Chikungunya virus vaccine (Valneva)

Plus, news about CG Oncology, Opus Genetics and Valneva: Surrozen’s pivot and capital raise: The South San Francisco drug developer is scrapping clinical development in severe alcohol associated hepatitis and instead focusing on its ophthalmology pipeline. It also lined up $175 million from a private placement. Surrozen’s stock $SRZN was down about 5% on Monday morning. — Kyle LaHucik CBC Group’s $1B fund: The largest healthcare-focused asset management firm in Asia marked the first close of its healthcare buyout fund. The firm has raised $1 billion so far of a targeted $1.4 billion. It plans to support biopharma, medical devices and other healthcare companies. — Kyle LaHucik CG Oncology touts updated Phase 3 bladder cancer data: The Irvine, CA-based biotech’s oncolytic virus candidate, cretostimogene grenadenorepvec, led to complete responses in 46% of high-risk non-muscle invasive bladder cancer patients at 12 months as of the January data cutoff. The median duration of response has not yet been reached but exceeds 28 months, according to the company’s presentation at the European Association of Urology’s annual meeting. CG’s shares $CGON were up around 6% on Monday morning. — Ayisha Sharma Opus Genetics’ $21.5M raise: The North Carolina retinal biotech is getting the new funds from a public offering and a private placement. The gene therapy company, based in Research Triangle Park, NC, merged with eye drop maker Ocuphire Pharma in the fall. — Kyle LaHucik French government buys doses of Valneva’s chikungunya vaccine: The biotech will supply 40,000 doses of its chikungunya vaccine, dubbed IXCHIQ, in early April to France’s La Réunion, an island located east of Africa where cases of chikungunya, a virus spread by mosquitoes, have risen since the start of 2025, according to a release . Valneva’s stock $VALN rose nearly 7% after sharing the supply announcement. — Anna Brown

Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France’s Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the Island’s wholesalers. This supply of doses, paid for by the French authorities, is in line with the recommendation of France’s national public health agency, the Haute Autorité de Santé (HAS), to prioritize for vaccination adults aged 65 and over, with co-morbidities. IXCHIQ® remains available for purchase in France (mainland and overseas). Chikungunya cases have spiked substantially in La Réunion since early 2025, with 8,600 cases recorded and almost 3,000 new cases during the week of March 3 to 9, 20251. Similar to the 2005-2006 chikungunya outbreak, there is a risk of transmission to mainland France and other French overseas territories. Local authorities of La Réunion have published a Level 4 emergency crisis management plan to contain the outbreak, while the Centers for Disease Control and Prevention (CDC) agency of the United States (U.S.) also issued a travel alert as millions of international travelers visit France's southern resorts and La Réunion Island annually. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, “Chikungunya outbreaks spread rapidly, so it is crucial to vaccinate as many people as possible to help contain the virus. We have the capacity to supply more doses and will continue working closely with Agence Régionale de Santé La Réunion to manage this outbreak locally and prevent its spread to other regions through international travel." IXCHIQ® is the world’s first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the United States2, Europe3, Canada4 and the United Kingdom5 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The European Medicines Agency (EMA) recently adopted a positive opinion recommending authorization of a label extension for IXCHIQ® to individuals 12 years of age and older6. On March 5, 2025, the Haute Autorité de Santé recommended to prioritize for vaccination adults aged 65 and over, especially those with comorbidities, followed by adults aged 18 and over with comorbidities, and vector control workers7. Valneva is focused on expanding the vaccine’s label and access. In the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)8, with support from the EU Horizon Europe program, through a $41.3 million grant to advance broader access to the vaccine in Low- and Middle-Income Countries (LMICs), post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women. Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII)9, the world’s largest manufacturer of vaccines by number of doses, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs. This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years10. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas11. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas12 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.13 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com About CEPICEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.Learn more at CEPI.net. Follow us on X (@CEPIvaccines), LinkedIn and Facebook. About Horizon EuropeHorizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95.5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones. CEPI Media Contactpress@cepi.net +44 7387 055214 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to possible additional sales in an outbreak context, the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Chikungunya à La Réunion : semaine du 3 au 9 mars 2025 | Agence Régionale de Santé La Réunion2 Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®3 Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ®4 Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ®5 Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ®6 Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ® - Valneva7 https://www.has-sante.fr/jcms/p_3594168/fr/epidemie-de-chikungunya-quelle-strategie-vaccinale-a-la-reunion-et-a-mayotte 8 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine - Valneva9 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India - Valneva10 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf 11 https://cmr.asm.org/content/31/1/e00104-1612 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.13 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int) Attachment 2025_03_24_IXCHIQ_La Reunion_Outbreak_Response_PR_EN_Final