Influenza vaccine, quadrivalent(CSL Ltd.)

SAN DIEGO--( BUSINESS WIRE )--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced its financial results for the third quarter ended September 30, 2024, and provided corporate updates. “I am thrilled about the approval of KOSTAIVE® for the COVID-19 JN.1 strain in Japan and for the continued success of the STARR® platform in multiple Phase 3 trials, underscoring CSL and Arcturus’ commitment to deliver disruptive technologies for protection against respiratory viral diseases,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “I am pleased that both of our flagship mRNA therapeutic programs, ARCT-032 and ARCT-810, are on track for interim Phase 2 proof-of-concept clinical data in the first half of 2025. These studies allow us to evaluate lung function improvement in individuals with cystic fibrosis, and meaningful biomarker changes in individuals with OTC deficiency.” “I am happy to report our first commercial milestone achieved from our CSL partnership for the first commercial sale of KOSTAIVE in Japan,” said Andy Sassine, Chief Financial Officer of Arcturus. “We anticipate another milestone related to potential European approval in the first quarter of 2025. I am also happy to announce that Arcturus is planning to transfer our cystic fibrosis manufacturing process technology to ARCALIS.” Recent Corporate Highlights In September, Arcturus received clearance of an Investigational New Drug application from the U.S. Food and Drug Administration (FDA), enabling the Company to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with cystic fibrosis (CF). The Phase 2 study is screening individuals with CF who do not qualify for, or benefit from, CFTR modulator medicines due to dysfunctional or absent CFTR protein and/or drug intolerance. The Company remains on track to share ARCT-032 Phase 2 proof-of-concept (POC) interim data in 1H25. In August, the Company announced the expansion of the Phase 2 clinical program of ARCT-810, an mRNA therapeutic to potentially treat ornithine transcarbamylase (OTC) deficiency, into the United States. This open-label multiple-dose study ( NCT06488313 ) evaluating pharmacodynamics and safety is currently enrolling adults and adolescents requiring clinical management for OTC deficiency. The placebo-controlled Phase 2 European study has completed the dosing phase (N = 8; 0.3 mg/kg) in OTC deficient individuals. The Company remains on track to share ARCT-810 Phase 2 POC interim data from both U.S. and European studies in 1H25. Meiji Seika Pharma, CSL’s exclusive partner in Japan, began KOSTAIVE commercial sales in September 2024. This event triggered a $25 million commercial milestone associated with the first sale of KOSTAIVE® in Japan. In September, the Company, along with partners CSL and Meiji, announced new 12-month post vaccination data for KOSTAIVE at OPTIONS XII for the Control of Influenza conference. The results of a head-to-head study demonstrated that KOSTAIVE maintained superior immunogenicity compared to the conventional mRNA vaccine COMIRNATY® for up to one year against Wuhan-Hu-1, Omicron BA.4/5 and certain other variants, and at one-sixth the dose of the comparator (5 μg vs 30 μg, respectively). The results were published in The Lancet Infectious Disease . Additional Phase 3 data presented by CSL, Meiji and Arcturus show that bivalent KOSTAIVE, ARCT-2301, induced superior immunogenicity over conventional bivalent mRNA vaccine COMIRNATY® that persists against key variants up to six months post vaccination. Earlier this year, CSL Seqirus’s partner Meiji Seika Pharma announced that it submitted a partial change application for an amendment to the manufacturing and marketing approval of KOSTAIVE® to include manufacturing sites in Japan, including ARCALIS, Inc., Arcturus’ manufacturing joint venture in Japan. When approved, Meiji Seika Pharma will begin selling domestically produced KOSTAIVE® this season. The Company announced the results of a Phase 3 study which demonstrated the added value of an updated COVID-19 vaccine (ARCT-2303) containing the Omicron XBB.1.5 variant. The study supports co-administration of KOSTAIVE with licensed influenza vaccines. ARCT-2303 demonstrated superior immune response versus ARCT-154 as measured by neutralizing antibodies against Omicron XBB.1.5.6 in terms of GMT ratio and SCR difference. Co-administration of ARCT-2303 and cell-based quadrivalent influenza vaccine (QIV; FLUCELVAX®, CSL) showed noninferior immune response vs standalone QIV administration. Co-administration of ARCT-2303 and QIV showed noninferior immune response vs standalone ARCT-2303 administration. Co-administration of ARCT-2303 and adjuvanted QIV (FLUAD®, CSL) in older adults showed similar responses vs standalone administration of ARCT-2303 and adjuvanted QIV. Financial Results for the three months ended September 30, 2024 Revenues in conjunction with strategic alliances and collaborations: Arcturus’ primary revenue streams include license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research and development arrangements with pharmaceutical and biotechnology partners. For the three months ended September 30, 2024, we reported revenue of $41.7 million, a slight decrease of $3.5 million from the $45.2 million reported in the same period in 2023. The decline was mostly attributable to a lower milestone achievement from the CSL agreement during the third quarter of 2024. This decrease was offset by revenue recognized from a supply agreement related to the commercial production of KOSTAIVE® and an increase in revenue from the BARDA agreement during the three months ended September 30, 2024. Revenue decreased by $6.4 million during the nine months ended September 30, 2024, as compared to the same period in 2023. The decrease was due to lower CSL revenue resulting from the timing and value of milestone achievements. This was offset by increased BARDA revenue due to progress of the pandemic flu program. Operating expenses: Total operating expenses for the three months ended September 30, 2024, were $52.4 million compared with $64.5 million for the three months ended September 30, 2023. Total operating expenses for the nine months ended September 30, 2024, were $191.8 million compared with $195.9 million for the nine months ended September 30, 2023. Research and development expenses: Research and development expenses consist primarily of external manufacturing costs, in vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel-related expenses, facility-related expenses and laboratory supplies related to conducting research and development activities. Research and development expenses were $39.1 million for the three months ended September 30, 2024, compared with $51.1 million for the three months ended September 30, 2023. Research and development expenses were $151.4 million for the nine months ended September 30, 2024, compared with $155.5 million for the nine months ended September 30, 2023. The decreases in research and development expenses were primarily driven by a decrease in manufacturing costs for the COVID program. The decrease was partially offset by an increase in clinical trial costs for the COVID and flu programs. General and Administrative Expenses: General and administrative expenses primarily consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional service fees for legal and accounting services as well as other general and administrative expenses. General and administrative expenses were $13.3 million and $40.4 million for the three and nine months ended September 30, 2024, respectively, compared with $13.4 million and $40.4 million for the comparable periods in the prior year. These expenses remained relatively consistent between the two periods. The Company expects that general and administrative expenses will remain relatively consistent over the next fiscal year with the current pipeline. Net Loss: For the three months ended September 30, 2024, Arcturus reported a net loss of approximately $6.9 million, or ($0.26) per diluted share, compared with a net loss of $16.2 million, or ($0.61) per diluted share in the three months ended September 30, 2023. For the nine months ended September 30, 2024, Arcturus reported a net loss of approximately $50.9 million, or ($1.89) per diluted share, compared with a net loss of $18.0 million, or ($0.68) per diluted share in the nine months ended September 30, 2023. Cash Position and Balance Sheet: Cash, cash equivalents and restricted cash were $294.1 million as of September 30, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $462.1 million in upfront payments and milestones from CSL as of September 30, 2024, and expects to continue to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu programs and three additional vaccine programs by CSL. Based on the current pipeline and programs, the cash runway is expected to extend through the first quarter of fiscal year 2027. Earnings Call: Thursday, November 7, 2024 @ 4:30 pm ET Domestic: 1-800-274-8461 International: 1-203-518-9814 Conference ID: ARCTURUS Webcast: Link About Arcturus Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus' pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com . In addition, please connect with us on Twitter and LinkedIn . Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success and continued advancement of the Company’s pipeline (including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood and extent of commercialization of KOSTAIVE and the timing thereof, the continued clinical development of the rare disease programs, the interim Phase 2 proof-of-concept clinical data and the timing therefor, the likelihood and timing of European Marketing Authorization application approval for KOSTAIVE and of a milestone payment from CSL related thereto, the planned transfer of the CF manufacturing process to ARCALIS and timing thereof, the anticipated enrollment in the Phase 2 clinical program for ARCT-810, the anticipated enrollment in the Phase 2 clinical program for ARCT-032, that preclinical or clinical data will be predictive of future clinical results, the likelihood and timing of clinical study updates, the likelihood of and timing for approval of Meiji Seika Pharma’s application to amend approval for KOSTAIVE to include domestic manufacturing sites in Japan, Meiji Seika Pharma’s plans to begin selling Japan-produced KOSTAIVE and the timing thereof, the likelihood or timing of collection of accounts receivables including expected future milestone and other payments from CSL, its current cash position and expected cash burn and runway, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website at www.sec.gov . Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Trademark Acknowledgements The Arcturus logo and other trademarks of Arcturus appearing in this announcement, including LUNAR® and STARR®, are the property of Arcturus. All other trademarks, services marks, and trade names in this announcement are the property of their respective owners. ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS September 30, 2024 December 31, 2023 (in thousands, except par value information) (unaudited) Assets Current assets: Cash and cash equivalents $ 237,178 $ 292,005 Restricted cash 55,000 55,000 Accounts receivable 30,199 32,064 Prepaid expenses and other current assets 8,444 7,521 Total current assets 330,821 386,590 Property and equipment, net 10,350 12,427 Operating lease right-of-use assets, net 27,598 28,500 Non-current restricted cash 1,885 1,885 Total assets $ 370,654 $ 429,402 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 10,131 $ 5,279 Accrued liabilities 32,396 31,881 Deferred revenue 26,936 44,829 Total current liabilities 69,463 81,989 Deferred revenue, net of current portion 13,338 42,496 Operating lease liability, net of current portion 25,987 25,907 Other non-current liabilities — 497 Total liabilities 108,788 150,889 Stockholders’ equity Common stock, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 27,084 at September 30, 2024 and 26,828 at December 31, 2023 27 27 Additional paid-in capital 680,641 646,352 Accumulated deficit (418,802 ) (367,866 ) Total stockholders’ equity 261,866 278,513 Total liabilities and stockholders’ equity $ 370,654 $ 429,402 ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) Three Months Ended Nine Months Ended September 30, September 30, (in thousands, except per share data) 2024 2023 2024 2023 Revenue: Collaboration revenue $ 38,815 $ 43,376 $ 117,389 $ 132,670 Grant revenue 2,858 1,764 12,155 3,274 Total revenue 41,673 45,140 129,544 135,944 Operating expenses: Research and development, net 39,134 51,077 151,376 155,513 General and administrative 13,276 13,377 40,443 40,364 Total operating expenses 52,410 64,454 191,819 195,877 Loss from operations (10,737 ) (19,314 ) (62,275 ) (59,933 ) (Loss) gain from foreign currency (201 ) 4 (642 ) (175 ) Gain on debt extinguishment — — — 33,953 Finance income, net 3,818 3,981 11,981 9,710 Net loss before income taxes (7,120 ) (15,329 ) (50,936 ) (16,445 ) Provision for income taxes (217 ) 893 — 1,573 Net loss $ (6,903 ) $ (16,222 ) $ (50,936 ) $ (18,018 ) Net loss per share, basic and diluted $ (0.26 ) $ (0.61 ) $ (1.89 ) $ (0.68 ) Weighted-average shares outstanding, basic and diluted 27,062 26,574 26,970 26,559 Comprehensive loss: Net loss $ (6,903 ) $ (16,222 ) $ (50,936 ) $ (18,018 ) Comprehensive loss $ (6,903 ) $ (16,222 ) $ (50,936 ) $ (18,018 )

Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines. Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.1,2 Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effective against medically attended, laboratory-confirmed influenza, with vaccine effectiveness (VE) highest in children six months to three years of age at 88%, compared with unvaccinated participants.3 RWE studies can play a key role in assessing influenza vaccine effectiveness each season. RWE complements randomized controlled trials (RCT), assessing influenza vaccine effectiveness on an ongoing basis and contributing to an ever-growing data set on real-world outcomes. SUMMIT, N.J., Oct. 1, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced data from a range of real-world evidence (RWE) studies, highlighting the important role influenza vaccination plays in protecting public health. The data are being presented in an oral presentation and poster sessions at OPTIONS for the Control of Influenza (OPTIONS XII), being held in Brisbane, Australia from September 29 to October 2, 2024. Given the ever-changing nature of the influenza virus, RWE studies are valuable in assessing influenza vaccine effectiveness season-over-season. RWE is a complement to randomized controlled trial (RCT) research, assessing influenza vaccine effectiveness on an ongoing basis and providing an ever-growing data set on real-world outcomes. "CSL Seqirus remains committed to evaluating vaccine effectiveness through the rigorous generation of real-world evidence," said Gregg Sylvester, Chief Health Officer, CSL Seqirus. "Our studies and presentations at OPTIONS XII reflect our dedication to helping to protect people against influenza and its associated medical complications across all ages, including those as young as six months old. We have chosen to include studies with test confirmed data. This approach may provide more robust evidence." Among others, RWE studies being presented by CSL Seqirus at OPTIONS XII include: Results of a study of the 2022/23 influenza season in the US showed that cell-based quadrivalent (QIVc) vaccines prevented more outpatient test-confirmed influenza for those aged six months to 64 years compared with the egg-based quadrivalent (QIVe) vaccines.1 Results from a study of the 2023/24 influenza season in the US showed that cell culture-based inactivated influenza vaccine (ccIIV4) generated real-world effectiveness against medically attended, laboratory-confirmed influenza, compared with unvaccinated participants. Vaccine effectiveness was highest in children six months to three years of age at 88%.3 Results from a review of the 2017 to 2020 influenza seasons revealed a higher relative effectiveness of QIVc over QIVe/egg-based trivalent (TIVe) vaccines across the three influenza seasons for both test-confirmed influenza and clinically diagnosed influenza.2 Results from a study of the 2022/23 influenza season in the US showed comparability between MF59® adjuvanted quadrivalent inactivated influenza vaccine (aQIV) and high-dose quadrivalent inactivated influenza vaccine (HD-QIV) in preventing test-confirmed influenza-related emergency department visits and/or inpatient admissions settings among adults aged 65 and over.4 "The results from these studies are a continued demonstration of the value of RWE in generating valuable insights into influenza vaccine effectiveness," said Mendel Haag, Senior Director, Center of Outcomes Research & Epidemiology, CSL Seqirus. "These studies have collected and analyzed data over several recent influenza seasons. They highlight the effectiveness of cell-based influenza vaccines in protecting people six months to 64 years old against test-confirmed influenza compared to standard egg-based vaccines, particularly in our more vulnerable populations, as well as the comparability between MF59® adjuvanted vaccines and high-dose vaccines in preventing flu-related ER and hospital admissions." CSL Seqirus is at the forefront of influenza research and is proud to present a series of compelling data that spans across various aspects of influenza prevention and ages. The research emphasizes the company's commitment to advancing public health through RWE and innovative vaccine technology. ABOUT THE STUDIES PRESENTED AT OPTIONS XII Relative vaccine effectiveness of cell-based versus egg-based quadrivalent influenza vaccines against test-confirmed influenza in the United States 2022-23 influenza season 1 Researchers applied a retrospective test-negative design among individuals aged 6 months to 64 years vaccinated with either QIVc or QIVe in 2022-23 and who had an influenza test obtained in routine outpatient care within +/- 7 days of a documented acute respiratory or febrile illness. Exposure, outcome, and covariate data were obtained from outpatient electronic health records linked to pharmacy and medical claims. rVE was calculated by comparing the odds of testing positive for influenza among QIVc recipients with the odds among QIVe recipients, using a doubly robust analysis that combined inverse probability of treatment weighting with multivariable adjustment. The study included 43,086 tested patients, of whom 18.6% received QIVc and 81.4% received QIVe. QIVc was generally more effective than QIVe in preventing test-confirmed influenza in the outpatient care setting, with an estimated rVE of 7.7% (95% CI: 0.9% – 13.9%). This study showed increased relative effectiveness of QIVc compared to QIVe in preventing outpatient test-confirmed influenza in the population aged 6 months to 64 years during the 2022-23 season in the United States. These findings add to the body of evidence supporting improved effectiveness of cell-based versus egg-based vaccines. Relative effectiveness of cell-based influenza vaccines versus egg-based influenza vaccines: A review of test-confirmed and clinical diagnosis-based influenza outcomes 2 Researchers identified 10 studies reporting on the rVE of QIVc vs QIVe/TIVe among persons aged 4–64 years from a prior systematic literature review (PROSPERO CRD42020160851) that included studies published between 01-January-2016 and 25-February-2022. Additionally, a scoping review was conducted to identify additional studies published between 25-February-2022 and 01-March-2024. A DerSimonian and Laird random effects model was applied for the meta-analyses of these data. Among persons aged 4–64 years, the pooled rVE showed a consistent benefit of QIVc for both outcome types, with estimates of 11.9% (95% CI, 3.0%–20%; n studies=3) for 2017–2018, 11.8% (3.5%–19.4%; n=2) for 2018–2019, and 10.0% (2.7%–16.7%; n=1) for 2019–2020 in preventing test-confirmed influenza and 18.7% (8.7%–27.6%; n=2) for 2017–2018, 5.9% (4.3%–7.5%; n=2) for 2018–2019, and 10.1% (6.1%–14.0%; n=2) for 2019–2020 in preventing clinically diagnosed influenza. Researchers found that for persons aged 4–64 years, QIVc showed increased effectiveness over QIVe/TIVe across the three influenza seasons for both test-confirmed influenza and clinically diagnosed influenza. The results do not suggest systematic over or underestimation of rVE for prevention of clinically diagnosed compared to test-confirmed influenza. Effectiveness of cell culture-based inactivated influenza vaccine against medically-attended, laboratory-confirmed influenza in Wisconsin, US, 2023-2024 3 Researchers actively recruited patients aged 6 months to 64 years with acute respiratory illness at Marshfield Clinic Health System outpatient facilities between October 2023 and May 2024. Respiratory specimens were tested using multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) to identify influenza cases; controls were influenza-negative. Analyses were restricted to ccIIV4 recipients and unvaccinated participants. Among 1,850 participants, 228 were aged 6 months to 3 years, 230 aged 4 to 8 years, 363 aged 9 to 17 years, and 1,029 aged 18 to 64 years. Adjusted VE of ccIIV4 against any influenza was 60% (95% CI, 47%−70%) in persons 6 months to 64 years. Adjusted VE was 88% (95% CI, 64%-97%) among children aged 6 months to 3 years, 63% (95% CI, 39%−78%) among children aged 4 to 17 years, and 50% (95% CI, 29%−65%) among adults 18 to 64 years. Adjusted VE against influenza B was 72% (95% CI, 49%–86%) overall. Analysis revealed that ccIIV4 was effective against medically attended, laboratory-confirmed influenza in 2023-24. ccIIV4 effectiveness was highest in children 6 months to 3 years of age and for influenza B in persons 6 months to 64 years. Relative vaccine effectiveness of adjuvanted quadrivalent inactivated influenza vaccine (aQIV) vs high-dose quadrivalent inactivated influenza vaccine (HD-QIV) for prevention of test-confirmed influenza during the 2022-2023 influenza season 4 This retrospective test negative design (TND) study included US adults age ≥65 years vaccinated with aQIV or HD-QIV who presented with acute respiratory or febrile illness during the 2022-2023 influenza season in any emergency department and/or inpatient admissions settings. Test-positive cases and test-negative controls were grouped by vaccine received. The rVE was evaluated using a doubly robust approach, combining inverse probability of treatment weighting (IPTW) and logistic regression to adjust for potential confounders. After applying eligibility criteria, 30,911 tested vaccinated patients were included (2,361 positive cases and 28,550 negative controls). No significant differences were found in the rVE of aQIV vs. HD-QIV in preventing test-confirmed influenza in any setting (-2.5% (95% CI: [-13.4 to 7.4]) or in ED/IP settings (0.0% [-15.9 to 13.7]). Researchers found that, consistent with prior evidence, these results show comparability between aQIV and HD-QIV for preventing test-confirmed influenza in any setting and in ED/IP settings among US adults ≥65 years during the 2022-2023 season. Study Limitations The above studies featuring RWE were subject to the typical limitations associated with retrospective analyses. Unmeasured and residual confounding remain a potential source of bias as in all observational research. The amount and quality of data available on individuals may vary and clinical and claims data do not include all data that could inform and adjust for health seeking behavior, such as individual or contextual socioeconomic data. Studies included outcomes which were obtained as part of routine care and not performed according to pre-set screening criteria, including test confirmed influenza in the retrospective test-negative designs. Vaccination in these observational studies was not randomly assigned. About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.5 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.5 Because transmission of influenza viruses to others may occur before symptoms develop and up to five to seven days after becoming sick, the disease can be easily transmitted to others.5 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.6 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.6 The CDC recommends that for most people who need only one dose of flu vaccine, vaccination should ideally happen in September or October.6 About CSL Seqirus CSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus offers a broad portfolio of innovative, differentiated influenza vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit . About CSL CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/we-are-csl/vita-original-stories and follow us on Twitter.com/CSL. For more information about CSL, visit . Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. FLUCELVAX® (Influenza Vaccine) IMPORTANT SAFETY INFORMATION What is FLUCELVAX® (Influenza Vaccine)? FLUCELVAX is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with FLUCELVAX may not protect all people who receive the vaccine. Who should not receive FLUCELVAX? You should not receive FLUCELVAX if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. Before receiving FLUCELVAX, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUCELVAX should be made by your healthcare provider, based on careful consideration of the potential benefits and risks. have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are the most common side effects of FLUCELVAX? pain and/or redness where the vaccine was given headache extreme tiredness muscle aches Additional side effects seen in children include: tenderness, bruising and/or a raised hardened area where the vaccine was given sleepiness irritability diarrhea changes in eating habits feeling unwell (malaise) These are not all of the possible side effects of FLUCELVAX. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider. To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus a t 1-855-358-8966 or VAERS at 1 ‐ 800 ‐ 822 ‐ 7967 or . Before receiving this vaccine, please see the full US Prescribing Information for FLUCELVAX. You can ask your healthcare provider or pharmacist for information about FLUCELVAX that is written for healthcare professionals. FLUAD ® (Influenza Vaccine, Adjuvanted) IMPORTANT SAFETY INFORMATION What is FLUAD® (Influenza Vaccine, Adjuvanted)? FLUAD is a vaccine that helps protect people aged 65 years and older from the flu. Vaccination with FLUAD may not protect all people who receive the vaccine. Who should not receive FLUAD? You should not receive FLUAD if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. Before receiving FLUAD, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUAD should be made by your healthcare provider, based on careful consideration of the potential benefits and risks have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are the most common side effects of FLUAD? Pain and tenderness where vaccine was given Muscle ache Tiredness Headache These are not all of the possible side effects of FLUAD. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider . To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and . Before receiving this vaccine, please see the full US Prescribing Information for FLUAD. You can ask your healthcare provider or pharmacist for information about FLUAD that is written for healthcare professionals. ### USA-CRP-24-0029 MEDIA CONTACT Em Dekonor +44 (0)7920500496 [email protected] REFERENCES 1 Stein, A. et al (2024). Relative vaccine effectiveness of cell-based versus egg-based quadrivalent influenza vaccines against test-confirmed influenza in the United States 2022-23 influenza season. 2 Imran, M. et al (2024). Relative effectiveness of cell-based influenza vaccines versus egg-based influenza vaccines: A review of test-confirmed and clinical diagnosis-based influenza outcomes. 3 Huong Q Nguyen et al. (2024) Effectiveness of cell culture-based inactivated influenza vaccine against medically-attended, laboratory-confirmed influenza in Wisconsin, US, 2023-2024. 4 Imran, M. et al (2024). Relative vaccine effectiveness of adjuvanted quadrivalent inactivated influenza vaccine (aQIV) vs high-dose quadrivalent inactivated influenza vaccine (HD-QIV) for prevention of test-confirmed influenza during the 2022-2023 influenza season. 5 CDC. (2024). Key Facts About Influenza (Flu). Retrieved from: . Accessed September 2024. 6 CDC. (2024). Who Needs a Flu Vaccine and When. Retrieved from: . Accessed September 2024. SOURCE CSL Seqirus WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED