Beyond Weight Loss: The "Cellular Reset" That Could Create the Next Biotech Supercycle

Issued on behalf of Avant Technologies Inc.

VANCOUVER – Baystreet.ca News Commentary – The longevity economy is entering a massive repricing event as researchers confirm that metabolic dysfunction in early adulthood leaves measurable markers of brain aging decades before symptoms appear^[1]. With parallel breakthroughs in blood-brain barrier technology now unlocking neuroprotective strategies to directly attack this inflammatory damage^[2], a lucrative new asset class is forming at the convergence of metabolic health and life extension, driving capital toward the specific platforms best positioned to capitalize on this shift. Avant Technologies, Inc. (OTC-BB:AVAI), Klotho Neurosciences, Inc. (NASDAQ:KLTO), Longeveron Inc. (NASDAQ:LGVN), Denali Therapeutics Inc. (NASDAQ:DNLI), and BioAge Labs, Inc. (NASDAQ:BIOA) are advancing novel approaches targeting these interconnected pathways.

Analysts project the Alzheimer's therapeutics market will surge to $23.8 billion by 2031, driven by disease-modifying therapies that address underlying pathology rather than symptoms^[3]. Investment is flowing toward platforms that target root causes of aging such as chronic inflammation and protein aggregation, with emerging therapies showing promise in reversing metabolic decline and restoring cellular cleanup mechanisms that deteriorate with age^[4].

Avant Technologies, Inc. (OTC-BB:AVAI) has highlighted the critical role of cell encapsulation technology in enabling effective, long-term treatments for type 1 and insulin-dependent type 2 diabetes. Through Insulinova, Inc., a joint venture with SGAustria Pte. Ltd., the company is advancing a proprietary differentiation process achieving high-efficiency conversion of stem cells into insulin-producing and regulating cells, targeting type 1 and insulin-dependent type 2 diabetes patients globally. This innovative approach addresses a fundamental challenge: the immune system's rejection of implanted cells, which historically required lifelong immunosuppressive drugs carrying significant risks.

"Cell encapsulation is a game-changer in the field of regenerative medicine," said Chris Winter, CEO of Avant Technologies. "By partnering with SGAustria, we're ensuring that any genetically modified insulin-producing cells that we develop together can thrive in the body long-term and offer the potential of restoring natural glucose control and dramatically improving patients' quality of life. This technology not only minimizes risks like immune rejection but also prevents potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies."

The market opportunity is substantial. According to the International Diabetes Federation, 589 million people globally live with both type 1 and insulin-dependent type 2 diabetes, projected to reach 853 million by 2050, a 46% increase. SGAustria's Cell-in-a-Box® technology creates a protective barrier around genetically modified cells, shielding them from immune attacks while allowing nutrients, oxygen, and insulin to pass through freely. Avant will provide initial funding over the next eight months to hit established criteria relevant for an efficient, sustainable, and reproducible diabetes treatment.

Avant's strategic transformation extends beyond a diabetes treatment through Klothonova, the company's 50/50 joint venture with Singapore-based cell therapy pioneer Austrianova, which is developing a cell-based therapy designed to sustainably restore circulating α-Klotho levels using genetically modified human cells. Recent research from the Mayo Clinic, published in the Journal of the American Heart Association, demonstrates a strong association between declining α-Klotho levels and arterial stiffness, endothelial dysfunction, and vascular calcification, providing urgent scientific backing for anti-aging therapies.

Both SGAustria and Austrianova utilize cell-encapsulation platforms backed by over 50 peer-reviewed publications representing decades of development. The potential market opportunity spans multiple therapeutic areas: the global Alzheimer's market is projected to reach $32.8 billion by 2033, cardiovascular disease remains the world's leading cause of death, and kidney disease affects 850 million people worldwide. The broader cell-based therapy market could reach $44 billion globally, representing urgent health crises requiring the innovative therapeutic solutions Avant is developing.

CONTINUED… Read this and more news for Avant Technologies Inc. at https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ and https://usanewsgroup.com/avai-profile/

Klotho Neurosciences, Inc. (NASDAQ:KLTO) has been selected as winner of the Fifth Annual BioTech Breakthrough Award in the "Cell Therapy Innovation of the Year" category for its pioneering work developing transformative gene and cell therapies using a patented, secreted form of the human Klotho gene (s-KL). The company is addressing devastating neurodegenerative and age-related diseases, including ALS, Alzheimer's disease, and Parkinson's disease. By targeting the underlying mechanisms of neuronal aging, Klotho's therapies aim to slow, halt, or reverse disease progression.

"This award highlights our commitment to translating cutting-edge scientific discoveries into meaningful therapies for patients suffering from neurodegenerative and age-related diseases," said Dr. Joseph Sinkule, CEO of Klotho Neurosciences. "As the global population ages, the need for therapies that address the root causes of age-related conditions has never been greater. Klotho's focus on the human Klotho protein positions us to meet this challenge, developing therapies that not only target neurodegeneration but also have the potential to improve health span and reduce the burden of age-related disease worldwide."

The BioTech Breakthrough Awards program recognizes the most innovative companies, technologies, and products in the global life sciences and biotechnology industries. Klotho Neurosciences is a biogenetics company focused on developing innovative, disease-modifying cell and gene therapies using a protein derived from a patented form of the "anti-aging" human Klotho gene (s-KL) and its novel delivery systems.

Longeveron Inc. (NASDAQ:LGVN) announced that its submission on reduced brain neuroinflammation after laromestrocel treatment in mild Alzheimer's disease has been selected for poster presentation at the 18th Clinical Trials on Alzheimer's Disease Conference (CTAD 2025) to be held December 1-4, 2025 in San Diego, California. The data stems from the CLEAR MIND study evaluating laromestrocel, a living cell product made from specialized mesenchymal stem cells (MSCs) isolated from the bone marrow of young healthy adult donors. These specialized cells have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative.

"We are excited to have been selected to present important laromestrocel data at this leading forum for Alzheimer's research and clinical investigation," said Joshua Hare, Co-founder, Chief Science Officer and Executive Chairman of Longeveron. "We believe the findings offer potential mechanistic and clinical insights in the development of cellular-based therapy for Alzheimer's disease."

Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and Pediatric Dilated Cardiomyopathy (DCM), with laromestrocel development programs having received five distinct and important FDA designations.

Denali Therapeutics Inc. (NASDAQ:DNLI) reported third quarter 2025 financial results and provided business highlights, including the ongoing FDA review of its Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, with a PDUFA target date extended to April 5, 2026. The extension follows Denali's submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers. The company reported a net loss of $126.9 million for the quarter ended September 30, 2025, compared to a net loss of $107.2 million for the same period in 2024, with cash, cash equivalents, and marketable securities of approximately $872.9 million as of September 30, 2025.

"Momentum is building across Denali as we prepare for the anticipated launch of tividenofusp alfa with an experienced and focused commercial team in place," said Ryan Watts, Ph.D., CEO of Denali Therapeutics. "We are also excited to have submitted regulatory applications to initiate clinical studies with two additional programs representing new opportunities to expand the TransportVehicle platform to Alzheimer's disease and Pompe disease. Our robust pipeline continues to lead the way in the emerging class of transferrin receptor (TfR)-enabled medicines designed to deliver the power of biotherapeutics throughout the body, including the brain."

The company completed enrollment in the ongoing Phase 1/2 study of DNL126 to support an accelerated approval path in MPS IIIA, also known as Sanfilippo syndrome type A, with previously announced data demonstrating a significant reduction in cerebrospinal fluid (CSF) heparan sulfate (HS) from baseline, including normalization. In October, the company submitted a Clinical Trial Application (CTA) for DNL628 (OTV:MAPT) to initiate clinical studies in Alzheimer's disease, marking a significant milestone in advancing the Oligonucleotide TransportVehicle (OTV) platform, and submitted an Investigational New Drug (IND) application for DNL952 (ETV:GAA) to begin clinical studies in Pompe disease.

BioAge Labs, Inc. (NASDAQ:BIOA) reported third quarter 2025 financial results and business highlights, including the dosing of the first participant in a Phase 1 clinical trial evaluating BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for obesity and cardiovascular risk factors. The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants, with initial single ascending dose (SAD) data anticipated by the end of 2025. Net loss was $20.2 million for the quarter ended September 30, 2025, or $0.56 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $23.4 million, or $6.70 per weighted-average common share outstanding, basic and diluted, for the same period in 2024.

"The third quarter of 2025 marked an important milestone as we advanced BGE-102 into clinical development with the dosing of our first participant in the Phase 1 trial," said Kristen Fortney, PhD, CEO and co-founder of BioAge. "We're on track to deliver initial single ascending dose data by year-end, providing critical insights into the safety, pharmacokinetics, and target engagement of this potential best-in-class oral, CNS penetrant NLRP3 inhibitor. We also continued to advance our oral and parenteral APJ agonist programs toward 2026 IND submissions, while our partnerships with Novartis and Lilly continue to progress as expected. The Company remains focused on strategic execution to deliver transformative therapies targeting the biology of metabolic aging."

Following successful completion of the Phase 1 SAD/MAD, the company plans to initiate a proof-of-concept clinical trial for BGE-102, with top-line data for this study anticipated in the second half of 2026. The company continued to advance its oral and parenteral APJ agonist development strategy, with BioAge and JiKang Therapeutics jointly advancing a novel APJ agonist nanobody demonstrating at least 10-fold greater potency than apelin toward IND-enabling studies, while BioAge is progressing its proprietary portfolio of orally active APJ agonists for which it filed a U.S. provisional patent application in May 2025, with both programs targeting IND submissions in 2026.

Sources: https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ and https://usanewsgroup.com/avai-profile/

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SOURCES CITED

1. https://www.news-medical.net/news/20251125/Obesity-related-metabolic-stress-may-affect-brain-health-far-earlier-than-expected.aspx

2. https://www.mdpi.com/2077-0383/14/2/386

3. https://www.ihealthcareanalyst.com/global-alzheimers-disease-market/