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Adds further support for its broad-spectrum mechanism of action following other recent TBI, ALS and tropical virus studies VIKEN, Sweden, Sept. 13, 2022 /PRNewswire/ -- TikoMed today announced the inclusion in bioRxiv* of an in vitro study evaluating the ability of the company's lead drug candidate ILB® to: inhibit infection of human cells by the NL63 coronavirus assessed by immunofluorescence of viral particles; and directly block the interaction of the SARS-CoV-2 viral spike protein with the ACE2 receptor; and modulate the downstream consequences of viral infection including the reactive cytokine release from human microglia induced by various SARS-CoV-2 variant spike proteins. The study shows that ILB® blocked ACE2:spike protein interaction and inhibited coronaviral infection. ILB® also attenuated the omicron-induced release of pro-inflammatory cytokines, including TNFa, from human microglia, indicating control of post-viral neuroinflammation. "This work extends our findings of ILB®'s antiviral impact upon flavivirus infections to now include coronavirus. Furthermore, we are excited to have uncovered a potential molecular mechanism for these findings by showing that ILB® inhibited SARS-CoV-2 spike protein interacting with ACE2, the key docking site for SARS-CoV-2 to gain entry to human cells," said Professor Ann Logan PhD (Professor of Regenerative Medicine & CSO, Axolotl Ltd). Professor Nicholas Barnes PhD PBPhS (Professor of Pharmacology & CEO, Celentyx Ltd) also commented: "In pathological post-viral fatigue syndromes such as long COVID, a key brain cell called microglia appear overactive and promote the associated neuroinflammation. This data showed that activated microglia are calmed by ILB® in vitro and suggests ILB® has the potential to inhibit neuroinflammation and hence improve symptoms of patients with conditions such as long COVID." TikoMed recently announced the publication of a peer-reviewed article on the mode of action of ILB®. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases. ILB® both mobilized and modulated naturally occurring tissue repair mechanisms, released heparin-binding growth factors, and restored cellular homeostasis and function, . Additionally, TikoMed has reported that ILB® inhibited infection of human cells by Dengue, Zika and Yellow Fever viruses in vitro, . Media: International: Richard Hayhurst [email protected] or +44 7711 821527 Nordics: Ola Bjorkman [email protected] or +46 70 245 7497 About Corona viruses Coronaviruses are a large family of enveloped, positive-stranded RNA pathogenic viruses that cause infectious disease in animals and humans. For example, the highly transmissible SARS-CoV-2 virus causes coronavirus disease (COVID-19) which causes a mild to moderate respiratory disease in most humans, but susceptible individuals can become dangerously ill, developing severe acute respiratory syndrome (SARS) and acute respiratory distress syndrome (ARDS) that can result in organ damage[1]. The global pandemic of COVID-19 disease that has spread since 2019 has had devastating health, social and economic consequences that remain burdensome[2]. By August 2022 that World Health Organisation report 599,825,400 confirmed cases of COVID19 and 6,469,458 confirmed deaths (), representing just over 1% of those infected. *bioRxiv is a free online archive and distribution service for unpublished preprints in the life sciences. It is operated by Cold Spring Harbor Laboratory, a not-for-profit research and educational institution. By posting preprints on bioRxiv, authors are able to make their findings immediately available to the scientific community and receive feedback on draft manuscripts before they are submitted to journals. For full study details on "A clinical stage LMW-DS drug inhibits cell infection by coronaviruses and modulates reactive cytokine release from microglia," please access the publication: . [1]Mistry P, Barmania F, Mellet J, Peta K, Strydom A, Viljoen IM, James W, Gordon S, Pepper MS. SARS-CoV-2 Variants, Vaccines, and Host Immunity. Front Immunol. 2022 Jan 3;12:809244. doi: 10.3389/fimmu.2021.809244. PMID: 35046961; PMCID: PMC8761766. [2]Koelle K, Martin MA, Antia R, Lopman B, Dean NE. The changing epidemiology of SARS-CoV-2. Science. 2022 Mar 11;375(6585):1116-1121. doi: 10.1126/science.abm4915. Epub 2022 Mar 10. PMID: 35271324; PMCID: PMC9009722 CONTACT: Contact: [email protected] or +46 42 23 84 40 This information was brought to you by Cision SOURCE Tikomed

VIKEN, Sweden, Sept. 7, 2022 /PRNewswire/ -- TikoMed today announced the inclusion in bioRxiv* of an in vitro study examining the ability of the company's lead drug candidate ILB® to inhibit infection of human cells by four serotypes of Dengue virus (DENV1-4), two strains of Zika virus (African and Asian) and Yellow Fever virus (vaccine strain YF17D) assessed by immunofluorescence of viral particles. In the study, ILB® potently inhibited infection by all the strains of Dengue, Zika and Yellow Fever virus in a concentration-dependent manner with IC50 for ILB® ranging from 31 to 343 μg/ml. Professor Nicholas Barnes PhD PBPhS (Professor of Pharmacology & CEO, Celentyx Ltd, and one of the world's most highly cited researchers ) commented: "It is well recognised that infection by flaviviruses like Dengue, Zika and Yellow Fever virus can lead to catastrophic life-threatening conditions. This emphasises the clinical need for safe and effective medicines to treat these infections. What I find particularly exciting about these results is the effects observed at ILB® concentrations that have been achieved in humans following doses that have been well tolerated. These findings offer hope to the millions of patients that continue to be devastated by flavivirus infections." TikoMed recently announced the publication of a peer-reviewed, scientific article on the mode of action of ILB®. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases. ILB® both mobilized and modulated naturally occurring tissue repair mechanisms, released heparin-binding growth factors, and restored cellular homeostasis and function. "These results provide further evidence of the anti-viral potential and unique broad spectrum mechanism of action of TikoMed's ILB® drug platform. We have already initiated clinical development programs for Amyotrophic Lateral Sclerosis (ALS), Traumatic Brain Injury (TBI) and islet cell transplantation and plan to consider additional evaluation in other diseases," said Anders Kristensson, CEO of TikoMed. *bioRxiv is a free online archive and distribution service for unpublished preprints in the life sciences. It is operated by Cold Spring Harbor Laboratory, a not-for-profit research and educational institution. By posting preprints on bioRxiv, authors are able to make their findings immediately available to the scientific community and receive feedback on draft manuscripts before they are submitted to journals. For full study details on "A clinical stage LMW-DS drug inhibits infection of human cells by Dengue, Zika and Yellow Fever viruses", please access the publication: . About flaviviruses Flaviviruses are responsible for the most abundant arboviral diseases of humans in terms of geographical distribution, morbidity and mortality; at least 2.5 billion people are at risk with, for example, an estimated 100-400 million Dengue infections a year. However, for infections by Dengue, Zika or Yellow Fever virus there are no effective anti-infective drug treatments nor for Dengue or Zika virus a safe effective vaccine and prevention at present focusses on vector (mosquito) control. Whilst symptoms from Dengue, Zika and Yellow Fever virus infection may be mild for some, they are very serious and life threatening for others. For instance, severe Dengue is a leading cause of hospitalisation and death among children and adults in Asian and Latin American countries. Likewise, Zika infection can have catastrophic consequences for pregnant women following the passing of the virus to their foetus with arising miscarriage or birth defects including microcephaly that can be fatal. CONTACT: Contact: [email protected] or +46 42 23 84 40 Media: International: Richard Hayhurst [email protected] or +44 7711 821527 Nordics: Ola Bjorkman [email protected] or +46 70 245 7497 This information was brought to you by Cision SOURCE Tikomed

Clover Biopharmaceutical made progress with a booster against Omicron BA.5, the European Commission authorized a biosimilar for wet age-related macular degeneration and TikoMed's platform demonstrated potential in Amyotrophic lateral sclerosis (ALS). For that and more global news, see below. Clover posted positive Phase II/III data for its lead COVID-19 vaccine candidate, SCB-2019. The China-based company announced that SCB-2019 prompted a robust immune response to Omicron BA.5 sub-variant, the dominant strain of COVID-19 circulating the globe. Clover reported that the data from the Phase II/III study adds to the growing evidence supporting the potential use of SCB-2019 as a universal COVID-19 booster vaccine. As a booster dose, SCB-2019 (CpG 1018/Alum) in individuals who previously received two doses of SCB-2019 sparked a "robust and rapid neutralizing antibody immune response," the company noted. Data showed that trial participants who had a prior COVID-19 infection and received two doses of the Clover vaccine three weeks apart saw a 61-fold increase in neutralizing antibodies against BA.5. Additionally, the vaccine also generated a 37-fold boost in neutralizing antibodies against the Omicron BA.2 sub-variant and a 20-fold boost in neutralizing antibodies against Omicron BA.1. These results indicate that Omicron BA.5 neutralizing antibody levels were approximately two to four-fold higher than Omicron BA.1 neutralizing antibody levels induced by SCB-2019. Nicholas Jackson, president of global research and development at Clover, said the new data provides evidence that supports the potential for SCB-2019 to be used across the globe to halt the continued spread of COVID. Clover is focused on completing regulatory submissions to the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization for SCB-2019 in the second half of 2022. Elsewhere around the globe: TikoMed: Sweden's TikoMed published research in Frontiers in Pharmacology supporting the mechanism of action of its ILB neuroprotective drug platform. In multiple preclinical and clinical studies across a variety of neuroinflammation-driven diseases, including ALS, the low molecular weight dextran sulfate compound mobilized and modulated naturally occurring tissue repair mechanisms, the company noted. TikoMed added that the compound restored cellular homeostasis and function by releasing heparin-binding growth factors. TikoMed stated its belief that this approach has the potential to transform current cell and gene therapy paradigms. PolPharma Biologics Group BV: PolPharma, along with Formycon AG and Bioeg AG, jointly announced that the European Commission granted marketing authorization to Ranivisio, a biosimilar to Lucentis used to treat renal diseases. Ranivisio is indicated for the treatment of wet age-related macular degeneration, the treatment of visual impairment due to diabetic macular edema or choroidal neovascularization and the treatment of proliferative diabetic retinopathy. It is also indicated for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. BrainsWay Ltd.: Israel's BrainsWay received 510(k) clearance from the U.S. FDA for the Deep TMS H7 Coil to treat adults suffering from major depressive disorder and depression, including those with comorbid anxiety symptoms commonly known as anxious depression. The FDA's clearance was based on the review of successful results from a multicenter trial designed to better understand the H7 Coil's efficacy in addressing treatment-resistant depression. The study found overall efficacy rates for the H7 Coil comparable to those achieved with BrainsWay's H1 Coil. Aeterna Zentaris Inc.: Toronto-based Aeterna Zentaris announced that Novo Nordisk exercised its right to terminate an agreement for Macrilen (macimorelin), an oral test for diagnosing adult growth hormone deficiency approved in the United States and Europe. Aeterna will regain full U.S. and Canadian rights to the test. In light of Novo's decision, Aeterna said it plans to engage in robust business development efforts to identify and secure a new development and commercialization partner. Immutep Limited: Based in Australia, Immutep secured a new patent from Japan that covers its lead active immunotherapy candidate, eftilagimod alpha, a LAG-3 fusion protein and an anti-PD-(L)1 antibody. Medtronic: Ireland's Medtronic completed its acquisition of Affera, Inc. The company noted that the acquisition expands its cardiac ablation portfolio to include cardiac mapping and navigation. Affera's investigational technology is designed to provide solutions for patients with cardiac arrhythmias such as atrial fibrillation. The acquisition brings the Affera Prism-1 cardiac mapping and navigation platform into the company, which will complement Medtron's therapeutic catheters and technologies. It also brings the Spere-0 cardiac diagnostic ablation catheter that rapidly creates detailed electro-anatomical maps and delivers radio frequency and pulsed field cardiac ablation therapies. Laverock Therapeutics: Based in the United Kingdom, Laverock was launched with the mission of developing a gene silencing platform for the creation of programmable, allogeneic cell therapies. With financing from its seed funding round, Laverock has opened labs in the Stevenage Bioscience Catalyst. It is conducting experiments to demonstrate cell type and condition-specific programmability, generating data to support allogeneic programs in Type 1 diabetes and solid tumor-directed immune therapy. Futura Medical plc: Also based in England, Futura Medical announced results from the Phase III study of MED3000, an investigational therapy for the treatment of erectile dysfunction. The company announced that the study met coprimary endpoints. MED3000 demonstrated a statistically significant improvement in erectile function compared to baseline. Also, the study achieved a clinically meaningful improvement in erectile function at 24 weeks. Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers. The company remains on track for potential filing with the FDA and other regulatory agencies. Volta Medical: France's Volta Medical, a health tech company developing AI software solutions, announced that the Journal of Cardiovascular Electrophysiology published peer-reviewed results from its successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution. The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram analysis. Results demonstrated that VX1 allowed for the building of standardized "Volta VX1 maps", used as a reference for operators to conduct EGM-guided ablation.