Latest news with #FluMist
Yahoo
02-04-2025
- Business
- Yahoo
AIM ImmunoTech Inc (AIM) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial ...
Cash, Cash Equivalents, and Marketable Securities: Approximately $4 million as of December 31, 2024. Research and Development Expenses: $6.2 million for the year ended December 31, 2024, compared to $10.9 million for the year ended December 31, 2023. General and Administrative Expenses: $13.7 million for the year ended December 31, 2024, compared to $21.1 million for the year ended December 31, 2023. Warning! GuruFocus has detected 6 Warning Signs with AIM. Release Date: April 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. AIM ImmunoTech Inc (AIM) announced a new clinical study evaluating Ampligen in combination with AstraZeneca's FluMist as a potential intranasal vaccine for influenza, including avian flu. The company strengthened its leadership team by adding two experienced Board members, Ted Kellner and David Chemerow, to guide strategic execution. The Erasmus Medical Center Safety Committee approved the continuation into the Phase 2 portion of the DURIPANC pancreatic cancer trial, marking progress in their clinical programs. AIM ImmunoTech Inc (AIM) reported final clinical results from the AMP-518 study, reinforcing Ampligen's potential in treating post-COVID conditions. The company expanded its intellectual property estate with new patents in the US and Netherlands, enhancing protection for Ampligen's applications. AIM ImmunoTech Inc (AIM) reported a decrease in cash, cash equivalents, and marketable securities to approximately $4 million as of December 31, 2024. Research and development expenses decreased from $10.9 million in 2023 to $6.2 million in 2024, indicating potential budget constraints. General and administrative expenses also decreased from $21.1 million in 2023 to $13.7 million in 2024, which may reflect cost-cutting measures. The company is facing challenges in maintaining its listing on the New York Stock Exchange American and is considering a reverse stock split to avoid delisting. Future clinical trials will require additional manufacturing of Ampligen, which necessitates capital investment and could pose a financial challenge. Q: Do you have adequate supply of Ampligen for all your clinical trials this year, and how easy would it be to get new supply? A: Thomas Equels, President, CEO, and Executive Vice Chairman, responded that they have a budget for Ampligen tied to ongoing clinical activities, ensuring sufficient supply for current trials. For future trials, manufacturing more Ampligen will require capital, but they are actively working with polymer manufacturers and other vendors to ensure a steady supply. They do not anticipate any supply issues unless unforeseen circumstances arise. Q: What are the financial highlights for AIM ImmunoTech for the year ended December 31, 2024? A: Thomas Equels noted that AIM ImmunoTech had approximately $4 million in cash, cash equivalents, and marketable securities as of December 31, 2024. Research and development expenses were $6.2 million, down from $10.9 million in 2023. General and administrative expenses were $13.7 million, compared to $21.1 million in 2023. Q: What steps are being taken to maintain AIM ImmunoTech's listing on the New York Stock Exchange American? A: Thomas Equels emphasized that maintaining the listing is a major priority. They are evaluating all available options to maintain compliance, including a potential reverse stock split. A special meeting of stockholders will be held to authorize the Board to effect the reverse stock split to avoid delisting. Q: Can you provide an update on the DURIPANC pancreatic cancer trial? A: Thomas Equels stated that the Erasmus Medical Center Safety Committee has approved the continuation into the Phase 2 portion of the DURIPANC trial, which evaluates Ampligen in combination with AstraZeneca's Imfinzi. Dosing for Phase 2 has commenced, and they anticipate enrolling the final patient by the second or third quarter of 2026. Q: What are the upcoming milestones for AIM ImmunoTech's clinical programs? A: Thomas Equels highlighted several milestones, including the completion of a Phase 2 study in advanced ovarian cancer in the first half of 2025, the dosing of the first patient in a refractory melanoma study in the first half of 2025, and the completion of enrollment for a Stage 4 triple negative breast cancer trial by the second quarter of 2026. They are also planning a follow-up study for long COVID and a new clinical study evaluating Ampligen with FluMist for influenza. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Associated Press
28-02-2025
- Health
- Associated Press
AIM announces Paul Goepfert, MD, as the principal investigator for the planned clinical study of Ampligen and FluMist as a vaccine for avian influenza
OCALA, Fla., Feb. 28, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ('AIM' or the 'Company') today announced that Paul Goepfert, MD, of the University of Alabama-Birmingham ('UAB'), has agreed to act as the Principal Investigator for the company's planned clinical study in the combination of Ampligen and AstraZeneca's FluMist as an intranasal vaccine for influenza, including avian influenza. Ampligen would serve as a vaccine adjuvant. This will be a follow-up study to a previous clinical trial at UAB, which indicated that intranasal delivery of Ampligen after the intranasal delivery of the FluMist seasonal influenza vaccine not only increased the immune response to seasonal variants in the vaccine by greater than four-fold, but most importantly induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3. Paul Goepfert, MD, Director for the Alabama Vaccine Research Clinic, stated: 'I'm excited for the opportunity to follow-up on my previous work regarding the combination of Ampligen and FluMist, especially with the rising threat of avian influenza.' AIM has engaged Amarex Clinical Research, its Clinical Research Organization, with the preparation of an Investigational New Drug application and the eventual management of the planned clinical study. A key next step will be to identify study funding through industry or governmental grants. AIM CEO Thomas K. Equels states: 'Our strong belief in the potential of a second Ampligen and FluMist study in humans stems directly from the pre-clinical and clinical work performed with Ampligen and multiple influenza variants, including in the original UAB study. We believe that the U.S. government — which has made the growing threat of avian influenza a top priority — should take a long and close look at this data when deciding how best to prepare for a potential epidemic. Rather than spend perhaps billions of dollars on the lengthy development of a new mRNA vaccine, the government should instead consider the combination of Ampligen and FluMist, which would be no more than $10 million in development costs and far quicker to develop, since it already has strong human and non-human primate data suggesting its potential preventive efficacy against avian influenza. AIM believes that the potential for a rapidly deployable vaccine that includes Ampligen is clear.' Read more about the Ampligen-involved avian influenza pre-clinical and clinical work here. About AIM ImmunoTech Inc. AIM ImmunoTech Inc., an Ocala, Florida-based company, is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company's lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit and connect with the Company on X, LinkedIn, and Facebook. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the 'PSLRA'). Words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'continue,' 'believe,' 'potential,' 'upcoming' and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy or vaccine adjuvant for any variant of influenza. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Yahoo
20-02-2025
- Health
- Yahoo
Global Influenza Vaccine Market is Projected to Cross USD 14 Billion Mark by 2032
The growing global prevalence of influenza, mainly due to the transmission of the virus through droplets from coughing and sneezing, is the primary driver for the need for influenza vaccination. The market growth is largely fueled by the increasing uptake of the influenza vaccine and government efforts to raise awareness and encourage vaccination. LAS VEGAS, Feb. 20, 2025 /PRNewswire/ -- DelveInsight's Influenza Vaccine Market Insights report provides the current and forecast market analysis, individual leading influenza vaccine companies' market shares, challenges, influenza vaccine market drivers, barriers, trends, and key market influenza vaccine companies in the market. Key Takeaways from the Influenza Vaccine Market Report As per DelveInsight estimates, North America is anticipated to dominate the global influenza vaccine market during the forecast period. In the type segment of the influenza vaccine market, the inactivated influenza vaccine category generated a significant revenue share in the influenza vaccine market in 2024. Notable influenza vaccine companies such as GSK plc, Pfizer Inc., BioNTech, SINOVAC, Moderna, Inc., Merck & Co., Inc., Sanofi, AstraZeneca, CSL, Abbott, Novavax, Gilead Sciences, Inc., Serum Institute Of India Pvt. Ltd., DAIICHI SANKYO COMPANY, LIMITED, Novartis AG, Cadila Pharmaceuticals, Boehringer Ingelheim International GmbH, Zydus Pharmaceuticals, Inc., Panacea Biotec, Bharat Biotech, and several others, are currently operating in the influenza vaccine market. In December 2024, Sanofi revealed that its two combination vaccine candidates, aimed at preventing both influenza and COVID-19 in individuals aged 50 and older, have been granted fast-track designation by the FDA. In September 2024, FluMist was approved in the US as the only self-administered influenza vaccine. This needle-free nasal spray can be used by adults up to 49 years old or administered by a parent or caregiver to children aged 2-17. In April 2024, CureVac SE announced the commencement of Phase 1 for a collaborative venture with GSK marking the initiation of a combined Phase 1/2 investigation into an experimental pre-pandemic vaccine targeting influenza A (H5N1). This is a monovalent vaccine candidate based on mRNA technology and encodes an influenza A H5-antigen. In October 2023, Moderna, Inc. announced the interim findings from the Phase 1/2 trial of mRNA-1083, a potential combination vaccine addressing both influenza and COVID-19, have been reported as favorable. mRNA-1083 showed a strong immunogenicity and safety profile against influenza. To read more about the latest highlights related to the influenza vaccine market, get a snapshot of the key highlights entailed in the Global Influenza Vaccine Market Report Influenza Vaccine Overview The influenza vaccine is a crucial preventive measure against the seasonal flu, which is caused by influenza viruses that mutate frequently. The vaccine is updated annually to protect against the most prevalent strains, typically including both influenza A and B viruses. It works by stimulating the immune system to produce antibodies that recognize and combat the virus, reducing the severity of illness and preventing complications such as pneumonia, hospitalization, and death. Influenza vaccines are available in different formulations, including inactivated (flu shots) and live attenuated (nasal spray) versions, catering to different age groups and medical conditions. Widespread vaccination is essential for public health, especially for high-risk groups such as young children, elderly individuals, pregnant women, and those with chronic conditions like asthma or heart disease. The flu vaccine also helps reduce the burden on healthcare systems by lowering the number of flu-related hospitalizations and medical visits. While the vaccine's effectiveness varies from year to year, studies consistently show that it significantly reduces the risk of severe illness. Public health organizations, such as the WHO and CDC, recommend annual flu vaccination as the best strategy for preventing influenza outbreaks and maintaining community immunity. Influenza Vaccine Market Insights North America held the largest share of the influenza vaccine market in 2024, driven by an increase in influenza cases across the region. In the assessment done by DelveInsight, the estimated total number of medical visits related to seasonal influenza in the US were 16 million in 2023. Type-specific cases of seasonal influenza were categorized into two types, Type A and Type B. The United States showed the highest cases of Type A compared to other 7MM countries. In 2023, the US, alone accounted for approximately 55% of total cases of Type A influenza. In 2023, the total vaccinated population was estimated to be 383 million in the 7MM. The highest vaccinated population was seen in the US. Furthermore, regional government efforts to prevent and treat the flu are playing a key role. For instance, in July 2022, GSK plc entered into a partnership with the Government of Canada to provide both pandemic and seasonal influenza vaccines for the protection of Canadian adults and children. As part of this agreement, GSK committed to supplying up to 80 million doses of pandemic influenza vaccine in the event of a pandemic, along with 16 million doses of seasonal influenza vaccine throughout the contract period. These are some of the factors contributing to the growth of the influenza vaccine market in the region. To know more about why North America is leading the market growth in the influenza vaccine market, get a snapshot of the Influenza Vaccine Market Outlook Influenza Vaccine Market Dynamics The influenza vaccine market is influenced by several dynamics, primarily driven by public health needs, vaccine efficacy, and technological advancements in vaccine development. Annual flu seasons create a constant demand for vaccines, as different strains of the virus circulate each year. This necessitates the formulation of updated vaccines, which boosts the demand for production. Leading vaccine manufacturers, such as Sanofi, GlaxoSmithKline, and Seqirus, dominate the market, but competition is emerging from smaller biotech firms focusing on novel vaccine platforms, such as mRNA technology. The market is also impacted by government procurement programs, especially during pandemic outbreaks or seasonal flu spikes. Countries around the world, particularly in regions with a higher prevalence of flu-related hospitalizations and deaths, invest heavily in vaccination programs. The rise in vaccination awareness, bolstered by media campaigns and educational efforts, has further stimulated vaccine uptake. Additionally, global initiatives, such as GAVI and the World Health Organization's support for immunization in low-income countries, are increasing access to vaccines and expanding market reach. Vaccine technology plays a critical role in market dynamics. Traditional egg-based vaccine production is being replaced by cell-based and recombinant DNA technologies, which are faster and more scalable. The emergence of mRNA vaccines, as seen in the COVID-19 pandemic, has introduced a new era of possibilities for influenza vaccines, promising better efficacy and faster production timelines. However, challenges remain, including the high cost of development and production, especially for mRNA vaccines, which may limit their accessibility in certain markets. Finally, consumer behavior and demographic trends are shaping the market. In developed countries, the elderly and those with chronic conditions are the primary recipients of the flu vaccine, driving demand. Meanwhile, the increasing acceptance of flu vaccinations among healthy adults and children is expanding the market base. At the same time, factors like vaccine hesitancy, misinformation, and accessibility issues in rural or underdeveloped regions present ongoing challenges. Nevertheless, continued advancements in vaccine research and public health policy are expected to drive growth in the global influenza vaccine market. Get a sneak peek at the influenza vaccine market dynamics @ Influenza Vaccine Market Dynamics Analysis Report Metrics Details Coverage Global Study Period 2022–2032 Influenza Vaccine Market CAGR ~7% Influenza Vaccine Market Size by 2032 USD 14 Billion Key Influenza Vaccine Companies GSK plc, Pfizer Inc., BioNTech, SINOVAC, Moderna, Inc., Merck & Co., Inc., Sanofi, AstraZeneca, CSL, Abbott, Novavax, Gilead Sciences, Inc., Serum Institute Of India Pvt. Ltd., DAIICHI SANKYO COMPANY, LIMITED, Novartis AG, Cadila Pharmaceuticals, Boehringer Ingelheim International GmbH, Zydus Pharmaceuticals, Inc., Panacea Biotec, Bharat Biotech, among others Influenza Vaccine Market Assessment Influenza Vaccine Market Segmentation Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the influenza vaccine market are set to emerge as the trendsetter explore @ Influenza Vaccine Companies Table of Contents 1 Influenza Vaccine Market Report Introduction 2 Influenza Vaccine Market Executive Summary 3 Competitive Landscape 4 Regulatory Analysis 5 Influenza Vaccine Market Key Factors Analysis 6 Influenza Vaccine Market Porter's Five Forces Analysis 7 Influenza Vaccine Market Layout 8 Influenza Vaccine Market Company and Product Profiles 9 KOL Views 10 Project Approach 11 About DelveInsight 12 Disclaimer & Contact Us Interested in knowing the influenza vaccine market by 2032? Click to get a snapshot of the Influenza Vaccine Market Trends Related Reports Vaccine Adjuvants Market Vaccine Adjuvants Market Insight, Competitive Landscape, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key vaccine adjuvants companies, including Dynavax Technologies, GSK plc, Croda International plc, SEPPIC, Novavax, SPI Pharma, Agenus Inc., Aurorium, Merck KGaA, Vaxine Pty Ltd., Hawaii Biotech Inc., CSL, OZ Biosciences, InvivoGen, Allergy Therapeutics, EUBIOLOGICS CO., LTD., Pacific GeneTech Limited, Riboxx GmbH, CaPtivate Pharmaceuticals LLC, Mukta Industries, among others. Vaccines Market Vaccines Market Insight, Competitive Landscape, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key vaccines companies, including GlaxoSmithKline, Bharat Biotech, AstraZeneca, Bavarian Nordic A/S, BioNTech, Sanofi, Merck & Co., Inc, Pfizer Inc, Moderna, Meiji Holdings Co., Ltd., EMERGENT, CSL Limited, Johnson & Johnson, VBI Vaccines Inc., Valneva SE., Novavax, CanSinoBIO, Biokangtai, Dynavax Technologies, Zhi Fei Biological, among others. Seasonal Influenza Market Seasonal Influenza Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key seasonal influenza companies, including SAb Biotherapeutics, Inc., Emergo Therapeutics, Inc., AlloVir, Cocrystal Pharma, Poolbeg Pharma, Ridgeback Biotherapeutics, Viriom, Inc., NanoViricides, Evrys Bio, ETHRIS, Kino Pharma, among others. Influenza Pipeline Influenza Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key influenza companies, including Moderna, SAB Biotherapeutics, ENA Respiratory Pty Ltd, Codagenix, AlloVir, Osivax, CureVac AG, GlaxoSmithKline, Cocrystal Pharma Inc, Viriom, Emergent BioSolutions, Pfizer, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Guangdong Raynovent Biotech Co., Ltd, FluGen Inc, BlueWillow Biologics, AVM Biotechnology LLC, Ansun Biopharma, Inc., Guangzhou Henovcom Bioscience, Sunshine Lake Pharma Co., Ltd., Emergex Vaccines, Vir Biotechnology, CSL Limited, Novavax, EMERGENT, Mitsubishi Chemical Group Corporation, Poolbeg Pharma, MYMETICS, CELLTRION INC., Avalia Immunotherapies, Meiji Holdings Co., Ltd., Clover Biopharmaceuticals, Airway Therapeutics, Inc., PrEP Biopharm, Ansun Biopharma, Cidara Therapeutics, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur info@ +14699457679https:// Logo: View original content: SOURCE DelveInsight Business Research, LLP Sign in to access your portfolio
