

The Group has converted cash to EUR and entered into EUR swaps

to mitigate the foreign exchange risk and to get a better predicta-

bility regarding future costs.

Interest rate risk

The Group has no interest-bearing debt. Bank deposits are exposed

to market fluctuations in interest rates, which impact the financial

income.

Ultimovacs’ financial risk exposures are described in more detail in

note 17 in this financial statement.

Ultimovacs is a clinical-stage biotechnology company. Ultimovacs

is exposed to the same generic risks as other companies within this

sector. The Company has not generated any revenues historically

and is not expected to do so in the short term, unless a potential

partnering agreement for UV1 provides early revenues. The Group’s

development, results of operations and operational progress have

been, and will continue to be, affected by a range of factors, many

of which are beyond the Group’s control.

Operational risks

Research and development up to approved registration is subject

to considerable risk and is a capital-intensive process. The Com-

pany’s cancer vaccine candidates and technology platforms are

dependent on research and development and may be delayed

and/or incur higher costs than currently expected.

Product risk

Ultimovacs' product and technology candidates may not meet the

anticipated efficacy requirements or safety standards, resulting in

discontinuation of the development.

Legislative and regulatory environment

Operations may be impacted negatively by changes or decisions

regarding laws and regulations. Several regulatory factors have in-

fluenced and will likely continue to influence the Group’s results

of operations. The Group operates in a heavily regulated market and

regulatory changes may affect the Group’s ability to commence and

perform clinical studies, include patients in clinical trials, protect

intellectual property rights and obtain patents, obtain marketing

authorization(s), market and sell potential products, operate within

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The annual accounts have been prepared on the basis of a going

concern assumption, in accordance with section 3-3(a) of the Nor-

wegian Accounting Act, and in the opinion of the Board of Directors,

these financial statements provide a fair presentation of the Compa-

ny’s business, financial results, and outlook. Apart from events de-

scribed under the section ‘Subsequent events’ below, no significant

events have occurred since the end of 2023, and the Board of Direc-

tors confirms that the going concern assumption has been satisfied.

Subsequent events

In March 2024, Ultimovacs announced topline results from INITIUM

study evaluating UV1 in Patients with Malignant Melanoma. The trial

did not meet the primary endpoint of prolonging progression-free

survival (PFS), and the evaluation of secondary endpoints did not

show a difference in overall survival and objective response rate

between the treatment and control arms. The Group has therefore

initiated cash preservation initiatives which will be implemented

to support that the available financial resources will sustain the

company into 2025.

Going concern

Outlook

The cancer vaccine is expected to generate immune responses

across the general population (i.e., regardless of HLA type). The

vaccine is easy to administer and does not require a sophisticated

hospital infrastructure. Ultimovacs has been granted patents in

major markets covering UV1 composition of matter and UV1 in

combination with anti-CTLA-4 and/or anti-PD(L)-1 checkpoint

inhibitors. A commercial-scale manufacturing process has been

developed in collaboration with reputable manufacturers.

As of now, UV1 is being investigated in five randomized Phase II

trials in five different cancer types in combination with various

checkpoint inhibitors, with Ultimovacs sponsoring one of the trials.

The five Phase II clinical trials will enroll more than 670 patients in

total, representing a potential foundation for Ultimovacs to support

a possible registration path of the UV1 vaccine. The main study

objectives are efficacy and safety data on combination therapies.

The negative readout of the INITIUM trial in malignant melanoma

was very disappointing for Ultimovacs. The NIPU trial in mesotheli-

oma showed a clinically meaningful improvement in overall survival

and the company looks forward to receiving more mature survival

data from this trial during 2024. During the third quarter of 2024,

Ultimovacs expects the readout of the FOCUS trial in head and

neck cancer. The data points from NIPU and FOCUS will be impor-

tant for the further development of UV1.

Ultimovacs will implement cash preservation initiatives, based on

updated programs and plans, to extend the financial runway further

into 2025.

Besides UV1, Ultimovacs is developing a vaccine technology, TET

(Tetanus-Epitope Targeting). TET vaccines harness pre-existing

antibody responses against tetanus induced by standard tetanus

vaccination. Different pre-clinical and CMC activities are currently

on-going. The TET technology may be used in many types of cancer

vaccines.

Ultimovacs’ off-the-shelf therapeutic cancer vaccine UV1 triggers

immune responses against telomerase, which is present in 85-90%

of all cancer indications in all stages of tumor growth. The nearly

universal nature of the target supports a clinical program investigat-

ing the potential effect of UV1 vaccination across multiple types of

cancer and in combination with different types of cancer treatment.

Board of Directors and CEO

of Ultimovacs ASA

Oslo, 20 March 2024

Sign

Jónas Einarsson

Chair of the Board

Sign

Ketil Fjerdingen

Board member

Sign

Henrik Schüssler

Board member

Sign

Haakon Stenrød

Board member

Sign

Leiv Askvig

Board member

Sign

Kari Grønås

Board member

Sign

Eva S. Dugstad

Board member

Sign

Carlos de Sousa

CEO

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Responsibility statement

We confirm that the financial statements for the period 1 January

to 31 December 2023, to the best of our knowledge, have been

prepared in accordance with IFRS Accounting Standards as adopt-

ed by the EU, that the accounts give a true and fair view of the

assets, liabilities, financial position and profit or loss, and that the

information in the report includes a fair review of the development,

performance and position of the Company and the Group, together

with a description of the principal risks and uncertainties facing

the Company and the Group.

Board of Directors and CEO

of Ultimovacs ASA

Oslo, 20 March 2024

Sign

Jónas Einarsson

Chair of the Board

Sign

Ketil Fjerdingen

Board member

Sign

Henrik Schüssler

Board member

Sign

Haakon Stenrød

Board member

Sign

Leiv Askvig

Board member

Sign

Kari Grønås

Board member

Sign

Eva S. Dugstad

Board member

Sign

Carlos de Sousa

CEO

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04 Governance

ESGataglance 

ESGinUltimovacs 

CorporateGovernanceReport 

Chapters

ESG at a glance

Goal 3

UN Sustainable Development

UV1 safety

More than 300 patients

have received treatment

with UV1 per date

with no severe safety

concerns reported.

Off-the-shelf

Access to medicines is

key to solving many public

health issues. UV1 can be

administered at hospitals

or community centers

without sophisticated

infrastructure.

Environmental

impact

Diversity

26 employees

7 nationalities

54%

46%

40%

60%

3 5

Employees

Management

team

Board of

Directors

(until Dec 13, 2023)

2 tonnes GHG emissions

0.9 tonne waste

52 m3

water

Zero recalls issued

Business

ethics

Zero complaints or

legal proceedings

associated with

breach of Code of

Conduct

None of Ultimovacs’ product candi-

dates are currently on the market.

5 randomized Phase II

trials enrolling

> 670 patients

in Europe, USA

and Australia

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General meeting

Audit Commitee

Board

of Directors

Remuneration

Commitee

Nomination

Commitee

ESG Commitee

ESG governance

Responsibility for Ultimovacs’ ESG performance

is ultimately held by the Board of Directors. All

board members have relevant experience as a

public or private company executive. ESG initi-

atives are managed by the CEO. Head of IR has

responsibility for reporting on ESG performance.

The Governance framework, Corporate Govern-

ance Policy, and Corporate Social Responsibility

guidelines are described in the Annual Report.

Accounting principles and tax disclosure is cov-

ered in the Financial Statement, and executive

compensation is described in the Remuneration

guidelines and report 2023.

"For Ultimovacs, ESG means building a sustainable business so that

we can deliver on our mission: To extend and improve the life of

patients, by directing the immune system against the core of cancer.

We aim to provide universally accessible solutions for patients.

The industry operates within a regulated framework aiming to support

medical innovation while ensuring that new biotechnology products

are safe for the environment and human health.

Despite our small company size, Ultimovacs acknowledges our re-

sponsibility for the indirect impact and potential for unintentional

ripple effects from our work. Our R&D and manufacturing partners,

suppliers, and collaborators, are reputable organizations located

in Europe and the US. We are conscious of associating with com-

panies sharing our ethical values and professional standards.

Ultimovacs ESG report reflects our commitment to transparency

as one of our company’s core values, and our ambition of contin-

uous improvement in taking a wider responsibility for both planet

and people.”

Carlos de Sousa,

Chief Executive Officer

ESG IN ULTIMOVACS

Chapters

People & planet

Environment

Ultimovacs is working to reduce the environmental impacts of our

operational activities. The energy use, waste, and water consump-

tion are measured as Ultimovacs % of the environmental reporting

for the office building. The property managers are committed to

improve the environmental footprint.

GHG emissions 2023:

Scope 1

• direct energy use: 0

Scope 2

• estimated indirect energy use (location based): 1.8 tonnes

– 80% hydropower

• Estimated water consumption: 52 m

Scope 3*

• waste generated in operations: 0.9 tonnes, whereof:

– Bio waste: 0.2 tonnes

– Hazardous waste 0.003

• Paper + plastic: 0.2 tonnes (recycled)

* Business travel, employee commuting, and emissions created by the

company’s value chain, have not been quantified at this time. 100% of

Ultimovacs’ CMC partners hold a Good Manufacturing Practice (GMP)

Certificate.

ESG IN ULTIMOVACS

People

Ultimovacs is proud of our history of attracting and retaining talent

with outstanding expertise, track record and grit. During 2023, we

had no turnover of staff in the company. We aim to provide a safe,

secure, and positive work environment, free of discrimination or

harassment on the grounds of ethnicity, nationality, age, gender

identity, sexual orientation, religion, physical disabilities or cultural

background.

The national Working Environment Act protects the health, envi-

ronment, and safety of employees by law. In addition, Ultimovacs’

process for handling whistle blowing incidents is described in the

Corporate Social Responsibilities (CSR) guidelines. Ultimovacs re-

ported zero whistle blower incidents in 2023.

Ultimovacs does not partner or conduct business with any indivi-

dual or company that participates in exploitation of children, in-

humane treatment, discrimination, human trafficking, any form of

modern slavery, or forced labor.

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ESG IN ULTIMOVACS

Biotechnology specific ESG risks

Research & Development

Ultimovacs collaborates with R&D partners following the principles

for Good Laboratory Practice. The Company is not involved in gene-

tic engineering or emerging technology considered high-risk.

In advancing development of medical products, animal research is

often essential and required by regulatory authorities before human

testing can take place. Ultimovacs conducts animal testing only when

necessary, and we are committed to humane and ethical treatment

of animals. We support the implementation of the 3 Rs standard

for the ethical use of animals in medicine testing: Replace – use

alternative methods, if possible, Reduce – use the minimum num-

ber of animals, and Refine – minimize suffering, pain and distress,

and improve the welfare of the animal used.

Most of our animal studies are conducted at external qualified and

certified vendors in the UK and Sweden. The testing is regulated by

the European Union legislation on the protection of animals used for

scientific purposes (Directive 2010/63/EU), one of the most stringent

ethical and welfare standards worldwide.

Safety

The safety of patients being enrolled in the clinical trials is the

highest priority. Ultimovacs has detailed protocols including the

Standard Operating Procedure for Adverse Event Reporting.

The trials are conducted in compliance with good clinical practice,

following the standards of Good Clinical Practice and Clinical Trials,

according to the regulations from FDA (US) and EMA (Europe).

The Company seeks advice and approval from independent ethics

committees and regulatory authorities. Collecting, obtaining, storing,

and using human biological samples requires informed consent.

Ultimovacs follows applicable bioethical principles and regulatory

requirements and standards, including General Data Protection

Regulation (GDPR) in Europe (2016/679). An annual review of all

aspects of the quality system and safety are conducted with the

Management Team.

For the year 2023, there were no quality or safety incidents that led

to any market actions or need for reporting to the health authori-

ties. Readouts from two randomized Phase II trials reported similar

safety and tolerability profile in the two arms, confirming the good

safety profile of the UV1 vaccine.

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ESG IN ULTIMOVACS

Compliance

Quality Assurance

The Company applies a comprehensive procurement process and

a structured assessment of suppliers critical to our operations, to

ensure that our work is in compliance with applicable laws, reg-

ulations, and guidelines. Ultimovacs’ Quality Management System

(QMS) ensures that the Company’s activities are in full compliance

with applicable:

• GxP regulations (Good Laboratory Practice (GLP)

• Good Manufacturing Practice (GMP)

• Good Distribution Practice (GDP)

• Good Clinical Practice (GCP)

• Good Pharmacovigilance Practice (GVP), and other

related requirements.

All activities must comply with applicable national laws, regulations,

and guidelines. Standard Operating Procedures (SOPs) give instruc-

tions for performing GxP activities at Ultimovacs. The Company com-

mits to following the standards of the International Conference of

Harmonisation (ICH) and the World Medical Association Declaration

of Helsinki on the Ethical Principles for Medical Research Involving

Human Subjects.

The QMS effectiveness is evaluated as a half-yearly review, per-

formed by the QA and the Management Team. Ultimovacs aims to

be always inspection-ready for audits from regulatory authorities.

For the year 2023, there were no quality or safety incidents that

led to any market actions or need for reporting to the health

authorities.

The Transparency Act

The Norwegian Transparency Act (Åpenhetsloven) requires compa-

nies to carry out human rights’ due diligence in line with the OECD

Guidelines for Multinational Enterprises. Ultimovacs has established

or initiated the following actions:

I. Accountability in the Board of Directors

II. Guidelines and integrated into internal processes

III. System for handling the obligation to provide information

IV. Supply chain mapping

V. Risk Analysis of the supply chains and other business relationships

Ultimovacs critical suppliers, defined as companies working within

GxP and/or companies processing personal data on behalf of Ultimo-

vacs, are screened for the existence of an ESG policy (or similar),

in accordance with The Transparency Act.

Furthermore, the Suppliers must comply with the Company’s Code

of Conduct, including issues relating to upholding Human Rights.

Ultimovacs is committed to ensuring respect for the inherent dignity

of people and their inalienable rights as a fundamental part of its

corporate responsibility and upholding of the UN Guiding Principles

on Business and Human Rights.

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A revised version was approved by the Board of Directors on 24

March 2022. The complete Corporate Governance Policy can be

found on the corporate website: www.ultimovacs.com

The corporate governance policy addresses the framework of guide-

lines and principles regulating the interaction between the Company’s

shareholders, the Board of Directors (the “Board”), the Chief Execu-

tive Officer (the “CEO”) and the Company’s executive management

team.

The Policy is based on the Norwegian Code of Practice for Corporate

Governance issued by the Norwegian Corporate Governance Board

(NUES). The Company will, in accordance with applicable legislation

and stock exchange listing rules, provide a report on the Company’s

corporate governance in the Board of Directors’ report or in a docu-

ment that is referred to in the Board of Directors’ report.

There has been no non-conformance with the recommendations

referred to below for the financial year of 2023, with the exception

for the Code of Practice recommendation which stipulates that the

Board of Directors should ensure that the General Meeting is able

to elect an independent chairman at General Meetings. Please refer

to section ‘6 - General Meetings’ regarding the deviation from this

NUES recommendation.

1. Implementation and reporting on

corporate governance

The Board of Directors ensures that the company implements and

operates by sound corporate governance principles. The objective

of the corporate governance is to regulate the division of roles be-

tween shareholders, the Board of Directors, the CEO and the Com-

pany’s Executive Management. In this reporting section, the Board

of Directors provides a systematic evaluation of the Company’s

corporate governance practice covering every section of the Code

of Practice. Any deviations from full compliance with the Code of

Practice is explained with a description of the solution that has

selected.

The Corporate Governance policy is reviewed annually, and an

updated version will be available in the ‘Governance’ section of

the Company’s website.

2. Business

Ultimovacs is a biotech company developing cancer vaccines, and

the company’s mission is:

Corporate Governance Report

“To extend and improve the life of patients by directing the immune

system against the core of cancer. We will provide universally acces-

sible solutions.”

Ultimovacs is committed to develop, manufacture and deliver inno-

vative cancer vaccines to address unmet medical needs and advance

cancer care. The Company’s business activity, as set out in Section

4 of the Articles of Association, is to develop, produce and sell medi-

cines for the treatment of cancer. The business may be carried out

by the Company, the Company’s subsidiaries or by participation in

other companies or in cooperation with others.

Ultimovacs will work to ensure a socially responsible business op-

eration involving good business ethics, addressing how employees

should be treated regarding equality and non-discrimination, respect

for human rights, anti-corruption and bribery, the relationship with

the environment and the work to deliver safe products to patients.

In addition to the contents in this report, the Articles of Association,

the Corporate Governance Policy and the Environmental, Social

and Governance (ESG) Guidelines give information regarding the

Company’s risk, goals, strategy and how Ultimovacs interacts with

internal external stakeholders and other parties.

The Board of Directors of Ultimovacs ASA (the

“Company”) has prepared a corporate governance

policy which was resolved by the Board of Direc-

tors on 4 December 2018 and which entered into

force from the date the company applied for

listing on the Oslo Stock Exchange, 21 May 2019.

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3. Equity and dividends

The Board aims to maintain a satisfactory equity ratio in the Com-

pany, in light of the Company’s goals, strategy and risk profile,

thereby ensuring that there is an appropriate balance between

equity and other sources of financing. The Board shall continuously

assess the Company’s capital requirements in light of the Compa-

ny’s strategy and risk profile.

The Board’s authorizations to increase the share capital and to buy

own shares shall be granted for periods no longer than until the

next Annual General Meeting of the Company.

At the Ordinary General Meeting on 20 April 2023, the Board of

Directors was given a general authorization to increase the share

capital by NOK 687,929.2 (20% increase in outstanding shares at

the time of the General Meeting). In addition, the Board of Di-

rectors was also authorized increase the share capital by NOK

343,964.6 (10% increase in outstanding shares at the time of the

General Meeting) in relation to the share-based incentive program

(share options) for the employees, and to increase the share cap-

ital by NOK 343,964.6 (10% increase in outstanding shares at the

time of the General Meeting) to acquire own shares.

These authorizations are valid until the next ordinary General

Meeting of the company in 2024, but no longer than 30 June 2024.

The Company has historically not distributed dividends and is not

expected to do so in the near future.

4. Equal treatment of shareholders and

transactions with close associates

There is only one class of shares in the Company and all shares

carry equal rights. The Company shall ensure equal treatment of

its shareholders.

Any transactions, agreements or arrangements between the Com-

pany and its shareholders, members of the Board, members of

the Executive Management Team or close associates of any such

parties shall only be entered into as part of the ordinary course

of business and on arm’s length market terms. All such transac-

tions shall comply with the procedures set out in the Norwegian

Public Limited Liability Companies Act. In case of a transaction

with close associates that is not part of ordinary course of busi-

ness, the Board shall arrange for a valuation to be obtained from

an independent third party unless the transaction, agreement or

arrangement in question must be considered to be immaterial. The

Company’s financial statements shall provide further information

about transactions with related parties. There have been no such

transactions in the financial year.

Board Members and members of the Executive Management Team

shall immediately notify the Board if they have any material direct

or indirect interest in any transaction entered into by the Company.

5. Shares and negotiability

The shares in the Company shall be and are freely transferable.

6. General Meetings

All shareholders have the right to participate in the General Meet-

ings of the Company, which exercise the highest authority of the

Company.

The full notice for General Meetings shall be sent to the sharehold-

ers no later than 21 days prior to the meeting. The notices for such

meetings shall include documents providing the shareholders with

sufficient detail in order for the shareholders to make an assess-

ment of all the cases to be considered as well as all relevant infor-

mation regarding procedures of attendance and voting. The Board

and the Company’s auditor shall be present at General Meetings.

Directors of the Board and the CEO have the right to attend and

speak at General Meetings. The Chair of the Board and CEO shall

attend General Meetings unless the General Meeting in each case

decides otherwise (the Companies Act Section 5-5).

The Chair of the Nomination Committee, or a person authorized by

the Chair, shall present the Committee’s recommendations for the

Annual General Meeting, and give an account of the reasons for its

recommendations.

Notices for the General Meeting shall provide information on the

procedures shareholders must observe in order to participate in

and vote at the General Meeting.

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The notice should also set out:

i. The procedure for representation at the meeting through

a proxy, including a form to appoint a proxy,

and

ii. The right for shareholders to propose resolutions in respect

of matters to be dealt with by the General Meeting.

The cut-off for confirmation of attendance shall be set as short

as practically possible and the Board will arrange matters so that

shareholders who are unable to attend in person will be able to

vote by proxy. The form of proxy will be distributed with the notice.

The Code of Practice stipulates that the Board of Directors should

ensure that the General Meeting is able to elect an independent

Chair at General meetings. Ultimovacs’ Corporate Governance

Policy deviates from this recommendation by not having such an

arrangement in place, both for practical reasons and due to the

size of the company.

7. Nomination committee

The Company has a Nomination Committee as set out in Section 11

and Appendix 1 in the Corporate Governance Policy. Members and

Chairman of the Nomination Committee shall be elected by the

General Meeting. At the outset, the Nomination Committee should

consist of three members unless special circumstances suggest a

different number of members.

The members of the Nomination Committee should be selected to

take into account the interests of shareholders in general. Board

Members and members of the Executive Management Team should

not be members of the Nomination Committee. Instructions for

the Nomination Committee shall be approved by the Company’s

General Meeting.

The Annual General Meeting stipulates the remuneration to be

paid to the Nomination Committee. The Nomination Committee’s

expenses shall be covered by the Company.

As per 31 December 2023, all three members of the Nomination

committee are independent of the Board of Directors and the

Executive Management Team, and consist of:

• Ole Kristian Hjelstuen (Chair)

• Hans Peter Bøhn (Member)

• Jakob Iqbal (Member)

The Nomination Committee shall present proposals to the Gen-

eral Meeting regarding election of the Chair of the Board, Board

Members and any deputy members of the Board. The Nomination

Committee shall also present proposals to the General Meeting for

remuneration of the Board and any sub-committees of the Board.

The Nomination Committee shall justify its recommendations and

provide relevant information about the candidates. Any dissenting

votes shall be stated in the recommendation.

In its work, the Nomination Committee may contact sharehold-

ers, members of the Board, the Executive Management Team and

external advisers. Shareholders should be given the opportunity to

propose Board Member candidates to the Nomination Committee.

The Nomination Committee should conduct individual discussions

with the Board Members to ensure the best possible assessment

basis for the Nomination Committee’s decisions.

8. Board of directors: Composition and

independence

The Board of Directors is elected by the General Assembly. In ap-

pointing members to the Board, it is emphasized that the Board

shall have the requisite competency to independently evaluate the

cases presented by the Executive Management Team as well as

the Company’s operation. It is also considered important that the

Board can function well as a body of colleagues. Board Members

shall be elected for periods not exceeding two years at a time, with

the possibility of re-election. Board Members shall be encouraged

to own shares in the Company.

The Board shall comply with all applicable requirements as set

out in the Norwegian Public Limited Liability Companies, Act, the

listing rules of Oslo Børs and the recommendations set out in the

Norwegian Code of Practice for Corporate Governance.

Following the resignation of one board member in December 2023,

whereby a new board member will be elected at the ordinary

General Meeting in 2024, the Board of Directors consists of sev-

en members, of which five men and two women. Six of the board

members are regarded as fully independent of the company and

the main shareholders. Each Board Member is presented in the

next section of this report and on the Company website.

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9. The work of the Board of Directors

The Board shall prepare an annual plan for its work with special

emphasis on goals, strategy and implementation. The Board’s pri-

mary responsibility shall be:

i. participating in the development and approval of the Company’s

strategy,

ii. performing necessary monitoring functions and

iii. acting as an advisory body for the Executive Management Team.

Its duties are not static, and the focus will depend on the Com-

pany’s ongoing needs. The Board is also responsible for ensuring

that the operations of the Company are in compliance with the

Company’s values and ethical guidelines. The Chair of the Board

shall be responsible for ensuring that the Board’s work is per-

formed in an effective and correct manner.

The Board shall ensure that the Company has a good management

with clear internal distribution of responsibilities and duties. A clear

division of work has been established between the Board and the

Executive Management Team. The CEO is responsible for the exe-

cutive management of the Company.

All members of the Board shall regularly receive information about

the Company’s operational and financial development. The Company’s

strategies shall regularly be subject to review and evaluation by the

Board.

The Board shall prepare an annual evaluation of its work.

The Board met 16 times in 2023.

Compensation Committee

The Company does not have a separate Compensation Committee

as of today. However, the Board of Directors has taken upon them-

selves the role and tasks that a separate committee would have had.

The Board of Directors, acting as a Compensation Committee, will

continue to review the employee incentive plan, as well as the re-

muneration of the Executive Management Team.

Audit Committee

The Company shall have an Audit Committee in accordance with

the rules of the Norwegian Public Limited Liability Companies Act

and the listing rules of the Oslo Stock Exchange from the date de-

cided by the Board of Directors. The Audit Committee’s main func-

tion is to be a working committee for the Board, preparing matters

and acting in an advisory capacity for the Company’s finance func-

tion. In addition, the Committee will ensure that the auditor is inde-

pendent and to ensure that the annual accounts give a fair picture

of the Group’s financial results and financial condition in accordance

with generally accepted accounting practice. The Audit Committee

shall receive reports on the work of the external auditor and the

results of the audit.

An Audit Committee was established in the second half of 2019 and

has, since 2021, consisted of Board Members Leiv Askvig (leader)

and Haakon Stenrød, both with prior relevant financial and accoun-

ting experience. The members shall be and are independent of the

Company’s senior Executive Management Team.

The Committee met with the financial management before the pub-

lication of all 2023 quarterly reports and the 2023 Annual Report in

2024. In addition, the Committee met with the auditor along with the

financial management in Ultimovacs before the publication of the

Annual Report 2023, and before the Q2 2023, Q3 2023 and Q4 2023

reports. The Audit Committee will continue to meet with Ultimovacs’

financial management and, at least twice a year, with the Company’s

audit partner before publication of quarterly and full year results.

ESG Committee

The Audit Committee also has the role as the ESG Committee of the

Board of Directors. This committee has been involved in the draft-

ing and review of the Environmental, Social and Governance (ESG)

Guidelines and ESG report. An updated version of these guidelines

was approved by the Board of Directors on 2 February 2023.

10. Risk management and internal control

As set out in the corporate governance guidelines of Ultimovacs,

the Board of Directors shall ensure that the Company has sound

internal controls and systems for risk management that are appro-

priate in relation to the extent and nature of the Company’s activi-

ties. The internal control and the systems shall also encompass the

Company’s corporate values and ethical guidelines. The objective of

the risk management and internal control shall be to manage expo-

sure to risks in order to ensure successful conduct of the Company’s

business and to support the quality of its financial reporting.

The Board shall carry out an annual review of the Company’s most

important areas of exposure to risk and its internal control arrange-

ments. The Board shall also focus on the need for developing ethical

guidelines ensuring that employees can safely communicate to the

Board matters related to illegal or unethical conduct by the Company.

The Board shall ensure that the Company has the necessary rou-

tines with respect to hired personnel to ensure that any outsourced

functions are handled in a satisfactory manner. The Board is given

information on the current business performance and risk situation

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in board meetings on a regular basis, which is also presented in

quarterly reports made publicly available.

It is of the greatest importance to the Company that all information

which could influence the value of the shares or other financial

instruments related to the shares is handled with confidentiality

and communicated to the market in accordance with all financial

market regulations.

The Board shall provide an account in the annual report of the main

features of the Company’s internal control and risk management

systems as they relate to the Company’s financial reporting. The

list of primary risk factors and how they are mitigated are provided

in the “Risk and uncertainties” section in this Annual Report. The

Company’s finance function is responsible for the preparation of

financial statements and reports, and to ensure that these are in

accordance with IFRS and other applicable laws and regulations.

These are also reviewed by the Audit Committee. In addition, the

annual financial statements are reviewed by the Company auditor.

The Company has established mechanisms to prevent and address

corruption, fraud, bribery and other irregularities including internal

channels for reporting. Such internal channels shall, if required,

protect the identity of the reporter.

11. Remuneration of the Board of Directors

The General Meeting shall annually determine the Board’s remu-

neration. Remuneration of Board Members shall be reasonable and

based on the Board’s responsibilities, work, time invested and the

complexity of the enterprise. The Board shall be informed if indi-

vidual Board Members perform tasks for the Company other than

exercising their role as Board Members. Work in sub-committees

may be compensated in addition to the remuneration received for

Board membership.

The annual Remuneration Report shall provide information regard-

ing the Board’s remuneration. The Remuneration Report for 2023 is

available on Ultimovacs’ website.

12. Remuneration of the Executive

Management Team

The Board decides the salary and other compensation to the CEO

within any legal and formal boundaries set out in the Remuneration

Guidelines on compensation to the CEO and Executive Management

as approved by the Company’s General Meeting. Any fringe benefits

shall be in line with market practice, and should not be substantial

in relation to the CEO’s basic salary. The Board shall annually carry

out an assessment of the salary and other remuneration to the CEO.

The Company’s financial statements shall provide further infor-

mation about salary and other compensation to the CEO and the

Executive Management Team.

The CEO determines the remuneration of executive employees. The

Board shall issue guidelines for the remuneration of the Executive

Management Team for approval by the General Meeting. The guide-

lines shall lay down the main principles for the Company’s manage-

ment remuneration policy. The salary level should not be of a size

that could harm the Company’s reputation, or above the norm in

comparable companies. The salary level should, however, ensure

that the Company can attract and retain executive employees with

the desired expertise and experience.

The Executive Management Team does not have bonus arrange-

ments or separate incentive schemes, but takes part in the gen-

eral share option incentive scheme which applies to all employees

in the Group. The main objectives of the share option incentive

scheme are to align interests of shareholders and management/

employees (value creation and risk taking) and ensure competitive

compensation for management/employees and the motivation to

stay (retention). The remuneration guidelines are available on the

Company website. Remuneration details to the Executive Man-

agement Team are available in a separate Remuneration Report,

available on the Company website.

13. Information and Communications

The Board and the Executive Management Team assign considerable

importance to giving the shareholders quick, relevant and current

information about the Company and its activity areas. Emphasis

is placed on ensuring that the shareholders receive identical and

simultaneous information.

Sensitive information will be handled internally in a manner that

minimizes the risk of leaks. All material contracts to which the

Company becomes a party, shall contain confidentiality clauses.

The Company shall have clear routines for who is allowed to com-

municate on behalf of the Company on different subjects and who

shall be responsible for submitting information to the market and

investor community. The CEO, CFO and the Head of Investor Rela-

tions & Communications shall be the main contact persons of the

Company in such respect.

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The Board should ensure that the shareholders are given the oppor-

tunity to make known their points of view at and outside of the

General Meeting.

Financial information is published on a quarterly basis, in addition

to the Annual Financial Statements. The financial information is

made available on the Company website as well as through distri-

bution on Newsweb (Euronext Oslo Stock Exchange’s public infor-

mation system). A financial calendar is published annually through

the same channels listing important dates such as publications of

quarterly and annual reports and dates of General meetings.

14. Take-overs

In a take-over process, the Board and the Executive Management

Team each have an individual responsibility to ensure that the

Company’s shareholders are treated equally and that there are no

unnecessary interruptions to the Company’s business activities.

The Board has a particular responsibility in ensuring that the share-

holders have sufficient information and time to assess the offer.

In the event of a take-over process, the Board shall ensure that:

i. the Board will not seek to hinder or obstruct any takeover

bid for the Company’s operations or shares unless there are

particular reasons for doing so;

ii. the Board shall not undertake any actions intended to give

shareholders or others an unreasonable advantage at the

expense of other shareholders or the Company;

iii. the Board shall not institute measures with the intention

of protecting the personal interests of its Members at the

expense of the interests of the shareholders; and

iv. the Board must be aware of the particular duty it has for

ensuring that the values and interests of the shareholders

are protected.

In the event of a take-over bid, the Board will, in addition to com-

plying with relevant legislation and regulations, seek to comply with

the recommendations in the Norwegian Code of Practice for Cor-

porate Governance. This includes obtaining a valuation from an

independent expert. On this basis, the Board will make a recom-

mendation as to whether or not the shareholders should accept

the bid.

15. Auditor

The Company’s auditor is Ernst & Young AS and has been the Com-

pany’s auditor since the financial year 2015.

Each year the auditor shall present to the Board a plan for the im-

plementation of the audit work and a written confirmation that the

auditor satisfies established requirements as to independence and

objectivity.

The auditor shall be present at Board meetings where the annual

accounts are on the agenda. Whenever necessary, the Board shall

meet with the auditor to review the auditor’s view on the Company’s

accounting principles, risk areas, internal control routines etc.

The auditor may only be used as a financial advisor to the Company

provided that such use of the auditor does not have the ability to

affect or question the auditors’ independence and objectiveness

as auditor for the Company. Only the Company’s CEO and/or CFO

shall have the authority to enter into agreements in respect of

such counselling assignments.

In connection with the auditor’s presentation to the Board of the

annual work plan, the Board should specifically consider if the au-

ditor also carries out a control function to a satisfactory degree.

The Board shall arrange for the auditor to attend all General Meet-

ings and certain Audit Committee meetings.

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05 Financial

Statements

Ultimovacs Group

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Financial Statements

Notes

51 ULTIMOVACS2023

Contents - Consolidated Financial Statement

Consolidated statement of profit and loss and other comprehensive income

Consolidated statement of financial position

Consolidated statement of cash flow

Consolidated statement of changes in equity

Note 1: General information

Note 2: Accounting principles

Note 3: Government grants

Note 4: Salary and personnel expenses and management remuneration

Note 5: Other operating expenses

Note 6: Financial items

Note 7: Income tax

Note 8: Earnings per share

Note 9: Non-current assets

Note 10: Other receivables

Note 11: Cash and cash equivalents

Note 12: Share capital, shareholder information and dividend

Note 13: Transactions with related parties

Note 14: Leases and commitments

Note 15: Share based payment

Note 16: Other current liabilities

Note 17: Financial instruments

Note 18: Events after the balance sheet date

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52 ULTIMOVACS2023

Financial statements

Consolidated statement of profit and loss and other comprehensive income

(NOK 1 000) EXCEPT PER SHARE DATA NOTES 2023 2022

Total revenues - -

Payroll and payroll related expenses

3, 4, 15

(75 130) (71 466)

Depreciation and amortization

9, 14

(2 768) (2 648)

Other operating expenses

3, 5

(137 837) (109 517)

Total operating expenses (215 736) (183 631)

Operating profit (loss) (215 736) (183 631)

Financial income

29 640 17 375

Financial expenses

(3 143) (1 536)

Net financial items 26 497 15 839

Profit (loss) before tax (189 239) (167 792)

Income tax expense

- -

Profit (loss) for the year (189 239) (167 792)

Profit (loss) for the year attributable to:

Non-controlling interest - -

Owners of the Company (189 239) (167 792)

Total profit (loss) for the year (189 239) (167 792)

Items that subsequently may be reclassified to profit or loss:

Exchange rate differences on translation of foreign operations 4 724 (1 889)

Total comprehensive income (loss) for the year (184 515) (169 681)

Total comprehensive income (loss) for the year attributable to:

Non-controlling interest - -

Owners of the Company (184 515) (169 681)

Total comprehensive income (loss) for the year (184 515) (169 681)

Basic and diluted earnings (loss) per share (NOK per share)

(5.5) (4.9)

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53 ULTIMOVACS2023

Financial statements

Consolidated statement of financial position

(NOK 1 000) NOTES 2023 2022

ASSETS

Non-current assets

Goodwill

11 653 10 701

Licenses

56 566 51 944

Patents

5 030 5 784

Property, plant and equipment

114 220

Right of use assets

3 561 5 444

Total non-current assets 76 923 74 093

Current assets

Receivables and prepayments

3, 10

5 557 10 270

Cash and cash equivalents

266 559 425 309

Total current assets 272 117 435 579

TOTAL ASSETS 349 039 509 672

EQUITY AND LIABILITIES

Equity

Share capital 3 441 3 440

Share premium 1 076 607 1 076 308

Total paid-in equity

1 080 047 1 079 747

Accumulated losses (861 352) (672 113)

Other equity 55 009 40 752

Translation differences 5 687 964

TOTAL EQUITY 279 391 449 350

Non-current liabilities

Lease liability

1 886 3 713

Deferred tax

11 653 10 701

Total non-current liabilities 13 539 14 414

Current liabilities

Lease liability

1 827 1 767

Accounts payable 11 169 7 655

Other current liabilities

15, 16

43 113 36 485

Total current liabilities 56 109 45 907

TOTAL LIABILITIES 69 648 60 321

TOTAL EQUITY AND LIABILITIES 349 039 509 672

Board of Directors and CEO of Ultimovacs ASA

Oslo, 20 March 2024

Sign Sign

Sign

Jónas Einarsson Kari Grønås Eva S. Dugstad

Chair of the Board Board member Board member

Sign

Henrik Schüssler Ketil Fjerdingen Leiv Askvig

Board member Board member Board member

Sign

Haakon Stenrød Carlos de Sousa

Board member CEO

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54 ULTIMOVACS2023

Financial statements

Consolidated statement of cash flow

(NOK 1 000) NOTES 2023 2022

Cash flow from operating activities

Profit (loss) before tax (189 239) (167 792)

Adjustments to reconcile profit before tax to net cash flow:

Depreciation and amortization

9, 14

2 768 2 648

Interest received including investing activities

(14 127) (8 887)

Net foreign exchange differences

(12 750) (7 176)

Other financial expenses

380 105

Share option expenses

14 256 20 395

Working capital adjustment:

Changes in prepayments and other receivables

3 629 (1 859)

Changes in payables and other current liabilities

5 256 (5 129)

Net cash flow from operating activities (189 827) (167 695)

Cash flow from investing activities

Purchase of property, plant and equipment

(25) (195)

Interest received

14 059 8 887

Net cash flow from investing activities 14 034 8 691

Cash flow from financing activities

Proceeds from issuance of equity

300 5 484

Interest paid

(380) (105)

Payment of lease liability

(1 767) (1 802)

Net cash flow from financing activities (1 847) 3 577

Net change in cash and cash equivalents (177 640) (155 426)

Effect of change in exchange rate

18 889 6 567

Cash and cash equivalents, beginning of period

425 309 574 168

Cash and cash equivalents, end of period 266 559 425 309

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55 ULTIMOVACS2023

Financial statements

Consolidated statement of changes in equity

(NOK 1000) NOTES

CAPITAL

PREMIUM

TOTAL

PAID IN

CAPITAL

ACCU-

MULATED

LOSSES

OTHER

EQUITY

TRANS-

LATION

DIFFER-

ENCES

TOTAL

EQUITY

Balance as of 31 December 2021 3 422 1 070 841 1 074 264 (504 321) 20 358 2 853 593 152

Profit (loss) for the year - (167 792) (167 792)

Other comprehensive income (loss) - (1 889) (1 889)

Issue of share capital

17 5 466 5 484 5 484

Share-issue costs

- -

Recognition of share-based payments

- 20 395 20 395

Balance as of 31 December 2022 3 440 1 076 308 1 079 747 (672 113) 40 752 964 449 350

Profit (loss) for the year - (189 239) (189 239)

Other comprehensive income (loss) - 4 724 4 724

Issue of share capital

1 299 300 300

Share-issue costs

- -

Recognition of share-based payments

- 14 256 14 256

Balance as of 31 December 2023 3 441 1 076 607 1 080 047 (861 352) 55 009 5 687 279 391

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Financial statements

Note 1: General information

Note 2: Accounting principles

I. Basis for preparation

The financial statements are prepared in accordance with IFRS Accounting Standards as adopted by the

EU. The financial statements are presented in NOK (Norwegian kroner) which is also the parent company’s

functional currency.

The financial statements have been prepared on the historical cost basis, with the exception of derivatives

which are measured at fair value. The preparation of financial statements in conformity with IFRS requires

the use of certain critical accounting estimates. It also requires management to exercise its judgments in

applying the Group’s accounting policies.

II. Going concern

The financial statements for 2023 have been prepared under the going concern assumption. The Group

has due to the negative results from its INITIUM phase II trial initiated cash preservation initiatives which

will be implemented to support that the available financial resources will sustain the company into 2025.

III. Accounting principles

i. Cash and cash equivalents

Cash and short-term deposits in the statement of financial position comprise cash at banks and on hand

and short-term highly liquid deposits with a maturity of three months or less, that are held for the purpose

of meeting short-term cash commitments and are readily convertible to a known amount of cash and

subject to an insignificant risk of changes in value.

ii. Cash Flow statement

The statement of cash flows is compiled using the indirect method. The statement of cash flows

distinguishes between cash flows from operating, investing and financing activities. For the purpose of the

cash flow statement, cash and cash equivalents comprise cash on hand, deposits held at call with banks,

other short-term highly liquid investments with original maturities of three months or less, cash pool

balances and bank overdrafts. Cash flows in foreign currencies are translated at the rate of the transaction

date. Interest paid is included under cash flow from financing activities, and interest received is included

in investing activities. Cash flows arising from the acquisition or disposal of financial interests (subsidiaries

and participating interests) are recognized as cash flows from investing activities, taking into account any

cash and cash equivalents in these interests. Cash flows from share issues are recognized as cash flows

from financing activities.

Ultimovacs ASA (the Company or Ultimovacs) and its subsidiary (together the Group) is a biotech Group

developing novel immunotherapies against cancer. Ultimovacs was established in 2011 and is a public limited

liability company listed on the Stock Exchange in Norway. The Company and its proprietary technology are

based on pre-clinical and clinical research on immunotherapies conducted at the Oslo University Hospital.

Ultimovacs is headquartered at the Oslo Cancer Cluster Innovation Park in Oslo, Norway and also has an

office in Uppsala, Sweden. Ultimovacs is an active member of Oslo Cancer Cluster.

Ultimovacs’ lead universal cancer vaccine candidate UV1 leverages the high prevalence of the human

telomerase (hTERT) to be effective across the dynamic stages of a tumor’s growth and its microenvironment.

By directing the immune system to hTERT antigens which are expressed at a high level in 85-90% of

human tumors, UV1 drives CD4 helper T cells to tumors with the goal of activating an immune system

cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s

impact in many cancer types and in combination with other immunotherapies. The Group will expand its

pipeline using its novel TET-platform which is a vaccine technology that can generate multiple vaccine

candidates designed to achieve increased T cell responses to a broad range of target antigens. The Group

is performing a broad clinical development program with clinical trials in Europe, Australia and the USA.

The financial statements were approved by the Board of Directors on 20 March 2024.

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Note 2: Accounting principles (continued)

iii. Financial instruments

The Group uses derivative financial instruments to hedge its risks associated with foreign exchange rates.

Derivatives are initially and subsequently measured at fair value. Derivatives are carried as assets when the

fair value is positive and as liabilities when the fair value is negative. The gain/(loss) arising from changes in

fair value of currency derivatives is presented as part of “Financial income/expenses” in the consolidated

statement of comprehensive income.

Financial liabilities are classified, at initial recognition, as financial liabilities at fair value through profit

or loss and other comprehensive income, loans and borrowings, or payables. All financial liabilities are

recognized initially at fair value and, in the case of loans and borrowings and payables, net of directly

attributable transaction costs. The Group’s financial liabilities include trade and other payables.

- Subsequent measurement

The measurement of financial liabilities depends on their classification.

- Loans and borrowings

After initial recognition, interest-bearing loans and borrowings are subsequently measured at amortized

cost using the effective interest rate method. Gains and losses are recognized in profit or loss when the

liabilities are derecognized as well as through the effective interest rate amortization process. Amortized

cost is calculated by taking into account any discount or premium on acquisition and fees or costs that are

an integral part of the effective interest rate. The effective interest rate amortization is included as finance

costs in the statement of profit or loss and other comprehensive income.

All assets and liabilities for which fair value is measured or disclosed in the financial statements are

categorized within the fair value hierarchy, described as follows, based on the lowest level input that is

significant to the fair value measurement as a whole:

• Level 1 — Quoted (unadjusted) market prices in active markets for identical assets or liabilities

• Level 2 — Valuation techniques for which the lowest level input that is significant to the fair value

measurement is directly or indirectly observable

• Level 3 — Valuation techniques for which the lowest level input that is significant to the fair value

measurement is unobservable

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Note 2: Accounting principles (continued)

iv. Current vs non-current classification

The Group presents assets and liabilities in the statement of financial position based on current/non-

current classification. An asset is current when it is:

• Expected to be realized or intended to be sold or consumed in the normal operating cycle

• Held primarily for the purpose of trading

• Expected to be realized within twelve months after the reporting period, or

• Cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at

least twelve months after the reporting period

All other assets are classified as non-current. A liability is current when:

• It is expected to be settled in the normal operating cycle

• It is held primarily for the purpose of trading

• It is due to be settled within twelve months after the reporting period, or

• There is no unconditional right to defer the settlement of the liability for at least twelve months

after the reporting period

The Group classifies all other liabilities as non-current. Deferred tax assets and liabilities are classified as

non-current assets and liabilities.

v. Foreign currencies

The Group’s presentation currency is NOK. This is also the parent company’s functional currency. The

statement of financial position figures of entities with different functional currency are translated at the

exchange rate prevailing at the end of the reporting period for balance sheet items, and the exchange

rate at the date of the transaction for profit and loss items. The monthly average exchange rates are

used as an approximation of the transaction exchange rate. Exchange differences are recognized in other

comprehensive income (OCI).

Transactions in foreign currencies are initially recorded by the Group in its respective functional currency

spot rate at the date the transaction first qualifies for recognition. Monetary assets and liabilities

denominated in foreign currencies are translated at the functional currency spot rates of exchange at the

reporting date. Differences arising on settlement or translation of monetary items are recognized in the

statement of profit or loss and other comprehensive income.

Intra-group balances and transactions, and any unrealized income and expenses arising from intra-group

transactions, are eliminated. Unrealized losses are eliminated in the same way as unrealized gains, but only

to the extent that there is no evidence of impairment.

The assets and liabilities of foreign operations, including goodwill and fair value adjustments arising on

acquisition, are translated into NOK at the exchange rates at the reporting date.

The income and expenses of foreign operations are translated into NOK at the average exchange rates

within each respective month of the date of the transactions. Foreign currency differences are recognized

in other comprehensive income (OCI) and accumulated in the translation reserve.

Exchange differences on intra-group items are recognized in profit or loss of the respective company and

Group accounts.

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Note 2: Accounting principles (continued)

vi. Impairment

The Group assesses at each reporting date whether there is an indication that an asset may be impaired.

If any indication exists, or when annual impairment testing for an asset is required, the Group estimates

the asset’s recoverable amount. An asset’s recoverable amount is the higher of an asset’s or CGU’s (cash-

generating unit) fair value less costs of disposal and its value in use. It is determined for an individual asset,

unless the asset does not generate cash inflows that are largely independent of those from other assets or

groups of assets. Where the carrying amount of an asset or CGU exceeds its recoverable amount, the asset

is considered impaired and is written down to its recoverable amount.

Goodwill is tested annually for impairment, as well as when there is any indication that the goodwill may

be impaired. For impairment testing, assets are grouped together into the smallest group of assets that

generates cash inflows from continuing use that are largely independent of the cash inflows of other

assets or cash generating units (CGU). Goodwill arising from a business combination is allocated to CGUs

or groups of CGUs that are expected to benefit from the synergies of the combination. An impairment loss

is recognized in the income statement when the carrying amount of CGU, including the goodwill, exceeds

the recoverable amount of the CGU. Recoverable amount of the CGU is the higher of the CGU’s fair value

less cost to sell and value in use.

The Group has goodwill created by deferred tax which is tested for impairment annually.

vii. Business combination and consolidation

The Group accounts for business combinations using the acquisition method when control is transferred

to the Group. The consideration transferred in the acquisition is generally measured at fair value, as are the

identifiable net assets acquired. Any goodwill that arises is tested annually for impairment. Any gain on a

bargain purchase is recognized in profit or loss immediately. Transaction costs are expensed as incurred,

except if related to the issue of debt or equity securities.

The Group controls an entity when it is exposed to, or has rights to, variable returns from its involvement

with the entity and has the ability to affect those returns through its power over the entity. The financial

statements of subsidiaries are included in the consolidated financial statements from the date on which

control commences until the date on which control ceases.

viii. Contingent liabilities

Contingent liabilities are not recognized in the statement of financial position but are reported in the

relevant schedules and notes. They may arise from uncertainty as to the existence of a liability represent a

liability in respect of which the amount cannot be reliably measured. Contingent liabilities are disclosed if

the possibility of an outflow of economic benefit to settle the obligation is more than remote.

ix. Interest income

Interest income is recognized using the effective interest method.

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Note 2: Accounting principles (continued)

x. Earnings per share

The basic earnings per share are calculated as the ratio of the total profit (loss) for the year divided by the

weighted average number of ordinary shares outstanding. When calculating the diluted earnings per share,

the profit that is attributable to the ordinary shareholders and the weighted average number of ordinary

shares outstanding are adjusted for all the dilution effects relating to share options.

No dilutive effect has been recognized as potential ordinary shares only shall be treated as dilutive if

their conversion to ordinary shares would decrease earnings per share or increase loss per share from

continuing operations. As the Group is currently loss-making, an increase in the average number of shares

would have anti-dilutive effects. As the Group has currently no issuable potential ordinary shares and basic

and diluted earnings per share is the same.

xi. Government grants

Government grants are recognized where there is reasonable assurance that the grant will be received, and

all attached conditions will be complied with. When the grant relates to an expense item, it is recognized

as income on a systematic basis over the periods that the costs, which it is intended to compensate,

are expensed. Government grants have been recognized in the statement of profit or loss and other

comprehensive income as a reduction of personnel- and other operating expenses.

xii. IFRS 16 Leases

Under IFRS 16, the Group recognizes right-of-use assets and lease liabilities for all leases.

Right-of-use assets are measured at an amount equal to the lease liability and are subsequently depreciated

using the straight-line method from the commencement date to the earlier of the end of the useful life of

the right-of-use asset or the end of the lease term.

The estimated useful lives of right-of-use assets are determined on the same basis as those of property

and equipment. In addition, the right-of-use asset is reduced by impairment losses, if any, and adjusted

for certain remeasurements of the lease liability.

The lease liability is initially measured at the present value of the lease payments that are not paid at the

commencement date, discounted using the interest rate implicit in the lease or, if that rate cannot be

readily determined, Ultimovacs’ incremental borrowing rate. The incremental borrowing rate is used as the

discount rate.

When applying the practical expedients in IFRS 16 for lease-contracts with low value or lease terms of

less than 12 months, the lease payments (net of any incentives received from the lessor) are taken to the

statement of profit and loss and other comprehensive income on a straight-line basis over the period of

the lease. When the lease is terminated before the lease period has expired, any payment required to be

made to the lessor by way of penalty is recognized as an expense in the period in which termination takes

place.

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Note 2: Accounting principles (continued)

xiii. Share-based payments

Employees in the Group receive remuneration in the form of share-based payment transactions, whereby

employees render services as consideration for equity instruments (equity-settled transactions) or granted

share appreciation rights, which can be settled in cash (cash-settled transactions). The determination of

whether the arrangement is cash or equity settled is based on a careful evaluation of the terms of the

agreement and also the Group’s ability to settle in shares and the promise and intent of settlement in cash.

- Cash-settled transactions:

A liability is recognized for the fair value of cash-settled transactions. The fair value is measured initially

and at each reporting date up to and including the settlement date, with changes in fair value recognized in

payroll and payroll related expenses. The fair value is expensed over the period until the vesting date with

recognition of a corresponding liability. The fair value is determined using a Black Scholes model.

- Equity-settled transactions

The cost of equity-settled transactions is recognized in payroll and other payroll related expenses, together

with a corresponding increase in equity over the period in which the service and, where applicable, the

performance conditions are fulfilled (the vesting period). The cumulative expense recognized for equity-

settled transactions at each reporting date until the vesting date reflects the extent to which the vesting

period has expired and the Company’s best estimate of the number of equity instruments that will ultimately

vest. The expense or credit in the statement of profit or loss and other comprehensive income for a period

represents the movement in cumulative expense recognized as of the beginning and end of that period.

xiv. Intangible assets

Intangible assets are stated at their historical cost and amortized on a straight-line basis over their

expected useful lives, which usually varies from 3 to 10 years and up to 15 years for patents. An adjustment

is made for any impairment. Intangible items acquired in a business combination must be recognized as

assets separately from goodwill if they meet the definition of an asset, are either separable or arise from

contractual or other legal rights, and their fair value can be measured reliably.

All research and development spending is expensed each year in the period in which it is incurred.

Development costs will be capitalized once the “asset” being developed has met requirements of technical

and commercial feasibility to signal that the intangible investment is likely to either be brought to market

or sold. Due to uncertainties regarding award of patents, regulations, ongoing clinical trials etc., the asset

recognition criteria of IAS 38 “Intangible Assets” are not met.

xv. Property, plant and equipment

Property, plant and equipment are carried at cost, net of accumulated depreciation and accumulated

impairment losses, if any. Acquisition cost includes expenditures that are directly attributable to the

acquisition of the individual item. Property, plant and equipment are depreciated on a straight-line basis

over the expected useful life of the asset. If significant individual parts of the assets have different useful

lives, they are recognised and depreciated separately. Depreciation commences when the assets are ready

for their intended use.

An item of property, plant and equipment and any significant part initially recognised is derecognised upon

disposal or when no future economic benefits are expected from its use or disposal. Any gain or loss arising

on derecognition of the asset (calculated as the difference between the net disposal proceeds and the

carrying amount of the asset) is included in the income statement when the asset is derecognised.

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Note 2: Accounting principles (continued)

xvi. Tax

The income tax expense includes tax payable and changes in deferred tax. Income tax on balances

recognized in other comprehensive income is recognized as other comprehensive income, and tax on

balances related to equity transactions is recognized in equity. The tax payable for the period is calculated

according to the tax rates and regulations ruling at the end of the reporting period.

Deferred tax is calculated on temporary differences between book and tax values of assets and liabilities

and the tax effects of losses to carry forward in the consolidated financial statements at the reporting

date. Deferred tax liabilities and assets are calculated according to the tax rates and regulations ruling at

the end of the reporting period and at nominal amounts. Deferred tax liabilities and assets are recognized

net when the Group has a legal right to net assets and liabilities.

Deferred tax assets are recognized only to the extent that it is probable that future taxable profits will be

available which the loss carry forward or other deductible temporary differences can be utilized. Currently

no deferred tax assets are recognized in the statement of financial position as the utilization is uncertain.

xvii. Segments

The Group is still in a R&D phase, and currently does not generate revenues. For management purposes, the

Group is organized as one business unit and the internal reporting is structured in accordance with this.

All non-current assets are located at the Group’s main office in Oslo, Norway.

IV. Significant estimates and judgements

In order to prepare the financial statements, management and the Board may have to make various judgments

and estimates that can affect the amounts recognized in the financial statements for assets, liabilities

and expenses. Uncertainties about these adjustments and estimates could result in outcomes that require

adjustment to the carrying amount of assets or liabilities affected in future periods. Assumptions and

estimates were based on available information at the time of the preparation of the financial statements.

Existing circumstances and assumptions about future developments, however, may change and such

changes are reflected when they occur.

- Share-based payments

Estimating fair value for share-based payment transactions requires determination of the most appropriate

valuation model, which depends on the terms and conditions of the grant. This estimate also requires

determination of the most appropriate inputs to the valuation model including the expected life of the

share option or appreciation right, volatility and dividend yield and making assumptions about them.

- Taxes

Deferred tax assets are recognized for unused tax losses to the extent that it is probable that taxable

profit will be available against which the losses can be utilized. The Group considers that a deferred tax

asset related to accumulated tax losses cannot be recognized in the statement of financial position until

the product under development has been approved for marketing by the relevant authorities. Significant

management judgement is required to determine the amount, if any, of deferred tax assets that can be

recognized, based upon the likely timing and the level of future taxable profits, together with future tax

planning strategies.

- Impairment of goodwill and intangible assets

The Group follows the guidance of IAS 36 to determine when impairment indicators exist for its goodwill

and intangible assets. When impairment indicators exist, the Group is required to make a formal estimate

of the recoverable amount of its intangible assets. This determination requires significant judgment. In

making this judgment, management evaluates external and internal factors, such as significant adverse

changes in the technological, market, economic or legal environment in which the Group operates as well

as the results of its ongoing development programs. Management also considers the carrying amount of

the Group’s net assets in relation to its market capitalization as a key indicator.

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GRANTS RECOGNIZED (NOK 1 000) 2023 2022Skattefunn 2 047 4 750Industrial Ph.D. grant from The Research Council of Norway (Forskningsrådet) - 594Innovation Project grant from The Research Council of Norway (Forskningsrådet) 3 088 4 194Innovation Norway 5 073 -Total grants 10 207 9 538

COSTS DEDUCTED (NOK 1 000) 2023 2022Payroll and payroll related expenses 1 544 1 822Other operating expenses 8 663 7 717Total costs deducted 10 207 9 538

GRANTS RECEIVABLES (NOK 1 000) 2023 2022Skattefunn 2 047 4 750Industrial Ph.D. grant from The Research Council of Norway (Forskningsrådet) - 198Innovation Project grant from The Research Council of Norway (Forskningsrådet) 952 42Total grants receivables 2 998 4 990

Note 3: Government grants

The following government grants have been recognized in the statement of profit and loss:

Skattefunn:

The Skattefunn R&D tax incentive scheme is a government program designed to stimulate research and

development in Norwegian. Two Skattefunn projects are ongoing, where one will report in 2024 and one in

2025.

Innovation Project grant from The Research Council of Norway (Forskningsrådet):

Innovation Project for the Industrial Sector is a funding instrument that provides grants to business-led

innovation projects that make extensive use of research and development activities. The FOCUS Phase II

trial has been granted an innovation grant of up to MNOK 16 from the Norwegian Research Council.

Innovation Norway:

Innovation Norway is the Norwegian Government’s most important instrument for innovation and

development of Norwegian enterprises and industry. In 2020, Innovation Norway granted Ultimovacs up to

MNOK 10 to support the execution of the Phase II DOVACC study. The project was concluded in December

2023, where the total grant from Innovation Norway amounted to MNOK 8.1.

All conditions and contingencies attached to the grants recognized in the accounts have been fulfilled.

Grants receivable as per 31 December are detailed as follows:

Government grants have been recognized in the statement of profit and loss and other comprehensive

income as a reduction for the related expenses with the following amounts:

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PAYROLL AND PAYROLL RELATED EXPENSES (NOK 1 000) 2023 2022Salaries and holiday pay 43 514 38 215Social security tax 8 787 9 142Social security tax related to options 6 104 2 016Pension expenses 3 586 2 818Share-based compensation 14 256 20 395Other personnel expenses 427 702Government grants (1 544) (1 822)Total payroll and payroll related expenses 75 130 71 466Number of FTEs employed during the financial year 25.0 23.2Number of FTEs at end of year 25.2 23.2

Note 4: Salary and personnel expenses and management remuneration

The Group’s Management team consists of the Company’s CEO, CFO and the managers of each department,

totaling ten employees. The Chief Business Officer and the Head of Regulatory Affair and QA are both

employed in Ultimovacs AB.

EXECUTIVE REMUNERATION (NOK 1 000) 2023 2022Management Team remuneration 35 009 37 599Short term employee benefits 25 965 24 121Share option (IFRS cost) 9 044 13 477Board of Director’s remunerations* 2 230 1 855

There were no outstanding loans or guarantees made to related parties, the Board of Directors, the

Management Team or any other employees as of 31 December 2022 or as of 31 December 2023.

Please refer to the Remuneration Report 2023 for more information.

Pensions

Ultimovacs ASA is required to have an occupational pension scheme in accordance with the Norwegian

law on required occupational pension (“lov om obligatorisk tjenestepensjon”). The company has a

defined contribution pension scheme which complies with the Act on Mandatory company pensions.

As at 31 December 2023, all 21 of Ultimovacs ASA’s employees were covered by the pension

scheme. A similar pension scheme is in place for the six employees in Ultimovacs AB in Sweden.

Other than the general pension schemes described above, there are no specific pension arrangements made for

any member of the Management team. The Group has no pension or retirement benefits for its Board Members.

The total pension contributions for all employees recognized as expenses equalled MNOK 2.8 and MNOK

3.6 in 2022 and 2023 respectively.

* Note that the table above shows the accumulated board remuneration for each respective year, which will be paid the following year.

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Note 4: Salary and personnel expenses and management remuneration (continued)

Severance pay/pay after termination of employment

Under certain conditions, the CEO is entitled to 12 months’ severance pay. The severance pay period will be

extended to 18 months if the termination of the CEO takes place in connection with a ‘change of control’

event in the Company.

The company’s CFO is entitled to receive pay after termination of his employment with the Group equal to

9 months’ base salary in addition to payment of his salary during his 3-month notice period.

There are no similar arrangements for any of the other employees of the Group with respect to termination

of their employment.

Other benefits received

There is no bonus scheme in the Group, however, sign-on-fees and bonus may be applied at the Board’s

discretion.

Statement on the executive employee remuneration policy during the previous financial year

The executive compensation for the fiscal year 2023 has been in accordance with the Remuneration

Guidelines for 2023. Please refer to Remuneration Guidelines 2022 and Remuneration Report 2023 available

on Ultimovacs’ website for more information.

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OTHER OPERATING EXPENSES (NOK 1 000) 2023 2022External R&D expenses 123 834 95 175 Clinical studies 70 922 66 772 Manufacturing costs 39 256 19 899 Other R&D expenses 13 656 8 504Patent related expenses 6 031 3 571Rent, office and IT 4 874 4 221Accounting, audit, legal, consulting 6 476 9 246Other operating expenses 5 284 5 020Less government grants (8 663) (7 717)Total operating expenses 137 837 109 517

Note 5: Other operating expenses

SPECIFICATION AUDITOR'S FEE (NOK 1 000) 2023 2022Statutory audit 392 404Audit related services 46 40Tax related services 21 10Other 18 3Total auditor’s fee 477 456

VAT is not included in the fees specified above.

Note 6: Financial items

FINANCIAL INCOME (NOK 1 000) 2023 2022Foreign exchange gains - related to derivatives 12 741 5 053Foreign exchange gains - related to EUR bank account 1 800 2 087Foreign exchange gains - other 972 1 329Interest income 14 127 8 906Total financial income 29 640 17 375

FINANCIAL EXPENSES (NOK 1 000) 2023 2022Foreign exchange losses - related to derivatives - -Foreign exchange losses - related to EUR bank account - -Foreign exchange losses - other 2 761 1 293Other financial expenses 382 243Total financial expenses 3 143 1 536

The Group is in a development phase, and the majority of the Group’s costs are related to R&D. These

costs are expensed in the statement of profit and loss and other comprehensive income.

Total expenses related to R&D, including other operating expenses, payroll and payroll related expenses,

less government grants, amounted to MNOK 128.5 in 2022 and MNOK 163.9 in 2023.

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TAX EXPENSE BASIS (NOK 1 000) 2023 2022Profit (loss) before tax (189 239) (167 792)Net non-taxable income (2 098) (4 759)Other items 11 753 18 089Change in temporary differences 10 901 1 051Basis for tax calculation (168 683) (153 411)

Note 7: Income tax

The corporate tax rate in Norway was 22% in 2022 and 2023. The corporate tax rate in Sweden was 20.6%

in 2022 and 2023, which is the basis of the deferred tax calculation for Ultimovacs AB.

INCOME TAX EXPENSE (NOK 1 000) 2023 2022Expected tax expense (41 555) (36 821)Net non-taxable income (462) (1 047)Other items 2 586 3 980Change in deferred tax assets not recognized 39 431 33 888Income tax expense - -

Ultimovacs has not recognized a deferred tax asset in the statement of financial position related to

its previous losses, as the Group does not expect taxable income to be generated in the short-term to

support the use of the deferred tax asset. Total tax losses carried forward and temporary differences as

per 31 December 2022 was MNOK 669.9, and MNOK 844.8 as per 31 December 2023 (of which MNOK 38.9

in Ultimovacs AB).

In relation to purchase price allocation conducted of Ultimovacs AB, acquired in July 2018, all excess

value has been allocated to the license agreement which gives access to the TET-technology. A deferred

tax liability of MNOK 11.7 has been calculated on the excess values utilizing the tax rate in Sweden of

20.6%. Please see note 9 for more information.

INCOME TAX EXPENSE (NOK 1 000) 2023 2022Tax losses carried forward 877 801 709 118Temporary differences - financial instruments 4 886 (1 083)Temporary differences - leasing liability 153 37Temporary differences - licenses (56 566) (51 944)Temporary differences - social security on options 18 323 13 488Temporary differences - PP&E 220 238Temporary differences and tax loss carry forward 844 816 669 854Deferred tax assets - not recognized in statement of financial position 197 760 158 329Deferred tax liability per 31 December (11 653) (10 701)

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Note 8: Earnings per share

The basic earnings per share (EPS) are calculated as the ratio of the total profit (loss) for the

year divided by the weighted average number of ordinary shares outstanding. As the Group has

currently no potential issuable ordinary shares, basic and diluted earnings per share is the same.

The issued share options have a potential dilutive effect on earnings per share. No dilutive effect has been

recognized, as potential ordinary shares only shall be treated as dilutive if their conversion to ordinary

shares would decrease earnings per share or increase loss per share from continuing operations. As the

Group is currently loss-making, an increase in the average number of shares would have anti-dilutive

effects. Diluted and basic (undiluted) earnings per share is therefore the same.

EARNINGS PER SHARE 2023 2022Profit (loss) for the year (NOK 1000) (189 239) (167 792)Average number of outstanding shares during the year (1 000) 34 398 34 247EPS - basic and diluted (NOK per share) (5.5) (4.9)

A share option program was introduced in June 2019 and at the ordinary General Assembly held on 20

April 2023, the Board was authorized until the next ordinary General Assembly in 2024 to increase the

Company’s share capital in connection with the share incentive arrangement by up to NOK 343,964.6. A

total of 2,289,285 share options are outstanding as per 31 December 2023, corresponding to 6.65% of the

outstanding number of shares in the Company.

Please see note 15 for more information regarding the option program.

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Financial statements

Note 9: Non-current assets

OFFICE AND NON-CURRENT ASSETS 2022 (NOK 1 000)PATENTS LICENSES GOODWILL TOTALLAB EQUIPM.Accumulated cost 1 Jan 2022 2 148 9 000 50 401 10 383 71 932Additions 195 - --195Cost at 31 Dec 2022 2 344 9 000 50 401 10 383 72 127Accumulated depreciation and amortization (1 936) (2 461)- -(4 397)at 1 Jan 2022Depreciations in the year (188) (754)- -(943)Accumulated depreciation and amortization (2 124) (3 215) --(5 339)at 31 Dec 2022Accumulated currency effects at 1 Jan 2022- -3 148 649 3 797Currency exchange effects in the year- -(1 605) (331) (1 935)Carrying value at 31 Dec 2022 220 5 784 51 944 10 701 68 649Economic life 3 years 15 years indefinite indefiniteDepreciation method linear linear

Patents

In 2015, the Group acquired all rights to the patents and technology from Inven2 AS, which is one of the

Group’s main shareholders. The price for the patent was MNOK 4.0 and was based on a purchase option

in the license agreement entered into with Inven2 AS in 2011. The purchase of these rights implies that

the Group no longer has to pay future royalties to Inven2 AS from potential commercial sales of products

related to the patents/patent applications. The patent period spans over 15 years and expires in 2031.

According to the purchase agreement related to the same patents, Inven2 AS is entitled to two milestone

payments of MNOK 5.0 and MNOK 6.0 at the commencement of a clinical phase IIb and phase III study (or

another registration study) respectively. The first milestone payment of MNOK 5.0 was paid to Inven2 in May

2020 due to the commencement of the INITIUM phase II trial. The milestone payment was capitalized in

the balance sheet when it was paid to Inven2, and will be depreciated linearly until February 2031.

OFFICE AND NON-CURRENT ASSETS 2023 (NOK 1 000)PATENTS LICENSES GOODWILL TOTALLAB EQUIPM.Accumulated cost 1 Jan 2023 2 344 9 000 50 401 10 383 72 127Additions 25 - --25Cost at 31 Dec 2023 2 368 9 000 50 401 10 383 72 152Accumulated depreciation and amortization (2 124) (3 215)- -(5 339)at 1 Jan 2023Depreciations in the year (130) (754)- -(885)Accumulated depreciation and amortization (2 255) (3 970) --(6 224)at 31 Dec 2023Accumulated currency effects at 1 Jan 2022- -1 544 318 1862Currency exchange effects in the year- - 4 621 952 5573Carrying value at 31 Dec 2023 114 5 030 56 566 11 653 73 362

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Note 9: Non-current assets (continued)

Licenses and Goodwill

Beyond UV1, which is the core product of the Ultimovacs group, Ultimovacs is pursuing development of a

first-in-class vaccine solution utilizing the proprietary Tetanus-Epitope Targeting-platform (TET-platform).

A preclinical program was initiated in 2019 to take the pharmaceutical product candidate to a decision

point for further clinical development, given that the results from the preclinical program are positive.

There has been and there are several significant milestones in terms of impairment testing of the value of

the TET technology. The current preclinical development of TET is planned to be funded until an expected

milestone in 2024 where the board will decide on the continued development. If Ultimovacs decides not

to go further in the development of the TET technology, it would be difficult to justify the value in the

balance-sheet, and a substantial part of the booked value is subject for impairment.

Impairment of assets

1. IAS 36 seeks to ensure that an entity’s assets are not carried at more than their recoverable amount.

2. Impairment means that asset has suffered a loss in value.

3. An asset is said to be impaired when its recoverable amount is less than its carrying amount.

Ultimovacs has both goodwill and intangibles with indefinite useful lives as of 31 December 2023. Under

IAS 36, ‘Impairment of assets’, these assets are required to be tested annually for impairment irrespective

of indictors of impairment. The intangible assets subject to impairment in the balance sheet are “Licenses”,

which are the basis for the TET technology. The license agreement with Academisch Ziekenhuis Leiden and

Technologiestichting STW gives Ultimovacs rights to commercial development, manufacture and sales of

immunotherapy treatments against cancer utilizing the TET technology. The license agreement does not

have any expiration date, and the license is therefore defined to have indefinite useful life.

The Group also has goodwill created by deferred tax, which is a result of the purchase price amount

for acquiring the licensed technology. The Goodwill is also tested for impairment annually. To test for

impairment, goodwill must be allocated to each of the acquirer’s cash-generating units (CGU), or groups

of cash-generating units, that are expected to benefit from the synergies of the combination, irrespective

of whether other assets or liabilities of the acquiree are assigned to those units or groups of units. The

legal entities Ultimovacs ASA and Ultimovacs AB, together the Group, is defined as the CGU subject for

impairment testing. The impairment testing of the Licenses and its corresponding goodwill will therefore

be performed at Group level.

Impairment test

The recoverable amount of a cash generating unit is the higher of the cash generating unit’s fair value

less costs of disposal and its value in use. The Value in use of an asset is the expected future cash flows

that the asset in its current condition will produce, discounted to present value using an appropriate

discount rate. Ultimovacs has chosen not to prepare a Value in use calculation from the TET technology as

the estimates of future cash flows would be highly unreliable. Potential earnings are years ahead, and it

would not be clear if these could come from direct sales, indirect sales or through licensing agreements.

To prepare a forecast in order to obtain any value for the assets tested for impairments would not be

reasonable and supportable.

Ultimovacs will therefore rely on the value from the Fair Value assessment, which normally is the market

value at measurement date. No active market exists for comparison; thus, the acquisition price, and book

value, is considered as the fair value. The fair value is thus based on a cost approach, i.e. the replacement

cost which reflects the amount that would be required currently to replace the service capacity of these

assets. This cost is then the acquisition price plus expensed development costs incurred subsequently to

the acquisition. Based on the current condition of the acquired license the recoverable amount is assessed

to be significantly higher than the book value of the license. The fair value, however, must be tested for

factors which may reduce is value, function etc.

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Note 9: Non-current assets (continued)

The following factors have been assessed when testing for impairment:

1. Market value declines: There is no indication that the value for adjuvants is in decline. Ultimovacs has

few or no real alternatives to the adjuvant currently being used, GM-CSF.

2. Negative changes in technology, markets, economy, or laws: There is still an unmet need for more

adjuvant solutions to be used with vaccines. Thus, the TET technology may potentially be utilized in other

vaccine candidates, and it could also be sold to third parties. No other negative factors are observed in

the markets.

3. Asset is idle, part of a restructuring or held for disposal: The current phase of the development plan is

further pre-clinical development of the TET technology, further CMC development of the TET compound

(i.e. to develop a manufacturing process for a lead product candidate based on the TET technology, further

development of the general technology platform, and completion of clinical testing of the TENDU prototype

vaccine in a phase I trial.

4. Worse economic performance than expected: Even though TET is still far from bringing any cash inflows

to the company, the technology will be highly valuable if the project is successful. Setting any value on

the TET technology using a CF model is of no real value/use at this very early stage of its research and

development.

In addition, Management has undertaken a review of the company’s business and the environment in which

it operates, and concluded that there are no significant changes in the business or its environment now or

in the future regarding:

• a decline in the market or price for products or services

• oversupply in markets for products or services

• problems in sourcing raw materials or services

• increases in the costs of production or delivering services

• changes in exchange rates affecting costs or sales

• new competitors

• new products or services from competitors

• technological change

• changes in law or regulations

• changes in economic conditions

Although the list above is not exhaustive, we do not observe any new risk factors related to the technology

which may reduce the value of the assets in the balance sheet.

The TET technology platform is independent of UV1. The negative readout of the UV1 INITIUM trial in

March 2024 is therefore not directly influencing the value of the TET platform. So far, Ultimovacs has

successfully completed preclinical development activities related to this platform, as well as successful

CMC development (manufacturing) for the core technology enabling upscaling and improved flexibility of

products based on the TET platform. Ultimovacs has also completed the TENDU Phase I trial testing as an

early vaccine solution within prostate cancer based on the TET platform. The TENDU trial met its primary

and secondary endpoints as reported in December 2023. The board will make a separate evaluation of the

further development of the TET platform later in 2024 and this evaluation is not directly influenced by the

UV1 results. This decision point will be important when considering impairment of the intangible assets, as

the asset could then be considered partly idle, reducing its value significantly.

Conclusion

In the impairment test performed, no indications of impairment were identified. The fair value of the

intangible assets are higher than carrying value. As a result, no impairment of these intangible assets has

been recognized.

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Note 10: Other receivables

OTHER RECEIVABLES (NOK 1 000) 2023 2022Government grants receivables (ref note 3) 2 998 4 990Prepayments 1 463 2 916Fair value of currency contracts - 1 083Other receivables 1 096 1 280Total other receivables 5 557 10 270

As of 31 December 2023, cash and cash equivalents amounted to MNOK 266.6, of which MNOK 2.4 (MEUR

0.2) on an EUR account and MNOK 3.5 (MSEK 3.4) in Ultimovacs AB on a Swedish bank account in SEK.

SHARE CAPITAL SHARE CAPITAL CHANGES TO SHARE CAPITALNUMBER OF SHARES(NOK)31 December 2021 34 221 761 3 422 176.1Issuance of ordinary shares 174 700 17 47031 December 2022 34 396 461 3 439 646.1Issuance of ordinary shares 9 600 96031 December 2023 34 406 061 3 440 606.1

Note 11: Cash and cash equivalents

CASH AND CASH EQUIVALENTS (NOK 1 000) 2023 2022Employee withholding tax 1 697 1 818Cash at bank 264 862 423 491Cash and cash equivalents 266 559 425 309

Note 12: Share capital, shareholder information and dividend

In November 2023, a total of 9,600 options, granted under Ultimovacs’ option program, were exercised.

Subsequently, the Company’s share capital was increased by NOK 960 by issuing 9,600 new shares, each

share of par value NOK 0.10.

In September and November 2022, a total of 174,700 options, granted under Ultimovacs’ option program,

were exercised. Subsequently, the Company’s share capital was increased by NOK 17,470 by issuing 174,700

new shares, each share of par value NOK 0.10.

The share capital as of 31 December 2023 was NOK 3,440,606.1, with 34,406,061 ordinary shares with a

nominal value of NOK 0.1. All issued shares have equal voting rights and the right to receive dividend.

No dividend has been paid in the period. Ultimovacs ASA has approximately 6,000 shareholders as of 31

December 2023, with the 20 largest shareholders as of this date listed in a table below on the next page.

The movement in the number of registered shares and share capital was in 2022 and 2023 as follows:

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Note 12: Share capital, shareholder information and dividend (continued)

NUMBER OF OWNERSHIP THE 20 MAIN SHAREHOLDERS AS OF 31 DECEMBER 2023SHARES INTERESTGjelsten Holding AS 6 495 866 18.9 %Canica AS 2 705 957 7.9 %Watrium AS 1 780 575 5.2 %Radforsk Investeringsstiftelse 1 519 263 4.4 %Langøya Invest AS 1 396 006 4.1 %Inven2 AS 1 372 163 4.0 %Helene Sundt AS 965 802 2.8 %CGS Holding AS 882 132 2.6 %Sundt AS 803 321 2.3 %Stavanger Forvaltning AS 583 416 1.7 %Danske Invest Norge Vekst 563 525 1.6 %Prieta AS 533 988 1.6 %Verdipapirfondet Nordea Avkastning 414 990 1.2 %Myrlid AS 400 000 1.2 %Folketrygdfondet 343 465 1.0 %SEB Prime Solutions Sissener Canopus 300 000 0.9 %Wiarom AS 250 000 0.7 %Gade, Leif Johan 240 000 0.7 %Verdipapirfondet Nordea Kapital 233 090 0.7 %Jakob Hatteland Holding AS 211 110 0.6 %20 Largest shareholders 21 994 669 63.9% Other shareholders 12 411 392 36.1% Total 34 406 061 100.0%

As of 31 December 2023, five members of the Management team in the Group held a total of 164,654

ordinary shares in Ultimovacs.

NUMBER OF SHARES HELD BY MANAGEMENT AND NUMBER OF POSITION THE BOARD OF DIRECTORS AS OF 31 DECEMBER 2023SHARESCarlos de Sousa CEO 15 406Hans Vassgård Eid - through Snøtind AS CFO 57 200Audun Tornes - through Aeolus AS CTO 87 500Antonius Berkien - through nominee account CBO 1 088Anne Worsøe - through Waverly AS Head of IR 3 460Ketil Fjerdingen - through Langøya Invest AS Board member 1 396 006 Leiv Askvig - through Basen Kapital AS Board member 91 500Henrik Schussler - through Fireh AS Board member 30 900Eva S. Dugstad Board member 6 400Kari Grønås - through K OG K AS Board member 6 640Total shares held by Management and the Board of Directors 1 696 100

As of 31 December 2023, Carlos de Sousa and closely related parties hold in total 23,056 shares in

Ultimovacs ASA.

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Note 12: Share capital, shareholder information and dividend (continued)

NUMBER OF OWNERSHIP THE 20 MAIN SHAREHOLDERS AS OF 31 DECEMBER 2022SHARES INTERESTGjelsten Holding AS 6 495 866 18.9 %Canica AS 2 705 957 7.9 %Watrium AS 1 780 575 5.2 %Inven2 AS 1 555 492 4.5 %Folketrygdfondet 1 515 813 4.4 %Radforsk Investeringsstiftelse 1 512 163 4.4 %Langøya Invest AS 1 389 006 4.0 %Helene Sundt AS 965 802 2.8 %CGS Holding AS 882 132 2.6 %Sundt AS 803 321 2.3 %Danske Invest Norge Vekst 736 440 2.1 %Stavanger Forvaltning AS 590 000 1.7 %Prieta AS 533 988 1.6 %Verdipapirfondet Nordea Avkastning 480 573 1.4 %SEB Prime Solutions Sissener Canopus 400 000 1.2 %Verdipapirfondet KLP Aksjenorge 348 416 1.0 %Swedbank AB 252 814 0.7 %Wiarom AS 250 000 0.7 %Verdipapirfondet Nordea Kapital 246 178 0.7 %Gade, Leif Johan 225 052 0.7 %20 Largest shareholders 23 669 588 68.8%Other shareholders 10 726 873 31.2%Total34 396 461100.0%

As of 31 December 2022, four members of the Management team in the Group held a total of 163,066

ordinary shares in Ultimovacs.

NUMBER OF SHARES HELD BY MANAGEMENT AND NUMBER OF POSITION THE BOARD OF DIRECTORS AS OF 31 DECEMBER 2022SHARESCarlos de Sousa CEO 14 906Hans Vassgård Eid - through Snøtind AS CFO 57 200Audun Tornes - through Aeolus AS CTO 87 500Anne Worsøe - through Waverly AS Head of IR 3 460Ketil Fjerdingen - through Langøya Invest AS Board member 1 389 006 Leiv Askvig - through Basen Kapital AS Board member 91 500Henrik Schussler - through Fireh AS Board member 30 900Eva S. Dugstad Board member 6 400Kari Grønås - through K OG K AS Board member 6 640Total shares held by Management and the Board of Directors 1 687 512

As of 31 December 2022, Carlos de Sousa and closely related parties hold in total 21,556 shares in

Ultimovacs ASA.

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Note 13: Transactions with related parties

In 2015, Ultimovacs acquired the patent rights for the core UV1 technology from Inven2 AS, a major

shareholder in the Group. Based on the agreements, Invent2 AS is entitled to receive two potential

milestone payments when certain clinical research criteria are reached; MNOK 5.0 and MNOK 6.0 at the

commencement of a clinical phase IIb and phase III study (or another registration study) respectively. The

first milestone payment of MNOK 5.0 was paid to Inven2 in May 2020 due to the commencement of the

INITIUM phase II trial.

Please refer to note 9 for additional information.

As part of ordinary business and at market price, Ultimovacs purchases services related to clinical trials and

laboratory services from Oslo University Hospital through Inven2 AS. Invoicing directly from or administered

by Inven2 AS amounted to MNOK 2.9 in 2022 and MNOK 2.8 in 2023 respectively (incl. VAT). As per 31

December 2023, Ultimovacs had no outstanding payables to Inven2 AS.

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Note 14: Leases and commitments

The right-of-use assets comprise a rental agreement for office premises in Oslo with 2 years left of the

rental contract as of 31 December 2023, and four car-leasing contracts. The weighted average discount rate

applied is 8.3% as per 31 December 2023.

The Group has utilized the practical expedients relating to leases where short term leases and lease-

contracts of low value have not been recognized as right of use assets. Expenses relating to short-term

lease comprise lab premises and parking spaces in Oslo, Norway, and office- and lab premises in Uppsala,

Sweden. These contracts can be terminated by both lessee and lessor within 1 - 3 months. Expense

relating to low-value assets comprise leasing of an office printer in Oslo.

The Group had total cash outflows related to leases of MNOK 2.8 in FY22 and MNOK 3.5 in FY23.

LEASE EXPENSES (NOK 1 000) 2023 2022Depreciation expense of right-of-use assets 1 883 1 705Interest expense on lease liabilities 380 105Expense relating to short-term leases (incl. in Other operating expenses) 1 242 1 018Expense relating to low-value assets (incl. in Other operating expenses) 11 11Total amount recognized in profit or loss 3 516 2 839

NON-DISCOUNTED LEASE LIABILITIES EXPIRING WITHIN THE FOLLOWING PERIODS 2023 2022FROM THE BALANCE SHEET DATE (NOK 1 000)Within 1 year 2 058 2 1471 to 2 years 1 862 2 058 2 to 3 years 112 1 862 3 to 4 years - 1124 to 5 years - -Over 5 years - -Sum 4 032 6 179

LEASE LIABILITIES (NOK 1 000) 2023 2022Lease liability as per 1 January5 481 2 084Additions - 5 199Cash payments for the principal portion of the lease liability(1 767) (1 802)Cash payments for the interest portion of the lease liability(380) (105)Interest expense on lease liabilities380 105Lease liability as per 31 December3 713 5 481Current1 827 1 767Non-current1 886 3 713

RIGHT-OF-USE ASSETS 2023 (NOK 1 000) CARS OFFICE TOTALRight-of-use assets as per 1 January 2023 1 270 4 174 5 444Depreciation costs during the year (492) (1 391) (1 883)Extension options exercised / additions - - -Balance sheet value as per 31 December 2023 778 2 783 3 561

RIGHT-OF-USE ASSETS 2022 (NOK 1 000) CARS OFFICE TOTALRight-of-use assets as per 1 January 2022 680 1 270 1 951Depreciation costs during the year (365) (1 340) (1 705)Extension options exercised / additions 955 4 244 5 199Balance sheet value as per 31 December 2022 1 270 4 174 5 444

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Note 15: Share based payment

Share option program

The equity-settled share option program which was introduced in June 2019 is groupwide and includes all

employees in the Group. At the Annual General Meeting held on 20 April 2023, the Board was authorized

to increase the Company’s share capital in connection with the share incentive arrangement by up to NOK

343,964.6. The authorization is valid until the next ordinary General Meeting in 2024.

Each option gives the right to acquire one share in the Company and is granted without consideration.

Pursuant to the vesting schedule, 25% of the options will vest one year after the day of grant, 25% of the

options will vest two years after the day of grant and the remaining 50% will vest three years after the day

of grant, with the exception that the options granted in 2020 to the CEO, Carlos de Sousa, will vest with

33.33% one year following the grant date, 33.33% after two years, and the remaining 33.34% on the third

anniversary following the grant date. Vesting is dependent on the option holder still being employed in

the Company.

The exercise price was NOK 31.25 for the options granted in 2019, NOK 39.15 for the options

granted in 2020, NOK 61.99 for the options granted in 2021, NOK 83.46 for the options granted in 2022 and

NOK 128.61 for the options granted in 2023.

Options that are not exercised within 7 years from the date of grant will lapse and become void. In 2022,

the Board of Directors decided to extend the duration of all options under the share option program from

5 years to 7 years. Due to this life extension, the unamortized value of the options increased, resulting in

an increased IFRS cost related to the options going forward, as well as a one-off cost of MNOK 4.5 booked

in FY 2022 in accordance with IFRS 2.

After the distribution of 160,000 new options on 21 April 2023, and the exercise of 9,600 shares during

2023, a total of 2,289,285 share options are granted per 31 December 2023, corresponding to 6.65% of the

outstanding number of shares in the Company.

NUMBER OF WEIGHTED AVERAGE MOVEMENTS OF OPTIONS DURING 2023INSTRUMENTSEXERCISE PRICEOutstanding at 1 January 2 138 885 54.55 Granted during the year 160 000 128.61 Terminated during the year - - Exercised during the year* (9 600) 31.25 Expired during the year - - Outstanding at 31 December 2 289 285 59.82 Vested options during the year 618 427 53.29

NUMBER OF WEIGHTED AVERAGE MOVEMENTS OF OPTIONS DURING 2022INSTRUMENTSEXERCISE PRICEOutstanding at 1 January 1 833 585 44.77Granted during the year 480 000 83.46Terminated during the year - -Exercised during the year* (174 700) 31.39Expired during the year - -Outstanding at 31 December 2 138 885 54.55Vested options during the year 441 126 45.85

* The weighted average market price for the options exercised in 2023 was NOK 93.20.

* The weighted average market price for the options exercised in 2022 was NOK 90.28.

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Note 15: Share based payment (continued)

Assumptions, costs and social security provisions:

The Ultimovacs Employee Share Options’ fair value is calculated according to the IFRS-2 regulations.

As stated in IFRS-2 Appendix B §B5 the Black-Scholes-Merton Option Pricing Model (“B&S Model”) may

be used to estimate the fair value of employee share options, which is therefore used to estimate the

fair value of the Ultimovacs Employee Share Options. The model uses the following parameters; the

exercise price, the current price of the underlying shares, the life of the option, the expected volatility of

the share price, the dividends expected on the shares, and the risk-free interest rate for the life of the

option.

The exercise price is set out in the Ultimovacs Award Agreements with each employee and is stated in

the Norwegian Krone. The current price of the underlying shares used in the model is the last available

closing price of Ultimovacs at grant date.

The risk-free interest rate used in the B&S Model is equal to the rates of the government bond issues of

the country in whose currency the exercise price is expressed, with the term equal to the expected term

of the option being valued. Since the exercise price is expressed in Norwegian Krone, the “Norges Bank

Statskasseveksler” and “Obligasjoner”-rate is used as input. The interest rates used for the options with

term structures outside of the quoted terms of Norges Banks interest rates are calculated with the use

of a linear interpolation between the two closest quoted rates.

A dividend parameter is not included in the calculations.

The B&S Model assumes that the time from grant until expiry gives the time parameter in the

model. This assumption is based on the options being free from restraints and that the owner of

the options holds the right to sell the option in the market at any time. As this is not the case for

most employee share options, IFRS-2 Appendix B §B16-18, states that a shorter time period can be

used as the expected lifetime of the options in some cases. Half a year after vesting date is therefore

assumed to be the estimated end-of-lifetime of each option in the model. However, exercise

patterns will be monitored, and expected option lifetime will be updated if needed for future grants.

As Ultimovacs has not been listed on a stock exchange long enough to have a sufficient share price history

to calculate the shares’ volatility, comparable firms’ share price volatility have been used to estimate the

expected volatility.

The fair value of the granted instruments in 2022 and 2023 have been calculated using a Black Scholes

model with the following assumptions:

FAIR VALUE PRICING ASSUMPTIONS 2023 2022Instrument Option Option Quantity as of 31 December 160 000 480 000Contractual life* 7.00 7.00Exercise price* 128.61 83.46Share price* 130.00 81.60Expected lifetime* 3.25 3.25Volatility* 58.21% 59.60%Interest rate* 3.290% 2.2451%Dividend* - -Fair value per instrument* 56.02 34.46Vesting conditions Service condition

*Weighted average parameters at grant of instrument

OUTSTANDING INSTRUMENTS OVERVIEW AT YEAR END 2023 2022

Number of instruments 2 289 285 2 138 885

Weighted Average Exercise Price (NOK) 59.82 54.55

Vested/Exercisable instruments as of 31 December 1 469 281 860 454

Weighted Average Exercise Price on vested instruments (NOK) 46.10 40.76

Weighted Average remaining contractual life (years) 4.1 3 4.96

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Note 15: Share based payment (continued)

Note 16: - Other current liabilities

OTHER CURRENT LIABILITIES (NOK 1 000) 2023 2022Public duties payable 4 914 3 698Public duties payable related to options 21 008 14 904Holiday pay payable 4 534 3 913Financial instruments 4 886 -Other accrued expenses 7 772 13 970Sum 43 113 36 485

NUMBER OF OPTIONS HELD BY MANAGEMENT TEAM POSITION 2023 2022Carlos de Sousa Chief Executive Officer 425 535 416 035Hans Vassgård Eid Chief Financial Officer 234 000 224 500Jens Egil Torbjørn Bjørheim Chief Medical Officer 224 500 215 000Audun Tornes Chief Technology Officer 147 000 137 500Gudrun Trøite Head of Project Coordination 106 314 96 814Ingunn Hagen Westgaard Head of Research 120 895 111 395Øivind Foss Head of Clinical Operations 114 000 104 500Ton Berkien Chief Business Officer 115 500 106 000Anne Worsøe Head of IR and Communication 32 000 22 500Orla Mc Callion Head of Regulatory Affairs and QA 47 500 38 000Total allocated share options to Management Team 1 567 244 1 472 244

Note 17: Financial instruments

Foreign exchange forward contracts are valued at fair value which is also the market value of the contract

based on the use of market observable inputs at Level 2 of the fair value hierarchy (please refer to ‘Note

2: Accounting principles - iii. Financial instruments’ for information regarding the ‘fair value hierarchy’).

Market values are calculated using mid-rates (excluding margins) as determined by the financial institution

counterparty on available market rates at reporting date.

Financial risks

The most significant financial risks for the Group are financing risks, liquidity risk, credit risk and foreign

currency risk. Management continuously evaluates these risks and determines policies related to how

these risks are to be handled within the Group.

Foreign exchange derivatives not designated as hedging instruments reflect the positive change in fair

value of those foreign exchange forward contracts that are not designated in hedge relationships, but are,

nevertheless, intended to reduce the level of foreign currency risk for expected purchases.

2023 2023 2022 2022CARRYING CARRYING FINANCIAL ASSETS AND LIABILITIES (NOK 1 000)FAIR VALUEFAIR VALUEVALUEVALUEForeign exchange forward contracts (4 886) (4 886) 1 083 1 083Total financial assets and liabilities (4 886) (4 886) 1 083 1 083

The total IFRS cost recognized for the option program was MNOK 20.4 in FY22 and MNOK 14.3 in FY23. The

total social security provision recognized was MNOK 2.0 in FY22 and MNOK 6.1 in FY23. The total social

security provision as per 31 December 2023 was MNOK 21.0.

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Note 17: Financial instruments (continued)

Financing risk

Adequate sources of funding may not be available when needed or may not be available on favorable

terms. The Group’s ability to obtain such additional capital or financing will depend in part upon

prevailing market conditions as well as conditions of its business and its operating results, and those

factors may affect its efforts to arrange additional financing on satisfactory terms. The Group monitors

the liquidity risk through monthly rolling consolidated forecasts for results and cash flow, and the Board

of Directors works continuously to secure the business operation’s need for financing. Following the

negative readout from the INITIUM trial, the financing risk is higher.

Credit risk

Credit risk is the risk that a counterparty will not meet its obligations under a financial instrument of

customer contract, leading to a financial loss. The Group is exposed to credit risk from its receivables,

deposits in banks.

Liquidity risk

Liquidity risk is the risk that the Group will not be able to meet its financial obligations as they fall

due. The Group’s approach to managing liquidity is to ensure, as far as possible, that it will always have

sufficient liquidity to meet its liabilities when due, under both normal and stressed conditions, without

incurring unacceptable losses or risking damage to the Group’s reputation.

Interest rate risk

The Group has no interest-bearing debt. Bank deposits are exposed to market fluctuations in interest

rates, which impact the financial income.

Foreign currency risk

Foreign currency risk is the risk that the fair value or future cash flows of an exposure will fluctuate

because of changes in foreign exchange rates. The Group’s exposure to the risk of changes in foreign

exchange-rates relates to the Group’s operating activities, primarily expenses in USD, EUR, SEK and GBP.

During 2023 the Company has held funds in EUR and entered into EUR swaps to mitigate the foreign

exchange risk and to get a better predictability regarding future costs. The fair value of forward exchange

contracts are determined using the forward exchange rate at the end of the reporting period, with

changes in the value recognized in the income statement. In the income statement, impacts from the

derivatives are presented as loss/gains in the financial items.

The Group does not use financial instruments, including financial derivatives, for trading purposes.

The table below shows a simulation of sensitivity to a 10% increase/decrease in EUR, GBP, USD and SEK

against NOK and the effect on Profit (loss) before tax:

FOREIGN CURRENCY SENSITIVITY (NOK 1 000) CHANGE IN FOREIGN CURRENCY 2023 2022+10%24 854 25 215EUR-10% (24 854) (25 215)+10% 915 629GBP-10% (915) (629)+10% 280 1 334USD-10% (280) (1 334)+10% 2 203 1 764SEK-10% (2 203) (1 764)

Note that the majority of the simulated EUR sensitivity effects are related to EUR at bank and the

forward exchange contracts which effects Profit (loss) before tax when EUR/NOK fluctuates.

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Financial statements

Note 17: Financial instruments (continued)

Fair value

The Management assessed that the fair values of cash and cash equivalents, accounts receivable,

accounts payable and other current liabilities approximate their carrying amounts largely due to the

short-term maturities of these instruments.

Capital management

The Group manages its capital to ensure that Group will be able to continue as a going concern while

maximizing the return to stakeholders through the optimization of the debt and equity balance. The Group’s

policy is to maintain a strong capital base so as to maintain investor, creditor and market confidence and

to support future development of the business. The Group is currently sufficiently capitalized as per 31

December 2023. The Group has however due to the negative results from its INITIUM phase II trial initiated

cash preservation initiatives which will be implemented to support that the available financial resources

will sustain the company into 2025. The Board of Directors and Management closely monitor the Group’s

cash flows short-term and long-term and continuously assesses the need for additional funding.

The capital structure of the Group consists of equity attributable to owners of the Group, comprising

share capital, share premium and accumulated losses.

The Group is not subject to any externally imposed capital requirements.

Note 18: Events after the balance sheet date

In March 2024, Ultimovacs announced topline results from INITIUM study evaluating UV1 in Patients with

Malignant Melanoma. The trial did not meet the primary endpoint of prolonging progression-free survival

(PFS), and th evaluation of secondary endpoints did not show a difference in overall survival and objective

response rate between the treatment and control arms. The Group has therefore initiated cash preservation

initiatives which will be implemented to support that the available financial resources will sustain the

company into 2025.

INTEREST RATE SENSITIVITY (NOK 1 000) CHANGE IN INTEREST RATE 2023 2022

Bank deposits

+2% 6 800 9 717

-2% (6 800) (9 717)

+5% 16 999 24 293

-5% (16 999) (24 293)

Currency fluctuations in regards to the bank deposits in foreign currency and the foreign exchange

forward contracts will not result in any ‘other comprehensive income’ (OCI) effects.

Chapters

05 Financial

Statements

Chapters

Ultimovacs ASA

Auditor’s Report

Glossary

83 ULTIMOVACS2023

Contents - Financial Statements Ultimovacs ASA

Statement of profit and loss and other comprehensive income Ultimovacs ASA

Statement of financial position Ultimovacs ASA

Statement of cash flow Ultimovacs ASA

Statement of changes in equity Ultimovacs ASA

Note 1: General information

Note 2: Accounting principles

Note 3: Government grants

Note 4: Salary and personnel expenses and management remuneration

Note 5: Other operating expenses

Note 6: Financial items

Note 7: Income tax

Note 8: Earnings per share

Note 9: Non-current assets

Note 10: Other receivables

Note 11: Cash and cash equivalents

Note 12: Share capital, shareholder information and dividend

Note 13: Transactions with related parties

Note 14: Leases and commitments

Note 15: Share based payment

Note 16: Other current liabilities

Note 17: Financial instruments

Note 18: Investment in subsidiary

Note 19: Events after the balance sheet date

100

101

104

105

106

108

110

111

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Financial statements

Statement of profit and loss and other comprehensive income Ultimovacs ASA

(NOK 1 000) EXCEPT PER SHARE DATA NOTES 2023 2022

Total revenues - -

Payroll and payroll related expenses

3, 4, 15

(61 232) (60 132)

Depreciation and amortization

9, 14

(2 768) (2 648)

Other operating expenses

3, 5

(146 152) (114 182)

Total operating expenses (210 152) (176 962 )

Operating profit (loss) (210 152) (176 962)

Financial income

29 572 17 365

Financial expenses

(3 141) (1 530)

Net financial items 26 431 15 836

Profit (loss) before tax (183 721) (161 126)

Income tax expense

- -

Profit (loss) for the year (183 721) (161 126)

Items that subsequently may be reclassified to profit or loss:

Other comprehensive income (loss) for the year - -

Total comprehensive income (loss) for the year (183 721) (161 126)

Basic and diluted earnings (loss) per share (NOK per share)

(5.3) (4.7)

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Financial statements

Statement of financial position Ultimovacs ASA

(NOK 1 000) NOTES 2023 2022

ASSETS

Non-current assets

Investment in subsidiary

13, 18

85 512 85 512

Patents

5 030 5 784

Property, plant and equipment

114 220

Right of use assets

3 561 5 444

Total non-current assets 94 216 96 960

Current assets

Receivables and prepayments

3, 10

5 097 9 424

Cash and cash equivalents

263 059 420 365

Total current assets 268 157 429 788

TOTAL ASSETS 362 373 526 748

EQUITY AND LIABILITIES

Equity

Share capital 3 441 3 440

Share premium 1 076 607 1 076 308

Total paid-in equity

1 080 047 1 079 747

Accumulated losses (819 922) (636 201)

Other equity 49 247 37 494

TOTAL EQUITY 309 373 481 041

Non-current liabilities

Lease liability

1 886 3 713

Total non-current liabilities 1 886 3 713

Current liabilities

Lease liability

1 827 1 767

Accounts payable 10 671 6 545

Other current liabilities

15, 16

38 615 33 681

Total current liabilities 51 114 41 994

TOTAL LIABILITIES 53 000 45 707

TOTAL EQUITY AND LIABILITIES 362 373 526 748

Board of Directors and CEO of Ultimovacs ASA

Oslo, 20 March 2024

Sign Sign

Sign

Jónas Einarsson Kari Grønås Eva S. Dugstad

Chair of the Board Board member Board member

Sign

Henrik Schüssler Ketil Fjerdingen Leiv Askvig

Board member Board member Board member

Sign

Haakon Stenrød Carlos de Sousa

Board member CEO

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86 ULTIMOVACS2023

Financial statements

Statement of cash flow Ultimovacs ASA

(NOK 1 000) NOTES 2023 2022

Cash flow from operating activities

Profit (loss) before tax (183 721) (161 126)

Adjustments to reconcile profit before tax to net cash flow:

Depreciation and amortization

9, 14

2 768 2 648

Interest received including investing activities

(14 059) (8 887)

Net foreign exchange differences

(12 752) (7 182)

Other financial expenses

380 105

Share option expenses

11 753 18 089

Working capital adjustment:

Changes in prepayments and other receivables

3 243 (1 561)

Changes in payables and other current liabilities

4 174 (6 103)

Net cash flows from operating activities (188 214) (164 018)

Cash flow from investing activities

Purchase of property, plant and equipment

(25) (195)

Shareholder contribution to subsidiary

- (8 000)

Interest received

14 059 8 887

Net cash flow from investing activities 14 034 691

Cash flow from financing activities

Proceeds from issuance of equity

300 5 484

Interest paid

(380) (105)

Payment of lease liability

(1 767) (1 802)

Net cash flow from financing activities (1 847) 3 577

Net change in cash and cash equivalents (176 027) (159 749)

Effect of change in exchange rate

18 721 6 858

Cash and cash equivalents, beginning of period

420 365 573 255

Cash and cash equivalents, end of period 263 059 420 365

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Financial statements

Statement of changes in equity Ultimovacs ASA

(NOK 1 000) NOTES

CAPITAL

PREMIUM

TOTAL PAID

IN CAPITAL

ACCU-

MULATED

LOSSES

OTHER

EQUITY

TOTAL

EQUITY

Balance as of 31 December 2021 3 422 1 070 841 1 074 263 (475 074) 19 405 618 594

Profit (loss) for the year (161 126) (161 126)

Other comprehensive income (loss) -

Issue of share capital

17 5 466 5 484 5 484

Share-issue costs

Recognition of share-based payments

18 089 18 089

Balance as of 31 December 2022 3 440 1 076 308 1 079 747 (636 201) 37 494 481 041

Profit (loss) for the year (183 721) (183 721)

Other comprehensive income (loss) -

Issue of share capital

1 299 300 300

Share-issue costs

Recognition of share-based payments

11 753 11 753

Balance as of 31 December 2023 3 441 1 076 607 1 080 047 (819 922) 49 247 309 373

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Financial statements

Note 1: General information

Ultimovacs ASA (the Company or Ultimovacs) is a biotech company developing novel immunotherapies

against cancer. Ultimovacs was established in 2011 and is a public limited liability company listed on the Oslo

Stock Exchange in Norway. The company and its proprietary technology is based on pre-clinical and clinical

research on immunotherapies conducted at the Oslo University Hospital. Ultimovacs is headquartered at

the Oslo Cancer Cluster Innovation Park in Oslo, Norway, and also has an office in Uppsala, Sweden.

Ultimovacs’ lead universal cancer vaccine candidate UV1 leverages the high prevalence of the human

telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment.

By directing the immune system to hTERT antigens which is expressed at a high level in 85-90% of human

tumors, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade

to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in many

cancer types and in combination with other immunotherapies. The Company will expand its pipeline using its

novel TET-platform, which is a vaccine technology that can generate multiple vaccine candidates designed

to achieve increased T cell responses to a broad range of target antigens. The Company is performing a

broad clinical development program with clinical trials in Europe, Australia and the USA.

The financial statements were approved by the Board of Directors on 20 March 2024.

Note 2: Accounting principles

I. Basis for preparation

The financial statements are prepared in accordance with IFRS Accounting Standards as adopted by the EU.

The financial statements are presented in NOK (Norwegian kroner) which is also the Company’s functional

currency.

The financial statements have been prepared on the historical cost basis, with the exception of derivatives

which are measured at fair value. The preparation of financial statements in conformity with IFRS requires

the use of certain critical accounting estimates. It also requires management to exercise its judgments in

applying the Company’s accounting policies.

II. Going concern

The financial statements for 2023 have been prepared under the going concern assumption. The Company