Nykode Announces Updated Strategy to Increase Value for Patients and Shareholders, Prioritizing VB10.16 as the Lead Value Driver

27 Aug 2025 07:01 CEST

• Nykode presents a highly focused strategy prioritizing core assets with the
greatest potential to deliver significant clinical and commercial impact.

• 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.

• 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.

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

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

• 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
Vaccibody™ 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; CIN 2/3) demonstrating a statistically
significant correlation of immune responses and clinical responses. Nykode is
currently investigating abi-suva in VB-C-03, an open-label, dose-finding Phase
1/2a trial evaluating abi-suva in combination with MSD’s PD-L1 inhibitor
pembrolizumab (KEYTRUDA®) in 1L patients with HPV16-positive, PD-L1-positive,
recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC).


About HPV16-Driven Cancers
One of the emerging challenges within oncology is the virus-induced cancer
types, with Human Papillomavirus (HPV) being one of the most prominent oncogenic
viruses. There are several types of cancer-causing high-risk HPV`s causing
cancers, HPV16 being one of the most common, with more than 130,000 new cancer
cases in the U.S. and EU per year. Using a therapeutic cancer vaccine targeted
specifically towards the HPV16 infected cells in the tumors, such as Nykode’s
cancer vaccine abi-suva (VB10.16), represents a novel immunotherapeutic
treatment option. By combining a therapeutic cancer vaccine with the immune
checkpoint inhibitors and/or other general immune therapies, the tumors can be
attacked by the cancer-specific T cells from several angles with the aim of
improving patient outcomes.

Cervical Cancer
Globally, the greatest burden of HPV-related cancers is cervical cancer.
Cervical cancer is often curable when detected early and effectively managed,
but treatment options are more limited in advanced disease stages or when the
cancer has spread.

Head and Neck Cancer
In the United States and other high-income countries, head and neck cancer has
now surpassed cervical cancer as the most common HPV related malignancy. In head
and neck squamous cell carcinoma (HNSCC), there's a significant unmet need for
improved therapies, particularly for recurrent or metastatic cases. While immune
checkpoint inhibition is now part of standard treatment for recurrent or
metastatic HNSCC in general, there are no established therapeutic treatments
specifically for HPV-related HNSCC.


About Nykode Therapeutics
Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to
the discovery and development of novel immunotherapies with a focus on the
treatment of cancer and autoimmune diseases. Nykode’s modular immunotherapy
technology specifically targets antigens to antigen presenting cells (APC),
which have been shown to induce a broad, strong and long-lasting antigen
specific immune response in cancer, which correlates with clinical responses.

Nykode’s lead product candidates are abi-suva, a therapeutic immunotherapy for
the treatment of HPV16 induced malignancies which demonstrated favorable safety
and efficacy results from its Phase 2 trial for the treatment of late-line r/m
cervical cancer. Abi-suva is currently being further developed in head and neck
cancer. VB10.NEO, an individualized cancer neoantigen immunotherapy, has been
investigated in two trials with more than 10 different indications.

Nykode is also utilizing its APC-targeted technology to create an immune
tolerance platform for the potential use in autoimmune disorders, organ
transplant rejections, anti-drug antibody reactions and allergy.

Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD).
Further information about Nykode Therapeutics can be found at
http://www.nykode.com.


Contact:
Alexandra Deschner, Head of IR
Nykode Therapeutics ASA
IR@nykode.com

Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway

Forward-looking statements for Nykode Therapeutics
This announcement and any materials distributed in connection with this
announcement may contain certain forward-looking statements. By their nature,
forward-looking statements involve risk and uncertainty because they reflect the
Company's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of material factors could
cause actual results and developments to differ materially from those expressed
or implied by these forward-looking statements.

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 the Norwegian Securities Trading Act. This stock exchange
announcement was published by Harald Gurvin, CFO at Nykode Therapeutics ASA, on
August 27, 2025 at 7:01 CET.

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653917_250827 Nykode - Strategy Update.pdf