Annual Report
Cantargia AB (publ.) 556791-6019
CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
02
INTRODUCTION
3 Cantargia in brief
4 Vision, business model and strategy
5 2023 – A summary of the year and next steps
7 Chief executive’s review
BUSINESS DESCRIPTION
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 Clinical strategy
16 Cantargia’s clinical program
19 Systemic Sclerosis - Dr. Prof. Jörg Distler
21 Drug development – From discovery to launch
23 Patent protection
24 Sustainability
MARKET OVERVIEW
28 Cantargia’s market focus
28 Cancer – A global challange
30 The market for pancreatic cancer treatment
30 The market for lung cancer treatment
30 The market for breast cancer treatment
31 The market for treatment of myocarditis and systemic
sclerosis
DIRECTORS’ REPORT
33 Operations
33 Five-year summary
34 Significant events during the financial year
34 Significant events after the end of the financial year
35 Revenues
35 Operating expenses and operating profit or loss
35 Net financial income/expense
35 Earnings
35 Cash flow and investments
35 Financial position
35 Share-based incentive schemes
36 Risks and risk management
37 Employees
37 Research and development
37 Environmental impact
37 Guidelines for remuneration and other terms of employment
for senior executives 2023
39 Outlook for 2024
39 Appropriation of retained earnings
SHAREHOLDER INFORMATION
41 Shareholder information
FINANCIAL STATEMENTS
44 Statement of comprehensive income
45 Statement of financial position
46 Statement of changes equity
47 Statement of cash flows
48 Notes
64 Signatures
AUDITOR’S REPORT
66 Report on the annual accounts
68 Report on other legal and regulatory requirements
CORPORATE GOVERNANCE
71 Corporate governance report
76 The auditor’s report on the corporate governance report
77 Board of directors, senior executives and auditors
82 Annual general meeting and financial calendar
Table of contents
7
Chief executive’s review
p.
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 provide strong
efficacy with fewer side effects
and can serve as a complement
to established treatment.
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Cantargia in brief
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.
Nadunolimab is primarily evaluated in combination with
chemotherapy as its mechanism of action enables synergy
with other cancer therapies. This is a consequence of IL1RAP
affecting various resistance mechanisms these therapies can
induce in tumors.
In addition to cancer, IL1RAP has a central role in autoimmune
and inflammatory diseases. In parallel with nadunolimab,
Cantargia is therefore developing another IL1RAP-binding
antibody, CAN10, with a focus on myocarditis and systemic
sclerosis. In 2023, the CAN10 project entered the clinical
development phase.
One target - Multiple potential treatments
I
L
1
R
A
P
Cancer
Autoimmune diseases
Inflammatory diseases
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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 collaborations. Cantargia has therefore signed agreements
with several different companies, 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
of CAN10.
Cantargia’s strategy is based on advancing the development
of each drug candidate in-house until the stage where a
development or commercialization agreement is reached.
”We contribute to the
development of safer and
more effective treatments for
life-threatening diseases”
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2023
– A summary of the year and the next steps
In 2023, additional strong efficacy data for nadunolimab were presented and the
CAN10 project entered clinical development phase.
Promising data in lung- and triple
negative breast cancer
The Phase II part of the TRIFOUR study was initiated during the
first quarter of 2023, and promising data from the initial Phase
Ib part were presented during the year. For the 15 patients
treated in Phase I, a response rate of 60% and a progression-
free survival over 6 months were noted. This is twice as high
as the expected response rate of approximately 30% and
approximately 2 months longer progression-free survivial than
historical controls. The Phase II study is progressing as planned,
and initial data are expected by the end of 2024.
Many patients with non-small cell lung cancer respond well
to treatment, and for two patients (5%), the treatment has
been so effective that the tumor has disappeared. Compared
to historical controls, this is very promising as fewer than
1% are expected to achieve a complete response with
currently available treatments. Cantargia’s focus within the
segmented market for lung cancer is to further analyze data
to understand which patient population could respond best
to treatment with nadunolimab. Cantargia currently does not
plan for further studies in-house in lung cancer.
Important milestones in the
CAN10 project
The GLP-regulated toxicity study was successfully concluded
in the first quarter, and regulatory approval to initiate the
study was obtained during the summer.
Treatment of healthy individuals in Phase I began during the
fall. The primary objective of Phase I is to document safety
and pharmacokinetics, but effects on biomarkers will also
be measured. In early January 2024, the first clinical results
based on the first four dose cohorts were presented. Safety
was satisfactory, and furthermore, CAN10 was shown to
bind to its target, IL1RAP, on immune cells in the blood.
The binding frequency corresponded to the results from a
preclinical model, further strengthening the project.
In 2024, Phase I is planned to advance with the treatment
of patients with psoriasis, and in 2025, we plan to initiate
Phase II in one of our main indications (systemic sclerosis
and myocardial inflammation).
Clinical progress
in pancreatic cancer
During the year, new data were presented showing that
the strongest effect of treatment with nadunolimab was
obsereved in patients with high tumor levels of IL1RAP,
the target for nadunolimab. These patients experienced a
significantly prolonged overall survivial compared to those
with low IL1RAP levels (14.2 vs. 10.6 months, p=0.017).
Similar results were also presented for the 17 patients
treated with nadunolimab monotherapy. Overall, these
signals validate the clinical efficacy of nadunolimab.
During the year, a new development plan was presented
in pancreatic cancer (PDAC). A regulatory application for a
controlled phase 2b study in combination with gemcitabine
and nab-paclitaxel was submitted in the latter half of 2023,
and in early 2024, clinical trial approval was granted in
the US. The PANFOUR study is planned to include a total
of 150 patients, divided into two arms with two doses of
nadunolimab plus chemotherapy and a control arm with
chemotherapy alone.
05
Strong patent protection
In addition to showing efficacy signals in the treatment of several
cancer types, further analyses of the results have provided
support for the idea that the antibody could potentially reduce
neuropathy, a serious side effect of chemotherapy. In-deph ana-
lysis of Cantargia’s own clinical data and preclinical experiments
in animal models, including with chemotherapy agents used in
antibody drug conjugates (ADCs), documents the ability of nadu-
nolimab to reduce neurpoathy. These promising results, which
will be presented in more detail at scientific conferences during
2024, highlight the potential for future expansion of nadunolimab
development into combinations with ADCs, one of the hottest
areas in new cancer therapies.
Activity focus led to reduced costs
The safety in CAN10 Phase I study after
the first four cohorts was satisfactory,
and furthermore, it was demonstrated
that CAN10 binds to its target IL1RAP,
on immune cells in the blood.
CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
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Potential development towards
ADC combinations
Cantargia’s projects have very strong patent protection. In
addition to product specific patents, we also have several
patents that provide broader protection against competitive
IL1RAP reactive antibodies. During the year, an opposition
process was conducted against one of Cantargia’s patent
for nadunolimab (EP3293202), which covers IL1RAP-bin-
ding antibodies with specific functional properties. After the
European Patent Office (EPO) decided to uphold the patent,
a third party initially filed an appeal against the decision.
However, the appeal was later withdrawn.
The focusing of the clinical program for nadunolimab, as pre-
sented in 2022, resulted in significantly lower costs during
2023. Cantargia’s research and development expenses
decreased by 25% from 365 MSEK in 2022 to 273 MSEK in
2023. The total operating costs decreased by 92 MSEK to
290 MSEK. With a positive financial result of 10 MSEK, the
year ended with a loss of 280 MSEK.
In a very challenging financial market, a directed new
share issue of approximately 60 MSEK before deduction
of transaction expenses, was conducted during the fourth
quarter. This crucial financing enabled Cantargia to continue
its activities vigorously and remain funded into 2025. The
issuance was supported by both existing institutional major
shareholders and new institutional investors.
CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
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Chief executive’s review
Cantargia made significant progress during 2023, despite the macroeconomic
challenges in our global environment. Cantargia aims to be a world leader in the
development of drugs targeting IL1RAP and despite increasing competition, we
are leading the way. As we generate more results in both of our clinical projects,
we get a clearer picture of where the best opportunities lie. Through the progress
in the CAN10 project and with an external validation of its mechanism of action,
we have created another leg to stand on in addition to our project in oncology with
the antibody nadunolimab. The platform Cantargia builds its operations on offers
significant opportunities for further expansion and growth. This provides increased
opportunities and stability that reduces development risks and increases the
conditions for us to achieve partnerships and sales, followed by stable revenues.
In 2023, we presented a lot of new data with nadunolimab in oncology. For a long
time, we have seen pancreatic cancer as a major development opportunity based
on our biological knowledge of the disease, as well as the high unmet medical need
and relatively limited competition. During the year, we were able to present new
results that strengthen our view that nadunolimab may be an important future tool
for the treatment of pancreatic cancer. When we measured the amount of IL1RAP
(the target of nadunolimab) in the tumor of the patients treated, we observed
that the patients with the highest levels also had the best treatment outcome,
despite having a worse prognosis. Thus, the higher the levels of IL1RAP, the more
nadunolimab can attack the tumor and slow tumor growth. To increase the likelihood
of success, we are therefore building in the future possibility of focusing on these
patients by being able to analyze the expression of IL1RAP on the tumor.
In addition to pancreatic cancer, we have also seen clear signals of activity in the
treatment of patients with non-small cell lung cancer (NSCLC) and triple-negative
breast cancer (TNBC). In lung cancer, we presented new results at the annual ASCO
conference in Chicago. The results generated great interest, not least because we
were able to present that two patients got rid of their tumor (complete response),
when they received treatment containing nadunolimab. These patients had
previously been treated with immunotherapy but the tumor had progressed. Overall,
many of the patients in the study have done very well, but there is fierce competition
in lung cancer and therefore the plan is to use a biomarker strategy to identify the
”We have many milestones to look forward to in both our
clinical projects and it is with great pride that we have
advanced development in our aim to to offer patients with
severe diseases new effective and safe treatments.”
07
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patient group that responds best. The studies are ongoing and
we plan to communicate these results later this year.
We also presented the first results with nadunolimab in TNBC.
These are based on a small group of 15 patients and follow
what we have seen in the treatment of pancreatic cancer and
lung cancer. TNBC is the most difficult-to-treat form of breast
cancer and a success here would be of great medical value. It
is therefore very interesting that we are conducting our first
study with a control group that only receives chemotherapy in
TNBC within the TRIFOUR study.
In addition to solid tumors, nadunolimab also has great
potential for the treatment of various forms of leukemia. The
first results generated around IL1RAP as a target for cancer
treatment were produced in leukemia. It was therefore very
gratifying that a prestigious grant from the U.S. Department
of Defense was awarded to researchers at one of the world’s
leading cancer centers, MD Anderson Cancer Center in
Houston, to conduct the first study of nadunolimab in leukemia.
We are planning for the first patients to start treatment this
summer.
In 2023, the first clinical study with CAN10 started, which
means that we now have two projects in clinical development.
CAN10 is being developed for use in immunological and
inflammatory diseases. This is an area that has previously
been globally neglected, but which has come into focus for
many stakeholders over the past year, not least due to the
increasing understanding of how the immune system affects
these diseases, while the economic potential is significant. A
term that is used and that is very much applicable to CAN10
is ”pipeline in a drug”. This means that there is a very good
opportunity to further develop the use of the same drug for
more diseases after an initial success in one disease. Many
autoimmune and inflammatory diseases are influenced
by similar disease-driving mechanisms. CAN10 recently
gained extra traction when an antibody targeting IL-1 alfa
and IL-1βbeta, lutikizumab, showed promising efficacy in a
phase II study in the inflammatory skin disease hidradenitis
suppurativa. CAN10 has a broader mechanism of action than
lutikizumab by also blocking IL-33 and IL-36.
Currently, the final phase of the first part of the Phase I study
in healthy volunteers is underway and the first clinical results
presented in early 2024 demonstrated good safety and the
ability of CAN10 to reach its target IL1RAP on immune cells.
During Q3, the study is planned to take the next step into
patients with psoriasis, which gives us the opportunity to
study how CAN10 affects biomarkers in skin biopsies. Our
hope is that it will provide both compelling proof that CAN10
works mechanistically and provide valuable information for
the phase II study, which is planned to start in 2025. The final
decision regarding which disease we will first investigate in
phase II will be made later in the year after further discussions
with external experts in the field. Our main indications are
systemic sclerosis and myocarditis, two diseases where we
have seen strong effects of CAN10 in different disease models.
At the same time, we know that these are just two of many
possibilities and we still have room to give the phase II study
the best chance of success.
Another important aspect of drug development concerns
patents. Cantargia has built up a strong portfolio around its
projects, and also with a breadth that other players have
chosen to challenge. When an examination of a patent
application is completed, but before a European patent
is formally approved, there is the possibility of filing an
opposition. Since Cantargia is located in a hot area, such
processes are not entirely unexpected. Also in 2023, there
was an opposition to one of Cantargia’s broad patents, but
the European Patent Office decided to follow Cantargia’s line
and approve the patent. At present, Cantargia has approved
patents on the antibodies in both clinical projects, on variants
of these and, in addition, more generally on the treatment of
cancer with antibodies directed against IL1RAP.
In summary, great progress was made in 2023 and the
beginning of 2024 has also offered a continued interesting
news flow. It is of course our ambition that the rest of 2024
will continue in the same way. We have many milestones
to look forward to in both our clinical projects and it is with
great pride that we have advanced development in our aim
to to offer patients with severe diseases new effective and
safe treatments. I sincerely hope that the macroeconomic
situation will change in a way that stimulates investments in
drug development, which is capital-intensive and long-term.
Finally, I would like to extend a big thank you to Cantargia’s
shareholders for your trust, to patients and their families
for your valuable contribution to our research, to Cantargia’s
employees who, with creativity and expertise, are advancing
our projects, and finally to our many commercial and academic
partners who contribute with their specialist knowledge in the
many different areas needed in drug development.
Göran Forsberg
Lund, April 2024
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Background to Cantargia’s projects
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 natural
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 interleukin-1 system, which
contributes to an environment favorable for tumors. The
interleukin-1 system is dependent on IL1RAP for transferring
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 combination
of nadunolimab and chemotherapy that indicates a higher
efficacy than expected with chemotherapy alone.
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.
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
additional established cancer therapies for optimal effect.
CAN10
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 interleukin-33 and
interleukin-36. Blocking of these three signaling molecules
has great potential in the treatment of autoimmune and
inflammatory diseases.
The first clinical study with CAN10 is currently ongoing, and
earlier this year, Cantargia reported that no safety concerns had
been observed at the initial dose levels.
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 antibody-
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.
Project Disease
Type of treat-
ment
Discovery
phase
Preclinical
phase
Clinical
phase I
Clinical
phase II
Clinical
phase III
Nadunolimab
PDAC 1
st
line
TNBC 1
st
/2
nd
line
NSCLS/non-squamous
NSCLC
1
st
/2
nd
line
CAN10
Myocarditis,
Systemic sclerosis
CANxx
New opportunities within
IL1RAP platform
PDAC - pancreatic cancer; TNBC - triple-negative breast cancer; NSCLC - non-small cell lung cancer
Gemcitabin/nab-paclitaxel
Carboplatin/gemcitabin
Platinum doublets
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Nadunolimab
– Cantargia’s project in oncology
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’s dual mechanism of action
Nadunolimab is unique in that it has a dual mechanism of action.
Nadunolimab can effectively kill cancer cells as well as block signals
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, nadunolimab stimulates the body’s killer
cells, known as natural killer (NK) cells, to seek out and eradicate the
cancer cells. Nadunolimab has also been optimized to possess an
improved ability to stimulate these killer cells.
IL1RAP is present not only on cancer cells, but also on other cell types
in the tumor that contribute to its growth. IL1RAP conveys 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 immune cells capable of killing the tumor,
but also stimulate blood vessel formation in the tumor. Nadunolimab
blocks the signaling of both interleukin-1 alpha and beta and can thus
impact the development and growth of the tumor.
Nadunolimab stimulates
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
reduced accumulation of
immunosuppressive cells
in 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 cytokines, including
interleukin-1.
endothelial cell
monocyte
fibroblast
tumor cell
neutrophil
macrophage
pro-inflammatory
cytokines
solid tumor
Augumented ADCC
Reduced angiogensis
Reduced activation and
infiltration of tumor-
supporting cells
NK celll
blood vessel
fibroblast
myeloid cell
Nadunolimab
blood vessel
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Nadunolimab synergizes with chemotherapy
Another important function of nadunolimab is its ability to
enhance the effect of chemotherapy drugs which are established
standard 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 platinum-based
chemotherapy, antitumor effects were achieved that were
much stronger than the effect of the individual treatments.
Preliminary clinical data point to similar effects in cancer patients.
Previous research as well as Cantargia’s own studies have
shown that treating cancer cells with chemotherapy triggers
them to release the alpha form of interleukin-1. This in turn
stimulates the release of the beta form of interleukin-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 interleukin-1, it is very well-
suited for combination with chemotherapy.
When nadunolimab was combined with the chemotherapy
docetaxel in preclinical studies, a stronger antitumor 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 nadunolimab’s interaction with
IL1RAP produces a broader effect on the interleukin-1 system
compared to blockade 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 interleukin-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 advantage of this
is that nadunolimab thereby has a broader mechanism of action
that is likely to contribute to a stronger antitumor effect and
synergy with chemotherapy.
Chemotherapy triggers the release of
interleukin-1 alpha in the tumor, which in
turn stimulates the release of interleukin-1
beta. These molecules contribute to the
tumor’s resistance to chemotherapy.
Nadunolimab 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 chemotherapy,
which are established standard treatments for different types of cancer.
IL-1β
IL-1α
IL1R1
IL1RAP
IL1R1
IL1RAP
IL1R1
IL1RAP
Chemotherapy
Nadunolimab
Macrophage
Tumor cells
Endothelial cells
CAF
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CAN10
– Cantargia’s project in autoimmunity and inflammation
In the CAN10 project, an antibody is being developed that blocks interleukin-1, -33 and -36, all of which are proinflammatory molecules.
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.
IL1RAP conveys signals from the molecule interleukin-1, but
also interleukin-33 and interleukin-36. These three signaling
molecules are pro-inflammatory and play a central role in
several severe diseases. Cantargia has developed the antibody
CAN10 which, by binding IL1RAP, can block all these signaling
pathways simultaneously without inducing cell death.
With these characteristics, CAN10 has the potential to be
a potent anti-inflammatory treatment for several diseases
where single drug therapy is not entirely effective. The
pathways blocked by CAN10 have been described to be
involved in diseases in barrier tissues such as skin, lungs, and
intestines, as well as in cardiovascular pathology, indicating
significant potential for CAN10 in multiple diseases. Following
an extensive review of potential target diseases, Cantargia
decided to initially focus on the development of CAN10 for the
treatment of myocarditis and systemic sclerosis, two serious
diseases with high medical need where IL1RAP blockade with
CAN10 may offer significant benefits.
Promising preclinical data
Myocarditis is a life-threatening disease characterized by
impaired heart function. The disease can be caused by
autoimmunity, but even more commonly by viral infections,
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 myocarditis. This effect was stronger
compared to blockade of interleukin-1 signaling alone.
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 sclerosis
where the surrogate antibody for CAN10 reduced skin and
pulmonary fibrosis and normalized the levels of several
disease-related biomarkers in skin biopsies.
INFLAMMATION ASTHMA/ALLERGY SKIN DISEASES
IL-1 receptor complex IL-33 receptor complex IL-36 receptor complex
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CANxx
- Cantargia’s IL1RAP-based platform
CANxx is a technology platform and an antibody library that leverages
Cantargia’s extensive knowledge and resources regarding IL1RAP
as a target for various types of drugs and treatment strategies.
Within Cantargia’s large antibody library, there are candidates for
the development of new drugs as well as antibodies developed for
diagnostics, in vitro analysis, and preclinical inquiries. CANxx is thus a
valuable resource for both our active clinical programs and a source of
new therapeutic antibodies, solidifying Cantargia’s strong position for
the future.
Cantargia was the first to develop drugs targeting IL1RAP and
has built a knowledge, technology, and antibody platform, CANxx,
in the field. Within this innovation platform, Cantargia has so far
developed over 200 unique antibodies that bind to IL1RAP and have
different properties. The antibodies within CANxx form the basis
for active strategic development of new therapeutic antibodies and
concepts with optimized efficacy and tailored solutions for specific
medical needs. CANxx is also a valuable source of antibodies that are
continuously integrated with the latest technologies and methods in
research technology for use in analytical and diagnostic methods and
analyses.
In addition to disease models for the initial target indications, the CAN10 surrogate
antibody has also shown potent effects in models of peritonitis, psoriasis, and
atherosclerosis, demonstrating the potential for IL1RAP blockade as a treatment for a
wide range of diseases.
The start of the first clinical study
The first clinical study with CAN10 is currently ongoing, and the first participant was
dosed with CAN10 in September 2023. The primary objective of the phase I study is
to investigate the safety and tolerability of CAN10, while additional objectives include
pharmacokinetics and effects on various immunological or disease-related biomarkers.
Initially, escalating doses will be administered intravenously to up to 64 healthy
volunteers. The subsequent part of the study is designed to also generate an early proof
of concept in up to 16 participants with mild to moderate psoriasis, who will receive
multiple injections of CAN10 subcutaneously at two dose levels. Indications of clinically
relevant effects on biomarkers will also be evaluated throughout the study. Further
details are available on clinicaltrials.gov (NCT06143371).
In January 2024, Cantargia reported that the study is progressing according to plan,
with the first four dose groups completed without any safety concerns. Additionally,
a receptor occupancy study indicates that even at initial dose levels, the majority of
IL1RAP molecules on immune cells bind to CAN10 in a dose-dependent manner. This
is consistent with results from preclinical studies. Furthermore, biomarker samples
taken during the study are currently being analyzed to document the blockade of IL-1
and IL-36 stimulation of immune cells.
Clinical Strategy
Cantargia’s objective for nadunolimab is to confirm the promising phase I/II
results in randomized trials, and the goal for CAN10 is to further advance
the project in the clinical phase. This progress will broaden the company’s
activities, but will also provide an opportunity to focus on diseases with the
best potential for success, based on clinical results.
During 2022, the clinical development of nadunolimab focused on randomized studies,
and the first controlled trial, TRIFOUR, began recruiting patients with triple-negative
breast cancer in early 2023. Cantargia also plans recruitment for a controlled phase IIb
study in metastatic pancreatic cancer (PANFOUR). The study will investigate nadunolimab
in combination with chemotherapy (gemcitabine/nab-paclitaxel), a standard treatment
for this disease. Two different dose levels of nadunolimab will be examined, and the study
will include a control arm receiving only chemotherapy. An additional aim of this study is
to build on promising results showing that pancreatic cancer patients with high levels of
IL1RAP on tumor cells respond best to treatment with nadunolimab and chemotherapy. In
the short term, this observation reinforces earlier signs of clinical efficacy of nadunolimab,
but in the longer term, it also provides an opportunity to select patients who are most
likely to respond to treatment. Each arm will consist of approximately 50 patients, totaling
150 patients in the study, with a results analysis after approximately 60 patients. The
study has received regulatory approval in the US and is scheduled to commence in 2024.
The CAN10 project initiated the first clinical phase I study in healthy volunteers in mid-
2023. Initially, the study involves single doses to evaluate safety and pharmacokinetics,
but also analyses of immunological biomarkers will be conducted. The subsequent part
of the study will focus on multiple dosing and is planned to be conducted in patients
with psoriasis to obtain initial indications of disease-related biomarkers. The goal is then
to initiate phase II studies in myocarditis or systemic sclerosis as soon as possible after
completion of the phase I study. However, the possibilities for IL1RAP blockade are vast,
and Cantargia is therefore simultaneously exploring the opportunities to broaden the
indications for CAN10.
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Cantargia’s clinical program
Nadunolimab in combination with chemotherapy shows
promising responses in pancreatic cancer patients.
The clinical development of nadunolimab has made
significant progress, particularly in pancreatic
cancer, triple-negative breast cancer, and non-
small cell lung cancer, where promising safety and
efficacy data have been reported for combination
therapy with chemotherapy. Cantargia is now
shifting its focus to randomized studies.
CANFOUR
Cantargia’s first clinical study, CANFOUR, is a phase I/IIa trial
focusing on pancreatic cancer and non-small cell lung cancer. In
the phase I part, the primary evaluation focused on the safety
and dosage of nadunolimab. The results were highly encouraging,
indicating good safety and effects on key biomarkers.
Based on the positive outcome in phase I, CANFOUR progressed
to the phase IIa part, which evaluates nadunolimab in
combination with chemotherapy. In this phase, nadunolimab
is combined with gemcitabine and nab-paclitaxel in first-line
treatment of pancreatic cancer, or with cisplatin 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 overall
survival of 13.2 months were reported. This is an improvement
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
1
. 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=0.026).
In 30 patients with non-small cell lung cancer, a 53 per cent
response rate was achieved resulting in median progression-free
survival of 7.0 months. This is an improvement over historical
controls, which show a 22-28 per cent response rate and
median progression-free survival of 5.1 months
2,3
. Moreover, an
even higher response was achieved in a subgroup of patients
with non-squamous non-small cell lung cancer.
To date, over one hundred patients have been treated in the
phase IIa stage of CANFOUR. Enrollment to this trial was ended in
April 2023, following treatment of ten additional non-squamous
non-small cell lung cancer patients with nadunolimab and
the chemotherapies carboplatin and pemetrexed. Continued
development in non-small cell lung cancer will further focus on
patient subgroups by implementation of a biomarker strategy to
identify best responders.
Additionally, the next step in the late-stage clinical development
phase for pancreatic cancer is being prepared, where regulatory
approval has been granted in the US to begin recruiting patients for
a controlled phase IIb study. The study will investigate nadunolimab
as combination therapy in first-line treatment for metastatic
pancreatic cancer and is scheduled to commence in 2024.
53%
Response rate of patients
with non-small cell lung
cancer
13.2
months
Median survival of patients
with pancreatic cancer
Effects of
nadunolimab and
chemotherapy in
CANFOUR
Confirmed progressive disease Stable disease
Unconfirmed progressive disease Partial response
-100%
-50%
0%
50%
Best changes in tumor size
1. Van Hoff et al, N Engl J Med 2013
2. Schiller et al, N Engl J Med 2002
3. Scagliotti et al, J Clin Oncol 2008
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CIRIFOUR, CAPAFOUR AND CESTAFOUR
Nadunolimab has been evaluated in three additional clinical
studies, CIRIFOUR, CAPAFOUR, and CESTAFOUR, where patient
recruitment was completed in October 2022.
In the phase Ib study CIRIFOUR, nadunolimab is evaluated
in combination with the checkpoint inhibitor pembrolizumab
(Keytruda®), with the main objective focusing on safety. A
total of 16 patients with non-small cell lung cancer, head and
neck cancer, or malignant melanoma have been treated. These
patients progressed during treatment with pembrolizumab and
then continued treatment with pembrolizumab in combination
with nadunolimab. Interim results show that nadunolimab in
combination with pembrolizumab is well tolerated, and disease
control for at least 30 weeks (up to 58 weeks) is achieved in
6 out of 15 evaluated patients, including a partial response.
In the phase Ib study CAPAFOUR, patients with pancreatic
cancer are treated with nadunolimab in combination with the
chemotherapy regimen FOLFIRINOX, and in the phase I/II study
CESTAFOUR, nadunolimab in combination with chemotherapy
is evaluated for the treatment of three types of solid cancer
forms. Preliminary results showed an acceptable safety profile
for the combinations and signs of efficacy in patients with non-
small cell lung cancer treated with nadunolimab and cisplatin/
gemcitabine in CESTAFOUR, consistent with the observations in
CANFOUR. Final safety and efficacy data from the three studies
are expected to be available in the first half of 2024.
TRIFOUR
In the phase Ib/II clinical study TRIFOUR, patients with
triple-negative breast cancer are treated with nadunolimab
in combination with the chemotherapy agents carboplatin/
gemcitabine. Results from the phase I part showed promising
safety and efficacy, with a response rate of 60% and a median
progression-free survival of 6.6 months in the 15 included
In non-small cell lung cancer (NSCLC), high responses were
observed particularly in patients with the nonsquamous subtype.
patients, significantly higher than historical control data
4
. The
study transitioned to the randomized phase II part in early 2023.
A top-line analysis for the entire study is planned after full
recruitment and is expected by the end of 2024 or early 2025.
Myelodysplastic syndrome and acute myeloid
leukemia
A phase Ib/IIa clinical study is planned to evaluate nadunolimab
in patients with myelodysplastic syndrome (MDS) or acute
myeloid leukemia (AML). The study will evaluate nadunolimab,
either alone or in combination with the chemotherapy drug
azacitidine, in patients with intermediate- or high-risk MDS.
Nadunolimab will also be investigated with azacitidine and
venetoclax, a targeted therapy, in patients with relapsed/
refractory AML. The primary objective of this investigator-
initiated study is to evaluate the safety of different dose levels
of nadunolimab; secondary objectives include early efficacy and
biomarker analysis. The study may include up to a total of 40
patients and is funded by a grant of $1.1 million USD from the
United States Department of Defense.
CAN10
A phase I clinical study was initiated in September 2023 to
investigate the safety, pharmacokinetics, and biomarkers of
CAN10 in healthy volunteers and psoriasis patients. Initially,
escalating single doses are being studied intravenously in up
to 64 healthy volunteers. A subsequent part of the study is
conducted in up to 16 patients with mild to moderate psoriasis
who will receive repeated treatments of CAN10 subcutaneously
at two dose levels, with the aim of demonstrating early proof-of-
concept. The study is progressing as planned, with the four initial
dose groups completed in early 2024 without any safety issues.
Additionally, the results from the four first cohorts demonstrated
that CAN10 binds to its target protein, IL1RAP, on immune cells
from the subjects in a dose-dependent manner, consistent with
calculations from preclinical studies.
-100%
-50%
0%
50%
Squamous NSCLC
Non-squamous NSCLC
Complete response Stable disease
Partial response Progressive disease
Best change in tumor size Best change in tumor size
-100%
-50%
0%
50%
4. O’Shaughnessy et al, J Clin Oncol 2014
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18
Study Disease Combination therapy Nr of patients Status NCT-number
Nadunolimab
CANFOUR
PDAC Gemcitabin/nab-paclitaxel 76 Recruitment completed
NCT03267316
NSCLC/non-squamous
NSCLC
Platinum doublets 33 + 10 Recruitment completed
CIRIFOUR Solid tumors Pembrolizumab 16 Recruitment completed NCT04452214
CAPAFOUR PDAC FOLFIRINOX 18 Recruitment completed NCT04990037
CESTAFOUR Solid tumors Docetaxel, cisplatin/gemcitabin or FOLFOX 36 Recruitment completed NCT05116891
TRIFOUR TNBC Carboplatin/gemcitabin Up to 117 Recruiting NCT05181462
PANFOUR PDAC Gemcitabin/nab-paclitaxel Up to 150-200 Under preparation -
Can10
Phase I study Healthy volunteers/psoriasis - 64+16 Recruiting NCT06143371
PDAC - pancreatic cancer; TNBC - tripple-negative cancer; NSCLC - non-small cell lung cancer
The antibody CAN10 strongly binds to IL1RAP and blocks the function of the signaling molecules IL-1,
IL-33, and IL-36, all of which play a crucial role in several autoimmune and inflammatory diseases.
CAN10 has previously shown promising effects in numerous models of these types of diseases,
including the main indications of systemic sclerosis and myocarditis. Clear effects have also been
observed in preclinical models of psoriasis, forming the basis for studies of CAN10 in psoriasis
patients in the ongoing phase I trial. Subsequent studies may focus on patients with systemic
sclerosis or myocarditis, but several indications are being considered.
19
SYSTEMIC SCLEROSIS
– An interview with Prof. Dr. Jörg Distler
Cantargia initiated its first clinical study with its asset CAN10 in
September 2023. CAN10 blocks signaling of three inflammatory
pathways, IL-1, IL-33 and IL-36, without inducing cell killing,
making CAN10 optimally designed for treatment of several
inflammatory and autoimmune diseases.
One of the initial target indications for CAN10 is systemic sclerosis, or scleroderma, a
disease with a large need for new treatment options where CAN10 recently received
orphan drug designation by the US food and drug administration (FDA).
Systemic sclerosis is a complex systemic autoimmune disease resulting in fibrosis
of the skin and internal organs. Cantargia has shown that IL1RAP and the IL1RAP-
dependent pathways are overexpressed in skin from patients with systemic
sclerosis and demonstrated strong beneficial effects of IL1RAP blockade in multiple
disease models of systemic sclerosis. IL1RAP-blockade also normalized the
expression levels of a majority of the key systemic sclerosis related biomarkers in
skin biopsies from a disease model. Taken together, this suggests that IL1RAP acts
as an important signaling node in systemic sclerosis and that CAN10 holds promise
as a new and effective treatment for systemic sclerosis patients. Cantargia has
generated a strong preclinical package supporting clinical development of CAN10 in
systemic sclerosis.
The preclinical studies in systemic sclerosis have been performed in collaboration
with one of the leading experts in the field, Prof. Dr. Jörg Distler at the Heinrich-Heine
University in Düsseldorf, Germany. We have asked Prof. Dr. Distler to explain more
about systemic sclerosis and the importance of developing new treatment options
for patients with the disease.
What is the typical disease course of systemic sclerosis?
Systemic sclerosis (SSc) is a complex, heterogeneous disease that
presents with a wide variety of clinical manifestations ranging from
minor symptoms (e.g., puffy, swollen fingers) to life-threatening
complications (e.g., interstitial lung disease), depending on the organs
involved.
Systemic sclerosis normally starts with vascular alterations known as
Raynaud’s disease, presenting as pale and cold fingertips, followed by
activation of immune cells, autoimmunity and subsequent fibroblast
activation and fibrosis. This can occur in several different tissues,
often beginning with the skin, which become hard and tight, but that
can progress to the lung, heart and gastrointestinal tract, among
others. Some patients develop a milder form of the disease known
as limited systemic sclerosis, but one third of the patients develop a
more aggressive form, diffuse systemic sclerosis, often with fibrosis
in multiple organs. These patients are more likely to have progressive
disease and are at higher risk of systemic sclerosis-related death,
most often caused by fibrotic lung disease (interstitial lung disease)
or because of cardiac involvement. However, it is important to note
that also the symptoms that are considered less severe still have a
substantial impact on the patient’s quality of life, for example issues
related to the digestive system.
19
Prof. Dr. Jörg Distler
”I am really looking forward to following the clinical
development of CAN10, which in preclinical studies has shown
potent effects on key aspects of systemic sclerosis in multiple
organs and therefore has the potential to become a valuable
treatment option for systemic sclerosis patients. ”
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How common is SSc and who’s at risk of developing the disease?
Systemic sclerosis is a rare disease with approximately 3 per 100,000 individuals diagnosed with
the disease every year. The typical patient is a woman in her thirties presenting with pale fingertips
and pitting scars, if the disease is diagnosed early. Systemic sclerosis is three times more common
in women compared to males with the first manifestation appearing at around 30-50 years of
age. Males with systemic sclerosis are, however, at high risk of getting a particularly aggressive and
progressive form of the disease.
What is the current treatment paradigm for managing diffuse SSc and what are the
key challenges with current treatments?
The treatment depends on the clinical manifestation but most often includes a broad-spectrum
immunomodulating approach and treatment of the symptoms rather than reversing the disease. For
a small subgroup of the most severe cases, stem cell transplantation can be an alternative as well.
Unfortunately, all the available options are associated with severe side-effects that significantly
impact the quality of life of the patients and may lead to treatment discontinuation or dose
reductions to doses lower than what has been shown to be effective. One of the key challenges
is that there are no drugs available that can halt progression or reverse the disease. Also, the two
recently approved drugs (nintedanib, a broad-spectrum growth receptor blocker, and tocilizumab ,
an antibody blocking the IL-6 receptor approved in the US only) are only approved for interstitial lung
disease in systemic sclerosis patients and not skin fibrosis or other manifestations.
What, in your view, is the primary unmet needs for patients with diffuse SSc?
Systemic sclerosis patients are in desperate need of new therapies. Medicines that have effects
in several organs and that could even reverse disease progression are lacking today. To do this,
the optimal drug would target the three most important hallmarks of the disease; the vascular
alterations, the inflammation and the fibrosis, in both the lung, skin and heart. These features create
vicious self-amplifying disease loops that lead to unstoppable disease progression. I am very much
looking forward to following the clinical development of CAN10, which in preclinical studies has
shown potent effects on key aspects of systemic sclerosis in multiple organs and therefore has the
potential to become a valuable treatment option for systemic sclerosis patients.
The first part of the CAN10 phase 1 study is currently ongoing with healthy volunteers, and
the second part of the trial with participants with mild to moderate psoriasis is expected to
start in the second half of 2024.
IL-1
IL-33
IL-36
IL1RAP
CAN10
IL1RAP
Fibrosis is characterized by excessive production of fibrous connective tissue, ultimately leading to organ
failure. In systemic sclerosis, fibrosis can occur in many organs, including the skin, lungs, and heart, where
CAN10 has shown promising results in preclinical models by reducing both fibrosis and inflammation.
CAN10 reduces fibrosis in several organs
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Drug development
– From discovery to launch
Preclinical phase
The preclinical phase is characterized by activities conducted 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 interact. Individual substances are then selected for further studies 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 candidate drug is sufficiently
safe and stable, and to establish how it behaves in and how it leaves
the human body. An application 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 application 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 national ethics committee. The approval
of an application is followed 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 II
Phase II is normally the first stage at which the new substance is administered
to patients with the relevant disease. At this stage, the test group is also
larger and normally consists 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 determining the dose to be used in large-scale trials. Phase
II studies can take between six months and two years to complete.
Phase I
Phase I is the first stage where a new substance is administered 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 patients
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 indicated
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 questions that
the trial is designed to answer. If the procedure progresses as planned, the dose
can then gradually be increased to the clinical use level. Phase I studies normally
take six months to a year to complete.
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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 relevant drug control authorities,
which in Europe is the European 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 indication 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 average, only one will normally advance
to regulatory approval. Approximately 35 new medical products are
introduced on the Swedish market every year.
Phase III
Phase III is initiated only if the results from phase II are sufficiently
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 physician nor the patients are
informed of which substance has been administered. This type of trial is
known as a ‘doubleblind 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
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 authorization, 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 studying 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.
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Patent protection
Cantargia’s strategy is to obtain broad patent protection
for its current and future product candidates 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
antibodies 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. During the year,
Cantargia has filed patent applications and obtained approved patents in
selected territories.
PATENT FAMILY PROCESSINGS APPROVED VALIDITY
Nadunolimab (Product) Brazil, India Australia, Europe (Belgium, Denmark, Estonia, France, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal,
Switzerland, Spain, UK, Sweden, Czech Republic, Turkey, Germany, Austria), Israel, Japan, China, Mexico, Singapore, South
Africa, South Korea, US
2035
CAN10 (Product) Australia, Brazil, Europe, India, Israel,
Japan, Canada, China, Mexico, Singapore,
South Africa, South Korea, US
US 2041
Leukemias (Treatment) - US 2029
Hematological cancers
(Treatment/Diagnosis)
China Australia, Europe (France, Italy, Netherlands, Switzerland, Spain, UK, Germany), Israel, Japan, Canada, China, Mexico, South
Africa, US
2030
Solid tumors
(Treatment/Diagnosis)
Europe, China Australia, Brazil, Japan, Canada, China, Mexico, South Korea, US 2032
CAN03 (Product) - Europe (France, UK, Germany), Japan, China, US 2035
Anti-IL1RAP antibodies (Product) Europe Japan, China, US 2037
Biepitopic antibody (Product) Japan, China, US Europe 2039
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Sustainability
Company overview, strategy, and commitment
Cantargia is a Swedish biotechnology company that specializes in the discovery and
development of pharmaceuticals for treatment of cancer as well as inflammatory
and autoimmune diseases. Our vision is to improve global health by contributing
to the treatment of unmet medical needs for severe diseases and to improve the
quality of life for these patients. To accomplish this, Cantargia is committed to
discovering, developing and launching future products on the market in a sustainable
way, taking Environmental, Social, and Governance (ESG) aspects into consideration.
Cantargia’s Board of Directors has adopted a Sustainability Policy. The policy outlines
Cantargia’s commitment to minimizing our environmental impact, preserving resources,
and contributing to a more sustainable future. Cantargia recognizes that all 17 of the
United Nations Sustainable Development Goals (SDGs) are important, but our internal
policy specifically aligns with and supports SDGs 3, 5, 8, 9, and 13, summarized below.
The policy further acknowledges the importance of and compliance with the European
Union’s Corporate Sustainability Reporting Directive (CSRD).
In the following sections, information about how the company works with
sustainability will be outlined.
Our vision is to
improve global health
by contributing to the
treatment of unmet
medical needs for severe
diseases and to improve
the quality of life for
these patients.
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Environmental responsibility
While trying to improve the life of patients with the drug candidates under development, we
focus on climate impact mitigation actions throughout the process. We are committed to reducing
our environmental impact as much as possible, by for example tracking and reducing our energy
use, water consumption, waste management, and greenhouse gas emission.
Rented Premises
Cantargia rents premises from Wihlborgs at Ideon Gateway Scheelevägen 27 in Lund. Ideon
Gateway is certified according to Miljöbyggnad (Sweden Green Building Council) and LEED
(Leadership in Energy and Environmental Design) BD+C (Building Design and Construction) with
a Platinum rating , which is the highest rating
1
. The building harnesses heat and cooling from
the ground, and a portion of the electricity comes from solar panels integrated into the building
facade. In order for Cantargia to reduce the environmental impact we have started to measure our
energy consumption from the premises.
Sustainable travels
Another aspect of the company’s environmental impact stems from emissions of greenhouse
gases from travels. Cantargia’s travel policy recommends travels by train whenever possible, both
from an environmental and cost perspective. However, there are for example some conferences
where air travel is necessary. During the year, the company has started measuring the annual
carbon emissions from travels.
In 2023, 137 travels were made (round trips calculated as 2 travels) which resulted in a total
yearly emission of 19 739 kg CO
2
. 90% of the travels were made by flight, 9% by train, and 1% by
car. The average amount of Co
2
emission per employee amounts to 822 kg.
% of total
travels
822 kg Co
2
per employee
137
travels
Flight Train Car
0
5000
10000
15000
20000
25000
30000
35000
40000
Energy, heating & cooling (kWh)
Electricity
kWh
Water consumption (m
3
)
0
50
100
150
200
250
300
350
Heating/Cooling Water (m
3
)
Usage of electricity, heating & cooling, and water Travels during 2023
1. Möblerad arbetsplats i stilfulla Gateway – Wihlborgs
2022 2023
CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
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Social Responsibility
Moreover, Cantargia is committed to social responsibility. The company provides fair wages and an inclusive work
environment, as well as promotes a work culture that values diversity. Employee well-being is highly prioritized,
and the company has a collective agreement with IKEM (Innovations- och Kemiindustrierna).
Governance
Cantargia is actively working with governance as a cornerstone of its
operations, ensuring transparency, ethical conduct, and accountability at every
level of the organization. There is a well-established Code of Conduct that
governs all employees, emphasizing integrity and adherence to the highest
ethical standards in research, development, and business practices.
The company’s leadership plays a crucial role in governance responsibility.
They are committed to transparency reporting in decision making and financial
reporting, regularly engaging with shareholders and other stakeholders to
provide insight into the company’s strategic direction. Moreover, the Board
of Directors include independent board members fostering impartiality and
strong oversight.
For more information about the Governance in Cantargia, please see the
Corporate Governance Reporton on page 71-76.
Age Structure within Personnel
General Managers
72%
women
72%
men
Board of
Directors
20%
women
80%
men
0
2
4
6
8
10
12
Number of employees
21-30 year 31-40 year 41-50 year 51-60 year 61-70 year
Gender Distribution
Gender Distribution
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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
only a 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 cancer 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-squamous 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. Other
inflammatory diseases will also be evaluated in the longer term to be included in Cantargia’s
portfolio.
Cancer – A global challenge
Cancer is one of the leading causes of death in the world, accounting for about 20 percent of
deaths in the Western world. Globally, more than 18 million people are diagnosed with cancer
annually and nearly 10 million die of cancer-related diseases
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
suggests that two independent events are required for cancer to develop: damaging of
normal cells resulting in rapid and uncontrolled cell growth, and location of these cells in a
microenvironment 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
Asia Europe North America Latin America & the Carribean Afrika Afrika
49%
23%
13%
8%
6%
1%
58%
20%
7%
1%
7%
7%
Mortality
Incidence
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29
The number of cancer cases is expected to increase continuously, and the forecast by the
WHO is that, by 2040, over 29 million new cases will be diagnosed annually
1
. 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
1
. Another
contributing factor is the Western lifestyle, characterized by factors such as smoking, alcohol
consumption, unhealthy diet, low physical activity, overweight, and unhealthy sun exposure
habits.
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
2
. An
important 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 addition, there is a strong focus on early diagnosing and thus treating patients at earlier
stages. Of the ten best-selling drugs globally in 2021, half consisted of medications for the
treatment of cancer
3
.
2. Iqvia Institute, Global Oncology Trends 2022, Outlook to 2026
3. RTTNews, Top 10 Blockbuster Drugs In 2021
0
50
100
150
200
250
2018 2022 2026
129
196
307
300
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).
The cost of cancer drugs 2018 - 2026
US EU5 Japan Pharmerging Rest of the world
New cases of pancreatic cancer (US)
Source: SEER Cancer Statistics ReviewSource: Iqvia Institute, Global Oncology Trends 2022, Outlook to 2026
Number of patients
20 000
30 000
40 000
50 000
60 000
70 000
80 000
2014
2022
2009
2017
2007
2015
2023
2011
2019
2008
2016
2012
2020
2010
2018
2013
2021
Billions of USD
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30
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
4
. In the US, the number of people diagnosed with
the disease has increased by nearly 70 per cent over the last 20 years and pancreatic cancer is
today the third most common cause of cancer-related deaths in the US
4
. 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
5
. This
corresponds to an annual growth rate of just over 12 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
1
. The increase in the number
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
In 2020, approximately 2.5 million cases of lung cancer were diagnosed globally and more than
1.8 million people died from the disease
1
. Around 85 per cent of all lung cancers are non-small
cell lung cancer
6
, 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
7
. 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 disease is increasing in countries such as
China and India, and in European countries such as Hungary, Denmark and Serbia.
4. SEER Cancer Stat Facts
5. Reportlinker.com, Pancreatic Cancer Treatment Market Research Report - Global Forecast to 2026
6. American Cancer Society
7. Paz-Ares et al, N Engl J Med 2018; 379:2040-2051
8. Reportlinker, Global Non-Small Cell Lung Cancer (NSCLC) Therapeutics Industry
9 . Pfeiffer RM et al, Cancer Epidemiol Biomarkers Prev. 2018;1:1 Source: WHO, The Global Cancer Observatory 2020, Cancer.gov (National Cancer Institute, Sep-20), American Cancer Society, Nov-17
Sales of drugs for non-small cell lung cancer totaled USD 20 billion in 2020 and are projected to
increase to USD 45 billion by 2027
8
. Sales are mainly driven by increasing use of various antibody-
based immunotherapies. Another important factor contributing to the growth of the global
market is the increasing incidence of lung cancer in many countries, as mentioned above.
The market for breast cancer treatment
Breast cancer is currently the most common form of cancer. In 2022, approximately 2.3 million
new cases were reported, and approximately 666,000 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
1
. The risk of developing breast cancer increases
with age up to the age of 70. In the US, the median age for developing breast cancer is 62
years
7
. According to a study conducted on American women, 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
9
.
Breast
Lung
Bowel
Prostate
Stomach
Liver
Cervix
Other
Lung
Breast
Bowel
Stomach
Liver
Esophagus
Pancreas
Other
46%
3%
5%
6%
7%
10%
12%
11%
40%
5%
5%
8%
8%
9%
7%
18%
Non-Small cell lung cancer
2.3m Annual global incidence
11% Fraction of cancer incidence
1.8m Annual global mortalities
18% Fraction of cancer mortality
19% Five-year survival rate
Pancreatic cancer
0.5m Annual global incidence
3% Fraction of cancer incidence
0.5m Annual global mortalities
5% Fraction of cancer mortality
9% Five-year survival rate
MortalityIncidence
Treatment: Surgery, Radiation,Chemotherapy,
immunotherapy
Treatment: Surgery, Radiation,Chemotherapy
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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
annual growth rate of approximately 8 per cent
10
. The market
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
6
. 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
11
.
The market for myocarditis and systemic
sclerosis
By blocking IL1RAP, CAN10 creates numerous opportunities
to influence conditions within the inflammation and
immunology field, an area that has grown immensely
over the past two years. More than half of all diseases
are considered to have an inflammatory or immunological
component, and drugs within immunology addressing a
fundamental physiological cause of autoimmunity, such
as CAN10, can therefore be applied to many indications,
which is a phenomenon known as ”pipeline in a drug”. The
latest forecasts show that costs within the inflammation
and immunology segment are expected to increase from
$108 billion this year to over $260 billion over the next
eight years
12
. Initially, Cantargia has chosen to focus on the
two serious diseases myocarditis and systemic sclerosis.
However, there are many more indications that may become
relevant for CAN10.
Myocarditis is characterized by inflammation of the muscular
tissues of the heart (myocardium) arising from, for example,
autoimmunity or various types of infections. Regardless
of its etiology, myocarditis is characterized by initial 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)
13
, and globally the disease accounts
for about 0.6 deaths per 100,000 (46,400) annually
14
. The
medical need is high for subgroups of patients with fulminant
myocarditis (acute disease) and dilated cardiomyopathy
(chronic disease), where mortality is very high in certain
subtypes. For these patients, heart transplantation is
currently the only definitive treatment.
Systemic sclerosis is a chronic autoimmune disease that is
mainly characterized by inflammation and fibrosis of the
10. Research and Markets, Breast Cancer Drugs Global Market Report 2021
11. FutureWise, Triple Negative Breast Cancer Treatment Market By Drug Type, 2020-2027
12. Precedence Research 2023, Report Code: 3867
13. J Am Coll Cardiol. 2016 Nov 29;68(21):2348-2364
14. Lancet. 2018;392:1736-88
15. Clin Epidemiol. 2019; 11:257-273
16. GlobalData, Systemic Sclerosis: Global Drug Forecast and Market Analysis to 2030
skin and subcutaneous tissue, as well as blood vessels and
internal organs such as the lungs, heart, and kidneys.
Systemic 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
approximately 1.4-5.6 per 100,000
15
. 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 sclerosis 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
16
. This corresponds to an
average annual growth rate of 14 per cent.
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CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
33
The Board of Directors and Chief Executive Officer of Cantargia AB
(publ), corporate ID no. 556791-6019, hereby present the annual
report for the financial year 1 January – 31 December 2023. 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 antibody-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 chemotherapy 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
treatment of serious autoimmune and inflammatory diseases, with
initial focus on myocarditis and systemic sclerosis.
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
Five-year comparision
Amounts in mSEK 2023 2022 2021 2020 2019
Net sales - - - - -
Loss after net financial income/expense -280.0 -371.8 -366.5 -173.1 -110.8
Cash and bank balances and liquid investments 139.7 189.6 247.3 693.4 39.9
Short-tem investments 55.0 237.1 312.1 210.0 110.0
Equity 168.7 389.7 532.7 891.9 142.3
Total assets 223.7 474.8 600.2 925.5 166.1
Equity/assets ratio (%) 75% 82% 89% 96% 86%
Quick ratio (%) 391% 543% 887% 2996% 669%
R&D costs -272.9 -364.7 -352.7 -158.4 -97.5
Project costs
1
-220.5 -306.7 -304.2 -121.9 -81.1
Total operating expenses -290.0 -381.5 -370.3 -173.9 -111.6
R&D costs as a percentage of total operating expenses (%) 94% 96% 95% 91% 87%
Project costs as a percentage of total operating expenses (%) 76% 80% 82% 70% 73%
Number of outstanding shares at 31 Dec 183,686,684 166,987,895 100,192,737 100,192,737 72,804,392
Number of outstanding warrants 31 Dec - - - - 85,000
Number of outstanding employee options at 31 Dec
2
4,097,333 3,069,333 3,170,333 1,740,000 -
Earnings per share before and after dilution (SEK)
3
-1.65 -2.90 -3.66 -1.94 -1.56
Equity per share (SEK) 0.92 2.33 5.32 8.90 1.95
Dividend (SEK) - - - - -
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
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CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
34
Significant events during the year
Nadunolimab
Clinical
Pancreatic cancer
• At (American Association for Cancer Research) AARC 2023,
it was presented that patients with pancreatic cancer
who have high tumor levels of IL1RAP, the target protein
for nadunolimab, benefit the most from treatment with
nadunolimab and chemotherapy.
• In May, Cantargia announced an intensification of the
development of nadunolimab in pancreatic cancer through a
new controlled Phase IIb clinical study.
• In September, new clinical data were presented, supporting
nadunolimab’s anti-tumor activity and demonstrating a key
role for its target IL1RAP in pancreatic cancer.
Triple-negative breast cancer
• In February, it was reported that Cantargia initiated the
randomized phase II part of the TRIFOUR study, based on
promising early safety and efficacy data. In March, the first
patient was treated.
Non-small cell lung cancer
• In June, Cantargia’s poster was published and presented at
ASCO, showing promising efficacy data for nadunolimab in
non-small cell lung cancer, with two complete responses.
Other
• In September, funding was announced with an external
American grant for a new clinical study in leukemia.
Preclinical
• At the AACR conference 2023, it was announced that a
surrogate antibody of nadunolimab reduced metastatic
burden and counteracted tumor-promoting processes in the
metastatic microenvironment.
• In October, Cantargia presented clinical phase Ib data for
nadunolimab in triple-negative breast cancer at the ESMO
Congress 2023. The data demonstrate promising efficacy
and safety.
• In September, new preclinical data were presented on
nadunolimab’s potential to enhance the anti-tumor effect of
immunotherapy at CRI-ENCI-AACR.
CAN10
Clinical
• In April, it was announced that Cantargia submitted an
application for a clinical phase I study for CAN10. In August,
Cantargia reported that a regulatory approval to initiate a
clinical phase I study was obtained. In September, the first
individual was treated.
Preclinical
• In January, it was announced that Cantargia successfully
completed the toxicity study for the CAN10 antibody.
• In November, data were presented demonstrating that
blocking IL1RAP leads to reduced inflammation in blood
vessels and that levels of IL1RAP correlate with various
inflammatory markers in inflamed tissue.
Other
• In September, it was announced that the FDA granted
orphan drug status to CAN10 for the treatment of systemic
sclerosis.
IP
• In July, a positive decision was announced following
oppositions against a European patent. The decicsion was
first appealed by a thrid party but was later withdrawn.
Organization
• In February, it was announced that Patrik Renblad had been
recruited as Chief Financial Officer (CFO). Patrik Renbald
started in June.
• In June, it was announced that Dr. David Liberg had been
promoted to Chief Scientific Officer (CSO).
• In November, the nomination committee for the 2024 annual
general meeting was appointed.
Financing
• In October, a new share issue of approximately 59 million
SEK before deduction of transaction costs was decided upon.
The final outcome was discloused in November, including the
new number of shares and voting rights in the company.
Significant events after the year
• In January, it was reported that the clinical phase I study in
CAN10 is progressing as planned, without any safety issues.
• In February, new clinical data were presented, demonstrating
that nadunolimab has additional effects that may be highly
valuable in combination with standard chemotherapy or
ADCs by reducing neuropathy and counteracting tumor-
promoting signals.
• In February, regulatory approval was announced in the US
to initiate a phase IIb study with nadunolimab in pancreatic
cancer.
•
New data were reported highlighting how nadunolimab can
induce anti-tumor activity in pancreatic cancer by blocking
the onset of fibrosis. The data was presented at AACR in
April 2024.
• In March, progress was reported towards the start of the
DoD-sponsored clinical trial of nadunolimab in leukemia.
• In April, three scientific articles were published on CAN10
within atherosclerosis, systemic sclerosis, and the
antibody’s mechanism of action.
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CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
35
Revenues
Cantargia’s net sales in 2023 was SEK 0 (0) million.
Operating expenses and operating profit or loss
Research and development costs totaled SEK 272.9 (364.7)
million. The decreased R&D expenses compared to previous
year are primarily a result of the focus within the clinical
program and lower production costs.
Administrative expenses totaled SEK 14.9 (15.0) million. 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 2.3 (1.9)
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 -290.0 (-381.5) million for
the year.
Net financial income/expense
Net financial income/expense primarily consists of currency
differences on the company’s currency accounts and interest
income from short-term investments. The financial net for the
full year was also positively affected by the sale of short-term
investments totaling SEK 5.7 million. The total financial net for
the full year amounted to SEK 10.0 (9.7) million.
Earnings
Cantargia’s loss before tax, which is the same as the loss for
the year, was SEK -280.0 (-371.8) million.
Cash flow and investments
Cash flow from the operating activities for the full year
amounted to SEK -286.7 (-358.9) million. As part of the cash
flow from operating activities, changes in working capital
amounted to SEK -14.5 (14.6) million.
Cash flow from investing activities totaled SEK 182.1 (67.9)
MSEK. Cash flow from investing activites is primarily related to
disposals as well as new short-term investments in fixed-rate
accounts and bond funds.
Cash flow from financing activities for the full year amounted
to SEK 54.7 (223.9) million. The positive cash flow in 2023 is
related to the directed new share issue completed in November
2023. The positive cash flow in 2022 is related to the rights
issue completed in August 2022.
Total change in cash and cash equivalents for the full year,
including exchange rate differences, amounted to SEK -49.9
(-67.1) million.
Financial position
The company’s cash and cash equivalents, which consist
of cash and demand deposits with banks and other credit
institutions, were SEK 139.7 (189.6) million at the balance
sheet date. In addition to cash and cash equivalents, the
company had short-term investments with banks and in fixed
income funds of SEK 55.0 (237.1) million. Total available funds,
bank deposits and short-term investments, at the balance
sheet date amount to SEK 194.7 (426.7) million.
The equity/assets ratio on 31 December 2023 was 75 (82) per
cent and equity was SEK 168.7 (389.7) million.
At the end of the period, total assets amounted to SEK 223.7
(474.8) million.
Share-based incentive schemes
The purpose of share-based incentive schemes is to promote
the company’s long-term interests by motivating and
rewarding the company’s senior executives and other
employees.
At the end of the reporting period, Cantargia had two
active employee stock option programs as well as one
approved program covering the company’s management,
other employees and consultants. The active programs are
the personnel option program 2020/2023, decided at the
Annual General Meeting (AGM) in 2020, and the personnel
option program 2021/2024, decided at the AGM in 2021.
The approved but not yet activated program at the end of the
reporting period is the personnel option program 2023/2026,
decided at the AGM in 2023. For more information about these
programs, please refer to Note 19.
In 2023, 1,406,000 employee stock options were granted and
378,000 employee stock options were revoked. The granted
options as of December 2023, amounted to 4,097,333,
corresponding to ta total of 4,916,800 potential shares.
Recalculation of the employee stock option program after
the completion of the rights issue in 2022 means that each
option in the employee stock option programs 2020/2023 and
2021/2024 entitles to 1.2 shares.
The cost of the share-based incentive schemes was SEK
4.5 (4.0) million, of which SEK 0.1 (-0.9) million refers to
provisions for social security contributions and SEK 4.4
(4.8) million to costs for share-based payments. The cost has
not affected cash flow. The company has issued warrants to
facilitate, in a simple and cost-effective manner, the delivery of
shares upon exercise of the issued employee stock options.
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CANTARGIA AB (PUBL) • ANNUAL REPORT 2023
36
Risks and risk management
Several risk factors can have a negative impact on the
operations of Cantargia. It is therefore very important to take
account of relevant risks in addition to assessing the company’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 factors without
making a general assessment of the company’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 significant
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
development 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 consistent
with the results of more comprehensive clinical studies. 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 license,
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 comprehensive
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 amended
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
withdrawn 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 general
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 negative
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,
preclinical 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
contracts 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
successful in its attempts to conclude future or maintain
existing partnership agreements for its product candidate, this
could have a significant negative impact on Cantargia’s
operations, 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
significant 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
significant negative impact on the company’s operations,
financial position and results.
Competition
If a competitor succeeds in developing and launching an
effective 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 acquired
or licensed by Cantargia’s competitors, and thereby prevent
Cantargia from obtaining such technology on commercially
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 position, and results.
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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 competitors 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
resources 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
significant negative impact on Cantargia’s operations, financial
position and results.
Product liability
Cantargia’s operations are subject to various liability risks
that are common for companies engaged in drug research and
development. This includes the risk of product 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 significant 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. The company is exposed to
currency risks, 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 results. 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 company
during the year was 24 (27), of whom 14 (17) are women.
The number of employees at year-end was 22 (26) fulltime
equivalents, of whom 13 (16) 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 continuous 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, 94 (96) percent,
are used for research and development.
Environmental impact
Cantargia AB does not engage in activities requiring a permit
under the Swedish Environmental Code, as the company
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 senior executives 2023
Under the Swedish Companies Act, guidelines for remuneration
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.
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The guidelines do not cover remuneration or share-based
incentive schemes adopted or approved by the shareholders’
meeting.
The guidelines applying for 2023 are presented below. For
more information, see also 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 agreements
with a number of companies, hospitals and academic groups.
A large number of international and local organizations are
currently engaged in research and development 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 further information about Cantargia’s
business strategy, see www.cantargia.com.
To successfully implement its business strategy and safeguard
its long-term interests, including its sustainability, it
is essential that Cantargia is able to recruit and retain
competent employees who work to achieve maximum
shareholder 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
shareholders’ 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 2023 AGMs are also not covered.
Forms of remuneration
The remuneration paid to senior executives shall be market
based and may consist of the following components: a
fixed cash salary, variable cash remuneration, pension benefits
and other benefits. The total remuneration paid to senior
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 exceed
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 collective bargaining
agreement.
Pension benefits shall be defined contribution benefits unless
the executive is covered by a defined benefit plan under
mandatory provisions of a collective bargaining agreement.
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 insurance
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 geographical 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 established 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 addition 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 predetermined
and measurable criteria, which may be financial or non-
financial and must be designed to promote the company’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 payments at
the time of entering into agreements, milestone compensation
or royalties). The criteria must also be designed to promote
Cantargia’s business strategy and longterm interests, including
its sustainability.
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Fulfilment of criteria for payment of variable cash remuneration
shall be measured over a period of one year. When the
measurement period for meeting the criteria for payment 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 senior executives
shall be made by the Remuneration Committee. 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 executives.
The Board shall prepare proposed new guidelines at least every
fourth year and submit its proposal for adoption by the AGM. The
guidelines shall apply until new guidelines 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 executives, and applicable remuneration structures
and remuneration levels in the company. The members of the
Remuneration 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 necessary
to safeguard Cantargia’s long-term interests, including its
sustainability, or to ensure Cantargia’s financial viability. As
stated above, it is part of the duties of the Remuneration
Committee to prepare the Board’s resolutions on remuneration
matters, which includes resolutions on deviations from the
guidelines.
Outlook for 2024
Cantargia’s goal is to develop drug candidates for treatment
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 candidates 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 objectives
is to confirm the pormising phase I/II results in randomized
studies. One such study, TRIFOUR, has already been initiated
for triple negative breastcancer, and in 2024, Cantargia also
plans to recruit for a randomized study in pancreatic cancer.
An additional 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. Furthermore, the goal is to advance Cantargia’s
other project, CAN10, in the ongoing clinical phase I study.
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:
Share premium account -1,242,455,507
Loss brought forward 1,676,529,714
Loss for the year -280,027,215
154,046,992
The Board of Directors proposes that: SEK 154,046,992 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.
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Shareholder information
The share
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 2023, the number of shares
amouted to 183,686,684 (166,987,895). At the balance sheet date, the total outstanding
option scheme including not assigned options comprised 7,097,333 employee stock
options, entitling the holders to subscribe for 7,916,800 shares, which would have a dilutive
effect of approximately 4,1 per cent and increase the share capital by SEK 633,344.
Ownership distribution
Cantargia’s ten largest owners as of December 31, 2023
Owner Number of shares Capital/Votes (%)
Fjärde AP-fonden 18,124,193 9.9%
Första AP-fonden 13,000,000 7.1%
Alecta Tjänstepension, Ömsesidigt 12,865,770 7.0%
Six Sis AG 8,474,922 4.6%
Försäkringsaktiebolaget, Avanza Pension 8,451,152 4.6%
Golman Sachs International 6,353,905 3.5%
Handelsbanken fonder 4,658,416 2.5%
Swedbank Robur Fonder 3,692,995 2.0%
Nordnet Pensionsförsäkring 2,812,241 1.5%
Brushamn Invest Aktiebolag 2,261,160 1.2%
Other 102,991,930 56.1%
Total 183,686,684 100.0%
Share price performance
Share price (SEK)
Jan-23 Feb-23 Mar-23 Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23
0
2
4
6
8
10
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42
Ownership distribution size classes as of December 31, 2023
Holding
Number of
shareholders
Number of
shares
Capital/
Votes (%)
Market Cap
(KSEK)
1 - 500 8,421 1,258,662 0.7% 4,705
501 - 1,000 2,111 1,674,666 0.9% 6,260
1,001 - 5,000 4,231 10,577,411 5.8% 39,538
5,001 - 10,000 1,230 9,214,826 5.0% 34,445
10,001 - 15,000 430 5,316,568 2.9% 19,873
15,001 - 20,000 286 5,101,045 2.8% 19,068
20,001 - 759 137,458,415 74.6% 512,424
Unknown ownership size - 13,458,415 7.3% 50,308
Summa 17,468 183,686,684 100.0% 686,621
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
2023 Issue of new shares 0.08 16,698,789 1,335,903.12 183,686,684 14,694,934.72
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STATEMENT OF COMPREHENSIVE INCOME
SEK thousand Note
1 Jan 2023
-31 Dec 2023
1 Jan 2022
-31 Dec 2022
Operating income
Net sales - -
Other operating income - -
Operating expenses 24
Research and development costs 7, 18 -272,882 -364,686
Administrative costs 6, 7, 18 -14,883 -14,964
Other operating expenses 9 -2,252 -1,899
-290,017 -381,549
Operating profit -290,017 -381,549
Financial income and expense
Interest income and similar items 10, 12 16,362 9,740
Interest expense and similar items 10, 12 -6,372 -4
9,990 9,736
Profit before taxes -280,027 -371,814
Tax for the period 11 - -
Loss for the period* -280,027 -371,814
Earnings per share before dilution (SEK)** 20 -1.65 -2.90
Earnings per share after dilution (SEK)** 20 -1.65 -2.90
* No items are reported in other comprehensive income, meaning total comprehensive income is consistent with the loss for the period.
**Based on the average number of shares.
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SEK thousand Note 31 Dec 2023 31 Dec 2022
ASSETS
Intangible assets
Patent 4,657 5,558
27 4,657 5,558
Tangible assets
Machinery and equipment 4,845 7,395
26 4,845 7,395
Total fixed assets 9,502 12,953
Currents assets
Other receivables 2,194 2,462
Prepaid expenses and accrued income 17,269 32,714
19,463 35,176
Short-term investments
Other short-term investments 14 55,000 237,095
55,000 237,095
Cash and bank balances
Cash and bank balances 15 139,747 189,573
139,747 189,573
Total current assets 214,210 461,845
TOTAL ASSETS 223,712 474,798
STATEMENT OF FINANCIAL POSITION
SEK thousand Note 31 Dec 2023 31 Dec 2022
EQUITY AND LIABILITIES
EQUITY
Restricted equity
Share capital 16 14,695 13,359
14,695 13,359
Non-restricted equity
Share premium account 1,676,530 1,623,185
Retained earnings -1,242,456 -875,046
Loss for the year -280,027 -371,814
21 154,047 376,325
TOTAL EQUITY AND LIABILITIES 168,742 389,684
Long-term liabilities
Provision for social security contributions, incentive program 13 119 24
119 24
Short-term liabilities
Trade payables 23,173 37,910
Tax liabilities - 342
Other liabilities 802 1,025
Accrued expenses and deferred income 17 30,877 45,813
54,851 85,090
TOTAL EQUITY AND LIABILITIES 223,712 474,798
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SEK thousand Restriced equity Non-restricted equity Total
1 Jan 2023 - 31 Dec 2023 Note Share capital
Share premium
account
Ret. earnings incl.
profit/loss for the year Total equity
Opening balance, 1 January 2023 13,359 1,623,185 -1,246,860 389,684
Loss for the period - - -280,027 -280,027
Transactions with shareholders
Issue of new shares for the year 1,336 57,945 - 59,281
Capital acquisition cost - -4,600 - -4,600
Employee stock option program 19 - - 4,405 4,405
1,336 53,345 4,405 59,085
Closing balance, 31 December 2023 14,695 1,676,530 -1 ,522,482 168,742
1 Jan 2022 - 31 Dec 2022
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
STATEMENT OF CHANGES IN EQUITY
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SEK thousand Note
1 Jan 2023
-31 Dec 2023
1 Jan 2022
-31 Dec 2022
Cash flow from operating activities
Operating loss -290,017 -381,549
Adjustments for non-cash items 23 7,951 7,643
Interest received etc. 10 9,929 388
Interest paid etc. 10 -1 -4
Cash flow from operating activities before changes in working capital -272,138 -373,523
Changes in working capital
Changes in receivables 15,713 -3,876
Changes in trade payables -14,737 3,398
Changes in other current liabilities -15,501 15,085
-14 525 14,607
Cash flow from operating activities -286,663 -358,915
Investing activities
Acquisition of tangible assets 26 - -7,089
Increase in other short-term investments 14 -55,000 -31
Decrease in other short-term investments 14 237,095 75,000
182,095 67,880
Financing activities
Issue of new shares for the year 59,281 250,482
Capital acquisition cost -4,600 -26,548
54,681 223,934
Change in cash and cash equivalents -49,888 -67,101
Cash and cash equivalents at beginning of period 189,573 247,322
Exchange rate difference in cash equivalents 10 62 9,352
Cash and cash equivalents at end of period * 15 139,747 189,573
*The company’s cash and cash equivalents consist of cash and disposable balances with banks and other credit institutions.
STATEMENT OF CASH FLOWS
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NOTE 1 - General information
Cantargia AB (publ), org. nr 556791–6019, is a biotechnology
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 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.
Postivie interim data from the combination with chemotherapy
indicate stronger efficacy than would be expected with
chemotherapy alone. Cantarga’s second project, the antibody
CAN10, blocks signaling via IL1RAP in a different manner than
nadunolimab and addresses treatment of serious autoimmune
diseases, with initial focus on myocarditis and systemic
sclerosis. CAN10 initiated clinical development in 2023.
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 annual
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 adopted
by the Board of Directors on 17 April 2024.
2.1 - Basis of preparation of financial statements
Cantargia AB has prepared its annual accounts in accordance
with the Swedish Annual Accounts Act and Recommendation
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 International 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
accounting 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 disclosures
Standards, amendments, and interpretations of existing standards
that have entered into force during the financial year. No IFRS or
IFRIC interpretations that have not yet become effective 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
statement of changes in equity is presented in the format
prescribed 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
responsible for the allocation of resources and evaluation of
results. The CEO receives reports containing financial
information for Cantargia as a whole. Cantargia has not yet
commercialized 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 engaged
in research and development of antibody-based therapy 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 development
can be reliably measure
Notes
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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 criteria
listed below. As of 31 December 2023 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 acquisition
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
development 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 functional
currency at the exchange rates applying at the transaction 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
exchange 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 balance
sheet when the company becomes a party to the contractual
terms and conditions of the instrument. A financial asset 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
postemployment benefit plans under which the company pays
fixed contributions into a separate legal entity. Cantargia has
no legal or constructive obligations to pay further contributions
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 recognized 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 family
pensions are secured through an insurance policy with Alecta.
According to a statement from the Swedish Financial 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
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2023, Cantargia has not had access to information 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 defined 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 individually 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
policyholders calculated using Alecta’s actuarial methods and
assumptions, which do not comply with IAS 19. The collective
funding ratio should normally be permitted to vary
within a range of 125 and 175 per cent. If Alecta’s collective
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, contributions
can be reduced. At the end of the financial year 2023,
Alecta’s surplus, as defined by the collective funding ratio,
was 158 per cent (2022: 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
employees
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 expense
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 employment
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 following:
(a) when the company can no longer withdraw the offer
of such benefits; and (b) when the company recognizes
restructuring costs provided for under IAS 37 which involve the
payment of severance pay. If the company has made an offer 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
consists 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
balance sheet date.
Deferred tax liabilities are recognized for all taxable temporary
differences. However, deferred tax attributable to untaxed
reserves 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
realized 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
classifies cash, available deposits with banks and other credit
institutions as cash and cash equivalents.
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2.12 - Share capital
Ordinary shares are classified as equity.
Transaction costs which are directly attributable to the
issuance 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:
• 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 accounting
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
between any net income from the disposal and its reported
value, 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 expensed 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 remain an
employee of the company for a specified period),
• including the effect of non-vesting conditions (e.g., a
requirement 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 reporting
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 remeasured
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 policy
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 1,404 (2,470) and kUSD 3 (131) in the form
of outstanding trade payables. 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 2023 would have
been approximately SEK -19.3 million and SEK 19.3 million
(-22,9 and 22.9, respectively) lower/higher.
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In addition to trade payables in EUR and USD, the company have EUR and USD currency accounts
which on 31 December 2023 had a balance of kEUR 6,304 (7,156) and kUSD 692 (2,790). If the
Swedish krona had weakende/strenghened by 10 per cent against the EUR and USD with all other
variable held constant, the effect on profit/loss for the year and equity on 31 December 2023
would have been approximately SEK -8.0 million and SEK 8.0 million (-10.4 and 10.4 respectivly)
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 0 (237,095) refers to investments 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.
(b) Credit risk
Credit risk in Cantargia arises through deposits and investments 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 preclinical and clinical studies will require significant
costs and the company’s development of its product candidate could prove to be more time- and
cost-consuming than planned. Cantargia will also continue to need significant capital for research
and development in order to conduct preclinical and clinical studies with nadunolimab and for its
continued research and development of CAN10 and CANxx. Access to and the terms and
conditions for further financing are affected by several factors, such as the possibility of
concluding partnership agreements 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 significant negative impact on the company’s operations, financial
position and results.
Cantargia uses rolling forecasts to ensure that the company has sufficient cash assets to meet
its operational requirements. 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 interest-bearing current accounts. At the balance sheet date,
Cantargia had short-term investments in twelve month fixed-rate accounts of kSEK 55,000 (0)
and kSEK 0 (237,095) invested in a short-term fixed income fund. In addition to this, Cantargia
had bank deposits of kSEK 139,747 (189,573) at the balance sheet date.
The following table shows an analysis of Cantargia’s financial liabilities by remaining maturity
from the balance sheet date. The amounts indicated in the table are the contractual,
undiscounted cash flows.
31 December 2023 Less than 2 months More than 2 months Total
Trade payables 23,173 - 23,173
Other liabilities 802 - 802
Total 23,975 - 23,975
31 December 2022 Less than 2 months More than 2 months Total
Trade payables 37,910 - 37,910
Other liabilities 1,025 - 1,025
Total 38,935 - 38,935
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(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 2023, Cantargia’s strategy, which remained unchanged from 2022, was to secure the
company’s ability to continue as a going concern by running the company’s research projects in an
optimal manner and thereby generate 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 company’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.
NOTE 4 - Critical accounting estimates and judgements
The preparation of financial statements and application of accounting policies are often based
on judgements, estimates and assumptions made by management that are deemed reasonable
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 circumstances. 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 reporting 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 criteria for capitalization can be considered to be met.
Tax losses
There is no expiration date which limits the use of the company’s tax losses. It is, however,
uncertain at what point in time it will be possible to use these tax losses to offset taxable profits,
as the company has not yet generated any profits. The deferred tax asset arising from the tax
loss has therefore 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 options 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 Black & Scholes model and Monte Carlo
simulation. Important 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 complete
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 perspective. 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 responsible for the allocation of resources and the evaluation of results. The
CEO receives reports containing financial information 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 constitute a single
operating segment.
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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.
2023 2022
PwC
Audit engagement* 375 270
Audit services in addition to audit engagement 0 60
Tax advisory services 97 30
Other services 121 127
Total 593 487
* Audit engagement refers to fees for the statutory audit, i.e. work that has been necessary to produce the auditor’s report.
NOTE 7 - Employee benefits, etc.
Salaries and other benefits and social security contributions
(employees)
2023 2022
Salaries and other benefits* 26,257 31,300
Social security contributions ** 4,825 5,095
Retirement benefit costs, defined contribution 5,898 6,425
Other personnel expenses 576 498
Total employee benefits 37,557 43,317
* Whereof share-based incentives 4,404 (4,819)
** Whereof share-based incentives 95 (-868)
2023
Salaries and other benefits
(of which bonuses)
Retirement
benefit costs
Directors, CEO and other senior executives 19,114 3,481
Other employees 13,316 2,417
Total 32,430 5,898
(2,964)
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)
Average number of employees 2023 2022
Number of
employees Of which men
Number of
employees Of which men
Sweden 24 10 27 11
Total 24 10 27 11
Gender distribution for Directors and
other senior executives
2023 2022
Number at
balance sheet
day Of which men
Number at
balance sheet
day Of which men
Directors 5 4 8 5
CEO and other senior executives
7 5 8 5
Total 12 9 16 10
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NOTE 8 - Operating leases
2023 2022
Lease payments expensed during the financial year 2,429 2,035
The distribution of the nominal value of future minimum lease payments under non-cancellable leases is as follows:
2023 2022
Due within one year 3,467 2,130
Due after more than one year but within five years 3,099 4,494
Due after more than five years - -
Total 6,566 6,624
Lease expenses refer to rent for premises and office equipment.
NOTE 9 - Other operating expenses
2023 2022
Foreign exchange losses, trade payable -2,252 -1,899
Total -2,252 -1,899
NOTE 10 - Financial income and expense
2023 2022
Interest income and similar income
Interest income 4,265 388
Profit on sale of short-term investments 5,664 -
Foreign exchange gains, currency accounts 6 433 9,352
Total 16,362 9,740
2023 2022
Interest expense and similar charges
Other interest expense -1 -4
Currency exchange losses, currency accounts -6,372 -
Total -6 ,372 -4
NOTE 11 - Income tax
2023 2022
Current tax
Current tax on profit for the year - -
Adjustments relating to prior year - -
Total current tax/income tax - -
The difference between the reported tax expense and the applicable tax rate is explained by the following table.
2023 2022
Reconciliation of reported tax for the year
Loss before tax -280,027 -371,814
Reported tax for the year
Tax at applicable tax rate 20,6% 57,686 76,594
Tax effect of non-deductible expenses -178 -171
Tax effect of non-taxable income - -
Tax effect of deductible expenses recognised directly in equity 948 5,469
Tax losses for which no deferred tax asset has been recognised -58,455 -81,892
Reported tax for the year 0 0
2023 2022
Tax losses
Unused tax losses for which no deferred tax asset has been recognised 1,664,031 1,380,267
Potential tax benefit, 20,6% 342,790 284,335
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.
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NOTE 12 - Net foreign exchange difference
Foreign exchange differences have been recognised in the state-
ment of comprehensive income as follows: 2023 2022
Other operating expenses (Note 9) -2,252 -1,899
Interest expense and similar charges (Note 10) 62 9,352
Total -2,190 7,453
NOTE 13 - Long-term liabilities
31 Dec 2023 31 Dec 2022
Provision for social security contributions, incentive program 119 24
Total 119 24
NOTE 14 - Short-term investments
31 Dec 2023 31 Dec 2022
Fixed-rate account, Sparbanken Skåne & SBAB 55,000 -
Liquidity funds, Sparbanken Skåne - 237,095
Total 55,000 237,095
Fixed rate account Sparbanken Skåne, 31 Dec 2023, 40 MSEK fixed 6 months, 3.65% interest.
Fixed rate accounts SBAB, 31 Dec 2023, 15 MSEK fixed 6 månader, 4.20% interest.
NOTE 15 - Cash and cash equivalents
Cash and cash equivalents in the statement of cash flows include
the following: 31 Dec 2023 31 Dec 2022
Available bank deposits
SEK 60,604 80,116
EUR 69,951 79,656
USD 6,948 29,122
GBP 1,616 445
CHF 2 34
NOK 24 200
DKK 601 -
Total 139,747 189,573
NOTE 16 - Share capital
Ordinary shares
Number of shares
(thousands) Share capital
1 January 2022 100,193 8,015
Issue of new shares 66,795 5,344
31 December 2022 166,988 13,359
1 January 2023 166,988 13,359
Issue of new shares 16,699 1,336
31 December 2023 183,687 14,695
At 31 December 2023, the share capital consisted of 183,686,684 shares with a quotient value of SEK 0.08 per share. Each share carries
one vote. 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. All shares issued by the parent company are fully paid up.
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NOTE 17 - Accrued expenses and deferred income
31 Dec 2023 31 Dec 2022
Accrued salaries and social security contributions 1,811 2,011
Project expenses 24,129 38,204
Other accrued expenses 4,936 5,598
Total 30,877 45,813
NOTE 18 - Remuneration to senior executives and other related party disclosure
Remuneration of senior executives 2023 2022
Salaries and other short-term benefits* 16,894 16,846
Post-employment benefits 3,481 3,375
Other long-term benefits - -
Termination benefits - -
Total 20,374 20,222
* Whereof share-based incentives 2,964 (2,575)
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. Decisions
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 2023 are described in the Director’s report.
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 executives for the year 2023 amounted to SEK 519 (762) thousand.
Directors’ fees
The Directors’ fees approved at the Annual General Meeting on 23 May 2023 are SEK 575,000 to
the Chairman of the Board and SEK 260,000 to each of the other Directors. For the Remuneration
Committee, a fee of SEK 50,000 is paid to the committee chairman and SEK 25,000 to each of the
other members, for the Audit Committee SEK 100,000 is paid to the committee chairman and SEK
50,000 to each of the other members and for the Drug Development Committee SEK 250,000
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 2023
and is specified on the next page.
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2023 Fee Basic salary
Variable
remuneration
Retirement benefit
cost Other benefits
Share-based
incentives
Social sec
contributions* Total
Magnus Persson, Chairman 650 - - - - - 204 854
Anders Martin-Löf, Director 360 - - - - - 113 473
Flavia Borellini, Director 550 - - - - - - 550
Damian Marron, Director 350 - - - - - - 350
Magnus Nilsson, Director 310 - - - - - 32 342
Göran Forsberg, CEO - 2,378 635 972 24 1,017 378 5,403
Total, Board and CEO 2,220 2,378 635 972 24 1,017 727 7,972
Other senior executives* - 9,076 1,373 2,509 127 2,415 1,114 16,614
Total 2,220 11,454 2,008 3,481 151 3,432 1,841 24,586
*Contains invoiced compensation for a senior executive.
2022 Fee Basic salary
Variable
remuneration
Retirement benefit
cost Other benefits
Share-based
incentives
Social sec
contributions* 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** - 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.
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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.
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 previously 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, would conduct 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. The agreement did not result in any costs during 2023.
Cantargia has also been 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 was a member of Cantargia’s Board of Directors until the AGM in 2023
and was therefore considered as an insider at Cantargia. The CANFASTER programme 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.
The following transactions have been made with related parties:
Sale of services 2023 2022
Lunds Universitet (Gunilla Westergren-Thorsson) 0 650
Lunds Universitet (Karin Leandersson) 519 651
Total 519 1,301
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.
Incentive scheme
At the Annual General Meeting of the Company on May 23, 2023, the shareholders decided
to introduce a variable share-based incentive scheme for 2023 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 under
which participants commit to use distributed variable cash remuneration 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
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
achievement 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 required 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 2023 is capped at 10 per cent of
his or her fixed annual salary. The total size of the scheme for 2023 is capped at SEK 2,200,000
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 2023 amounted to SEK 519 (762) thousand
and the total outcome for all employees amounted to SEK 718 (1,481) thousand.
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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 1.1 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 1.5 per
cent.
Employee Stock Option Scheme 2023/2026
At the Annual General Meeting on 23 May 2023, the shareholders approved the introduction
of Employee Stock Option Scheme 2023/2026. 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 shares of the company at a pre-defined price. The price per share
will be determined as 130 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 1.6 per cent.
Summary of total cost for incentive programs
2023 2022
Share-based remuneration -4,405 -4,819
Provision for social security contributions, incentive programs -95 868
Total -4,499 -3,951
Summary of provisions for social security contributions for share-based remuneration*
Long-term liabilities 2023 2022
Amount at the start of the year 24 892
Provisions for the year 95 -868
Total long-term liabilities 119 24
* All provisions have a term of more than 1 year, which is why all provisions are long-term.
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Changes in existing incentive programs (number of options) 2023 2022
1 January 3,069,333 3,170,333
Granted instruments
Employee stock option program 2020/2023 - -
Employee stock option program 2021/2024 1,406,000 260,000
Employee stock option program 2023/2026 - -
Lapsed instruments
Employee stock option program 2020/2023 -369,000 -110,000
Employee stock option program 2021/2024 -9,000 -251,000
Employee stock option program 2023/2026 - -
Total change 1,028,000 -101,000
31 December 4,097,333 3,069,333
Number of shares granted instruments may entitle to* 2023-12-31 2022-12-31
Employee stock option program 2020/2023 2,827,200 2,100,400
Employee stock option program 2021/2024 2,089,600 1,582,800
Total number of shares granted instruments may entitle to 4,916,800 3,683,200
* Recalculation of employee stock option programs after the rights issue in 2022 means that each option in employee option program
2021/2023 and 2021/2024 entitles to 1.2 share. Each option in employee option program 2023/2026 entitles to 1.0 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,
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% 1,583,333 100%
2020/2023:2 2020-07-10 2025-07-10 7.44 27.68 50% 60,000 100%
2020/2023:3 2021-02-04 2026-02-04 16.55 73.12 49% 71,333 99%
2020/2023:4 2021-02-24 2026-02-24 15.57 70.99 49% 26,667 100%
2021/2024:1 2021-09-17 2026-09-17 7.28 30.62 53% 975,000 76%
2021/2024:2 2021-11-10 2026-11-10 5.48 20.44 55% 30,000 71%
2021/2024:3 2022-02-09 2027-02-09 7.57 22.52 55% 70,000 63%
2021/2024:4 2022-08-29 2027-08-29 1.63 7.20 63% 0 45%
2021/2024:5 2023-02-22 2028-02-22 4.30 7.63 72% 1,256,000 28%
2021/2024:6 2023-04-24 2028-04-24 2.98 10.50 73% 25,000 23%
*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 means that each option in employee option program
2021/2023 and 2021/2024 entitles to 1.2 share. Each option in employee option program 2023/2026 entitles to 1.0 share.
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 2023 or 2022, as a
conversion of warrants into ordinary shares would result in a lower loss per share.
2023 2022
Profit/loss for the period attributable to parent company shareholders -280,027 -371,814
Total -280,027 -371,814
Weighted average number of outstanding ordinary shares (thousands) 169,771 128,024
Earnings per ordinary share, SEK -1.65 -2.90
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NOTE 21 - Appropriation of retained earnings
The Annual General Meeting is asked to decide on the appropriation of the following earnings (SEK)
Loss brought forward - 1,242,455,507
Share premium account 1,676,529,714
Loss for the year -280,027,215
The Board of Directors proposes that the following sum be carried forward: 154,046,992
The Board of Directors proposes that no dividend be paid for the financial year 2023.
NOTE 22 - Events after the end of the reporting period
• The initial results from the ongoing clinical phase I study of CAN10 indicate that the antibody
binds to the target IL1RAP and demonstrates good safety. The study is proceeding as planned.
•
New clinical and preclinical findings show that nadunolimab can reduce neuropathy, which is
a serious side effect of treatment with chemotherapy and antibody drug conjugates (ADCs).
• Regulatory approval was obatained in the US to inititate the pahse IIb study with
nadunolimab in pancreatic cancer.
• New data were reported highlighting how nadunolimab can induce anti-tumor activity
in pancreatic cancer by blocking the onset of fibrosis. THe data will be presented at the
American Association for Cancer Research (AACR) 2024.
• In March, progress was reported towards the start of the DoD-sponsored clinical trial of
nadunolimab in leukemia.
• In April, three scientific articles were published on CAN10 within atherosclerosis, systemic
sclerosis, and the antibody’s mechanism of action.
NOTE 23 - Adjustments for non-cash items
2023 2022
Depreciation -3,451 -3,692
Employee option program -4,499 -3,951
Total -7,951 -7,643
NOTE 24 - Costs by nature of expense
2023 2022
Project costs -220,479 -306,691
Other external expenses -26,278 -25,951
Personnel expenses -37,557 -43,317
Other operating expenses -2,252 -1,899
Depreciation -3,451 -3,692
Total -290,017 -381,549
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
BioWa Inc.
Cantargia signed a licensing agreement with BioWa Inc. (”BioWa”) in 2015. Under the
agreement, Cantargia is granted a nonexclusive 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 milestone payments when fulfilling certain clinical, regulatory,
and commercial targets.
Patheon Biologics B.V. (en del av 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 Biotechnology 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
the process is scaled up the to 2,000 liters. Patheon is under the agreement entitled to
compensation for ongoing work, but no part of future sales revenue for nadunolimab.
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GEICAM
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. In 2021, Cantargia initiated the clinical
study TRIFOUR, which is conducted at around 20 hospitals in Spain in collaboration with
GEICAM. The treatment in the phase I part commenced in early 2022 and was concluded in
February 2023. Currently, the randomized pahse II part of the study is ongoing.
NOTE 26 - Tangible assets
Machinery and other technical facilities 2023 2022
Ingoing accumulated acquisition value 14,143 7,070
Investments 0 7,072
Outgoing accumulated acquisition value 14,143 14,143
Ingoing accumulated depreciation -7,269 -4,714
Depreciation -2,357 -2,553
Outgoing accumulated depreciation -9,627 -7,269
Closing balance 4,515 6,874
Fixtures, tools and installations 2023 2022
Ingoing accumulated acquisition value 1,101 1,084
Investments - 17
Outgoing accumulated acquisition value 1,101 1,101
Ingoing accumulated depreciation -580 -342
Depreciation -192 -238
Outgoing accumulated depreciation -771 -580
Closing balance 329 521
NOTE 27 - Intangible assets
Patent 2023 2022
Ingoing accumulated acquisition value 8,111 8,111
Investments - -
Outgoing accumulated acquisition value 8,111 8,111
Ingoing accumulated depreciation -2,553 -1,652
Depreciation -901 -901
Outgoing accumulated depreciation -3,454 -2,553
Closing balance 4,657 5,558
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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 2024.
Lund den 17 april 2024
Magnus Persson
Chairman
Ander Martin-Löf
Director
Flavia Borellini
Director
Damian Marron
Director
Magnus Nilsson
Director
Göran Forsberg
CEO
Our audit report was submitted on April 18 2024.
Öhrlings PricewaterhouseCoopers AB
Mikael Nilsson
Authorized auditor
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Auditor’s report
Report on the annual accounts
Opinions
We have audited the annual accounts of Cantargia AB (publ) for
the year 2023. The annual accounts and of the company are
included on pages 32-64 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 company
as of 31 December 2023 and its financial performance and
cash flow for the year then ended in accordance with the
Annual Accounts Act. The statutory administration report is
consistent with the other parts of the annual accounts and
consolidated accounts.
We therefore recommend that the general meeting of
shareholders adopts the income statement and balance sheet
for the parent company and the group.
Our opinions in this report on the annual accounts and
consolidated accounts are consistent with the content of
the additional report that has been submitted to the parent
company’s audit committee in accordance with the Audit
Regulation (537/2014) Article 11.
Basis for Opinions
We conducted our audit in accordance with International
Standards on Auditing (ISA) and generally accepted auditing
standards in Sweden. Our responsibilities under those
standards are further described in the Auditor’s Responsibilities
section. We are independent of Cantargia AB (publ) in
accordance with professional ethics for accountants in Sweden
and have otherwise fulfilled our ethical responsibilities in
accordance with these requirements. This includes that, based
on the best of our knowledge and belief, no prohibited services
referred to in the Audit Regulation (537/2014) Article 5.1 have
been provided to the audited company or, where applicable, its
parent company or its controlled companies within the EU.
We believe that the audit evidence we have obtained is
sufficient and appropriate to provide a basis for our opinions.
Our audit approach
Audit scope
Cantargia is a research-based biotechnology company that
conducts research and development of antibody-based
therapy against severe diseases. The most significant balance
sheet items are bank funds and short-term investments. The
largest cost item in the company consists of research and
development costs, which is why we have assessed that this is
a key audit matter.
We designed our audit by determining the level of materiality
and assessing the risk of material misstatement of the financial
statements. We particularly considered the areas where the
Board of Director’s and the Managing Director made subjective
judgments, for example important accounting estimates that
have been made based on assumptions and forecasts about
future events, which are inherently uncertain.
As with all audits, we have also taken into account the risk of
of the Board of Director’s and the Managing Director overriding
the internal control, and considered, among other things,
whether there is evidence of systematic deviations that have
given rise to the risk of material inaccuracies as a result of
irregularities. We adapted our audit to carry out an appropriate
review in order to be able to express an opinion on the financial
statements as a whole, taking into account the company’s
structure, accounting processes and controls as well as 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
assurance whether the financial statements are free from
material misstatement. Misstatements may arise due to
fraud or error. They 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
consolidated financial statements.
Based on our professional judgement, we determined
certain quantitative thresholds for materiality, including the
overall materiality for the financial statements as a whole.
These, together with qualitative considerations, helped us
to determine the scope of our audit and the nature, timing
and extent of our audit procedures and to evaluate the effect
of misstatements, both individually 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.
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Other Information than the annual accounts
This document also contains other information than the annual
accounts and is found on pages 1-31 and 70-82. 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.
Key audit matter How our audit considered the key audit matter
Costs related to research and development – accrual and
completeness
The costs for the company’s activities in research and
development during the financial year 2023 amounted to
a total of approx. SEK 273 million, which corresponds to
approx. 94% of the company’s total operating costs. The costs
mainly consist of personnel-related costs and external costs
for the clinical work that is carried out.
In our audit, we have focused on these costs as they amount
to a significant amount and that there is a risk regarding the
completeness and accrual and accuracy of the expenses.
Our examination of the costs for research and development
has included, but is not limited to, the following measures:
• Obtained an understanding of the company’s routines,
operational follow-up and internal control.
• Testing of internal controls for approval of payment of
invoices and salaries.
• Reconciled and carried out detailed testing against
invoices and other closing documentation.
• Based on selection, we have requested and received
external confirmation from suppliers on the financial
year’s purchases and respective size of outgoing
accounts payable per 231231.
• Performed detailed testing of salaries. Analyzed costs
based on our knowledge of the business and follow-up
against internal reports.
In connection with our audit of the annual accounts, our
responsibility 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
information, 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
responsible 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
Director 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 ability to continue as a going concern. They
disclose, as applicable, matters related to going 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 realistic alternative
but to do so.
The board’s audit committee shall, without affecting the
board’s responsibilities and tasks otherwise, among other
things, monitor the company’s financial reporting.
Auditor’s responsibility
Our objectives are to obtain reasonable assurance about
whether the annual accounts as a whole are free from material
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 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
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or in the aggregate, they could reasonably be expected 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 website:
www.revisorsinspektionen.se/revisornsansvar. This description
is part of the auditor´s report.
Report on other legal and regulatory
requirements
The auditor’s examination of the administration
of the company and the proposed appropriations
of the company’s profit or loss
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 2023 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
discharged from liability for the financial year.
Basis for Opinions
We conducted the audit in accordance with generally
accepted auditing standards in Sweden. Our responsibilities
under those standards are further described in the Auditor’s
Responsibilities section. We are independent of Cantargia AB
(publ) in accordance with professional ethics for accountants in
Sweden and have otherwise fulfilled our ethical responsibilities
in accordance with these requirements.
We believe that the audit evidence we have obtained is
sufficient 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
appropriations 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 type of operations, size and risks place on the size
of the company’s equity, consolidation requirements, liquidity
and position in general.
The Board of Directors is responsible for the company’s
organization and the administration of the company’s affairs.
This includes among other things continuous assessment
of the company’s financial situation and ensuring that the
company´s organization is designed so that the accounting,
management of assets and the company’s financial affairs
otherwise are controlled in a reassuring manner. The Managing
Director shall manage the ongoing administration according to
the Board of Directors’ guidelines and instructions 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 reassuring 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
assurance 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 omission
which can give rise to liability to the company
• in any other way has acted in contravention of the
Companies Act, the Annual Accounts Act or the Articles of
Association.
Our objective concerning the audit of the proposed
appropriations 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 Companies Act.
A further description of our responsibility for the audit of the
administration is available on Revisorsinspektionen’s website:
www.revisorsinspektionen.se/revisornsansvar. This description
is part of the auditor’s report.
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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 Director
have prepared the annual accounts in a format that enables
uniform electronic reporting (the Esef report) pursuant to
Chapter 16, Section 4(a) of the Swedish Securities Market Act
(2007:528) for Cantargia AB (publ) for the financial year 2023.
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
reporting.
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 section. We
are independent of Cantargia AB (publ) in accordance 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
responsible for the preparation of Esef report in accordance
with the Chapter 16, Section 4(a) of the Swedish Securities
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 achieve
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 firm applies International Standard on Quality
Management 1, which requires the firm to design, implement
and operate a system of quality management including policies
or procedures regarding compliance with ethical requirements,
professional standards and applicable legal and regulatory
requirements.
The examination involves obtaining evidence, through various
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 audit
procedures that are appropriate in the circumstances, 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 Managing Director.
The procedures mainly include a validation that the Esef report
has been prepared in a valid XHMTL format and a reconciliation
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 2023 and has been
the company’s auditor since the 13 January 2010.
Malmö 18 April 2024
Öhrlings PricewaterhouseCoopers AB
Mikael Nilsson
Authorized Public Accountant
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Corportate 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 Corporate
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 itself
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
deviations from the Code.
Shareholders
Cantargia’s shares have been listed for trading on Nasdaq
Stockholm since 25 September 2018 (Small Cap). At 31 December
2023, the total number of shares and voting rights in the Company
was 183,686,684, represented by 17,468 shareholders.
For further information on the Company’s ownership structure and
major shareholders, see page 41-42 of the annual report.
Shareholders’ meeting
In accordance with the Swedish Companies Act, the
shareholders’ 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
income statements and balance sheets, the appropriation of
the Company’s earnings, release from liability for the members
of the Board and the Chief Executive Officer, the election 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 register
maintained by Euroclear Sweden AB six business days
before the meeting and register to attend the shareholders’
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 persons. A
shareholder has the right to vote all shares held. Each share in
Cantargia entitles the holder to one vote. Shareholders 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 Genereal Meeting of Cantargia
on 23 May 2023, the Chariman of the Board is required, prior to
the Annual Genereal Meeting 2024, to convene a Nomination
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 av Fjärde AP-fonden
• Daniel Kristiansson, appointed by Alecta Pensionsförsäkring
Ömsesidigt
• Mats Larsson, appointed by Första AP-fonden
• Magnus Persson, Chariman 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 3 meetings prior to
the Annual General Meeting 2024. The Nomination Committee’s
complete proposals for the 2024 AGM will be published in
connection with the notice of AGM.
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Board of Directors
Under Cantargia’s Articles of Association, the Board of Directors
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 five ordinary Directors, including the Chairman, who
have been elected by the shareholders’ meeting until the period
of the end of the 2024 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 Company’s major shareholders. For a detailed presentation
of the Directors, see page 77 of the annual report.
Independence of Attendance
Total Director’s fee
2023, KSEK
Name Position Member since
The Company and
management
Major
shareholders Board meetings
Audit
Committee
meetings
Remuneration
Committee
meetings
Drug development
Committee meetings
Magnus Persson Chariman 2016 Yes Yes 12/12 - 2/2 3/3
650
Patricia Delaite* Director 2017 Yes Yes 5/5 - - 1/2
-
Thoas Fioretos* Director 2010 Yes Yes 5/5 - 2/2 -
-
Karin Leandersson* Director 2016 Yes Yes 5/5 3/3 - -
-
Anders Martin-Löf Director 2018 Yes Yes 10/12 5/5 - -
360
Flavia Borellini Director 2020 Yes Yes 12/12 - - 3/3
550
Damian Marron Director 2021 Yes Yes 10/12 - 2/2 -
350
Magnus Nilsson Director 2021 Yes Yes 12/12 5/5 - -
310
*Member of the Board until the Annual Genereal Meeting 2023
Responsibilities and work of the Board
Under the Companies Act, the Board of Directors is
responsible for the Company’s administration and
organisation, which means that it is responsible for adopting
goals and strategies, 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
regulate Board practices, functions, and the division of
responsibilities between the Board and CEO, and between
the Board and its committees. In connection with the
inaugural Boardmeeting 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 annually. In addition to these Board
meetings, further meetings can be convened to address
issues which cannot be deferred to the next regular meeting.
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In 2023, the Board convened on 12 occasions, including 9
Teams meetings or meeting by correspondence. The Directors’
attendance is shown in the table above. The activities of the
Board in 2023 were dominated by discussions and strategic
decisions on matters relating to the Company’s product
development, in particular its main project nadunolimab and
the development projects CAN10 and CANxx. The Board
also adopted resolutions regarding the rights issue that was
completed in 2023, the business plan with financial targets, risk
management, dividend policy and financial reports.
Board committees
The Board has established an Audit Committee, a Remuneration
Committee, and a Drug Development committee. The members
of the committees are appointed at the inaugural Board meeting
and the committees’ activities and authority 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 two members:
Anders Martin-Löf (Chairman) and Magnus Nilsson. 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 annual accounts, and on the conclusions
presented in the quality control report of the Swedish
Inspectorate of Auditors, assess and monitor 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 two
members: Damian Marron (Chairman) and Magnus Persson. The
Remuneration Committee is tasked with preparing proposals for
remuneration principles, and remuneration 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 two members: Flavia Borellini (chairman) and
Magnus Persson. The Drug Development Committee shall act as
an advisor and discussion partner for the company management
in scientific and strategic issues concerning the development of
the company’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 2023, it was resolved
that Directors’ fees of SEK 575,000 to the Chairman of the
Board and SEK 260,000 to each of the other ordinary Directors
be paid for the period until the end of the Annual General
Meeting 2024. It was also resolved that the Chairman of the
Audit Committee should receive SEK 100,000 and the other
members of the Audit Committee SEK 50,000 each, and
that the Chairman of the Remuneration Committee receive
SEK 50,000 and the other members of the Remuneration
Committee SEK 25,000 each and that the Chairman of the
Drug development Committee should receive SEK 250, 000
and the other members of the Drug development Committee
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 meeting
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 evaluation
of the work of the Board is carried out in which the Directors are
given an opportunity to present their views on Board practices,
Board meeting materials, their own and other Directors’
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 Nomination 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 considered to be good. The
Board continually evaluates the work of the Chief Executive
Officer by monitoring the Company’s progress towards the
defined goal.
Chief executive officer and management
The Chief Executive Officer reports to the Board of Directors
and is responsible for the Company’s day-to-day management
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 sufficient 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
performance, 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.
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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 79-81.
Remuneration
At the Annual General Meeting on 27 May 2020, it was resolved
to adopt guidelines for remuneration of the CEO and other senior
executives in accordance with what is stated on page 37 of the
annual report.
For information on the remuneration paid to the CEO and other
senior executives in the financial year 2023, see Note 18.
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
auditors with or without deputy auditors. The Company’s
auditors are Öhrlings PricewaterhouseCoopers AB with Mikael
Nilsson as auditor-in-charge.
For information on the remuneration to the auditor during the
financial year of 2023, see Note 6.
Authorisation to issue shares
At the Annual General Meeting of the Company on 23 May
2023, it was resolved to authorise the Board, during the period
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 outstanding 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 2023, Cantargia had three incentive schemes
for senior executives and key personnel of the Company. The
incentive schemes have been introduced to provide longerterm
incentives for the Company’s management and employees 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
2023, it was decided to introduce a variable share-based
incentive scheme for 2023, 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 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 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.
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 personnel 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 1.2 share of the Company at a predetermined
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.
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, compromising not more than
3,000,000 employee stock options. The purpose of the scheme
is to enable the company to retain skilled personnel through a
longterm incentive scheme.
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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 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.
Employee Stock Option Scheme 2021/2024
At the Annual General Meeting on 23 May 2023, the
shareholders approved the introduction of Employee Stock
Option Scheme 2023/2026, compromising not more than
3,000,000 employee stock options. The purpose of the scheme
is to enable the company to retain skilled personnel through a
longterm 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 130 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
Dilution
To enable the Company to deliver shares to participants
in Employee Stock Option Scheme 2020/2023, 2021/2024 as
well as 2023/2026 in a simple and cost-effective manner, the
AGM resolved to approve a directed issue of 7,900,000 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 4.1 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, formalised
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 reasonable degree of certainty that
the Company’s external financial reports are reliable and correct
and have been prepared in accordance with generally accepted
accounting policies, applicable laws, and regulations as well as
other requirements applying to companies listed on Nasdaq
Stockholm.
The Company monitors, follows and manages any risks in
accordance with a risk management and corporate governance
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 reporting. 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, governing
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 accounting manual
and the authorisation manual. The Company’s policies and
governing documents are evaluated on an ongoing 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 Company’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 assess 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 proposals for the
management of the Company’s financial risk exposure and risk
management.
1
Committee of Sponsoring Organizations of the Threadway Commission.
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Control environment and risk assessment
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 governing
documents in the form of internal policies, guidelines and
instructions for financial reporting are made available 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 external communication.
The Board is responsible for control and monitoring of the
CEO’s risk management activities. This is done through reviews
and monitoring of the Company’s governing documents
related to risk management and, for example, through reviews
and assessments by the Board of adopted 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.
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 2023 (the financial year)
on pages 71-76 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
different 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
paragraph 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 18 April 2024
Öhrlings PricewaterhouseCoopers AB
Mikael Nilsson
Authorized Public Accountant
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Board of Directors,
senior executives,
and auditors
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, 2023, it was resolved that the
Board should consist of five ordinary
Directors with no deputies. The board
members are elected for the period until
the end of the 2024 Annual General
Meeting.
77
Chairman of the Board since 2016, born 1960.
Member of the Remuneration 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 development
teams in clinical phase II and phase III programmes in the
pharmaceutical industry and has founded and led private
as well as public biotech and medtech companies, 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 Eir Ventures Partners
AB and associated companies, Attgeno AB, Initiator Pharma
AS, and Board Member of Avalo Inc.
Independent in relation to the Company and its
management and the Company’s major shareholders.
Board member since 2018, born 1971.
Chairman of the Audit Committee.
Number of shares: 50,000
Anders Martin-Löf is the 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 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 Companys major shareholders.
Magnus
Persson
Anders
Martin-Löf
Board of Directors
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Board member since 2020, born 1959.
Chairman 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,
Program 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 Companys major shareholders.
Board member since 2021, born 1956.
Member of the Audit Committee.
Number of shares: 100,000
Magnus Nilsson is founder, previously President and CEO at
XVIVO Group. 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 and
is Chairman of the Board of Directors at Mentice AB.
Nilsson is PhD in Medicine from Uppsala University and has
published over twenty scientific articles.
Independent in relation to the Company and its
management and the Companys major shareholders.
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 positions as CEO and Executive Vice President
in several biotech companies. He is currently Chairman
of the Board of Targovax ASA, Imophoron Ltd, Indegra
Therapeutics Ltd and Board Member of Resolys Bio Inc. and
Onya Therapeutics Ltd, 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 Companys major shareholders
Flavia
Borellini
Magnus
Nilsson
Damian
Marron
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CEO employed since 2014, born 1963.
Holdings: 304,412 shares and 1,220,000 options
Göran Forsberg has a PhD in biochemistry and is associate
professor and author 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).
COO employed since 2014, born 1963.
Holdings: 70,166 shares and 475,000 optioner
Liselotte Larsson has a PhD in biotechnology and has
over 25 years of experience in various management
positions in pharmaceutical and biotechnology companies
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.
VP Clinical Development employed since 2015, born 1961.
Holdings: 141,349 shares and 435,000 optioner
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 evaluation and
documentation of new substances and has the experience
of regulatory activities and interactions with health
authorities.
Göran
Forsberg
Liselotte
Larsson
Lars
Thorsson
Management
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CSO employed since 2015, born 1969.
Holdings: 25,194 shares and 475,000 options
David Liberg graduated with a PhD in 2001 and has
over twentyfive years of research experience within
immunology and tumour biology. Liberg has worked within
the pharmaceutical industry for the last eighteen years,
with responsibility for early research projects and activities
in tumour 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.
VP Biometrics employed since 2021, born 1969.
Holdings: 25,750 shares and 330,000 options
Nedjad Losic holds an MSc in Mathematics and a diploma
in Management of Medical Product Innovation (SIMI). Losic
has over 25 years of experience in providing biostatistics
expertise in clinical drug development, mostly in antibody
development and oncology. Losic has been directly involved
in the planning and obtaining market approvals for several
biological drugs at Genmab and Y-mAbs Therapeutics. He
has previously held managerial positions and worked for
Ferring, Spadille, Genmab and Y-mAbs.
CMO employed since 2022, born 1962.
Holdings: 0 shares and 0 options
Dominique Tersago is MD and has over 25 years of
experience in the biotech/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.
David
Liberg
Nedjad
Losic
Dominique
Tersago
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CFO employed since 2023, born 1970.
Holdings: 55 000 shares and 170,000 options
Patrik Renblad holds a MSc in Business Administration
and Economics from Lund University. He has more than
20 years of experience from the Life Science industry. With
a strong financial background and focus, he has served in
various roles across the pharmaceutical value chain and
across geographies for AstraZeneca, LEO Pharma and
SynAct Pharma. Prior to joining Cantargia, Renblad led
SynAct Pharmas listing on Nasdaq Stockholm in 2022
as CFO. Before that, he served 10 years at LEO Pharma,
amongst his roles were head of Research & Development
Finance unit and local CFO for the Chinese affiliate in
Shanghai.
Patrik
Renblad
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 potential 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 participated or been involved in any bankruptcy, liquidation or
administration proceedings in the capacity of Director or senior 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,
professional association or similar body, been disqualified from engaging 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 2023, Öhrlings
PricewaterhouseCoopers AB were re-appointed as auditors for the
Company for the period until the end of the Annual General Meeting
2024. Mikael 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 calendar
Cantargia’s Annual General Meeting will be held on Tuesday 23 May 2024.
Shareholders who wish to participate in the Annual General Meeting must
be registered in the share register maintained by Euroclear Sweden AB as of
Wednesday 15 May 2023 and register with the company no later than Friday
17 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]om.
The board has decided that shareholders may exercise their voting rights at the
annual general meeting by postal voting. Shareholders may thus exercise their
voting rights at the meeting through physical attendance, by proxy, or by postal
voting. See more information in the notice to the meeting.
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 15 May 2024.
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 15 May 2024 will be entered in the share register.
2024-05-21 Interim Report January-March 2024
2024-05-23 Annual Genereal Meeting
2024-08-28 Half-year report April-June 2024
2024-11-15 Interim Report July - September 2024
2025-02-21 Year-end report for 2024
Cantargia AB
Scheelevägen 27
SE-223 63 Lund, Sweden
Telephone: +46(0)46 2756260 | E-mail: info@cantargia.com
www.cantargia.com