Metabolic Reset: Cell Therapies and Novel Drugs Reshape Chronic Disease Market

Issued on behalf of Avant Technologies Inc.

VANCOUVER – Baystreet.ca News Commentary – The metabolic disorder therapeutics market projects growth to $120.7 billion by 2030 as biotechnology firms pioneer organ-level treatments addressing diabetes, liver disease, and aging-related decline[1]. Cell therapy and biologics investments surged past $30 billion since 2020, positioning advanced therapeutic platforms to capture expanding opportunities across interconnected metabolic pathways[2]. Positioned to capitalize on this convergence of metabolic innovation are Avant Technologies, Inc. (OTCQB: AVAI), Tandem Diabetes Care, Inc. (NASDAQ: TNDM), Crinetics Pharmaceuticsl, Inc. (NASDAQ: CRNX), Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), and Altimmune, Inc. (NASDAQ: ALT).

Analysts tracking obesity and liver disease therapeutics highlight dual metabolic benefits driving institutional interest, with FDA approvals expanding treatment paradigms beyond symptom management toward disease reversal[3]. Longevity biotech investments raised $5.3 million monthly through late 2024[4] as investors recognize metabolic dysfunction as the linchpin connecting age-related diseases, creating urgent timing advantages for companies delivering integrated solutions before major competitive waves consolidate market positions.

Avant Technologies, Inc. (OTCQB: AVAI), through its joint venture Klothonova, has secured a transformative exclusive worldwide license that positions the company at the forefront of next-generation anti-aging therapeutics. Klothonova, a 50/50 partnership between Avant and Singapore-based cell therapy pioneer Austrianova, recently entered into an exclusive license agreement with Klothea Bio, Inc., granting global rights to develop, manufacture, and commercialize Klothea Bio's proprietary Klotho producing cells using Austrianova's Cell-in-a-Box® encapsulation technology for treating diseases and conditions in humans and animals.

"This license represents a pivotal milestone for Klothonova and underscores Avant's commitment to transforming biotech innovation into real-world impact," said Chris Winter, CEO of Avant. "By combining Klothea's cutting-edge Klotho expertise with our joint venture's advanced cell encapsulation technology, we're poised to pioneer therapies that could redefine healthy aging and extend quality of life for millions."

The agreement provides Klothonova access to Klothea Bio's proprietary Klotho generating cell line, which will be encapsulated using Austrianova's proven technology to create implantable therapies capable of sustained, localized delivery. The license encompasses comprehensive development programs from preclinical research through commercialization, with key terms including milestone payments tied to development and regulatory achievements, as well as royalties on net sales.

Since its October 2025 launch, Klothonova has initiated preparatory work for GMP-manufacturing of the encapsulated Klotho-overexpressing cell line, with plans to advance into IND-enabling studies in the coming year.

The scientific foundation for Klotho-based therapies is widely considered compelling. Studies show higher Klotho levels correlate with up to 30% increased lifespan, while individuals with lower Klotho levels had 31% higher mortality rates. Natural Klotho levels drop by 50% after age 40, creating vast and urgent therapeutic opportunities for this "longevity protein."

Avant's strategic transformation extends beyond anti-aging through Insulinova, Inc., a joint venture with SGAustria Pte. Ltd. aimed at revolutionizing diabetes treatment through innovative stem cell and encapsulation technologies.

The partnership will advance a proprietary differentiation process achieving high-efficiency conversion of stem cells into insulin-producing and regulating cells, targeting type 1 and some insulin-dependent type 2 diabetes patients globally. Avant will provide initial funding over the next eight months to hit established criteria relevant for an efficient, sustainable, and reproducible diabetes treatment.

Both SGAustria and Austrianova utilize cell-encapsulation platforms backed by over 50 peer-reviewed publications representing decades of development studied for multiple therapeutic protein applications.

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 cell-based therapy market could reach $44 billion globally, while diabetes affects over 500 million people worldwide, representing urgent health crises requiring innovative therapeutic solutions.

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/

Tandem Diabetes Care, Inc. (NASDAQ: TNDM) received FDA clearance for the Android version of its Tandem Mobi mobile app, expanding access to the world's smallest durable automated insulin delivery system powered by Control-IQ+ technology. The approval enables patients with diabetes to manage their condition directly from compatible Android smartphones, including Google Pixel models 6 through 10 and Samsung Galaxy models S21 through S25, with clinical data demonstrating 79% time in glycemic range and 90% overnight time in range.

"We're excited to bring Tandem Mobi and the best-in-class outcomes of Control-IQ+ to Android users," said John Sheridan, CEO of Tandem Diabetes Care. "This latest integration gives Android users access to the life-changing benefits of Control-IQ+ on a system that emphasizes convenience, discretion, and customization."

A limited release is expected to begin in December 2025, followed by commercial availability in early 2026, with the app downloadable from the Google Play Store on compatible smartphones. The system's intuitive interface and secure connectivity to the Tandem Source platform supports enhanced engagement between patients and healthcare providers for more informed treatment decisions.

Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) reported strong early momentum for its recently approved acromegaly treatment PALSONIFY (paltusotine), with approximately 95% of filled prescriptions coming from switch patients and 50% achieving reimbursement since the September 25, 2025 FDA approval. The company's field force has engaged 95% of top priority healthcare provider targets, with payer reimbursement presenting no barrier to treatment access, while third quarter 2025 research and development expenses increased to $90.5 million from $61.9 million year-over-year as the company advances five clinical trials across its endocrine-focused pipeline.

"September 25, 2025 was a historic day for Crinetics with the approval of Palsonify for the treatment of people with acromegaly," said Scott Struthers, Ph.D., CEO of Crinetics. "For years, acromegaly patients have endured significant challenges with existing therapies. Since approval, our team has executed seamlessly to get Palsonify to patients and the launch is off to a very good start. Healthcare providers both at pituitary centers and in the community have written prescriptions, and we are seeing uptake in patients switching from prior therapies and in those newly initiating medical therapy. With the approval milestone, we are now a fully integrated pharmaceutical company. Five clinical trials across our deep pipeline are advancing and our financial position remains robust. We are executing with speed and focus on our mission to bring life-changing treatments to the patients who need them most."

The company expects to randomize first patients in its CAREFNDR Phase 3 trial of paltusotine for carcinoid syndrome in the fourth quarter of 2025, along with initiating the CALM-CAH Phase 3 study in adults with congenital adrenal hyperplasia and the BALANCE-CAH Phase 2/3 study in pediatrics. Crinetics maintains cash, cash equivalents and investments totaling $1.1 billion as of September 30, 2025, providing a runway into 2029 with anticipated 2025 cash burn of $340-370 million.

Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) recently published two-year data in The Lancet demonstrating that Rezdiffra (resmetirom) significantly improved multiple noninvasive imaging tests and biomarkers in patients with compensated MASH cirrhosis, including a mean 7.9 kPa reduction in liver stiffness and meaningful shifts in clinically significant portal hypertension risk scores in advanced patients with baseline platelet counts below 100,000/µL. In this vulnerable population excluded from other F4c MASH trials, two-thirds of patients shifted to lower Baveno CSPH risk scores by year two, with 39% achieving no/low CSPH status compared to just 7% at baseline, despite a treatment interruption period between years one and two that temporarily reversed beneficial effects.

"Patients with platelet count <100,000/µL have been excluded from other trials in F4c MASH, so these new data from MAESTRO-NAFLD-1 offer unique insights about a population that is on the cusp of progressing to liver decompensation events," said Naim Alkhouri, M.D., Chief Academic Officer at Summit Clinical Research and Director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio. "Rezdiffra reduced multiple imaging and biomarker parameters in these vulnerable patients despite their advanced state of compensated cirrhosis and a period of treatment interruption between the first and second year of treatment. These data give me greater confidence in the ongoing Phase 3 MAESTRO-NASH OUTCOMES trial of Rezdiffra, which also includes patients with platelet count <100,000/µL."

The therapy demonstrated consistent improvements in liver enzymes, fibrosis biomarkers including Enhanced Liver Fibrosis score and PRO-C3, corrected T1 relaxation time, and atherogenic lipids, while also improving disease-specific quality of life measures in both cirrhotic and noncirrhotic patients with sustained effects through two years of treatment. Analysis from the MAESTRO-NAFLD-1 open-label extension underscored the critical need for continuous therapy, as patients who paused treatment experienced an immediate reversal of earlier gains and evidence of renewed disease progression that was restored only upon treatment resumption.

Altimmune, Inc. (NASDAQ: ALT) announced publication in The Lancet of 24-week data from its IMPACT Phase 2b trial showing pemvidutide achieved statistically significant MASH resolution without worsening of fibrosis in 58% of patients at the 1.2 mg dose and 52% at the 1.8 mg dose, compared to 20% with placebo, while also delivering meaningful reductions in liver stiffness, Enhanced Liver Fibrosis scores, and body weight. The balanced 1:1 glucagon/GLP-1 dual receptor agonist demonstrated strong evidence of anti-fibrotic activity across multiple noninvasive tests, with 44% of patients in the 1.8 mg group achieving normalization of liver fat content to ≤5% and significant improvements in corrected T1 relaxation time, indicating reductions in liver inflammation.

"As the primary goal of treatment for patients with MASH is to reverse liver fibrosis to prevent progression to cirrhosis and other serious and life-threatening complications, the totality of the 24-week clinical data from the IMPACT trial is very encouraging," said Mazen Noureddin, M.D., IMPACT trial principal investigator and Professor of Medicine at Houston Methodist Hospital. "Given the significant resolution of MASH that occurred after only 24 weeks of treatment, along with strong evidence of anti-fibrotic activity and weight loss, the profile of pemvidutide suggests it has the potential to meaningfully alter the course of this disease."

The FDA has granted Fast Track designations to pemvidutide for both MASH and alcohol use disorder, with the 48-week final readout from the IMPACT trial expected in the fourth quarter of 2025 along with longer-term noninvasive test data and weight loss results. Altimmune's Phase 2 RECLAIM trial in alcohol use disorder and RESTORE trial in alcohol-associated liver disease, initiated in May 2025 and July 2025 respectively, are currently enrolling patients to evaluate pemvidutide's therapeutic potential across multiple liver and metabolic disease indications.

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.grandviewresearch.com/industry-analysis/metabolic-disorder-therapeutics-market

2. https://www.biospace.com/press-releases/cell-and-gene-therapy-market-size-rapidly-approaching-117-46-billion-by-2034

3. https://www.ajmc.com/view/weight-loss-medications-show-promise-in-masld-mash

https://www.labiotech.eu/best-biotech/anti-aging-biotech-companies/