EXPRES2ION BIOTECH HOLDING AB Annual report 2023
Innovative vaccines for a healthier world
ExpreS2ion Biotech Holding AB Org. Nr. 559033-3729
ExpreS2ion Annual report 2023 | Contents | Introduction | Our business | Our People | Director's report | Financial statements | Page 2 / 57 |
Contents
Introduction
- About ExpreS2ion
- 2023 highlights
- CEO statement
Our business
- Strategic objectives
- Proprietary pipeline
- ExpreS2 platform
- Proofs-of-concept
- Contract research organisation
19 Environmental, social and governance considerations
Our People | 17 |
Director's report
- Director's report
- Key figures
- Risk factors
32 Financial highlights
Financial statements
- Group
- Parent
- Notes
- Statement by the Board of Directors and Managing Director on the 2023 Annual report
- Auditor's report
27
Director's report
- Management team
- Board of Directors
Proofs-of-concept
ExpreS2ion Annual report 2023 | Contents | Introduction | Our business | Our People | Director's report | Financial statements | Page 3 / 57 |
About
ExpreS2ion
Our mission
Develop innovative
Our approach
We leverage our proprietary ExpreS2™ protein expression system, employing insect cells to synthesise complex proteins essential for vaccine development. Through years of expertise, we have developed a process to customise cell factories to efficiently produce intricate antigen proteins with high yield and quality. Additionally, we engineer advanced industrial processes for manufacturing these proteins as active pharmaceutical ingredients in state-of-the-art vaccines. Through this process, we are committed to delivering vaccines of exceptional quality, contributing substantively to advancements in healthcare and disease prevention.
Team
Our team is committed to developing innovative vaccines for the world's worst infectious diseases and cancer, channeling their expertise and passion into pioneering advancements in vaccine development.
Our company vision
We want to transform healthcare by developing novel vaccines that are lifesaving and improving quality of life around the world.
The management promise
Looking into a future in which healthcare undergoes a profound transformation - we strive to lead
the change in pioneering revolutionary vaccines. Through our dedication to innovation, we aim to catalyze breakthroughs in life-saving solutions or far better prevention of disease.
vaccines for a healthier world.
2010 | 2016 | >500 | >90% | >€53m |
Founded in Hørsholm, | Listed on Nasdaq First | Different proteins | Protein production | Raised in non-dilutive funding |
Denmark | North Growth Market in | expressed by our | success rate | in projects leveraging the |
Sweden | ExpreS2 platform | ExpreS2 platform |
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2023 highlights
Breast Cancer | Cytomegalovirus | Nipah | ||||
ES2B-C001 | ES2B-I002 | ExpreS2ion directly awarded | ||||
over €4 million in grant funding | ||||||
Progression through safety studies and manufacturing, | Advancing through AI-driven accelerated | as part of VICI-Disease | ||||
and evaluation of Phase I clinical study plan | candidate selection process | consortium to develop | ||||
vaccines to protect from | ||||||
viruses with epidemic and | ||||||
pandemic outbreak potential | ||||||
Corona Virus/ | Malaria | Influenza | Cash and equivalents | |||
SEK 58 Million | ||||||
COVID-19ABNCoV2 | Using antigens produced by our ExpreS2 | Grant awarded for development | as of 31 December 2023 | |||
platform, Oxford University is advancing | of mucosal influenza vaccine and | |||||
Demonstration of 12-month durability in Phase II trial and | two candidates through a Phase II trial | discovery initiated | ||||
and four candidates through Phase I | SEK 57.9 million | |||||
non-inferiority to market-leading mRNA vaccine in Phase | clinical trials, with the intention to start | |||||
III trial, however the exclusive licensee sees no commercial | three new trials in the next year | Raised via rights issue | ||||
opportunity in its present form | and associated warrants | |||||
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A word from our CEO
As we close the year 2023, I am pleased to share with you the achievements and progress of ExpreS2ion Biotechnologies, an innovator in developing novel vaccines for a healthier world.
scalable, and cost-effective, and has the potential to address a wide range of unmet medical needs.
We continued to advance our pipeline of innovative vaccines based on our ExpreS2 platform. We are especially excited about our lead asset, ES2B-C001, a therapeutic vaccine for breast cancer that targets
develop vaccines for diseases with endemic and pandemic potential, which we added to our pipeline in 2023. We also initiated discovery research for
a mucosal influenza vaccine candidate, which is designed to elicit a broad and durable immune response at the site of infection.
Bent U. Frandsen
CEO, ExpreS2ion Biotech Holding AB
Dear shareholders,
The year 2023 was marked by the completion of the Phase III clinical trial for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 booster vaccine, which was developed by Bavarian Nordic under an exclusive license collaboration. This vaccine showed a good safety profile and efficacy, which was impressive since it was based on the original strain of the virus, but unfortunately did not meet the predefined criteria for protection against the circulating variant at the time of the clinical Phase III trial (XBB.1.5). Therefore, Bavarian Nordic decided not to pursue regulatory approval for this vaccine in 2024, and instead focus on their other pipeline candidates. We are proud of the scientific and clinical achievements that was made with this vaccine, and we thank Bavarian Nordic for their collaboration and support. Importantly, this vaccine provided a clinical Phase III validation of our platform technology, ExpreS2, which enables the expression of complex and multimeric proteins in insect cells. This technology has proven to be versatile,
the HER2 receptor. This vaccine has shown promising preclinical results in terms of safety, immunogenicity, and anti-tumor activity, and we are considering the initiation of a Phase I clinical trial in 2024, subject to securing the necessary funding. We believe that this vaccine has the potential to offer a new treatment
option for patients with HER2-positive breast cancer, a major unmet medical need.
We also made significant progress with our malaria vaccine candidates, which are being developed by the University of Oxford based on our ExpreS2 protein expression platform. These candidates target both the blood stage and the transmission -blocking malaria, and have the potential to prevent clinical malaria and reduce transmission. The Phase I/II clinical trial for these candidates is ongoing, and we expect to report the results in 2024.
Furthermore, we expanded our portfolio of vaccine candidates for other infectious diseases, for example as part of the VICI consortium seeking to
To support our growth and development, we successfully completed a rights issue in April 2023, raising SEK 54.5 million in gross proceeds, with an additional SEK 3.4 million raised from associated warrants in September. We also enhanced our communication and engagement with our stakeholders, through various channels such as our website, social media, press releases, and investor events.
Looking ahead, we have a strong technology platform and a clear strategy to achieve our vision of transforming healthcare by developing novel vaccines that are life-saving and improving quality of life around the world. We are grateful for the trust and support of our shareholders, partners, customers, and employees, who are essential to our success. We are excited about the opportunities and challenges that lie ahead, and we are committed to delivering value and innovation to our stakeholders.
Thank you for your continued interest in ExpreS2ion Biotechnologies.
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Our business
ExpreS2ion Annual report 2023 | Contents | Introduction | Our business | Our People | Director's report | Financial statements | Page 7 / 57 |
Strategic objectives
In August, we initiated a review of ExpreS2ion's strategy, pipeline, and organisation, aimed at extending our financial runway. This strategic review led to the evaluation of the ES2B-C001 breast cancer program due to financial limitations. In October of 2023, we concluded this review and established four strategic goals, all underpinning our overall vision to transform healthcare by developing novel vaccines that are lifesaving and improving quality of life across the world.
01
Advancing our proprietary pipeline
Our breast cancer vaccine demonstrates promising pre-clinical results. In 2023, we achieved significant milestones, including safety studies and the initiation of GMP manufacturing. Our next steps involve completing the manufacturing process, preparing the Phase I clinical trial plan, and submitting a clinical trial application. Additionally, ExpreS2ion collaborates with Evaxion A/S on a cytomegalovirus vaccine, utilising a proprietary AI-driven technology platform.
02
Actively drive and intensify collaborative initiatives in the development of vaccines
ExpreS2ion is committed to advancing global health through collaborative vaccine development. Our strategic partnerships drive innovation and impact. Notably, we collaborate with Evaxion on a promising CMV vaccine, contribute to the University of Oxford's malaria projects in clinical development, and actively participate in the VICI-Disease consortium targeting endemic and pandemic diseases. Additionally, our recent exploratory research with the University of Copenhagen focuses on a mucosal influenza vaccine candidate. Together, we strive for breakthroughs that benefit humanity.
03
Achieve proof-of- concept for new vaccine candidates and enhance our platform technology
The Phase III clinical outcomes of the COVID-19 program, along with compelling preclinical safety and efficacy data from the breast cancer project, robustly affirm the efficacy of our ExpreS2 antigen production system in conjunction with AdaptVac's VLP technology. Capitalising on this successful combination, which is characterised by safety, immunogenicity, durability, versatility, scala- bility, and cost-efficiency, we aim to leverage this technology to address a diverse range of unmet healthcare needs. This approach is geared towards accelerating the development of assets with shorter timelines and cost-effective paths to value creation.
04
Advance contract research (CRO) activities, subject to resource availability
Until 2020, our primary focus was on the Contract Research Organisation (CRO) business, which has played a pivotal role in demonstrating the proof- of-concept of our platform technology across a diverse spectrum of applications. By strategically harnessing the varied portfolios of our CRO clients, this business has the potential to yield valuable licensing opportunities spanning therapeutic areas, ultimately culminating in proof-of-concept achievements and potential royalties in the future.
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Proprietary pipeline
ES2B-C001
HER2+ breast cancer | Oncology |
(therapeutic) |
ES2B-I002Infectious
Cytomegalovirusdisease (prevention)
Exploratory
Undisclosed
Discovery | Pre-clinical | cGMP / Tox |
Pharmacology | ||
Tox studies and manufacturing |
Lead optimisation
Discovery
Phase 1
Phase 2
Phase 3 | Estimated |
market size | |
>€10 billion1 |
>€2 billion2
>€2 billion3
1) Global Data, 2022, for HER2+ breast cancer, 2) Market estimate from Moderna, 41st Annual J.P. Morgan Healthcare Conference (Presentation) 3) Based on data for global market for existing therapies from Future Market Insights
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ES2B-C001
Therapeutic HER2+ breast
Breast cancer: Disease background
Breast cancer, a disease characterised by the uncontrolled growth of breast cells, is a significant global health concern. It is estimated that 1 in 8 women will be diagnosed with invasive breast cancer during their lifetime. In 2020 alone, this disease led to approximately 685,000 deaths worldwide 1. A crucial aspect of breast cancer is the overexpression of the Human Epidermal growth factor Receptor 2 (HER2), which is observed in approximately 25% of breast cancer tumors2. HER2 overexpression is associated with a more aggressive disease, a higher recurrence rate, and increased mortality, making it a critical factor in the prognosis and treatment of breast cancer. The ongoing efforts and investments in combating this disease are reflected in the expected global market size for breast cancer treatments, which is projected to reach $32 billion by 20263. This underscores the importance of continued research and innovation in the fight against breast cancer.
ExpreS2ion's vaccine target is aimed at generating a broader immune response by targeting the entire HER2 extracellular domain
ES2B-C001
Herceptin®
IV
III
II
I | PERJETA® | |
cancer vaccine
Discovery | Pre-clinical | cGMP / Tox | Phase 1 | Phase 2 | Phase 3 |
Pharmacology | |||||
Tox studies and | manufacturing | ||||
1 Breast Cancer Research Foundation (https://www.bcrf.org/breast-cancer-statistics-and-resources) 2 Mitri Z et al. The HER2 Receptor in Breast Cancer: Pathophysiology, Clinical Use, and New Advances in Therapy (Chemother Res Pract. 2012; 2012: 743193)
3 Mordor Intelligence, breast cancer therapeutics market, 2021.
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Standard of care
Current standard of care limitations
In the current landscape of breast cancer treat- ment, monoclonal antibodies (mAbs) and Antibody- Drug Conjugates (ADCs) have emerged as dominant therapies. However, these treatments are not without their limitations, and there is a clear need for continued innovation in this field.
4. High cost
The high cost of these therapies can pose a significant barrier to access and burden on health care systems.
Potential ES2B-C001 advantages
ES2B-C001, our novel HER2 breast cancer vaccine, holds significant promise for improving patient treatment outcomes.
1. Resistance to monoclonal antibodies
A significant challenge with mAbs is the development of resistance over time. This resistance can render the treatment ineffective, leading to disease progression and limiting the therapeutic options available to patients.
2. Repeated intravenous infusions required
The administration of these therapies often requires repeated intravenous infusions. This process is not only time-consuming for patients but also places a substantial resource burden on healthcare facilities. The need for frequent hospital visits can also impact the quality of life for patients.
3. Potential for a range of toxicities
Treatment can cause a range of toxicities, some of which can be severe. These side effects can negatively impact patient health and well-being, and in some cases, may lead to discontinuation of therapy.
1. Efficacy in resistant cells
In vitro testing has demonstrated that ES2B-C001 is effective against HER2+ human breast cancer cells, even those that have developed tolerance to prevailing monoclonal antibody therapies. This suggests that ES2B-C001 could provide a viable treatment option for patients who have become resistant to current therapies.
2. Improved dosing schedule and process
The dosing schedule and process for ES2B-C001 are expected to be less time-consuming and expensive compared to existing treatments. This would not only reduce the burden on healthcare systems but also improve patient compliance and quality of life.
3. Favourable safety profile
ES2B-C001 utilises a virus-like particle delivery vehicle, which has a favourable safety profile compared to other vaccine types. This could potentially lead to fewer side effects and improved patient tolerance.
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ExpreS2ion Biotech Holding AB published this content on 08 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 May 2024 10:18:39 UTC.
