CSL LTD SP/ADR - CSLLY STOCK NEWS

CSL Seqirus presented five studies at IDWeek 2024, emphasizing the need to increase influenza vaccination rates and showcasing the benefits of cell-based influenza vaccines. Key findings include:

1. A dynamic model showed that increasing vaccination rates to at least 45% is necessary to avoid hospital system resource saturation, especially in ICUs.

2. Multiple real-world evidence studies demonstrated improved relative vaccine effectiveness of cell-based vaccines compared to egg-based vaccines across different age groups, including children as young as 6 months.

3. A model based on the 2022-23 flu season estimated that cell-based vaccines would have averted a significant burden of influenza-related illnesses compared to egg-based vaccines.

4. Cell-based vaccines were found to be cost-saving compared to recombinant influenza vaccines for adults aged 18-64.

CSL Seqirus, a global leader in pandemic preparedness, has received a $34 million award from the Biomedical Advanced Research and Development Authority (BARDA) to complete the fill and finish process for additional pre-pandemic vaccines. This marks the sixth avian influenza pandemic preparedness award from BARDA to CSL Seqirus. The company will deliver approximately 3 million finished doses of MF59®-adjuvanted H5N1 pre-pandemic vaccine and manufacture an additional lot of H5N8 antigen.

CSL Seqirus' manufacturing facility in Holly Springs, North Carolina, is the largest cell-based influenza vaccine producer in the world. It can deliver 150 million influenza vaccine doses within six months of a pandemic declaration. This project is supported by federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA.

CSL Seqirus presented real-world evidence (RWE) studies at OPTIONS XII, showcasing the effectiveness of influenza vaccinations. Key findings include:

1. Cell-based vaccines showed improved relative vaccine effectiveness (rVE) compared to egg-based vaccines across different age groups, including children as young as six months.

2. A 2023/24 season study revealed cell-based vaccine effectiveness was highest in children 6 months to 3 years at 88% against laboratory-confirmed influenza.

3. MF59® adjuvanted quadrivalent vaccine showed comparability to high-dose quadrivalent vaccine in preventing flu-related ER visits and hospitalizations for adults 65+.

These studies highlight CSL Seqirus' commitment to evaluating vaccine effectiveness through RWE, complementing randomized controlled trials and providing ongoing insights into real-world outcomes.

CSL and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine ARCT-154 maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated:

1. Higher antibody levels against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants.

2. Effectiveness at one-sixth the dose of Comirnaty® (5 μg vs 30 μg).

3. Superior durability of immune response in both younger and older adults.

Additionally, their bivalent vaccine ARCT-2301 showed superior immunogenicity over Comirnaty® bivalent vaccine up to six months post-vaccination. The sa-mRNA platform vaccine targeting the JN.1 variant is now approved in Japan under the name KOSTAIVE®.

CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.

Key findings include:

• ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
• Similar advantages were observed against Omicron BA.4-5 and other variants
• A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®

The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.

CSL Seqirus, a business of CSL (ASX: CSL), has received a $121.4 million multi-year award from the Biomedical Advanced Research and Development Authority (BARDA) to expand its Vendor Managed Inventory (VMI) program for MF59® adjuvant. This marks the fifth avian influenza pandemic preparedness award for CSL Seqirus. The expanded program will increase the inventory to 40 million equivalent doses, enhancing the U.S. government's pandemic preparedness efforts.

MF59® adjuvant, manufactured at CSL Seqirus' Holly Springs, North Carolina facility, is important for pandemic preparedness as it reduces the antigen required to produce an immune response, thereby increasing vaccine doses. This expansion comes in response to sustained highly pathogenic avian influenza (HPAI) activity, which the CDC reports is widespread in wild birds and causing outbreaks in poultry and U.S. dairy cows.

CSL Vifor announced that Japan's Ministry of Health and Labor Welfare (MHLW) has approved Veltassa® (patiromer) for treating hyperkalemia in adult patients. This approval, granted to CSL Vifor's partner Zeria Pharmaceutical Co., , marks Veltassa®'s 41st country authorization worldwide.

Veltassa® offers effective long-term potassium control for patients with chronic kidney disease and chronic heart failure. The approval is based on positive clinical data from the Japanese development program of ZG-801 (Veltassa®).

This milestone addresses the needs of over 300,000 hyperkalemia patients in Japan. Zeria, which obtained exclusive rights to develop and market Veltassa® in Japan in 2018, plans to launch the product following National Health Insurance price listing.

CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October COVID-19 vaccination campaign.

KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine. Clinical evidence supports its safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.

CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare has approved their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE®, for adults 18 and older. The vaccine is tailored to protect against the JN.1 lineage of Omicron subvariants. Meiji Seika Pharma, CSL's exclusive partner in Japan, will distribute the vaccine for the October 2024 vaccination campaign.

KOSTAIVE® is the world's first commercially available sa-mRNA COVID-19 vaccine for adults. Clinical data showed superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA vaccines and immunity lasting up to one year. This approval aligns with recent World Health Organization recommendations and demonstrates CSL and Arcturus' commitment to innovative vaccine technology for viral respiratory diseases.