Onsdag 3 September | 11:07:36 Europe / Stockholm

Kalender

Est. tid*
2026-02-25 07:00 Bokslutskommuniké 2025
2025-11-26 07:00 Kvartalsrapport 2025-Q3
2025-08-27 - Kvartalsrapport 2025-Q2
2025-05-28 - Kvartalsrapport 2025-Q1
2025-05-27 - X-dag ordinarie utdelning NYKD 1.00 NOK
2025-05-26 - Årsstämma
2025-04-23 - Extra Bolagsstämma 2025
2025-02-26 - Bokslutskommuniké 2024
2024-11-27 - Kvartalsrapport 2024-Q3
2024-08-21 - Kvartalsrapport 2024-Q2
2024-05-21 - X-dag ordinarie utdelning NYKD 0.00 NOK
2024-05-16 - Årsstämma
2024-05-14 - Kvartalsrapport 2024-Q1
2024-02-28 - Bokslutskommuniké 2023
2023-11-15 - Kvartalsrapport 2023-Q3
2023-08-23 - Kvartalsrapport 2023-Q2
2023-05-16 - Kvartalsrapport 2023-Q1
2023-05-12 - X-dag ordinarie utdelning NYKD 0.00 NOK
2023-05-11 - Årsstämma
2023-02-28 - Bokslutskommuniké 2022
2022-11-23 - Kvartalsrapport 2022-Q3
2022-08-24 - Kvartalsrapport 2022-Q2
2022-05-16 - Kvartalsrapport 2022-Q1
2022-05-13 - X-dag ordinarie utdelning NYKD 0.00 NOK
2022-05-12 - Årsstämma
2022-03-31 - Bokslutskommuniké 2021
2021-12-22 - Extra Bolagsstämma 2021
2021-11-17 - Kvartalsrapport 2021-Q3
2021-08-26 - Kvartalsrapport 2021-Q2
2021-05-12 - Kvartalsrapport 2021-Q1
2021-05-06 - X-dag ordinarie utdelning NYKD 0.00 NOK
2021-05-05 - Årsstämma
2021-04-21 - Bokslutskommuniké 2020
2020-11-17 - Kvartalsrapport 2020-Q3
2020-08-27 - Kvartalsrapport 2020-Q2
2020-07-07 - Split NYKD 1:5
2020-07-06 - Extra Bolagsstämma
2020-05-12 - Kvartalsrapport 2020-Q1
2020-04-22 - Extra Bolagsstämma

Beskrivning

LandNorge
ListaOslo Bors
SektorHälsovård
IndustriBioteknik
Nykode Therapeutics är verksamt inom bioteknik. Bolaget är specialiserat inom forskning och utveckling av immunologiska terapier och vacciner. Lösningarna används huvudsakligen för behandling av patienter med cancersjukdomar samt övriga allvarliga hälsotillstånd som kräver långsiktig behandling. Störst verksamhet återfinns inom den europeiska marknaden.
2025-08-27 07:01:00
o	Nykode presents a highly focused strategy prioritizing core assets with the
greatest potential to deliver significant clinical and commercial impact.

o VB10.16 prioritized as lead value driver, with a focus on initiating a new
randomized controlled trial in HPV16 driven 1st-line recurrent/metastatic head
and neck cancer (1L r/m HNSCC) designed to demonstrate clinical efficacy and
support continued advancement of the asset.

o VB10.NEO development streamlined, with targeted investments focused on
strengthening its position as the most attractive unencumbered individualized
neoantigen therapy, leveraging anticipated peer data readouts.

o Tolerance platform further advanced, aiming to leverage the differentiated
technology with best-in-class potential and pursuing partnerships to accelerate
development.

o Disciplined execution and financial focus to reach key inflection points
within the expected cash runway.

o Additional high-caliber Board members, including a new Chair, expected to be
elected at the Annual General Meeting in 2026, with the current Chair remaining
on the Board.


Oslo, Norway, August 27, 2025 - Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced its updated corporate
strategy, in line with the commitment made at its first quarter results in May
2025. The updated strategy includes prioritization of VB10.16 as the lead
clinical asset and value driver, given the Company's increasing conviction in
its potential to treat HPV16 positive cancers. As a natural step in the
development of VB10.16, the WHO has accepted the International Non-proprietary
Name (INN) abipapogene suvaplasmid (abi-suva).

Michael Engsig, Chief Executive Officer, commented: "Nykode's updated strategy
is about focus, execution, and creating value for patients and the Company's
shareholders. Abi-suva (VB10.16) targets a highly attractive commercial market
and, with its potential to set a new standard of care, addresses a patient
population with few effective treatment options. Furthermore, we see VB10.NEO
positioned as the most attractive unpartnered individualized neoantigen therapy,
ready to leverage peer readouts expected within the next 18 months. In parallel,
our tolerance platform has the potential to open the door to breakthrough
treatments in autoimmune diseases. With a focused pipeline and key inflection
points within our estimated cash runway, we are advancing our most promising
assets with disciplined capital allocation, ensuring that Nykode is
well-positioned to deliver meaningful results for patients and attractive
returns for shareholders."


Abi-suva (formerly VB10.16): Lead Value Driver
At the core of the updated strategy is abi-suva, Nykode's lead asset and highest
priority for new investment. A randomized, open-label, multicenter Phase 2
trial, referred to as Abili-T, will evaluate abi-suva in combination with MSD's
(Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, pembrolizumab (KEYTRUDA®
) versus pembrolizumab alone as first-line treatment for human papilloma virus
(HPV)16-positive, PD-L1-positive recurrent or metastatic head and neck squamous
cell carcinoma (1L r/m HNSCC).

The trial will enroll up to 100 patients and is powered to deliver robust
efficacy data in combination with pembrolizumab, the current standard-of-care
for PD-L1-positive 1L r/m HNSCC patients. Interim analyses for efficacy are
planned throughout the trial, with the first expected during 2027.

Unmet need in 1L r/m HNSCC remains high. The selected trial population
represents a well-characterized subgroup of patients with limited durable
treatment options and rising incidence. Despite recent advances in 1L r/m HNSCC,
HPV16-positive patients remain an underserved subgroup with limited durable
treatment options. Abi-suva may offer additional benefits without added
toxicity, making it particularly relevant for this vulnerable patient
population.

Abi-suva is an off-the-shelf therapeutic cancer vaccine with a favorable safety
profile and demonstrated clinical activity in HPV16-positive, late-line r/m
cervical cancer. In the VB-C-02 trial, abi-suva in combination with atezolizumab
(Tecentriq®), achieved a median overall survival of 24.7 months in
PD-L1-positive patients which is more than double what has been reported with
immune checkpoint inhibitor monotherapy. Importantly, strong and durable
responses generated in this study were correlated with the patient's immune
response. Furthermore, preliminary data from the ongoing VB-C-03 trial indicate
similar level of added benefit of abi-suva on top of pembrolizumab in 1st line
head and neck cancer.

Agnete Fredriksen, Co-founder & Chief Scientific Officer, added: "Abi-suva has
been tested in three clinical trials, two complete and one ongoing. The trials
VB-C-02 and VB-C-01 provided strong and consistent efficacy signals. The
preliminary data from the ongoing VB-C-03 trial indicate similar level of added
benefit of abi-suva. This reinforces our confidence in abi-suva's potential to
deliver meaningful benefit to patients and provides a strong rationale for
advancing abi-suva into a randomized setting."


VB10.NEO: Well-positioned as best unencumbered individualized therapy
With an established supply chain, an in-house AI-powered epitope selection
algorithm and strong durable clinical immune responses, VB10.NEO is
well-positioned to attract potential partners following key peer data readouts
expected within the next 18 months.

Nykode will make targeted, limited investments to further strengthen VB10.NEO's
standing as the most attractive unencumbered INT asset.


Best-in-Class Antigen-Specific Immune Tolerance Platform
Nykode will increase investments to accelerate the development of its
antigen-specific immune tolerance (ASIT) platform. Recent advancements support
best-in-class potential specifically reducing unwanted, disease-causing immune
responses. The addressable field of ASIT covers a broad range of autoimmune
diseases, allergy and organ transplant rejections. Nykode will further
substantiate the platform's potential and explore partnerships to advance
development and diversify indications.


Partnering Strategy
Nykode's updated strategy with focused advancement of the three prioritized
programs aligns value-generating with optionality to enter strategic
partnerships in oncology and autoimmune indications.


Capital Allocation and Cash Runway
With this disciplined and sharper strategic focus, the Company's current cash
runway is expected to extend into 2029. This guidance is predicated on a
positive outcome of the pending tax case, while a ruling against Nykode would
result in a cash runway extending into 2028. As of June 30, 2025, Nykode had a
strong cash position of USD 70.0 million, excluding a non-current receivable of
USD 32.2 million related to the pending tax case.


Future Board Composition
In line with the Company's ambitions, and as previously stated, Nykode plans to
further strengthen its governance and expertise in selected strategic areas by
expanding the Board with additional high-caliber members, including a new Chair,
to help guide the next phase of the Company's evolution. These new members are
expected to be elected at the Company's Annual General Meeting in spring 2026.


About Abipapogene Suvaplasmid (formerly VB10.16)
Abipapogene Suvaplasmid (abi-suva) is a potentially first-in-class off-the-shelf
therapeutic DNA-based cancer vaccine candidate in development for the treatment
of HPV16-positive cancers. The cancer vaccine is designed based on Nykode's
VaccibodyTM technology platform of targeting antigens to antigen presenting
cells. Abi-suva has reported promising data from a Phase 2 trial in late-line
PD-L1 positive r/m cervical cancer patients (NCT04405349) in combination with
atezolizumab. The candidate has also demonstrated favorable clinical data in a
Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical
intraepithelial neoplasia (HSIL