Category: News

Valerio Therapeutics announces signing of definitive agreements for the acquisition of Etherna Immunotherapies, building a leading platform in targeted RNA, and €40.25 million PIPE financing from new and existing investors

• Definitive share purchase agreement signed for the acquisition of 100% of Etherna Immunotherapies NV (“Etherna“), and the related contribution agreement, based on an enterprise value of €30 million, to be settled through a combination of a cash consideration and a share consideration (the “Contributions“)
• €40.25 million PIPE financing successfully priced with support from new and existing investors, to finance the cash consideration of the Acquisition and support the development of the combined company
• Shareholder approval of the Contributions, at an extraordinary general meeting to be convened for that purpose, with approval already secured through irrevocable voting undertakings from existing shareholders representing more than 70% of the voting rights of the Company
• The Acquisition marks a major milestone in Valerio’s strategy to build a leading platform in the development of next-generation precision-guided RNA therapeutics

 Villejuif, August 24, 2026, 8:00 a.m. CET— Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company pioneering next-generation precision-guided RNA therapeutics (“Valerio” or the “Company“), today announces the signing of a definitive share purchase agreement (the “SPA“) and of the related contribution agreement (the “Contribution Agreement“) for the acquisition of 100% of the share capital and voting rights of Etherna Immunotherapies NV (“Etherna“) (the “Acquisition“), based on an enterprise value of €30 million, and a €40.25 million private investment in public equity (PIPE) financing supported by existing shareholders and new investors (the “Financing“).

“The acquisition of Etherna marks a decisive step in Valerio’s strategy: to build a leading player in RNA therapeutics. By combining Etherna’s RNA and LNP platforms with our proprietary cell-targeting technologies, we are creating a powerful innovation engine designed to accelerate the development of next-generation RNA medicines. Most importantly, our combined platforms enable us to overcome a bottleneck that has held the field back for decades: reaching tissues beyond the liver and, in doing so, opening the way to the treatment of a broad range of diseases that have so far been beyond the reach of conventional mRNA delivery.” said Gilles Besin, Ph.D., CEO of Valerio.

“Signing this agreement is a defining moment for Etherna, and I could not be prouder of what our team has built with the support of our investors. Over the past years, we have turned a decade of mRNA and LNP expertise into platforms capable of reaching far beyond what conventional mRNA and delivery and manufacturing technologies could ever achieve. Joining forces with Valerio gives that platform the scale, the targeting capabilities and the resources to move faster and further than we could alone. I want to thank our shareholders, partners and, above all, our people for their trust and dedication in getting us here. Together with Valerio, Etherna’s science and manufacturing will deliver transformative medicines to patients who need them most.”, said Bernard Sagaert, CEO of Etherna.

Terms and Conditions of the Acquisition

The Acquisition marks a major milestone in Valerio’s strategy to build a leading platform in targeted nucleic acid medicines. By uniting three complementary technology platforms – nucleic acid chemistry, LNP delivery and targeted moiety engineering – within a fully integrated biotech supported by in-house manufacturing capabilities, the Acquisition aims to position Valerio to accelerate the development of next-generation RNA medicines targeting tissues beyond the liver.

The Acquisition will be settled through (i) a cash consideration, fully funded by the Financing, and (ii) a share consideration through contributions in kind of Etherna shares (the “Contributions“) to the Company.

The Contributions remain subject to Valerio shareholders approval at an extraordinary general meeting to be convened for that purpose expected to be held on or about October 6, 2026. Approval is secured by irrevocable voting undertakings from existing shareholders representing more than 70% of the voting rights of the Company.

Shares issued as consideration for the Contributions will be valued at the same Subscription Price as the New Shares issued in the Financing. A contribution auditor (commissaires aux apports) has been appointed to assess the valuation of the Contributions and issue a fairness report. Certain lenders and managers of Etherna will also subscribe to new Valerio shares through the set-off of their receivables owed by Etherna at the same subscription price.

The consideration for the Acquisition is based on an enterprise value of €30 million (on a debt-free, cash-free basis) subject to customary purchase price adjustments and contingent earn-out payments.

Main Terms of the Financing

The Financing was carried out through the issuance of 68,220,333 new ordinary shares (the “New Shares”), at a subscription price of €0.59 per share (i.e., a par value of €0.01 and an issuance premium of €0.58 per New Share) (the “Subscription Price”), representing a discount of 25% to the 3-day VWAP prior to pricing.

The New Shares are issued through a capital increase without shareholders’ preferential subscription rights by way of an offering referred to in paragraph 1 of article L. 411-2 of the French Monetary and Financial Code (Code monétaire et financier), and pursuant to the decisions of the Company’s Chief Executive Officer on August 21, 2026, acting upon sub-delegation of the Company’s Board of Directors on July 30, 2026, in accordance with the delegations granted pursuant to the 15^th resolutions and within the limits set by the 22^nd resolution of the Company’s combined shareholders’ meeting held on June 16, 2026 (the “General Meeting”).

The issuance of the 68,220,333 New Shares will result in a capital increase of €40.25 million (i.e., a nominal amount of €682,203.33 and a total issuance premium of €39,567,793.14), representing approximately 13.7% of the Company’s share capital and voting rights outstanding before the Financing.

Existing shareholders Artal International SCA, Financière de la Montagne and Saint James Luxembourg subscribed for €18.0 million, €7.0 million and €1.0 million respectively. Artal International SCA and Financière de la Montagne, who are also members of or represented on Valerio’s Board of Directors, did not take participate in the vote on the Financing at the Board of Directors’ meeting held on July 30, 2026.

Following the settlement-delivery of the New Shares expected on August 26, 2026, the Company’s share capital will be €5,676,686.34 divided into 567,668,634 ordinary shares.

 Impact of the Financing on Cash Flow and Use of Proceeds

The Company intends to use the net proceeds from the Financing, together with its existing cash and cash equivalents, to: (i) fund the cash component of the consideration payable in connection with the Acquisition; (ii) advance its proprietary pipeline, including VTX-001, VTX-002 and VTX-003, as well as IND-enabling activities for VTX-001; (iii) integrate Etherna into Valerio, including by investing in and scaling Etherna’s GMP manufacturing capabilities at its Niel facility to support the Company’s clinical supply requirements and build internal capacity for mRNA and LNP production, and by combining the two organizations’ research, technical operations and quality functions on a single platform; and (iv) fund working capital and other general corporate purposes.

The expected use of net proceeds reflects the Company’s current intentions, based on its present plans and business condition. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of its development programs, the timing and outcome of the integration of Etherna, and any unforeseen cash needs.

Based on its current operating plan and forecasted expenses, and taking into account its cash and cash equivalents together with the net proceeds from the Financing, the Company believes it has sufficient resources to fund its planned operating expenses and capital expenditure requirements for at least 18 months following the closing of the Financing. This estimate is based on assumptions that may prove to be incorrect, and the Company may use its capital resources sooner than currently expected.

Shareholding Structure after the Financing

On an illustrative basis, a shareholder holding 1% of the Company’s share capital before the Financing and who did not participate in the Financing will hold 0.88% of the Company’s share capital after the issuance of the New Shares.

To the Company’s knowledge, the shareholding structure, on a non-diluted basis, before and after the Financing, breaks down as follows:

Lock-up Agreements

In connection with the Financing, the Company has entered into a lock-up agreement restricting the issuance of additional ordinary shares for a period ending ninety (90) calendar days following the date of settlement-delivery, subject to customary exceptions.

In addition, the investors subscribing to the Financing, have agreed to a sixty (60) calendar days lock-up on the New Shares, following the date of settlement-delivery, subject to customary exceptions.

Settlement-delivery of the Financing

The admission of the New Shares to trading on the Euronext Growth market in Paris is scheduled for the time of settlement and delivery, which is expected to take place on August 26, 2026.

The New Shares will be immediately assimilated to the Company’s existing shares already traded on Euronext Growth in Paris, and will be able to be traded, from their issuance, on the same listing line (ISIN code: FR0010095596).

The Financing has not given rise to a prospectus submitted for approval by the AMF, nor to an information document containing the information set out in Annex IX of Regulation (EU) 2017/1129, as amended.

Risk Factors

The Company draws the public’s attention to the risk factors related to the Company and its activities presented in the 2025 annual financial report published on April 28, 2026, which is available free of charge on the website of the Company (https://valeriotx.com/).

In addition, investors are invited to consider the following risks: (i) shareholders’ stake in the Company will be diluted further to the issuance of the New Shares for the shareholders who did not participate in the Financing, (ii) the market price for the Company’s shares may fluctuate and fall below the subscription price of the shares issued pursuant to the Financing, (iii) the volatility and liquidity of the Company’s shares may fluctuate significantly, (iv) sales of the Company’s shares may occur on the market and have a negative impact on the market price of the shares, and (v) the Company’s shareholders could undergo a potentially material dilution resulting from any future capital increases that are needed to finance the Company.

Advisors

Van Lanschot Kempen NV is acting as exclusive financial advisor for the Acquisition and as Sole Placement Agent in connection with the Financing. Goodwin Procter LLP is acting as legal counsel to Valerio Therapeutics.

Moelis & Company is acting as financial advisor to Etherna. Deloitte (Belgium) and August Debouzy (France) are acting as legal counsels to Etherna.

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About Valerio Therapeutics

Valerio Therapeutics (FR0010095596 – ALVIO) is a pioneering biotechnology company specialized in the discovery and development of innovative targeted RNA therapeutics. The Company is listed on Euronext Growth Paris.

For more information: https://valeriotx.com/.

About Etherna Immunotherapies, a Valerio company

Etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP grade. With over a decade of expertise, the company provides pharma and biotech partners with an integrated suite of proprietary platforms, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry to enable the delivery of high-quality and efficacious Nucleic Acid based therapeutics.

mRNA technology gained worldwide recognition through the COVID-19 vaccines. Researchers from the Biomedical Research Institute (BIOMED) at Hasselt University and the Belgian biotech company etherna have now demonstrated that the same technology also holds promise for a very different application: the targeted treatment of autoimmune diseases. Their findings have been published in the leading scientific journal Advanced Science.

In autoimmune diseases, the immune system mistakenly attacks healthy body tissue. Many existing treatments suppress this immune response, but they do not always do so in a targeted manner. This new mRNA approach aims to modulate the immune system more precisely. The researchers successfully reduced disease severity in preclinical models of multiple sclerosis (MS) and type 1 diabetes.

Simple injection proves equally effective

With this study, the researchers demonstrate that mRNA can be used not only to activate the immune system, as is the case with vaccines against infectious diseases, but also to selectively suppress harmful immune responses. One of the study’s most remarkable findings is that a simple intramuscular injection proved to be just as effective as intravenous administration. This is important because intramuscular injections are much easier to administer and could significantly improve the practical applicability of future mRNA therapies.

Although further research is required to demonstrate safety and efficacy in humans, these findings represent an important step towards the development of new targeted therapies for autoimmune diseases.

Strong collaboration

The research is the result of a close collaboration between etherna and the Biomedical Research Institute (BIOMED) at Hasselt University, bringing together the complementary expertise of both partners. etherna contributed its expertise in mRNA and lipid nanoparticle (LNP) technology, while the BIOMED research team led by Professor Bieke Broux and Dr Paulien Baeten provided immunological expertise and in-depth knowledge of the mechanisms underlying autoimmune diseases.

“For more than a decade, we have built etherna’s mRNA-LNP platform on one simple conviction: this technology is far more versatile than vaccines alone. These results prove it. They show that our platform can be used not only to activate the immune system, but also to calm it and re-establish immune tolerance in models of multiple sclerosis and type 1 diabetes. This achievement was only possible through collaboration. Combining our platform technology with BIOMED’s leading immunology expertise, is exactly the kind of partnership that turns scientific ambition into therapeutic progress.” – Bernard Sagaert, CEO, etherna

A major driving force

“For my team and me, developing effective treatments for people with autoimmune diseases is the greatest driving force behind everything we do. What we have achieved together with etherna is, quite honestly, remarkable. Although further validation in patients remains essential, these findings demonstrate great potential, not only for multiple sclerosis and type 1 diabetes, but possibly for a broader range of autoimmune diseases.” – Professor Bieke Broux, BIOMED, Hasselt University

“Results like these remind us why our research matters. This project also demonstrates what becomes possible when scientific expertise and biotechnology reinforce one another.” – Dr Paulien Baeten, BIOMED, Hasselt University

This project was supported by VLAIO and carried out in collaboration with researchers from Ghent University–VIB and UMass Chan Medical School (USA).

The study was published in Advanced Science and is available here.

About etherna

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP grade. With more than a decade of expertise, the company provides pharmaceutical and biotech partners with an integrated suite of proprietary platform technologies, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry, enabling the delivery of high-quality and effective nucleic acid-based therapeutics.

About BIOMED at Hasselt University

The Biomedical Research Institute (BIOMED) at Hasselt University is a multidisciplinary research institute where advanced technologies are used to generate new insights into three disease domains: immunology, neurosciences and cardiovascular diseases. The institute combines high-quality fundamental research with translational research programmes to develop applications for patients and the healthcare sector. Its work focuses on identifying risk factors throughout the different stages of life, improving our understanding of disease mechanisms, monitoring diseases, and developing strategies to manage, treat and prevent disease.

More information

etherna: media@etherna.be

Prof. Dr. Bieke Broux (BIOMED UHasselt): +32 468 14 30 54

• Valerio Therapeutics announces binding offer for the proposed acquisition of etherna immunotherapies, creating a global leader in targeted RNA medicines
• The proposed acquisition represents a major step in Valerio’s strategy to become a leading developer of next-generation targeted RNA medicines targeting cells beyond the liver, addressing diseases with high unmet medical needs
• The Acquisition aims to create the only player combining active sdAb targeting and passive LNP delivery within a fully integrated RNA medicines platform, accelerating the development of therapeutics and supporting a growing proprietary pipeline
• The news follows the recent appointment of seasoned biotech leader Gilles Besin as Chief Executive Officer to lead Valerio’s next phase of innovation in precision targeted therapeutics, bringing deep expertise in RNA medicines, targeted delivery and in vivo cell therapy
• Supported by leading life sciences investors, with key etherna shareholders becoming Valerio shareholders as part of the transaction, reflecting confidence in the strategic vision and value creation potential of the combined entities
• 6-week exclusivity period to finalize transaction documentation under the binding offer
• Binding offer at €30 million enterprise value (cash and shares), subject to Belgian FDI clearance, financing (secured by subscription undertakings covering the cash consideration) and shareholders’ approval on the share consideration (secured by voting undertakings above 70% of the voting rights)
• The binding offer has received the unanimous approval of Etherna’s board of directors

1 July, 2026 — Valerio Therapeutics (FR0010095596 – ALVIO), a biotechnology company pioneering next-generation precision-guided RNA therapeutics (“Valerio” or the “Company”), today announces that it has signed a binding offer for the acquisition of 100% of the share capital of etherna immunotherapies NV (“etherna“) (the “Acquisition”).

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP. With over a decade of expertise, etherna has built an integrated suite of proprietary technologies, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry, enabling the development and delivery of differentiated RNA therapeutics.

The Creation of a Global Leader in Targeted RNA Medicines
The Acquisition marks a major milestone in Valerio’s strategy to become a global leader in targeted nucleic acid medicines. By uniting three complementary technology platforms – nucleic acid chemistry, LNP delivery and targeted moiety engineering – within a fully integrated biotech supported by in-house manufacturing capabilities, the Acquisition positions Valerio to accelerate the development of next-generation RNA medicines targeting cells beyond the liver.

The Acquisition combines Valerio’s proprietary sdAb-targeting and conjugation technologies with Etherna’s mRNA and LNP capabilities. Together, these technologies enable targeted delivery of nucleic acid payloads to specific cell types and tissues, while in-house GMP manufacturing and CMC capabilities address a key bottleneck many nucleic acid companies face when scaling programs into the clinic.

The Acquisition would create a fully integrated RNA medicines company with a proprietary pipeline and the capabilities to discover, develop and manufacture its own product candidates, with the ambition to advance at least two programs in immunological indications through IND-enabling studies and into the clinic within 18 to 24 months. The lead program demonstrates the potential of the combined platform, focused on the development of an in vivo CAR-T approach to target and modulate pathological B- and T cells in immunological diseases. Furthermore, the company aims to unlock substantial partnership, co-development, and licensing opportunities with major pharmaceutical companies seeking to extend nucleic acid medicines beyond the liver and into a broader spectrum of tissues and indications, while continuing to support existing collaborations and partnerships through its manufacturing capabilities.

Today’s announcement follows the appointment of Gilles Besin as Chief Executive Officer. Dr. Besin brings more than 20 years of experience in drug discovery, immunology, and RNA-based medicine, and has played a key role in building and scaling several biotechnology companies. Most recently, he served as Chief Scientific Officer at Orbital Therapeutics, an in vivo CAR‑T company that leveraged targeted LNP technology and was acquired by BMS in 2025. Following the acquisition, he led BMS’s RNA and in vivo CAR‑T programs. Earlier in his career, he held senior leadership roles at Affinivax, playing a key role in the acquisition by GSK, and Moderna.

“The acquisition of Etherna is a transformative moment for Valerio, propelling us toward our vision of building a fully integrated RNA therapeutics company. By bringing together Etherna’s cutting-edge science with our proprietary targeted delivery technologies, we are creating a powerful engine for innovation. Together, these capabilities position us to efficiently and confidently advance the next generation of RNA medicines beyond the liver, opening new therapeutic frontiers and expanding what is possible for patients worldwide.” said Gilles Besin, Ph.D., CEO of Valerio.

“This transaction represents a natural next step in Etherna’s mission to unlock the full potential of nucleic acid-based medicines. Together with Valerio, we will have the scientific capabilities, leadership and ambition to translate these technologies into a growing pipeline of targeted medicines, building long-term value while advancing novel therapies for patients – while continuing to support our partners in discovery, development and manufacturing.” said Bernard Sagaert, CEO of etherna.

Terms and Conditions of the Acquisition
The acquisition of 100% of the share capital and voting rights of etherna is contemplated for a total enterprise value of €30 million, subject to customary adjustments.
The Acquisition would be settled through a mix of:
(i) a cash consideration, fully backed by committed financing from Valerio’s existing shareholders; and
(ii) a share consideration consisting of contribution in kind of etherna shares (the “Contributions”) to the Company.

The Acquisition is supported by leading life sciences investors, with key etherna shareholders becoming Valerio shareholders as part of the transaction, reflecting confidence in the strategic vision and value creation.
Completion of the Acquisition remains subject to (i) applicable regulatory approvals in the relevant jurisdictions, including foreign direct investment control, (ii) finalizing of the transaction documentation (iii) completion of a financing pursuant to outstanding shareholders’ resolutions, fully secured by subscription undertakings from Valerio’s existing shareholders up to the cash consideration, and (iv) the approval by Valerio’s shareholders of the Contributions at an extraordinary general meeting to be convened for that purpose, secured by voting undertakings from shareholders representing more than 70% of the voting rights, whose decision shall be based in particular on a report by a contributions auditor assessing the fairness of the contribution transaction.
The parties have entered a 6-week exclusivity period to finalize the definitive transaction documentation required in the context of the contemplated Acquisition, in accordance with the provisions of the binding offer.

The binding offer has received the unanimous approval of etherna’s board of directors.

Advisors
Van Lanschot Kempen NV is serving as exclusive financial advisor to Valerio Therapeutics with Goodwin Procter LLP serving as legal counsel.
Moelis & Company is serving as financial advisor to etherna with Deloitte serving as legal counsel.

About etherna

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP grade. With over a decade of expertise, the company provides pharma and biotech partners with an integrated suite of proprietary platforms, including customizable lipid nanoparticles (cLNPs) and advanced mRNA chemistry to enable the delivery of high-quality and efficacious Nucleic Acid based therapeutics.

About Valerio Therapeutics
Valerio Therapeutics (FR0010095596 – ALVIO) is a pioneering biotechnology company specialized in the discovery and development of innovative targeted RNA therapeutics. The Company is listed on Euronext Growth Paris.
For more information: https://valeriotx.com/.

CONTACTS

etherna Media Relations: media@etherna.be
Valerio Therapeutics
Investor Relations: ir@valeriotx.com | +33 (0) 1 45 58 95 10

Niel, Belgium – May 19, 2026 – etherna (www.etherna.be), a leading provider of cutting-edge mRNA and lipid nanoparticle (LNP) technologies across the biotech and pharma industry, today announces a major milestone in its ongoing partnership with Dropshot Therapeutics. Dropshot has officially decided to advance one of its selected targets in renal disease to the clinical stage, successfully validating etherna’s platform technologies. Notably, this milestone marks the advancement of an mRNA LNP renal disease clinical trial.

Moving forward, the collaboration will leverage etherna’s extensive manufacturing capabilities. In fact, GMP-grade material manufacturing is a critical step in the mRNA LNP clinical trial process for renal disease. The partnership will now focus on manufacturing GMP-grade material for IND enabling studies and intended Phase I clinical trials.

Executive Quotes

“We are pleased to see that Dropshot has achieved their preclinical milestones based on our nucleic acid and LNP platforms and has decided to move to the next steps. We will now support them fully in all manufacturing and regulatory steps needed to launch the clinical campaign in 2027.”
— Bernard Sagaert, CEO of etherna

“Dropshot Therapeutics is committed to advancing innovation to address unmet medical needs in renal and cardiac diseases. We are very pleased with the results we have obtained. We are delighted to see the rapid progress of our collaboration, based on etherna’s nucleic acid and LNP capabilities, which has paved the way for a renal disease mRNA LNP clinical trial.”
— Marijn Dekkers, CEO of Dropshot

About etherna

etherna is a leading technology platform company pioneering the development of mRNA and lipid nanoparticle (LNP) technologies, including manufacturing up to GMP. Through collaborations like the mRNA LNP renal disease clinical trial, etherna continues to support innovative projects. Having evolved into a key strategic partner for the global life sciences industry, etherna supports projects from early research over development to GMP manufacturing.

Key commercial highlights:

• Decade of Expertise: Offers over 10 years of experience providing pharma and biotech partners with an integrated suite of proprietary platforms.
• Advanced Technologies: Utilizes advanced mRNA chemistry and customizable lipid nanoparticles (cLNPs) to enable the delivery of differentiated and efficacious RNA therapeutics. Importantly, these technologies support innovative clinical trials such as those targeting renal disease with mRNA LNPs.
• Strong Foundation: Founded in 2013 as a spin-off from the Vrije Universiteit Brussel (VUB).
• Global Reach: Headquartered in Niel, Belgium, with specialized R&D facilities in Ghent and commercial operations in the U.S.

About Dropshot Therapeutics

• Dropshot Therapeutics is an early stage biotechnology company dedicated to developing innovative RNA-based therapeutics for heart and kidney diseases. Through their partnership, a pioneering mRNA LNP clinical trial in renal disease is now underway.
• The company is based near Boston, USA and was co-founded in 2023.
• Its co-founders are Kenneth R. Chien, co-founder of Moderna and former Professor at Karolinska Institutet, and Marijn E. Dekkers, Chairman of Novalis LifeSciences and former CEO of Bayer and of Thermo Fisher Scientific.

Contact Information

• etherna Media Relations: media@etherna.be
• Dropshot Therapeutics: info@dropshottherapeutics.com

Niel, Belgium – February 19th, 2026 – etherna, a leading provider of cutting-edge mRNA and
lipid nanoparticle (LNP) technology across the biotech and pharma industry, announces that one
of its key collaborators, Almirall (www.almirall.com), a leading medical dermatology company,
nominated LAD116 as a novel therapy targeting non-melanoma skin cancer for further
development in IND enabling studies. LAD116 is based on etherna’s intratumoral mRNA/LNP
platform for therapies intended to generate a potent immune response directly within the tumor
microenvironment. The collaboration with Almirall on this potential new therapy will now focus
on manufacturing and producing GMP-grade material for IND enabling studies and intended
Phase I clinical trials.

Bernard Sagaert, CEO, etherna, added:
“This collaboration is a perfect example of what can be achieved when teams are fully aligned
and driven to succeed. The combined efforts of both companies to discover and advance an
mRNA-LNP based therapy to preclinical candidate nomination, on time and on budget, has been
outstanding. We are extremely happy to continue to support Almirall as they advance this
promising approach for non-melanoma skin cancer patients.”

Karl Ziegelbauer, Chief Scientific Officer, Almirall, commented:
“Almirall is committed to advancing innovation in medical dermatology to address significant
unmet medical needs. We are very excited to advance this innovative intratumoral approach to
potentially treat patients with non-melanoma skin cancer and we are delighted to see rapid
progress of our collaboration with etherna based on their mRNA and LNP capabilities.”

About etherna
etherna is a leading technology platform company pioneering the development of mRNA and
lipid nanoparticle (LNP) technologies, including manufacturing up to GMP. With over a decade of
expertise, the company provides pharma and biotech partners with an integrated suite of
proprietary platforms, including customizable lipid nanoparticles (cLNPs) and advanced mRNA
chemistry to enable the delivery of differentiated and efficacious RNA therapeutics. Founded in
2013 as a spin-off from the Vrije Universiteit Brussel (VUB), etherna has evolved from a developer
of immunotherapies into a key strategic partner for the global life sciences industry, supporting
projects from early research over development to GMP manufacturing. The company is
headquartered in Niel, Belgium, with R&D facilities in Ghent and commercial operations in the
U.S. and Asia. www.etherna.bio

Media Contact: 

media@etherna.be

Niel, Belgium, July 22, 2025 –  etherna immunotherapies NV (“etherna”), a biotech company and a platform technology leader in pioneering mRNA and Lipid Nanoparticle (LNP) technologies, today announces breakthrough innovation in the efficient in vivo extrahepatic delivery of mRNA to several key tissues, including to hematopoietic and progenitor stem cells (HSPCs) in bone marrow and to T cells. Key highlights of the data presented include:

• New rodent and non-human primate data on proprietary etherna vaccine LNPs that outperform by at least 5-fold the clinical benchmark LNP compounds for vaccine applications
• New rodent and non-human primate data using etherna liver LNP that outperform by at least 4-fold the clinical benchmark LNP compounds for liver repeat dose protein expression and gene editing applications
• New LNPs that have been optimized for efficient delivery of RNA payloads to hematopoietic stem and progenitor cells (HSPC) in the bone marrow, achieving mRNA payload expression in over 90% of all mouse bone marrow HSPCs using an untargeted LNP
• Other newly described and optimized LNPs that have shown efficient delivery to T cells in vivo in both mice and humanized mouse models, including demonstration of robust CAR-T mediated killing using both untargeted and CD8 antibody-targeted LNP
• Data to be presented by Antonin de Fougerolles at the 5^th annual mRNA-based Therapeutics Summit held in Boston

Nucleic acid-based therapeutics, including mRNA-based medicines, are rapidly reshaping the treatment landscape for genetic diseases, vaccines, and protein replacement therapies. While lipid nanoparticles (LNPs) have proven highly effective in liver-targeted applications, achieving robust delivery to extrahepatic cells remain a major challenge.

etherna’s proprietary library of bio-reducible ionizable lipids has been key in addressing this delivery challenge. In etherna’s recent Non-Human Primate (NHP) studies, the company’s proprietary LNP formulations demonstrated at least 5-fold improved mRNA expression compared to clinical benchmarks for both vaccine and liver repeat-dose protein expression applications. These LNPs were also very well tolerated in NHP and this improvement in liver-directed expression was also demonstrated in a rodent transthyretin gene editing study where it significantly outperformed the LP01 clinical benchmark and where equivalent efficacy was seen at ¼ the LP01 dose. These results are further proof of the potency and translational potential of etherna’s proprietary lipid library.

etherna has now developed a Bio-Reducible LNP for delivery of mRNA to bone marrow stem cells, a novel LNP platform optimized for extra-hepatic delivery. This platform is systematically optimized for increased mRNA expression through proprietary linker, tail, and headgroup chemistry modifications.

We have optimized an LNP formulation specifically for hematopoietic stem and progenitor cells (HSPCs). This formulation enabled a controlled shift in biodistribution away from the liver and toward bone marrow tissue. The resulting formulations achieved mRNA expression in over 90% of all bone marrow HSPCs, marking a transformative leap in the ability to deliver RNA therapeutics systemically to extrahepatic cell types.

This breakthrough was made possible through a structure activity relationship (SAR) optimization process which significantly enhanced the targeting of hematopoietic stem cells (HSCs). By adjusting lipid composition and systematically analyzing biodistribution outcomes, the research team unlocked a delivery profile that favors bone marrow uptake while maintaining stability, safety, and high transfection efficiency.

In addition, using a similar but slightly different approach, etherna scientists have optimized other LNP formulations for improved delivery to T cells. Efficient delivery to T cells using a passive targeting approach (consisting of just an ionizable lipid, helper lipid, cholesterol, and PEG lipid) was demonstrated in rodents. The addition of an anti-CD8 antibody on the LNP surface served to further increase in vivo uptake and mRNA expression in CD8+ T cells.

Importantly, we also demonstrated the ability of both our non-targeted and targeted T cell LNP formulations to deliver mRNA in a humanized mouse (mice reconstituted with human immune cells). When we used these formulations to deliver a CD19-CAR mRNA, a dramatic CAR-T-mediated killing of B cells was seen with both our untargeted and targeted LNP formulations. The level of CAR-T expression and activity seen using an unoptimized CD19-CAR mRNA was comparable to the current pre-clinical state of the art in the field, and we expect this to improve a further 3-5 fold upon incorporation of etherna’s proprietary mRNA designs.

These innovations represent a major advancement in the field of in vivo liver gene editing and therapeutic protein expression in hematopoietic stem cells and T cells. etherna’s breakthrough research offers a new treatment possibilities for hematologic disorders and beyond.

These data will be presented on July 22^nd 2025 at the 5^th annual mRNA-based Therapeutics Summit in Boston. This innovation positions etherna as a leader in Bio-Reducible LNP for delivery of mRNA to bone marrow stem cells, addressing a key challenge in extrahepatic targeting.

We welcome partners who are committed to pushing the boundaries of what’s possible in nucleic acid-based medicine therapeutics and delivery of payload to extrahepatic cell types.

Contact information:

etherna: media@etherna.be

www.etherna.be/contact

We are pleased to announce that Antonin (Tony) de Fougerolles has been appointed as our new Chair. Tony, has been a key member of our Board since January 2023, and we are confident that his extensive experience and vision will drive our mission forward. Our outgoing Chair, Marijn Dekkers, will remain on the Board, continuing his contributions.

Tony brings a wealth of expertise in mRNA and Lipid Nanoparticle (LNP) therapeutics, having held pivotal leadership roles at Moderna and Alnylam. His accomplishments include pioneering modified mRNA as a therapeutic and vaccine modality and advancing several new drug modalities to the market. His leadership will be instrumental as we continue to expand our partnerships.

Bernard Sagaert, our CEO, expressed his enthusiasm: “I am thrilled to work more closely with Tony. His vast experience, business relationships, and strategic vision in the field will further accelerate the development and success of etherna.”

Tony de Fougerolles, etherna Chair added: “Over the last 18 months I have seen first-hand how the cLNPs and mRNA manufacturing expertise that etherna has developed is world-leading and impressive in its quality, breadth, and novelty. The recently announced partnership with Almirall is a clear recognition of this. I look forward to guiding Bernard and his talented team to seize exciting opportunities to bring novel mRNA-based therapeutics to patients.”

Marijn Dekkers, etherna Board Member noted: “Tony has already proven to be an extremely valued addition to the Board and therefore I am delighted to welcome him as my successor. His combination of scientific and entrepreneurial excellence as well as clear strategic vision will enable him to steer etherna successfully through the next stage of its development.”

Meet our board members 

• Sagaert’s CEO appointment follows his successful interim period implementing etherna’s new partnership-driven business strategy. The etherna CEO appointment marks a pivotal point in the company’s strategic direction.
• Sagaert joined etherna in 2017 and brings extensive operational and strategic experience in the life sciences industry.
• Dekkers, who is the founder of investment and advisory firm Novalis Capital Partners LLC and former CEO of Bayer AG and Thermo Fisher Scientific, is widely recognized as a visionary industry leader.
• etherna’s integrated technology offering is internationally recognized as key differentiator – proprietary RNA chemistry and customized LNP platforms matched with deep GMP process know-how.
• The company has also rebranded its name from eTheRNA immunotherapies to etherna, and has launched new websites.

Niel, Belgium, October 16, 2023 – etherna (“the Company”), a leading mRNA/LNP technologies company, announced today that Bernard Sagaert has been confirmed as Chief Executive Officer. This follows an interim 12-month period during which he has successfully led the Company’s pivot to a new partnership-driven business strategy. At the same time Marijn Dekkers, an existing Board Member representing investor Novalis LifeSciences LLC, has been appointed Chairman of the Board. Both appointments come as etherna’s new strategy is gaining significant traction globally. The etherna CEO appointment further establishes firm leadership in the company. etherna is enabling a growing number of life science and pharma companies to accelerate their pursuits into the fast-growing nucleic acid sector by leveraging the Company’s industry-leading proprietary RNA-based chemistry, its custom LNP delivery platforms, and its GMP process knowhow.

Prior to the interim CEO role, Bernard Sagaert was COO at etherna. The significance of Sagaert’s etherna CEO appointment is evident in his extensive career, having joined the Company in 2017 after a successful career in both industry and consulting including roles as QA & Supply Chain Director at Mylan in Belgium, and VP QA EMEAA at Sterigenics, a Sotera company.

Marijn Dekkers is the Founder and Chairman of Novalis Capital Partners LLC, an investment and advisory firm for the Life Science industry. Previously, he served as CEO of Bayer AG in Leverkusen, Germany and as CEO of Thermo Fisher Scientific near Boston, MA, USA.

Tony de Fougerolles, Board Member and Head of Remuneration Committee added: “Bernard has shown exceptional leadership and clarity of purpose over the last year. I am therefore pleased to confirm his appointment as CEO. Equally I congratulate Marijn on his appointment to Chairman and look forward to working with both of them as etherna further exploits its mRNA/LNP expertise that is world-leading and impressive in both its breadth and novelty.”

Bernard Sagaert commented: “I am delighted to be confirmed as CEO and thank the board for their confidence. I also welcome Marijn as Chairman, and would like to thank Russell Greig, our previous Chairman, for his long term engagement with the company and the support he has given me during the Interim CEO period. etherna’s new partnership strategy has been very well-received in both Europe and the US. With the help of our highly dedicated and professional team, I now intend to continue and accelerate our drive towards becoming the premier discovery and development partner for pharma and biotech aiming to deliver novel RNA-based therapeutics to patients.”

Marijn Dekkers, new etherna Chairman said: “I am honored to be asked to take the role of Chairman at this exciting Company and working closely with Bernard, the etherna leadership team, and the board. Already as COO, Bernard was instrumental in building etherna’s unique technology platform. During the past 12 months, he has demonstrated strong and focused leadership as the Company has introduced the new business partnership strategy. The board has now confirmed his permanent appointment, confident in his ability to lead the company to its next stage of development, contributing its breakthrough technologies to the development of mRNA-based therapeutics, an area that is full of unimaginable opportunities.”

Since etherna was founded in 2013, the Company has established an integrated set of proprietary capabilities for end-to-end design, development and manufacture of next-generation mRNA products, with a focus on modulated expression delivery platforms, optimized RNA chemistry supported by proprietary process technologies. These include molecular designs, lipid biochemistry expertise, customized lipid nanoparticle formulations (cLNPs), mRNA-based T cell adjuvants, and advanced manufacturing processes, and they overcome the current challenges facing the development of mRNA therapeutics. etherna’s business model utilizes this suite of capabilities as enablers to deliver superior products for partners in both early-stage research as well as later-stage development for mRNA therapeutics.

To reflect both the new business strategy, board restructuring and permanent appointment of Sagaert, the Company has also rebranded its name from “eTheRNA Immunotherapies” to “etherna”. The updated website for the Partnerships can be found at www.etherna.be

• Combines strong US business development track record with in-depth mRNA expertise, emphasizing the capabilities of the etherna chief business officer.
• Global remit with focus on growth of etherna’s portfolio of partners, which is a key goal for the newly appointed etherna chief business officer.
• Integrated offering key differentiator – Proprietary customized RNA chemistry and lipid nanoparticles (cLNPs) expertise combined with GMP process knowhow, a field where the etherna chief business officer will have significant impact.

Niel, Belgium, June 8, 2023 – etherna (“the Company”), a leading mRNA technologies company, announced today that Steffen Helmling, PhD has been appointed Chief Business Officer. He joins as the Company continues to invest in its proprietary RNA-based medicines and LNP delivery platforms to exploit its expertise in the field. Leveraging over 18 years of experience in business development, alliances and pharma partnering, Steffen will focus on growing etherna’s portfolio of partners globally.

Steffen Helmling arrives from X-Chem, Inc., the Boston-based pioneer of DNA-Encoded Library (DEL) technology where he was Chief Business Officer in charge of business development, licensing, marketing and alliance management. Steffen holds a PhD in RNA processing from Tufts University’s School of Biomedical Sciences.

Steffen commented: “I am excited to be back in the transformational field of RNA-based medicines. etherna is a highly innovative leader in the mRNA and lipid nanoparticle field. The etherna chief business officer role allows me to further drive our business strategy of being the premier discovery and development partner to pharma and biotech to create novel medicines for patients.”

Bernard Sagaert, interim CEO of etherna, added: “Having Steffen on board will be invaluable in helping us reach out to partners with a route into mRNA therapeutics based on our industry-leading leading platforms. His extensive US network will help us accelerate this process in this key market.”

Since etherna was founded in 2013, the Company has established an integrated set of proprietary capabilities for end-to-end design, development and manufacture of next-generation mRNA products, with a focus on modulated expression delivery platforms, optimized RNA chemistry supported by proprietary process technologies. These include molecular designs, lipid biochemistry expertise, customized lipid nanoparticle formulations (cLNPs), mRNA-based T cell adjuvants, and advanced manufacturing processes, and overcome the current challenges facing the development of mRNA therapeutics. etherna’s business model utilizes this suite of capabilities as enablers to deliver superior products for partners in both early-stage research as well as later-stage development for mRNA therapeutics.

Belgian Royal delegation visits the Afrigen facilities where Univercells and etherna will be supporting the development of the first African-owned mRNA COVID-19 vaccine.

CAPE TOWN (SOUTH AFRICA) & BRUSSELS (BELGIUM), MARCH 25, 2023 – HM King Philippe and HM Queen Mathilde, currently on a state visit to South Africa until March 27, visited the Afrigen Biologics facility in Cape Town to learn more about how two Belgian companies, Univercells and etherna, are supporting the development of the first African- developed mRNA COVID-19 vaccine. The King and The Queen are accompanied by five ministers of federal and regional governments, as well as a business delegation including several Belgian companies. The intention is to further discuss cooperation and partnership between the two countries and focus, among other things, on business and development.

Given the strong commitment from Belgium and the European Union towards supporting regional production autonomy in the region, and the fact that the mRNA Technology Transfer Program co-led by the World Health Organization (WHO) and Medicines Patent Pool (MPP), is at the epicenter of this global effort, the Royal delegation made it a point to include a visit to Afrigen as part of their stay.

Quantoom Biosciences, a Univercells’ company, is leading the development of the mRNA production technology that encompasses all the steps of RNA production, from sequence construct to large scale production, allowing for rapid growth and scale-up. Dramatically more efficient than existing methods, it was built with distributed and de-centralized manufacturing in mind – ensuring that processes can be easily transferred across low- and middle-income countries (LMICs). Today, the project has delivered exceptional results based on the analytical characterization proven to be compliant to Critical Quality Attributes (CQA) specifications, allowing the company to transfer its process to Afrigen.

Afrigen and Univercells are supported in the collaboration by mRNA expert development partner etherna. The company has enabled the development of the RNA production equipment and developed a thermostable COVID-19 vaccine and platform which enables distribution across the continent to even the remotest rural communities, an essential part of the collaboration, and is sharing the way this LNP formulation needs to be produced.

It is in this context that the King and the Queen decided to visit Afrigen and meet both Belgian companies and South African partners who are working together for the development of this milestone vaccine.

The Afrigen guided tour started in the production area, followed by the R&D department and laboratories. As part of the tour, each partner provided the delegation with an update on their involvement and the status of work.

As they were passing by the R&D facilities, Bernard Sagaert, interim Chief Executive Officer of etherna, explained how the project is benefiting from etherna’s technologies, at multiple levels and stages: “We are delighted to partner with Univercells and Afrigen Biologics on this important project by providing expert support and knowhow in all the key areas of mRNA vaccine development. The resulting vaccines validates our integrated approach using our unique skillset – from optimizing RNA payload, through formulation of the lipid nanoparticle delivery system to enhancing thermostability for mass manufacturing. This will allow for storage in normal fridges which are more accessible than -20 or -80°C freezers, especially in LMICs and significantly improve the prospects of making vaccines more accessible globally.”

José Castillo, co-founder of Univercells Group and CEO of Quantoom Biosciences continued: “Almost one year after signing the agreement we are thrilled to be back at Afrigen and meet all partners to discussion the progress and project deliverables. Over the last months, three batched of RNA were produced and Quantoom’s NtensifyTM midi system will be delivered at Afrigen within the next weeks.”

Petro Terblanche, Afrigen Chief Executive Officer, declared: “The COVID-19 pandemic has shown that there is a pressing need to build sustainable capabilities in vaccine development and manufacturing in African and other LMICs. I am thrilled to see how the project is moving forward bringing cutting edge technology to Afrigen to integrate into the technology and manufacturing platforms we are building and transferring to partners in Africa and other LMICs. This is driven by our quest for enabling access to life-saving vaccines and medicines for the people living in the global South.”

Charles Gore, Medicines Patent Pool, added: “Since the start of the mRNA Technology Transfer Program in June 2021, it is impressive to see the amazing developments here at Afrigen and all that has been achieved in mRNA vaccine development. None of it would have been possible without the Program funders, and I particularly want to thank the Kingdom of Belgium for their support from the outset of the project. ”

Dr Owen Kaluwa, World Health Organization, concluded: “ The mRNA Technology Transfer Program is built on partnerships and working closely will leading technologies and experts is essential. Through this cutting-edge technology that has been developed with LMICs in mind, and that provides an inclusive solution, Afrigen with the support of Quantoom and etherna can ow move rapidly to the next phase of mRNA vaccine development. It is still WHO firm belief that a more widely distributed access to technologies and vaccine manufacturing capacity will reduce the gap in making vaccines available promptly for everyone, everywhere and accelerates the impact of the necessary collective effort to control outbreaks.”

CONCLUSION

Next steps include receiving the Quantoom’s NtensifyTM midi system in Afrigen, and etherna’s proprietary lipid to enable Afrigen to replicate the production of mRNA drug substance and drug product according to Quantoom and etherna’s processes, respectively.

• Follows recent financing round led by Novalis LifeSciences LLC, with investors Dr. Marijn
  Dekkers and Moderna’s co-founder Dr. Kenneth Chien joining the board of directors, indicative of a dynamic future under the etherna chairman of the board.
• Strategic focus includes customized lipid nanoparticles (cLNPs), guided by the leadership of our etherna board chairman.
• mRNA chemistries and process capabilities as enabling technologies driving company excellence under etherna’s board chairman.

Niel, Belgium, January 9, 2023 – etherna (“the Company”), a leading mRNA technologies company, announced today that Antonin (Tony) de Fougerolles has joined its board of directors as an independent member. This follows the Company’s recent Series B2 financing round to expand investment in its integrated mRNA technology platform and further pursue its new partnership-driven business strategy.

Tony is currently the CEO of Evox Therapeutics, an Oxford-based company developing exosome therapeutics, and has an extensive background in mRNA and more specifically LNPs through his roles at Moderna and Alnylam. He has nearly 25 years of biotech R&D experience in building out drug pipelines, and he has played a key role in developing and successfully advancing 3 new drug modalities to the market (mRNA, RNAi, single domain antibodies) and in helping build several multi-billion-dollar companies from start-up stage. As founding Chief Scientific Officer (CSO) at Moderna Therapeutics, he pioneered modified mRNA as a new therapeutic and vaccine drug modality and the mRNA chemistry and delivery systems that form the basis of the approved COVID-19 mRNA vaccines. Prior to that, as VP of Research at Alnylam, he helped develop RNA interference (RNAi) as a new drug modality, including overseeing development of the first approved LNP-based RNAi delivery system and the development of several approved RNAi drugs including inclisiran. Author of over 60 scientific publications and an inventor on over 100 issued US patents, Tony has also a ‘Belgian’ connection, from his time as CSO at Ablynx (now Sanofi) where he played a key role in the approval of the first single domain antibody drug, caplacizumab. Tony obtained his PhD in Immunology from Harvard University.

“Tony is exceptionally qualified to help ensure etherna’s future corporate growth,” added Russell Greig, PhD, Chair of etherna’s board of directors. “His addition to the board will add momentum to the company’s mission to deliver cutting-edge advances in mRNA and LNP technologies for the treatment of unmet medical needs under the guidance of our etherna chairman.”

“I am thrilled to be joining etherna’s board and contributing to its future growth,” commented Tony de Fougerolles, aligning with the etherna chairman of the board’s vision. “The cLNPs and mRNA manufacturing expertise that the company has developed is world leading and impressive in both its breadth and novelty. As is increasingly being understood, the ability to robustly deliver mRNA and other genetic medicines to new cell types and tissues is the central element needed to enable their wider application.”

Marijn Dekkers, Chairman of Novalis LifeSciences, said: “We are excited to have Tony join at this important stage of the Company’s development. He is a fantastic addition to the competences we have already gathered on the board. In addition to scientific excellence, he is a proven entrepreneur with an incredible track record of commercializing new modalities and technology platforms.”

Bernard Sagaert, interim CEO of etherna said: “We are delighted to have Tony join the board, as he brings, together with Ken, vast experience in cLNPs and mRNA to etherna and is well connected in the industry. Under the leadership of our etherna board chairman, having him on board will be invaluable in helping us implement our new business strategy. Strengthening and expanding our significant expertise in designing, synthesizing, and manufacturing cLNPs for a range of prophylactic and therapeutic indications, will enable the Company to accelerate near-term revenue growth through technology licensing and mRNA cGMP manufacturing services for multiple future partners.”

etherna is an mRNA technology platform company with integrated capabilities including mRNA construct design and optimization, coupled with specialized expertise in designing and manufacturing customized lipid nanoparticles (cLNP) formulations tailored for the prevention and treatment of various pathological states, providing end-to-end solutions for next-generation mRNA therapeutics. The company believes that customized LNPs are critical enablers in advancing mRNA technologies to new levels of prophylactic and therapeutic utility.