Light up cancer
maximize surgical outcome
Annual
Report
2025
FluoGuide A/S
CVR no.39 29 64 38
Titanhus, Titangade 9-13
DK-2200 Copenhagen N
CONTENTS
FLUOGUIDE AT A GLANCE ........................................................................................................ 3
CEO LETTER: FROM CLINICAL PROMISE TO A CLEAR PATH TO APPROVAL .............................. 4
SPECIAL TOPIC: IND SUBMISSION – A DE-RISKED PATH TO U.S. APPROVAL ............................ 6
2025 HIGHLIGHTS ..................................................................................................................... 7
STRATEGY: 2026 - FROM DIRECTION TO EXECUTION .............................................................. 8
2026 OUTLOOK ....................................................................................................................... 11
FG001 PIPELINE ...................................................................................................................... 12
FINANCIAL HIGHLIGHTS AND KEY FIGURES ............................................................................ 13
FINANCIAL DEVELOPMENT ..................................................................................................... 14
MANAGEMENT STATEMENT ON THE ANNUAL REPORT ........................................................ 16
INDEPENDENT AUDITOR’S REPORT ........................................................................................ 17
MANAGEMENT ....................................................................................................................... 20
SHAREHOLDER INFORMATION ............................................................................................... 22
RISK MANAGEMENT ............................................................................................................... 24
COMPANY INFORMATION ...................................................................................................... 25
TERMS AND EXPLANATIONS ................................................................................................... 26
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME ............................... 27
BALANCE SHEET ...................................................................................................................... 28
STATEMENT OF CHANGES IN EQUITY ..................................................................................... 29
CASH FLOW STATEMENTS ...................................................................................................... 30
NOTES ..................................................................................................................................... 32
GET IN TOUCH WITH FLUOGUIDE........................................................................................... 62
ANNUAL REPORT 2025
3
FLUOGUIDE AT A GLANCE
Oncology surgery
Lighting up cancer
uPAR targeted fluorescence
Relevant for all solid cancers
3 positive clinical
phase 2 results in different
tumors
≈ 20 millions
New patients diagnosed
every year
FDA clear IND of trial
supporting registration
FG001 in high grade glioma
FluoGuide (Nasdaq: FLUO)
7,474 shareholders
As of 31 December 2025
FG001 lead in
high-grade glioma
Focused on the U.S.
Partnering with leading
MedTech companies
Non-exclusive partnerships
ANNUAL REPORT 2025
4
CEO letter
FROM CLINICAL PROMISE TO A CLEAR PATH TO APPROVAL
2025 was a defining year for FluoGuide. We
evolved from a development-driven project into a
focused and increasingly de-risked company with
a clear regulatory path, strong industrial
partnerships, and the organizational capabilities
required for long-term value creation.
FG001 is at the core of our progress. Across
multiple indications, we have demonstrated that
FG001 consistently lights up cancer, supports
surgeons in removing more tumor tissue, and is
well tolerated by patients. In 2025, our task was
no longer to prove scientific relevance alone, but
to turn clinical promise into a robust, credible
development and commercialization pathway.
A clear and de-risked path to approval
The most important milestone of the year was the
regulatory clarity achieved for our lead indication,
high-grade glioma (HGG) in the U.S. During the
third quarter, we received alignment from the
Food and Drug Administration (FDA) on the design
of our U.S. Phase 2 trial supporting registration
and on key elements of the subsequent Phase 3
program. This alignment was part of preparing the
Investigational New Drug (IND) application for
FG001 and provided the regulatory basis to
initiate U.S. clinical trials. This significantly de-risks
our regulatory strategy as we move toward a
future NDA (New Drug Application) submission
and marks a critical inflection point for the
company.
In parallel, we strengthened the foundation
around the HGG program by securing support
from leading neurosurgeons and surgical
equipment manufacturers, and by reinforcing our
organization with experienced profiles in clinical
development, regulatory affairs, and
commercialization. These actions reflect a
deliberate shift toward company-wide execution.
Strengthening the organization for execution
Alongside our regulatory progress, we
strengthened FluoGuide’s leadership and
governance to support the transition into an
execution-driven phase. In 2025, Donna Haire
joined as Chief Operating Officer, adding senior
experience in clinical development and regulatory
execution, and Camilla Harder Hartvig joined the
Board of Directors, strengthening the company’s
commercial and strategic capabilities. Together,
these changes support FluoGuide advancing
toward registration and future commercialization.
Expanding the value of FG001 beyond HGG
While HGG remains our primary focus, we
continue to expand the potential of FG001 across
additional indications. Data presented during the
year demonstrated FG001’s ability to light up the
most common brain tumor (meningioma), as well
as gliomas that has not destroyed the blood–brain
barrier (presumable low-grade tumors). These
results highlight FG001’s broad potential in brain
tumors and its ability to visualize cancer tissue
even when located behind the blood–brain
barrier. In head and neck cancer, our phase 2 trial
(CT-005) progressed, exploring not only surgical
guidance but also real-time intraoperative
assessment of image quality across multiple
imaging systems.
Together, these efforts have the potential to
expand the number of patients who may benefit
from FG001 and to strengthen the long-term
commercial opportunity.
Building an ecosystem for commercial success
Our ambition is to build FG001 as a foundational
component of the surgery of the future, where
advanced imaging, workflow integration, and
“With regulatory alignment, 2025 marked a
defining year for us and we operate with
clarity, confidence, and discipline towards an
approval.”
CEO Morten Albrechtsen
ANNUAL REPORT 2025
5
precision technologies work together to improve
outcomes in the operating room.
During 2025, we expanded and deepened our
partnerships with global MedTech leaders in
preparation for integration in the head and neck
clinical trial (CT-005). These collaborations are
essential to ensure that FG001 can seamlessly be
integrated across multiple surgical platforms and
adopted at scale.
Financial strength and long-term perspective
In November, we raised SEK 104 million with
minimal dilution, ensuring that FluoGuide is well
financed to execute its development plans.
Combined with disciplined cost management, this
positions the company to reach key milestones
while maintaining focus toward
commercialization.
2025 also marked a shift in how we think about
value creation. We are no longer building
optionality alone; we are building a company with
a clear roadmap, defined milestones, and a long-
term perspective grounded in regulatory clarity,
clinical evidence, and stakeholder alignment.
2026 outlook
As we enter 2026, FluoGuide is positioned to
advance with confidence. We have a de-risked
lead program, a growing number of indications
providing strategic optionality, strong
partnerships, and a committed team focused on
execution. Our mission remains unchanged: to
maximize the outcomes of cancer surgery for
patients. What has changed is our predictability to
deliver on that mission – and to do it successfully.
We would like to thank our shareholders for their
continued support as we build FluoGuide into a
company that delivers extraordinary value to
patients and sustainable long-term value to our
owners.
I would also like to thank patients, partners,
investigators, and employees for your continued
trust and support.
Morten Albrechtsen
CEO, FluoGuide A/S
ANNUAL REPORT 2025
6
Special topic
IND SUBMISSION – A DE-RISKED PATH TO U.S. APPROVAL
Regulatory alignment and preparing the U.S.
Phase 2 trial supporting registration in high-grade
glioma.
What is the IND and why is it important?
An Investigational New Drug (IND) application is
required under U.S. regulations to initiate clinical
trials of a new drug. For FluoGuide, the IND
enables the initiation of the U.S. Phase 2 trial
supporting registration in high-grade glioma
(HGG), which is the first U.S. clinical trial
conducted under the IND.
The IND represents a critical step toward a future
New Drug Application (NDA), which is required for
U.S. marketing approval of FG001.
Prior to the IND submission, FluoGuide held a pre-
IND meeting with the U.S. Food and Drug
Administration (FDA). During this process, the FDA
reviewed a comprehensive development package
covering work completed to date and the
proposed plan going forward. This resulted in
regulatory alignment of the development
strategy.
What is the Phase 2 trial supporting registration
in high-grade glioma?
The U.S. Phase 2 trial supporting registration in
high-grade glioma (HGG) is planned as one of two
clinical trials intended to support a future New
Drug Application (NDA), based on current
interactions with the FDA. The formal endpoint is
the complete resection (CR) rate, defined as the
proportion of patients achieving CR, identified by
contrast-enhanced MRI (T1, gadolinium)
performed within 48 hours postoperatively.
The trial is planned to include 4–6 clinical centers,
partly to secure a smooth transition to the
subsequent Phase 3 trial. Site selection has not yet
been finalized, but discussions are very advanced.
The planned number of patients is approximately
76 in Phase 2 and approximately 150 patients in
Phase 3. Timing, patient numbers and other trial
parameters are subject to trial results, the amount
of safety data required to support an NDA, and
equipment collaborations.
How does the IND de-risk the path to approval?
The IND establishes the regulatory framework for
the U.S. development program. By defining the
requirements, it increases predictability in the
path toward NDA submission and potential U.S.
approval of FG001.
It also enables dialogue with the FDA throughout
the development process, reducing uncertainty
around regulatory expectations and supporting
informed long-term planning. This clarity
strengthens the foundation for the predictability
of the overall execution.
“The IND submission reflects rigorous end-to-
end execution across regulatory, clinical and
technical areas and sets a clear path toward
U.S. registration trials in high-grade glioma.”
COO Donna Haire
ANNUAL REPORT 2025
7
2025 HIGHLIGHTS
In 2025, FluoGuide reached several key clinical and
regulatory milestones that further de-risk the path
toward future U.S. approval. These milestones
included advancement of FG001, strengthening
the clinical evidence base and bringing us one step
closer to our goal of improving precision in cancer
surgery.
With a clear clinical strategy and strong execution,
we enter 2026 focused on further clinical progress
and strengthen the foundation for long-term
development planning as the company advances
its program in the U.S.
Link to PR
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Link to PR
15.04
21.07
16.09
03.11
05.11
25.11
20.02
Enrolled the
first patient in
the Phase 2
clinical trial
with FG001 in
head and neck
cancer.
Entered a
strategic
collaboration
with Olympus
focusing on
gathering a
body of
evidence on
Olympus’
technology
platforms.
Received
positive FDA
feedback on
FG001 in high
grade glioma
for both the
IND
submission
and future
NDA filing.
Successfully
raised SEK 104
million
through a
directed issue
strengthening
the financial
foundation for
ongoing
clinical
development.
Strengthening
leadership by
appointing
Donna Haire
as Chief
Operating
Officer and
Camilla
Harder
Hartvig to the
Board of
Directors.
Entered a
strategic
collaboration
with Zeiss
focus is on
tumor imaging
and surgical
margins
assessment for
head and neck
cancer.
FDA cleares
the IND for
FG001 to
initiate first
U.S. Phase 2
clinical trial
supporting
registration
with FG001 in
high grade
glioma.
ANNUAL REPORT 2025
8
Strategy
2026 - FROM DIRECTION TO EXECUTION
FluoGuide’s strategy remains unchanged and
focuses on advancing FG001 toward its first
approval in the U.S. as an image agent to guide
surgery of high-grade glioma (HGG) being one of
the most aggressive type of cancers.
The second priority is to broaden the use of FG001
across oral head and neck cancer and other brain
tumors. These priorities are supported by strategic
partnerships with surgical equipment
manufacturers to accelerate clinical adoption and
deepen commercial penetration.
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
Sullivan et al. “Global Cancer Surgery: Delivering Safe, Affordable,
and Timely Cancer Surgery.” The Lancet Oncology 16, no. 11
(2015): 1193–224
FG001 has demonstrated positive results in its
ability to light up malignant tissue during surgery in
brain, head and neck, and lung cancers, and it is
well-tolerated by all patients. FG001 binds to uPAR
(urokinase-type plasminogen activator receptor)
and scientific data suggests its broad potential
across all solid tumor types.
Potential market
FluoGuide's lead product, FG001, targets a broad
market, covering most of the solid tumors 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
, some more than once. FluoGuide aims
to enhance surgical precision for these patients
and provide additional treatment opportunities for
the remaining 40% who are not currently offered
surgery. The total number of surgical procedures
where FG001 could make a difference is estimated
4
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
er&group_populations=1&multiple_populations=0&cancers=20&
populations=900
5
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
to be more than 45 million annually in 2030
3
. For
brain tumor and head and neck cancer the near-
term opportunity is approximately 640 thousand
procedures per year and assuming the current
pricing of the image agents this adds up to a
blockbuster potential.
High grade glioma (aggressive brain
cancer
FG001 has demonstrated clinical benefit during
surgery of patients with HGG, as shown in the trial
where all (12) patients (press release) had
additional cancerous tissue removed due to
FG001’s guidance. High-grade glioma remains a
major challenge, with over 90-95% recurrence rate
post-surgery
4
5
6
7
in Ontario: a population-based study. Current Oncology, 28(2),
1218-1229. https://doi.org/10.3390/curroncol28020057
6
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
diagnosed in the United States in 2012–2016. Neuro-Oncology,
21(Suppl 5), v1–v100. https://doi.org/10.1093/neuonc/noz150
7
Ivy Brain Tumor Center. (2023, February 24). Brain tumor
recurrence. Retrieved from
https://www.ivybraintumorcenter.org/blog/brain-tumor-
recurrence/
Our mission is to maximize outcomes for
cancer patients by enabling surgeons to
remove cancer more accurately.
ANNUAL REPORT 2025
9
In 2025, FluoGuide obtained alignment with the
U.S. FDA to the design of the trials supporting
registration for FG001 as an intraoperative
imaging agent in HGG.
Key 2026 milestones include initiation of the first
trial in the U.S. supporting registration and
enrollment of first patient during H1 2026. The
long-term objective is to obtain the first drug
approval of FG001 in the U.S.
Brain tumor
There are estimated 2.8 million patients diagnosed
with primary and secondary brain tumor diagnoses
annually where HGG constitutes only approx. 5%.
The remaining 95% of other brain tumors include
meningioma (most frequent brain tumor), low
grade glioma, metastases to the brain from
different cancers such as breast, skin and lung
cancers. Surgery is offered to most of those
patients.
All patients with a brain tumor offered surgery
desire precision and could benefit from an
intraoperative imaging agent. The positive
preliminary data presented in 2025 demonstrated
FG001’s capability to light up meningioma and
presumed Low-Grade Glioma pointing to FG001 as
the imaging agent that potentially could have
broad application for use in brain tumor surgery.
8
Gal TJ et al. Treatment trends in oropharyngeal carcinoma:
Surgical technology meets the epidemic. Oral Oncology, Vol 97,
2019, p 62-68
The positive data in patients with presumed Low-
Grade Glioma is important for all patients with
glioma, including high-grade glioma as it points on
FG001 passing the blood brain barrier which is
essential for it to illuminate high-grade glioma
hidden behind the blood brain barrier.
In 2025, positive interim data was published from
the ongoing investigator-initiated clinical trial
(IIT-001) in patients with meningioma and
presumed Low-Grade Glioma.
During 2026 FluoGuide anticipates initiating
enrollment of the remaining 10 patients with
presumed Low-Grade Glioma.
Oral head and neck cancer
Head and neck cancers affect approximately
950,000 people worldwide each year, with an
estimated 40% of patients requiring surgery
8
9
.
FG001's high-precision visualization capabilities
aims to improve surgical resection, potentially
reducing the need for additional treatments such
as chemo-radiotherapy and the associated adverse
effects.
FG001 has been well tolerated in clinical studies,
supporting its potential use across multiple cancer
types.
In head and neck cancer (Oral Squamous Cell
Carcinoma), FG001 completed a phase II trial (CT-
003) in the EU, successfully lighting up cancerous
9
Cramer JD et al. The changing therapeutic landscape of head and
neck cancer. Nat. Rev. Clin. Oncol. 16, 669–683 (2019)
tissues in all 16 patients. The ongoing Phase 2
clinical trial (CT-005) in the Netherlands of FG001
in head and neck cancer investigates several
clinical endpoints as well as multiple types of
surgical imaging equipment.
The trial has a two-phased design, which includes
15 patients in a dose finding phase where the
optimal dose is defined and includes many
endpoints and assessments of multiple imaging
equipment types, with an option to expand with an
additional 5 patients.
The second phase includes 10 patients
investigating the optimal time of administering
FG001. The regulatory and partnering planning can
be initiated when the first phase of 15 patients is
completed.
In 2025, FluoGuide initiated the first part of the
Phase 2 trial enrolling 15 patients and providing
the basis for planning the path to regulatory
approval and partnering.
Key 2026 milestones include reporting interim
data from the first part of the trial from the 15
patients
Partnerships
Since FG001 is visualized using intraoperative
imaging equipment, surgical imaging equipment
manufacturers play a key role in its application. The
interface between FG001 and the surgical imaging
ANNUAL REPORT 2025
10
equipment presents a significant opportunity for
synergies, enabling better surgery for more
patients with cancer. These partnerships include
manufacturers of microscopes, endoscopes, open-
field cameras, surgical robots, and excised
specimen imaging equipment – creating broad
collaboration opportunities for FluoGuide.
FluoGuide has partnered with major MedTech
companies representing the different categories of
surgical equipment such as robots, microscopes
and endoscopes to optimize and prepare
integration of FG001 with their different surgical
systems. The basis for future integration is laid out
in the ongoing oral head and neck clinical trial (CT-
005). These collaborations also evaluate the
integration of FG001 and the partner’s technology.
They are mutually non-exclusive partnerships at
this stage.
FluoGuide believes the key direct benefit of these
collaborations provide a faster and deeper
penetration of FG001 into head and neck surgery
market. The indirect benefits go far beyond, by
potentially expanding into other indications as well
as making better combined offerings to surgeons
and expanding treatment options for patients with
cancer.
During 2025, we initiated the clinical phase of
partnerships with Intuitive Surgical, Olympus,
Zeiss and SurgVision.
During 2026, FluoGuide anticipates the formation
of an additional strategic partnership to
10
Simón M, Jørgensen, JT, Juhl, K, Kjaer, A (2021) The use of a
uPAR-targeted probe for photothermal cancer therapy prolongs
complement the first phase of the partnering and
preparing for deepening the partnerships
supporting the company’s long-term objective to
commercialization of FG001.
Photosensitizer
Beyond enhancing surgical precision, FG001 also
has photosensitizer properties
10
, enabling it to
actively destroy cancer cells when exposed to
specific light demonstrated in pre-clinical models
via two potential mechanisms; Photothermal
therapy (PTT) – FG001 heats up and burns cancer
cells and Photodynamic therapy (PDT) – FG001
triggers a reaction that produces toxic molecules
deadly to 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.
During 2025, we obtained data on the therapeutic
property (PTT) of FG001 while the PDT therapy
property remains to be concluded. The PTT will be
a stand-alone development program not
integrated directly into the HGG development.
A key milestone for 2026 is to determine the
optimization use of FG001 and the laser system in
survival in a xenograft mouse model of glioblastoma, Oncotarget,
12(14):1366-1376. doi: 10.18632/oncotarget.28013
pre-clinical models and to present a plan for
further development.
Intellectual property protection
FluoGuide has established 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 the US and EU,
last until 2035. Additional patent families have
been filed and are being processed around the
world and is expected to prolong the protection
until 2040.
FluoGuide has been granted an orphan designation
in the US for FG001 as a diagnostic for the
management of malignant glioma which provides
potential additional market exclusivity for seven
years after approval.
During 2025, additional patent applications were
submitted to further strengthen the IP protection
beyond 2040.
More information
More information can be found on our website:
www.fluoguide.com
ANNUAL REPORT 2025
11
2026 OUTLOOK
Strategic Area
Ongoing tasks
2026 Milestones
Long term objectives
Brain
FG001 - guiding surgery of
High-Grade Glioma (HGG)
Execute trials supporting the NDA in the
U.S. for FG001 in the lead indication
✓ H1: Submission of IND for first trial in
U.S. supporting registration
H1: First patient enrolled in U.S. Phase 2
trial for HGG
First approval of FG001 in U.S.
FG001 - guiding surgery of
additional brain tumors
Potential: x20 # patients
compared to HGG alone
Evaluate additional indications, clinical
benefit endpoints and image system
optimization in brain tumor surgery
H1: Initiate enrollment of the remaining
10 patients with presumable low-grade-
glioma (investigator-initiated trial)
H2: Interim result of low-grade glioma
H2: FluoGuide brain tumor plan
presentation
Expand FG001 indication to target a larger
part of the brain tumor market where
currently no imaging agents are approved
– helping more patients
FG001 - photosensitizer
therapy
Potential: x20 in price
compared to guided surgery
Evaluating and optimizing the
photothermal and photodynamic effect of
FG001 used in treatment of cancer in the
hand of the surgeon.
H2: Optimizing use of FG001 and the
laser system in pre-clinical models. The
treatment claim will not be part of the
lead indication for HGG. Plans to be
presented
Expand FG001 as a photosensitizer to
address another large unmet medical need
and broaden market potential
Head and
neck
FG001 - guiding surgery of oral
head and neck cancer
Evaluate multiple clinical benefit endpoints
for use in registration trial(s) together
with different intraoperative image
systems
H1: Interim result of 15 patients (first
phase of CT-005)
H2: Interim result for additional 10
patients (second phase of CT-005)
exploring the timing of dosing
First approval of FG001 in oral head and
neck cancer
Expand FG001 indication to large market for
oral head and neck cancer where currently
no intraoperative imaging agents are
approved
Partnering
Partnerships for FG001
Completing the first round of partnering
H2: 1 additional partnership
Facilitate commercialization with support
from partner(s)
ANNUAL REPORT 2025
12
’FGS’ Fluorescence guided surgery
Abbreviation
Indication
Status
CT-005
OSCC (head & neck)
Ongoing
CT-006
HGG (brain)
IND green light
IIT-001
Meningioma and LGG (brain)
Ongoing
FG001 is an uPAR target imaging agent designed to work with any standard intraoperative imaging device
FG001 PIPELINE
ANNUAL REPORT 2025
13
FINANCIAL HIGHLIGHTS AND KEY FIGURES
KEY FIGURES
2025
2024
2023
2022
2021
DKK thousand
Income statement
Other operating income
220
385
423
6,511
9,613
Other external expenses
-23,980
-17,709
-29,234
-24,099
-20,593
Staff expenses
-15,504
-15,259
-14,848
-14,623
-17,671
Depreciation and amortization
-558
-456
-265
-251
-158
Income/(Loss) before interest and tax (EBIT)
-39,822
-33,040
-43,924
-32,461
-28,809
Net financial items
-5,137
-1,419
47
-379
-461
Income/(Loss) before tax
-44,959
-34,459
-43,877
-32,840
-29,270
Tax on income for the year
5,500
5,500
5,500
5,500
5,500
Net result for the year
-39,459
-28,959
-38,377
-27,340
-23,770
Balance sheet
Non-current assets
1,548
1,877
1,346
726
485
Current assets
86,744
26,503
28,263
34,894
52,824
Total assets
88,292
28,380
29,609
35,620
53,309
Equity
54,528
23,067
12,720
31,969
38,701
Non-current liabilities
28,038
395
623
0
0
Current liabilities
5,727
4,918
16,889
3,652
14,608
Cash flow statement
Cash and cash equivalents
48,785
18,608
21,668
26,013
46,758
Cash flow from:
Operating activities
-36,957
-29,152
-31,809
-37,645
-15,062
Investing activities
-29,904
-987
-37
-117
0
Financing activities
97,038
27,080
27,500
17,018
51,183
The period’s cash flow
30,176
-3,059
-4,345
-20,745
36,121
Key ratios
Equity share (solvency ratio)
62%
81%
43%
90%
73%
Earnings per share (DKK)
-2.81
-2.23
-3.22
-2.33
-2.15
ANNUAL REPORT 2025
14
FINANCIAL DEVELOPMENT
Figures in ‘()’ refer to the same period last year.
Operating income & Other operating
income
For the period January 1 – December 31, 2025, the
Operating income amounted to DKK 0 (DKK 0).
Other operating income amounted to DKK 220
thousand (DKK 385 thousand) and comprised of
the income relating to the part of incurred costs
covered by Danish Innovation Fund
(Innovationsfonden) regarding project FluoCure.
Other external expenses
In 2025, other external expenses amounted to
DKK 23,980 thousand (DKK 17,709 thousand) and
comprised:
• Research & development costs including IP
but excluding salaries DKK 18,509 thousand
(DKK 12,075 thousand)
• Sales & marketing costs of DKK 441 thousand
(DKK 600 thousand)
• General & Admin costs of DKK 5,030 thousand
(DKK 5,034 thousand).
The increase in Research & Development costs is
due to the timing of the clinical trials. In 2025 the
clinical trial in head and neck cancer initiated
enrolling and regulatory work on the pre-IND and
the IND was also kicked off. Whilst in 2024 no
clinical trials were enrolling and instead the study
reports from three clinical trials were finalized
(CT001 – CT003).
The decrease in Sales & marketing costs is
primarily related to less spending in Market
research.
Staff expenses
Staff expenses for the year amounted to DKK
15,504 thousand (DKK 15,259 thousand) and
comprised:
• Wages and salaries including bonus and Board
fee’s DKK 12,500 thousand (DKK 12,596
thousand)
• Employee share schemes DKK 1,205 thousand
(DKK 2,021 thousand)
• Other staff and social security costs including
pension DKK 1,799 thousand (DKK 642
thousand). Pension contribution from the
Company was introduced during 2024.
In 2025 the average number of full-time
employees was 6.7 (7.8).
Financial items
Financial income and expenses reflect interest
income/expense and currency transaction
gains/losses, bank charges and interest.
In 2025, the financial income amounted to DKK 50
thousand (DKK 101 thousand).
In 2025, the financial expenses amounted to DKK
5,187 thousand (DKK 1,520 thousand) primarily
due to interest in connection with the prolonged
(April 2027) credit facility of SEK 40 million.
Tax
In 2025, 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 2025, the net result showed a loss of DKK 39,459
thousand (loss of DKK 28,959 thousand) each
reflecting the mix of variances described above. The
result was in accordance with the Company’s
expectations for the period.
Balance sheet
As of December 31, 2025, the Company’s total
assets were DKK 88,292 thousand (DKK 28,380
thousand).
ANNUAL REPORT 2025
15
The assets primarily consist of securities, cash and
cash equivalents from the capital raise in
November 2025 and a tax benefit related to tax
credits derived from investments in research &
development in 2025.
The liabilities primarily consist of the drawn credit
facility of SEK 40,000 thousand - equal to DKK
27,616 thousand.
Securities, cash and cash equiva-
lents
As of December 31, 2025, FluoGuide’s balance of
securities, cash and cash equivalents totaled DKK
78,799 thousand (DKK 18,608 thousand). The cash
of DKK 48,785 thousand is partly deposited at one
Danish bank and partly through money market
deposits. The securities amounting to DKK 30,015
thousand is placed in Danish securities that
matures in July 2026.
As a development stage start-up life-science
company, and like other similar development
stage companies, the Company expects negative
cash flow in 2025 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.
Equity
The total equity on December 31, 2025, amounted
to DKK 54,528 thousand (DKK 23,067 thousand).
The change in equity is primarily due to the
realized net loss of DKK 39,459 thousand in the
period January 1 – December 31, 2025, off-set by
the capital raise in November 2025 of DKK 70,366
thousand.
As of December 31, 2025, the solvency ratio was
62 percent (81 percent).
Current and non-current liabilities
As of December 31, 2025, the current liabilities
amounted to DKK 5,727 thousand (DKK 4,918
thousand). The current liabilities primarily consist
of payables of DKK 5,054 thousand (DKK 4,048
thousand). The non-current liabilities as of
December 31, 2025, amounted to DKK 28,038, and
primarily consisted of the drawn credit facility of
DKK 27,616 thousand (DKK 0).
Subsequent events
On January 21, 2026, the Company submitted an
IND for FG001 to initiate first U.S. trial supporting
registration.
On February 20, 2026, FDA cleares the IND.
Except as noted above, there have been no
significant events between December 31, 2025,
and the date of approval of these financial
statements that would require a change to or
additional disclosure in the financial statements.
ANNUAL REPORT 2025
16
Executive Management:
Board of Directors:
ANNUAL REPORT 2025
17
ANNUAL REPORT 2025
18
ANNUAL REPORT 2025
19
CVR No 33 77 12 31
__________________________________________
Mne29465
ANNUAL REPORT 2025
20
MANAGEMENT
Board of Directors
Peter Mørch Eriksen – Chair of the Board since 2021
Peter has over 25 years of international experience in the medtech and life
science sectors. He is currently focusing on Board leaderships and serves as
Chairman of Monsenso A/S and AptaShape ApS. Peter previously held senior
roles as CEO of BioPorto A/S and at Medtronic in both the U.S. and Denmark,
including Vice President. Peter has a strong track record in driving growth,
leading restructurings, and securing funding in complex, technology-driven
organizations. With a background in accounting and executive management
training, he combines financial expertise with strategic leadership. He is
Director of PME Holding ApS and is a member of the Medical Device and
Diagnostics Advisory Committee at Cincinnati Children’s Hospital Medical
Center.
Mats Thorén – Vice-Chair 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 20 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.
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).
Camilla Harder Hartvig – Board member since 2025
Camilla has 30 years of operational and strategic commercial experience
within the worldwide lifescience industry. She has lived abroad for most of
her career, only returning to Denmark in 2023. Her most recent roles were
as EVP, CCO in Ascendis Pharma in Copenhagen; EVP, CCO in Theramex Ltd
based in London and before that SVP for the International region in Alexion
Pharmaceuticals based out of Zurich. Camilla has launched numerous
products worldwide, most notably as the VP Global Marketing for
AstraZeneca. She has served on boards for more than a decade, in leading
companies like Danish Crown and CWorldWide and currently sits on the
board of Goddess Gaia Ventures (London), MagCath ApS and Biobridge
Partners in Copenhagen. She is a member of the female investor group
Angella Invest and is currently enrolled in their Angel and Venture Capital
Investor Accelerator Programme. Camilla holds a MBSc in economics and
business administration - international marketing and management from
CBS, a CEMS MIM from HEC in Paris and board educations from Harvard and
INSEAD.
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, PET/MRI and optical probes 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.
ANNUAL REPORT 2025
21
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.
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.
Corporate Management
Donna Haire – COO since 2025
Donna Haire is an accomplished board director and Chief Executive Officer
of The Eriah Group, Inc., a global consulting firm specializing in turn-key
R&D operations, including regulatory, quality, clinical, and medical affairs
for drugs, biologics, medical devices, in vitro diagnostics, and combination
products. With over 30 years of leadership experience in healthcare,
pharmaceuticals, and medical devices, she has a proven track record of
designing, developing, and successfully commercializing innovative
products. Donna currently serves on the boards of BioPorto A/S and Sedana
Medical AB. Her previous executive roles include Executive Vice President
of Regulatory and Quality at On Target Laboratories, Vice President, Head
of Medical Care Global Regulatory Affairs at Bayer, and Senior Vice
President of Regulatory, Quality, Clinical, and Medical Affairs at
AngioDynamics. She held senior leadership roles at Philips Healthcare,
Medtronic, and STERIS, and was appointed as a U.S. regulatory expert to
lead international trade negotiations. She served on AdvaMed’s Technical
and Regulatory Board Committee and was an Adjunct Professor at the
University of Akron School of Law. Donna holds an M.S. in Biology from
Cleveland State University and a B.S. in Biology from The University of
Akron.
Andreas Kjær – CSO 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, PET/MRI and optical probes 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.
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.
ANNUAL REPORT 2025
22
SHAREHOLDER INFORMATION
The share
FluoGuide is listed on Nasdaq First North Growth
Market Sweden. The trading name is FLUO, and the
ISIN-code is DK0061123312.
By January 1, 2025, FluoGuide’s share capital
amounted to SEK 1,362,014.90 divided into
13,620,149 shares of nominal value SEK 0.10 each.
There is only one class of shares, and each share
represents one vote.
On November 3, 2025, the Company executed a
Directed Issue of 2,729,164 shares resulting in a
Capital raise of SEK 104 million (DKK 71 million). The
new shares were issued and listed for trading on
Nasdaq First North Growth Market, Stockholm on
November 17, 2025.
As of December 31, 2025, FluoGuide’s share capital
amounted to 1,634,931.30 divided into 16,349,313
shares of nominal value SEK 0.10 each.
At year-end, FluoGuide’s market capitalization
was SEK 561 million against SEK 533 million at the
end of 2024.
Share price performance in 2025
At year-end, the closing price for FluoGuide shares
on Nasdaq First North Growth Market, Sweden
was SEK 34.30 – down 12.4% since year-end 2024.
During the same period, the First North Health
Care GI decreased by 26.9%.
The total trading volume of FluoGuide shares on
Nasdaq First North Growth Market, Sweden was
1,867,038 in 2025 (2,287,492 in 2024) equivalent
to 13.3% of the average number of shares in 2025
(17.6% in 2024).
ANNUAL REPORT 2025
23
Ownership
Based on the available information as of
December 31, 2025, FluoGuide had 7,474
registered shareholders compared to 7,893 by the
end of 2024. The 20 largest shareholders owned
71.2% (72.7%) of the share capital.
FluoGuide has no majority shareholders.
Shareholders owning more than 20% in FluoGuide
according to the latest shareholding notifications
are:
• Life Science ApS, a company owned by
Board Member, CSO Andreas Kjær and (CEO
Morten Albrechtsen (22.1%)
Shareholders owning more than 5% in FluoGuide
according to the latest shareholding notifications
are:
• Linc AB
• Arbejdernes Landsbank A/S
• 3F
• Fødevareforbundet NNF
• Dansk Metal
Management and the Board of Directors own 24.9%
of the total amount of outstanding shares after the
issuance of new shares in connection with the capital
increase. Compared to 29.9% on December 31, 2024.
The number of shares is always defined, however
there is no complete record at any given time of all
shareholders and their ownership.
Warrants
FluoGuide has established incentive programs for
its employees, management, and Board. On
November 3, 2025, the Board of Directors of
FluoGuide exercised its authorization to issue new
warrants by issuing 161,500 warrants to
management and employees and 37,500 warrants
to the Board of Directors. On December 31, 2025,
the total number of outstanding warrants is
722,800, equal to a dilution of the current share
capital of 4.2% if exercised.
A total of six warrant programs is 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 Please see note 5.
Financial calendar 2026
AGM 25 March 2026
Q1 report 2026 27 May 2026
Q2 report 2026 25 August 2026
Q3 report 2026 26 November 2026
All financial reports are available on FluoGuide’s
company page:
www.fluoguide.com/investor/financial-reports.
Proposed appropriation of retained
earnings
The Board of Directors have proposed that no
dividend is paid out for the fiscal year, January 1,
2025 – December 31, 2025.
ANNUAL REPORT 2025
24
RISK MANAGEMENT
FluoGuide A/S operates as a clinical-stage
biotechnology company in a highly regulated
environment. Risk management is therefore an
integral part of the Company’s governance and
supports the execution of its strategy and clinical
development plans.
Risks are identified, assessed, and managed on an
ongoing basis and are considered in connection with
strategic planning, budgeting, clinical trial execution,
and financing activities. Risk assessments focus on
both the likelihood of occurrence and the potential
impact on the Company.
The Board of Directors has overall responsibility for
risk oversight. Executive Management is responsible
for the day-to-day management of risks and reports
material risks to the Board as part of regular business
reviews.
Key operational risks
Risk area Description Impact Mitigating actions
Clinical
development and
regulatory approval
Financing and
liquidity
Technology
integration and
partnerships
Intellectual
property and
competitive
environment
Key personnel and
organizational
capacity
Commercialization
and launch
FluoGuide depends on a
limited number of highly
specialized employees and
external consultants.
Loss of key personnel or difficulties in
attracting talent could impact execution.
Mitigated through retention initiatives,
knowledge sharing, succession
planning, and use of external expertise.
The Company's value
creation is dependant on
its ability to effectively
commercialize and launch
FG001 and secure a deep
market penetration.
Mitigated through partnerships with
MedTech companies with large(r) market
share who supports market entry and
ensure smooth integration in surgical
workflows.
A failed or unseccessful launch could
reduce the commercial potential and
reduce interest for FG001 from partners
for other cancer indications.
FluoGuide’s imaging
agents must function
seamlessly with surgical
imaging systems.
Delays or technical challenges in partner
integrations could affect clinical
execution and future adoption.
Mitigated through early technical
collaboration with imaging partners,
platform-agnostic development, and
validation across multiple systems.
The Company’s value
creation depends on its
ability to protect its
technology and maintain a
competitive position.
Failure to obtain or defend intellectual
property rights, or rapid technological
advances by competitors, could reduce
commercial potential.
Mitigated through active patent portfolio
management, freedom-to-operate
analyses, and monitoring of the
competitive landscape.
FluoGuide is dependent on
the successful execution
of clinical studies and
regulatory interactions.
Clinical setbacks, delays in patient
recruitment, or requests for additional
data from regulatory authorities could
delay development timelines or increase
costs.
Mitigated through early and ongoing
dialogue with regulatory authorities,
careful trial design, use of experienced
CROs, and continuous monitoring of
safety and enrollment data.
As a clinical-stage
company without product
revenues, FluoGuide relies
on external financing to
fund its operations.
Adverse market conditions or higher-
than-expected development costs could
impact the Company’s ability to raise
capital on acceptable terms.
Mitigated through disciplined cost
management, rolling cash runway
assessments, and active evaluation of
financing and partnering opportunities.
High
Impact
Low High
Likelihood
ANNUAL REPORT 2025
25
COMPANY INFORMATION
The Company
Company address: Postal address:
CVR no.: 39 29 64 38
Board of Directors
Peter Mørch Eriksen (Chair)
Mats Thorén (Vice-Chair)
Michael Engsig
Camilla Harder Hartvig (elected 24 November 2025)
Andreas Kjær
Executive Management
Morten Albrechtsen, CEO
Ole Larsen, CFO
Auditors
CVR-no. DK 33 77 12 3 1
NASDAQ
FluoGuide is listed on Nasdaq First North Growth Market, Sweden (FLUO).
ANNUAL REPORT 2025
26
Terms and Explanations
Term
Explanation
Blood-brain barrier (BBB)
Protective barrier protecting the nerve system, including the brain from toxic drugs circulating in the blood.
Brain tumor
Abnormal growth of cells in the brain.
Clinical Trial Application (CTA)
Request European regulators to begin human trials.
C
max
The highest blood (serum) level a drug reaches after dosing.
Extent of resection (EOR)
Percent of the tumor removed; higher is better.
FG001
Our lead product. A targeted imaging agent that makes tumor light up during surgery.
Fluorescent guided surgery (FGS)
Surgery that uses image agent lighting up and cameras to help see cancer tissue.
Glioblastoma multiforme (GBM)
The most aggressive and common adult brain cancer (WHO grade IV glioma).
Gross Total Resection (GTR)
Removal of all visible tumor tissue.
High-grade glioma (HGG)
Aggressive, fast‑growing brain tumors (WHO grade III and IV glioma).
Indocyanine Green (ICG)
A dye that glows under near‑infrared light but is not tumor‑specific. Approved for vascular visualization
Investigational New Drug application (IND)
Request to FDA to begin human trials in the U.S.
Meningioma
Often (80-90%) benign tumor that forms in the meninges, the protective layers of tissue that cover the brain and spinal cord.
Near-infrared (NIR)
Light that penetrates tissue well and visible by digital camaras.
Neurosurgery
Surgery involving the brain or nervous system.
New Drug Application (NDA)
Request to FDA to approve a drug for sale.
Orphan Drug Designation
Regulatory benefits for drugs targeting rare diseases.
Phase I, 2a, 2b, 3 trials
Progressive stages testing clinical safety, effectiveness, and comparison to standard care.
Photodynamic therapy (PDT)
Using light‑activated drugs to kill cancer cells chemically.
Photothermal therapy (PTT)
Using light to heat and kill cancer cells.
Positive / Negative predictive value
Accuracy parameters of a test, indicating how likely positive or negative results truly indicate disease status, respectively.
Proof-of-concept
Early evidence showing treatment works.
Recurrent glioblastoma
Glioblastoma that returns after treatment.
Residual tumor
Tumor left behind after surgery.
Sensitivity / Specificity
Accuracy parameters of a test, indicating how well a test detects disease or excludes disease, respectively.
Surgical resection
Removal of tumor tissue during surgery.
Survival benefit
Improved lifespan gained from a treatment.
T
½
(half-life)
Time for drug levels in the body to decrease to half the concentration.
Tumor margin
The border of supposed normal tissue surrounding tumor tissue after surgical removal.
Tumor-to-background ratio
How brightly the tumor lights up compared to normal tissue.
urokinase-type plasminogen activator receptor (uPAR)
A protein found on all cancer tissue and used to target tumor specific imaging.
The list represents abbreviations and technical terms frequently used in the materials about FluoGuide.
ANNUAL REPORT 2025
27
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME
2025
2024
DKK thousand
Note
1 Jan - 31 Dec
1 Jan - 31 Dec
3
Other operating income
Other external expenses
-23,980
-17,709
4
Staff expenses
-15,504
-15,259
Depreciation and amortization
-558
-456
Income/(Loss) before interest and tax (EBIT)
-39,822
-33,040
6
Financial income
6
Financial expenses
-5,187
-1,520
Income/(Loss) before tax
-44,959
-34,459
7
Tax on income for the year
Net result for the year
-39,459
-28,959
Other comprehensive income for the year, net of tax
Total comprehensive income
-39,459
-28,959
12
Basis and diluted earnings per share (DKK)
-2.81
-2.23
ANNUAL REPORT 2025
28
BALANCE SHEET
ASSETS
2025
2024
DKK thousand
31 Dec
31 Dec
Note
Non-current assets
8
Acquired patents
9
Right of use assets
10
Tangible fixed assets
Deposits
Total non-current assets
Current assets
Other receivables
7
Receivable corporate tax
Prepayments
11
Securities
Cash & cash equivalents
Total current assets
Total assets
EQUITY AND LIABILITIES
2025
2024
DKK thousand
31 Dec
31 Dec
Note
Equity
Share capital
Share premium
Retained earnings
12
Total equity
Liabilities
14
Debt to credit institutions
13
Lease liabilities
Non-current liabilities
13
Lease liabilities
Trade payables
Other payables
Deferred income
Current liabilities
Total liabilities
Total equity and liabilities
ANNUAL REPORT 2025
29
STATEMENT OF CHANGES IN EQUITY
EQUITY
Share capital
Share premium
Retained earnings
Total equity
DKK thousand
Equity as of December 31, 2023
Total comprehensive income 2024
-28,959
-28,959
Capital increase
Expenses in connection with capital increase
-2,016
-2,016
Employee share schemes – value of employee services
Transfer
-39,160
Equity as of December 31, 2024
Total comprehensive income 2025
-39,459
-39,459
Capital increase
Expenses in connection with capital increase
-650
-650
Employee share schemes – value of employee services
Transfer
-70,093
Equity as of December 31, 2025
ANNUAL REPORT 2025
30
CASH FLOW STATEMENTS
CASH FLOW
2025
2024
DKK thousand
Note
1 Jan - 31 Dec
1 Jan - 31 Dec
Income before tax
-44,959
-34,459
Net financial items reversed
16
Change in working capital
-2,670
Depreciation and amortization
5
Adjustment for non-cash employee benefits expense – share-based payments
Cash flows from operating activities before net financials
-37,320
-33,233
Net financial items paid
-5,137
-1,419
Tax credit received
Cash flows from operating activities
-36,957
-29,152
Purchase of securities
-30,015
Purchase of tangible assets
-850
Paid/repaid deposit
-137
Cash flows from investing activities
-29,904
-987
Proceeds from capital increase
Proceeds from credit facility
-10,000
Principal elements of lease payments
-294
-205
Costs related to capital increase
-650
-2,016
Cash flows from financing activities
Total cash flows for the year
-3,059
Cash and cash equivalents as of January 1
Cash and cash equivalents as of December 31
ANNUAL REPORT 2025
31
CASH FLOW STATEMENTS CONTINUED
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
2025
2024
DKK thousand
As per primo period
623
10,828
Repayment (negative)/Proceeds from credit facility
0
-10,000
New leases
894
0
Disposals of leases
-605
0
Interest
61
56
Repayment
-304
-261
As per December 31
669
623
ANNUAL REPORT 2025
32
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. Securities
12. Share capital
13. Lease Liabilities
14. Debt to credit institutions
15. Distribution of profit/loss for the year
16. Change in working capital
17. Financial risks and financial instruments
18. Related parties
19. Fees to Statutory Auditors
20. Operating lease commitments and other commitments
21. Events occurring after the balance sheet date
ANNUAL REPORT 2025
33
Financial statements
The financial statements of FluoGuide A/S for
2025 are the Company’s seventh 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 are 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.
New and amended accounting
standards and interpretations for
2025
The Company has adopted all new or amended
accounting standards and interpretations (IFRS’s)
issued by IASB and endorsed by the European
Union effective for the accounting year 2025. The
standard and amendment relevant to the Group
is:
• Amendments to IAS 21 Lack of Exchangeability,
effective January 1, 2025
Management has assessed the impact of new or
amended accounting standard and interpretation
effective on or after 1 January 2025. It is assessed
that application of amendments effective from 1
January 2025 has not had a material impact on
the consolidated financial statements for 2025.
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
Lease assets are recognized at the
commencement date of the contract if it is or
contains a lease. Lease assets are recognized at
cost less accumulated depreciation and
impairment. Cost is defined as the lease liability
adjusted for any lease payments made at or
before the commencement date. Lease assets are
depreciated on a straight-line basis over the lease
term. Lease assets are remeasured when the
lease liability is impacted by reassessment of
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 2025
34
lease terms, modifications to lease agreements,
and when applying indexation or a rate. On initial
recognition, lease liabilities are measured as the
present value of future payments. The lease
payments contain fixed payments, less any lease
incentives receivable and variable lease
payments that depend on an index or a rate. On
subsequent recognition, lease liabilities are
measured at amortized cost. Short-term lease
expenses and low value assets are not recognized
as part of lease liabilities. They are recognized in
the income statement when incurred as an
operating expense.
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
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.
The tax credit is not considered as a subsidy as the
paid-out tax credit reduces the Company´s tax
loss carries forward.
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 by 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 assets.
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 is 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,
ANNUAL REPORT 2025
35
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 in which all the
specified vesting conditions are to be satisfied. At
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.
Depreciation
Depreciation is recognized in the income
statement on a straight-line basis over the
estimated useful lives of the assets, reflecting the
pattern in which the asset’s future economic
benefits are expected to be consumed.
The estimated useful lives, residual values and
depreciation methods are reviewed at least at
each reporting date and adjusted if appropriate.
Typical useful lives applied by the Company are as
follows:
• Leasehold improvements: 3–5 years
• Office equipment and fixtures: 3–5 years
• Equipment for clinical development: 3 years
Depreciation begins when the asset is ready for
its intended use and continues until the asset is
derecognized or classified as held for sale.
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 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
ANNUAL REPORT 2025
36
when patent is taken into commercial use.
Amortization methods, useful lives and residual
values are reviewed every year.
Right-of-use assets
For right-of-use assets under leases (IFRS 16), the
related lease asset is depreciated on a straight-
line basis over the shorter of the lease term and
the useful life of the underlying asset. The
accounting for leases follows IFRS 16 (Leases),
including the recognition of lease liabilities and
right-of-use assets.
Tangible fixed assets
Property, plant and equipment are measured at
cost on initial recognition. Cost comprises the
purchase price and any direct attributable costs
necessary to bring the asset to the location and
condition required for it to be capable of
operating in the manner intended by
management.
After initial recognition, property, plant and
equipment are measured at cost less
accumulated depreciation and impairment
losses.
The carrying amount of an item of property, plant
and equipment is derecognized on disposal or
when no future economic benefits are expected
from its use or disposal. The gain or loss arising
from derecognition (difference between net
disposal proceeds and the carrying amount) is
recognized in profit or loss when the asset is
derecognized.
At each reporting date, the carrying amounts of
tangible assets are reviewed to determine
whether there is any indication of impairment.
Deposits
Deposits are measured at cost. Deposits
represent security deposits paid to lessors in
connection with lease agreements for office
premises or other leased assets.
Receivables
Receivables comprise trade receivables and other
receivables. Receivables are included in the
category loans and receivables.
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.
Prepayments
Prepayments are measured at cost. Prepayments
comprise expenditures that relate to subsequent
periods.
Cash and cash equivalents
Cash includes deposits in bank accounts and
money market deposits.
Securities
Bond investments which are held to collect the
contractual cash flows and whose cash flows are
solely payment of principal and interest are
measured at amortized cost.
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.
Debt to credit institutions
Debt to credit institutions is recognized initially at
fair value, net of transaction costs incurred. Debt to
credit institutions is subsequently stated at
amortized cost; any difference between the
proceeds (net of transaction costs) and the
redemption value is recognized in the consolidated
income statement over the period of the debt using
the effective interest method.
ANNUAL REPORT 2025
37
Cash flow statement
The cash flow statement shows cash flow from
operating, investing, and financing activities as
well as cash at the beginning and end of the year.
Cash flow 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 flow from investing activities comprises
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 flow from financing activities comprises
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 flow 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
2025.
ANNUAL REPORT 2025
38
As a development stage start-up life-science
company, and like other similar development
stage companies, the Company has had a
negative cash flow from operations in 2025 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 2025 the company raised SEK 104 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 2025
Annual report.
The Budget for 2026 and the cash position on
December 31, 2025, are based on assumptions of
finalizing the Phase 2 clinical trial in head and
neck cancer (CT-005), initiating the first trial
supporting registration in the U.S. in high grade-
glioma (CT-006) and continuation of CMC work in
2026.
Based upon these assumptions the Company has
funding into the end of first quarter of 2027.
If against expectations, the assumptions for
Budget 2026 do not hold, the Board of Directors
and Management will take mitigating actions to
secure sufficient cash until December 31, 2026.
On this background the Board of Directors and
Management has decided to prepare the
financial statements for 2025 on a going concern
basis.
2.
CAPITAL
RESOURCES AND
LIQUIDITY
ANNUAL REPORT 2025
39
Other operating income amounted to DKK 220
thousand (DKK 385 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
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Other, including subsidy/grant for business PhD
220
385
Total
220
385
3.
OTHER
OPERATING
INCOME
ANNUAL REPORT 2025
40
Compensation for key management personnel
includes Morten Albrechtsen, Ole Larsen (from 1
March 2024), Andreas Kjær, and the Board of
Directors.
The average number of full-time employees
during 2025 was 6.7 (7.8).
STAFF EXPENSES
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Wages and salaries
12,500
12,596
Employee share schemes – value of employee services
1,205
2,021
Other social security costs including pension etc.
1,799
642
Total
15,504
15,259
COMPENSATION FOR KEY MANAGEMENT PERSONNEL
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Short-term employee benefits
8,165
5,964
Share based payments
996
1,665
Total
9,161
7,629
4.
STAFF EXPENSES
ANNUAL REPORT 2025
41
FluoGuide has established incentive programs for
its employees, management, and Board of
Directors. In November 2025, the Company
issued 161,500 warrants to members of the
management and employees in total and 37,500
warrants to two members of the Board of
Directors. Each warrant grants the holder the
right to subscribe for one (1) new share of
FluoGuide. The warrants are issued to ensure
alignment of interest 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 4.2 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 2025
42
Set out below are summaries of warrants granted under the plan:
WARRANT OVERVIEW - 2025
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
307,400
0
0
0
0
307,400
307,400
95
Mar 2022
36,000
0
0
0
0
36,000
36,000
65
July 2023
112,900
0
0
0
0
112,900
94,080
79
Feb 2024
45,000
0
0
0
0
45,000
0
55
Nov 2024
37,500
0
0
-15,000
0
22,500
0
36
Nov 2025
0
199,000
0
0
0
199,000
0
38
TOTAL
538,800
199,000
0
-15,000
0
722,800
437,480
WARRANT OVERVIEW - 2025
Outstanding as
of January 1
Additions
Exercised
Forfeited
Terminated
Transferred
Outstanding as of
December 31
Board of Directors
102,500
37,500
0
0
0
-7,500
132,500
Executive Management
192,950
70,000
0
0
0
0
262,950
Corporate Management
182,450
60,000
0
-15,000
0
7,500
234,950
Other employees
10,600
31,500
0
0
0
0
42,100
Former employees
50,300
0
0
0
0
0
50,300
TOTAL
538,800
199,000
0
-15,000
0
0
722,800
Weighted average exercise
price (SEK)
82
38
0
0
0
0
71
Number of exercisable warrants as of December 31, 2025
437,480
at a weighted average exercise price of SEK
89
ANNUAL REPORT 2025
43
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
SPECIFICATION OF PARAMETERS FOR BLACK-SCHOLES MODEL
May 2021
May 2021
Mar 2022
Jul 2023
Feb 2024
Nov 2024
Nov 2025
Exercise price at grant (SEK)
95.0
95.0
65.0
79.0
55.0
36.0
38.0
Applied volatility
1)
53.5%
53.5%
48.3%
56.3%
58.4%
55.3%
57.7%
Expected life (years)
6.3
7.3
6.3
6.3
6.5
6.5
6.5
Expected dividend per share
0
0
0
0
0
0
0
Risk-free interest rate p.a.
-0.07%
-0.07%
0.63%
2.65%
2.45%
2.04%
2.22%
Fair value per share at grant (SEK)
2)
47.29
50.32
30.74
44.33
31.95
19.88
21.76
Fair value per share at grant (DKK)
2)
34.73
36.96
21.83
28.51
21.31
12.73
14.86
1) The applied volatility is based on the historical volatility of the FluoGuide share, except for programs issued July 2023 - November 2024 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 2025
44
RECOGNIZED COSTS FROM SHARE-BASED PAYMENT TRANSACTIONS
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Warrants issued under employee share scheme
1,205
2,021
Total for the year
1,205
2,021
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 for the
program issued July 2023 – November 2024 also
the correlations and volatilities of the peer group
companies.
Warrants are granted for no consideration and
vests based on receivers not leaving the Company
and certain activity-based milestones. Vested
warrants are exercisable for a period of 10 years
after grant date. Vesting periods 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 2025
45
FINANCIAL INCOME
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Interest income from financial assets measured at amortized costs
33
101
Other
17
0
Total
50
101
FINANCIAL EXPENSES
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Interest expense on liabilities measured at amortized costs
0
30
Interest related to right-of-use assets
61
56
Credit facility costs
4,272
1,360
Net foreign exchange losses
794
73
Other
60
1
Total
5,187
1,520
6.
FINANCIAL INCOME
AND EXPENSES
ANNUAL REPORT 2025
46
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 2026 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 16,647 thousand (DKK 11,952 thousand)
can be carried forward indefinitely. Tax has been
computed at 22 percent corresponding to the
current tax rate.
TAX
2025
2024
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
-9,891
-7,361
Non-deductible expenses
266
448
Other permanent differences
-570
-459
Non-recognized deferred tax asset
4,695
1,873
Effective tax (12% / 16%)
-5,500
-5,500
Deferred tax:
Tax loss carried forward
16,504
11,867
Right of use assets
16
20
Intangible and tangible fixed asset
127
65
Total
16,647
11,952
Write down to accessed value
-16,647
-11,952
Total
0
0
7.
TAX
ANNUAL REPORT 2025
47
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, 2025
378
378
Addition for the year
0
0
Costs on December 31, 2025
378
378
Amortization and impairment losses January 1, 2025
0
0
Amortization and impairment losses for the year
0
0
Amortization and impairment losses December 31, 2025
0
0
Net book value on December 31, 2025
378
378
8.
INTANGIBLE
ASSETS
ANNUAL REPORT 2025
48
RIGHT OF USE ASSETS
Buildings
Right of use assets
DKK thousand
Costs on January 1, 2025
936
936
Addition for the year
894
894
Disposals for the year
-936
-936
Costs on December 31, 2025
894
894
Depreciation January 1, 2025
363
363
Depreciation for the year
275
275
Depreciation disposals for the year
-382
-382
Depreciation December 31, 2025
256
256
Net book value on December 31, 2025
639
639
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
9.
RIGHT OF USE
ASSETS
ANNUAL REPORT 2025
49
TANGIBLE FIXED ASSETS
Equipment
Tangible assets
DKK thousand
Costs on January 1, 2025
914
914
Addition for the year
0
0
Costs on December 31, 2025
914
914
Amortization and impairment losses January 1, 2025
270
270
Amortization and impairment losses for the year
283
283
Amortization and impairment losses December 31, 2025
553
553
Net book value on December 31, 2025
361
361
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
10.
TANGIBLE FIXED
ASSETS
ANNUAL REPORT 2025
50
Securities
2025
2024
DKK thousand
31 Dec
31 Dec
Danish mortgage bonds
30,015
0
Total
30,015
0
11.
SECURITIES
Bond investments comprise Danish listed
mortgage bonds with a maturity of less than 1
year. The intention is to hold the bonds to
maturity. Fair value as of December 31, 2025,
amounts to DKK 30,015 thousand based on the
quoted price (level 1).
ANNUAL REPORT 2025
51
Share capital
The share capital consists of 16,349,313 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
2025
2024
Shares issued as of January 1
13,620,149
12,208,384
Increase in shares in directed issue and exercise of warrants
2,729,164
1,411,765
Shares issued as of December 31
16,349,313
13,620,149
Weighted average number of shares used as the denominator, when
calculating earnings per share
14,053,824
12,968,268
12.
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 November 3, 2025, FluoGuide completed a
directed share issue to existing and new investors
raising proceeds of SEK 104 million by issuing
2,729,164 shares.
ANNUAL REPORT 2025
52
LEASE LIABILITIES
2025
2024
DKK thousand
31 Dec
31 Dec
Non-current
422
395
Current
248
229
Total
670
624
13.
LEASE LIABILITIES
ANNUAL REPORT 2025
53
Debt to credit institutions
2025
2024
DKK thousand
31 Dec
31 Dec
Non-current
27,616
0
Current
0
0
Total
27,616
0
14.
DEBT TO CREDIT
INSTITUTIONS
On November 3, 2025, the Company prolonged
its loan with Fenja Capital of SEK 40,000 thousand
equivalent to DKK 27,616 thousand. The new
maturity date is April 1, 2027. The loan carry
interest STIBOR 3M, minimum 2%, and interest
margin of 10%.
In case the loan is in default the lender can
choose to convert parts or all the loan into
shares. The subscription price upon default will
be the lowest volume-weighted average price in
the 15 trading days before the lender’s decision,
discounted by 15 percent.
ANNUAL REPORT 2025
54
DISTRIBUTION OF PROFIT/LOSS FOR THE YEAR
2025
2024
DKK thousand
31 Dec
31 Dec
Proposed dividend for the year
0
0
Retained earnings
-39,459
-28,959
Total
-39,459
-28,959
15.
DISTRIBUTION OF
PROFIT/LOSS FOR
THE YEAR
ANNUAL REPORT 2025
55
CHANGE IN WORKING CAPITAL
2025
2024
DKK thousand
31 Dec
31 Dec
Other receivables and prepayments
-50
-1,300
Change in trade payables
296
-1,714
Change in other payables
711
-298
Change in deferred income
-218
642
Total
739
-2,670
16.
CHANGE IN WORKING
CAPITAL
ANNUAL REPORT 2025
56
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 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, or as money market deposits, or
in Danish securities.
Liquidity risk
The Company's liquidity risk covers the risk that
the Company cannot meet its liabilities as they
fall due.
As a development stage life-science company, the
Company has had a negative cash flow from
operations in 2025. 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, reducing investments
in fixed assets, loans and increasing 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.
17.
FINANCIAL RISKS AND
FINANCIAL
INSTRUMENTS
ANNUAL REPORT 2025
57
2025 - MATURITIES OF FINANCIAL LIABILITIES
< 1
year
1-2
year(s)
2-5
years
> 5
years
Total
DKK thousand
As of December 31, 2025
Debt to credit institutions
0
27,616
0
0
27,616
Interest to credit institutions
4,000
1,000
0
0
5,000
Lease Liabilities
248
422
0
0
670
Trade payables
2,676
0
0
0
2,676
Other payables
2,379
0
0
0
2,379
Total
9,303
29,038
0
0
38,340
2024 - MATURITIES OF FINANCIAL LIABILITIES
< 1
year
1-2
year(s)
2-5
years
> 5
years
Total
DKK thousand
As of 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
There were no liabilities measured at fair value as
of 31 December 2025 and 2024.
ANNUAL REPORT 2025
58
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 only
transactions with one related party in 2025.
TRANSACTIONS RELATED PARTIES
2025
2024
DKK thousand
31 Dec
31 Dec
Other related parties:
Regulatory and clinical consultancy - The Eriah Group Inc.*
5,023
1,627
*) The Eriah Group Inc. is a company owned by Donna Haire. She was a board member
until 24 November 2025 when she stepped down and joined FluoGuide as Chief
Operating Officer. The Company has used consultants through The Eriah Group for the
pre-IND and IND.
There have been no other transactions with related parties - except from wages etc cf Note 4
18.
RELATED PARTIES
ANNUAL REPORT 2025
59
FEES TO STATUTORY AUDITORS
2025
2024
DKK thousand
1 Jan - 31 Dec
1 Jan - 31 Dec
Statutory audit
164
164
Audit related services
0
0
Tax advisory services
7
38
Other services
15
35
Total
186
237
19.
FEES TO STATUTORY
AUDITORS
The fee for non-audit services provided by PricewaterhouseCoopers Statsautoriseret Revisionspartnerselskab of
DKK 22 thousand (DKK 73 thousand) relates to tax advisory, and other general financial accounting matters.
ANNUAL REPORT 2025
60
20.
OPERATING LEASE
COMMITMENTS AND
OTHER COMMITMENTS
The company has entered purchase obligations
with suppliers in the amount of DKK 5.9 million
(DKK 9.8 million) as of December 31, 2025,
regarding the clinical Phase 2 trial with FG001
in head and neck cancer and CMC work.
ANNUAL REPORT 2025
61
On January 21, 2026, the Company submitted an
IND for FG001 to initiate first U.S. trial supporting
registration.
On February 20, 2026, FDA cleares the IND.
Except as noted above, there have been no
significant events between December 31, 2025,
and the date of approval of these financial
statements that would require a change to or
additional disclosure in the financial
statements.
21.
EVENTS OCCURING
AFTER THE BALANCE
SHEET DATE
