Precision Surgery
Improving Outcome for
Cancer Patients
Annual
Report
2024
FluoGuide A/S
CVR no. 39296438
Titanhus, Titangade 9-13
DK - 2200 Copenhagen N
ANNUAL REPORT 2024
2
IN THIS REPORT
COMPANY INFORMATION & MANAGEMENT REVIEW ............................................................. 3
CEO LETTER – PROGRESS AND PARTNERSHIPS ........................................................................ 4
FINANCIAL HIGHLIGHTS ............................................................................................................ 6
HIGHLIGHTS 2024 ..................................................................................................................... 7
FLUOGUIDE ............................................................................................................................... 8
FG001 PIPELINE ...................................................................................................................... 10
2025 OUTLOOK ....................................................................................................................... 11
MANAGEMENT ....................................................................................................................... 12
SHAREHOLDER INFORMATION ............................................................................................... 14
FINANCIAL DEVELOPMENT ..................................................................................................... 16
MANAGEMENT STATEMENT ON THE ANNUAL REPORT ........................................................ 18
INDEPENDENT AUDITOR’S REPORT ........................................................................................ 19
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME ............................... 22
BALANCE SHEET ...................................................................................................................... 23
STATEMENT OF CHANGES IN EQUITY ..................................................................................... 24
CASH FLOW STATEMENTS ...................................................................................................... 25
NOTES ..................................................................................................................................... 27
"2024 was a pivotal year for
FluoGuide, marked by a new
strategic partnership,
advancements in FG001’s
therapeutic potential and
successful capital raise."
Morten Albrechtsen, CEO
ANNUAL REPORT 2024
3
COMPANY INFORMATION
& MANAGEMENT REVIEW
In this document, the following definitions shall apply unless otherwise specified:
“the Company” or “FluoGuide” refers to FluoGuide A/S, with CVR number 39 29
64 38. Figures in ‘()’ refer to the same period last year.
The Company
Company address: Postal address:
CVR no.: 39 29 64 38
Board of Directors
Peter Mørch Eriksen (Chairman)
Mats Thorén (Vice Chairman)
Andreas Kjær
Michael Engsig
Donna Haire
Executive Management
Morten Albrechtsen, CEO
Ole Larsen, CFO
Auditors
CVR-no. DK 33 77 12 31
NASDAQ
FluoGuide is listed on Nasdaq First North Growth Market, Sweden (FLUO).
ANNUAL REPORT 2024
4
CEO LETTER – PROGRESS AND PARTNERSHIPS
FluoGuide is dedicated to help patients with
cancer by improving precision surgery. Our lead
product, FG001, has been clinically proven to light
up cancer and guide surgeons in performing more
precise surgeries.
Clinical trials confirm FG001s effect
Clinical trials have demonstrated that FG001 not
only effectively lights up various cancers but is also
well-tolerated by patients. Scientific data
indicates FG001 broad potential across all solid
cancer types.
In addition to its role in guiding surgery, FG001
also shows potential as a therapeutic tool. When
exposed to specific light, it actively destroys
cancer tissue demonstrated in pre-clinical models.
This capability has the potential to significantly
improve treatment outcomes for patients with
cancer, representing a meaningful advancement
for both patients and shareholders.
Unlocking growth and partnering
Our strategy focuses on brain tumors and head
and neck cancer; two complementary indications
that together offer significant growth potential
and the potential for early partnership
opportunities.
The market for brain tumor surgery has a low
entrance barrier, with patients having a high
unmet medical need for precision surgery,
specialized surgeons and available equipment.
The market for head and neck cancer surgery,
offers numerous partnership opportunities with
equipment manufacturers interested in
expanding in this market to enable surgery of
patients with difficult to reach cancer.
To support the continued development of FG001
for brain tumors and head and neck cancer, we
successfully completed a directed share issue in
2024, raising SEK 60 million with strong
participation from both new institutional
investors and existing shareholders.
Strong progress in both head and neck, and brain
cancer
Our efforts in head and neck cancer have
progressed significantly in the last year. The
positive Phase II data (FG001-CT-003) published in
Theranostics in November 2024 further detailed
FG001’s ability to light up solid tumors and
revealed a range of different ways FG001 can help
patients with head and neck cancers. A key
milestone was the successful submission of a
Clinical Trial Application for FG001 in head and
neck cancer (FG001-CT-005). The clinical trial is
designed to assess the utilization of FG001 in
combination with various types of surgical
equipment and regulatory endpoints, paving the
way for further collaborations with surgical
equipment manufacturers.
In brain cancer, we have also made strong
progress, working closely with key opinion leaders
and regulators in preparation for registration trials
in high-grade glioma. To advance FG001’s
photosensitizer therapy, we have selected a laser
system designed to deliver the precise light
needed to activate FG001, ensuring seamless
integration from clinical development to
commercialization. This therapeutic potential
opens new treatment possibilities, whether in
combination with surgery or as an additional tool
for surgeons to target local cancer recurrence and
inoperable tumors.
High-Grade Gliomas (HGG) are aggressive, life-
threatening brain tumors with limited treatment
options. Advancing therapies for this population is
crucial to improving survival and quality of life.
While 5-10% of brain cancer patients are
diagnosed with HGG, the remaining 90-95%
currently have no treatment options to assist in
guiding surgery, highlighting the broader need for
innovation in brain tumor management. An
investigator-led trial has been initiated in
ANNUAL REPORT 2024
5
meningioma and low-grade glioma, which are
frequent and important types of brain cancer,
with the first results expected in during first half of
this year.
Partnerships
Partnerships are essential to advancing
FluoGuide’s mission. By collaborating with leading
technology companies specializing in various
types of surgical equipment, we enhance
treatment options for patients undergoing surgery
today and expand surgical possibilities for those
who currently lack access to such procedures. At
the same time, we are broadening the
applications of FG001.
In 2024, we partnered with Intuitive Surgical, a
global leader in robotic-assisted surgery.
Together, we are collaborating to integrate FG001
with Intuitive Surgical’s technology to improve
surgical outcomes for patients with cancer and
extend surgical options to more patients.
This collaboration opens new treatment
possibilities for patients who are not currently
offered surgery due to the complexity of the
location of their cancer. This includes e.g. patients
with head and neck cancers located deep in the
throat. For patients with this type of cancer,
chemo-radiotherapy is typically the only
treatments option, which can cause significant
side effects. By combining FG001 with robotic-
assisted surgery, we aim to provide an additional
treatment option that offers these patients better
and more effective treatment.
FluoGuide utilizes the ongoing head and neck trial
exploring new partnership opportunities to
advance surgical innovation and expand
treatment options for cancer patients.
Preparing our team for registration trials and
approvals
In 2024, we strengthened our team to secure
excellence in late-stage clinical development,
regulatory approval, and commercialization. We
welcomed Donna Haire to our Board of Directors,
bringing extensive expertise in regulatory affairs,
operations, and R&D. Additionally, we brought on
Jens Ellrich as our Chief Medical Officer, a
seasoned medical scientist with vast experience in
biotechnology and medical devices.
With these additions to our team, we were well-
positioned to support the execution of late-stage
initiatives and drive FluoGuide toward approval
and beyond.
On track for 2025
As we move into 2025, FluoGuide is on track to
achieve key milestones as outlined in the 2025
outlook. In brain cancer, we are advancing FG001
toward FDA consultations and the initiation of
clinical trials to support registration. We are also
progressing with the development of
photothermal therapy, completing the
optimization of FG001’s combined use with the
laser system.
In head and neck cancer, our goal is to enroll the
first patient in the Phase II clinical trial (CT-005)
during Q1 and deliver interim data to guide
regulatory decisions for the registration trial.
Furthermore, we will expand our partnerships to
accelerate FG001’s commercialization.
I would like to extend our gratitude to our
shareholders, team members, and partners for
their unwavering support and dedication.
Together, we are advancing precision cancer
surgery and helping people with cancer around
the globe.
Morten Albrechtsen
CEO, FluoGuide A/S
ANNUAL REPORT 2024
6
FINANCIAL HIGHLIGHTS
KEY FIGURES 2024 2023 2022 2021 2020
DKK thousand
Income Statement
Income before interest and tax (EBIT) -33.040 -43.924 -32.461 -28.809 -22.161
Net financial items -1.419 47 -379 -461 -25
Net result for the year -28.959 -38.377 -27.340 -23.770 -17.460
Balance sheet
Total assets 28.380 29.609 35.620 53.309 16.742
Equity 23.067 12.720 31.969 38.701 4.411
Cash flow
Cash flow from:
Operating activities -29.152 -31.809 -37.645 -15.062 -8.847
Investing activities -987 -37 -117 0 -42
Financing activities 27.080 27.500 17.018 51.183 17.182
The period’s cash flow -3.059 -4.345 -20.745 36.121 8.293
Dividend 0 0 0 0 0
Ratios
Solvency ratio 81% 43% 90% 73% 26%
Earnings per share (DKK) -2,23 -3,22 -2,33 -2,15 -1,78
FluoGuide had no revenue for the period 1 January to 31
December 2024 and posted a net loss of DKK 28,959
thousand (DKK 38,377 thousand) for the period. The
financial result for the period is in line with the Company's
expectations.
For definitions of ratios, see under accounting policies.
The total number of shares as of December 31, 2024,
amounted to 13,620,149 shares. The total number of
shares as of December 31, 2023, amounted to
12,208,384 shares. The average number of shares in
2024 amounted to 12,968,268 shares.
ANNUAL REPORT 2024
7
HIGHLIGHTS 2024
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PARTNERSHIP
INTUITIVE SURGICAL
Entered a strategic collaboration with Intuitive Surgical
SEK
60 MILLION
Raised SEK 60 million through a directed share issue
2024 was a year of important achievements for
FluoGuide. We strengthened FG001’s potential
through a strategic collaboration with Intuitive Surgical
and advanced its dual capability with photothermal
therapy. A successful SEK 60 million financing round
supported our clinical development, leading to the
submission of a Clinical Trial Application (CTA) for
FG001 in head and neck cancer. The publication of
positive Phase II data providing early evidence
indicating the potential to improve surgical precision
and outcomes.
With strong clinical progress and key partnerships, we
are well-positioned for the next phase.
ANNUAL REPORT 2024
8
FLUOGUIDE
Precision surgery improving outcome for cancer patients
FluoGuide is a biotech company specializing in precision cancer surgery to improve the outcome for patients with cancer. FluoGuide's lead product, FG001, light
up cancer tissue during surgery using fluorescent light to enhance surgical accuracy. Clinical studies have confirmed that FG001’s ability to light up cancer in
patients with brain, head and neck and lung cancer, with scientific literature suggesting potential applicability across all solid cancer types. The technology aims
to improve patient outcomes by reducing the likelihood of local recurrence after surgery, reducing surgical complications, and lowering healthcare costs.
Pipeline
FluoGuide's lead product, FG001, targets a broad
market, covering over 80% of solid cancers where
precise surgical removal is essential. Each year,
approximately 20 million people are diagnosed
with cancer, of which around 60% will require
surgery
1
2
. FluoGuide aims to enhance surgical
precision for these patients and provide additional
treatment opportunities for the remaining 40%
who are not currently offered surgery. FluoGuide
primary focus are brain cancer and head and neck
cancers.
1
World Health Organization. (2024, February 1). Global cancer
burden growing, amidst mounting need for services. Retrieved
from https://www.who.int/news/item/01-02-2024-global-cancer-
burden-growing--amidst-mounting-need-for-services
2
MD Anderson Cancer Center. (2024). Surgery for cancer.
Retrieved from https://www.mdanderson.org/treatment-
options/surgery.html
3
International Agency for Research on Cancer. (n.d.). Cancer
Tomorrow: Estimated number of deaths in 2040, all cancers,
worldwide, males, all ages. Global Cancer Observatory. Retrieved
May 29, 2024, from
https://gco.iarc.who.int/tomorrow/en/dataviz/tables?mode=canc
FG001 has successfully completed a phase II clinical
trial in aggressive brain cancer, demonstrating
clinical benefit. In the study, all (12) patients had
additional cancerous tissue removed due to
FG001’s guidance. With an estimated 2.8 million
cancer tumor diagnoses annually, aggressive brain
cancer (high grade glioma) remains a major
challenge, with over 90% recurrence rate post-
surgery
3
4
5
6
.
er&group_populations=1&multiple_populations=0&cancers=20&
populations=900
4
Habbous, S., Forster, K., Darling, G., Jerzak, K., Holloway, C. M.
B., Sahgal, A., & Das, S. (2021). Incidence and real-world burden
of brain metastases from solid tumors and hematologic
malignancies in Ontario: a population-based study. Current
Oncology, 28(2), 1218-1229.
https://doi.org/10.3390/curroncol28020057
5
Ostrom, Q. T., Cioffi, G., Gittleman, H., Patil, N., Waite, K.,
Kruchko, C., & Barnholtz-Sloan, J. S. (2019). CBTRUS Statistical
Report: Primary brain and other central nervous system tumors
In head and neck cancer (Oral Squamous Cell
Carcinoma), FG001 completed a Phase II trial /CT-
003), successfully lighting up cancerous tissues in
all (16) patients. Head and neck cancers affect
approximately 950,000 people worldwide each
year, with an estimated 40% of patients requiring
surgery
7
8
. FG001's precision aims to improve
surgical resection, potentially reducing the need
for additional treatments such as chemo-
radiotherapy and its associated adverse effects.
diagnosed in the United States in 2012–2016. Neuro-Oncology,
21(Suppl 5), v1–v100. https://doi.org/10.1093/neuonc/noz150
6
Ivy Brain Tumor Center. (2023, February 24). Brain tumor
recurrence. Retrieved from
https://www.ivybraintumorcenter.org/blog/brain-tumor-
recurrence/
7
Gal TJ et al. Treatment trends in oropharyngeal carcinoma:
Surgical technology meets the epidemic. Oral Oncology, Vol 97,
2019, p 62-68
8
Cramer JD et al. The changing therapeutic landscape of head
and neck cancer. Nat. Rev. Clin. Oncol. 16, 669–683 (2019)
ANNUAL REPORT 2024
9
FG001 has shown itself to be well tolerated in
clinical studies, supporting its potential use across
multiple cancer types.
Partnerships
Since FG001 is visualized using intraoperative
imaging equipment, surgical equipment
manufacturers play a key role in its application. The
interface between FG001 and the surgical
equipment presents a significant opportunity for
synergies, enabling better surgery for more
patients with cancer. These partnerships include
manufacturers of microscopes, endoscopes, open-
field camaras, surgical robots, and excised
specimen imaging equipment – creating broad
collaboration opportunities for FluoGuide.
FluoGuide has partnered with Intuitive Surgical, a
global leader in robotic-assisted surgery, to
evaluate FG001's effectiveness in head and neck
surgeries. This collaboration also evaluates the
integration of FG001 and the technology from
Intuitive Surgical. It is a non-exclusive partnership,
allowing FluoGuide to collaborate with other
manufacturers of surgical and imaging systems.
FluoGuide has also secured a partnership with a
laser system manufacturer to support FG001’s use
in photosensitizer therapy, with promising pre-
clinical results already achieved.
9
Simón M, Jørgensen, JT, Juhl, K, Kjaer, A (2021) The use of a uPAR-
targeted probe for photothermal cancer therapy prolongs survival
FluoGuide continues to explore new collaborative
opportunities to advance surgical innovation and
expand treatment options for patients with cancer.
Photosensitizer
Beyond enhancing surgical precision, FG001 also
has photosensitizer properties
9
, enabling it to
actively destroy cancer cells when exposed to
specific light demonstrated in pre-clinical models
via two potential mechanisms.
Photothermal therapy – FG001 heats up
and burns cancer cells
Photodynamic therapy – FG001 triggers a
reaction that produces toxic molecules
deadly cancer cells.
A major advantage of FG001 as a photosensitizer is
its potential for high precision, making it suitable
for treating tumors that are difficult to remove
surgically or those embedded in critical structures
such as brain and head and neck region. FG001’s
therapeutic potential extends to most solid cancer
types.
In 2024, FluoGuide selected a laser system capable
of supporting the entire development process
from pre-clinical animal studies to
commercialization. Recent pre-clinical results have
confirmed that FG001 can selectively eliminate
in a xenograft mouse model of glioblastoma, Oncotarget,
12(14):1366-1376. doi: 10.18632/oncotarget.28013
cancerous tissue without damaging the
surrounding healthy tissue. Current efforts focus
on optimizing the dosing, timing, and application
to define clinical trial parameters.
Route to market
FluoGuide is advancing clinical studies in brain
cancer and head and neck cancer, while also
exploring FG001’s potential in photosensitizer
therapy. These efforts aim to accelerate market
entry, enhance treatment outcomes for cancer
patients, and drive long-term value for FluoGuide
shareholders.
Intellectual property protection
FluoGuide has established a strong protection
related to FG001 and, more broadly, uPAR targeted
cancer imaging agents in general. Several patent
families contribute to the protection of FG001. The
first filed patent family, issued in US and EU, last
until 2035. Additional patent families filed is being
processed around the world and is expected to
prolong the protection until 2040.
FluoGuide has been granted orphan designation in
the US for FG001 in high grade glioma which
provide potential additional market exclusivity for
seven years after approval.
ANNUAL REPORT 2024
10
’FGS’ Fluorescence guided surgery
FG001 is a uPAR target imaging agent designed to work with any standard imaging device
FG001 PIPELINE
ANNUAL REPORT 2024
11
2025 OUTLOOK
Ongoing tasks 2025 Milestones Long term objectives
Brain
FG001
-
guiding surgery of
High-Grade Glioma (HGG)
Continue development and regulatory path
towards market approval
H1: Regulatory evaluation and
consultation with FDA to confirm the
design of registration trial for FG001
as an imaging agent in guiding
aggressive brain cancer
H2: Submit application for clinical trial
First a
pproval of FG001 in US
FG001
-
guiding surgery of
additional brain tumors (e.g.
Meningioma)
Evaluate FG001 for
additional brain indications
(expand market potential by up to 20x
compared to HGG)
H1: Preliminary data from an
investigator-initiated trial involving
20 patients with meningioma and
low-grade glioma
Expand FG001 indication to target
larger part of the brain tumor market
where currently no imaging agents are
approved
FG001
-
photosensitizer
therapy for brain cancer
Evaluate and implement photosensitizer
therapy into brain cancer development
(expand potential in value by up to 20x
compared to guiding surgery)
H1: Complete optimization of the
combined use of FG001 and the laser
system in pre-clinical models
Expand FG001 as a photosensitizer to
address another large unmet medical
need and broaden market potential
Head and
neck
FG001
-
guiding surgery of
head and neck cancer
Continue development of head and neck
clinical program towards market approval
Q1: Enrolment of first patient (CT
-
005)
H2: Interim data from first 15 patients
(CT-005)
H2: Submit for regulatory feedback for
registration trial
First approval of FG001 in head and
neck
Expand FG001 indication to large
market for head and neck cancer
where currently no imaging agents are
approved
Partnering
Preparing additional
partnerships for FG001
Advancing the tasks
defined in the partnership
with Intuitive Surgical
H1: 1
-
2 additional partnerships
Facilitate commercialization with
support from partner(s)
ANNUAL REPORT 2024
12
MANAGEMENT
Board of Directors
Peter Mørch Eriksen – Chairman of the Board since 2021
Peter has more than 20 years of experience in the medtech/life science
sectors, both in Denmark and internationally. He is CEO at BioPorto A/S. His
extensive background includes key positions such as Vice President of
Medtronic in the US and Denmark. These roles have endowed Peter with a
wealth of knowledge in driving growth, executing restructuring, and securing
funding in technologically advanced and complex organizations. Peter's
professional foundation is in accounting, complemented by various
management courses. He chairs the board of Monsenso A/S, Chairman in
AptaShape ApS and Director of PMEconsult ApS. Additionally, he contributes
his expertise to the Medical Device and Diagnostics Advisory Committee of
Cincinnati Children’s Hospital Medical Center in Ohio, US.
Mats Thorén – Vice-Chairman of the Board since 2022
Mats brings 25 years of financial market experience, specializing in healthcare
through roles in equity analysis and corporate finance. He has spent 19 years
as a Healthcare investment expert, working with firms like Nalka Life Science
AB and MedCap AB, and now leads Vixco Capital. Mats holds board positions
at Xbrane BioPharma AB, Arcoma AB, Herantis Pharma Oy, BioPorto A/S and
C-Rad AB with past board roles at Duocort AB, Cellartis AB, and others. His
educational background includes Economics, focusing on Accounting and
Financial Economics, and medical studies at the Karolinska Institute in
Stockholm.
Andreas Kjær – Board member since 2018
Andreas is an MD, PhD, DMSc, and professor at the University of
Copenhagen as well as chief physician at Rigshospitalet, the National
University Hospital of Denmark. His research is focused on molecular
imaging with PET and PET/MRI in cancer and cardiovascular disease and his
achievements include development of several new tracers that have
reached first-in-humans clinical use. He is the holder of an ERC Advanced
Grant, has published 700 peer-review articles, and has received multiple
prestigious scientific awards throughout the years. Andreas also holds an
MBA from Copenhagen Business School.
Michael Engsig – Board member since 2023
Michael has extensive experience within the pharmaceutical industry with 20+
years of experience in both foreign capital markets and publicly listed
companies. This includes a successful track record in general management,
R&D, and commercial functions. Since 2019 Michael has been CEO at Nykode
Therapeutics, Norway. Michael holds a M.Sc. in chemistry with a specialization
in biotechnology from the Technical University of Denmark (DTU) and a
graduate diploma in Business Administration (HD) from Copenhagen Business
School (CBS).
Donna Haire – Board member since 2024
Donna is CEO of The Eriah Group, Inc., specializing in global regulatory, quality,
clinical, and medical affairs consulting for drugs, biologics, medical devices/in
vitro diagnostics, and combination products. With over 30 years in the
healthcare, pharmaceutical, and medical device industries, she has extensive
experience in regulatory, quality, clinical affairs, operations, business
development, and R&D. Donna is currently a Board Member at Sedana
Medical AB. She has served in executive roles at On Target Laboratories, Bayer,
AngioDynamics, Philips Healthcare, and Medtronic. Donna was also an Adjunct
Professor at the University of Akron School of Law, an AdvaMed Technical and
Regulatory Board Committee Member, and a U.S. regulatory expert for
international trade negotiations. She is a keynote speaker and panelist at
global regulatory and compliance events.
ANNUAL REPORT 2024
13
Executive Management
Morten Albrechtsen – CEO since 2018
Morten Albrechtsen is an MD and BBA (‘HD’ in marketing, CBS). Morten is a
seasoned entrepreneur with a strong medical, commercial, and financial
background. The expertise is gained within a broad range of therapeutic
areas and with both drugs and devices. Morten has developed and launched
new health care products and concepts internationally, e.g. in Nycomed
Pharma, now Takeda Pharmaceuticals Ltd., Nanovi A/S and Boehringer
Ingelheim GmbH.
Corporate Management
Andreas Kjær – CSO and CMO since 2018
Andreas Kjær is an MD, PhD, DMSc and professor at the University of
Copenhagen and chief physician at Rigshospitalet, the National University
Hospital of Denmark. His research is focused on molecular imaging with PET,
PET/MRI and OPTICAL IMAGING in cancer and cardiovascular disease and his
achievements include development of several new tracers that have reached
first-in-humans clinical use. He is the holder of an ERC Advanced Grant, has
published 700 peer-review articles and has received numerous prestigious
scientific awards over the years. Andreas also has an MBA from Copenhagen
Business School.
Grethe Nørskov Rasmussen – CDO since 2019
Grethe Nørskov Rasmussen holds a M.Sc. and PhD. Grethe Rasmussen is an
experienced product developer with a profound understanding of CMC and
former Senior Vice President Product Development at Ascendis Pharma A/S,
where she worked for over 10 years. Previously, Grethe served as Vice
President for Protein Science at Maxygen, Inc. and later as Managing Director
for the Danish subsidiary of Maxygen. Prior to joining Maxygen, Grethe held
various positions at Novo Nordisk A/S, a global healthcare company, where
she contributed to research and development. Grethe holds a PhD in
Biochemistry from the Danish Technical University.
Ole Larsen – CFO since 2023
Ole Larsen holds a M.Sc. and is an experienced CFO with a strong history of
working in various industries in both listed and unlisted companies, including
Bavarian Nordic, BioPorto, Nordisk Film, and Berlingske Tidende. Ole is skilled
in growth/start-ups, M&A and Corporate Finance, and has a finance
professional background with a M.Sc. focused on Economics from
Copenhagen Business School. Ole currently serves as member of the board
at Linkfire.
Jens Ellrich - CMO since 2024
Jens Ellrich, brings over 30 years of extensive experience in translational
neuroscience, medical devices, biotechnology, pharmacology, and digital
therapeutics. His proven track record spans both academia and the start-up
ecosystem, where he has successfully advanced innovative medical solutions
across drugs, devices, and their combinations. Jens has played a key role in
the development and launch of groundbreaking therapies at companies such
as the Dutch Sapiens Steering Brain Stimulation acquired by Medtronic.
ANNUAL REPORT 2024
14
SHAREHOLDER INFORMATION
The share
The shares in FluoGuide were listed in 2019 on
Spotlight Stock Market and moved from Spotlight
to Nasdaq First North Growth Market, Stockholm
in February 2021. The ticker is FLUO, and the ISIN
code is DK0061123312.
The total number of outstanding shares as of
December 31, 2024, amounted to 13,620,149
(12,208,384) shares, each with a nominal value of
DKK 0.10. Each individual share entitles to one
vote in the company and has an equal right to the
company’s assets and results.
In June 2024, FluoGuide completed a directed
share issue and raised SEK 60 million by issuing
1,411,765 shares. The shares were subscribed by
several Nordic and international investors. New
institutional investors joined as shareholders in
the Company as well as the existing institutional
investors participated in the directed issue.
Share price performance in 2024
At year-end, the closing price for FluoGuide shares
on Nasdaq First North Growth Market, Sweden
was SEK 39.15 – down 36.0% since year-end 2023.
During the same period, the First North Health
Care GI decreased by 3.0%.
The total trading volume of FluoGuide shares on
Nasdaq First North Growth Market, Sweden was
2,287,492 in 2024 (16.8% of shares issued).
At year-end, FluoGuide’s market capitalization
was SEK 533 million against SEK 747 million at the
end of 2023.
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FluoGuide First North Healthcare GI
ANNUAL REPORT 2024
15
Ownership
The number of shares is always defined, however
there is no complete record at any given time of
all shareholders and their ownership. Based on
the available information as of December 31,
2024, FluoGuide had 7,893 registered
shareholders. The 20 largest shareholders owned
72.7% of the share capital.
FluoGuide has no majority shareholders.
Shareholders owning more than 15% in FluoGuide
according to latest shareholding notifications are:
Life Science ApS, a fully owned company
by Board Member, CSO and CMO Andreas
Kjær (15.62%)
Shareholders owning more than 10% in FluoGuide
according to latest shareholding notifications are:
Wexotec ApS, a fully owned company by
CEO Morten Albrechtsen (10.94%)
Shareholders owning more than 5% in FluoGuide
according to latest shareholding notifications are:
Linc AB
Arbejdernes Landsbank,
Management and Board of Directors owns 29.94%
of the total amount of outstanding shares.
Warrants
FluoGuide has established incentive programs for
its employees, management, and Board. On
November 12, 2024, the Board of Directors of
FluoGuide has exercised its authorization to issue
new warrants by issuing 30,000 warrants to
management and 7,500 warrants to the Board of
Directors. On February 23, 2024, the Company
decided to issue 45,000 warrants to the CFO. The
warrants were issued as part of the remuneration
of the involved persons.
The total of five warrant programs are issued to
ensure alignment of interests between the
Company’s employees, management, Board of
Directors, and shareholders. The Company
believes that the issue of warrants will provide
motivation for the achievement of FluoGuide’s
short-term and long-term goals to support the
Company’s business strategy, sustainability, and
value creation for the benefit of shareholders.
Warrants represent a total dilution of 3.8 percent
of the current share capital, if vested and
exercised. Please see note 5.
Proposed appropriation of retained
earnings
The Board of Directors have proposed that no
dividend is paid out for the fiscal year, January 1,
2024 – December 31, 2024.
ANNUAL REPORT 2024
16
FINANCIAL DEVELOPMENT
Operating income & Other operating
income
For the period January 1 – December 31, 2024, the
Net revenue amounted to DKK 0 (DKK 0). Other
operating income amounted to DKK 385 thousand
(DKK 423 thousand) and comprised of the income
relating to the part of incurred costs covered by
Danish Innovation Fund (Innovationsfonden).
Other external expenses
For the period January 1 – December 31, 2024,
other external expenses amounted to DKK 17,709
thousand (DKK 29,234 thousand). Research &
development costs including IP, but excluding
salaries amounted to DKK 12,075 thousand (DKK
23,027 thousand), Sales & marketing costs of DKK
600 thousand (DKK 450 thousand) and General &
admin costs of DKK 5,034 thousand (DKK 5,756
thousand).
The reduction in Research & Development costs is
due to the timing of the clinical trials. In 2024 the
study reports from the three clinical trials
performed have been finalized. Whilst in 2023 the
Company had the three clinical trials with FG001
in aggressive brain cancer (HGG), lung cancer and
head & neck cancer ongoing.
The increase in Sales & marketing costs is primarily
related to increased travelling and Market
research.
Staff expenses
Staff expenses for the period January 1 –
December 31, 2024, amounted to DKK 15,259
thousand (DKK 14,848 thousand) and comprised:
Wages and salaries including bonus and
Board fee’s DKK 12,684 thousand (DKK
11,594 thousand)
Employee share schemes DKK 2,021
thousand (DKK 3,115 thousand)
Other staff and social security costs
including pension DKK 554 thousand (DKK
139 thousand). Pension contribution from
the Company was introduced during 2024.
In 2024 the average number of full-time
employees was 7.8 (7.8).
Financial items
Financial income and expenses reflect interest
income/expense and currency transaction
gains/losses, bank charges and interest.
In the period January 1 – December 31, 2024, the
financial income amounted to DKK 101 thousand
(DKK 1,824 thousand). In the period January 1 –
December 31, 2023, the financial income was
impacted by a change in the fair value of
subscription rights to shares in FluoGuide in
connection with warrants issued to investors in
July 2023.
In the period January 1 – December 31, 2024, the
financial expenses amounted to DKK 1,520
thousand (DKK 1,777 thousand) primarily due to
interest in connection with the former and now
repaid credit facility of DKK 20 million.
Tax
In the period January 1 – December 31, 2024,
deferred tax related to tax credits from
investments in research & development
amounted to DKK 5,500 thousand (DKK 5,500
thousand).
Once approved by the Tax authorities the tax
credit is paid out in cash in fourth quarter for the
previous calendar year (equal to fiscal year for
FluoGuide).
The paid-out tax credit is capped at DKK 5,500
thousand annually.
Net result for the year
In the period January 1 – December 31, 2024, the
net result showed a loss of DKK 28,959 thousand
(loss of DKK 38,377 thousand) each reflecting the
mix of variances described above. The result was
in accordance with the Company’s expectations
for the period.
ANNUAL REPORT 2024
17
Balance sheet
As of December 31, 2024, the Company’s total
assets were DKK 28,380 thousand (DKK 29,609
thousand).
The assets primarily consist of cash and a tax
benefit related to tax credits derived from
investments in research & development in 2024.
There are no significant liabilities.
Cash and cash equivalents
As of December 31, 2024, FluoGuide’s balance of
cash totaled DKK 18,608 thousand (DKK 21,668
thousand) and is primarily deposited at one
Danish bank.
In addition, FluoGuide has a credit facility of SEK
40 million equivalent to approximately DKK 26
million with maturity end-2025.
The facility is currently un-drawn meaning that the
cash preparedness of the Company as per
December 31, 2024, is approximately DKK 44.6
million (cash position + un-drawn credit facility).
As a development stage start-up life-science
company, and like other similar development
stage companies, the Company expects negative
cash flow in 2024 from operating activities.
The company is dependent on being financed via
capital injections or by way of selling rights to its
products against cash until reaching the point
where the size of the revenue surpasses the costs,
resulting in a positive cash flow.
The activities of the company in the future will
depend on proceeds obtained from capital
increases, sales of rights, loans and so forth.
Please refer to note 2 in the Financial Statements.
Equity
The total equity on December 31, 2024, amounted
to DKK 23,067 thousand (DKK 12,720 thousand).
The change in equity is primarily due to the
realized net loss of DKK 28,959 thousand in the
period January 1 – December 31, 2024, off-set by
the capital raise in June 2024 of DKK 39,301
thousand. As per December 31, 2024, the solvency
ratio was 81 percent (43 percent).
Current liabilities
As of December 31, 2024, the current liabilities
amounted to DKK 4,918 thousand (DKK 16,266
thousand). The current liabilities primarily consist
of payables of DKK 4,048 thousand (DKK 6,060
thousand). The current liabilities December 31,
2023, also consisted of Debt to credit institutions
of DKK 10,000 thousand.
Subsequent events
On January 15, 2025, the Company received
approval for phase II trial in head and neck cancer.
Operational risks and uncertainties
The risks to and uncertainties of FluoGuide’s
operations are related to several factors such as
development, clinical trials, regulatory, patents
and other intellectual property rights, key
individuals and employees, registration and
licensing with agencies / governmental
authorities, competitors, customers, suppliers /
manufacturers, international operations, and
exchange rate changes, interest rates, tax,
financing needs and capital. During the current
period, no significant changes in risk factors or
uncertainties have occurred.
The company description is available on our
website: www.fluoguide.com/investor/filings-
archive/
Financial calendar 2025
Annual General Meeting 27 March
Q1 report 28 May
Q2 report 28 August
Q3 report 27 November
All financial reports are available on FluoGuide’s
company page:
www.fluoguide.com/investor/financial-reports
More information
A comprehensive description of the company’s
strategy, development plans and programs can
be found on our website: www.fluoguide.com.
ANNUAL REPORT 2024
18
Executive Management:
Board of Directors:
ANNUAL REPORT 2024
19
ANNUAL REPORT 2024
20
ANNUAL REPORT 2024 21
CVR No 33 77 12 31
Mne18651 Mne29465
ANNUAL REPORT 2024
22
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
2024 2023
DKK thousand
Note
1 Jan - 31 Dec 1 Jan - 31 Dec
3
Other operating income 385 423
Other external expenses -17,709 -29,234
4
Staff expenses -15,259 -14,848
Depreciation and amortization -456 -265
Income/(Loss) before interest and tax (EBIT) -33,040 -43,924
6
Financial income 101 1,824
6
Financial expenses -1,520 -1,777
Income/(Loss) before tax -34,459 -43,877
7
Tax on income for the year
Net result for the year -28,959 -38,377
Other comprehensive income for the year, net of tax 0 0
Total comprehensive income -28,959 -38,377
11
Basis and diluted earnings per share (DKK)
-2.23 3.22
ANNUAL REPORT 2024
23
BALANCE SHEET
ASSETS 2024 2023
DKK thousand 31 Dec 31 Dec
Note
Non-current assets
8 Acquired patents 378 378
9 Right of use assets 573 803
10 Tangible fixed assets 644 21
Deposit 281 144
Total non-current assets 1,877 1,346
Current assets
Other receivables 446 915
7 Receivable corporate tax 5,500 5,500
Prepayments 1,949 180
Cash 18,608 21,668
Total current assets 26,503 28,263
Total assets 28,380 29,609
EQUITY AND LIABILITIES 2024 2023
DKK thousand 31 Dec 31 Dec
Note
Equity
Share capital 1,362 1,221
Share premium 0 0
Retained earnings 21,705 11,499
11 Total equity 23,067 12,720
Liabilities
12 Lease liabilities 395 623
Non-current liabilities 395 623
Debt to credit institutions 0 10,000
12 Lease liabilities 229 205
Trade payables 2,380 4,094
Other payables 1,668 1,966
Deferred income 642 0
Current liabilities 4,918 16,266
Total liabilities 5,313 16,889
Total equity and liabilities 28,380 29,609
ANNUAL REPORT 2024
24
STATEMENT OF CHANGES IN EQUITY
EQUITY Share capital Share premium Retained earnings Total equity
DKK thousand
Equity as of December 31, 2022 1,181 0 30,787 31,969
Total comprehensive income 2023 -38,377 -38,377
Capital increase 39 17,770 17,809
Expenses in connection with capital increase -84 -84
Employee share schemes – value of employee services 3,115 3,115
Fair value of warrants issued subsequently to right of issue -1,712 -1,712
Transfer -17,770 17,770 0
Equity as of December 31, 2023 1,221 0 11,499 12,720
Total comprehensive income 2024 -28,959 -28,959
Capital increase 141 39,160 39,301
Expenses in connection with capital increase -2,016 -2,016
Employee share schemes – value of employee services 2,021 2,021
Transfer -39,160 39,160 0
Equity as of December 31, 2024 1,362 0 21,705 23,067
ANNUAL REPORT 2024
25
CASH FLOW STATEMENTS
CASH FLOW 2024 2023
DKK thousand
Note 1 Jan - 31 Dec 1 Jan - 31 Dec
Income before tax -34,459 -43,877
Net financial items reversed 1,419 -47
14 Change in working capital -2,670 4,900
Depreciation and amortization 456 265
5 Adjustment for non-cash employee benefits expense – share-based payments 2,021 3,115
Cash flows from operating activities before net financials -33,233 -35,644
Net financial items paid -1,419 -1,665
Tax credit paid out 5,500 5,500
Cash flows from operating activities -29,152 -31,809
Purchase of tangible assets -850 0
Paid deposit -137 -37
Cash flows from investing activities -987 -37
Proceeds from capital increase 39,301 17,809
Repayment/proceeds from credit facility -10,000 10,000
Principal elements of lease payments -205 -225
Costs related to capital increase -2,016 -84
Cash flows from financing activities 27,080 27,500
Total cash flows for the year -3,059 -4,345
Cash as of January 1 21,668 26,013
Cash as of December 31 18,608 21,668
ANNUAL REPORT 2024
26
CASH FLOW STATEMENTS CONTINUED
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES 2024 2023
DKK thousand
As per primo period 10,828 205
Repayment (negative)/Proceeds from credit facility -10,000 10,000
New leases 0 936
Interest 56 43
Repayment -261 -356
As per December 31 623 10,828
ANNUAL REPORT 2024
27
NOTES
1. Accounting policies
2. Capital resources and liquidity
3. Other operating income
4. Staff expenses
5. Warrants
6. Financial Income and Expenses
7. Tax
8. Intangible assets
9. Right of use of assets
10. Tangible fixed assets
11. Share capital
12. Lease Liabilities
13. Distribution of profit/loss for the year
14. Change in working capital
15. Financial risks and financial instruments
16. Related parties
17. Fees to statutory auditors
18. Operating lease commitments and other commitments
19. Events occurring after the balance sheet date
ANNUAL REPORT 2024
28
Financial statements
The financial statements of FluoGuide A/S for
2024 are the Company’s sixth financial year and
are prepared in accordance with IFRS Accounting
Standards as adopted by the EU and further
requirements in the Danish Financial Statements
Act for annual reports of class B companies.
New standards not yet effective
There are no IFRSs or IFRIC interpretations that
are not yet effective that is expected to have a
material impact on the Company, except for IFRS
18 that may have an effect of the presentation of
the financial statements.
Foreign currency translation
On initial recognition, transactions in currencies
other than the functional currency of the
Company are recognized at the exchange rate
applicable at the transaction date. Receivables,
payables, and other monetary items
denominated in foreign currency not settled at
the balance sheet date are translated using the
exchange rate applicable at the balance sheet
date. Exchange rate differences between the
exchange rate applicable at the transaction date
and the exchange rate at the date of payment and
the balance sheet date, respectively, are
recognized in the income statement as net
financials.
Leases
Leases in terms of which the Company assumes
substantially all the risks and rewards of
ownership are recognized in the balance sheet at
the lower of the fair value of the leased asset and
the net present value of the lease payments
computed by applying the interest rate implicit in
the lease or an approximated value as the
discount rate, if leases exceed DKK 33,000 in
value and are longer than twelve months.
Leased assets acquired under finance leases are
depreciated and written down for impairment
under the same policy as determined for the
other fixed assets of the Group.
The remaining lease liability is capitalized and
recognized in the balance sheet under debt, and
the interest element on the lease payments is
charged over the lease term to the income
statement.
Tax
Tax for the year, consisting of current tax and
changes in deferred tax, is recognized in the
income statement with the portion attributable
to tax on the profit or loss for the year, and
directly in equity or in other comprehensive
income with the portion attributable to amounts
recognized directly in equity or in other
comprehensive income, respectively.
Current tax payables and receivables are
recognized in the balance sheet as tax computed
FluoGuide A/S is a limited liability
company domiciled in Denmark. The
Financial Statements have been
prepared in accordance with IFRS
Accounting Standards as adopted by
the EU and further requirements in the
Danish Financial Statements Act.
Danish kroner (DKK) is the Company's
presentation currency and functional
currency. The financial statements are
presented in Danish kroner thousand.
1.
ACCOUNTING
POLICIES
ANNUAL REPORT 2024
29
based on the taxable income for the year results
in taxes to be paid or refunded.
Current tax for the year is computed based on the
tax rules and tax rates applicable at the balance
sheet date.
Deferred tax is recognized using the balance
sheet liability method on the basis of all
temporary differences between the carrying
amounts and tax bases of assets and liabilities,
except for deferred tax on temporary differences
due to either initial recognition of goodwill or
initial recognition of a transaction that is not a
business combination, and where the temporary
difference ascertained at the time of initial
recognition does not affect either the tax results
or the taxable income. The deferred tax is
calculated based on the planned use of the
individual asset or settlement of the individual
liability.
Deferred tax is measured applying the tax rules
and tax rates expected to be applicable when the
deferred tax is expected to crystallize as current
tax. Any change in deferred tax because of
changes in tax rules or rates is recognized in the
income statement unless the deferred tax is
attributable to transactions that have previously
been recognized directly in equity or in other
comprehensive income. In the latter case, the
change is recognized directly in equity or in other
comprehensive income, respectively.
Deferred tax assets, including the tax value of tax
losses allowed for carryforward, are recognized in
the balance sheet at the expected realizable
value, either through offsetting against deferred
tax liabilities or as a net tax asset for offsetting
against future positive taxable incomes. An
assessment is made on each balance sheet date
of whether it is probable that sufficient taxable
income will be generated in future to enable
utilization of the deferred tax asset.
Statement of comprehensive income
Other operating income
Other income comprises income of a secondary
nature in relation to the group’s activities,
including grants and license income. Income from
licenses that do not transfer the right of
ownership to an intangible asset are recognized
over time in accordance with the substance of the
agreements. Government grants relating to costs
are deferred and recognized in profit or loss over
the period necessary to match them with the
costs that they are intended to cover.
Other external expenses
Other external expenses comprise expenses
relating to administrative expenses, costs of
premises, etc. as well as research & development
costs.
Research & development costs comprise external
expenses relating to research & development
work, clinical trials, clinical consultants, IP,
patents, and external costs related to patent
processing etc. excluding salaries.
Staff expenses
Staff expenses comprise wages, salaries, and
bonuses as well as social security expenses,
pensions for group staff, other staff-related
expenses, and share-based payment
compensation.
Employee options Plan
The fair value of warrants granted under the
FluoGuide A/S’s Employee Option Plan is
recognized as an employee benefits expense,
with a corresponding increase in equity. The total
amount to be expensed is determined by
reference to the fair value of the options granted:
- including any market performance conditions
(e.g. the entity’s share price) - excluding the
impact of any service and non-market
performance vesting conditions (e.g. profitability,
sales growth targets and remaining an employee
of the entity over a specified time period), and -
including the impact of any non-vesting
conditions (e.g. the requirement for employees
to save or hold shares for a specific period of
time).
The total expense is recognized over the vesting
period, which is the period over which all the
specified vesting conditions are to be satisfied. At
ANNUAL REPORT 2024
30
the end of each period, the entity revises its
estimates of the number of options that are
expected to vest based on the non-market
vesting and service conditions. It recognizes the
impact of the revision to original estimates, if any,
in profit or loss, with a corresponding adjustment
to equity.
Net financials
Net financials comprise interest income and
expenses, realized and unrealized gains and
losses on transactions in foreign currency and
realized and unrealized gains and losses on other
financial assets.
Amortization of capital losses and borrowing
costs relating to financial liabilities is recognized
on an ongoing basis as part of the interest
expenses.
Earnings per share
Basic net result per share is calculated as the net
result for the year divided by the weighted
average number of outstanding ordinary shares,
excluding treasury shares.
Diluted net result per share is calculated as the
net result for the year divided by the weighted
average number of outstanding ordinary shares,
excluding treasury shares adjusted for the
dilutive effect of share equivalents. As the income
statement shows a net loss, no adjustments have
been made for the dilutive effect.
Balance sheet
Acquired patents
Acquired patents are measured in the balance
sheet at the lower of cost less accumulated
amortization and recoverable amount.
Cost comprises the acquisition price, costs
directly related to the acquisition and costs for
preparation of the asset until such time as the
asset is ready for use. The amortization is
performed on a straight-line basis with no
residual value over the period of validity starts
when patent is taken into commercial use.
Amortization methods, useful lives and residual
values are reviewed every year.
Receivables
Receivables comprise trade receivables and other
receivables. Receivables are included in the
category loans and receivables, which are
financial assets with fixed or determinable
payments that are not listed in an active market
and are not derivative financial instruments.
On initial recognition, receivables are measured
at the amount of consideration that is
unconditional unless they contain significant
financing components, when they are recognized
at fair value and subsequently at amortized cost,
which usually corresponds to the nominal value,
less write-downs for bad debts.
The Company applies the IFRS 9 simplified
approach to measuring expected credit losses
which uses a lifetime expected loss allowance for
all receivables.
Cash
Cash includes deposits in bank accounts as well as
operating cash.
Equity
Direct and incremental costs associated with
capital increases are accounted for as a reduction
in the proceeds from the capital increase and
recognized in shareholders’ equity.
Liabilities
Other financial liabilities comprise debt to credit
institutions, trade payables, other payables to
public authorities and other liabilities. On initial
recognition, other financial liabilities are
measured at fair value less any transaction costs.
Subsequently, the liabilities are measured at
amortized cost according to the effective interest
method, so that the difference between the
proceeds and the nominal value is recognized in
the income statement as a financial expense over
the period of the loan.
Cash flow statement
The cash flow statement shows cash flows from
operating, investing, and financing activities as
well as cash at the beginning and end of the year.
ANNUAL REPORT 2024
31
Cash flows from operating activities are
presented in accordance with the indirect
method and are determined as the operating
profit or loss adjusted for non-cash operating
items, changes in working capital and paid
financial income, financial expenses, and income
tax.
Cash flows from investing activities comprise
payments in connection with the acquisition and
sale of companies and financial assets as well as
the purchase, development, improvement and
sale of property, plant and equipment and
intangible assets.
Cash flows from financing activities comprise
changes in the Company's share capital and
associated costs as well as the raising and
repayment of loans, the repayment of interest-
bearing debt, the purchase and sale of treasury
shares and the payment of dividends.
Cash flows in currencies other than the functional
currency are recognized in the cash flow
statement using average exchange rates unless
they deviate significantly from the actual
exchange rates at the transaction dates.
Cash and cash equivalents comprise cash less
overdraft facilities that are an integrated part of
the cash management.
Financial highlights
Explanation of financial ratios:
Solvency ratio:
Equity at year end x 100
Total assets at year end
Earnings per
share:
Net result for the year
Average numbers of
outstanding shares
Significant accounting estimates
and judgements
In connection with the preparation of the
financial statements, the management performs
accounting estimates and judgements that affect
the recognized values of assets, liabilities,
income, expenses, and cash flows as well as their
presentation.
Accounting estimates reflect the management's
best estimates in terms of amounts where the
measurement is subject to uncertainty, typically
because the estimate is based on assumptions
concerning future events. The accounting
estimates are based on historical experience and
other assumptions deemed relevant, but the
actual results may, naturally, deviate from the
estimates made. The estimates are regularly
reassessed, and the effect of changes is
recognized in the consolidated financial
statements.
Accounting judgements reflect decisions made by
the management as to how the accounting
policies are applied in specific situations where
the accounting treatment depends on qualitative
assessments. Examples could be when the risk
passes or how a certain transaction or item is best
presented to provide reliable and relevant
information.
Costs incurred in relation to individual
development projects are capitalized only when
the future economic benefit of the project is
probable and the following main conditions are
met: (i) the development costs can be measured
reliably, (ii) the technical feasibility of the product
has been ascertained and approved by an
authority like the European Medicines Agency
(EMA), the U.S. Food & Drug Administration or
the like and (iii) Management has the intention
and ability to complete the intangible asset and
use or sell it.
Currently no other significant accounting
estimates and judgements have been applied in
the preparation of the financial statements for
2024.
ANNUAL REPORT 2024
32
As a development stage start-up life-science
company, and like other similar development
stage companies, the Company has had a
negative cash flow in 2024 why the company is
dependent on being recapitalized or selling rights
to its products against cash until reaching the
point where the size of the revenue exceeds the
costs resulting in a positive cash flow.
The activities of the company in the future will
depend on proceeds obtained from capital
increases or sales of rights. The company, if
necessary, will in the future carry out external
capital increases to finance the future activities.
In 2024 the company raised SEK 60 million to fund
the ongoing and planned activities.
The Company continually evaluates its liquidity
requirements, capital needs and availability of
capital resources based on its operating needs
and planned initiatives. Such assessment has also
been carried out in relation to preparing the 2024
Annual report.
The Budget for 2025 and the expected cash
position on December 31, 2025, are based on
assumptions of financing or re-financing with net
proceeds of DKK 40 million. This amount includes
initiation of a clinical phase II trial in head and
neck cancer and initiation of CMC work in 2025.
The Company will seek funding that is equity
friendly being issuance of new shares or a
convertible loan.
If against expectations, FluoGuide do not
complete the financing or raises a lower cash
amount than expected in the financing, the Board
of Directors and Management will take mitigating
actions to secure sufficient cash until December
31, 2025.
On this background the Board of Directors and
Management has decided to prepare the
financial statements for 2024 on a going concern
basis.
Although the Board of Directors and
Management based on this assessment considers
that FluoGuide A/S will secure adequate and
enough liquidity resources to finance the
operations of the Company for the coming year,
the above indicate that a material uncertainty
exists that may cast significant doubt on the
Company’s ability to continue as a going concern.
2.
CAPITAL
RESOURCES AND
LIQUIDITY
ANNUAL REPORT 2024
33
Other operating income amounted to DKK 385
thousand (DKK 423 thousand) and comprised of
the first part of the grant that the Company with
two academic partners were awarded from
Danish Innovation Fund (Innovationsfonden)
regarding research and development of
photothermal therapy. The income relates to the
part of incurred costs covered by Danish
Innovation Fund (Innovationsfonden).
OTHER OPERATING INCOME 2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Other, including subsidy/grant for business PhD 385 423
Total 385 423
3.
OTHER
OPERATING
INCOME
ANNUAL REPORT 2024
34
Compensation for key management personnel
includes Morten Albrechtsen, Ole Larsen (from
March 1, 2024), Andreas Kjær, and the Board of
Directors.
The average number of full-time employees
during 2024 was 7.8 (7.8).
STAFF EXPENSES
2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Wages and salaries
12,684 11,594
Employee share schemes – value of employee services
2,021 3,115
Other social security costs including pension etc.
554 139
Total 15,259 14,848
COMPENSATION FOR KEY MANAGEMENT PERSONNEL 2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Short term employee benefits 5,964 4,100
Share based payments 1,665 2,215
Total 7,629 6,315
4.
STAFF EXPENSES
ANNUAL REPORT 2024
35
FluoGuide has established incentive programs for
its employees, management, and Board of
Directors. In February and November 2024, the
Company issued in total 75,000 warrants to two
members of the management and 7,500 warrants
to a member of the Board of Directors. Each
warrant grants the holder the right to subscribe
for one (1) new share in FluoGuide. The warrants
are issued to ensure alignment of interests
between the Company’s employees,
management, Board of Directors, and
shareholders. The Company believes that the
issue of warrants will provide motivation for the
achievement of FluoGuide’s short-term and long-
term goals to support the Company’s business
strategy, sustainability, and value creation for the
benefit of shareholders. Warrants represent a
total dilution of 3.8 percent of the current share
capital, if vested and exercised.
The number of warrants that will vest depends
mainly on the receiver not leaving the Company
in the vesting period.
For the programs up and until 2023 the warrants
vest with 1/36 per month. For 200,000 warrants
granted to management in 2021 vesting
furthermore depends on achievement of certain
activities-based milestones KPI's and vest with
1/60 per month.
For the programs from 2024 an onwards the
warrants vest after 36 months.
Warrants are granted under the plan for no
consideration and carry no dividend or voting
rights. The vested warrants remain exercisable
for a period of 10 years after the grant date. The
exercise price of warrants is based on the
Company's prevailing share price at the day of
grant.
5.
WARRANTS
ANNUAL REPORT 2024
36
Set out below are summaries of warrants granted under the plan:
WARRANT OVERVIEW - 2024
Outstanding as
of January 1
Additions Exercised Forfeited Terminated
Outstanding as
of December 31
Can be exercised
as of December 31
Average exercise
price (SEK)
May 2021 322,700
0
0
-15,300
0
307,400
267,400
95
Mar 2022 40,000
0
0
-4,000
0
36,000
32,997
65
July 2023 128,175
0
0
-15,275
0
112,900
56,450
79
Feb 2024 0
45,000
0
0
0
45,000
0
55
Nov 2024 0
37,500
0
0
0
37,500
0
36
TOTAL 490,875
82,500
0
-34,575
0
538,800
356,847
WARRANT OVERVIEW - 2024
Outstanding as
of January 1
Additions Exercised Forfeited Terminated Transferred
Outstanding as of
December 31
Board of Directors 95,000 7,500 0 0 0 0 102,500
Executive Management 128,750 60,000 0 0 0 4,200 192,950
Corporate Management 200,325 15,000 0 -28,675 0 -4,200 182,450
Other employees 28,000 0 0 -5,900 0 0 22,100
Former employees 38,800 0 0 0 0 0 38,800
TOTAL 490,875 82,500 0 -34,575 0 0 538,800
Weighted average exercise price
(SEK) 88 46 0 0 0 0 82
Number of exercisable warrants as of December 31, 2024 356,847
at a weighted average exercise price of SEK 90
ANNUAL REPORT 2024
37
WARRANT OVERVIEW - 2023
Outstanding as
of January 1
Additions Exercised Forfeited Terminated Transferred
Outstanding as of
December 31
Board of Directors 50,000 45,000 0 0 0 0 95,000
Executive Management 110,000 18,750 0 0 0 0 128,750
Corporate Management 156,800 43,525 0 0 0 0 200,325
Other employees 7,100 20,900 0 0 0 0 28,000
Former employees 38,800 0 0 0 0 0 38,800
TOTAL 362,700 128,175 0 0 0 0 490,875
Weighted average exercise price
(SEK) 92 79 0 0 0 0 88
Number of exercisable warrants as of December 31, 2023 266,031
at a weighted average exercise price of SEK 92
SPECIFICATION OF PARAMETERS FOR BLACK-SCHOLES MODEL May 2021 May 2021 Mar 2022 Jul 2023 Feb 2024 Nov 2024
Exercise price at grant (SEK) 95.0
95.0
65.0
79.0
55.0
36.0
Applied volatility
1)
53.5% 53.5% 48.3% 56.3% 58.4% 55.3%
Expected life (years) 6.3
7.3
6.3
6.3
6.5
6.5
Expected dividend per share 0
0
0
0
0
0
Risk-free interest rate p.a. -0.07% -0.07% 0.63% 2.65% 2.45% 2.04%
Fair value per share at grant (SEK)
2)
47.29 50.32 30.74 44.33 31.95 19.88
Fair value per share at grant (DKK)
2)
34.73 36.96 21.83 28.51 21.31 12.73
1) The applied volatility is based on the historical volatility of the FluoGuide share, except for programs issued since July 2023 where the volatility is based on the volatility for a peer
group.
2) Fair value of each warrant at grant date applying the Black-Scholes model.
ANNUAL REPORT 2024
38
RECOGNIZED COSTS FROM SHARE-BASED PAYMENT TRANSACTIONS 2024 2023
DKK thousand
1 Jan - 31 Dec 1 Jan - 31 Dec
Warrants issued under employee share scheme 2,021 3,115
Total for the year 2,021 3,115
Fair value of options granted:
The fair value at grant date is independently
determined using the Black-Scholes model which
includes, the share price at grant date and
expected price volatility of the underlying share,
the expected dividend yield, the risk-free interest
rate for the term of the warrants, and the
correlations and volatilities of the peer group
companies.
Warrants are granted for no consideration and
vests based on receiver not leaving the Company
and certain activity-based milestones. Vested
warrants are exercisable for a period of 10 years
after grant date. Vesting period are from 36
months to 60 months (the ladder only applies to
warrants granted to management in 2021).
The expected price volatility is based on the
historic volatility (based on the remaining life of
the warrants), adjusted for any expected changes
to future volatility due to publicly available
information.
ANNUAL REPORT 2024
39
FINANCIAL INCOME 2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Interest income from financial assets measured at amortized costs 101 112
Change in fair value of subscription rights to shares in the company 0 1,712
Total 101 1,824
FINANCIAL EXPENSES 2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Interest expense on liabilities measured at amortized costs 30 0
Interest related to right-of-use assets 56 43
Credit facility costs 1,360 1,646
Net foreign exchange losses 73 88
Other 1 0
Total 1,520 1,777
6.
FINANCIAL INCOME
AND EXPENSES
ANNUAL REPORT 2024
40
Under the Danish tax credit scheme, the 22
percent tax value of negative taxable income
related to costs from development activities up to
DKK 25 million can be received in cash. Tax value
of costs to the related to development activities
amounts to DKK 5,500 thousand (DKK 5,500
thousand), is anticipated to be paid out from the
tax authority in Q4 2025 to the Company. The tax
credit is not considered as a subsidy as the paid-
out tax credit reduces the Company´s tax loss
carries forward.
The unrecognized deferred tax assets amounted
to DKK 11,952 thousand (DKK 10,080 thousand)
can be carried forward indefinitely. Tax has been
computed at 22 percent corresponding to the
current tax rate.
TAX 2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Tax on profit/loss for the year:
Current tax (tax under the tax credit scheme) 5,500 5,500
Total 5,500 5,500
Reconciliation of effective tax:
Tax computed on loss -7,361 -9,653
Non-deductible expenses 448 689
Other permanent differences -459 -643
Non-recognized deferred tax asset 1,872 4,107
Effective tax (16% / 11%) -5,500 -5,500
Deferred tax:
Tax loss carried forward 11,867 10,050
Right of use assets 20 15
Intangible and tangible fixed asset 65 15
Total 11,952 10,080
Write down to accessed value -11,952 -10,080
Total 0 0
7.
TAX
ANNUAL REPORT 2024
41
8. Intangible Asset
INTANGIBLE ASSETS Acquired patents Intangible assets
DKK thousand
Costs on January 1, 2024 378 378
Addition for the year 0 0
Costs on December 31, 2024 378 378
Amortization and impairment losses January 1, 2024 0 0
Amortization and impairment losses for the year 0 0
Amortization and impairment losses December 31, 2024 0 0
Net book value on December 31, 2024 378 378
INTANGIBLE ASSETS
Acquired patents Intangible assets
DKK thousand
Costs on January 1, 2023 378 378
Addition for the year 0 0
Costs on December 31, 2023 378 378
Amortization and impairment losses January 1, 2023 0 0
Amortization and impairment losses for the year 0 0
Amortization and impairment losses December 31, 2023 0 0
Net book value on December 31, 2023 378 378
8.
INTANGIBLE
ASSETS
ANNUAL REPORT 2024
42
RIGHT OF USE ASSETS Buildings Right of use assets
DKK thousand
Costs on January 1, 2024 936 936
Addition for the year 0 0
Disposals for the year 0 0
Costs on December 31, 2024 936 936
Depreciation January 1, 2024 134 134
Depreciation for the year 229 229
Depreciation disposals for the year 0 0
Depreciation December 31, 2024 363 363
Net book value on December 31, 2024 573 573
RIGHT OF USE ASSETS
Buildings Right of use assets
DKK thousand
Costs on January 1, 2023 705 705
Addition for the year 936 936
Disposals for the year -705 -705
Costs on December 31, 2023 936 936
Depreciation January 1, 2023 506 506
Depreciation for the year 244 244
Depreciation disposals for the year -617 -617
Depreciation December 31, 2023 134 134
Net book value on December 31, 2023 803 803
9.
RIGHT OF USE
ASSETS
ANNUAL REPORT 2024
43
TANGIBLE FIXED ASSETS Equipment Tangible assets
DKK thousand
Costs on January 1, 2024 64 64
Addition for the year 850 850
Costs on December 31, 2024 914 914
Amortization and impairment losses January 1, 2024 43 43
Amortization and impairment losses for the year 227 227
Amortization and impairment losses December 31, 2024 270 270
Net book value on December 31, 2024 644 644
TANGIBLE FIXED ASSETS Equipment Tangible assets
DKK thousand
Costs on January 1, 2023 64 64
Addition for the year 0 0
Costs on December 31, 2023 64 64
Amortization and impairment losses January 1, 2023 21 21
Amortization and impairment losses for the year 21 21
Amortization and impairment losses December 31, 2023 43 43
Net book value on December 31, 2023 21 21
10.
TANGIBLE FIXED
ASSETS
ANNUAL REPORT 2024
44
Share capital
The share capital consists of 13,620,149 shares
with a nominal value of DKK 0.1 each. The shares
are not divided into classes, and no shares have
special rights.
SHARE CAPITAL 2024 2023
Shares issued as per January 1 12,208,384 11,814,500
Increase in shares in directed issue and exercise of warrants 1,411,765 393,884
Shares issued as per December 31 13,620,149 12,208,384
Weighted average number of shares used as the denominator, when calculating
earnings per share 12,968,268 11,930,746
11.
SHARE CAPITAL
Capital management
The Company aims to ensure structural and
financial flexibility as well as competitive
strength. For that purpose, the Company
regularly assesses what the appropriate capital
structure for the Company.
On June 18, 2024, FluoGuide completed a
directed share issue to existing and new investors
raising proceeds of SEK 60 million by issuing
1,411,765 shares.
ANNUAL REPORT 2024
45
LEASE LIABILITIES 2024 2023
DKK thousand 31 Dec 31 Dec
Non-current 395 623
Current 229 205
Total 624 828
12.
LEASE LIABILITIES
ANNUAL REPORT 2024
46
DISTRIBUTION OF PROFIT/LOSS FOR THE YEAR 2024 2023
DKK thousand 31 Dec 31 Dec
Proposed dividend for the year 0 0
Retained earnings -28,959 -38,377
Total -28,959 -38,377
13.
DISTRIBUTION OF
PROFIT/LOSS FOR
THE YEAR
ANNUAL REPORT 2024
47
CHANGE IN WORKING CAPITAL 2024 2023
DKK thousand 31 Dec 31 Dec
Other receivables and prepayments -1,300 2,286
Change in trade payables -1,714 2,490
Change in other payables -298 302
Change in deferred income 642 -178
Total -2,670 4,900
14.
CHANGE IN WORKING
CAPITAL
ANNUAL REPORT 2024
48
Risk management policy
The Company's financial risks are managed by the
Executive Management. The Company has an
insurance plan. Otherwise, the company has not
prepared policies for the identification and
handling of risks. The management of the
Company's risks is included in the Executive
Management's day-to-day monitoring of the
Company.
Interest rate risk
The Company is not subject to material interest
rate risks.
Currency risk
The Company is not subject to material currency
risks.
Credit risk
The Company’s cash is placed on deposit accounts
without restrictions at a national Danish bank, with a
Moody’s rating A2.
Liquidity risk
The Company's liquidity risk covers the risk that
the Company is not able to meet its liabilities as
they fall due.
As a development stage life-science company, the
Company has had a negative cash flow in 2024.
Thus, the company is dependent on being able to
finance the operations until reaching the point
where the size of the revenue increases the costs
resulting in a positive cash flow.
The Board of Directors and Executive
Management are constantly monitoring the
Company’s financial position to be prepared to
take adequate measures to secure the company.
Several options are possible such as partnering
deals, service agreements, reduce investments in
fixed assets, loans and increase the capital in the
company.
The Board of Directors and Management have
confidence in the company as a going concern.
See Note 2 for further explanation.
The maturities of financial liabilities appear from
the tables below. All amounts are contractual
cash flows, i.e. inclusive of interest.
15.
FINANCIAL RISKS AND
FINANCIAL
INSTRUMENTS
ANNUAL REPORT 2024
49
2024 - MATURITIES OF FINANCIAL LIABILITIES
< 1
year
1-2
year(s)
2-5
years
> 5
years
Total
DKK thousand
As per December 31, 2024
Debt to credit institutions 0 0 0 0 0
Lease Liabilities 229 395 0 0 624
Trade payables 2,380 0 0 0 2,380
Other payables 1,668 0 0 0 1,668
Total 4,276 395 0 0 4,671
2023 - MATURITIES OF FINANCIAL LIABILITIES
< 1
year
1-2
year(s)
2-5
years
> 5
years
Total
DKK thousand
As per December 31, 2023
Debt to credit institutions 10,000 0 0 0 10,000
Lease Liabilities 205 623 0 0 828
Trade payables 4,094 0 0 0 4,094
Other payables 1,966 0 0 0 1,966
Total 16,266 623 0 0 16,889
There were no assets nor liabilities measured at
fair value as of 31 December 2024 and 2023.
ANNUAL REPORT 2024
50
The Board of Directors and the Executive
Management of FluoGuide A/S are considered
related parties.
Besides the remuneration of the Board of
Directors and the Executive Management and the
share-based payments, there are one transaction
with related parties in 2024.
TRANSACTIONS RELATED PARTIES 2024 2023
DKK thousand 31 Dec 31 Dec
Other related parties:
Regulatory and clinical consultancy - The Eriah Group Inc.*) 1,627 0
Financial Advisory Services - Vixco Capital AB
**)
0 95
*) The Eriah Group Inc. is a company owned by board member Donna Haire
**) Vixco Capital AB is a wholly owned company by board Member Mats Thorén
There have been no other transactions with related parties - exempt from wages etc cf Note 4
16.
RELATED PARTIES
ANNUAL REPORT 2024
51
FEES TO STATUTORY AUDITORS 2024 2023
DKK thousand 1 Jan - 31 Dec 1 Jan - 31 Dec
Statutory audit 164 142
Audit related services 0 35
Tax advisory services 38 13
Other services 35 103
Total 237 292
17.
FEES TO STATUTORY
AUDITORS
The fee for non-audit services provided by
PricewaterhouseCoopers Statsautoriseret
Revisionspartnerselskab of DKK 73 thousand
(DKK 151 thousand) relates to tax advisory, and
other general financial accounting matters.
ANNUAL REPORT 2024
52
18.
OPERATING LEASE
COMMITMENTS AND
OTHER COMMITMENTS
The company has entered purchase obligations
with suppliers in the amount of DKK 9.8 million
(DKK 4.7 million) as of December 31, 2024,
regarding the clinical phase II trial with FG001
in head and neck cancer and CMC work.
The Company has entered a lease starting 1
January 2025 with 3 years irrevocability and 6
months’ notice. The obligation amounts to DKK
1.6 million (DKK 0).
ANNUAL REPORT 2024
53
On January 15, 2025, the Company received
approval for phase II trial in head and neck cancer.
Except as noted above, there have been no
significant events between December 31, 2024,
and the date of approval of these financial
statements that would require a change to or
additional disclosure in the financial
statements.
19.
EVENTS OCCURING
AFTER THE BALANCE
SHEET DATE
ANNUAL REPORT 2024
54