Annual Report
2022
Cantargia AB (publ.) 556791-6019
INTRODUCTION
3 Cantargia in brief
4 Vision, business model and strategy
5 2022 - A summary of the year and next steps
7 Chief executive’s review
10 Background to Cantargia’s projects
11 Nadunolimab – Cantargia’s most advanced project
13 CAN10 – Cantargia’s project in autoimmunity and
inflammation
14 CANxx – Cantargia’s IL1RAP-based platform
15 Cantargia’s clinical program
18 TRIFOUR – Cantargia’s first controlled clinical trial
20 Clinical strategy
21 Patent protection
MARKET OVERVIEW
23 Cantargia’s market focus
23 Cancer – A global challenge
25 The market for pancreatic cancer treatment
25 The market for lung cancer treatment
26 The market for breast cancer treatment
26 The market for treatment of myocarditis and
systemic sclerosis
28 Drug development – From discovery to launch
DIRECTORS’ REPORT
31 Operations
31 Five-year comparison
32 Significant events during the financial year
32 Significant events after the end of the financial year
33 Revenues
33 Operating expenses and operating profit or loss
33 Net financial income/expense
33 Earnings
33 Financial position
33 Cash flow and investments
33 Share-based incentive schemes
33 Risks and risk management
35 Employees
35 Research and development
35 Environmental impact
35 Guidelines for remuneration and other terms of
employment for senior executives 2021
37 Outlook for 2023
37 Appropriation of retained earnings
SHAREHOLDER INFORMATION
39 Shareholder information
FINANCIAL STATEMENTS
42 Statement of comprehensive income
43 Statement of financial position
44 Statement of changes in equity
45 Statement of cash flows
46 Notes
64 Signatures
AUDITOR’S REPORT
65 Report on the annual accounts
67 Report on other legal and regulatory requirements
CORPORATE GOVERNANCE
70 Corporate governance report
75 The auditors’ examination of the corporate
governance report
77 Board of directors, senior executives and auditors
82 Annual general meeting and financial calendar
TABLE OF CONTENTS
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ANNUAL REPORT 2022
INTRODUCTION
Cantargia was founded in 2009-2010 based on research
at Lund University that showed that the molecule IL1RAP
is present on cancer cells from a large number of tumor
types. IL1RAP is therefore a suitable target for potential
cancer therapies. Cantargia’s main project nadunolimab
(CAN04) is an antibody that can bind IL1RAP and has
reached clinical development stage.
The clinical development of nadunolimab focuses on
pancreatic cancer, triple-negative breast cancer and non-
small cell lung cancer. For these and many other cancers,
chemotherapy is an established standard treatment. Na-
dunolimab is mainly evaluated in combination with che-
motherapy as its mechanism of action enables synergy
with other cancer therapies. This is because IL1RAP may
affect various resistance mechanisms that tumors can
develop to these therapies.
In addition to cancer, IL1RAP has a central role in auto-
immune and inflammatory diseases. In parallel with na-
dunolimab, Cantargia is for this reason developing an-
other IL1RAP-binding antibody, CAN10, with a focus on
myocarditis and systemic sclerosis. Cantargia’s goal is for
CAN10 to reach clinical development stage in mid-2023.
Cantargia in brief
Cantargia is a Swedish biotech company that develops targeted antibody-based drugs for cancer as
well as autoimmune and inflammatory diseases. Cantargia’s drug candidates have the potential to pro-
vide strong efficacy with fewer side effects and can serve as a complement to established treatments.
A prerequisite for a tumor to grow is that it evades our immune system. For such a tumor, immunotherapy is the primary treatment option, and in
cases where immunotherapy is not sufficient to kill or slow down the tumor, chemotherapy or targeted agents are administered. These therapies
can be counteracted by the tumor through various resistance mechanisms where IL1RAP plays a central role. For this reason, IL1RAP constitutes an
attractive target for cancer therapies.
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IMMUNOTHERAPY
CHEMOTHERAPY
TARGETED AGENTS
S�mulate T cells
to eradicate
tumor cells
EFFECT OF TREATMENT RESISTANCE MECHANISM
Kill cancer cells
Blocks central
mechanism for
tumor growth
Regulatory immune
suppressive cells
such as MDSC
Danger signals
such as IL-1α
Alterna�ve
signaling pathways
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ANNUAL REPORT 2022
WE CONTRIBUTE TO THE DEVELOPMENT OF SAFER
AND MORE EFFECTIVE TREATMENTS FOR LIFE-
THREATENING DISEASES
Our vision, business model
and strategy
Cantargia’s vision is to develop a new generation of targeted antibody-based
treatments for IL1RAP with the potential to become an important part of future,
more effective and safe treatments for life-threatening diseases.
Cantargia’s business model is based on partnerships and long-term collabora-
tions. Cantargia has therefore signed agreements with several different compa-
nies, hospitals and academic research groups. Currently, about 50 international
and local organizations are working on research and development of Cantargia’s
main project nadunolimab, as well as the development project CAN10.
Cantargia’s strategy is based on advancing the development of each drug can-
didate in-house until the stage where a development or commercialization
agreement is reached.
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ANNUAL REPORT 2022
In 2022, additional strong clinical efficacy data were presented for nadunolimab and a rights issue of SEK
250 million was completed to enable future investments in the most promising indications. In addition,
the CAN10 project made progress towards a first clinical trial.
INTRODUCTION
2022
– A summary of the year and
next steps
•
Promising clinical results for nadunolimab
For pancreatic cancer and non-small cell lung cancer,
updated interim data from over 100 patients from the
CANFOUR clinical trial were presented in 2022 at the
ASCO congress, one of the world’s largest in oncology.
The results showed stronger efficacy of nadunolimab in
combination with chemotherapy compared to historical
data for chemotherapy alone.
The promising results were further strengthened by new
efficacy data presented at the AACR congress in 2023
which showed that pancreatic cancer patients with high
tumor levels of IL1RAP, the target of nadunolimab, have
the best response to treatment with nadunolimab and
chemotherapy.
•
Focus on randomized clinical trials
As a next step in pancreatic cancer, Cantargia initiat-
ed a collaboration with the US organization PanCAN
in early 2022 to include nadunolimab in PanCAN’s
adaptive phase II/III clinical trial Precision Promise
SM
,
a potentially pivotal randomized trial.
In early 2023, the TRIFOUR clinical trial which evalu-
ates treatment of triple-negative breast cancer, was
expanded to a second, randomized phase. Preliminary
results from the first phase of the trial showed good
safety as well as promising signal of efficacy of nadu-
nolimab in combination with chemotherapy.
To enable financing for these randomized studies, a
significantly oversubscribed rights issue of SEK 250
million was carried out during the summer of 2022.
•
Prioritizing the most promising opportu-
nities
Additional non-small cell lung cancer patients with
the non-squamous subtype were recruited to the
CANFOUR trial during 2022 and early 2023, and pa-
tient enrollment ended in April 2023. To guide further
clinical development steps, a biomarker strategy will
be implemented to identify best responders among
the total lung cancer patients treated with combina-
tion therapy.
The clinical trials CAPAFOUR and CESTAFOUR
reached an important milestone during the year when
a total of over 50 cancer patients had been treated.
Although preliminary data showed good safety of the
evaluated combinations, the decision was made not
to advance any of the activities evaluated in these
trials now, but instead focus on the aforementioned
indications.
Also for CIRIFOUR, which evaluates combination
between nadunolimab and the checkpoint inhibitor
Keytruda®, the decision was made not to expand the
trial. Interim results presented at the ASCO congress
showed good safety of the combination and signs of
disease control in a patient subgroup.
•
Preclinical data provide insight into the
mechanism of action
During the year, preclinical results that provided in-
depth understanding of the synergy between nadu-
nolimab and chemotherapy were published in the
journal Cancer Immunology, Immunotherapy.
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ANNUAL REPORT 2022
Furthermore, several presentations of preclinical re-
sults were made at various international congresses.
These showed that nadunolimab has an effect on the
so-called stromal cells that constitute an important
component of pancreatic cancer. This can affect the
recruitment of immunosuppressive cells to the tu-
mor as well as tumor growth. Results demonstrating
the anti-metastatic effect of nadunolimab were also
presented.
•
CAN10 well on its way towards clinical
trial
Promising preclinical efficacy data were also presented
for CAN10 during the year, including an oral presenta-
tion at the ACR Convergence conference in November
2022, focusing on CAN10’s effect in three different
models for systemic sclerosis. During the year, the ef-
fect of CAN10 was also reported in models for myocar-
ditis and atherosclerosis.
In 2022, CAN10 completed GLP toxicity studies, which
showed good safety of both intravenous and subcu-
taneous administration. CAN10 is thus approaching
clinical development stage: During the second quarter
of 2023, an application was submitted to start a first
clinical trial and the ambition is that treatment in the
trial can start shortly after the application is approved.
Another important success for CAN10 was that a first
composition of matter patent was granted in the US.
•
Strengthening of the organization
During the year, Cantargia’s organization was
strengthened by two recruitments to the manage-
ment team. In the summer of 2022, Dr. Dominique
Tersago was appointed as new Chief Medical Officer
(CMO) and Cantargia also hired a new Chief Financial
Officer (CFO), Patrik Renblad, who will replace the
current CFO, Bengt Jöndell, in 2023.
INTRODUCTION
“Our projects continue to
generate strong results,
which in the long run is
what secures the compa-
ny’s value.”
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ANNUAL REPORT 2022
Without a doubt, 2022 was a challenging year caused by great uncertainty in the world. Pandemic,
war in Europe and high inflation left their marks. Despite these challenges, Cantargia made signifi-
cant progress during the year and I have rarely been as enthusiastic about the future as I am now.
In this year’s CEO review, I will focus on how Cantargia has advanced its positions in this turbu-
lent environment. Our projects continue to generate strong results, which in the long run is what
strengthens the company’s value.
Chief executive’s review
Let me start with our main project, nadunolimab, which
focuses on the treatment of cancer. In 2021, we were
able to present the first robust results in combination
with chemotherapy. We saw early encouraging indica-
tions that nadunolimab enhances the effect of chemo-
therapy commonly used in the treatment of patients
with pancreatic cancer and non-small cell lung cancer.
As a result of these data, we were contacted by the US
organization PanCAN regarding participation in a poten-
tially pivotal trial conducted under their sponsorship,
with the goal of developing new treatments for pancre-
atic cancer. This is an important strategic collaboration
that provides an external validation of our results, but
also attracts attention in the US, the largest pharma-
ceutical market. In 2022, we therefore began prepara-
tions to include nadunolimab in PanCAN’s clinical trial,
and at the ASCO congress in June 2022, we presented
new results in an even larger number of pancreatic can-
cer and lung cancer patients. The results generated great
interest and we are very now motivated to move forward
with PanCAN’s trial. During the year, the US Food and
Drug Administration (FDA) introduced new guidelines
for clinical development in oncology. Although this has
prolonged the discussions around the upcoming trial de-
sign, it also means that the trial will be adapted to the
new regulations, which provides long-term benefits. In
2023, we have also presented updated efficacy data in
pancreatic cancer and a new important finding, namely
that patients with the highest levels of the target of na-
dunolimab, IL1RAP, on their cancer cells, respond best
to the combination treatment. It is a logical observation
that clearly indicates that nadunolimab makes a differ-
ence. This opens up a large number of opportunities for
future development.
In patients with non-small cell lung cancer, we have also
documented a signal of efficacy for nadunolimab with
chemotherapy, and new results, which also received
significant attention, were presented at the ASCO con-
gress. The lung cancer market is segmented and highly
competitive. For this reason, we are holding off on the
next step until we have a better understanding of rele-
vant biomarkers in the patients we have treated to date.
Our ambition is to identify subgroups with the strongest
responses to treatment, in analogy with our progress in
pancreatic cancer. There are many opportunities within
lung cancer, and it is important to choose the path with
the greatest likelihood of success.
In parallel with the development in pancreatic cancer and
non-small cell lung cancer, we have also investigated na-
dunolimab in combination with additional cancer thera-
pies or in other types of cancer. The challenging market
conditions of 2022 required a balancing act between
focusing on the most important opportunities without
terminating promising activities prematurely. After the
summer, we decided to end several studies with new
combination therapies in pancreatic cancer and lung
cancer, as well as in colon cancer and bile duct cancer,
while continuing our studies in triple-negative breast
cancer. At present, I am very pleased with that decision
as we recently revealed the first promising clinical re-
sults in triple-negative breast cancer and took the next
step towards a randomized trial where we are now as-
sessing combination therapy in these patients compared
to a control group. We plan to present additional results
for this indication in the second half of the year, including
more detailed data from the first group of 15 patients,
as well as the first interim analysis in the randomized
trial. We are very pleased with the collaboration we have
established with the specialist group GEICAM in this trial,
and in parallel studies, with the goal of gaining a deeper
understanding of how nadunolimab can provide benefit
to patients. Collectively, these results form a solid foun-
dation for further progress.
In three different cancers, which have the common de-
nominator that independent studies have established
that the diseases are largely driven by systems where
IL1RAP plays a key role, nadunolimab shows a clear sig-
nal of activity in combination with certain types of che-
motherapy. We have thus identified an area where we
will be placing a great deal of focus in the coming years.
The priorities we made among our clinical programs in
INTRODUCTION
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ANNUAL REPORT 2022
”With a solid cash position, strong long-term
owners, highly competent and reputable part-
ners, and an experienced team, I feel confident
that Cantargia, based on the promising results
reported, has an excellent prospect of further
strengthening its position.”
Göran Forsberg
INTRODUCTION
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ANNUAL REPORT 2022
Göran Forsberg
Lund, April 2023
2022 have freed up the necessary resources and enable us
to continue creating value in this area. We have a lot of work
ahead of us, but if all goes according to plan, the commercial
potential is huge.
Similar to nadunolimab, our second development project,
CAN10, also targets IL1RAP. However, there are major differ-
ences in the design of the two molecules, and CAN10 is opti-
mized for treatment of autoimmune or inflammatory diseases.
In 2022, we presented new strong data for CAN10 in models of
various disorders, including myocarditis and systemic sclerosis,
the two diseases that the project is focusing on. At the end of
the year, an important safety study, the so-called GLP toxicity
study, was completed without any safety signals for CAN10
being documented. We are planning the start of a clinical phase
I trial in healthy volunteers during the middle of 2023. Once the
study protocol has been approved and recruitment has started,
I expect that we will be able to provide more detailed informa-
tion about timelines and milestones.
Drug development is costly, and we have been able to main-
tain our strong position, despite the very challenging market,
through the addition of SEK 250 million we received from our
shareholders in connection with a new share issue in 2022.
This has enabled us to continue creating value in our projects
while focusing on the most promising opportunities based on
our results. We currently have a solid cash position that will last
at least until mid-2024. We have also built an organization with
great expertise. In 2022, we hired Dominique Tersago as CMO
and in early 2023, Patrik Renblad was hired as CFO. Both have
solid experience that will serve the company well in the com-
ing years. With a solid cash position, strong long-term owners,
highly competent and reputable partners, and an experienced
team, I feel confident that Cantargia, based on the promising
results reported, has an excellent prospect of further strength-
ening its position. I therefore want to take the opportunity to
thank our shareholders for their support, and I would like to
emphasize that although Cantargia has already experienced an
exciting and successful journey, there is every possibility that
the next few years could be even more rewarding.
INTRODUCTION
INTRODUCTION
Clinical
phase III
Clinical
phase II
Clinical
phase I
Preclinical
phase
Discovery
phase
Type of
treatment
DiseaseProject
1
st
line
PDAC
Nadunolimab
1
st
/2
nd
line
TNBC
1
st
/2
nd
line
NSCLC/
non-squamous NSCLC
Myocarditis,
Systemic sclerosis
CAN10
New opportunities within
IL1RAP platform
CANxx
Gemcitabine/nab-paclitaxel
Planum doublets
Carboplan/gemcitabine
PDAC – pancreatic cancer; TNBC – triple-negative breast cancer; NSCLC – non-small cell lung cancer
NaduNolimab (CaN04)
Cantargia’s main project nadunolimab is an IL1RAP-binding
antibody that has shown promising clinical and preclinical
results in the treatment of various types of cancer.
In addition to locating cancer cells and stimulating our natu-
ral immune system to kill these cells, nadunolimab can also
block signals that favor the development and growth of the
tumor. In a large number of cancer types, tumor growth is
promoted by the so-called interleukin-1 system, which
contributes to an environment favorable for tumors. The
interleukin-1 system is dependent on IL1RAP for transfer-
ring signals to cells, and blocking IL1RAP with nadunolimab
prevents this signaling.
The clinical development of nadunolimab focuses primarily
on pancreatic cancer, triple-negative breast cancer and non-
small cell lung cancer. In recent years, positive interim results
have been presented from patients treated with a combina-
tion of nadunolimab and chemotherapy that indicates a high-
er efficacy than expected with chemotherapy alone.
In parallel with the clinical development, studies are also
being conducted on different types of biomarkers to obtain
more information regarding which patients respond best to
treatment and how nadunolimab can be combined with ad-
ditional established cancer therapies for optimal effect.
CAN10
IL1RAP is also a suitable target in diseases outside the field
of cancer. In the CAN10 project, Cantargia is developing a
new antibody against IL1RAP that has a unique ability to
prevent signaling not only via interleukin-1, but also inter-
leukin-33 and interleukin-36. Blocking of these three sig-
naling molecules has great potential in the treatment of, for
example, myocarditis and systemic sclerosis, where CAN10
has shown strong preclinical data.
CAN10 is currently in late preclinical development phase,
and the goal is to start a first clinical trial in mid-2023.
CANxx
In the CANxx project, Cantargia is expanding its knowledge
of IL1RAP and develops new antibodies that complement
nadunolimab and CAN10. The goal is to identify new anti-
body-based IL1RAP-targeting drugs with properties that
differ from those of nadunolimab and CAN10 and are thus
specifically designed for the treatment of new diseases.
Background to Cantargia’s
projects
Modern drug development is based on identifying unique molecules against which new
potential drug substances can be targeted. Cantargia’s research has shown that IL1RAP is a
promising target for treatment of cancer as well as autoimmune and inflammatory diseases.
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ANNUAL REPORT 2022
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ANNUAL REPORT 2022
macrophage
endothelial cell
blood vessel solid tumor
pro-inflammatory
cytokines
monocyte
tumor cell
neutrophil
fibroblast
Augmented ADCC
Reduced angiogenesis
Reduced ac�va�on and
infiltra�on of
tumor-suppor�ng cells
NK cell
myeloid cell
fibroblast
blood vessel
Nadunolimab
Nadunolimab
– Cantargia’s main project
Cantargia has performed extensive research on IL1RAP and results have shown that this molecule
is present on tumor cells from a large number of tumors. Antibodies targeting IL1RAP thus have
the potential to treat several different types of cancer.
Nadunolimab stimulates so-called NK cells to kill cancer cells, an effect known
as ADCC, and blocks signals that promote tumor development and survival. This
signal blockade leads to, for example, reduced blood vessel formation and re-
duced accumulation of immunosuppressive cells in the tumor.
INTRODUCTION
IL1RAP is present not only on cancer cells,
but also on other cell types in the tumor
that contribute to its growth. IL1RAP con-
veys signals between these cells from the
two forms of the molecule interleukin-1,
alpha and beta, that provide support to
the tumor in its development and survival.
These signals can, for example, strengthen
the tumor’s defenses against various im-
mune cells capable of killing the tumor,
but also stimulate blood vessel formation
in the tumor. Nadunolimab blocks the sig-
naling of both interleukin-1 alpha and beta
and can thus impact the development and
growth of the tumor.
A tumor consists of cancer cells and a variety of tumor-stimulating cells that
communicate with each other via different signaling molecules, so-called cyto-
kines, including interleukin-1.
NADUNOLIMAB’S DUAL MECH-
ANISM OF ACTION
Nadunolimab is unique in that it has a dual
mechanism of action. Nadunolimab can ef-
fectively kill cancer cells as well as block sig-
nals that favor the development and growth
of the tumor.
In the human body, nadunolimab acts as a
guided missile that seeks out and binds its
target IL1RAP, which is highly present on
cancer cells. By binding IL1RAP, naduno-
limab stimulates the body’s killer cells, the
so-called Natural Killer cells, to seek out and
eradicate the cancer cells. Nadunolimab has
also been optimized to possess an improved
ability to stimulate these killer cells.
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ANNUAL REPORT 2022
IL-1β
Chemotherapy
Macrophage
IL-1α
Macrophage
CAF
Neutrophils
IL1R1
IL1RAP
IL1R1
IL1RAP
Tumor cells
Endothelial cells
IL1R1
IL1RAP
Nadunolimab
NADUNOLIMAB SYNERGIZES
WITH CHEMOTHERAPY
Another important function of nadunolimab
is its ability to enhance the effect of chemo-
therapy drugs which are established stan-
dard treatments in a number of cancers.
Cantargia has in preclinical studies shown
that nadunolimab has a potent antitumor
effect in combination with chemotherapy.
When nadunolimab was combined with
so-called platinum-based chemotherapy,
antitumor effects were achieved that were
much stronger than the effect of the indi-
vidual treatments. Preliminary clinical data
point to similar effects in cancer patients.
Chemotherapy triggers the release of interleukin-1 alpha in the tumor,
which in turn stimulates the release of interleukin-1 beta. These mole-
cules contribute to the tumor’s resistance to chemotherapy. Nadunoli-
mab blocks signaling of both forms of interleukin-1 and can thus break
this chemoresistance.
chemo-
therapy
resistant tumor
durable response
Nadunolimab
+
Nadunolimab has the potential to enhance the effect of chemot-
herapy, which are established standard treatments for different
types of cancer.
Previous research as well as Cantargia’s own studies have
shown that treating cancer cells with chemotherapy trig-
gers them to release the alpha form of interleukin-1. This
in turn stimulates the release of the beta form of interleu-
kin-1 from surrounding cells in the tumor. The presence
of both alpha and beta forms of interleukin-1 in the tumor
contributes to development of chemotherapy resistance.
Since nadunolimab blocks signaling of both forms of in-
terleukin-1, it is very well-suited for combination with
chemotherapy.
When nadunolimab was combined with the chemother-
apy docetaxel in preclinical studies, a stronger antitu-
mor effect was achieved compared to docetaxel alone,
or docetaxel in combination with an antibody that only
blocks the beta form of interleukin-1. This shows that na-
dunolimab’s interaction with IL1RAP produces a broader
effect on the interleukin-1 system compared to block-
ade of only one form of interleukin-1, and is necessary to
counteract the tumor’s resistance to chemotherapy.
NADUNOLIMAB EXCELS AGAINST OTHER
CONCEPTS FOR BLOCKING THE INTER-
LEUKIN-1 SYSTEM
Various types of treatments based on blockade of the
interleukin-1 system are currently being investigated in
clinical trials. These treatments are either developed to
block signaling of the alpha or beta form of interleukin-1
alone, or completely lack the ability to stimulate killer cells
to eradicate cancer cells.
Cantargia’s nadunolimab stands out from these by being
the only treatment targeting IL1RAP. The major advan-
tage of this is that nadunolimab thereby has a broader
mechanism of action that is likely to contribute to a stron-
ger antitumor effect and synergy with chemotherapy.
INTRODUCTION
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ANNUAL REPORT 2022
The CAN10 project was initiated with the goal of developing an anti-IL1RAP antibody for the
treatment of autoimmune or inflammatory diseases. CAN10 thus covers a disease segment that
complements nadunolimab and diversifies Cantargia’s project portfolio.
PROMISING PRECLINICAL DATA
IL1RAP conveys signals from the molecule interleukin-1, but
also interleukin-33 and interleukin-36. These three signal-
ing molecules are pro-inflammatory and play a central role
in several severe diseases. Cantargia has developed the an-
tibody CAN10 which, by binding IL1RAP, can block all these
signaling pathways simultaneously. After extensive review
of a large number of diseases, Cantargia decided to focus
CAN10 on myocarditis and systemic sclerosis.
CAN10 – Cantargia’s project in
autoimmunity and inflammation
Myocarditis is a life-threatening disease characterized
by impaired heart function. The disease can be caused
by autoimmunity, but even more commonly by viral in-
fections, and the incidence of this disease has increased
during the COVID-19 pandemic. Cantargia has shown
that a surrogate antibody for CAN10 reduces the disease
burden in models of both autoimmune and viral myocar-
ditis. This effect was stronger compared to blockade of
interleukin-1 signaling alone.
In the CAN10 project, an antibody is being developed that
blocks interleukin-1, -33 and -36, all of which are pro-
inflammatory molecules.
IL-33
CAN10 CAN10 CAN10
INFLAMMATION ASTHMA/ALLERGY SKIN DISEASES
IL1RAP IL1RAP
IL1R1IL1RAP
IL-1α
IL-1β
IL-36α
IL-36β
IL-36γ
ST2
ILRrp2
IL-1 receptor complex IL-33 receptor complex IL-36 receptor complex
In a myocarditis model caused by viral infection, CAN10 was
shown to reduce disease burden. This effect was stronger com-
pared to an IL-1 receptor antagonist, IL1RA, which only blocks
interleukin-1 signaling.
0 1 2 3
CAN10
IL1RA
Control
Viral myocarditis
Disease score
*
INTRODUCTION
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ANNUAL REPORT 2022
Cantargia was the first company to develop drugs targeting
IL1RAP and has built up a knowledge and technology plat-
form in this field. Within CANxx, Cantargia has generated
over one hundred unique antibodies that bind to IL1RAP and
possess different properties. CANxx enables Cantargia to
rapidly develop new antibodies, with unique properties, that
can be used for treatment of various types of diseases. The
development of novel drugs also depends on analyses and
diagnostics, and CANxx is a valuable source of antibodies for
these purposes as well.
CANxx is a technology platform that takes advantage of Cantargia’s extensive knowledge of IL1RAP as
a drug target. Within CANxx, a large library of antibodies has been produced which can be used for the
development of new drugs, or for other purposes such as diagnostics or various analyses. CANxx is a
source of new antibodies and consolidates Cantargia’s strong position for the future.
CANxx – Cantargia’s IL1RAP-
based platform
Systemic sclerosis is a serious disease that leads to fibrosis
of the skin and internal organs. Strong effects have also been
demonstrated in three different models of systemic sclero-
sis where the surrogate antibody for CAN10 reduced skin
and pulmonary fibrosis and normalized the levels of several
disease-related biomarkers in skin biopsies.
In addition to these disease models, the CAN10 surrogate
antibody has also shown effects in models for psoriasis, ath-
erosclerosis, and peritonitis.
COMPLETED GLP TOXICITY STUDY
At the end of 2022, a GLP toxicity study for CAN10 was com-
pleted. This showed that CAN10 is well-tolerated when ad-
ministered intravenously for six weeks at dose levels up to
50 mg/kg. Subcutaneous administration also demonstrated
a good safety profile. An application to start the first clini-
cal trial for CAN10 has been submitted. The goal is to start
treatment of healthy volunteers in the trial in mid-2023.
INTRODUCTION
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Cantargia’s clinical program
Advances have been made in the clinical development of nadunolimab, above all in pancreatic cancer,
triple-negative breast cancer and non-small cell lung cancer, where promising safety and efficacy
have been reported for combination treatment with chemotherapy. Cantargia is now turning its focus
to randomized trials.
CANFOUR
Cantargia’s first clinical trial, CANFOUR, is a phase I/IIa
trial focusing on pancreatic cancer and non-small cell lung
cancer. In the phase I part, the safety and dosage of nadu-
nolimab were primarily evaluated. The results were very
encouraging and indicated good safety as well as effects
on important biomarkers.
Based on the positive outcome in phase I, CANFOUR pro-
gressed to the phase IIa part, which evaluates nadunolim-
ab in combination with chemotherapy. In this phase, nadu-
nolimab is combined with gemcitabine and nab-paclitaxel
in first-line treatment of pancreatic cancer, or with cispla-
tin and gemcitabine in first- or second-line treatment of
non-small cell lung cancer. Positive interim results from
the phase IIa part show clear signals of efficacy for both
combination therapies as stronger effects are observed
compared to what is expected for chemotherapy alone.
In a total of 73 patients with pancreatic cancer, median
progression-free survival of 7.2 months and median over-
all survival of 12.9 months were reported. This is an im-
provement over historical control data for gemcitabine and
nab-paclitaxel alone, which show median progression-free
survival of 5.5 months and median overall survival of 8.5
months. Even stronger efficacy was observed in patients
with high tumor levels of IL1RAP, the target of nadunolimab,
including significantly prolonged median overall survival
compared to patients with low IL1RAP levels (14.2 vs 10.6
months; p=0.017).
53%
-100%
-50%
0%
50%
Best change in tumor size
Partial response
Stable disease
Unconfirmed progressive disease
Confirmed progressive disease
Nadunolimab in combination with
chemotherapy shows promising
responses in pancreatic cancer
patients.
INTRODUCTION
12.9
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To date, over one hundred patients have been
treated in the phase IIa stage of CANFOUR. En-
rollment to this trial was ended in April 2023,
following treatment of ten additional non-squa-
mous non-small cell lung cancer patients with
nadunolimab and the chemotherapies carbopla-
tin and pemetrexed. Continued development in
non-small cell lung cancer will further focus on
patient subgroups by implementation of a bio-
marker strategy to identify best responders.
In addition, the next step in the late clinical develop-
ment in pancreatic cancer is being prepared, where
nadunolimab will be included in the potentially
pivotal clinical phase II/III trial Precision Promise
SM
conducted by the US organization PanCAN.
In 30 patients with non-small cell lung cancer,
a 53 per cent response rate was achieved re-
sulting in median progression-free survival of
6.8 months. This is an improvement over his-
torical controls, which show a 22-28 per cent
response rate and median progression-free
survival of 5.1 months. Moreover, an even
higher response was achieved in a subgroup
of patients with non-squamous non-small cell
lung cancer.
In non-small cell lung cancer (NSCLC), high responses
were observed particularly in patients with the non-
squamous subtype.
INTRODUCTION
-100%
-50%
0%
50%
Squamous NSCLC
Best change in tumor size
Stable disease
Complete response Partial response
Progressive disease
-100%
-50%
0%
50%
Non-squamous NSCLC
Best change in tumor size
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CIRIFOUR
In the phase Ib trial CIRIFOUR, nadunolimab is evaluated
in combination with the checkpoint inhibitor pembrolizumab
(Keytruda®) where the main objective concerns safety. For
CIRIFOUR, patient recruitment ended in October 2022 and
a total of 16 patients with non-small cell lung cancer, head
and neck cancer, or malignant melanoma have been treated.
Interim results show that nadunolimab in combination with
pembrolizumab is well-tolerated and that disease control
for at least 30 weeks (up to 58 weeks) is achieved in 6 out
of 15 evaluated patients, which includes a partial response.
CAPAFOUR, CESTAFOUR AND TRIFOUR
Nadunolimab is investigated in three additional clinical tri-
als. In the phase Ib trial CAPAFOUR, patients with pancre-
atic cancer are treated with nadunolimab in combination
with the chemotherapy regimen FOLFIRINOX, and in the
phase I/II trial CESTAFOUR, nadunolimab is evaluated in
combination with chemotherapy for the treatment of three
types of solid cancers. In October 2022, patient recruit-
ment to both CAPAFOUR and CESTAFOUR was ended. Pre-
liminary results showed an acceptable safety profile for the
combinations as well as signs of efficacy in patients with
non-small cell lung cancer treated with nadunolimab and
cisplatin/gemcitabine in CESTAFOUR, in line with the ob-
servations in CANFOUR. More mature safety and efficacy
from the two trials is planned to be presented during the
second half of 2023.
In the clinical phase Ib/II trial TRIFOUR, patients with tri-
ple-negative breast cancer are treated with nadunolimab
in combination with the chemotherapy carboplatin/gem-
citabine. This trial advanced to the randomized phase II
stage in early 2023 after initial results from phase I showed
promising safety and efficacy.
NCT-nummerStatusAntal patienterKombinationsterapiSjukdomStudie
NCT03267316
Aktiv,
rekryterar ej
76Gemcitabin/nab-paclitaxelPDAC
CANFOUR
Aktiv,
rekryterar ej
33 + 10Platinadubbletter
NSCLC/
icke-skivepitel NSCLC
NCT04452214
Aktiv,
rekryterar ej
16PembrolizumabSolida tumörer
CIRIFOUR
NCT04990037
Aktiv,
rekryterar ej
18FOLFIRINOXPDAC
CAPAFOUR
NCT05116891
Aktiv,
rekryterar ej
36
Docetaxel, cisplatin/
gemcitabin eller FOLFOX
Solida tumörer
CESTAFOUR
NCT05181462RekryterarUpp till 113Carboplatin/gemcitabinTNBC
TRIFOUR
NCT04229004
Rekryterar
ännu ej
Upp till 350Gemcitabin/nab-paclitaxelPDAC
Precision Promise℠
PDAC – bukspottkörtelcancer; TNBC – trippelnegativ bröstcancer; NSCLC – icke-småcellig lungcancer
INTRODUCTION
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TRIFOUR – Cantargia’s first
controlled clinical trial
In 2021, Cantargia initiated the clinical trial TRIFOUR, which evaluates nadunolimab with che-
motherapy in patients with triple-negative breast cancer. TRIFOUR is conducted at around 20
hospitals in Spain in a joint effort with the Spanish breast cancer group, GEICAM, and was recently
expanded to a randomized stage after promising early safety and efficacy data were presented for
the first phase of the trial. Dr. Dominique Tersago, CMO at Cantargia, and Dr. Eva Carrasco, CEO of
GEICAM, comment on the treatment options for triple-negative breast cancer, the TRIFOUR trial,
and the collaboration behind the trial.
Triple-negative breast cancer is an aggressive and diffi-
cult-to-treat form of breast cancer with about 200,000
cases reported globally each year. It accounts for 10-15%
of all breast cancer cases and is more common in people
under the age of 50.
Eva Carrasco explains why triple-negative breast cancer
is so difficult to treat: ”Unlike other forms of breast cancer,
triple-negative breast cancer lacks the hormone receptors
for estrogen and progesterone, as well as the growth factor
receptor HER2, which limits the benefit of various targeted
treatments.” She continues: “It is a biologically aggressive
cancer, with highly proliferative cells, which, together with
limited treatment options, leads to the poorest prognosis
among all breast cancer subtypes.”
In the phase Ib/II trial TRIFOUR, patients with advanced
triple-negative breast cancer in the first or second line
of treatment are given Cantargia’s nadunolimab together
with a chemotherapy doublet, carboplatin and gemcitabine.
“Current guidelines recommend the use of chemotherapy as the
first treatment option for patients with metastatic triple-nega-
tive breast cancer. Other options have recently emerged, includ-
ing targeted inhibitors, checkpoint inhibitors, and antibody-drug
conjugates. Still, the medical need for triple-negative breast
cancer remains high,” comments Eva Carrasco.
An application to initiate TRIFOUR was submitted to the
Spanish regulatory authority and ethics committee in July
2021 and approval to start the trial was obtained in Sep-
tember the same year. Treatment of patients in the phase
I part began in early 2022. This part of the trial constitutes
a dose escalation phase where different dose levels of na-
dunolimab are evaluated together with standard doses of
the chemotherapy doublet. The primary objective here is
to evaluate the safety of the combination, and antitumor
activity is evaluated as a secondary objective.
Dominique Tersago comments why nadunolimab has the
potential to contribute to great benefit for these patients:
”In our previous clinical and preclinical studies, we have seen
clear indications that nadunolimab can enhance the effect of
chemotherapy. In addition, IL1RAP, the target of nadunolimab,
is present on a large number of solid tumors, including breast
cancer, and has particularly high levels in triple-negative
breast cancer.”
INTRODUCTION
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The dose escalation phase of TRIFOUR, where a total
of 15 patients were treated, was finalized in February
2023. An early evaluation of the results showed favorable
safety of the combination. To prevent the treatment to
cause neutropenia, i.e. a low concentration of neutrophil
granulocytes in the blood, the patients were treated prophy-
lactically with G-CSF, a granulocyte growth factor. An early
assessment of the treatment effect was also made based
on 12 patients who had participated long enough in the trial.
This assessment showed signs of efficacy and a preliminary
response rate of 50 per cent was observed.
”The results from the first part of the TRIFOUR trial are very
promising. We could see higher responses in patients treated
with nadunolimab in addition to chemotherapy, than is ex-
pected with chemotherapy alone. Also, the combination was
well-tolerated, and the side effects were manageable,” says
Dominique Tersago. She continues: ”Confirmation of these
results in the second part of the trial would give us the op-
portunity to further develop nadunolimab for the treatment
of advanced triple-negative breast cancer and ultimately lead
to a clear improvement in patients’ lives.”
Based on these results, the TRIFOUR trial progressed to
the phase II part, which is a randomized stage including
a control group, where up to 98 additional patients can
be recruited. In the phase II part, patients are randomized
in a 1:1 ratio to either a control arm where only chemo-
therapy is given, or an experimental therapy arm where
nadunolimab is also administered, with the objective to
investigate antitumor activity. ”We will also analyze bio-
markers that are linked to better response to treatment, es-
pecially markers involved in the IL-1 signaling pathway in the
tumor and blood, so that in future studies we can identify the
patients who would benefit most from our treatment,” com-
ments Dominique Tersago.
In March 2023, the first patient was treated in the phase
II part of the trial and additional patients are now continu-
ously being enrolled. A first indication of how the trial is pro-
gressing is expected to be given during the fourth quarter
of 2023 when an interim futility analysis is expected to be
performed. In such an analysis, a preliminary assessment
is made of the probability that the combination therapy will
produce a stronger efficacy than the control treatment.
Both Dominique Tersago and Eva Carrasco highlight the
ongoing collaboration between Cantargia and GEICAM
as a great success. ”The partnership between GEICAM and
Cantargia in the TRIFOUR trial is highly constructive with
very good communication and interactions,” comments Eva
Carrasco. Dominique Tersago adds: ”The collaboration with
GEICAM has been very important for the successful manage-
ment of the trial. The study teams and other staff in GEICAM’s
network are extremely motivated and receive strong support
from GEICAM. They are all very committed to improving the
treatment of patients with breast cancer.”
GEICAM is a non-profit organization founded in 1995
with the aim of being a driving force in the development
of breast cancer research in Spain. Today, GEICAM consists
of more than 900 experts in over 200 hospitals in Spain.
GEICAM has conducted more than 100 studies in which
over 66,000 women and men have participated.
Early signs of efficacy have been observed in the first 12
patients in the TRIFOUR trial, including one complete re-
sponse and five partial responses.
-100 %
-50 %
0 %
50 %
100 %
Best change in tumor size
Partial response
Stable disease
Progressive disease
Complete response
INTRODUCTION
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INTRODUCTION
Clinical strategy
Cantargia’s objective for nadunolimab is to confirm the promising phase I/II
results in randomized trials. An additional goal is to advance CAN10 towards
clinical stage and thus have a second project in clinical development. This
progress will broaden the company’s activities, but will also provide an op-
portunity to focus on diseases with the best potential for success, based on
clinical results.
During 2022, the clinical development of nadunolimab was focused on ran-
domized trials. A first such trial with a control group, TRIFOUR, has already
started to recruit patients with triple-negative breast cancer. Cantargia is
also planning for recruitment in a controlled trial in pancreatic cancer in
2023. A further objective is to build on the promising results that show that
pancreatic cancer patients with high levels of IL1RAP respond best to treat-
ment with nadunolimab and chemotherapy. In the short term, this observa-
tion strengthens previous signs of clinical efficacy of nadunolimab, but in the
longer term it also provides an opportunity to select for patients who have
the best chance of responding to treatment.
The CAN10 project is planned to begin its first clinical phase I trial in healthy
volunteers in mid-2023. Initially, the trial will focus on single dosing to evaluate
safety and pharmacokinetics, however, additional analyses of immunological
biomarkers will also be performed. The subsequent part of the trial will focus
on repeated dosing and is planned in patients with psoriasis to obtain an initial
indication of effects on disease-related biomarkers. However, the goal is to start
phase II trials in myocarditis and systemic sclerosis as soon as possible after the
completion of the phase I trial.
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INTRODUCTION
Patent protection
Cantargia’s strategy is to obtain broad patent protection for its current and future product candi-
dates in markets deemed to be of clinical and commercial relevance to its projects.
Cantargia’s patent protection can be divided into two layers.
The first layer consists of patents whose primary purpose
is to protect Cantargia’s drug candidates, nadunolimab and
CAN10. The second layer consists of patents that mainly
serve to extend Cantargia’s protection to anti-IL1RAP an-
tibodies with broader functional or structural properties, or
for the treatment or diagnosis of a particular type of disease.
One purpose of this second layer of protection is to limit the
ability of potential competitors to develop drug candidates
targeting IL1RAP.
PATENT FAMILY
PATENT APPLICATION APPROVED PATENTS VALIDITY
Nadunolimab (Product) Australia, Brazil, Canada, China,
Europe, India, Israel, Japan, Mexico,
Singapore, South Africa, South Korea,
US
Australia, China, Europe (Austria, Belgium,
Czech Republic, Denmark, Estonia, France,
Germany, Ireland, Italy, Latvia, Lithuania,
Netherlands, Poland, Portugal, Spain, Sweden,
Switzerland, Turkey, UK), Israel, Japan, Mexico,
Singapore, South Africa, US
2035
CAN10 (Product) PCT, US US 2041
Leukemias (Treatment) Europe, US Europe (France, Germany, UK), US 2029
Hematological cancers
(Treatment/Diagnosis)
Australia, Canada, China, Europe,
Israel, Japan, Mexico, South Africa, US
Australia, Canada, China, Europe (France,
Germany, Italy, Netherlands, Spain, Swit-
zerland, UK), Israel, Japan, Mexico, South
Africa, US
2030
Solid tumors (Treatment/
Diagnosis)
Australia, Brazil, Canada, China, Eu-
rope, Japan, Mexico, South Korea, US
Australia, Canada, China, Europe (Austria,
Belgium, Czech Republic, Denmark, Finland,
France, Germany, Ireland, Italy, Netherlands,
Norway, Poland, Spain, Sweden, Switzerland,
UK), Japan, Mexico, South Korea, US
2032
CAN03 (Product) China, Europe, Japan, US China, Europe (France, Germany, UK) Japan,
US
2035
Anti-IL1RAP antibodies (Product) China, Europe, India, Japan, US Japan, US 2037
Biepitopic antibody (Product) China, Europe, Japan, US 2039
21
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MARKET OVERVIEW
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Cantargia’s market focus
Since IL1RAP, the target of nadunolimab, is present on a
large number of solid tumors, there is potential to utilize
Cantargia’s immuno-oncology platform for treatment of
several additional forms of cancer.
Cantargia is focusing the development of nadunolimab on
pancreatic cancer, triple-negative breast cancer and non-
small cell lung cancer. Pancreatic cancer is very difficult to
treat, and few effective therapies have been developed to
date. Triple-negative breast cancer is a very aggressive type
of breast cancer with limited therapeutic options. Lung can-
cer is the form of cancer that causes the greatest number of
deaths and non-small cell lung cancer is the most common
form of the disease. Cantargia has focused on the non-squa-
mous subtype, which is the largest subgroup of non-small
cell lung cancer.
In parallel with nadunolimab, Cantargia is also developing the
project CAN10 which is aimed at harnessing the full potential
of IL1RAP as a molecular target. In CAN10, the objective is to
develop a novel antibody for treatment of myocarditis and
systemic sclerosis. The medical need for both diseases is high,
with few approved drugs currently available.
CaNCer – a global ChalleNge
Cancer is one of the leading causes of death in the world, ac-
counting for about 20 percent of deaths in the Western world.
Globally, more than 18 million people are diagnosed with can-
cer annually and nearly 10 million die of cancer-related diseas-
es
1
. Despite significant advances in treatment and diagnostics,
there is a great need for new therapies.
There are approximately 200 different types of cancer, all of
which have in common that cells begin to divide and grow
uncontrollably somewhere in the human body. Research sug-
gests that two independent events are required for cancer to
develop: damaging of normal cells resulting in rapid and un-
controlled cell growth, and location of these cells in a micro-
environment that provides the right conditions to grow and
protects against attacks from the immune system. The chart
below shows the distribution of cancer incidence and mortality
in the world by type of cancer and major region in 2020.
1
Globocan 2020
Source: WHO, The Global Cancer Observatory 2023
MARKET OVERVIEW
49%
23%
13%
8%
6%
1%
Incidence
Mortality
58%
20%
7%
1%
7%
7%
Asia
Europe
North America
Latin America & the Caribbean
Africa
Oceania
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2
Globocan 2020
3
Globocan 2020
4
Iqvia Institute, Global Oncology Trends 2022, Outlook to 2026
5
RTTNews, Top 10 Blockbuster Drugs In 2021
6
Iqvia Institute, Global Oncology Trends 2022, Outlook to 2026
7
Iqvia Institute, Global Oncology Trends 2022, Outlook to 2026
The number of cancer cases is expected to increase con-
tinuously, and the forecast by the WHO is that, by 2040,
over 29 million new cases will be diagnosed annually
2
. A
significant factor behind the growing incidence of cancer
is the aging population. By 2040, people above the age of
60 are expected to account for more than 75 per cent of all
cancer cases
3
. Our Western lifestyle is considered another
contributing factor as smoking, alcohol consumption, un-
healthy diets, low physical activity, obesity and unhealthy
sun habits become more widespread.
As more people are diagnosed with cancer and as additional
new drugs are approved, the total costs of cancer drugs have
risen significantly, reaching USD 196 billion by 2022
4
. An im-
portant factor behind the rising costs is that more innovative,
and thus costly, treatments are made available, with a larger
number of patients having access to these treatments. In ad-
dition, there is a strong focus on early diagnosing and thus
treating patients at earlier stages. Half of the ten best-selling
drugs globally in 2021 were drugs for treatment of cancer, ac-
counting for about half of the total turnover for the ten best-
selling pharmaceuticals
5
.
Source: Iqvia Institute, Global Oncology Trends 2022, Outlook to 2026
The cost of cancer drugs 2018 - 2026
0
20
40
60
80
2000
2008
1995
2003
2011
1993
2001
2009
1997
2005
2013
1994
2002
2010
1998
2006
2014
1996
2004
2012
1999
2007
2015
2016
2017
2018
100
120
140
Pancreatic cancer
Lung cancer
Breast cancer
Source: SEER Cancer Statistics Review
Number of new cancer cases in the US per 100,000 inhabitants
Since the number of cancer cases is expected to increase
considerably, a rapid growth of the market is anticipated.
Globally, the cost of cancer therapies is expected to in-
crease to approximately USD 300 billion by 2026, corre-
sponding to an annual growth rate of approximately 11
percent
6
. In the coming years, over one hundred new can-
cer therapies are expected to become approved
7
. It is also
estimated that the development of precision medicines
and biomarker treatments will accelerate.
Billions of USD
EU5 (France, Germany, Italy,
Spain, UK). Pharmerging (China,
Brazil, India, Russia, Poland,
Argentina, Turkey, Mexico,
Venezuela, Romania, Saudi
Arabia, Colombia, Vietnam,
South Africa, Algeria, Thailand,
Indonesia, Egypt, Pakistan,
Nigeria, Ukraine).
USA
EU5
Japan
Pharmerging
The rest of the world
0
50
100
150
200
250
2018 2022 2026
129
196
307
300
MARKET OVERVIEW
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8
SEER Cancer Stat Facts
9
SEER Cancer Stat Facts
10
Reportlinker.com, Pancreatic Cancer Treatment Market Research Report - Global Forecast to 2026
11
Globocan 2020
12
Globocan 2020
13
American Cancer Society
14
Paz-Ares et al, N Engl J Med 2018; 379:2040-2051
15
Reportlinker, Global Non-Small Cell Lung Cancer (NSCLC) Therapeutics Industry
THE MARKET FOR PANCREATIC CANCER
TREATMENT
Globally, approximately 495,000 new cases of pancreatic
cancer were diagnosed in 2020. In the same year, 466,000
people died from the disease
8
. In the US, the number of people
diagnosed with the disease has increased by nearly 13 per cent
over the last 20 years and pancreatic cancer is today the third
most common cause of cancer-related deaths in the US
9
. Since
pancreatic cancer is difficult to diagnose, it is also difficult to
treat as it is often well-advanced at the time of diagnosis.
Pancreatic cancer treatment was valued at approximately
USD 2.4 billion in the eight largest markets in 2021 and is
expected to grow to approximately USD 4.2 billion by 2026
10
.
This corresponds to an annual growth rate of just over 8 per
cent during these years. The growth in this market is mainly
due to an increasing number of cancer cases. The number
of people diagnosed with pancreatic cancer is estimated to
increase by 60 per cent by 2040
11
. The increase in the num-
ber of cases is in turn caused by an aging population and an
increasing incidence of diabetes, which are both risk factors
for developing pancreatic cancer. Improved diagnostics also
contribute to the expected market growth as they increase
the likelihood of discovering pancreatic cancer at an earlier
stage, thus enabling treatment.
THE MARKET FOR LUNG CANCER
TREATMENT
In 2020, approximately 2.3 million cases of lung cancer were
diagnosed globally and more than 1.8 million people died
from the disease
12
. Around 85 per cent of all lung cancers
are non-small cell lung cancer
13
, which is subdivided into the
squamous and non-squamous subgroups, where the latter is
the largest and corresponds to 70-80 per cent of all cases
14
.
In the US, the number of people diagnosed with lung cancer
has decreased by approximately 27 per cent over the last 20
years, while the number of people diagnosed with this dis-
ease is increasing in countries such as China and India, and
in European countries such as Hungary, Denmark and Serbia.
Sales of drugs for non-small cell lung cancer totaled USD 20
billion in 2020 and are projected to increase to USD 45 bil-
lion by 2027
15
. Sales are mainly driven by increasing use of
various antibody-based immunotherapies. Another impor-
tant factor contributing to the growth of the global market is
the increasing incidence of lung cancer in many countries, as
mentioned above.
Incidence
46%
3%
5%
6%
7%
10%
12%
11%
Mortality
40%
5%
5%
8%
8%
9%
7%
18%
Non-Small Cell Lung Cancer Pancreatic cancer
Annual global incidences
Fraction of cancer incidence
Annual global mortalities
Fraction of cancer mortality
2.3m
11%
1.8m
18%
Five-year survival sate
19%
Annual global incidences
Fraction of cancer incidence
Annual global mortali�es
Fraction of cancer mortality
0.5m
3%
0.5m
5%
Five-year survival sate
9%
Lung
Breast
Bowel
Stomach
Liver
Esophagus
Pancreas
Other
Lung
Breast
Bowel
Prostate
Stomach
Liver
Cervix
Other
Treatment: Surgery, Radiaon,
Chemotherapy, Immunotherapy
Treatment: Surgery, Radiaon,
Chemotherapy
Source: WHO, The Global Cancer Observatory 2020,
Cancer.gov (National Cancer Institute, Sep-20),
American Cancer Society, Nov-17
MARKET OVERVIEW
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16
Globocan 2020
17
American Cancer Society
18
Pfeiffer RM, Webb-Vargas Y, Wheeler W, Gail MH. Proportion of U.S. Trends in Breast Cancer Incidence Attributable to Long-term
Changes in Risk Factor Distributions. Cancer Epidemiol Biomarkers Prev. 2018;1:1
19
Research and Markets, Breast Cancer Drugs Global Market Report 2021
20
American Cancer Society
21
FutureWise, Triple Negative Breast Cancer Treatment Market By Drug Type, 2020-2027
22
J Am Coll Cardiol. 2016 Nov 29;68(21):2348-2364
23
Lancet. 2018;392:1736-88
24
Bairkdar, Rossides, Westerlind, Hesselstrand, Arkema, Holmqvist, Incidence and prevalence of systemic sclerosis globally:
A comprehensive systematic review and meta-analysis, Rheumatology 2021:7
25
GlobalData, Systemic Sclerosis: Global Drug Forecast and Market Analysis to 2030
THE MARKET FOR BREAST CANCER
TREATMENT
Breast cancer is currently the most common form of can-
cer. In 2020, approximately 2.3 million new cases were re-
ported, and approximately 685,000 women died from the
disease. In 2040, around 3 million women are expected to
be diagnosed with the disease and just over one million will
die as a consequence of the disease
16
. The risk of develop-
ing breast cancer increases with age up to the age of 70. In
the US, the median age for developing breast cancer is 62
years
17
. According to a study conducted on American wom-
en, increases in BMI and the fact that women on average
give birth to fewer children, likely contribute to the increase
in cases in the US between 1980 and 2018
18
.
The global market for breast cancer treatment amounted to
approximately USD 17.9 billion in 2021 and is expected to
increase to USD 20 billion by 2025, corresponding to an an-
nual growth rate of approximately 13 per cent
19
. The mar-
ket growth is primarily caused by an increased incidence of
the disease, but also the need for preventive measures and
early treatment. The market growth is also expected to be
driven by the launch of new therapies.
Triple-negative breast cancer tends to be more common
in women under the age of 40, African-American women
and women with a BRCA1 mutation. Approximately 10-15
per cent of breast cancer cases are triple-negative breast
cancer
20
. The market for the treatment of triple-negative
breast cancer is expected to be worth over USD 820 million
by 2027 following an annual growth rate of approximately
4.5 per cent between 2020 and 2027
21
.
THE MARKET FOR MYOCARDITIS AND
SYSTEMIC SCLEROSIS TREATMENT
Myocarditis is characterized by inflammation of the mus-
cular tissues of the heart (myocardium) arising from, for
example, autoimmunity or various types of infections. Re-
gardless of its etiology, myocarditis is characterized by ini-
tial acute inflammation that can progress to subacute and
chronic stages, resulting in tissue remodeling, fibrosis, and
loss of contractile function.
The incidence of myocarditis is approximately 22 per
100,000 (1.7 million)
22
, and globally the disease accounts
for about 0.6 deaths per 100,000 (46,400) annually
23
. The
medical need is high for subgroups of patients with fulmi-
nant myocarditis (acute disease) and dilated cardiomyopa-
thy (chronic disease), where mortality is very high in certain
subtypes. For these patients, heart transplantation is cur-
rently the only definitive treatment.
Systemic sclerosis is a chronic autoimmune disease that is
mainly characterized by inflammation and fibrosis of the
skin and subcutaneous tissue, as well as blood vessels and
internal organs such as the lungs, heart, and kidneys. Sys-
temic sclerosis is a complex, heterogeneous disease that
can occur with a variety of clinical manifestations ranging
from minor to life-threatening.
The estimated annual incidence of systemic sclerosis is ap-
proximately 1.4 per 100,000
24
. The main cause of death in
patients with systemic sclerosis is interstitial lung disease
and the medical need is particularly high in these patients.
The worth of the pharmaceutical market for systemic scle-
rosis was estimated to approximately USD 500 million in
2020 and is expected to grow to USD 1.8 billion by 2030 in
the seven major markets
25
. This corresponds to an average
annual growth rate of 14 per cent.
MARKET OVERVIEW
27
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Drug development
– From discovery to launch
PRECLINICAL PHASE
The preclinical phase is characterized by activities con-
ducted by chemists, biologists and pharmacologists who
study and develop various substances in laboratories. With
the help of effective disease models, researchers can study
how various pharmaceutical substances behave and inter-
act. Individual substances are then selected for further stud-
ies in the laboratory and in animal models. Some questions
that are commonly addressed include: “Does the substance
have any treatment efficacy?”, “What dose of the substance
is appropriate?” and “Does the substance cause serious side
effects?” The purpose of the preclinical phase is to select a
candidate drug (CD) for which an application for clinical trials
in humans is submitted.
Before a candidate drug is allowed for testing in humans, a
large amount of work is required to ensure that the candi-
date drug is sufficiently safe and stable, and to establish how
it behaves in and how it leaves the human body. An appli-
cation to conduct clinical studies in humans is submitted to
the relevant drug regulator, which in Sweden is the Medical
Products Agency. In the United States, the clinical trial ap-
plication is called Investigational New Drug (IND) Application
and in the EU, Clinical Trial Application (CTA). Applications are
filed in countries where the clinical trial will be conducted
and are then evaluated by independent medical experts who
assess whether the trial can be initiated or whether further
documentation is required. Apart from obtaining permission
from the drug regulators, the company must also apply for
and receive permission from each country’s local and/or na-
tional ethics committee. The approval of an application is fol-
lowed by a long and complex process involving several years
of clinical studies before the company can apply to have the
product approved for general use.
CLINICAL PHASE
In the clinical phase, studies in humans are performed.
These studies are normally conducted at hospitals or health
centers and are formally divided into four phases – phase I,
II, III and IV – although the differences between the phases
are not always obvious in practice. To ensure that the studies
can be interpreted objectively, endpoints for the evaluation
of the studies are defined in advance. The design of the study
program for a particular drug should be continually evaluated
and regulatory approval is required for each sub-study.
Phase I
Phase I is the first stage where a new substance is admin-
istered to a human. The trial subjects are normally healthy
volunteers and are subject to constant medical monitoring.
In clinical studies in cancer, however, it is common for pa-
tients to be included already at this stage. Phase I studies
normally involve 20-100 individuals. The purpose of the
trial is to determine whether the trial subjects tolerate the
drug and whether its behavior in the body is the same as in-
dicated in the earlier animal studies and other research. The
purpose is also to identify safe dose levels and any potential
side effects. The initial dose is kept as low as possible but
should be sufficiently high to provide answers to the ques-
tions that the trial is designed to answer. If the procedure
progresses as planned, the dose can then gradually be in-
creased to the clinical use level. Phase I studies normally
take six months to a year to complete.
Phase II
Phase II is normally the first stage at which the new sub-
stance is administered to patients with the relevant disease.
At this stage, the test group is also larger and normally con-
sists of 100-500 subjects. The objective of this phase is to
show ‘proof of concept’, i.e., that the drug actually achieves
a treatment effect. Other objectives include studying how
the drug affects the disease or its symptoms and determin-
ing the dose to be used in large-scale trials. Phase II studies
can take between six months and two years to complete.
Phase III
Phase III is initiated only if the results from phase II are suf-
ficiently encouraging to justify further studies. In this phase,
the candidate drug is given to even larger groups, often
1,000-5,000 subjects. The new substance is tested against
an ineffective placebo or against another already approved
drug for the same disease condition. Patients are distributed
randomly between treatment groups and neither the physi-
cian nor the patients are informed of which substance has
been administered. This type of trial is known as a ‘double-
blind and randomized’ trial and is considered to be the method
that produces the best and most objective evaluation. Once
the trial has been completed, the treatment of each patient is
revealed. It is then possible to determine and evaluate what
effect the candidate drug had compared to the placebo. The
studies provide a statistical basis, which means that the
difference between the two products must be statistically
MARKET OVERVIEW
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
significant. Phase III studies can take between one to four
years to complete depending on the disease, the length of
time during which the patients are studied, and the number
of patients included.
Phase IV
In phase IV, the therapeutic use of the drug is studied. After
the phase I-III studies have been completed and the drug has
been approved by the drug regulator and received market au-
thorization, further clinical studies are often conducted in the
area of use for which the product has already been approved.
These are known as phase IV studies and are aimed at study-
ing and monitoring the dose and effect relation, the impact
on additional simultaneous drug treatments, and any side
effects which may occur after the market launch. The overall
objective is to optimize the use of the drug.
REGISTRATION PHASE
If the drug appears to be promising and is well-tolerated by
patients, further trials are conducted to verify the results. An
application for approval is subsequently filed with the rel-
evant drug control authorities, which in Europe is the Euro-
pean Medicines Agency (EMA). The application must include
all documentation describing the quality, safety and effect of
the drug and is generally very extensive. Examination of an
application takes one year on average. The examination can
result in the drug being approved or rejected, or the regulator
may demand that further studies be conducted. An approval
can also involve the regulator approving a more limited indi-
cation than was originally intended. Once regulatory approval
has been obtained, the drug can be marketed.
Research and development costs for drug development are
high, in the range of billions of SEK, and mainly comprise costs
for research, development, production and clinical studies of
a drug. Of 10-15 products that are studied in phase I, on av-
erage, only one will normally advance to regulatory approval.
Approximately 35 new medical products are introduced on
the Swedish market every year.
MARKET OVERVIEW
DIRECTOR’S REPORT
31
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
The Board of Directors and Chief Executive Officer of
Cantargia AB (publ), corporate ID no. 556791-6019, here-
by present the annual report for the financial year 1 January
2022 – 31 December 2022. The company has its registered
office in Lund, Sweden. Amounts in the annual report are
expressed in thousands of Swedish kronor (kSEK) unless
otherwise indicated.
OPERATIONS
Cantargia is a biotechnology company that develops anti-
body-based treatments for life-threatening diseases and
has established a platform based on the protein IL1RAP,
involved in a number of cancer forms and inflammatory
diseases. The lead project, the antibody nadunolimab
(CAN04), is studied clinically primarily in combination
with chemotherapy, focusing on pancreatic cancer, triple-
negative breast cancer and non-small cell lung cancer.
Positive interim data from the combination with chemo-
therapy indicate stronger efficacy than would be expected
from chemotherapy alone. Cantargia’s second develop-
ment project, the antibody CAN10, blocks signaling via
IL1RAP in a different manner than nadunolimab and ad-
dresses treatment of serious autoimmune/inflammatory
diseases, with initial focus on myocarditis and systemic
sclerosis.
1
See also Note 24
2
See also Note 19
3
Cantargia has and had potential ordinary shares in the form of warrants during the period. These do not have a dilutive effect,
however, as a conversion of warrants into ordinary shares would result in a lower loss.
Amounts in mSEK 2022 2021 2020 2019 2018
Net sales - - - - -
Loss after net financial income/expense -371.8 -366.5 -173.1 -110.8 -91.2
Cash and bank balances and liquid investments 189.6 247.3 693.4 39.9 76.5
Short-term investments 237.1 312.1 210.0 110.0 90.3
Equity 389.7 532.7 891.9 142.3 155.0
Total assets 474.8 600.2 925.5 166.1 171.4
Equity/assets ratio (%) 82% 89% 96% 86% 90%
Quick ratio (%) 543% 887% 2996% 669% 1027%
R&D costs -364.7 -352.7 -158.4 -97.5 -77.0
Project costs
1
-306.7 -304.2 -121.9 -81.1 -66.2
Total operating expenses -381.5 -370.3 -173.9 -111.6 -93.3
R&D costs as a percentage of total operating expenses 96% 95% 91% 87% 82%
Project costs as a percentage of total operating expenses 80% 82% 70% 73% 71%
Number of outstanding shares at 31 Dec 166,987,895 100,192,737 100,192,737 72,804,392 66,185,811
Number of outstanding warrants at 31 Dec - - - 85,000 85,000
Number of outstanding employee options at 31 Dec
2
3,069,333 3,170,333 1,740,000 - -
Earnings per share before and after dilution (SEK)
3
-2.90 -3.66 -1.94 -1.56 -1.36
Equity per share (SEK) 2.33 5.32 8.90 1.95 2.34
Dividend (SEK) - - - - -
FIVE-YEAR COMPARISON
DIRECTOR’S REPORT
DEFINITIONS
Cash and bank balances and liquid investments - Cash and available deposits with banks and other credit institutions
Equity/assets ratio - Adjusted equity as a percentage of total assets
Quick ratio - Current assets as a percentage of current liabilities
R&D costs - Total project costs plus allocated portion of personnel expenses and other external expenses
Project costs - The sum of external costs in Preclinical, Clinical, CMC, Regulatory and Patents
Earnings per share - Profit for the year divided by number of outstanding shares at end of period
Equity per share - Equity divided by number of shares at end of period
32
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
SIGNIFICANT EVENTS DURING THE
FINANCIAL YEAR
The following is a summary of events that took place in
the company during the year.
Nadunolimab
Cantargia has ongoing clinical studies that primarily inves-
tigate nadunolimab in combination with chemotherapy or
with checkpoint inhibitor.
CLINICAL
Pancreatic cancer
•
In January, it was reported that Cantargia would advance
nadunolimab in pancreatic cancer in PanCAN’s phase II/III
clinical trial Precision Promise
SM
.
•
In May, new robust data were presented at ASCO 2022
confirming the promising efficacy of nadunolimab in the
treatment of pancreatic cancer.
Triple-negative breast cancer
•
In January, Cantargia reported on treatment of the first
patient with triple-negative breast cancer in the TRI-
FOUR trial.
Non-small cell lung cancer
•
In February, Cantargia reported on treatment of the first
patient with non-squamous non-small cell lung cancer
in a new arm of the CANFOUR trial.
•
In May, data from the CANFOUR trial were presented at
ASCO 2022 confirming the positive phase IIa interim re-
sults for nadunolimab in NSCLC.
Combination with checkpoint inhibitor
•
In February, positive safety data from the clinical
trial CIRIFOUR with nadunolimab in combination with
Keytruda® were reported.
•
In May, interim clinical data were presented at ASCO
2022 showing the potential of nadunolimab in combi-
nation with Keytruda®.
•
In September, it was announced that the first patient
with non-squamous NSCLC had been treated with na-
dunolimab, Keytruda® and chemotherapy.
Other
•
In September, it was announced that Cantargia had
reached a milestone in patient recruitment in the
CAPAFOUR and CESTAFOUR trials as over 50 patients
had been treated, and that the development of nadu-
nolimab would be focused on future randomized trials.
PRECLINICAL
•
In August, preclinical data were published showing a
strong antitumor effect for nadunolimab in combination
with chemotherapy.
•
In September, preclinical data were presented showing
unique treatment effects of nadunolimab on stromal
cells in pancreatic cancer.
•
In November, new data were presented at SITC 2022
supporting nadunolimab’s promising clinical antitumor
effects.
CAN10
•
In February, new promising toxicology results were re-
ported for CAN10 and the phase I trial was scheduled
for 2023.
•
In March, positive preclinical efficacy data were reported
for CAN10 showing anti-fibrotic and anti-inflammatory
effects in systemic sclerosis.
•
In May, positive preclinical effects in atherosclerosis
were reported, demonstrating the potential of CAN10 in
cardiovascular diseases.
•
In July, new preclinical efficacy data were reported for
CAN10 supporting development in myocarditis.
•
In November, positive effects of CAN10 in models of
systemic sclerosis were presented at ACR Convergence
2022.
IP
•
In January, a third-party appealed against the EPO’s
previous decision in favor of Cantargia’s patent.
•
In July, a Notice of Allowance was received from the
USPTO for Cantargia’s product patent for the CAN10
antibody.
Organization
•
In March, Dr. Roger Belusa was appointed as Interim
Chief Medical Officer (CMO) and the former CMO, Dr. Ig-
nacio Garcia-Ribas, took up a new position at Cantargia
to focus on ongoing early-phase clinical trials. In July, Dr.
Dominique Tersago was appointed as CMO.
Financing
•
In June, it was decided to raise approximately SEK 250
million through a fully underwritten rights issue. An ex-
traordinary general meeting was held in June and in July
the terms of the fully underwritten rights issue and the
prospectus containing new financial information were
published. The final outcome was announced in August,
including the new number of shares and votes in the
company.
SIGNIFICANT EVENTS AFTER THE END OF
THE FINANCIAL YEAR
•
In January, Cantargia successfully completed a GLP
toxicity study for the CAN10 antibody.
•
In January, it was announced that Cantargia had recruit-
ed Patrik Renblad as Chief Financial Officer.
•
In February, it was reported that Cantargia would be
starting the randomized part of the TRIFOUR trial based
on promising early safety and efficacy data with nadu-
nolimab in triple-negative breast cancer. In March, the
first patient with triple-negative breast cancer was
treated in the randomized part of TRIFOUR.
•
In April, Cantargia presented new clinical data at AACR
DIRECTOR’S REPORT
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
2023 strongly supporting nadunolimab development in
pancreatic cancer. Cantargia also presented anti-meta-
static effects of nadunolimab in cancer models.
•
In April, a phase I clinical trial application was submitted
for CAN10.
•
In April, favorable safety was reported for a new nadu-
nolimab combination therapy and enrollment of non-
small cell lung cancer patients in the CANFOUR trial
was completed.
REVENUES
Cantargia’s net sales in 2022 were SEK 0 (0) million.
OPERATING EXPENSES AND OPERATING
PROFIT OR LOSS
Research and development costs totaled SEK 364.7 (352.7)
million. The essentially unchanged cost level compared to
the previous year is mainly a result of the focus of the clini-
cal program that has occurred during the year. The majority
of the costs are, as in previous years, related to the main
project, nadunolimab, with clinical trials and CMC as the
primary cost drivers.
Administrative expenses totaled SEK 15.0 (15.3) million for
the year. The unchanged level reflects the development of
R&D costs and the fact that administrative costs are largely
fixed in nature.
Other operating expenses, which comprise foreign exchange
differences on trade payables, amounted to SEK 1.9 (2.2)
million. Other operating expenses is mainly related to the
change in the value of the Swedish krona against the Euro.
The operating loss amounted to SEK -381.5 (-370.3) million
for the year.
NET FINANCIAL INCOME/EXPENSE
Net financial income/expense consists substantially of for-
eign exchange differences on the company’s EUR- and USD
account. Net financial income amounted to SEK 9.7 (3.8) mil-
lion for the year.
EARNINGS
Cantargia’s loss before tax, which is the same as the loss for
the year, was SEK -371.8 (-366.5) million.
FINANCIAL POSITION
Cantargia’s equity/assets ratio at 31 December 2022 was
82 (89) percent and equity was SEK 389.7 (532.7) million.
The company’s cash and cash equivalents, which consist
of cash and demand deposits with banks and other credit
institutions, were SEK 189.6 (247.3) million at the balance
sheet date. In addition to cash and cash equivalents, the
company has short-term investments with banks and
in fixed income funds of SEK 237.1 (312.1) million. The
company’s liquidity (including short-term investments)
decreased by SEK -132.7 million in 2022. At the end of
the period, total assets totaled SEK 474.8 (600.2) million.
CASH FLOW AND INVESTMENTS
Cash flow from operating activities for the full year was SEK
-358.9 (-346.5) million. As part of cash flow from operating
activities, changes in working capital were SEK 14.6 (14.4)
million.
Cash flow from investing activities totaled SEK 67.9 (-102.4)
million. For the full year 2022 as well as for the previous year,
changes in short-term investments accounted for the ma-
jority of cash flow from investing activities.
Cash flow from financing activities was SEK 223.9 (0.0) mil-
lion. The outcome in 2022 is related to a rights issue that
was completed during the year.
The total change in cash and cash equivalents, including for-
eign exchange difference in cash and cash equivalents, was
SEK -67.1 (-448.9) million.
SHARE-BASED INCENTIVE SCHEMES
The purpose of share-based incentive schemes is to promote
the company’s long-term interests by motivating and reward-
ing the company’s senior executives and other employees.
At the Ordinary General Meeting in May 2020, it was
decided to introduce Employee Stock Option Scheme
2020/2023, which is one of the company’s active share-
based incentive schemes. At the Ordinary General Meeting
in May 2021, it was decided to introduce another Employee
Stock Option Scheme 2021/2024. For information on the
schemes, see Note 19.
In 2022, 260,000 employee stock options were granted,
and 361 000 stock options were recalled. The options
granted as of 31 December 2022 represent rights to pur-
chase 3,683,200 shares. Recalculation of the Employee
Stock Option Programs after the rights issue in 2022
means that each option entitles to 1.2 shares.
The cost of the share-based incentive schemes was SEK
4.0 (5.1) million, of which SEK -0.9 (2.2) million refers to
provisions for social security contributions and SEK 4.8
(7.3) million to costs for share-based payments. The cost
has not affected cash flow. The company has issued war-
rants to enable it to deliver shares in a simple and cost-
effective manner upon exercise of the issued employee
stock options.
DIRECTOR’S REPORT
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
RISKS AND RISK MANAGEMENT
Several risk factors can have a negative impact on the op-
erations of Cantargia. It is therefore very important to take
account of relevant risks in addition to assessing the com-
pany’s growth prospects. A description of risk factors, not
in order of importance and not exhaustive, is given below.
For natural reasons it is not possible to assess all risk fac-
tors without making a general assessment of the com-
pany’s operations and external factors. See also Note 3,
Financial risk management.
Research and development and dependence on
one candidate drug
The development of nadunolimab is associated with sig-
nificant risks of failure and/or that the results will be such
that continued research and development will be required.
These risks include that the company’s drug will prove to
be ineffective, dangerous, toxic, or otherwise fail to meet
the applicable requirements or that the candidate drug will
prove to be difficult to develop into a commercially viable
product that generates revenue for the company. There
is also a risk that delays and unexpected difficulties in the
development (for example, production or clinical studies)
could incur additional costs for the company. If the devel-
opment of nadunolimab fails, this would have a significant
adverse impact on Cantargia’s operations, financial position
and results, and there is a risk that Cantargia would not be
able to continue its operations in the current form.
Implementation of preclinical and clinical studies
Results from early clinical studies are not always consis-
tent with the results of more comprehensive clinical stud-
ies. There is a risk that the planned studies will not indicate
levels of safety and efficacy that are sufficient to obtain the
required regulatory permits or to enable the company to li-
cense, establish partnerships for or sell its potential product.
Regulatory permits and registrations
To obtain the right to market and sell a drug, all candidate
drugs under development need to go through a comprehen-
sive registration process and be approved by the relevant
regulator in an individual market.
There is also a risk that the rules which currently apply for
registration, or interpretations of these rules, will be amend-
ed in a way that is to the disadvantage of Cantargia. In the
event that Cantargia does not obtain the required product
approvals or in the event that any future approvals are with-
drawn or limited, this could have significant negative effects
on Cantargia’s operations, financial position and results.
Changes in economic activity and the pricing of drugs
The pricing and demand for pharmaceutical drugs could be
adversely affected by a general economic decline in major
pharmaceuticals markets. In certain countries, the pricing
of drugs is determined at the regulatory level and, in case
of the launch of drugs, the pricing could thus be regulated
by authorities in several countries. A deterioration in gen-
eral economic conditions and/or regulatory decisions could
therefore result in a lower pricing of the drug projects than
expected by Cantargia, which could have a significant nega-
tive impact on the company’s operations, financial position,
and results.
Partnerships, licensing and marketing
Cantargia is and will in future be dependent on partnerships
in connection with the development of candidate drugs, pre-
clinical and clinical studies, and licensing/partnerships for
any future sale of drugs. In the event that these or future
partnerships were to be terminated, there is a risk that the
company would be unable, on short notice, to conclude con-
tracts with suitable new business partners, which could have
a significant negative impact on the company’s operations,
financial position and results.
In the future, Cantargia could also be dependent on external
parties for marketing and sales. If the company is not suc-
cessful in its attempts to conclude future or maintain exist-
ing partnership agreements for its product candidate, this
could have a significant negative impact on Cantargia’s op-
erations, financial position, and results.
Financing and capital requirements
Since starting its operations, Cantargia has been reporting
an operating loss and cash flow is expected to remain mainly
negative until Cantargia succeeds in generating revenue from
a launched product. Cantargia will also continue to need sig-
nificant capital for research and development in order to
conduct preclinical and clinical studies. If Cantargia, wholly or
partly, were to fail to acquire sufficient capital, or succeed in
doing so only on unfavourable terms, this could have a signifi-
cant negative impact on the company’s operations, financial
position and results.
Competition
If a competitor succeeds in developing and launching an ef-
fective cancer drug, this could have a negative impact on
the company’s ability to generate revenue. Furthermore,
technology that is controlled by outside parties and that
could be of use for the company’s operations could be ac-
quired or licensed by Cantargia’s competitors, and thereby
prevent Cantargia from obtaining such technology on com-
mercially acceptable terms, or at all. Competitors with
greater resources could also successfully market a similar
or even an inferior drug and obtain wider recognition in
healthcare in general for such a drug, which could have a
negative impact on the company’s operations, financial po-
sition, and results.
DIRECTOR’S REPORT
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Dependence on key individuals and employees
Cantargia is dependent on a number of key individuals for
the continued development of the company’s operations
and preclinical and clinical projects. There is, however, a
risk that one or several of the company’s employees will
terminate their employment with the company or that the
company will fail to recruit new individuals with relevant
knowledge, which could delay the company’s development
and commercialization of its candidate drug.
Patents and other intellectual property rights
There is a risk that it will not be possible to obtain patent
protection for drugs and production methods developed
by Cantargia, that Cantargia will be unable to register and
complete all necessary or desirable patent applications
at a reasonable cost or that a future patent portfolio and
other intellectual property rights held by the company will
not provide adequate commercial protection. There is also
a risk that a patent will not create a competitive advantage
for the company’s drugs and/or methods or that competi-
tors will succeed in circumventing the company’s patents.
If Cantargia is forced to defend its patent rights against a
competitor, this could entail significant costs, especially in
any disputes with competitors with significantly greater re-
sources than Cantargia. If Cantargia in its own operations
uses or is alleged to be using products or methods which
are protected by patents or will be patented by another
party, the holder of these patents could accuse Cantargia
of patent infringement.
The failure to maintain its own, and/or any infringement of
other parties’, intellectual property rights could have a sig-
nificant negative impact on Cantargia’s operations, finan-
cial position and results.
Product liability
Cantargia’s operations are subject to various liability risks
that are common for companies engaged in drug re-
search and development. This includes the risk of prod-
uct liability that can arise in connection with production
and clinical studies where the participating patients can
experience side effects or fall ill during treatment. There
is a risk that product liability claims could have a signifi-
cant negative impact on Cantargia’s operations, financial
position, and results.
Insurance cover
Cantargia believes that the insurance cover for its current
operations is appropriate. There is, however, a risk that
such cover will prove insufficient for claims that could arise
in relation to product liability and other damage. There is
therefore a risk that insufficient or excessively expensive
insurance cover could have a significant negative impact on
the company’s operations, financial position, and results.
Currency risk
Assets, liabilities, income and expenses in foreign currency
give rise to currency exposures. A weakening of the Swed-
ish krona (SEK) against other currencies increases the rec-
ognised amounts of Cantargia’s assets, liabilities, income
and earnings while a strengthening of the SEK against
other currencies decreases these items. The company is
exposed to such changes, as some the company’s costs
are paid in EUR, USD and other international currencies and
because a part of the company’s future sales revenue may
be received in international currencies. A material change in
such exchange rates could have a negative impact on the
company’s financial statements, which in turn could have
negative effects on Cantargia’s financial position and re-
sults. See also Note 3 for information about how Cantargia
handles this risk.
EMPLOYEES
One of Cantargia’s key success factors is the company’s
employees. The average number of employees of the com-
pany during the year was 27 (22), of whom 17 (13) are
women. The number of employees at year-end was 26 (26)
fulltime equivalents, of whom 16 (15) are women. The level
of education among the employees is generally high. Nearly
all employees hold a PhD in medicine or natural sciences or
have higher university degrees.
In addition to its employees, Cantargia engages a number
of consultants who are tied to the business on a continu-
ous basis. The large network with which Cantargia works
ensures access to top-level expertise, flexibility, and cost
effectiveness.
RESEARCH AND DEVELOPMENT
The majority of the company’s resources, 96 (95) percent,
are used for research and development.
ENVIRONMENTAL IMPACT
Cantargia AB does not engage in activities requiring a per-
mit under the Swedish Environmental Code, as the compa-
ny does not engage in the production of pharmaceuticals or
pharmaceutical substances and does not handle solvents
and chemicals.
GUIDELINES FOR REMUNERATION AND
OTHER TERMS OF EMPLOYMENT FOR SE-
NIOR EXECUTIVES 2022
Under the Swedish Companies Act, guidelines for remu-
neration of the CEO and other senior executives must be
adopted by the shareholders’ meeting. A set of guidelines
were adopted at the Annual General Meeting on 27 May
2020. No deviations from these guidelines have been made.
The Board has not proposed that any changes be made
DIRECTOR’S REPORT
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
to the remuneration guidelines at the 2023 AGM and the
guidelines will therefore continue to apply in accordance
with the resolution of the 2020 AGM.
The guidelines do not cover remuneration or share-based
incentive schemes adopted or approved by the sharehold-
ers’ meeting.
The guidelines applying for 2023 are presented below. For
remuneration in 2022, see Note 18.
How the guidelines promote Cantargia’s business
strategy, long-term interests and sustainability
Cantargia’s business model and scientific strategy are
based on partnerships, and Cantargia has entered agree-
ments with a number of companies, hospitals and aca-
demic groups. A large number of international and local
organizations are currently engaged in research and devel-
opment related to Cantargia’s nadunolimab and the CAN10
antibody. The strategy is to advance the development of
these drug candidates in-house until the stage where a
development or commercialization agreement is reached
with companies within Cantargia’s business area. For fur-
ther information about Cantargia’s business strategy, see
www.cantargia.com.
To successfully implement its business strategy and safe-
guard its long-term interests, including its sustainability, it
is essential that Cantargia is able to recruit and retain com-
petent employees who work to achieve maximum share-
holder and customer value. To do so, Cantargia must be
able to offer competitive remuneration. These guidelines
enable senior executives to be offered competitive total
remuneration.
Long-term incentive schemes have been established in
Cantargia. The schemes have been approved by the share-
holders’ meeting and are therefore not covered by these
guidelines. For the same reason, the share-based incentive
scheme and employee stock option scheme approved by
the 2020, 2021 and 2022 AGMs are also not covered.
Forms of remuneration, etc.
The remuneration paid to senior executives shall be mar-
ket-based and may consist of the following components: a
fixed cash salary, variable cash remuneration, pension ben-
efits and other benefits. The total remuneration paid to se-
nior executives shall comprise a balanced mix of the above
components. The Board shall annually evaluate whether
long-term incentive schemes should be proposed to the
shareholders’ meeting.
The fixed cash salary shall be individual and based on the
senior executive’s areas of responsibility, role, competence
and position.
For the CEO, the variable cash remuneration shall not ex-
ceed 30 percent of the fixed annual cash salary. For other
senior executives, the corresponding remuneration shall
not exceed 20 percent of the executive’s fixed annual cash
salary. Variable cash remuneration can be pensionable if
this is provided for under mandatory provisions of a collec-
tive bargaining agreement.
Pension benefits shall be defined contribution benefits un-
less the executive is covered by a defined benefit plan un-
der mandatory provisions of a collective bargaining agree-
ment. Pension premiums for defined contribution pensions
shall not exceed 35 percent of the fixed annual cash salary.
Notwithstanding the above, the Board shall have the right
to instead offer other solutions that are equivalent from a
cost perspective for the company.
Other benefits may include benefits such as health insur-
ance and occupational health care. Such benefits must be
of limited value in relation to other remuneration and be
consistent with normal market practice in each geographi-
cal market. The combined value of other benefits shall not
exceed 10 percent of the fixed annual cash salary.
With regard to employment relationships that are subject
to other rules than Swedish rules, appropriate adjustments
may be made in respect of pension benefits and other
benefits in order to comply with mandatory rules or estab-
lished local practice, in which case the general purpose of
these guidelines shall be adhered to as far as possible.
Termination of employment
If employment is terminated by Cantargia, the notice period
shall not exceed six months. If employment is terminated by
the executive, the notice period shall not exceed six months
for the CEO and three months for other senior executives.
For the CEO, severance pay of up to twelve months’ fixed
cash salary and employment benefits may be paid, in ad-
dition to a fixed basic salary during the notice period. For
other senior executives, the sum of the fixed basic salary
during the notice period and severance pay shall not exceed
the amount of the executive’s annual fixed cash salary.
Criteria for payment of variable cash remuneration, etc.
Variable cash remuneration must be linked to predeter-
mined and measurable criteria, which may be financial or
non-financial and must be designed to promote the com-
pany’s long-term value creation. The criteria must relate
to development activities in the development projects in
which the company is engaged and the partnerships the
company enters into to accelerate the clinical development
process and advance towards commercialization as well as
the remuneration resulting therefrom (e.g. one-time pay-
ments at the time of entering into agreements, milestone
DIRECTOR’S REPORT
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
compensation or royalties). The criteria must also be de-
signed to promote Cantargia’s business strategy and long-
term interests, including its sustainability.
Fulfilment of criteria for payment of variable cash remu-
neration shall be measured over a period of one year. When
the measurement period for meeting the criteria for pay-
ment of variable cash remuneration has ended, it shall be
determined to what extent the criteria have been met. The
assessment regarding variable cash remuneration of se-
nior executives shall be made by the Remuneration Com-
mittee. With regard to financial targets, the assessment
shall be based on the company’s most recently published
financial information.
Salary and terms of employment for employees
In preparing these proposed remuneration guidelines, the
Board has taken account of salaries and employment terms
for the company’s employees by including information on
employees’ total remuneration, the components of the
remuneration and the increase and rate of increase of the
remuneration over time in the decision basis used by the
Board to assess the reasonableness of the guidelines and
the limitations arising therefrom.
The decision-making process for determining,
reviewing and implementing the guidelines
The Board has established a Remuneration Committee. The
committee’s duties include preparing the Board’s resolution
on the proposed guidelines for remuneration of senior ex-
ecutives. The Board shall prepare proposed new guidelines
at least every fourth year and submit its proposal for adop-
tion by the AGM. The guidelines shall apply until new guide-
lines have been adopted by the shareholders’ meeting. The
Remuneration Committee shall also monitor and evaluate
programmes for variable remuneration for management,
the application of guidelines for remuneration of senior ex-
ecutives, and applicable remuneration structures and remu-
neration levels in the company. The members of the Remu-
neration Committee are independent of the company and
management. During the Board’s deliberations and when
resolutions on remuneration-related matters are made, the
CEO or other members of management shall not be present,
insofar as they are affected by the matters concerned.
Deviation from the guidelines
The Board may decide temporarily to deviate, wholly or
partially, from the guidelines if in an individual case there
are special reasons therefor and such deviation is neces-
sary to safeguard Cantargia’s long-term interests, includ-
ing its sustainability, or to ensure Cantargia’s financial
viability. As stated above, it is part of the duties of the Re-
muneration Committee to prepare the Board’s resolutions
on remuneration matters, which includes resolutions on
deviations from the guidelines.
OUTLOOK FOR 2023
Cantargia’s goal is to develop drug candidates for treat-
ment of life-threatening diseases with a focus on cancer
as well as autoimmune and inflammatory diseases. The
strategy is to advance the development of these drug can-
didates in-house until the stage where a development or
commercialization agreement is reached with companies
within Cantargia’s business area.
For Cantargia’s main project, nadunolimab, the goal is to
confirm the promising phase I/II results in randomized tri-
als. One such trial, TRIFOUR, has already been initiated for
triple-negative breast cancer and in 2023, Cantargia also
plans to recruit for a randomized trial in pancreatic can-
cer. Another ambition is to build on the promising results
showing that pancreatic cancer patients with high levels of
IL1RAP respond best to treatment with nadunolimab and
chemotherapy. Additionally, the goal is to advance CAN10
into clinical phase and thereby have a second project in
clinical development.
APPROPRIATION OF RETAINED EARNINGS
Proposed appropriation of retained earnings (see also Note
21). The Annual General Meeting is asked to decide on the
appropriation of the following:
The Board of Directors proposes that: SEK 376,325,002 be
carried forward.
For more information on the company’s results and financial
position, see the following income statement and balance
sheet and the additional disclosures.
Share premium account 1,623,184,970
Loss brought forward - 875,045,855
Loss for the year - 371,814,113
376,325,002
DIRECTOR’S REPORT
38
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
SHAREHOLDER INFORMATION
39
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
SHAREHOLDER INFORMATION
SHAREHOLDER INFORMATION
As of 25 September 2018, Cantargia’s shares have been
listed on the main list of Nasdaq Stockholm, under the
stock symbol “CANTA”. At 31 December 2022, the num-
ber of shares was 166,987,895 (100,192,737). At the
balance sheet date, the total outstanding option scheme
including not assigned options comprised 4,475,333
employee stock options, entitling the holders to sub-
scribe for 5,370,400 shares, which would have a dilutive
effect of approximately 3.1 per cent and increase the
share capital by SEK 429,632.
Share price performance
5
10
15
Jan-22 Feb-22 Mar-22 May-22 Jun-22 Jul-22Apr-22 Aug-22 Sep22 Oct-22 Nov-22 Dec-22
SHARE PRICE (SEK)
20
25
30
Owner Number of shares Capital/Votes (%)
Fjärde AP-fonden 14,743,911 8.8%
Alecta Tjänstepension, Ömsesidigt 12,240,992 7.3%
Försäkringsaktiebolaget, Avanza Pension 11,216,197 6.7%
Första AP-fonden 10,540,406 6.3%
Swedbank Robur Fonder 8,102,958 4.9%
Six Sis AG 7,895,983 4.7%
Handelsbanken fonder 7,148,994 4.3%
Goldman Sachs International 5,399,573 3.2%
Nordnet Pensionsförsäkring 2,396,835 1.4%
Brushamn Invest Aktiebolag 1,979,470 1.2%
Other 85,322,576 51.1%
Total 166,987,895 100,0%
OWNERSHIP DISTRIBUTION
Cantargia’s ten largest owners as of December 31, 2022
40
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
SHAREHOLDER INFORMATION
Holding
Number of
shareholders
Number of
shares
Capital/Votes
(%)
Market Cap
(kSEK)
1 - 500 6,189 935,052 0.6% 2,880
501 - 1 000 1,468 1,151,931 0.7% 3,548
1 001 - 5 000 2,964 7,539,688 4.5% 23,222
5 001 - 10 000 827 6,137,569 3.7% 18,904
10 001 - 15 000 317 3,942,775 2.4% 12,144
15 001 - 20 000 218 3,856,486 2.3% 11,878
20 001 - 671 143,424,394 85.9% 441,747
Total 12,654 166,987,895 100.0% 514,323
OWNERSHIP DISTRIBUTION SIZE CLASSES AS OF DECEMBER 31, 2022
SHARE CAPITAL HISTORY
Year Event
Quotient
value
Increase in no.
of shares
Increase in share
capital
Total no. of
shares
Total share
capital
2009 Incorporation 1,00 100,000 100,000.00 100,000 100,000.00
2010 Issue of new shares 1,00 10,870 10,870.00 110,870 110,870.00
2011 Issue of new shares 1,00 14,130 14,130.00 125,000 125,000.00
2012 Issue of new shares 1,00 3,571 3,571.00 128,571 128,571.00
2012 Issue of new shares 1,00 7,143 7,143.00 135,714 135,714.00
2012 Issue of new shares 1,00 7,143 7,143.00 142,857 142,857.00
2013 Issue of new shares 1,00 3,572 3,572.00 146,429 146,429.00
2013 Issue of new shares 1,00 25,001 25,001.00 171,430 171,430.00
2014 Issue of new shares 1,00 12,500 12,500.00 183,930 183,930.00
2014 Bonus issue 2,96 - 360,502.80 183,930 544,432.80
2014 37:1 share split 0,08 6,621,480 - 6,805,410 544,432.80
2014 Debt-for-equity swap 0,08 789,464 63,157.12 7,594,874 607,589.92
2015 Issue 0,08 5,800,000 464,000.00 13,394,874 1,071,589.92
2015 Issue of new shares TO 2010:1 0,08 111,000 8,880.00 13,505,874 1,080,469.92
2016 Issue of new shares TO1/TO3 0,08 4,127,260 330,180.80 17,633,134 1,410,650.72
2016 Issue of new shares 2011/2016 0,08 46,250 3,700.00 17,679,384 1,414,350.72
2016 Issue of new shares TO2/TO4 0,08 3,237,816 259,025.28 20,917,200 1,673,376.00
2017 Issue of new shares 0,08 11,158,308 892,664.64 32,075,508 2,566,040.64
2017 Issue of new shares 0,08 14,865,000 1,189,200.00 46,940,508 3,755,240.64
2018 Issue of new shares 0,08 19,245,303 1,539,624.24 66,185,811 5,294,864.88
2019 Issue of new shares 0,08 6,618,581 529,486.48 72,804,392 5,824,351.36
2020 Issue of new shares 0,08 18,201,097 1,456,087.76 91,005,489 7,280,439.12
2020 Issue of new shares TO
2017/2020
0,08 86,700 6,936.00 91,092,189 7,287,375.12
2020 Issue of new shares 0,08 9,100,548 728,043.84 100,192,737 8,015,418.96
2022 Issue of new shares 0,08 66,795,158 5,343,612.64 166,987,895 13,359,031.60
41
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
FINANCIAL STATEMENTS
42
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
STATEMENT OF COMPREHENSIVE INCOME
1 Jan 2022 1 Jan 2021
SEK thousand
Note -31 Dec 2022 -31 Dec 2021
Operating income
Net sales - -
Other operating income
- -
Operating expenses 24
Research and development costs 7, 18 -364,686 -352,709
Administrative costs 6, 7, 18 -14,964 -15,309
Other operating expenses 9 -1,899 -2,249
-381,549 -370,267
Operating profit -381,549 -370,267
Financial income and expense
Interest income and similar items 10, 12 9,740 3,766
Interest expense and similar items 10, 12 -4 -3
9,736 3,763
Profit before taxes -371,814 -366,504
Tax for the period 11 - -
Loss for the period *) -371,814 -366,504
Earnings per share before and after dilution (SEK) based
on average number of shares
-2.90 -3.66
*) No items are reported in other comprehensive income, meaning total comprehensive income is consistent with the loss
for the period.
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
STATEMENT OF FINANCIAL POSITION
SEK thousand Note 31 Dec 2022 31 Dec 2021
ASSETS
Intangible assets
Patent 5,558 6,459
27 5,558 6,459
Tangible assets
Machinery and equipment 7,395 3,097
26 7,395 3,097
Total fixed assets 12,953 9,556
Current assets
Other receivables 2,462 4,588
Prepaid expenses and accrued income 32,714 26,713
35,176 31,301
Short-term investments
Other short-term investments 14 237,095 312,064
237,095 312,064
Cash and bank balances
Cash and bank balances 15 189,573 247,322
189,573 247,322
Total current assets 461,845 590,688
TOTAL ASSETS 474,798 600,244
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 16 13,359 8,015
13,359 8,015
Non-restricted equity
Share premium account 1,623,185 1,404,595
Retained earnings -875,046 -513,362
Loss for the year -371,814 -366,504
21 376,325 524,729
Total equity 389,684 532,745
Long-term liabilities
Provision for social security contributions, incentive program 13 24 892
24 892
Short-term liabilities
Trade payables 37,910 34,512
Tax liabilities 342 570
Other liabilities 1,025 1,105
Accrued expenses and deferred income 17 45,813 30,420
85,090 66,607
TOTAL EQUITY AND LIABILITIES 474,798 600,244
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
STATEMENT OF CHANGES IN EQUITY
SEK thousand Restricted equity Non-restricted equity Total
1 Jan 2022 - 31 Dec 2022 Note Share capital
Share premium
account
Ret earnings incl
profit/loss for
year Total equity
Opening balance, 1 January 2022 8,015 1,404,595 -879,866 532,745
Loss for the period - - -371,814 -371,814
Transactions with shareholders
Issue of new shares for the year 5,344 245,138 - 250,482
Capital acquisition cost - -26,548 - -26,548
Employee stock option program 19 - - 4,819 4,819
5,344 281,590 4,819 228,753
Closing balance, 31 December
2022
13,359 1,623,185 -1,246,860 389,684
1 Jan 2021 - 31 Dec 2021
Opening balance, 1 January2021 8,015 1,404,595 -520,676 891,935
Loss for the period - - -366,504 -366,504
Transactions with shareholders
Employee stock option program 19 - - 7,314 7,314
- - 7,314 7,314
Closing balance, 31 December
2021
8,015 1,404,595 -879,866 532,745
FINANCIAL STATEMENTS
45
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
STATEMENT OF CASH FLOWS
1 Jan 2022 1 Jan 2021
SEK thousand Note -31 Dec 2022 -31 Dec 2021
Cash flow from operating activities
Operating loss -381,549 -370,267
Adjustments for non-cash items 23 7,643 8,541
Interest received etc. 10 388 927
Interest paid etc. 10 -4 -3
Cash flow from operating activities
before changes in working capital -373,523 -360,802
Changes in working capital
Change in receivables -3,876 -21,782
Change in trade payables 3,398 23,834
Changes in other current liabilities 15,085 12,304
14,607 14 357
Cash flow from operating activities -358,915 -346,445
Investing activities
Acquisition of tangible assets 26 -7,089 -383
Increase in other short-term investments 14 -31 -177,046
Decrease in other short-term investments 14 75,000 75,000
67,880 -102,429
Financing activities
Issue of new shares for the year 250,482 -
Capital acquisition cost -26,548 -
223,934 -
Change in cash and cash equivalents -67,101 -448,873
Cash and cash equivalents at beginning of period 247,322 693,354
Exchange rate difference in cash equivalents 10 9,352 2,839
Cash and cash equivalents at end of period *) 15 189,573 247,322
*) The company’s cash and cash equivalents consist of cash and disposable balances with banks and other credit
institutions.
FINANCIAL STATEMENTS
46
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Notes
NOTE 1
General information
Cantargia AB (publ), reg. no. 556791-6019, is a biotech-
nology company that develops antibody-based treatments
for life-threatening diseases and has established a platform
based on the protein IL1RAP, involved in a number of can-
cer forms and inflammatory diseases. The lead project, the
antibody nadunolimab (CAN04), is studied clinically primarily
in combination with chemotherapy, focusing on pancreatic
cancer, triple-negative breast cancer and non-small cell lung
cancer. Positive interim data from the combination with che-
motherapy indicate stronger efficacy than would be expected
from chemotherapy alone. Cantargia’s second development
project, the antibody CAN10, blocks signaling via IL1RAP in
a different manner than nadunolimab and addresses treat-
ment of serious autoimmune/inflammatory diseases, with
initial focus on myocarditis and systemic sclerosis.
Cantargia consists of one legal entity, Cantargia AB, corporate ID
number 556791-6019.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA) since
September 2018.
NOTE 2
Accounting policies and valuation principles
Significant accounting policies applied in preparing this an-
nual report are described in the following. Unless otherwise
stated, these policies have been applied consistently for all
the annual periods presented. This annual report was adopt-
ed by the Board of Directors on 27 April 2023.
2.1 Basis of preparation of financial statements
Cantargia AB has prepared its annual accounts in accor-
dance with the Swedish Annual Accounts Act and Recom-
mendation RFR 2 Financial Reporting for Legal Entities
of the Swedish Financial Reporting Board (RFR 2). RFR 2
states that a legal entity is required to apply the Interna-
tional Financial Reporting Standards (IFRS), as adopted by
the EU, insofar as this is possible under the Swedish Annual
Accounts Act and Pension Obligations Vesting Act and with
regard to the relationship between accounting and taxation.
The recommendation specifies the exemptions from and
the additional disclosures that are required in relation to
IFRS. The preparation of financial statements in compliance
with the applied regulations requires the use of critical ac-
counting estimates. Management is also required to make
certain judgements in applying the company’s accounting
policies. Areas which involve a high degree of judgement,
are complex or where assumptions and estimates have a
material impact are described in Note 4.
2.1.1 Changes to accounting policies and dis-
closures
Standards, amendments, and interpretations of existing stan-
dards that have entered into force during the financial year. No
IFRS or IFRIC interpretations that have not yet become ef-
fective are expected to have a material impact on Cantargia.
2.1.2 Formats
The format prescribed in the Swedish Annual Accounts Act is
used for the income statement and balance sheet. The state-
ment of changes in equity is presented in the format pre-
scribed in IAS 1 Presentation of Financial Statements but must
contain the columns indicated in the Annual Accounts Act.
2.2 Segment reporting
Cantargia’s chief operating decision maker is the company’s
Chief Executive Officer (CEO), as it is primarily he who is re-
sponsible for the allocation of resources and evaluation of
results. The CEO receives reports containing financial infor-
mation for Cantargia as a whole. Cantargia has not yet com-
mercialized any part of the development projects in which it
is engaged and therefore is not yet generating any income.
All activities of Cantargia are considered to constitute a single
operating segment.
2.3 Intangible assets
(i) Research and development costs
Cantargia is a research-based biotech company that is en-
gaged in research and development of antibody-based ther-
apy for severe diseases. All expenditure directly attributable
to the development and testing of identifiable and unique
products which are controlled by Cantargia is accounted for
as an intangible asset when the following criteria are met:
•
it is technically feasible to complete the product so that it
will be available for use,
•
Cantargia intends to complete the product for use or sale,
•
there is reason to expect that the company will be able to
use or sell the product,
•
it can be shown that the product will generate probable
future economic benefits,
•
adequate technical, economic and other resources are
available to complete the development of and use or sell
the product, and
•
the costs attributable to the product during its develop-
ment can be reliably measured.
FINANCIAL STATEMENTS
47
CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
The overall risk in ongoing development projects is high. The
risk includes safety and efficacy risks that can arise in clinical
studies, regulatory risks related to applications and approval
for clinical studies and marketing authorization, as well as
IP risks related to approval of patent applications and the
maintenance of patents. All development work is therefore
deemed to be research, as the work does not meet the cri-
teria listed below. As of 31 December 2022 no development
costs had been recognized as intangible assets in the balance
sheet, as it was not considered that all of the above criteria
for capitalization had been met for any of the development
projects in which the company is engaged.
Research expenditure is expensed as incurred.
Capitalized development costs are recognized as intangible
assets and amortized from the date when the asset is ready
for use.
(ii) Patents, licenses, and similar assets
Intangible assets also include patents, licenses, and other
similar rights. Acquired such assets are reported at acquisi-
tion value and amortized on a straight-line basis over the
expected period of utilization, which normally coincides with,
for example, the patent’s validity period.
2.4 Impairment of intangible assets
Intangible assets which are not ready for use (capitalized de-
velopment costs) are not amortized but are tested annually
for impairment. However, no capitalized development costs
are currently recognized in Cantargia’s balance sheet.
2.5 Leases
Cantargia is a lessee only under operating leases, of which
rental of office premises is the most significant. Leases in
which a significant share of the risks and benefits of ownership
are retained by the lessor are classified as operating leases.
Payments made during the lease term (after deducting for any
incentives from the lessor) are recognized as an expense in the
statement of comprehensive income on a straight-line basis
over the lease term.
2.6 Foreign currency
Transactions in foreign currency are translated to the func-
tional currency at the exchange rates applying at the transac-
tion date or the date when the items were restated. Foreign
exchange gains and losses are recognized in the statement of
comprehensive income in other operating expenses (foreign ex-
change differences trade payables) and in net financial income/
expense (foreign exchange differences currency accounts).
2.7 Financial assets and liabilities
Recognition and derecognition in the balance sheet
A financial asset or financial liability is recognized in the bal-
ance sheet when the company becomes a party to the con-
tractual terms and conditions of the instrument. A financial as-
set is derecognized in the balance sheet when the contractual
right to the cash flow from the asset expires or is settled. The
same applies when the risks and benefits of ownership of the
asset have essentially been transferred to another party and
the company no longer has control over the financial asset. A
financial liability is derecognized in the balance sheet when the
contractual obligation is fulfilled or extinguished.
Measurement of financial instruments
Cantargia applies the exemption in RFR 2 under which IFRS 9
Financial Instruments is not applied. Instead, cost is applied
in accordance with the Annual Accounts Act.
Financial assets are initially measured at cost including any
transaction costs directly attributable to the acquisition of
the asset. After initial recognition, current financial assets are
measured at the lower of cost and net realizable value at the
balance sheet date.
Trade receivables and other receivables classified as current
assets are measured individually at the amounts expected
to be paid. Interest-bearing financial assets are measured at
amortized cost using the effective interest method.
Measurement of financial liabilities
Short-term trade payables are recognized at cost.
2.8 Employee benefits
Retirement benefit obligations
Cantargia has both defined contribution and defined benefit
pension plans. Defined contribution pension plans are post-
employment benefit plans under which the company pays
fixed contributions into a separate legal entity. Cantargia
has no legal or constructive obligations to pay further con-
tributions if this legal entity does not hold sufficient assets
to pay all employee benefits relating to employee service in
the current and prior periods. The contributions are recog-
nized as personnel expenses when they fall due.
Cantargia’s defined benefit pension plans consist of the ITP
2 plan’s defined benefit pension obligations. The ITP 2 plan’s
defined benefit pension obligations for retirement and fam-
ily pensions are secured through an insurance policy with
Alecta. According to a statement from the Swedish Finan-
cial Reporting Board, UFR 10 Recognition of the ITP 2 Plan
that is funded through an insurance policy with Alecta, this
is a defined benefit plan covering several employers. For the
financial year 2020, Cantargia has not had access to infor-
mation that would enable it to account for its proportionate
share of the plan’s obligations, assets, and expenses. It has
therefore not been possible to recognize the plan as a de-
fined benefit plan. The ITP 2 pension plan secured through
an insurance policy with Alecta is therefore accounted for
as a defined contribution plan. The contribution for defined
benefit retirement and family pensions is calculated indi-
vidually and depends on factors such as salary, previously
earned pension and expected remaining period of service.
The collective funding ratio is defined as the market value of
Alecta’s assets as a percentage of its commitments to poli-
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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cyholders calculated using Alecta’s actuarial methods and
assumptions, which do not comply with IAS 19. The col-
lective funding ratio should normally be permitted to vary
within a range of 125 and 175 per cent. If Alecta’s collec-
tive funding ratio were to fall below 125 per cent or exceed
175 per cent, it would be necessary to take measures that
will enable the ratio return to the normal range. In case of
a low funding ratio, one measure that can be taken is to
raise the agreed price for new policies and the expansion
of existing benefits. If the funding ratio is high, contribu-
tions can be reduced. At the end of the financial year 2022,
Alecta’s surplus, as defined by the collective funding ratio,
was 172 per cent (2021: 172 per cent).
Short-term benefits
Short-term benefits are employee benefits which are payable
within twelve months of the balance sheet date in the year in
which the employee earned the benefit, with the exception of
post-employment benefits and termination benefits.
Short-term benefits include
1. salaries, social security contributions and other payroll costs,
2. paid short-term leave such as paid holiday and paid sick
leave,
3. bonuses, and
4. non-monetary benefits such as health care for current em-
ployees.
Accounting treatment – paid short-term leave
Short-term benefits for paid leave that can be saved should
be accounted for as an expense and current liability when
the employees have performed the services which entitle
them to future paid leave. Short-term benefits for paid
leave that are not saved should be recognized as an ex-
pense when the leave is taken.
Accounting treatment – bonus plans
The expected expense for profit sharing and bonuses
should be recognized only if
1. the company has a legal or constructive obligation as a
result of past events, and
2. the amount of the obligation can be reliably estimated.
Termination benefits
Termination benefits are paid when an employee’s employ-
ment has been terminated by the company before the normal
time of retirement or when an employee accepts voluntary
redundancy in exchange for such compensation. Cantargia
recognizes termination benefits at the earliest of the follow-
ing: (a) when the company can no longer withdraw the offer
of such benefits; and (b) when the company recognizes re-
structuring costs provided for under IAS 37 which involve the
payment of severance pay. If the company has made an of-
fer to encourage voluntary redundancy, termination benefits
are calculated based on the number of employees that are
expected to accept the offer. Benefits expiring more than 12
months after the end of the reporting period are discounted
to present value.
2.9 Tax
The tax on the profit for the year in the income statement con-
sists of current tax and deferred tax. Current tax is calculated
on the taxable profit for the period at the applicable tax rate.
The actual tax expense is calculated based on the tax rules
that have been enacted or substantively enacted by the bal-
ance sheet date.
Deferred tax liabilities are recognized for all taxable temporary
differences. However, deferred tax attributable to untaxed re-
serves is accounted for separately, as untaxed reserves are
recognized as a separate item in the balance sheet. Deferred
tax liabilities are recognized to the extent that it is probable
that future taxable profits will be available against which the
temporary differences can be wholly or partially offset.
Deferred tax is calculated using tax rates (and laws) which
have been adopted or announced at the balance sheet date
and are expected to apply when the deferred tax asset is real-
ized or the deferred tax liability is settled.
As the company is not generating any profit, the deferred tax
asset on tax losses arising from tax losses presented in Note
11 has not been assigned any value.
2.10 Revenue
Interest income
Interest income is recognized using the effective
interest method.
2.11 Cash and cash equivalents and statement
of cash flows
The statement of cash flows is prepared using the indirect
method. The reported cash flow only includes transactions
involving incoming or outgoing payments. The company clas-
sifies cash, available deposits with banks and other credit in-
stitutions as cash and cash equivalents.
2.12 Share capital
Ordinary shares are classified as equity.
Transaction costs which are directly attributable to the issu-
ance of new shares or options are recognized, net of tax, in
equity less a deduction from the proceeds of the issue.
2.13 Earnings per share
(i) Earnings before dilution
Earnings per share before dilution are calculated by dividing:
•
Profit/loss for the year
•
with a weighted average number of outstanding ordinary
shares during the period
(ii) Earnings per share after dilution
To calculate earnings per share after dilution, the amounts
used in calculating earnings per share before dilution are
adjusted by taking into account:
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
•
the weighted average of those additional ordinary shares
that would have been outstanding on the conversion of
all potential ordinary shares.
2.14 Tangible Assets
Tangible assets consist of furniture, work machinery and
production equipment. These are reported at historical cost
minus cumulative depreciation and any impairments. The
historical cost includes the purchase price and any expenses
directly attributable to the asset for putting it in place and
making it fit for its intended purpose.
Depreciation of tangible assets is posted to expenses in such
a way that the value of the asset minus its estimated residual
value at the end of its service life is written down on a linear
basis over its expected service life, estimated at:
•
Machinery and other technical facilities, 3-5 years
•
Fixtures, tools and installations, 3-5 years
Estimated service lives, residual values and depreciation
methods are reviewed at least at the end of each account-
ing period, and the effects of any changes in estimates are
reported in advance.
The reported value of a tangible asset is removed from the
statement of financial position when it is scrapped or sold, or
when no future economic benefits are expected from using
or scrapping/disposing of the asset. The gain or loss made
from scrapping or disposing of the asset is the difference be-
tween any net income from the disposal and its reported val-
ue, posted to the income statement in the period in which the
asset is removed from the statement of financial position.
2.15 Employee stock option program
The fair value of the service entitling an employee to an
allotment of options under Cantargia’s employee stock
option scheme is recognized as a personnel expense with
a corresponding increase in equity. The total amount ex-
pensed is based on the fair value of the allocated options:
•
including all market-related terms (e.g., target share
price),
•
excluding any effect of service and non-market vesting
conditions (e.g., profitability and that the employee re-
main an employee of the company for a specified pe-
riod),
•
including the effect of non-vesting conditions (e.g., a re-
quirement that the employee save or hold the shares
for a specified period).
The total expense is recognized over the vesting period,
which is the period during which all of the specified vesting
conditions are to be satisfied. At the end of each report-
ing period, the company reviews its assessments of how
many shares are expected to be vested based on the non-
market vesting conditions and service vesting conditions.
Any deviations from the original assessments resulting
from the review are recognized in the income statement
with corresponding adjustments in equity.
As a basis for provisions for social security contributions,
the fair value of vested employee stock options is remea-
sured at the end of each reporting period. Social security
contributions are accounted for as personnel expenses and
a corresponding provision is made in non-current or current
liabilities depending on the remaining term of each scheme.
NOTE 3
Financial risk management
Through its activities, Cantargia is exposed to a wide range of
financial risks: market risk (mainly currency risk), credit risk
and liquidity risk. Cantargia’s overall risk management pol-
icy focuses on the unpredictability of financial markets and
strives to minimize potential adverse effects on Cantargia’s
financial results.
(a) Market risk
(i) Currency risk
Cantargia is primarily exposed to EUR and USD currency risk.
Currency risks arise when future business transactions or
recognized assets or liabilities are expressed in a currency
that is not the functional currency of the unit. In Cantargia,
these transactions mainly comprise purchases and trade
payables in EUR and USD. Cantargia’s policy is to hedge 50%
of the anticipated cash flow in EUR and USD. At the end of the
reporting period, Cantargia had an exposure to EUR of kEUR
2,470 (396) and kUSD 131 (22) in the form of outstanding
trade payables. In addition to trade payables in EUR and USD,
the company has a EUR and USD currency accounts which
on 31 December 2022 had a balance of kEUR 7,156 (18,523)
and kUSD 2,790 (1,244).
If the Swedish krona had weakened/strengthened by 10 per
cent against the EUR and USD with all other variables held
constant, the effect on profit/loss for the year and equity on
31 December 2022 would have been approximately SEK -22.9
million and SEK 22.9 million (-24,5 and 24.5, respectively)
lower/ higher. The corresponding effect in respect of the com-
pany’s EUR and USD currency accounts on 31 December 2022
would have been approximately SEK -10.4 million and SEK
10.4 million (-19.9 and 19.9 respectively) lower/higher.
(ii) Cash flow interest rate risk and fair value
The interest rate risk is considered to be limited as there is no
borrowing and the interest-bearing investments only include
low-risk funds. kSEK 237,095 (237,064) refers to invest-
ments in fixed income funds, where the return is dependent
on short-term interest rates.
(iii) Price risk
Cantargia is not exposed to any significant price risk.
FINANCIAL STATEMENTS
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(b) Credit risk
Credit risk in Cantargia arises through deposits and invest-
ments with banks and financial institutions. All bank deposits
and investments are held with counterparties with low credit
risk. Cantargia is not exposed to any significant credit risk, as
all counterparties are large, well-known banks.
(c) Liquidity risk
Since starting its operations, Cantargia has been reporting an
operating loss and cash flow is expected to remain mainly
negative until Cantargia succeeds in generating revenue
from a launched product. The company’s planned preclini-
cal and clinical studies will require significant costs and the
company’s development of its product candidate could prove
more time- and cost-consuming than planned. Cantargia will
also continue to need significant capital for research and de-
velopment in order to conduct preclinical and clinical studies
with nadunolimab and for its continued research and devel-
opment of CAN10 and CANxx. Access to and the terms and
conditions for further financing are affected by several fac-
tors, such as the possibility of concluding partnership agree-
ments and general access to risk capital. If Cantargia, wholly
or partly, were to fail to acquire sufficient capital, or succeed
in doing so only on unfavorable terms, this could have a sig-
nificant negative impact on the company’s operations, finan-
cial position and results.
Cantargia uses rolling forecasts to ensure that the company
has sufficient cash assets to meet its operational require-
ments. This monitoring takes the form of reporting to the
Board, whereby outcomes and forecasts are compared with
the three-year business plan that is produced and approved
by the Board each year.
Surplus liquidity in Cantargia, in excess of what is required
to manage working capital requirements, is invested in in-
terest-bearing current accounts. At the balance sheet date,
Cantargia had short-term investments in twelve month
fixed-rate accounts of kSEK 0 (kSEK 75,000) and kSEK
237,095 (kSEK 237,064) invested in a short-term fixed in-
come fund. In addition to this, Cantargia had bank deposits
of kSEK 189,573 (kSEK 247,322) at the balance sheet date.
The following table shows an analysis of Cantargia’s fi-
nancial liabilities by remaining maturity from the balance
sheet date. The amounts indicated in the table are the
contractual, undiscounted cash flows.
(d) Management of capital
To maintain or adjust its capital structure, Cantargia can
choose to return capital to the shareholders, issue new
shares or sell assets to reduce its liabilities.
In 2022, Cantargia’s strategy, which remained unchanged
from 2021, was to secure the company’s ability to con-
tinue as a going concern by running the company’s re-
search projects in an optimal manner and thereby gen-
erate returns for its shareholders and benefits for other
stakeholders. Cantargia also aims to maintain an optimal
capital structure in order to keep its capital costs down
with a low to minimal risk. Cantargia is mainly engaged in
research and development. Prior to the listing of the com-
pany’s shares on the main list of Nasdaq Stockholm on 25
September 2018, the company’s activities were financed
through a number of share offerings. Equity is therefore
regarded as the company’s capital.
Less than
2 months
More than
2 months
Total
31 December 2022
Trade payables 37,910 - 37,910
Other liabilities 1,025 - 1,025
Total 38,935 - 38,935
Less than
2 months
More than
2 months
Total
31 December 2021
Trade payables 34,512 - 34,512
Other liabilities 1,105 - 1,105
Total 35,617 - 35,617
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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NOTE 4
Critical accounting estimates and judgements
The preparation of financial statements and application of ac-
counting policies are often based on judgements, estimates
and assumptions made by management that are deemed rea-
sonable at the time when they are made. The estimates and
assumptions applied are based on historical experience and
other factors which are deemed reasonable under current cir-
cumstances. The results of these are then used to determine
carrying amounts of assets and liabilities that are not readily
apparent from other sources. Actual outcomes may differ from
these estimates and assessments.
Estimates and assumptions are reviewed regularly. Any
changes are recognized in the period in which the change is
made if the change affects only that period, or in the period
in which the change is made and future periods if the change
affects both the current and future periods.
Capitalization of development costs
The most critical judgement in Cantargia’s financial report-
ing refers to the date of capitalization of development costs.
Based on the accounting policies that are presented in Note
2, all development activities in which Cantargia is engaged
are currently classified as research, for which costs should
not be capitalized. The achievement of positive results in
phase III clinical trials is the earliest point at which the crite-
ria for capitalization can be considered to be met.
Tax losses
There is no expiration date which limits the use of the com-
pany’s tax losses. It is, however, uncertain at what point in
time it will be possible to use these tax losses to offset tax-
able profits, as the company has not yet generated any prof-
its. The deferred tax asset arising from the tax loss has there-
fore not been assigned any value. Changes in ownership and
historical and potential future capital acquisitions may limit
the amount of tax losses that can be used in future.
Incentive program (employee stock option program)
The company has an incentive program in the form of an
employee stock option program. The accounting principles
for this are described in Note 2. The cost of remuneration
reported in a period depends on the original valuation made
at the time of the agreement with the option holder, the
number of months the participant must serve to be entitled
to his options (accrual over this time), the number of op-
tions expected to be earned by the participants according to
the terms of the plans and a continuous revaluation of the
value of the tax benefit for the participants in the plans (as
a basis for allocation for social costs). The estimates that
affect the cost in a period and the corresponding increase
in equity are primarily input data in the valuations of the
options. The models used for this purpose are the so-called
Black & Scholes model and Monte Carlo simulation. Impor-
tant assumptions in these valuations are set out in Note 19.
In addition to the valuations, the cost is affected for a period
by an estimate of the number of people who are expected
to earn their options. Through mainly the history of staff
turnover, the company management has a very good basis
for estimating the number of participants who will com-
plete the program.
The Invasion of Ukraine
The invasion of Ukraine has negatively affected large parts
of our world, both from a humanitarian and a business per-
spective. However, Cantargia does not have any operation in
Russia or Ukraine, and therefore the invasion has not had any
impact on our financial reporting.
NOTE 5
Segment information
Cantargia’s chief operating decision maker is the company’s
Chief Executive Officer (CEO), as it is primarily he who is re-
sponsible for the allocation of resources and the evaluation
of results. The CEO receives reports containing financial in-
formation for Cantargia as a whole. Cantargia has not yet
commercialised any part of the development projects in
which it is engaged and therefore is not yet generating any
income. All activities of Cantargia are considered to consti-
tute a single operating segment.
FINANCIAL STATEMENTS
52
CANTARGIA AB (PUBL) 556791-6019
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2022
Salaries and other benefits
(of which bonuses)
Retirement
benefit costs
Directors, CEO and other senior executives 19,891 3,375
Other employees 14,454 3,350
Total 34,345 6,725
(2,818)
NOTE 7
Employee benefits, etc.
Salaries and other benefits and social security contributions (for employees)
2022 2021
Salaries and other benefits *) 31,300 29,608
Social security contributions **) 5,095 2,531
Retirement benefit costs, defined contribution 6,425 5,554
Other personnel expenses 498 270
Total employee benefits 43,317 37,964
*) Whereof share-based incentives 7,314 (4,233)
**) Whereof share-based incentives -2,219 (3,111)
2021
Salaries and other benefits
(of which bonuses)
Retirement
benefit costs
Directors, CEO and other senior executives 21,225 3,774
Other employees 11,427 1,781
Total 32,652 5,554
(2,641)
2022 2021
PwC
Audit engagement* 270 339
Audit services in addition to audit engagement 60 -
Tax advisory services 30 167
Other services 127 58
Total 487 564
* Audit engagement refers to fees for the statutory audit, i.e. work that has been necessary to
produce the auditor’s report.
NOTE 6
Auditors’ fees and expenses
Expensed audit fees for the financial year and expensed fees for other services provided by
the company’s auditors are presented in the following.
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Average number of employees
2022 2021
Number of
employees
Of which
men
Number of
employees
Of which
men
Sweden 27 11 22 9
Total 27 11 22 9
Gender distribution for Directors and other senior executives
2022 2021
Number at
balance sheet day Of which men
Number at
balance sheet day Of which men
Directors 8 5 8 5
CEO and other senior executives
8 5 9 7
Total 16 10 17 12
The contract between the company and CEO is subject to six months’ notice by either party.
Disclosures on benefits for the CEO, Directors and other senior executives are presented in Note 18.
NOTE 8
Operating leases
2022 2021
Lease payments expensed during the financial year 2,035 1,513
The distribution of the nominal value of future minimum lease payments under non-cancellable leases is as follows:
2022 2021
Due within one year 2,130 2,039
Due after more than one year but within five years 4,494 6,563
Due after more than five years - -
Total 6,624 8,602
Lease expenses refer to rent for premises and office equipment.
NOTE 9
Other operating expenses
2022 2021
Foreign exchange losses, trade payable -1,899 -2,249
Total -1,899 -2,249
FINANCIAL STATEMENTS
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NOTE 10
Financial income and expense
2022 2021
Interest income and similar income
Interest income 388 927
Foreign exchange gains, currency accounts 9,352 2,839
Total 9,740 3,766
NOTE 11
Income tax
2022 2021
Current tax
Current tax on profit for the year - -
Adjustments relating to prior years - -
Total current tax/income tax - -
The difference between the reported tax expense and the applicable tax rate is explained by the following table.
2022 2021
Reconciliation of reported tax for the year
Loss before tax -371,814 -366,504
Reported tax for the year
Tax at applicable tax rate 20,6% 76,594 75,500
Tax effect of non-deductible expenses -171 -154
Tax effect of non-taxable income - -
Tax effect of deductible expenses recognised directly in equity 5,469 -
Tax losses for which no deferred tax asset has been recognised -81,892 -75,346
Reported tax for the year 0 0
2022 2021
Tax losses
Unused tax losses for which no deferred tax asset has been recognised
1,353,719 982,734
Potential tax benefit, 20,6% 278,866 202,443
There is no expiration date which limits the use of the tax losses. It is, however, uncertain at what point in time it will be possible
to use these tax losses to offset taxable profits. The deferred tax asset arising from the tax loss has therefore not been assigned
any value.
2022 2021
Interest expense and similar charges
Other interest expense -4 -3
Total -4 -3
FINANCIAL STATEMENTS
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CANTARGIA AB (PUBL) 556791-6019
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NOTE 12
Net foreign exchange difference
Foreign exchange differences have been recognised in the statement of comprehensive income as follows:
2022 2021
Other operating expenses (Note 9) -1,899 -2,249
Interest expense and similar charges (Note 10) 9,352 2,839
Total 7,453 590
NOTE 14
Short-term investments
31 Dec 2022 31 Dec 2021
Fixed-rate account, Sparbanken Skåne - 75,000
Liquidity funds, Sparbanken Skåne 237,095 237,064
Total 237,095 312,064
Fixed-rate account, Sparbanken Skåne, 31 Dec 2021, 75 MSEK fixed 12 months, 0.30% interest.
Liquidity funds, Sparbanken Skåne, low risk category 2.
NOTE 15
Cash and cash equivalents
Cash and cash equivalents in the statement of cash flows include the following:
31 Dec 2022 31 Dec 2021
Available bank deposits
SEK 80,116 45,149
EUR 79,656 189,477
USD 29,122 11,254
GBP 445 571
CHF 34 458
NOK 200 413
Total 189,573 247,322
NOTE 13
Long-term liabilities
31 Dec 2022 31 Dec 2021
Provision for social security contributions, incentive program 24 892
Total 24 892
FINANCIAL STATEMENTS
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Remuneration of senior executives 2022 2021
Salaries and other short-term benefits *) 16,846 18,180
Post-employment benefits 3,375 3,774
Other long-term benefits - -
Termination benefits - -
Total 20,222 21,954
*) Whereof share-based incentives 2,575 (4,562)
NOTE 16
Share capital
Ordinary shares
Number of shares
(thousands) Share capital
1 January 2021 100,193 8,015
Issue of new shares - -
31 December 2021 100,193 8,015
1 January 2022 100,193 8,015
Issue of new shares 66,795 5,344
31 December 2022 166,988 13,359
At 31 December 2022, the share capital consisted of 166,987,895 shares with a quotient value of SEK 0.08 per
share. Each share carries one vote. At 31 December 2021, the share capital consisted of 100,192,737 shares with
a quotient value of SEK 0.08 per share. Each share carries one vote. All shares issued by the parent company are
fully paid up.
NOTE 17
Accrued expenses and deferred income
31 Dec 2022 31 Dec 2021
Accrued salaries and social security contributions 2,011 1,926
Project expenses 38,204 23,358
Other accrued expenses 5,598 5,135
Total 45,813 30,420
NOTE 18
Remuneration to senior executives and other related party disclosure
Guidelines for executive remuneration
Fees are paid to the Chairman and members of the Board of Directors in accordance with the resolution of the Annual General
Meeting. A separate fee is paid for committee work. In essence, the guidelines for remuneration and other terms of employment
for management, which are adopted by the shareholders’ meeting, stipulate that the company shall offer its senior executives a
normal market remuneration, that resolutions on remuneration shall be prepared by a special Remuneration Committee of the
Board and that the applicable criteria shall comprise the senior executive’s responsibilities, role, expertise and position. Deci-
sions on remuneration of senior executives are made by the Board excluding any Directors who are in a dependent position in
relation to the company and management. The guidelines must be applied to new contracts, or to changes to existing contracts
that are entered into with senior executives after the adoption of the guidelines and until new or revised guidelines are adopted.
Complete guidelines for 2022 and the ones proposed for 2023 are described in the Director’s report.
FINANCIAL STATEMENTS
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Salaries and remuneration for the year
Salaries, remuneration, social security contributions and retirement benefit costs have been paid in the following amounts. Please note
that under the heading ”Variable remuneration” are in addition to variable remuneration, incentive programs decided by the Annual
General Meeting also included (see Note 19). The outcome for AGM-decided incentive programs regarding the CEO and senior execu-
tives for the year 2022 amounted to SEK 762 (925) thousand.
2022 Fee Basic salary
Variable
remuneration
Retirement
benefit cost
Other
benefits
Share-based
incentives
Social sec
contribu-
tions*) Total
Magnus Persson, Chairman 620 - - - - - 195 815
Thoas Fioretos, Director 270 - - - - - 85 355
Karin Leandersson, Director 290 - - - - - 91 381
Patricia Delaite, Director 340 - - - - - 47 387
Anders Martin-Löf, Director 345 - - - - - 108 453
Flavia Borellini, Director 520 - - - - - - 520
Damian Marron, Director 330 - - - - - - 330
Magnus Nilsson, Director 330 - - - - - - 330
Göran Forsberg, CEO - 2,285 645 932 23 1,008 175 5,069
Total, Board and CEO 3,045 2,285 645 932 23 1,008 702 8,640
Other senior executives
(7 persons) **)
- 10,037 1,305 2,444 122 1,566 908 16,382
Total 3,045 12,321 1,950 3,375 145 2,575 1,610 25,022
*) Social security contributions for the CEO and other senior executives has been affected positivly in 2022 as the reserve for social
secutiry contribution related to the employee option program has decreased under 2022, due to a falling share price. The positive
effect amounts to SEK 171 thousand for the CEO and SEK 468 thousand for other senior executives.
**) Contains invoiced compensation for a senior executive.
FINANCIAL STATEMENTS
2021 Fee Basic salary
Variable
remuneration
Retirement
benefit cost
Other
benefits
Share-based
incentives
Social sec
contribu-
tions *) Total
Magnus Persson, Chairman 620 - - - - - 195 815
Thoas Fioretos, Director 270 - - - - - 85 355
Karin Leandersson, Director 290 - - - - - 91 381
Patricia Delaite, Director 340 - - - - - 47 387
Anders Martin-Löf, Director 345 - - - - - 108 453
Flavia Borellini, Director 520 - - - - - - 520
Damian Marron, Director 330 - - - - - - 330
Magnus Nilsson, Director 330 - - - - - - 330
Göran Forsberg, CEO - 2,236 737 927 38 1,219 -102 5,056
Total, Board and CEO 3,045 2,236 737 927 38 1,219 424 8,627
Other senior executives (8 persons) - 8,946 1,699 2,846 81 3,343 373 17,288
Total 3,045 11,182 2,436 3,774 119 4,562 797 25,915
*) Social security contributions for the CEO and other senior executives has been affected positivly in 2021 as the reserve for social
secutiry contribution related to the employee option program has decreasd under 2021, due to a falling share price. The positive effect
amounts to SEK 453 thousand for the CEO and SEK 1,228 thousand for other senior executives.
58
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Pensions
The retirement age for the CEO is 65 years.
The pension contribution for the CEO is 35 per cent of the pensionable salary. Pensionable salary refers to the fixed monthly
salary multiplied by 12.2.
For other employed senior executives, the retirement age is currently 65 years, in accordance with the applicable ITP Agreement.
The pension contribution is calculated in accordance with Section 2 of the ITP Agreement and its contribution tariffs, which are
determined by Alecta.
Term of notice and severance pay
The term of notice in case of termination by Cantargia shall be no more than six months for the Chief Executive Officer and no
more than six months for other senior executives. The term of notice in case of termination by the employee shall be at least six
months for the CEO and at least three months for other senior executives. In addition to the term of notice, severance pay may
be paid to the CEO up to a maximum of twelve months’ salary and employment benefits.
Directors’ fees
The Directors’ fees approved at the Annual General Meeting on 23 May 2022 are SEK 550,000 to the Chairman of the Board
and SEK 250,000 to each of the other Directors. For the Remuneration Committee, a fee of SEK 40,000 is paid to the commit-
tee chairman and SEK 20,000 to each of the other members, for the Audit Committee SEK 95,000 is paid to the committee
chairman and SEK 40,000 to each of the other members and for the Drug Development Committee SEK 230,000 is paid to the
committee chairman and SEK 50,000 to each of the other members. It was also resolved that, for each physical Board meeting
(up to a maximum of six meetings) that is held in Sweden and attended by the Director, a meeting fee of SEK 20,000 be paid to
each Director living outside the Nordic region. The full amount of Directors’ fees has been charged to earnings in 2022.
Related party disclosures
Related parties comprise senior executives of the company, i.e. the Board of Directors and management team and their
family members.
Cantargia has entered a research agreement with Lund University, with Gunilla Westergren-Thorsson, Professor of Lung
Biology. Under the agreement, Gunilla Westergren-Thorsson, who is a related party of an insider at Cantargia, will con-
duct a project aimed at expanding knowledge about IL1RAP as part of her employment at Lund University. Under the
agreement, Cantargia has the right to use and, if applicable, take ownership of all research results from the projects free
of charge.
Cantargia is co-financing a postdoctoral position as part of Lund University’s CANFASTER programme where Professor Karin
Leandersson is Head of Research. Under the agreement, Karin Leandersson is conducting research aimed at expanding the
knowledge about IL1RAP’s function in tumors. Cantargia owns the right to research results and IP arising from the project.
Karin Leandersson is a member of Cantargia’s Board of Directors and is also an insider at Cantargia. The CANFASTER pro-
gramme centres on collaborations between industry and universities and is funded in equal parts by both parties.
The company considers that the above agreements have been concluded on market terms.
NOTE 19
Share-based incentive programs
Cantargia’s incentive program aims to create a long-term commitment to the company, create opportunities to attract and
retain expertise and deliver long-term shareholder value.
FINANCIAL STATEMENTS
Sale of services 2022 2021
Lunds Universitet (Gunilla Westergren-Thorsson) 650 650
Lunds Universitet (Karin Leandersson) 651 0
Total 1,301 650
The following transactions have been made with related parties:
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ANNUAL REPORT 2022
Summary of total cost for incentive programs
2022 2021
Share-based remuneration -4,819 -7,314
Provision for social security contributions, incentive programs 868 2,219
Total -3,951 -5,095
Summary of provisions for social security contributions for share-based remuneration *)
Long-term liabilities 2022 2021
Amount at the start of the year 892 3,110
Provisions for the year -868 -2,219
Total long-term liabilities 24 892
*) All provisions have a term of more than 1 year, which is why all provisions are long-term.
Incentive scheme
At the Annual General Meeting of the Company on May 23, 2022, the shareholders decided to introduce a variable sha-
re-based incentive scheme for 2022 to senior executives and key employees of the Company. The scheme is based on
the incentive scheme adopted at the 2019 Annual General Meeting which has been designed to promote investment
in and ownership of the Company’s shares. The scheme is designed as a variable long-term remuneration scheme un-
der which participants commit to use distributed variable cash remuneration to acquire shares of the Company. The sche-
me is based on that or those annual bonus targets which are defined by the board for the Company and which refer to the
Company’s activities, financial key performance indicators and internal processes. Target achievement will be assessed by
the Company’s board of directors in connection with the adoption of the annual report for each year. When the target ac-
hievement has been determined by the Company’s board of directors, the amount due to each participant in the scheme is
distributed, whereupon acquisition of shares by the participants should be made as soon as possible. Participants are re-
quired to use their whole remuneration under the scheme, net of tax, to acquire shares of Cantargia on the stock market.
The maximum payout to each participant in the scheme for 2022 is capped at 10 per cent of his or her fixed annual salary. The
total size of the scheme for 2022 is capped at SEK 2,300,000 excluding social security contributions. In case of partial target
achievement, a portion of the maximum payout will be distributed. The outcome for incentive programs decided by the AGM
regarding the CEO and senior executives for the year 2022 amounted to SEK 762 (925) thousand and the total outcome for all
employees amounted to SEK 1,481 (1,462) thousand.
Employee Stock Option Scheme 2020/2023
At the Annual General Meeting on 27 May 2020, the shareholders approved the introduction of Employee Stock Option
Scheme 2020/2023. The options will be offered to employees of or consultants to the company and will be allocated to the
participants free of charge. The options have a three-year vesting period (1/3 per year) from the date of allocation, provided,
with the usual exceptions, that the participant remains an employee of or continues to provide services to Cantargia. Once
vested, the options can be exercised during a two-year period. Each vested option gives the holder the right to purchase 1.2
shares of the company at a pre-defined price. The price per share will be determined as 150 percent of the volume weighted
average price of the company’s shares traded on Nasdaq Stockholm during the ten trading days preceding the allocation
date. If fully exercised, the warrants would dilute the Company’s share capital and voting rights by approximately 1.2 per cent.
Employee Stock Option Scheme 2021/2024
At the Annual General Meeting on 26 May 2021, the shareholders approved the introduction of Employee Stock Option
Scheme 2021/2024. The options will be offered to employees of or consultants to the company and will be allocated to
the participants free of charge. The options have a three-year vesting period from the date of allocation, provided, with the
usual exceptions, that the participant remains an employee of or continues to provide services to Cantargia. Once vested, the
options can be exercised during a two-year period. Each vested option gives the holder the right to purchase 1.2 shares of
the company at a pre-defined price. The price per share will be determined as 150 percent of the volume weighted average
price of the company’s shares traded on Nasdaq Stockholm during the ten trading days preceding the allocation date. If fully
exercised, the warrants would dilute the Company’s share capital and voting rights by approximately 1.9 per cent.
FINANCIAL STATEMENTS
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Changes in existing incentive programs (number of options)
2022 2021
1 January 3,170,333 1,740,000
Granted instruments
Employee stock option program 2021/2024 260,000 1,334,000
Employee stock option program 2020/2023 - 147,000
Lapsed instruments
Employee stock option program 2021/2024 -251,000 -24,000
Employee stock option program 2020/2023 -110,000 -26,667
Total change -101,000 1,430,333
31 December 3,069,333 3,170,333
Number of shares granted instruments may entitle to**) 2022-12-31 2021-12-31
Employee stock option program 2021/2024 1,582,800 1,310,000
Employee stock option program 2020/2023 2,100,400 1,860,333
Number of shares granted instruments may entitle to 3,683,200 3,170,333
**) Recalculation of employee stock option programs after the rights issue in 2022 means that each option entitles to 1.2 shares.
In 2021, each option entitled to 1 share.
Calculation of fair value of employee option programs
The fair value on the allotment date was calculated using an adapted version of the Black & Scholes valuation model, which
takes into consideration the exercise price, the term of the options, share price on the allotment date and expected volatility in
the share price, and risk-free interest for the term of the options.
Employee
option
Allotment/
start date
Maturity
date
Fair value
upon issue
of the option
program,
SEK
Exercise
price,
SEK**) Volatility
Number of
options *) Vested
2020/2023:1 2020-06-09 2025-06-09 7.15 26.48 50% 1,583,333 96%
2020/2023:2 2020-07-10 2025-07-10 7.44 27.68 50% 60,000 94%
2020/2023:3 2021-02-04 2026-02-04 16.55 73.12 49% 80,333 88%
2020/2023:4 2021-02-24 2026-02-24 15.57 70.99 49% 26,667 96%
2021/2024:1 2021-09-17 2026-09-17 7.28 30.62 53% 1,029,000 43%
2021/2024:2 2021-11-10 2026-11-10 5.48 20.44 55% 70,000 38%
2021/2024:3 2022-02-09 2027-02-09 7.57 22.52 55% 70,000 30%
2021/2024:4 2022-08-29 2027-08-29 1.63 7.20 63% 150,000 11%
*) Refers to the number of outstanding options net after deduction of revoked options.
**) Recalculation of employee stock option programs after the rights issue in 2022 resulted in updated
exercise prices and that each option entitles to 1.2 shares.
FINANCIAL STATEMENTS
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NOTE 20
Earnings per share
Earnings per share are calculated by dividing the profit/loss for the year by a weighted average number of outstanding ordinary shares
during the period.
Cantargia has potential ordinary shares in the form of warrants. These do not have a dilutive effect for 2022 or 2021, as a conversion of
warrants into ordinary shares would result in a lower loss per share.
2022 2021
Profit/loss for the period attributable to parent company shareholders -371,814 -366,504
Total -371,814 -366,504
Weighted average number of outstanding ordinary shares (thousands) 128,024 100,193
Earnings per ordinary share, SEK -2.90 -3.66
NOTE 21
Appropriation of retained earnings
The Annual General Meeting is asked to decide on the appropriation of the fol-
lowing earnings (SEK).
Loss brought forward -875,045,855
Share premium account 1,623,184,970
Loss for the year -371,814,113
The Board of Directors proposes that the following sum be carried forward: 376,325,002
The Board of Directors proposes that no dividend be paid for the financial year 2022.
NOTE 22
Events after the end of the reporting period
•
In January, Cantargia successfully concluded a GLP toxicity study for the CAN10 antibody.
•
In January, the appointment of Patrik Renblad as new CFO was announced.
•
In February, Cantargia announced that the TRIFOUR trial would advance to the randomized stage following
promising early safety and efficacy of nadunolimab in triple-negative breast cancer. The first patient in the
randomized phase was treated in March.
•
In April, Cantargia presented new clinical data at AACR 2023 strongly supporting nadunolimab development in
pancreatic cancer. Cantargia also presented anti-metastatic effects of nadunolimab in cancer models.
•
In April, a phase I clinical trial application was submitted for CAN10.
•
In April, favorable safety was reported for a new nadunolimab combination therapy and enrollment of non-
small cell lung cancer patients in the CANFOUR trial was completed.
NOTE 23
Adjustments for non-cash items
2022 2021
Depreciation -3,692 -3,446
Employee option program -3,951 -5,095
Total -7,643 -8,541
FINANCIAL STATEMENTS
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NOTE 24
Costs by nature of expense
2022 2021
Project costs -306,691 -304,229
Other external expenses -25,951 -22,378
Personnel expenses -43,317 -37,966
Other operating expenses -1,899 -2,249
Depreciation -3,692 -3,446
Total -381,549 -370,267
As of the year-end report 2018, operating expenses are presented based on a classification into the functions “Research
and development costs, “Administrative expenses” and “Other operating expenses”. On a “by nature” basis, the sum of
expenses by function is distributed as follows.
NOTE 25
Agreements for cooperation
Patheon Biologics B.V. (part of ThermoFischer Scientific)
In May 2019, Cantargia signed an agreement with Patheon Biologics B.V. (”Patheon”) on future production of the antibody
CAN04 (nadunolimab). This agreement complements the earlier agreement with Celonic AG (previous Glycotope Biotech-
nology GmbH). This agreement secures Cantargia’s additional production capacity for future clinical trials. In preparation
for later phases of clinical development, an increase in production capacity is part of the development plan. Patheon has
manufacturing facilities in both Europe and the US, and during 2021 Patheon scaled up the process to 2,000 liters. Patheon
is under the agreement entitled to compensation for ongoing work, but no part of future sales revenue for nadunolimab.
Allucent (Formerly: Specialized Medical Services-oncology BV)
In May 2016, Cantargia entered into a framework agreement with Allucent on the execution of clinical studies as a so-
called CRO. The parties have subsequently agreed under the framework agreement that Allucent should act as CRO for the
company’s first clinical phase I/IIa trial with nadunolimab.
BioWa Inc.
Cantargia signed a licensing agreement with BioWa Inc. (”BioWa”) in 2015. Under the agreement, Cantargia is granted a non-
exclusive license to use the technology platform POTELLIGENT® for the manufacture of the drug candidate nadunolimab. For
the license, Cantargia pays an annual fixed fee and step-by-step sales-based royalties. In addition, BioWa also has the right
to so-called “milestone payments” when fulfilling certain clinical, regulatory, and commercial targets.
PanCAN
Cantargia has initiated a collaboration with Pancreatic Cancer Action Network (PanCAN) to include nadunolimab in combi-
nation with chemotherapy as first-line experimental therapy in metastatic pancreatic cancer (PDAC), in the clinical phase
II/III trial Precision Promise
SM
. The trial utilizes a Bayesian platform designed by PanCAN in collaboration with the US Food
and Drug Administration (FDA) to provide a basis for marketing approval of therapies in PDAC.
FINANCIAL STATEMENTS
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2022 2021
Ingoing accumulated acquisition value 7,070 7,070
Investments 7,072 -
Outgoing accumulated acquisition value 14,143 7,070
Ingoing accumulated depreciation -4,714 -2,357
Depreciation -2,553 -2,357
Outgoing accumulated depreciation -7,269 -4,714
Closing balance 6,874 2,356
Tangible assets
Machinery and other technical facilities
NOTE 26
2022 2021
Ingoing accumulated acquisition value 1,084 701
Investments 17 383
Outgoing accumulated acquisition value 1,101 1,084
Ingoing accumulated depreciation -342 -152
Depreciation -238 -190
Outgoing accumulated depreciation -580 -342
Closing balance 521 742
Fixtures, tools and installations
Patent
2022 2021
Ingoing accumulated acquisition value 8,111 8,111
Investments - -
Outgoing accumulated acquisition value 8,111 8,111
Ingoing accumulated depreciation -1,652 -751
Depreciation -901 -901
Outgoing accumulated depreciation -2,553 -1,652
Closing balance 5,558 6,459
Intangible assets
NOTE 27
FINANCIAL STATEMENTS
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Signatures
The annual accounts have been prepared in accordance with generally accepted accounting standards and
provide a true and fair view of the company’s financial position and results. The Directors’ Report for the
company gives a true and fair overview of the performance, financial position and earnings of the company,
and describes significant risks and uncertainties faced by the company. The income statement and balance
sheet will be presented for adoption at the Annual General Meeting on 23 May 2023.
We presented our auditor´s report on 27 April 2023.
Öhrlings PricewaterhouseCoopers AB
Mikael Nilsson
Authorised Public Accountant
Magnus Persson
Chairman
Karin LeanderssonMagnus Nilsson
Anders Martin-Löf
Thoas Fioretos Patricia Delaite
Lund, 27 April 2023
Damian Marron
Flavia Borellini
Göran Forsberg
Chief Executive Officer
FINANCIAL STATEMENTS
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Report on the annual accounts
Opinions
We have audited the annual accounts of Cantargia AB (publ)
for the year 2022. The annual accounts of the company are
included on pages 30-64 in this document.
In our opinion, the annual accounts have been prepared in
accordance with the Annual Accounts Act and present fairly,
in all material respects, the financial position of parent com-
pany and the group as of 31 December 2022 and their finan-
cial performance and cash flow for the year then ended in
accordance with the Annual Accounts Act. The statutory ad-
ministration report is consistent with the other parts of the
annual accounts.
We therefore recommend that the general meeting of share-
holders adopts the income statement and balance sheet for
the parent company and the group.
Basis for Opinions
We conducted our audit in accordance with International
Standards on Auditing (ISA) and generally accepted audit-
ing standards in Sweden. Our responsibilities under those
standards are further described in the Auditor’s Responsi-
bilities section. We are independent of the parent company
and the group in accordance with professional ethics for ac-
countants in Sweden and have otherwise fulfilled our ethi-
cal responsibilities in accordance with these requirements.
We believe that the audit evidence we have obtained is suf-
ficient and appropriate to provide a basis for our opinions.
Our audit approach
Audit scope
We designed our audit by determining materiality and as-
sessing the risks of material misstatement in the financial
statements. In particular, we considered where manage-
ment made subjective judgements; for example, in respect
of significant accounting estimates that involved making
assumptions and considering future events that are inhe-
rently uncertain. As in all of our audits, we also addres-
sed the risk of management override of internal controls,
including among other matters consideration of whether
there was evidence of bias that represented a risk of ma-
terial misstatement due to fraud.
We tailored the scope of our audit in order to perform
sufficient work to enable us to provide an opinion on the
financial statements as a whole, taking into account the
structure of the company, the accounting processes and
controls, and the industry in which the company operates.
Materiality
The scope of our audit was influenced by our application of
materiality. An audit is designed to obtain reasonable assu-
rance whether the financial statements are free from ma-
terial misstatement. Misstatements may arise due to fraud
or error. They are considered material if individually or in ag-
gregate, they could reasonably be expected to influence the
economic decisions of users taken on the basis of the finan-
cial statements.
Based on our professional judgement, we determined certain
quantitative thresholds for materiality, including the overall
To the general meeting of the shareholders of Cantargia AB (publ), corporate identity number 556791-6019
AUDITOR’S REPORT
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AUDITOR’S REPORT
group materiality for the financial statements as a whole as
set out in the table below. These, together with qualitative
considerations, helped us to determine the scope of our au-
dit and the nature, timing and extent of our audit procedures
and to evaluate the effect of misstatements, both individu-
ally and in aggregate on the financial statements as a whole.
Key audit matters
Key audit matters of the audit are those matters that, in our
professional judgment, were of most significance in our audit
of the annual accounts of the current period. These matters
were addressed in the context of our audit of, and in forming
our opinion thereon, the annual accounts as a whole, but we do
not provide a separate opinion on these matters.
Key audit matters How our audit addressed the Key audit matter
Research and development expenses- cut-off and completeness
The expenses for the company´s research and development
activities during the financial year 2022 totaled approxima-
tely SEK 365 million, which corresponds to approximately
96% of the company´s total. The expenses consist of mainly
personnel related expenses and external expenses for the
clinical work that is being conducted.
In our audit we have focused on these expenses since they
are material amounts and that there is a risk regarding the
completeness, the cut-off and the accuracy in the expenses.
Our audit of the expenses of research and development has
included, but is not limited to, the following measures:
•
Obtained an understanding of the company´s routi-
nes, business monitoring and internal control.
•
Testing of internal controls for approval of payment
of invoices and salaries.
•
Checked and performed detail testing against invoi-
ces and other supporting financial documentation.
•
Based on samples requested and received external
confirmations from suppliers of the year´s purcha-
ses and size of outgoing accounts payable as per 31
December 2022.
•
Performed detailed testing of salaries. Analyzed
costs based on our knowledge of the business and
follow up of the company´s internal reports.
Other Information than the annual accounts
This document also contains other information than the
annual accounts and is found on pages 1-29 and 69-81.
The other information also consists of the Remuneration
Report that we obtained prior to the date of this auditor’s
report. The Board of Directors and the Managing Director
are responsible for this other information.
Our opinion on the annual accounts does not cover this other
information and we do not express any form of assurance
conclusion regarding this other information.
In connection with our audit of the annual accounts, our re-
sponsibility is to read the information identified above and
consider whether the information is materially inconsistent
with the annual accounts. In this procedure we also take into
account our knowledge otherwise obtained in the audit and
assess whether the information otherwise appears to be
materially misstated.
If we, based on the work performed concerning this infor-
mation, conclude that there is a material misstatement of
this other information, we are required to report that fact.
We have nothing to report in this regard.
Responsibilities of the Board of Director’s and the
Managing Director
The Board of Directors and the Managing Director are re-
sponsible for the preparation of the annual accounts and that
they give a fair presentation in accordance with the Annual
Accounts Act. The Board of Directors and the Managing Di-
rector are also responsible for such internal control as they
determine is necessary to enable the preparation of annual
accounts that are free from material misstatement, whether
due to fraud or error.
In preparing the annual accounts, The Board of Directors and
the Managing Director are responsible for the assessment of
the company’s and the group’s ability to continue as a going
concern. They disclose, as applicable, matters related to go-
ing concern and using the going concern basis of accounting.
The going concern basis of accounting is however not applied
if the Board of Directors and the Managing Director intend to
liquidate the company, to cease operations, or has no realis-
tic alternative but to do so.
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Auditor’s responsibility
Our objectives are to obtain reasonable assurance about
whether the annual accounts as a whole are free from mate-
rial misstatement, whether due to fraud or error, and to issue
an auditor’s report that includes our opinions. Reasonable
assurance is a high level of assurance, but is not a guarantee
that an audit conducted in accordance with ISAs and gener-
ally accepted auditing standards in Sweden will always de-
tect a material misstatement when it exists. Misstatements
can arise from fraud or error and are considered material if,
individually or in the aggregate, they could reasonably be ex-
pected to influence the economic decisions of users taken on
the basis of these annual accounts.
A further description of our responsibility for the audit of the
annual accounts is available on Revisorsinspektionen’s web-
site: www.revisorsinspektionen.se/revisornsansvar. This de-
scription is part of the auditor´s report.
Report on other legal and regulatory re-
quirements
Opinions
In addition to our audit of the annual accounts, we have also
audited the administration of the Board of Director’s and the
Managing Director of Cantargia AB (publ) for the year 2022 and
the proposed appropriations of the company’s profit or loss.
We recommend to the general meeting of shareholders that
the profit be appropriated in accordance with the proposal in
the statutory administration report and that the members
of the Board of Director’s and the Managing Director be dis-
charged from liability for the financial year.
Basis for Opinions
We conducted the audit in accordance with generally accept-
ed auditing standards in Sweden. Our responsibilities under
those standards are further described in the Auditor’s Respon-
sibilities section. We are independent of the parent company
and the group in accordance with professional ethics for ac-
countants in Sweden and have otherwise fulfilled our ethical
responsibilities in accordance with these requirements.
We believe that the audit evidence we have obtained is suf-
ficient and appropriate to provide a basis for our opinions.
Responsibilities of the Board of Director’s and the
Managing Director
The Board of Directors is responsible for the proposal for ap-
propriations of the company’s profit or loss. At the proposal
of a dividend, this includes an assessment of whether the
dividend is justifiable considering the requirements which
the company’s and the group’s type of operations, size and
risks place on the size of the parent company’s and the group’
equity, liquidity and position in general.
The Board of Directors is responsible for the company’s orga-
nization and the administration of the company’s affairs. This
includes among other things continuous assessment of the
company’s and the group’s financial situation and ensuring
that the company´s organization is designed so that the ac-
counting, management of assets and the company’s finan-
cial affairs otherwise are controlled in a reassuring manner.
The Managing Director shall manage the ongoing adminis-
tration according to the Board of Directors’ guidelines and in-
structions and among other matters take measures that are
necessary to fulfill the company’s accounting in accordance
with law and handle the management of assets in a reas-
suring manner.
Auditor’s responsibility
Our objective concerning the audit of the administration, and
thereby our opinion about discharge from liability, is to obtain
audit evidence to assess with a reasonable degree of assur-
ance whether any member of the Board of Directors or the
Managing Director in any material respect:
•
has undertaken any action or been guilty of any omis-
sion which can give rise to liability to the company, or
•
in any other way has acted in contravention of the Com-
panies Act, the Annual Accounts Act or the Articles of
Association.
Our objective concerning the audit of the proposed appro-
priations of the company’s profit or loss, and thereby our
opinion about this, is to assess with reasonable degree of
assurance whether the proposal is in accordance with the
Companies Act.
Reasonable assurance is a high level of assurance, but is
not a guarantee that an audit conducted in accordance with
generally accepted auditing standards in Sweden will always
detect actions or omissions that can give rise to liability to
the company, or that the proposed appropriations of the
company’s profit or loss are not in accordance with the Com-
panies Act.
A further description of our responsibility for the audit of the
administration is available on Revisorsinspektionen’s web-
site: www.revisorsinspektionen.se/revisornsansvar. This de-
scription is part of the auditor’s report.
The auditor’s examination of the ESEF report
Opinion
In addition to our audit of the annual accounts, we have also
examined that the Board of Directors and the Managing Di-
rector have prepared the annual accounts in a format that
enables uniform electronic reporting (the Esef report) pursu-
ant to Chapter 16, Section 4 a of the Swedish Securities Mar-
ket Act (2007:528) for Cantargia AB (publ) for the financial
year 2022.
AUDITOR’S REPORT
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Our examination and our opinion relate only to the statutory
requirements.
In our opinion, the Esef report has been prepared in a format
that, in all material respects, enables uniform electronic re-
porting.
Basis for Opinion
We have performed the examination in accordance with
FAR’s recommendation RevR 18 Examination of the Esef
report. Our responsibility under this recommendation is
described in more detail in the Auditors’ responsibility sec-
tion. We are independent of Cantargia AB (publ) in accor-
dance with professional ethics for accountants in Sweden
and have otherwise fulfilled our ethical responsibilities in
accordance with these requirements.
We believe that the evidence we have obtained is sufficient
and appropriate to provide a basis for our opinion.
Responsibilities of the Board of Director’s and the
Managing Director
The Board of Directors and the Managing Director are re-
sponsible for the preparation of the Esef report in accordan-
ce with the Chapter 16, Section 4(a) of the Swedish Securi-
ties Market Act (2007:528), and for such internal control that
the Board of Directors and the Managing Director determine
is necessary to prepare the Esef report without material
misstatements, whether due to fraud or error.
Auditor’s responsibility
Our responsibility is to obtain reasonable assurance whether
the Esef report is in all material respects prepared in a format
that meets the requirements of Chapter 16, Section 4(a) of
the Swedish Securities Market Act (2007:528), based on the
procedures performed.
RevR 18 requires us to plan and execute procedures to ac-
hieve reasonable assurance that the Esef report is prepared
in a format that meets these requirements.
Reasonable assurance is a high level of assurance, but it is
not a guarantee that an engagement carried out according
to RevR 18 and generally accepted auditing standards in
Sweden will always detect a material misstatement when it
exists. Misstatements can arise from fraud or error and are
considered material if, individually or in aggregate, they could
reasonably be expected to influence the economic decisions
of users taken on the basis of the Esef report.
The audit firm applies ISQC 1 Quality Control for Firms that
Perform Audits and Reviews of Financial Statements, and
other Assurance and Related Services Engagements and ac-
cordingly maintains a comprehensive system of quality con-
trol, including documented policies and procedures regarding
compliance with professional ethical requirements, profes-
sional standards and legal and regulatory requirements.
The examination involves obtaining evidence, through vari-
ous procedures, that the Esef report has been prepared in
a format that enables uniform electronic reporting of the
annual accounts. The procedures selected depend on the
auditor’s judgment, including the assessment of the risks of
material misstatement in the report, whether due to fraud
or error. In carrying out this risk assessment, and in order to
design procedures that are appropriate in the circumstan-
ces, the auditor considers those elements of internal control
that are relevant to the preparation of the Esef report by the
Board of Directors and the Managing Director, but not for
the purpose of expressing an opinion on the effectiveness
of those internal controls. The examination also includes an
evaluation of the appropriateness and reasonableness of
assumptions made by the Board of Directors and the Ma-
naging Director.
The procedures mainly include a validation that the Esef re-
port has been prepared in a valid XHTML format and a recon-
ciliation of the Esef report with the audited annual accounts.
Öhrlings PricewaterhouseCoopers AB, 113 97 Stockholm,
was appointed auditor of Cantargia AB (publ) by the general
meeting of the shareholders on the 23 May 2022 and has
been the company’s auditor since the 13 January 2010.
Malmö, April 27 2023
Öhrlings PricewaterhouseCoopers AB
Mikael Nilsson
Authorized Public Accountant
AUDITOR’S REPORT
CORPORATE GOVERNANCE
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ANNUAL REPORT 2022
Corporate governance report
CANTARGIA AB (publ) (“Cantargia” or “the Company”) is a
Swedish public limited company listed on Nasdaq Stockholm.
Cantargia’s corporate governance is based on Swedish law,
Nasdaq Stockholm’s rules for issuers and internal rules and
regulations. The Company also applies the Swedish Corpo-
rate Governance Code (“the Code”). The Code is available at
www.bolagsstyrning.se.
APPLICATION OF THE CODE
The Code applies to all Swedish companies whose shares are
listed on a regulated market in Sweden. The Company is not
required to comply with all rules in the Code, as the Code it-
self allows for deviations from the rules, provided that any
such deviations, and the chosen solution, are described and
the reasons for the deviation are explained in the corporate
governance report (in accordance with the ‘comply or explain’
principle). The Company has currently not identified any de-
viations from the Code.
SHAREHOLDERS
Cantargia’s shares have been listed for trading on Nasdaq Stock-
holm since 25 September 2018 (Small Cap). At 31 December
2022, the total number of shares and voting rights in the Com-
pany was 166,987,895, represented by 12,654 shareholders.
For further information on the Company’s ownership structure
and major shareholders, see page 70-71 of the annual report.
SHAREHOLDERS’ MEETINGS
In accordance with the Swedish Companies Act, the share-
holders’ meeting is the Company’s highest decision-making
body. At a shareholders’ meeting, the shareholders exercise
their voting rights on key issues, such as the adoption of in-
come statements and balance sheets, the appropriation of
the Company’s earnings, release from liability for the mem-
bers of the Board and the Chief Executive Officer, the elec-
tion of Directors and auditors, and remuneration of Directors
and auditors’ fees. Under Cantargia’s Articles of Association,
notice of a shareholders’ meeting is given by advertisement
in Post- och Inrikes Tidningar and through publication of the
notice on the Company’s website. When notice is given, this
must be advertised simultaneously in Svenska Dagbladet.
Shareholders who wish to participate in the negotiations at
a shareholders’ meeting must be registered in the share reg-
ister maintained by Euroclear Sweden AB six business days
before the meeting and register to attend the sharehold-
ers’ meeting with the Company by the date indicated in the
notice of the meeting. Shareholders can attend the meeting
personally or by proxy and can be assisted by up to two per-
sons. A shareholder has the right to vote all shares held. Each
share in Cantargia entitles the holder to one vote. Sharehold-
ers who wish to request that a particular issue be addressed
at a shareholders’ meeting must submit a written request to
the Board of Directors.
NOMINATION COMMITTEE
Under a resolution of the Annual General Meeting of Cantargia
on 23 May 2022, the Chairman of the Board is required, prior
to the Annual General Meeting 2023, to convene a Nomina-
tion Committee consisting of one representative for each of
the three largest shareholders of the Company as well as the
Chairman of the Board. In accordance with these principles,
the following Directors have been appointed:
•
Jan Särlvik, appointed by Fjärde AP-fonden
•
Mikael Wiberg, appointed by Alecta Pensionsförsäkring
Ömsesidigt
•
Mats Larsson, appointed by Första AP-fonden
•
Magnus Persson, Chairman of the Board
The Nomination Committee has appointed Jan Särlvik as its
chairman.
The Nomination Committee is required to perform the duties
assigned to it under the Code and held 4 meetings prior to
the Annual General Meeting 2023. The Nomination Commit-
tee’s complete proposals for the 2023 AGM will be published
in connection with the notice of AGM.
CORPORATE GOVERNANCE
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ANNUAL REPORT 2022
Responsibilities and work of the Board
Under the Companies Act, the Board of Directors is responsi-
ble for the Company’s administration and organisation, which
means that it is responsible for adopting goals and strate-
gies, ensuring that procedures and systems for evaluating
adopted goals are put in place, monitoring the Company’s
results and financial position, and evaluating its operational
management. Under the Code, the Chairman of the Board
shall be elected by the AGM and hold a special responsibility
for leading the work of the Board and ensuring that the Board
operates in an organised and effective manner.
The Board of Directors operates in accordance with written
rules of procedure which are reviewed and adopted annually
at the inaugural Board meeting. The rules of procedure regu-
late Board practices, functions, and the division of responsi-
bilities between the Board and CEO, and between the Board
and its committees. In connection with the inaugural Board
meeting after each Annual General Meeting, the Board also
adopts the terms of reference for the Chief Executive Officer,
which include instructions for financial reporting. The Board
convenes in accordance with a schedule that is defined an-
nually. In addition to these Board meetings, further meetings
can be convened to address issues which cannot be deferred
to the next regular meeting.
In 2022, the Board convened on 15 occasions, including
through 14 Teams meetings or meetings by correspondence.
The Directors’ attendance is shown in the table above. The
activities of the Board in 2022 were dominated by discus-
sions and strategic decisions on matters relating to the
Company’s product development, in particular its main proj-
ect nadunolimab and the development projects CAN10 and
CANxx. The Board also adopted resolutions regarding the
rights issue that was completed in 2022, the business plan
with financial targets, risk management, dividend policy and
financial reports.
Independence of Attendance
Total Director´s
fee 2022, TSEK
Name Position
Member
since
The Company
and management
Major share-
holders
Board
meetings
Audit
Committee
meetings
Remu-
neration
Committee
meetings
Drug de-
velopment
Committee
meetings
Magnus Persson Chariman 2016 Yes Yes 15/15 - 2/2 3/3 620
Patricia Delaite Director 2017 Yes Yes 14/15 - 1/1 3/3 340
Thoas Fioretos Director 2010 Yes Yes 14/15 - 1/1 - 270
Karin Leandersson Director 2016 Yes Yes 14/15 5/5 - - 290
Anders Martin-Löf Director 2018 Yes Yes 15/15 5/5 - - 345
Flavia Borellini Director 2020 Yes Yes 12/15 - - 3/3 520
Damian Marron Director 2021 Yes Yes 13/15 - 1/1 - 330
Magnus Nilsson Director 2021 Yes Yes 12/15 5/5 - - 330
BOARD OF DIRECTORS
Under Cantargia’s Articles of Association, the Board of Di-
rectors shall, insofar as it is elected by the shareholders’
meeting, consist of not less than three and not more than
eight Directors, with no deputies. Currently, the Company’s
Board of Directors consists of eight ordinary Directors, in-
cluding the Chairman, who have been elected by the share-
CORPORATE GOVERNANCE
holders’ meeting until the period of the end of the 2023
AGM. The composition of Cantargia’s Board of Directors is
considered to meet the requirements of the Code in respect
of independence from the Company and from the Compa-
ny’s major shareholders. For a detailed presentation of the
Directors, see page 77 of the annual report.
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Board committees
The Board has established an Audit Committee, a Remuner-
ation Committee, and a Drug Development committee. The
members of the committees are appointed at the inaugural
Board meeting and the committees’ activities and author-
ity are regulated in the committees’ terms of reference. The
matters addressed at the meetings of the committees are
minuted and a report is presented at the following meeting
of the Board.
Audit Committee
The Company’s Audit Committee consists of three members:
Anders Martin-Löf (Chairman), Magnus Nilsson, and Karin
Leandersson. The Audit Committee shall, without prejudice
to other responsibilities and duties of the Board, monitor
the Company’s financial reporting, monitor the effectiveness
of the Company’s internal control, internal auditing and risk
management, keep itself informed on the audit of the an-
nual accounts and consolidated financial statements, and
on the conclusions presented in the quality control report
of the Swedish Inspectorate of Auditors, assess and moni-
tor the impartiality and independence of the auditor, paying
particular attention to whether the auditor provides other
services than auditing to the Company, and assist in drafting
proposed resolutions on the choice of auditors for adoption
by the shareholders’ meeting.
Remuneration Committee
The Company’s Remuneration Committee consists of three
members: Damian Marron (Chairman), Magnus Persson and
Thoas Fioretos. The Remuneration Committee is tasked with
preparing proposals for remuneration principles, and remu-
neration and other terms of employment for the CEO and
other senior executives.
Drug development Committee
The Board has established a Drug Development Committee
consisting of three members: Flavia Borellini (chairman),
Magnus Persson and Patricia Delaite. The Drug Develop-
ment Committee shall act as an advisor and discussion
partner for the company management in scientific and
strategic issues concerning the development of the com-
pany’s project portfolio.
Remuneration
Fees and other remuneration of Directors, including the
Chairman, are determined by the shareholders’ meeting. At
the Annual General Meeting on 23 May 2022, it was resolved
that Directors’ fees of SEK 550,000 to the Chairman of the
Board and SEK 250,000 to each of the other ordinary Direc-
tors be paid for the period until the end of the Annual General
Meeting 2023. It was also resolved that the Chairman of the
Audit Committee should receive SEK 95,000 and the other
members of the Audit Committee SEK 40,000 each, and
that the Chairman of the Remuneration Committee receive
SEK 40,000 and the other members of the Remuneration
Committee SEK 20,000 each and that the Chairman of the
Drug development Committee should receive SEK 230, 000
and the other members of the Drug development Commit-
tee SEK 50 000 each. It was further resolved that, for each
physical Board meeting (up to a maximum of six meetings)
that is held in Sweden and attended by the Director, a meet-
ing fee of SEK 20,000 be paid to each Director living outside
the Nordic region.
Evaluation
The Chairman of the Board ensures that an annual evalua-
tion of the work of the Board is carried out in which the Direc-
tors are given an opportunity to present their views on Board
practices, Board meeting materials, their own and other Di-
rectors’ contributions as well as the scope of the duties. The
results of the evaluation have been discussed by the Board
and presented by the Chairman of the Board to the Nomina-
tion Committee. It is considered that the combined expertise
of the Board is appropriate for the Company’s activities and
goals. The Board is considered to function very well, with all
members making constructive contributions to discussions
on strategy as well as the governance of the Company. The
dialogue between the Board and management is also con-
sidered to be good. The Board continually evaluates the work
of the Chief Executive Officer by monitoring the Company’s
progress towards the defined goals.
CHIEF EXECUTIVE OFFICER AND
MANAGEMENT
The Chief Executive Officer reports to the Board of Direc-
tors and is responsible for the Company’s day-to-day man-
agement and the operations of the group. The division of
responsibilities between the Board and CEO is defined in the
rules of procedure for the Board and the terms of reference
for the CEO. Under the instructions for financial reporting, the
CEO is responsible for financial reporting in the Company and
is therefore required to ensure that the Board receives suf-
ficient information to enable it continuously to evaluate the
Company’s financial position.
The CEO shall keep the Board continuously informed about
the development of the Company’s business, its sales perfor-
mance, earnings and financial position, its liquidity and credit
situation, significant business events and any other event, and
any other event, circumstance or relationship that may be of
material importance to the Company’s shareholders.
To assist him in his activities, the CEO has appointed a
management team. For a more detailed presentation of
the CEO and other members of the management team, see
page 79-80.
Remuneration
At the Annual General Meeting on 27 May 2020, it was re-
solved to adopt guidelines for remuneration of the CEO and
other senior executives in accordance with what is stated on
page 35 of the annual report.
For information on the remuneration paid to the CEO and
other senior executives in the financial year 2022, see Note
18 on page 56 of the annual report.
CORPORATE GOVERNANCE
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ANNUAL REPORT 2022
AUDITOR
The auditor is tasked with examining the Company’s annual
report and accounts as well as the Board of Directors’ and
CEO’s management of the Company. Under the Company’s
Articles of Association, the Company may have up to two au-
ditors with or without deputy auditors. The Company’s au-
ditors are Öhrlings PricewaterhouseCoopers AB with Mikael
Nilsson as auditor-in-charge.
For information on the remuneration paid to the auditor
in the financial year 2022, see Note 6 on page 52 of the
annual report.
AUTHORISATION TO ISSUE SHARES
At the Annual General Meeting of the Company on 23 May
2022, it was resolved to authorise the Board, during the pe-
riod until the next AGM, on or one or several occasions and
with or without pre-emption rights for existing shareholders,
to decide to issue new shares, provided that such issuance
not comprise more than ten per cent of the number of out-
standing shares of the Company on the day of the AGM. It
shall also be possible to stipulate that such new shares be
issued for non-cash consideration or paid for by means of
set-off or subject to other terms and conditions.
SHARE-BASED INCENTIVE SCHEMES
At the end of 2022, Cantargia had three incentive schemes
for senior executives and key personnel of the Company. The
incentive schemes have been introduced to provide longer-
term incentives for the Company’s management and em-
ployees and to promote investments in and ownership of the
Company’s shares.
Incentive scheme
At the Annual General Meeting of the Company on 23 May
2022, it was decided to introduce a variable share-based in-
centive scheme for 2022, aimed at senior executives and key
personnel of the Company, based on the incentive scheme
adopted at the 2020 AGM.
The scheme is designed to offer the participants variable
long-term remuneration in the form of a group bonus that
must be used to acquire shares of the Company. The scheme
is based on that or those annual bonus targets which are
defined by the Board for the Company, and which refer to
the Company’s activities, financial key performance indica-
tors and internal processes. Target achievement will be
assessed by the Company’s Board of Directors in connec-
tion with the adoption of the annual report for each year.
When the target achievement has been determined by the
Board of Directors, the amount due to each participant in
the scheme will be paid out, and the participant will then be
required to acquire shares as soon as possible. Participants
must use the full amount of remuneration received under
the scheme to acquire shares of the Company in the stock
market. It is the intention of the Board that the scheme be a
recurring annual scheme.
For further information about the scheme, see Note 19 on
page 58 of the annual report.
Employee Stock Option Scheme 2020/2023
At the Annual General Meeting on 27 May 2020, it was
resolved to introduce Employee Stock Option Scheme
2020/2023 for employees of the Company, comprising not
more than 1,900,000 employee stock options. The purpose
of the scheme is to enable the Company to retain skilled per-
sonnel through a long-term incentive scheme.
The employee stock options will be offered to employees
of or consultants to the Company and will be granted to the
participants free of charge. The employee stock options have
a three-year vesting period (1/3 per year) calculated from
the grant date, provided, with the usual exceptions, that the
participant is still employed by or otherwise engaged in the
Company and that the participant has not terminated his or
her employment or engagement in the Company as at the
vesting date. Once vested, the employee stock options can
be exercised over a two-year period.
Each vested employee stock option entitles the holder the
right to purchase one share of the Company at a predeter-
mined price. The price per share is determined as 150 per
cent of the weighted average price of the Company’s shares
traded on Nasdaq Stockholm during the ten trading days
preceding the grant date.
For further information about the scheme, see Note 19 on
page 58 of the annual report.
Employee Stock Option Scheme 2021/2024
At the Annual General Meeting on 26 May 2021, the share-
holders approved the introduction of Employee Stock Option
Scheme 2021/2024, compromising not more than 3,000,000
employee stock options. The purpose of the scheme is to en-
able the company to retain skilled personnel through a long-
term incentive scheme.
The options will be offered to employees of or consultants
to the company and will be allocated to the participants free
of charge. The options have a three-year vesting period from
the date of allocation, provided, with the usual exceptions,
that the participant remains an employee of or continues to
provide services to Cantargia. Once vested, the options can
be exercised during a two-year period.
Each vested option gives the holder the right to purchase
one share of the company at a pre-defined price. The price
per share will be determined as 150 percent of the volume
weighted average price of the company’s shares traded on
Nasdaq Stockholm during the ten trading days preceding the
allocation date.
For further information about the scheme, see Note 19 on
page 58 of the annual report.
CORPORATE GOVERNANCE
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Dilution
To enable the Company to deliver shares to participants
in Employee Stock Option Scheme 2020/2023 as well as
2021/2024 in a simple and cost-effective manner, the AGM
resolved to approve a directed issue of 4,900,000 warrants
to the Company (i.e. Cantargia AB (publ)).
If fully exercised, the warrants would dilute the Company’s
share capital and voting rights by approximately 3.1 per cent.
INTERNAL CONTROL IN RESPECT OF
FINANCIAL REPORTING
The Board of Directors is responsible for ensuring that
Cantargia has good internal control and adequate, for-
malised procedures for ensuring compliance with adopted
principles for financial reporting. The general purpose of the
internal control system is to obtain reasonable assurance
that the Company’s operational strategies and goals are
monitored and that the owners’ investments are protected.
The internal control system should also ensure with a rea-
sonable degree of certainty that the Company’s external
financial reports are reliable and correct and have been pre-
pared in accordance with generally accepted accounting poli-
cies, applicable laws, and regulations as well as other require-
ments applying to companies listed on Nasdaq Stockholm.
The Company monitors, follows and manages any risks in
accordance with a risk management and corporate gov-
ernance policy that is evaluated on an ongoing basis and
adopted annually by the Board of Directors. Cantargia has
decided to adopt the COSO
1
framework, which is the most
widely accepted internal control framework for financial re-
porting. The framework consists of five components: control
environment, risk assessment, control activities, information
and communication, and monitoring.
Control environment and risk assessment
The Board of Directors has adopted several policies, govern-
ing documents, and instructions with the aim of creating
and maintaining a functioning control environment. This is
achieved mainly through the rules of procedure for the Board
of Directors, the terms of reference for the Chief Executive
Officer, the rules of procedure for the Audit Committee, the
instructions for financial reporting, the Company’s account-
ing manual and the authorisation manual. The Company’s
policies and governing documents are evaluated on an on-
going basis and adopted annually by the Board of Directors.
The Board has also established an Audit Committee, which,
among other duties, is tasked with monitoring the Compa-
ny’s financial position and the effectiveness of the internal
control as well as internal auditing and risk management.
Responsibility for the day-to-day internal control activities
in respect of financial reporting has been delegated to the
Company’s Chief Executive Officer.
Cantargia’s Board of Directors is also required to carry out an
annual risk assessment in respect of strategic, operational,
legal, and financial risks to identify potential issues and as-
sess the Company’s risk exposure. The Audit Committee is
responsible for evaluating the Company’s risk situation on an
ongoing basis and shall assist the Board by submitting pro-
posals for the management of the Company’s financial risk
exposure and risk management.
Information and communication, and control activities
The Company’s information and communication paths are
aimed at ensuring the accuracy of financial reporting and
enabling reporting and feedback from the business to the
Board and management, for example be ensuring that gov-
erning documents in the form of internal policies, guide-
lines and instructions for financial reporting are made avail-
able to and are known by the employees concerned. With
regard to external communications, guidelines have been
prepared to ensure that the Company meets the relevant
disclosure requirements. The CEO is responsible for exter-
nal communications.
The Board is responsible for control and monitoring of the
CEO’s risk management activities. This is done through re-
views and monitoring of the Company’s governing docu-
ments related to risk management and, for example,
through reviews and assessments by the Board of adopt-
ed decisions. The effectiveness of the control activities is
evaluated annually, and the results of these evaluations are
reported to the Board and Audit Committee.
Monitoring
The CEO ensures that the Board receives regular reports on
the results of the risk assessment, identified financial risks
and processes, and the development of the Company’s
business. The Board also follows up the assessment of the
internal control system, partly through contacts with the
Company’s auditor.
1
Committee of Sponsoring Organizations of the Threadway Commission.
CORPORATE GOVERNANCE
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Auditor’s report on the Corporate
Governance Statement
To the general meeting of the shareholders in Cantargia AB (publ), corporate identity number 556791-6019
Engagement and responsibility
It is the board of directors who is responsible for the corporate governance statement for the year 2022 (the financial year)
on pages 69-74 and that it has been prepared in accordance with the Annual Accounts Act.
The scope of the audit
Our examination has been conducted in accordance with FAR’s auditing standard RevR 16 The auditor’s examination of
the corporate governance statement. This means that our examination of the corporate governance statement is dif-
ferent and substantially less in scope than an audit conducted in accordance with International Standards on Auditing
and generally accepted auditing standards in Sweden. We believe that the examination has provided us with sufficient
basis for our opinions.
Opinions
A corporate governance statement has been prepared. Disclosures in accordance with chapter 6 section 6 the second para-
graph points 2-6 the Annual Accounts Act and chapter 7 section 31 the second paragraph the same law are consistent with
the annual accounts and the consolidated accounts and are in accordance with the Annual Accounts Act.
Malmö 27 april 2023
Öhrlings PricewaterhouseCoopers AB
Mikael Nilsson
Authorized Public Accountant
CORPORATE GOVERNANCE
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Board of Directors, senior
executives, and auditors
Magnus Persson
Chairman of the Board since 2016, born 1960. Member of the Remu-
neration Committee and the Drug Development Committee.
Number of shares: 190,154
Magnus Persson is MD and associate professor in physiology at the Karolinska
Institute in Stockholm. Persson has extensive experience of financing within the
fields of medicine, life sciences and biotech. Persson has previously led develop-
ment teams in clinical phase II and phase III programmes in the pharmaceutical in-
dustry and has founded and led private as well as public biotech and medtech com-
panies, either as Chairman or Member of the Board, in Europe and the US. Persson
has also been involved in multiple IPOs.
Persson is Chairman of the Board of Attgeno AB, Initiator Pharma AS, Eir Ventures
Partners AB and associated companies and Board Member of Avalo Inc.
Independent in relation to the Company and its management and the Company’s
major shareholders.
Karin Leandersson
Board member since 2016, born 1972. Member of the Audit Committee.
Number of shares: 2,500
Karin Leandersson is professor in Tumour Immunology at the Medical Faculty of
Lund University. Leandersson has gained a wide range of cancer research ex-
perience in the fields of tumour immunology and tumour inflammation in solid
tumours, mainly in breast cancer. Leandersson has also authored around 50
scientific publications in international journals.
Independent in relation to the Company and its management and the Company’s
major shareholders.
Thoas Fioretos
Board member since 2010, born 1962. Member of the Remuneration
Committee. Number of shares: 575,600
Thoas Fioretos is professor and physician at the Department of Clinical Genetics at
Lund University. Fioretos research focuses on molecular and functional studies of
genetic changes in leukaemia and how such changes can be used for diagnostic and
therapeutic purposes. Fioretos has authored over 140 scientific publications and is
one of the founders of Cantargia AB and the bio-IT company Qlucore AB. Fioretos is
Board Member in Qlucore AB and alternate Board Member in Neodos AB.
Independent in relation to the Company and its management and the Company’s
major shareholders.
CORPORATE GOVERNANCE
BOARD OF DIRECTORS
Under Cantargia’s Articles of Association, the Board of Directors shall consist of at least three and no
more than eight Directors. At the Annual General Meeting on 23 May, 2022, it was resolved that the
Board should consist of eight ordinary Directors with no deputies. The board members are elected for
the period until the end of the 2022 Annual General Meeting.
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CANTARGIA AB (PUBL) 556791-6019
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ANNUAL REPORT 2022
Patricia Delaite
Board member since 2017, born 1963. Member of the Drug Development
Committee. Number of shares: 0
Patricia Delaite holds an MD/MBA from University of Geneva and Lausanne.
Delaite has had leading positions at Nouscom, AMAL Therapeutics, Incytes In-
ternational Biosciences, ARIAD Pharmaceuticals, Novartis, and Eli Lilly. Delaite
also has 10 years of experience in clinical management from the University
Hospital in Geneva.
Independent in relation to the Company and its management and the Company’s
major shareholders.
Flavia Borellini
Board Member since 2020, born 1959. Member of the Drug Development
Committee. Number of shares: 0
Flavia Borellini holds a PhD in Pharmaceutical Chemistry and Technology from
the University of Modena in Italy. Borellini has broad experience in oncology and
other therapeutic areas and has held senior positions at Astra Zeneca (Global
Franchise Head, Hematology and Vice President, Global Product and Portfolio
Strategy), Acerta Pharma (CEO), ONYX Pharmaceuticals (Vice President, Pro-
gram Leadership), and Roche/Genetech (Lifecycle Leader). Borellini serves as a
Member of the Board of Directors of Kartos Therapeutics, Revolution Medicines
and Viracta.
Independent in relation to the Company and its management and the Company’s
major shareholders.
Anders Martin-Löf
Board member since 2018, born 1971. Chairman of the Audit Committee.
Number of shares: 50,000
Anders Martin-Löf is the incoming CFO of BioArctic AB and Board Member of
Affibody Medical AB. He has extensive experience as CFO for companies listed
on the Stockholm stock exchange and has served as CFO for A3P Biomedical
AB, Oncopeptides AB, Wilson Therapeutics AB and RaySearch Laboratories AB.
Martin-Löf has also held the position of Head of Investor Relations and different
positions within business development at Swedish Orphan Biovitrum. Martin-Löf
holds an MSc in Engineering Physics from the Royal Institute of Technology and a
BSc in Business Administration and Economics from Stockholm University.
Independent in relation to the Company and its management and the Company’s
major shareholders.
Magnus Nilsson
Board member since 2021, born 1956. Member of the Audit Committee.
Number of shares: 100,000
Magnus Nilsson is founder, previously President and CEO, and since 2020 Se-
nior Advisor at XVIVO Perfusion. Nilsson has also been President and CEO of
Vitrolife and held prior to that various positions as Project Manager for drug
development projects at Pharmacia & Upjohn, Pharmacia, and Karo Bio. Nilsson
serves as a Member of the Board of Directors of Corline Biomedical. Nilsson is
Doctor of Medicine (Med Dr Sc) from Uppsala University and has published over
twenty scientific articles.
Independent in relation to the Company and its management and the Company’s
major shareholders.
CORPORATE GOVERNANCE
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Damian Marron
Board member since 2021, born 1962. Chairman of the Remuneration
Committee. Number of shares: 0
Damian Marron has extensive experience as a Board Member and CEO within
the life science industry, with a successful track record of leadership and value
creation in public and private biotechnology companies. Marron has held posi-
tions as CEO and Executive Vice President in several biotech companies. He is
currently Chairman of the Board of Targovax ASA, Imophoron Ltd, CytoseeK Ltd
and Board Member of Resolys Bio, and Head of Biopharma at Treehill Partners.
Marron holds a BSc degree in Pharmacology from the University of Liverpool.
Independent in relation to the Company and its management and the Company’s
major shareholders.
MANAGEMENT
Lars Thorsson
VP Clinical Development employed since 2015, born 1961. Holdings:
131,036 shares and 205,000 options
Lars Thorsson graduated with a PhD in clinical pharmacology in 1998 and has
extensive experience from the pharmaceutical industry, including leading roles in
clinical studies and project management in a large number of development phases
at AstraZeneca and Novo Nordisk A/S. Thorsson has been responsible for evalua-
tion and documentation of new substances and has the experience of regulatory
activities and interactions with health authorities.
Liselotte Larsson
COO employed since 2014, born 1963. Holdings: 58,166 shares and
205,000 options
Liselotte Larsson has a PhD in biotechnology and has over 25 years of experience
in various management positions in pharmaceutical and biotechnology com-
panies including BioGaia Fermentation, Novozymes Biopharma and Camurus.
Larsson’s main fields of expertise are business development, marketing &
sales/out licensing, ISO certification, good manufacturing practice (GMP) and
overall project management.
Göran Forsberg
CEO employed since 2014, born 1963. Holdings: 246,412 shares and
575,000 options
Göran Forsberg has a PhD in biochemistry and is associate professor and au-
thor of over 40 scientific publications. For over 30 years he has had leading
positions in research and development, business development and investor
relations at pharmaceutical and biotechnology companies, including KabiGen,
Pharmacia, Active Biotech and the University of Adelaide, Australia. Forsberg
has extensive experience in leading drug development and clinical trials, with a
special focus on oncology. Forsberg is a board member of Guard Therapeutics
International AB (publ).
CORPORATE GOVERNANCE
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David Liberg
VP Research employed since 2015, born 1969. Holdings: 15,044
shares and 205,000 options
David Liberg graduated with a PhD in 2001 and has over twenty years of re-
search experience within immunology and tumor biology. Liberg has worked
within the pharmaceutical industry for the last fifteen years, with responsi-
bility for early research projects and activities in tumor immunology. He has
extensive experience of pre-clinical phase cancer projects. His most recent
position was at Active Biotech AB, where he worked as Project Manager Drug
Development as well as Head of Cell Biology and Biochemistry. Liberg has
also carried out research at Imperial College in the UK and at Lund University.
Bengt Jöndell
CFO employed since 2017, born 1960. Holdings: 196,499 shares and
205,000 options
Bengt Jöndell has a BSc in Business Administration and a MSc in Chemical
Engineering. Jöndell has extensive experience in various executive financial
functions such as CFO and Administrative Manager at BTJ Group AB, Senior
Financial Advisor for BoneSupport, CFO/Administrative Manager at Inpac,
Business Controller at Pharmacia & Upjohn Consumer Healthcare, Pharmacia,
Pharmacia Consumer Pharma and Pharmacia Nicorette. Jöndell’s most recent
position was CFO for Enzymatica AB.
Nedjad Losic
VP Biometrics employed since 2021, born 1969. Holdings: 17,250
shares and 100,000 options
Nedjad Losic holds an MSc in Mathematics and a diploma in Management of Medi-
cal Product Innovation (SIMI). Losic has over 25 years of experience in providing
biostatistics expertise in clinical drug development, mostly in antibody develop-
ment and oncology. Losic has been directly involved in the planning and obtaining
market approvals for several biological drugs at Genmab and Y-mAbs Therapeu-
tics. He has previously held managerial positions and worked for Ferring, Spadille,
Genmab and Y-mAbs.
Domenique Thersago
CFO employed since 2022, born 1962. Holdings: 0 shares and
150,000 options
Dominique Tersago is MD and has over 25 years of experience in the bio-
tech/pharmaceutical industry in early and late-stage clinical development,
regulatory strategy and interactions. In biotech as of 2011, Tersago in the
position of Chief Medical Officer has led the clinical development of various
biologics and supported the transition and growth of the companies Ablynx,
Bioncotech (now Highlight Therapeutics) and Exevir. Her experience covers
the therapeutic areas of immune oncology, virology, auto-immune disease,
and hematology. Pharmaceutical industry positions were with Bristol-Myers
Squibb and Janssen Pharmaceutical.
CORPORATE GOVERNANCE
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Other disclosures on Directors and senior executives
There are no family connections among any Directors or
senior executives. There are no conflicts of interest or po-
tential conflicts of interest between the Directors’ and senior
executives’ undertakings to the Company and their private
interests and/or other undertakings. As shown above, some
Directors and senior executives have financial interests
in the Company in the form of shareholdings. None of the
Directors or senior executives has in the last five years par-
ticipated or been involved in any bankruptcy, liquidation or
administration proceedings in the capacity of Director or se-
nior executive of a company. None of the Directors or senior
executives has in the last five years been accused of and/or
been subject to any sanction from a public authority, profes-
sional association or similar body, been disqualified from en-
gaging in business activities or otherwise been disqualified
by a court from acting as a member of the administrative,
management or supervisory bodies of or from acting in the
management or conduct of the affairs any company. There
exist no special agreements on post-employment benefits
for the current Directors or senior executives. All Directors
and senior executives can be contacted at the Company’s
address: Scheelevägen 27, SE-223 63 Lund, Sweden.
Auditors
At the Annual General Meeting on 23 May 2022,
Öhrlings PricewaterhouseCoopers AB were re-ap-
pointed as auditors for the Company for the period
until the end of the Annual General Meeting 2023. Mi-
kael Nilsson (born 1981) is auditor-in-charge. He is an
Authorised Public Accountant and a member of FAR,
the professional institute for accountants in Sweden.
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ANNUAL GENERAL MEETING AND FINANCIAL CALENDAR
Cantargia’s Annual General Meeting will be held on Tuesday 23 May 2023. Shareholders who wish to
participate in the Annual General Meeting must be registered in the share register maintained by
Euroclear Sweden AB as of Friday 12 May 2023 and register with the company no later than Tues-
day 16 May 2023, in writing to Cantargia AB, Scheelevägen 27, SE-223 63 Lund. Shareholders
can also register by telephone on +46 (0)46-27 56 260 or by e-mail at [email protected].
Shareholders whose shareholding is registered with a nominee must, to be entitled to participate
in the AGM, ensure that their shareholding is temporarily re-registered in their own name with
Euroclear Sweden AB so that the shareholder is registered in the share register as of 12 May
2023. Such registration may be temporary (registration of voting rights) and must be requested
from the nominee in accordance with the nominee’s procedures by the deadline specified by the
nominee. Voting rights registered no later than the second business day after 12 May 2023 will
be entered in the share register.
23 May 2023 Interim report January – March 2023
23 May 2023 Annual General Meeting
22 Aug 2023 Half-year report April – June 2023
10 Nov 2023 Interim report July – September 2023
22 Feb 2024 Year-end report for 2024
CORPORATE GOVERNANCE
www.cantargia.com