Institut National de la Santé et de la Recherche Médicale

Preliminary analysis shows the study did not reach statistical significance on its primary endpoint of tecovirimat being superior to placebo in lesion resolution for all patientsResults suggest tecovirimat provides clinical benefit vs. placebo in two important patient populations: those treated early and those with severe diseaseResults affirm tecovirimat’s strong safety profileMultiple additional clinical trials evaluating tecovirimat for mpox continue NEW YORK, Aug. 15, 2024 (GLOBE NEWSWIRE) -- The National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) today announced topline results from a preliminary analysis of the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial (NCT05559099). NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo (DRC) with monkeypox (mpox), who were administered SIGA’s tecovirimat, a highly targeted antiviral treatment, versus placebo. All patients in this study were hospitalized for the entire duration of treatment. This study was not a registration study conducted under an U.S. FDA Investigational New Drug Application. A meaningful improvement was observed in patients receiving tecovirimat whose symptoms began seven days or fewer before randomization and in those with severe or greater disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions. While more analysis is required, the Company believes these data support further trials to assess the potential benefit of tecovirimat in those who present to medical care soon after symptoms and in those with severe disease. “These data showing maximum benefit in patients treated early and with severe disease are entirely consistent with the mechanism of action of tecovirimat and with the studies in animals that led to U.S. FDA approval of this medicine for smallpox, a virus closely related to monkeypox virus, but which produces much more severe illness. We believe these data warrant further investigation and support our view that post exposure prophylaxis will be vital for treatment of severe cases of mpox and all cases of smallpox,” stated Dennis Hruby, Chief Scientific Officer. Additionally, in this study, tecovirimat exhibited a safety profile comparable to placebo. These results are consistent with several prior studies in healthy volunteers and further support the strong safety profile that has been observed with tecovirimat over the past 15 years. “We are highly encouraged by the PALM 007 study results which showed that tecovirimat is safe and offers potential benefit to important groups of patients with mpox disease, particularly those with severe disease and those who sought treatment early. As with other acute viral infections, patients benefit the most when antiviral treatment is administered as soon as possible after infection. Missing the primary endpoint is not entirely unexpected given that the study population was hospitalized during the duration of treatment receiving a high level of supportive care, and since many presented for treatment more than a week after their illness started,” stated Diem Nguyen, Chief Executive Officer. “SIGA and the National Institute of Allergy and Infectious Diseases (NIAID), the trial sponsor, are in the process of thoroughly analyzing the data to gain a comprehensive understanding of the results and potential implications. We look forward to future research on the impact of early treatment on improving outcomes in mpox patients in real world settings. Our team is committed to leveraging these findings to investigate effective treatment regimens for mpox and other infectious diseases.” As background, the PALM 007 study was part of a globally coordinated initiative to address the 2022 mpox outbreak occurring in the DRC and around the world. It was, therefore, designed with important humanitarian considerations, such as allowing patients at varying stages of disease, age, health, among other factors, to participate in the trial. To ensure study data could be collected accurately and that patients had access to food, all patients in the study were hospitalized for the duration of treatment, and therefore received a level of care unavailable to most mpox patients in real world situations. In PALM 007, patients in the placebo arm had much more favorable outcomes than those in the observational studies from the DRC that were used to plan this trial, which could have reduced the measured benefit of tecovirimat compared to placebo. The exact impact of this controlled environment on the trial results is not yet known. Additional studies are being conducted by trial sponsors around the world and are expected to help the Company gain a deeper understanding of the potential for tecovirimat to benefit patients with mpox. Four randomized clinical trials are currently enrolling patients, including STOMP (U.S. and other countries), UNITY (Switzerland, Brazil, Argentina), Platinum-CAN (Canada), and EPOXI (EU). Because the PALM 007 study differs in significant respects from these other studies, data from these studies will help SIGA to understand whether the PALM 007 results were influenced by factors such as trial design, patient population, medical protocols, disease clade, or other variables. For example, compared to PALM 007, the STOMP, UNITY, Platinum-CAN, and EPOXI trials to date have enrolled no children and a much higher percentage of immunocompromised patients, such as those living with HIV. Dr. Nguyen continued, “We thank all our partners, the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and Institut National de la Recherche Biomédicale (INRB), for their unwavering support. We are also grateful to all the patients who participated in this trial and the investigators who supported this trial in the DRC. Their dedication and commitment to public health have been critical in gaining a greater understanding of tecovirimat.” About the PALM 007 Clinical Trial in MpoxThe PALM 007 study is a randomized, placebo-controlled, double-blind trial to evaluate the safety and efficacy of oral tecovirimat to treat mpox virus disease in combination with standard of care (SOC). Participating patients were diagnosed with laboratory-confirmed mpox as determined by a PCR test within 48 hours of screening in the DRC. There were no age restrictions, but patients were required to weigh more than three kilograms (approximately 6.6 pounds). Patients were randomly (1:1) assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days. The number of capsules and frequency of dosage were based on patient weight. Patients receiving tecovirimat remained hospitalized for at least two weeks and were followed for 28 days with an optional visit at Day 59 for long-term assessment. The primary measure of efficacy was the number of days to the first day on which all lesions on the total body were scabbed or desquamated or a new layer of epidermis had formed up to 28 days. About SIGA SIGA Technologies (SIGA) (NASDAQ: SIGA) is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit www.siga.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the potential benefit of tecovirimat in certain mpox patients or for use of tecovirimat as a post-exposure prophylaxis. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “will”, “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 75A50118C00019 BARDA Contract (the “BARDA Contract”), not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market TPOXX for smallpox or additional uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xii) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiv) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, and (xvii) risks associated with responding to an mpox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. Contacts:Suzanne Harnettsharnett@siga.com and InvestorsJennifer Drew-Bear, Edison GroupJdrew-bear@edisongroup.com MediaJenna Urban, Berry & Companyjurban@berrypr.com

Partnership will expand Evotec's molecular patient database in the area of metabolic diseases and in particular obesity Evotec will leverage its leading PanOmics technologies for the generation of large omics data sets including transcriptomics, proteomics and metabolomics Lille University Hospital will provide human biological samples and associated clinical data from its ABOS Biobank and will collect specific human biosamples for the collaboration All parties will jointly identify and validate novel key mechanisms of obesity & other metabolic diseases based on human data sets HAMBURG, GERMANY / ACCESSWIRE / May 30, 2024 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced that the Company entered a partnership with Inserm, the French National Institute of Health and Medical Research, Lille University Hospital and Inserm Transfert (the private subsidiary of Inserm) to identify novel therapeutic targets and diagnostic and prognostic markers in obesity and metabolic diseases. Lille University Hospital is the sponsor of the clinical study entitled ABOS / DIABOMICS (Biological Atlas of Severe Obesity). In the framework of this study, started in 2012, Lille University Hospital develops and maintains the ABOS Biobank composed of a biobank and different associated databases dedicated to the study of obesity and its comorbidities. Obesity, a medical condition characterised by an excess accumulation of fat cells and uncontrolled ectopic fat deposition in the body, is currently recognised as one of the most important public health problems. It is estimated that over one billion adults globally will be affected by 2030. The strategic partnership between Evotec, Inserm, Lille University Hospital and Inserm Transfert aims at identifying novel multi-modality therapeutic targets. Evotec will gain access to a large patient cohort with severe obesity for the longitudinal assessment of metabolic outcomes after bariatric surgery-induced weight loss. The cohort consists of more than 8,000 human samples. Evotec will support the recruitment of 200 additional subjects within the next two years. Under the agreement, Lille University Hospital will provide human biological samples and associated clinical data from its ABOS biobank and will collect specific human biological samples for the collaboration. Evotec will perform various omics studies on cohort samples to generate large omics data sets including transcriptomics, proteomics, and metabolomics data to better understand the etiology of metabolic diseases like metabolic dysfunction-associated steatohepatitis ("MASH"), obesity, diabetes, and cardiovascular disease. These PanOmics data will feed into Evotec's proprietary translational molecular patient data platform E.MPD, which serves as the central data repository for molecular patient data. The data will be analysed by all parties to identify and validate key mechanisms of obesity and other metabolic diseases. Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are excited to enter this partnership with Inserm and Lille University Hospital accessing a cohort of obese patients that is extremely well characterised. Currently over 40% of the US population suffers from obesity. The condition is a major health threat as it is connected to a plethora of other medical conditions such as type 2 diabetes, hypertension, cardiovascular disease, congestive heart failure, kidney disease and non-alcoholic fatty liver disease. This collaboration will help to understand obesity as a disease, something not achieved despite recent breakthroughs. Expanding our understanding of the key molecular mechanisms driving disease progression will allow us to identify and develop more effective but also safer treatment options than currently available." Prof. Francois Pattou, Translational Research Laboratory for Diabetes, Inserm UMR 1190 (under the joint supervision of Inserm, University of Lille and Lille University Hospital), PhD at Lille University Hospital, and Chairman of the Scientific Committee of Lille University Hospital ABOS Biobank, added: "Collaborating on cutting-edge science with a human data-centric approach gives us a unique opportunity to discover novel treatments for the benefit of patients living with obesity and metabolic diseases. The strong know-how and capabilities from Evotec will enable us to further strengthen and advance our research efforts within obesity and metabolic diseases based on human-relevant biology, to contribute to our overall mission of improving human health for all." Prof. Bart Staels, Nuclear receptors, cardiovascular diseases and diabetes Laboratory, Inserm UMR 1011 (under the joint supervision of Inserm, Lille University Hospital, University of Lille and Institut Pasteur of Lille), said: "We are very excited about the collaboration and are confident that the combination of Evotec's excellent expertise and our commitment to therapeutic innovation, translational research, and multidisciplinary approaches, will open up new possibilities in discovery and development of novel drugs targeting obesity and metabolic diseases, with the potential to make a difference for patients living with these conditions." Noémie Pellegrin, Director of Industry Partnerships and Entrepreneurship of Inserm Transfert, adds: We are delighted with this research partnership, which capitalises on the wealth of know-how within the Inserm laboratories, the quality data from Lille University Hospital and the cutting-edge molecular translational technologies developed by Evotec. This collaboration will advance our understanding of obesity and associated metabolic diseases through the identification of key molecular mechanisms and new therapeutic targets. About Obesity Obesity is defined as abnormal or excessive fat accumulation that presents a risk to health. A body mass index ("BMI") over 30 is obese. However, BMI categories for defining obesity vary by age and gender in infants, children, and adolescents. The issue has grown to epidemic proportions and obesity constitutes a major public health challenge that undermines social and economic development. The worldwide prevalence of obesity nearly tripled between 1975 and 2016. The World Obesity Federation estimates that by 2020 around 770 million adults globally were affected by obesity, and that figure is anticipated to exceed one billion by 2030. Once associated with high-income countries, obesity is now also prevalent in low-and middle-income countries, including among lower socio-economic groups. Overweight and obesity are caused by many factors including behaviours like eating patterns, lack of sleep or physical activity, and some medicines, as well as genetics and family history. Obesity is a chronic health condition that raises the risk for heart disease and is linked to many other health problems, including MASH, type 2 diabetes and cancer. About E.MPD E.MPD, Evotec's translational molecular patient database, is one of the largest and highest quality molecular databases globally. Evotec's integrated technology platforms show that the best way to effectively treat disease is to identify underlying disease mechanisms and find the most suitable therapy on the basis of molecular data guiding all experimental processes towards early disease relevance. Therefore, data aggregation, integration, and the precise analysis of data is the critical path to effective and affordable medicine in the future. E.MPD serves as the backbone for data-driven partnerships that will lead to innovative new medicines, better patient stratification, and potentially pave the way towards a new paradigm of more effective diagnostic and preventative healthcare. Through gathering and analysing patient-derived data in combination with AI/ML tools, Evotec is also able to better predict both safety and efficacy indicators in drug development. About Inserm Founded in 1964, Inserm is a public scientific and technological institute which operates under the joint authority of the French Ministries of Health and Research. The institute is dedicated to biomedical research and human health, and is involved in the entire range of activities from the laboratory to the patient's bedside. It also partners with the most prestigious research institutions in the world that are committed to scientific challenges and progress in these fields. About Lille University Hospital With over 16,000 professionals and 10 hospitals on a single campus, the Centre Hospitalier Universitaire de Lille is one of the four largest university hospital centers in France, and one of the largest in Northern Europe. As a regional referral centre as well as teaching, innovation and research hospital, it serves the 6 million inhabitants of the Hauts-de-France region. Lille University Hospital is strongly committed to the development of therapeutic innovation and clinical research. Its research strategy focuses on the early diagnosis and treatment of multi-factorial diseases, including cancer, neuroscience, cardiovascular, metabolic, inflammatory and infectious pathologies. For further information: , X/Twitter and LinkedIn. About Inserm Transfert Inserm Transfert, the private subsidiary of the French National Institute of Health and Medical Research (Inserm), is responsible for value creation of Inserm and its academic partners' innovations in human health and promotes long-term technology transfers in line with international best practices. Inserm Transfert SA was founded in 2000, and manages, under a Public Service Management Contract (Concession de Service Public) the entire innovation value chain and the transfer of knowledge from Inserm's research laboratories to industry, from invention disclosure to industrial partnerships and startups incorporation. Inserm Transfert also offers services relating to setting up and managing national, European and international projects, as well as supporting the technology transfer of clinical research and health data/databases and cohorts. For more information: About Evotec SE Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company's sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to and follow us on X/Twitter @Evotec and LinkedIn. Forward-looking-statements This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec's securities. Words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "should," "target," "would" and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec's expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Media Gabriele Hansen SVP Head of Global Corporate Communications Gabriele.Hansen@evotec.com Hinnerk Rohwedder Director of Global Corporate Communications Hinnerk.Rohwedder@evotec.com Investor Relations Volker Braun EVP Head of Global Investor Relations & ESG Volker.Braun@evotec.com SOURCE: Evotec SE View the original press release on accesswire.com

One of the molecules responsible for triggering the inflammation that causes allergic respiratory diseases, such as asthma and allergic rhinitis, has just been discovered. This molecule, from the alarmin family, represents a therapeutic target of major interest for the treatment of allergic diseases. One of the molecules responsible for triggering the inflammation that causes allergic respiratory diseases, such as asthma and allergic rhinitis, has just been discovered by scientists from the CNRS, Inserm and the Université Toulouse III -- Paul Sabatier. This molecule, from the alarmin family, represents a therapeutic target of major interest for the treatment of allergic diseases. The study, co-directed by Corinne Cayrol and Jean-Philippe Girard, is published in the Journal of Experimental Medicine on 10 April. The inflammation process plays a crucial role in allergic respiratory diseases, such as asthma and allergic rhinitis. Although the pulmonary epithelium, the carpet of cells that forms the inner surface of the lungs, is recognised as a major player in the respiratory inflammation that causes these diseases, the underlying mechanisms are still poorly understood. A research team has identified one of the molecules responsible for triggering these allergic reactions, in a study co-led by two CNRS and Inserm scientists working at l'Institut de pharmacologie et de biologie structural (CNRS/Université Toulouse III -- Paul Sabatier). This molecule from the alarmin family, named TL1A, is released by lung epithelium cells a few minutes after exposure to a mould-type allergen. It cooperates with another alarmin, interleukin-33, to alert the immune system. This double alarm signal stimulates the activity of immune cells, triggering a cascade of reactions responsible for allergic inflammation. Alarmins, therefore, constitute major therapeutic targets for the treatment of respiratory allergic diseases. In a few years' time, treatments based on antibodies blocking the TL1A alarmin could benefit patients suffering from severe asthma or other allergic diseases. In France, at least 17 million people are affected by allergic diseaseswith the most severe forms of asthma being responsible for several hundred deaths every year.