Remestemcel-L-rknd

Issued on behalf of Avant Technologies Inc. Equity Insider News Commentary VANCOUVER, BC, Dec. 16, 2025 /PRNewswire/ -- The cell therapy manufacturing sector reached a pivotal inflection point in late 2025, with contract development and manufacturing organizations capturing 67.5% market share as the industry transitions from boutique R&D operations to scalable bioprocessing infrastructure[1]. Gene and CAR-T therapy demand has driven CDMO partnerships to expand viral vector production and GMP-compliant facilities at unprecedented velocity, overcoming bottlenecks that previously constrained commercial access[2]. Five companies positioned at this manufacturing convergence point are attracting institutional attention: Avant Technologies, Inc. (OTCQB: AVAI), ProKidney Corp. (NASDAQ: PROK), Mesoblast Limited (NASDAQ: MESO), Lineage Cell Therapeutics, Inc. (NYSE-A: LCTX), and BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI). The regenerative medicine market is projected to surge from $48.45 billion in 2024 to $403.86 billion by 2032, with cell-based therapies representing the fastest-growing segment, yet most emerging biotechs trade at steep discounts to this trajectory[3]. Platform technologies including cell encapsulation and delivery systems are unlocking the broader $44 billion cell-based therapy opportunity by enabling off-the-shelf, scalable treatments for kidney disease, diabetes, CNS disorders, and cardiovascular conditions, creating an urgent window for investors to capture this industrial transformation[4]. Avant Technologies, Inc. (OTCQB: 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 at: ProKidney Corp. (NASDAQ: PROK) recently presented full results from its Phase 2 REGEN-007 study at the American Society of Nephrology Kidney Week, demonstrating that bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m² improvement in annual eGFR decline—a statistically significant 78% improvement (p<0.001). Among the 63% of Group 1 patients who met key Phase 3 PROACT 1 inclusion criteria, treatment produced an even more pronounced 5.5 mL/min/1.73m² improvement representing an 85% benefit over control (p=0.005). Post-hoc analysis suggests rilparencel demonstrated treatment effects incremental to standard-of-care medications including SGLT2 inhibitors and GLP-1 receptor agonists. "The Phase 2 REGEN-007 full results recently presented at ASN Kidney Week further strengthen the body of evidence supporting our ongoing Phase 3 PROACT 1 study and underscore the potential of rilparencel to become a novel treatment option for patients with advanced CKD and diabetes," said Bruce Culleton, M.D., CEO of ProKidney. "In Group 1, which mirrored the dosing regimen being evaluated in the ongoing Phase 3 PROACT 1 study, treatment with rilparencel led to statistically significant and clinically meaningful stabilization of kidney function." More than half of the approximately 360 patients required for the accelerated approval analysis using eGFR slope have been enrolled as of August 2025, with topline results anticipated in Q2 2027. The company ended the third quarter with $271.7 million in cash and marketable securities, supporting operations into mid-2027. Mesoblast Limited (NASDAQ: MESO) announced that an independent comparative analysis of efficacy and safety between remestemcel-L and ruxolitinib for treatment of steroid-refractory acute graft versus host disease was presented at the 67th American Society of Hematology Annual Meeting, with study authors concluding that remestemcel-L showed superior outcomes in complete and overall remission. The meta-analysis involved 2,732 patients across 11 studies, with 644 patients receiving remestemcel-L and 1,349 receiving ruxolitinib, demonstrating that while both therapies significantly improved quality of life, remestemcel-L exhibited notable differences in hematology, cardiac, and hepatic adverse events. Ryoncil, the company's FDA-approved formulation of remestemcel-L, represents the first mesenchymal stromal cell product approved by the U.S. Food and Drug Administration for any indication and remains the only product approved for children under age 12 with SR-aGvHD. The flagship journal Blood featured FDA approval of Ryoncil as an important advance in the field for treatment of acute GvHD, underscoring the therapy's clinical significance. Mesoblast is advancing additional indications for remestemcel-L including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while also developing rexlemestrocel-L for heart failure and chronic low back pain. Lineage Cell Therapeutics, Inc. (NYSE-A: LCTX) reported third quarter 2025 financial results showing $3.7 million in revenues and a cash position of $40.5 million expected to support operations into Q2 2027. The company successfully completed cGMP production runs for both OpRegen and OPC1 from a master and working cell bank system capable of producing millions of doses, while its OpRegen cell therapy for age-related macular degeneration continues advancing under a collaboration with Roche and Genentech. Lineage also entered a research collaboration with William Demant Invest A/S to develop ReSonance (ANP1) for sensorineural hearing loss and launched a new Type 1 Diabetes cell therapy initiative focused on large-scale islet cell production. "We entered into a research collaboration with William Demant Invest A/S, which is designed to fund all currently planned preclinical development of our ReSonance program, demonstrating the ability of our technology platform to produce a partnered program with limited investment and in a short amount of time," said Brian M. Culley, CEO of Lineage Cell Therapeutics. "We solidified our position as a leader in allogeneic cell process development by reporting cGMP production for each of OpRegen and OPC1, from a master and working cell bank system which, in its current form, can support a production capability of millions of doses of a single-administration product, all from our in-house facility." The company treated its first chronic spinal cord injury participant in the DOSED clinical study evaluating OPC1 and continues pursuing grant funding from the California Institute for Regenerative Medicine (CIRM) for this program. Lineage plans to capitalize on its cell transplant platform and manufacturing achievements to advance additional programs through funded collaborations. BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) secured FDA clearance for its Phase 3b ENDURANCE study of NurOwn in amyotrophic lateral sclerosis, designed to enroll approximately 200 participants at leading ALS centers in a 24-week randomized, double-blind, placebo-controlled trial followed by a 24-week open-label extension. The primary efficacy measure will assess change from baseline to Week 24 on the ALSFRS-R scale, with data from the controlled portion expected to support a Biologics License Application. A Citizen Petition was recently filed with the FDA by representatives of the ALS community requesting renewed regulatory review of data supporting NurOwn, which the company acknowledges as underscoring continued interest in the therapy's potential therapeutic value. "We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn, designed to generate confirmatory data to support a potential BLA submission," said Chaim Lebovits, CEO of BrainStorm Cell Therapeutics. "We have been working closely with our network of clinical sites and with our selected manufacturing partners to ensure operational readiness." The company reported cash and restricted cash of approximately $0.23 million as of September 30, 2025, with third quarter net loss of $2.1 million compared to $2.7 million in the prior year period. Research and development expenses decreased to $0.9 million from $1.0 million year-over-year, while general and administrative expenses declined from $2.0 million to $1.1 million. Source: need-to-know/ CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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