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Limula raises $6.8M to democratise access to life-saving Cell and Gene Therapies with Swiss-made manufacturing platform

limula

Over the last decade, several breakthrough Cell and Gene Therapy products have been approved in the USA and Europe to turn stem cells and immune cells into ‘living cures’, bringing hope to millions living with life-threatening conditions. However, these treatments remain out of reach for 98% of patients suffering from what are now curable conditions. This is in part due to complex, manual and costly manufacturing processes. Life science startup Limula announces today it has raised CHF6.2M ($6.8M) to take their solution for automating cell therapy manufacturing to the next stage of development. The oversubscribed seed round was led by LifeX Ventures, with participation from Verve Ventures, Zühlke Ventures, Oxford Seed Fund, Lichtsteiner Foundation, W.A. de Vigier Foundation, the founders, and a lineup of private individuals who have been supporting Limula’s vision from its inception. The company was founded in 2020 by Dr. Yann Pierson, Dr Luc Henry. Dr. Thomas Eaton to deliver a disruptive approach to the ‘ex vivo’ manipulation of cells, based on a novel technology. The trio witnessed that outdated manufacturing methods were a speed bump to the adoption of Cell and Gene Therapy products – like chimeric antigen receptor (CAR) T-cells. Combining breakthrough discoveries in genetic engineering and medicine led to a revolution in medicine, but boosting the patients’ own cells to produce a dose in a laboratory still requires too many manual steps. Highly skilled labour and sterile infrastructures represent the majority of the costs of a therapy, leading to a price tag of $500,000 or more per dose. As a result, these treatments are inaccessible for a majority of eligible patients. To combat this, Limula developed a modular solution for on-demand and at-scale manufacturing of cell therapies in a single device. By combining the functionalities of a bioreactor and a centrifuge into one single closed vessel, Limula’s proprietary solution can handle a wide range of volumes and cell numbers, removing transfer steps and therefore limiting stress, losses, and potential contamination. With a potential for scalability, it can be used by cell therapy providers in their transition from pre-clinical evaluation to clinical trials, and later commercial scale manufacturing of clinical-grade cell products. Luc Henry, co-founder and CEO of Limula said: "Our team is driven by the ambitious goal of developing tools that are based on a fundamentally novel way of manipulating cells outside of the body. Our technology supports manufacturing workflows that are impossible to automate with existing tools. We believe automation is the only route to scalability and digital traceability. These two aspects are keys unlocking the full potential of Cell and Gene Therapy, making them accessible to the many, not just the few”. Limula’s founders built a high performing multidisciplinary team, most recently joined by domain experts Olivier Waridel, former CEO of Cytiva-owned Biosafe, Caroline Boudousquié, former Head of Process Development at the Center for experimental therapeutics (CTE) of the University Hospital in Lausanne, and Maria Elena Grisostolo, former VP Operations at Lunaphore. After completing an initial proof of concept, the company launched a program to provide selected industry and academic partners access to the innovative platform ahead of its commercial launch. With the aim to broaden the scope of applications, Limula has signed partnerships with several research centres including San Raffaele Telethon Institute for Gene Therapy in Milan, Italy - a world-recognized centre of excellence for research and clinical translation of cell and gene therapy. Prof. Bernhard Gentner at San Raffaele Telethon Institute for Gene Therapy said: “We believe the solution Limula is advancing can support our current process development activities and later enable the manufacturing of these cell products at scale. We also see its potential in improving the status quo in Cell & Gene Therapy manufacturing in general, and in the field of haematopoietic stem cell transplantation in particular.” Dr Inaki Berenguer, managing partner at LifeX Ventures added: "We're thrilled to stand with the Limula team as they reinvent cell and gene therapy manufacturing. It's evident that production tools have lagged behind scientific and clinical advancements, particularly in terms of price and scalability. Limula's commitment to addressing these bottlenecks is crucial to enhancing accessibility for patients.” Looking ahead, Limula will use its new seed capital to significantly advance the development of the proprietary platform composed of a device and single use consumables, towards meeting good manufacturing practice (GMP) requirements. The solution developed by Limula is an enabling tool for a rapidly growing market. The potential of Cell and Gene Therapies to save the lives of millions of patients globally has generated significant interest – and investment – leading to a significant pipeline and several recent approvals by health authorities. Both industrial and academic players are now eager to adopt next-generation automated and scalable solutions with the shared goal to significantly increase market reach and broaden accessibility. About Limula Limula SA is a Life Science Tools company based in Lausanne, Switzerland, looking to disrupt the status quo in the manufacturing of Cell & Gene Therapies. Their mission is to support rapid and cost-effective introduction of new advanced therapy products to the market. Their cell processing platform leverages a proprietary design and automation to bring all functionalities required for on-demand and at-scale manufacturing of cell therapies in a single device. www.limula.ch About LifeX Ventures ‍LifeX Ventures is a New York-based venture capital firm investing in global visionary entrepreneurs using software and AI to develop transformational solutions that will extend the life of humans and the planet. With its $100M debut fund, LifeX is targeting the two largest sectors in the world: People (bio/health) and Planet (climate), where Software and AI suddenly matter. ‍www.lifex.vc About Verve Ventures Verve Ventures is one of the most active venture investors in Europe with over 140 science and technology-driven startups in its portfolio. Verve Ventures’ dedicated team helps startups with their most pressing needs such as hiring, client introductions, and an expert network of high-profile individuals. www.verve.vc About Zühlke Ventures Zühlke Ventures is an early stage venture capital investor with focus on HealthTech. Zühlke Ventures’s investment is paired with actionable expertise for finding product-market-fit, for developing and deploying novel products, and for entering international markets. www.zuehlke.com/en/about-us/ventures About Oxford Seed Fund Oxford Seed Fund, run by the Entrepreneurship Centre at Saïd Business School is the largest student-led VC fund outside of North America, investing in top Oxford-affiliated technology enabled pre-seed and seed stage companies. Supporting them with access to funding, talent, skills and networks. The Fund deploys £600,000+ per year across 10+ companies. https://www.sbs.ox.ac.uk/research/centres-and-initiatives/entrepreneurship-centre/oxford-seed-fund About Lichtsteiner Foundation The Lichtsteiner Foundation supports pioneers and early-stage startups in the field of health (medical technology, biotechnology, life science, mental health, public health and wellbeing) in order to improve people’s health in a sustainable way. https://lichtsteinerfoundation.org/ About W.A. de Vigier Foundation Since the foundation’s establishment in 1987, the goal of the W.A. de Vigier Foundation has been to actively invigorate business development and further provide direct financial support to young people with innovative business ideas wishing to build performance and growth-oriented businesses in Switzerland. Until today, the W.A. de Vigier Foundation has awarded CHF 14.3 million in seed capital to Swiss startups. https://devigier.ch/ Contact Details Limula Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://limula.ch/

May 21, 2024 09:00 AM Eastern Daylight Time

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Immunic CMO discusses role of clinical trials in biotech development for Clinical Trials Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses the importance of clinical trials in the biotech industry to mark Clinical Trials Day on May 20. Dr Muehler noted that Immunic focuses on translating research ideas into clinical trials to demonstrate clinical proof of concept as well as safety and efficacy of a drug candidate. He explained the stages of clinical development, from preclinical trials to late-stage phase 3 trials and commercialization. Preclinical trials involve testing in animals and cell cultures to ensure safety before human testing begins. Phase 1 trials assess safety and pharmacokinetics, while phase 2 trials determine the appropriate dosage. Phase 3 trials involve large-scale testing to obtain statistically significant outcomes for regulatory approval. Dr Muehler emphasized the importance of continuous clinical development, even after drug approval, to monitor for rare side effects and test in different populations. Clinical trials at Immunic are organized by medical and clinical operations teams and executed with the help of contract research organisations (CROs) to manage the trials across various countries. Dr Muehler highlighted the challenges in clinical trials, such as patient recruitment and the need for effective planning and communication with key opinion leaders and investigators. He shared that staying in close contact with investigators through meetings, site visits, and newsletters helps in efficient trial execution and patient enrolment. Immunic's approach has been successful in rapidly enrolling patients for trials, particularly in multiple sclerosis studies, he added. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 20, 2024 10:00 AM Eastern Daylight Time

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Neural Therapeutics - How do we prevent people getting addicted to opioids?

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell is answering some of the questions raised by Scientific Advisor Professor David Nutt's presentation on the potentially revolutionary untapped effects of psychedelic medicine. Today's questions asks: "The opioid crisis has touched every sector of society and shows no sign of stopping. How do we prevent more people from becoming addicted?" He emphasised that contrary to common concerns, the substances developed by the company have not shown addictive properties in clinical trials. Campbell highlighted that there is no evidence of withdrawal symptoms in patients. Moreover, ongoing scientific work supports the effectiveness of these substances in treating individuals with substance use disorders. The presentation focused on what Professor Nutt describes as the utility of psychedelic compounds and their potential to transform the treatment of mental illness. To watch the full presentation, click here: https://www.proactiveinvestors.co.uk/companies/news/1035785/professor-david-nutt-presents-his-insights-into-psychedelic-medicine-neural-therapeutics-1035785.html Neural Therapeutics is a drug-discovery company focusing on plant-based active substances with the goal of delivering beneficial, over-the-counter dietary supplements and psychedelic-based therapeutic medicines to treat serious mental ailments where no significant treatment is available today. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

May 20, 2024 09:00 AM Eastern Daylight Time

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Immunic chief medical officer discusses promising treatments to mark World IBD Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses Inflammatory Bowel Disease (IBD) with Proactive's Stephen Gunnion to mark World IBD Day on May 19. Muehler explained that IBD encompasses Crohn's disease and ulcerative colitis, characterised by an immune response triggered by the interaction between gut bacteria and the immune system, leading to bowel wall damage and ulcerations. This condition affects 1-2% of the population, presenting significant social challenges due to symptoms like diarrhoea and abdominal pain, which can limit social and professional activities. Currently, IBD is managed with immunosuppressive drugs, which, while effective, increase susceptibility to infections and other autoimmune diseases and often show immunosuppression. Dr Muehler highlighted the need for treatments that do not suppress the immune system. Immunic Inc. has been exploring new therapies, including a drug that strengthens the bowel barrier. A recent phase two trial with Vidofludimus calcium (IMU-838) in ulcerative colitis showed promising results in maintaining remission. This drug, primarily tested in multiple sclerosis, is part of a class not previously tested in large IBD trials. Another promising drug, IMU-856, aims to regenerate the bowel barrier, preventing harmful interactions between gut bacteria and the immune system without immunosuppression. This drug has shown positive results in animal experiments as well as in healthy volunteers and celiac disease trials. Immunic currently evaluates potential testing of IMU-856 in IBD. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 17, 2024 02:35 PM Eastern Daylight Time

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Tackling Childhood Peanut Allergies

YourUpdateTV

Right now, more children in the U.S. are living with peanut allergy than ever before, and approximately 75% will not outgrow their allergy. Recently, Pediatric Allergist, Dr. Douglas Mack, and Sarah Korieshi, the Mother of a peanut allergic child, participated in a nationwide satellite media tour to discuss the impact on children and innovative new treatment options that can help. A video accompanying this announcement is available at: https://youtu.be/5uKicnsGHv8 The repercussions of this condition are profound, extending beyond mere dietary restrictions to impacting a child's daily life, social interactions, and overall well-being. The constant fear of accidental exposure and the potential for severe allergic reactions can also be extremely difficult for families to navigate. The increase in prevalence over the past 20 years has driven a growing need for effective treatment options to manage the condition. For doctors, that means treatments that reduces the likelihood of an allergic reaction in the case of accidental exposure, and treatments that work within the lifestyle of the child and family. The good news is that recent years have brought about a spate of new innovations in the allergy space. For example, there is currently an ongoing clinical trial evaluating Viaskin TM Peanut, a patch containing the equivalent of one one-thousandth of one peanut kernel. The patch is applied each day to a child’s back in order to build up a tolerance to peanut protein, making it less likely that a child will have a reaction after an accidental exposure. For parents, a treatment like this would be life-changing, as a non-invasive option – something that can be incorporated into our busy lives, without any restrictions to regular activities. Having access to a treatment option that allows children and parents to participate in typical activities for a child, such as birthday parties, sports activities, attending camp, or even school, would give parents peace of mind and children the care-free life they deserve. For more information, visit vitesseallergystudy.com About Dr. Douglas Mack Dr. Mack is co-author of clinical guidelines on the prevention of allergy, oral immunotherapy and anaphylaxis and focuses on oral immunotherapy for food at Halton Pediatric Allergy clinic. Dr. Douglas Mack has been a pediatric allergy, asthma, and immunology specialist for over 10 years. Dr. Mack is an assistant clinical professor in the Department of Pediatrics at McMaster University and is an affiliate of Sick Kids. He sits on the board of directors at the Canadian Society of Allergy and Clinical Immunology. He is co-author of clinical guidelines on the prevention of allergy, oral immunotherapy, and anaphylaxis. Dr. Mack is co-founder of Halton Pediatric Allergy clinic where his focus is on oral immunotherapy for food. About Sarah Korieshi Sarah learned that her daughter Zara had a deadly peanut allergy when she was just 9 months old. The first thing she thought was, not only how life-threatening eating a food can be, but also living with the constant fear of what may happen every time she eats. There has always been constant fear with how unpredictable a reaction can be, and the anxiety that comes with solely relying on avoidance really takes a toll. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

May 17, 2024 10:09 AM Eastern Daylight Time

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Neural Therapeutics CEO Ian Campbell discusses potential CSE listing and future plans

Neural Therapeutics Inc.

Neural Therapeutics CEO Ian Campbell discusses the company's conditional approval to list on the Canadian Securities Exchange (CSC) in an interview with Proactive's Stephen Gunnion. Campbell explained that the CSE listing is a strategic move, enabling broader market participation and capitalisation on its advancements. The company aims to raise $500,000, primarily for research and development efforts and securing intellectual property, including two patents. Campbell highlighted the growing interest in psychedelic treatments, noting the significant investment in this sector and the 44% rise of the Psychedelic Invest Index this year. He emphasised the mental health crisis and the inadequacy of outdated therapies, positioning psychedelics as a promising and disruptive alternative. Neural Therapeutics specialises in mescaline extracted from the San Pedro cactus, a substance with a long history of safe use. Campbell noted mescaline's unique properties, such as its longer duration in the body, which supports neuroplasticity and potential treatment for mental illnesses like addiction without causing hallucinations. The CSE listing is expected to enhance the company's visibility, attract investment, and accelerate drug development. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

May 17, 2024 08:00 AM Eastern Daylight Time

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Arecor Therapeutics reports strong 2023 results and outlines expanding product pipeline

Arecor Therapeutics PLC

Arecor Therapeutics PLC (AIM:AREC)C CEO Sarah Howell discusses the company's 2023 performance and future plans with Proactive's Stephen Gunnion. Howell highlighted that Arecor has seen significant growth, particularly with the launch of products incorporating its Arestat technology under a global licensing agreement, generating royalties. Six new technology partnerships were established with major pharma and biotech companies, offering potential for future licensing and market development. Arecor focuses on diabetes and obesity, with clinical results for their proprietary product, AT278, expected soon. This highly concentrated, rapid-acting insulin aims to provide better glucose control for type 2 diabetics with high BMI and support the next generation of insulin pump devices. Tetris Pharma, a subsidiary, has shown strong growth under new leadership, with product sales tripling to £2.9 million in 2023. Its lead product, glucagon, has contributed significantly to this growth. Howell also noted the importance of technology partnerships and licensing programs. Arecor has entered into three active license programs and is progressing well with its partners. One notable partnership is with Medtronic to develop a concentrated, stable insulin for intra-peritoneal delivery, aiming to reduce hospital visits for patients with brittle diabetes. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 17, 2024 03:20 AM Eastern Daylight Time

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Immunic highlights IMU-856 gastrointestinal candidate to mark International Celiac Day

Immunic Inc

Immunic Inc (NASDAQ:IMUX) chief scientific officer Hella Kohlhof joined Proactive's Stephen Gunnion on International Celiac Day, in the middle of Celiac Disease Awareness Month, to discuss the disease and the company’s developments in treating it. Kohlhof explained that celiac disease is a severe autoimmune disorder affecting around 1% of the global population, predominantly females. Unlike gluten intolerance, celiac disease involves an immune reaction to gluten, leading to gut inflammation and destruction. The only current treatment is a gluten-free diet, which is not effective for all patients. Kohlhof elaborated on the disease's scientific background, highlighting its genetic association with specific HLA genotypes (HLA-DQ2 and HLA-DQ8). She explained that celiac disease is triggered by the immune system's reaction to deaminated gluten peptides, causing inflammation and damage to the gut lining. Immunic is developing IMU-856, an epigenetic modulator, to treat gastrointestinal diseases like celiac disease. IMU-856 enhances gut regeneration and strengthens the gut barrier, improving patients' conditions. Kohlhof detailed the successful completion of a Phase 1b study in celiac patients, which demonstrated the drug’s safety, good pharmacokinetic properties, and positive effects on symptoms, biomarkers, gut histology, and nutrient uptake during a gluten challenge. The study confirmed the potential of IMU-856 in treating celiac disease, and further exploration of its mode of action is ongoing. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 16, 2024 05:54 PM Eastern Daylight Time

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FOR IMMEDIATE RELEASE

Apple Rush Company, Inc.

Apple Rush Company, Inc. (Otcpink:APRU), a leading player in the functional beverage industry, proudly announces it has cleared up final details of brand ownership with Bob Corr and Corr Brands, Inc. Tony Torgerud, CEO of Apple Rush, has negotiated a historical closing on the rights and trademarks of Corr Brands, Inc. In the transaction, Bob Corr has agreed to transfer the rights of the Corr Brands, Inc. trademarks and to forgo any royalties from previous agreements to give Tony and Apple Rush the best opportunity to succeed moving forward. Tony Torgerud said, “I have been negotiating for a year with Bob and he finally felt it was time to work out an agreement that would benefit everyone. Over the next couple months, all the required paperwork will be filed for transference and updates on all intellectual property held by Corr Brands, Inc. Not having to pay royalties will add thousands to the bottom line.” This agreement solidifies the future of the “Rush” family of brands that have been in the market since 1972. Bob Corr stated, “I want to see Apple Rush succeed and I feel the timing is right to get this deal done. I retired a long time ago and it is now time to write the next chapters of this story and with Apple Rush having its own production capabilities and its own tunnel pasteurizer, it is an opportunity that shouldn’t be wasted. I have given up hundreds of thousands of dollars in royalties, licensing fees and shares to enhance shareholder value.” With our pilot production abilities, we hope to do some reformulations to introduce a 2024 version of Ginseng Rush and the relaunch of the original Apple Rush flavor line. Apple Rush has held a license for 13 states and International distribution for the last 8 years and now owns the IP without paying the $5,000 per state license, another bottom line gain for all of our stockholders. About The Apple Rush Company, Inc. The Apple Rush Company, Inc., through its subsidiary APRU, LLC, is a distributor of CPG products under the trademarked Apple Rush brand, Element brand and other labels. The Apple Rush brand has more than 50 years of existence in the natural beverage industry. As a historical leader in the organic and natural beverage sector our goal is to now become a leader in the distribution of anhydrous hemp oil products nationwide. For more information, please go to www.aprubrands.com, www.element-brands.com, elementk.kratomwave.store www.alkhemicalroots.com with our expanded product portfolio. Safe Harbor Act: Forward-Looking Statements are included within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations including words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. We are under no obligation to (and expressly disclaim any such obligation to) update or alter forward-looking statements, whether as a result of new information, future events or otherwise. Contact Details Apple Rush Company, Inc. Tony Torgerud +1 888-741-3777 dtorgerud@aprullc.com Company Website http://www.aprubrands.com

May 14, 2024 10:00 AM Eastern Daylight Time

Healthcare

Limula raises $6.8M to democratise access to life-saving Cell and Gene Therapies with Swiss-made manufacturing platform

Immunic CMO discusses role of clinical trials in biotech development for Clinical Trials Day

Neural Therapeutics - How do we prevent people getting addicted to opioids?

Immunic chief medical officer discusses promising treatments to mark World IBD Day

Tackling Childhood Peanut Allergies

Neural Therapeutics CEO Ian Campbell discusses potential CSE listing and future plans

Arecor Therapeutics reports strong 2023 results and outlines expanding product pipeline

Immunic highlights IMU-856 gastrointestinal candidate to mark International Celiac Day

FOR IMMEDIATE RELEASE