Immunis, Inc.

Springbok Analytics, a life sciences muscle and analytics company, has received FDA 510(k) clearance for MuscleView, an AI-powered technology that analyzes muscle health via magnetic resonance (MR) images. The AI-based technology analyzes MRI data and produces personalized 3D visualizations and metrics of muscle health. Springbok Analytics's full body muscle analysis capabilities were introduced initially for research purposes in 2023. According to Springbok, its technology was developed after more than 13 years of research and scientific validation. The aim of the AI technology is to alter complex magnetic resonance imaging (MRI) data produced from rapid scan protocols into simple 3D visualizations of someone's precise musculature thereby building a new standard in muscle health. In a statement, the company explained that AI accountable for muscle segmentation inside MuscleView was trained and tested on MRI scans generated across different patients, demographics as well as scan sites and MRI parameters such as manufacturer, magnetic field strength, series settings/types, matrix size, field of view and scan resolution. "Achieving FDA 510(k) clearance is a significant milestone for our company and a true testament to the integrity, diligence and collaboration our entire team has brought to Springbok every day over the last several years," Scott Magargee, chief executive officer and cofounder of Springbok Analytics, said in a statement. "This clearance is a key pillar to our commercialization strategy, allowing us to further integrate MuscleView and our cutting-edge muscle analytics into sports medicine, orthopedics, and therapeutic applications." THE LARGER TREND In July, Immunis, a clinical-stage biotech company partnered with Springbok Analytics to build a new standard in muscle health with its MRI-based AI muscle analysis technology that is utilized in elite sports, human performance and life sciences. Immunis is using Springbok’s technology to assess the effectiveness of its investigational secretome therapeutic, IMMUNA, in restoring muscle growth and function in a sarcopenic Phase 1/2a clinical trial population. In June, Springbok Analytics announced its participation in a Phase 1 Clinical Trial to analyze safe dosage for clenbuterol that is used as a treatment for Facioscapulohumeral muscular dystrophy (FSHD). Springbok's MRI-based muscle analysis aids researchers in better understanding and identifying disease progression of FSHD by providing individual muscle volume and fat fraction metrics in clinical trial participants.

IRVINE, Calif.--(BUSINESS WIRE)-- #ClinicalTrials -- Immunis, Inc. , a clinical-stage biotech developing novel secretome therapeutics for age-related diseases and immune dysfunction, was recently granted permission by the FDA to proceed with its Phase II clinical trial testing its investigational secretome (IMMUNA) in reversing sarcopenic obesity. The news comes shortly after Immunis completed secretome-treatment of its third patient cohort in a Phase I/IIa clinical trial for age-related muscle atrophy (sarcopenia). In the U.S., obesity rates have skyrocketed within the past few decades, with a heavy impact on the elderly population. According to the National Center for Health Statistics , the percentage of obese Americans aged 65+ has doubled from about 20% to 40% for both men and women. Age-related obesity is strongly linked with additional health concerns including diabetes and muscle loss, which can have detrimental effects on quality of life. Recently, GLP-1 drugs have become popularized by celebrities and those looking for a “quick fix” to managing weight problems, but questions remain regarding their long-term effects on health. Scientific publications reported that about 20-50% of the total weight lost from these drugs is attributed to a decrease in muscle mass, not fat. This means that individuals who take GLP-1s over an extended period may experience a decline in muscle size and function over time. This is an area of concern as muscle loss is associated with an increase in falls, fractures, and comorbidities, accounting for more than $40 billion in annual health care costs in the U.S. alone. Immunis is seeking to change this outcome with its investigational secretome, IMMUNA , which can reduce fat, while preserving muscle. This year, Immunis published preclinical data in Aging Cell supporting that IMMUNA increases whole-body lean mass and reduces fat mass, while increasing muscle size, enhancing muscle regeneration, and improving muscle function. Immunis’ Phase I/IIa results demonstrate no adverse events attributable to drug, with a strong suggestion of enhanced muscle function resulting in an increased quality of life measurement, the 6-minute walk test. Immunis will conduct a follow-up Phase II clinical trial to test the efficacy of IMMUNA in combating sarcopenic obesity, in the hopes of increasing mobility and independence. “Our innovative therapy shows promising results by simultaneously decreasing fat and enhancing muscle and muscle function. We’re taking a significant stride towards improving healthspan,” explains Dr. Hans Keirstead, Chairman of Immunis. About Immunis Inc. Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis’ leading-edge capabilities in secretome technology to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis’ Phase I/IIa clinical trial please visit: Cautionary Note Regarding Forward-Looking Statements This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein. Contacts contact@immunisbiomedical.com

IRVINE, Calif.--(BUSINESS WIRE)-- Immunis, Inc., a clinical-stage biotech developing innovative secretome therapies to address age-related disease and immune dysfunction, obtained a significant strategic milestone in partnering with Toray, a Japanese drug company part of the Toray Group. Founded in 1926, Toray has grown into a highly successful conglomerate known for its commitment to solving pressing global health and environmental challenges. With its production of various advanced material sciences, Toray has diversified expertise in industries including pharmaceuticals, electronics, textiles, and aerospace. This press release features multimedia. View the full release here: (Photo: Business Wire) Immunis licensed development and commercial rights to the Japan-commercially-approved drug called TRK-820, an opioid receptor agonist developed initially for the treatment of pruritus or sever itching. Immunis’ formulation of TRK-820 shows pre-clinical benefits for sarcopenia, and may serve as a promising pharmaceutical complement to IMMUNA, Immunis’ human-derived regenerative biologic published to reverse age-related muscle loss, promote muscle growth and function, and enhance metabolism. Immunis is currently conducting independent validations to measure the efficacy of TRK-820 in reversing sarcopenia and will apply for a Phase 2 clinical trial to assess efficacy in humans. The advantages of adding TRK-820 to Immunis’ portfolio are that it can be taken orally and that it offers a different mechanism of action than IMMUNA to potentially enhance muscle regeneration in humans. Both Immunis and Toray operate with the mission of advancing human healthcare and enhancing quality of life. Immunis is excited by the opportunities that this partnership can offer, and we hope to successfully address sarcopenia as a united front. About Immunis Inc. Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis’ leading-edge capabilities in secretome technology to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis’ Phase 1/2a clinical trial please visit: Cautionary Note Regarding Forward-Looking Statements This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.