Nivolumab

VIENNA, Va.--( BUSINESS WIRE )--CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2024, as well as key clinical and corporate developments. “We are very optimistic about the prospects of our investigational drug Multikine in 2025 and 2026. We look ahead to Multikine being able to deliver much needed relief to a patient population with a severe unmet medical need. We see several very important milestones and value drivers upcoming. Positive data on presurgical response rates, previously shown to be indicative of overall survival, could enable us to apply for early approval,” stated CEL-SCI CEO, Geert Kersten. “This confirmatory Registration Study is designed to do two things: create a new standard of care for newly diagnosed treatment naïve locally advanced head and neck cancer patients; and provide survival benefit for the population of patients with low/negative tumor expression of PD-L1, those patients who have historically not responded well to widely used checkpoint inhibitors such as Keytruda and Opdivo.” Clinical and Corporate Developments: The U.S. Food and Drug Administration (FDA) gave CEL-SCI the ‘go-ahead’ to conduct a confirmatory 212-patient Registration Study of Multikine in the treatment of locally advanced head and neck cancer based on strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The FDA agreed with the pre-surgical selection of patients most likely to benefit from Multikine—those with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). In this target population in the completed Phase 3 study, Multikine demonstrated a 5-year survival of 73% vs a 45% survival in the control patients and a hazard ratio of 0.35. A report on the FDA’s agreement and Multikine’s path forward is available on CEL-SCI’s website and at the following LINK . CEL-SCI selected Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, as the CRO for its relatively small registration study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study. Data from an analysis of CEL-SCI’s Phase 3 study were shared at the International Drug Discovery Science & Technology (IDDST) 20th Annual Congress in a presentation titled “Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT”. Highlights of the presentation include: Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression, a population in which approved checkpoint inhibitors, which inhibit PD-L1, are generally not successful 73% survival for Multikine vs 45% in the control arm at 5 years Statistically significant log rank p = 0.0015 5-year risk of death reduced in half from 55% to 27% Hazard ratio = 0.35 (95% CIs [0.19, 0.66], Wald p=0.0015) The presentation may be accessed on CEL-SCI’s website at the following LINK New data from the Phase 3 study were also presented at the European Society for Medical Oncology (ESMO) 2024 Congress in a poster titled “Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy”. Positive regulatory decision letters were received from the European Medicines Agency (EMA) Paediatric Committee and the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine a product-specific waiver for the treatment of head and neck cancer in a pediatric population up to 18 years of age. As a result, CEL-SCI is not required to evaluate Multikine in a pediatric population as part of its license and marketing clearance review in the UK and in the European Union (EU). A patient population analysis of CEL-SCI’s Phase 3 study demonstrated well-balanced populations for both overall population and the selected population for the upcoming Registration Study (N0, PD-L1 low) , providing greater confidence in the clinical results of the confirmatory Registration Study. This bias analysis, a standard process to ensure a trial’s findings are reliable, analyzed detailed data on parameters including patient age, sex, race, tumor locations, and staging, demonstrating a balance between the treatment and control arms. No bias favoring Multikine treated patients was found, lending confidence that Multikine is the reason for the large increase in patient survival. CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed , a significant milestone toward regulatory approval of Multikine. Financial Results During the fiscal year ended September 30, 2024, research and development expenses were $18.2 million, which decreased by approximately $4.3 million, or 19%, compared to the year ended September 30, 2023. General and administrative expenses in fiscal 2024 were $8.2 million, which decreased by approximately $0.8 million, or 9%, compared to the year ended September 30, 2023. Net loss decreased by $4.6 million to approximately $26.9 million for the twelve months ended September 30, 2024 from $32.2 million in fiscal 2023. The operating cash expenditures for the year were approximately $18.8 million. CEL-SCI’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to CEL-SCI’s ability to continue as a going concern. About CEL-SCI Corporation CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

MEDIA RELEASE Strong first year as standalone company; global leader Sandoz uniquely positioned in attractive and growing USD 200 billion market for generics and biosimilarsLeading in home market Europe, which represents half of total sales; strategically positioning company to become #1 in biosimilars in US, with three US launches expected in 2025Ambitious GLP-1 strategy in place, addressing each opportunity with mix of internal capabilities and external partnershipsIndustry-leading pipeline for rapidly-growing biosimilar segment now comprises 28 moleculesStrongly positioned to capitalize on unprecedented global market opportunity, with reference medicines worth more than USD 400 billion in sales due to lose exclusivity from 2029 onwards Basel, January 14, 2025 – Sandoz, the global leader in generic and biosimilar medicines, will confirm its strategic roadmap and highlight pipeline catalysts in a presentation today at the 43rd Annual J.P. Morgan Healthcare Conference, taking place from January 13 to 16 in San Francisco. CEO Richard Saynor will highlight several recent additions to the global biosimilar pipeline, which now comprises 28 molecules. He will also reiterate the company’s ambition to become the leader in US biosimilars, with three US launches expected in 2025. Richard will say: “We are proud of the progress we have made on our spin-off commitments since October 2023. Generics and biosimilars represent 80% of medicines used by patients worldwide, at 30% of the total cost. That means that, when we deliver on our promises, we create value for all. As we enter our second full year as a standalone company, we will continue to execute our purpose-driven strategy.” Sandoz uniquely positioned to benefit from market fundamentals, aims to lead in US biosimilarsThe global generics and biosimilars market is worth more than USD 200 billion in gross sales and expected to grow at an annual compound rate of 7% for the next 10 years. Growth will be driven by aging populations, higher rates of chronic disease, increasing market adoption as healthcare systems and payors seek to reduce the cost of medicines, and a consistent supply of upcoming losses of exclusivity (LoEs) as patents for reference medicines expire. From 2029 through 2034, reference medicines worth more than USD 400 billion in sales are due to lose exclusivity, significantly more than during any comparable timeframe previously. Nearly half of this opportunity is in the biosimilar segment, while GLP-1 medicines represent by far the single largest opportunity in the generic space. As the global leader, Sandoz is uniquely positioned to benefit from these attractive market fundamentals, in terms of both geographic and portfolio balance. Europe represents half of its total sales, with half of the remainder coming from North America. The portfolio combines a strong focus on the rapidly-growing biosimilar segment with a leading position in its core generics business. Sandoz also aspires to achieve sustainable leadership in the US biosimilar segment. As Richard will say: “We have become the #1 biosimilars provider on a worldwide basis and now have an industry-leading biosimilars pipeline of 28 molecules. We are leading in Europe. In the US, we rank #4 in biosimilars today and have the ambition to become #1.” Sandoz plans five biosimilar launches in the mid-term, including three this year in the US. Pipeline progress and new value drivers fueling future growth Sandoz has made significant progress since spin-off, including successful launches of biosimilar Hyrimoz® (adalimumab) in the US and Tyruko® (natalizumab) in Europe, as well as stabilization of the North American business ahead of key launches. It has also steadily expanded its strong and diverse pipeline, with over 450 generic pipeline products to complement the 28 biosimilars. This progress is underpinned by a strong balance sheet, which offers investment flexibility. Sandoz has also added multiple new value drivers since its initial Capital Markets Day. These include the launch of biosimilar Pyzchiva® (ustekinumab) in Europe, a private-label agreement to boost uptake of Hyrimoz® in the US, the addition of five new biosimilars to the pipeline, a clear strategy to address the emerging GLP-1 opportunity, and potential additional organic investments to support long-term growth. In 2024, pembrolizumab and nivolumab, two large oncology assets addressing more than USD 40 billion of LoE value, entered late-stage clinical trials. Biosimilars as single-biggest growth driverSandoz sales were up over 30% in the first nine months of 2024 and Saynor will say that biosimilars are now the company’s single-biggest growth driver. Its pipeline of 28 biosimilars is industry-leading in terms of both number of assets and coverage of addressable market value. Sandoz is on track with its plans for further biosimilar launches, including four in 2025: Pyzchiva® and Tyruko® (natalizumab) in the US, Wyost®/Jubbonti® (denosumab) in the US and Europe, and Afqlir® (aflibercept) in Europe. These medicines cover the therapy areas of chronic inflammatory diseases (ustekinumab), multiple sclerosis (natalizumab), osteoporosis (denosumab) and various retinal diseases (aflibercept) respectively. By providing these biosimilar alternatives, Sandoz is delivering on its Purpose of pioneering access for patients. GLP-1s as key LoE growth driver in generics spaceSaynor will add: “Since the initial Sandoz Capital Markets Day just 18 months ago, GLP-1s have become the largest LoE opportunity in the industry and the key LoE growth driver in the generics space. Sandoz has a clear and ambitious strategy in place and will address each opportunity with a mix of internal capabilities and external partnerships across development and manufacturing. “Last year, we mentioned our partnership agreement with Pharmathen focused on diabetes indications. We are currently exploring further partnerships to commercialize future GLP-1 medicines in the US, Europe and other markets for weight-loss indications.” Committed to delivering superior value for our shareholders and for society in long termSaynor will conclude: “We are the world leader in a growing market. Our home base is Europe, but we are well positioned in the US and other regions. We have a plan to deliver on our mid-term outlook, in terms of both portfolio and pipeline, bolstered by opportunities to simplify our business. “We have the internal resources to execute on our pipeline and the scale to develop and attract strong partners to capture high-value, long-term opportunities. Our strong balance sheet gives us optionality for future technologies. And all of this is underpinned by our objective of delivering superior value for our shareholders and for society, by consistently delivering on our Purpose.” KEY LINKSWebcast – Live at 09:45 Pacific Time / 18:45 CET Presentation DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. ABOUT SANDOZSandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contactsInvestor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comJoerg E. AllgaeuerLaurent de Weck+49 171 838 4838+41 79 795 7364 Chris LewisTamara Hackl+49 174 244 9501+41 79 790 5217 Gregor Rodehueser +49 170 574 3200 Attachment Media release_JPM Healthcare Conference.pdf