Longeveron Inc【LGVN】株式ニュース

Cell Therapies Moving From Lab to Factory Floor, and the Stocks Behind ThemMarch 3, 2026 10:02 AM
PR Newswire (US)

Issued on behalf of Avaí Bio, Inc.VANCOUVER, BC, March 3, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary — The global cell therapy market is projected to surpass $8.2 billion in 2026, driven by a wave of clinical breakthroughs and manufacturing milestones reshaping regenerative medicine[1]. CAR T-cell therapy alone is valued at nearly $7 billion this year, expanding at an 18% compound annual growth rate as off-the-shelf platforms eliminate the logistical barriers that once limited patient access[2]. Among the companies advancing next-generation cell-based treatments are Avaí Bio (OTCQB: AVAI), FibroBiologics (NASDAQ: FBLG), Fate Therapeutics (NASDAQ: FATE), Mesoblast (NASDAQ: MESO), and Longeveron (NASDAQ: LGVN).

The broader cell and gene therapy sector is forecast to surge from $10.4 billion to more than $45 billion by 2035, with North America commanding over half the global market as clinical pipelines mature and reimbursement pathways solidify[3]. With more than 40 FDA-approved cell and gene therapy products now available and dozens more advancing through late-stage trials, institutional capital is accelerating into the companies building scalable manufacturing platforms[4].Avaí Bio (OTCQB: AVAI) recently announced a production milestone alongside joint venture partner Austrianova, initiating manufacturing of a Master Cell Bank (MCB) of genetically modified cells that overexpress the a-Klotho protein. These cells will enable Klothonova, the parties' joint venture, to advance its anti-aging product candidate within the ongoing a-Klotho development program.A Master Cell Bank is a GMP-compliant, fully characterized collection of vials derived from a single clone, forming the critical starting material for scale-up and production of cell therapies. It serves as the primary source for all working cell banks, ensuring product consistency while reducing risk by safeguarding against contamination, degradation, extraneous agents, and genetic instability. Establishing a high-quality MCB under Good Manufacturing Practices positions the partners for long-term success by supporting a reliable and sustainable supply chain.This milestone supports the joint venture's efforts to create a sustainable, cell-based approach to restoring circulating levels of the a-Klotho "longevity protein" for potential therapeutic benefits in aging and related conditions. All preparatory activities were completed in February, enabling the partners to move directly into the production phase."We are excited to enter the first step in the production phase of a-Klotho producing cells as part of our commitment to deliver safe, effective treatments for aging associated diseases," said Chris Winter, CEO of Avaí Bio.Prof. Walter H. Gunzburg, Chairman of Austrianova, added, "MCBs are a prerequisite for the production of Cell-in-a-Box® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards."The banked cells will be used to produce the final Cell-in-a-Box® encapsulated cell product, intended for innovative therapies targeting age-related diseases such as Alzheimer's and cancer, while advancing anti-aging and longevity treatments. Peer-reviewed research has linked higher Klotho levels to reduced risk of neurodegenerative disease and certain cancers, drawing growing scientific interest to the protein's therapeutic potential.Back in September, Avaí Bio and Austrianova established Klothonova as a Nevada-based entity equally owned by both companies. The JV focuses on sustainable production of a-Klotho, a key regulatory protein documented for its anti-aging and protective effects on organs, using encapsulated cell-based therapies.Following its recent rebrand from Avant Technologies, Avaí Bio has fully pivoted to biotechnology, concentrating on sourcing, developing, and protecting advanced cellular therapies through strategic joint ventures and licensing agreements. The company's dual-program approach targets both the Insulinova diabetes program and the Klothonova a-Klotho anti-aging program, each leveraging Austrianova's proprietary Cell-in-a-Box® encapsulation technology.CONTINUED… Read this and more news for Avaí Bio at: https://usanewsgroup.com/avai-profile/In other industry developments:FibroBiologics (NASDAQ: FBLG), a clinical-stage biotechnology company with more than 270 patents issued and pending, recently announced the issuance of a new U.S. patent covering fibroblast cell therapy for the treatment of osteoporosis. The patent covers methods of treating bone diseases through the administration of fibroblast cells, including modified fibroblasts designed to modulate bone remodeling by inhibiting osteoclast activity and promoting osteoblast activity."This patent is more than a milestone, it's a bold step forward in our mission to rethink what's possible in regenerative medicine," said Pete O'Heeron, CEO of FibroBiologics. "Osteoporosis impacts millions of lives across the globe, often quietly and profoundly. We see fibroblasts not just as cells, but as catalysts for change, with the potential to transform the way we treat bone degeneration by tackling both inflammation and the rebuilding process at its core. That's the kind of innovation that truly excites us."The patent further strengthens the company's intellectual property portfolio in regenerative medicine and bone-related disorders. FibroBiologics is developing a pipeline of treatments using fibroblast cells and fibroblast-derived materials across multiple clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, and cancer. The Houston-based company represents the next generation of medical advancement in cell therapy and tissue regeneration.Fate Therapeutics (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to induced pluripotent stem cell-derived off-the-shelf cellular immunotherapies, recently reported that patients in its FT819 clinical trial have been successfully treated with off-the-shelf CAR T-cell therapy as same-day hospital discharge, a milestone that eliminates the extended hospitalization requirements seen with traditional CAR T-cell programs. FT819 is enrolling across 16 clinical sites in the U.S., U.K. and E.U., with 15 systemic lupus erythematosus patients and four systemic sclerosis patients treated to date. The first systemic sclerosis patient reaching the three-month evaluation timepoint showed meaningful disease improvement using less-intensive conditioning chemotherapy."I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics," said Bob Valamehr, CEO of Fate Therapeutics. "We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation."The company ended fiscal 2025 with $205 million in cash and investments, projecting operating runway through year-end 2027. Fate Therapeutics expects to commence its first planned Phase 2 clinical trial in lupus nephritis while actively expanding clinical site activation and patient enrollment across multiple autoimmune indications, including systemic sclerosis, vasculitis, and inflammatory myositis.Mesoblast (NASDAQ: MESO), a global leader in allogeneic cellular medicines for inflammatory diseases, recently presented data showing that Ryoncil® achieved similarly high survival outcomes in steroid-refractory acute graft-versus-host disease regardless of whether used in children or adults, and whether as second or third line treatment. The results, presented at the Tandem Meetings of the American Society for Transplantation and Cellular Therapy in Salt Lake City, demonstrated that adult patients treated under the Emergency Investigational New Drug program had at least as favorable day-100 survival as pediatric patients."Treatment initiation as early as possible is essential in order to give Ryoncil® the best chance to save as many precious lives as possible," said Dr. Silviu Itescu, CEO of Mesoblast. "The Phase 3 trial in adults with SR-aGvHD will position Ryoncil® as the earliest treatment regimen for severe disease after steroid resistance."Ryoncil® is the first mesenchymal stromal cell product approved by the FDA for any indication. Mesoblast plans to commence enrollment this quarter in a pivotal trial of early second-line Ryoncil® in adults with severe SR-aGvHD, targeting a population approximately three times the size of the pediatric market. The company holds over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions, manufacturing methods, and indications.Longeveron (NASDAQ: LGVN) recently announced that results of its Phase 2b clinical trial were published in Cell Stem Cell, demonstrating that intravenous laromestrocel improved the physical condition of patients with age-related frailty after nine months compared to placebo. The randomized trial of 148 ambulatory individuals showed clinically meaningful, dose-dependent increases in the six-minute walk test, the primary endpoint."We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with aging-related frailty," said Joshua M. Hare, MD, Chief Science Officer at Longeveron. "Those with Aging Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery. This development area is at the core of Longeveron's mission – advancing stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly."Patients receiving laromestrocel showed a 63.4-meter improvement in six-minute walk distance at nine months. Longeveron is developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, with programs spanning hypoplastic left heart syndrome, Alzheimer's disease, and pediatric dilated cardiomyopathy. Laromestrocel has received five FDA designations across its pipeline, including Orphan Drug, Fast Track, Rare Pediatric Disease, and Regenerative Medicine Advanced Therapy.Article Source: usanewsgroup.comCONTACT:
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Original: Cell Therapies Moving From Lab to Factory Floor, and the Stocks Behind Them

Longeveron® Announces Full-Year 2024 Financial Results and Provides Business Update
Pivotal Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ (laromestrocel) in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric disease and orphan-designated indication, has achieved more than 90% enrollment and is expected to complete enrollment in the second quarter of 2025
Lomecel-B™ Biological License Application (BLA) submission for full traditional approval anticipated in 2026, if ELPIS II is successful
FDA meeting anticipated late in first quarter of 2025 to discuss possible development paths for Lomecel-B™ in mild Alzheimer’s disease
WHO International Nonproprietary Names (INN) Expert Committee approved “laromestrocel” for the non-proprietary name of Lomecel-B™
Total Revenue for 2024 increased 237% year-over-year to $2.4 million, primarily due to the successful initiation of contract manufacturing services and increased participant demand for the Bahamas Registry Trial
Company to host conference call and webcast today at 4:30 p.m. ET
MIAMI, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today reported financial results for the full-year ended December 31, 2024 and provided a business update.

“Throughout 2024, we continued to advance the development of our investigational cellular therapy candidate, Lomecel-B™, as a potential treatment for both Hypoplastic Left Heart Syndrome, or HLHS, and mild Alzheimer’s disease,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We are now approaching multiple potentially transformational milestones over the next 12 months, including, completion of enrollment in our pivotal Phase 2b clinical trial in HLHS, which may establish the timeline for a potential Biological License Application, or BLA, submission for full traditional approval for HLHS, and our upcoming meeting with the FDA to determine the development pathway for the Alzheimer’s disease program. Our team’s expertise in clinical development and manufacturing, combined with several positive initial results across five clinical trials in three indications, continues to position Longeveron as a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics.”

Development Programs
Longeveron’s investigational therapeutic candidate is Lomecel-B™, a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications.

In February 2025, the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved “laromestrocel” for the non-proprietary name of Lomecel-B™.

Hypoplastic Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is severely underdeveloped.

Phase 2b controlled clinical trial (ELPIS II) evaluating Lomecel-B™ as a potential adjunct therapy for HLHS is currently enrolling 38 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. ELPIS II has achieved more than 90% enrollment and is currently anticipated to complete enrollment in the second quarter of 2025.
In 2024, the U.S. Food and Drug Administration (FDA) indicated that ELPIS II is a pivotal trial and, if it demonstrates sufficient evidence of efficacy, it would be acceptable for a Biologics License Application (BLA) submission for full traditional approval.
ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).
In the open-label Phase 1 ELPIS I study, 10 children treated with Lomecel-B™ achieved 100% transplant-free survival up to five years post-Glenn surgery. This represents a significant improvement compared to historical control data, which show an 80% transplant-free survival rate at five years. These findings underscore the potential of Lomecel-B™ to enhance long-term outcomes and quality of life for children with single ventricle congenital heart disease.
The FDA has granted Lomecel-B™ Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS.
Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options.

The Company anticipates meeting with the FDA late in the first quarter of 2025 to discuss possible development paths in mild Alzheimer’s disease.
The FDA has granted Lomecel-B™ both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.
2024 Summary Financial Results

Revenues: Revenues for the year ended December 31, 2024 and 2023 were $2.4 million and $0.7 million, respectively. This represents an increase of $1.7 million, or 237%, in 2024 compared to 2023, primarily driven by higher participant demand for our investigational Frailty and Cognitive Impairment registry trial in the Bahamas (the “Bahamas Registry Trial”) and the addition of a third-party manufacturing services contract. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the year ended December 31, 2024 and 2023 was $1.4 million and $0.7 million, respectively. This increase of $0.7 million, or 110%, for the year ended December 31, 2024 was a result of increased participant demand. Contract manufacturing revenue for the year ended December 31, 2024 was $1.0 million, consisting of $0.5 million from manufacturing lease services and $0.5 million from manufacturing services contract.
Cost of Revenues and Gross Profit: Cost of revenues for the year ended December 31, 2024 and 2023 was $0.5 million and $0.5 million, respectively. This resulted in a gross profit of approximately $1.9 million for the year ended December 31, 2024, an increase of $1.7 million, or 752%, compared to a gross profit of $0.2 million in 2023.
General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2024 decreased to approximately $10.3 million, compared to $12.2 million for the same period in 2023. This decrease of approximately $1.9 million, or 16%, was primarily due to lower personnel expenses as a result of reduced severance in 2024 and lower legal and other administrative expenses.
Research and Development Expenses: Research and development expenses for the year ended December 31, 2024 decreased to approximately $8.1 million from approximately $9.1 million for the same period in 2023. This decrease of $1.0 million, or 10%, was primarily driven by a reduction of $2.3 million in expenses related to the completed CLEAR MIND Alzheimer’s disease clinical trial, reduced costs for the Aging-related Frailty clinical trial following our decision to discontinue trial activities in Japan, and a $0.9 million decrease in supply costs. These reductions were partially offset by $1.7 million in higher compensation and benefit costs and a $0.3 million increase in equity-based compensation expenses allocated to research and development.
Other Income (Expense), net: Other income (expense) for the years ended December 31, 2024 and 2023 was an income of $0.6 million and an expense of $0.4 million, respectively. Net other income for 2024 was driven by higher interest income, compared to net other expense for 2023 driven by realized losses on sales of marketable securities of $0.3 million, write-offs of intangible assets of $0.3 million and reduced benefit of tax credits of $0.3 million.
Net Loss: Net loss decreased to approximately $16.0 million for the year ended December 31, 2024, from a net loss of $21.4 million for the same period in 2023. The decrease in the net loss of $5.4 million, or 25%, was for reasons outlined above.
Cash and cash equivalents as of December 31, 2024 were $19.2 million. The Company currently believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025 based on its current operating budget and cash flow forecast. However, as a result of its successful Type C meeting with the FDA in August 2024 with respect to the HLHS regulatory pathway, the Company has started to ramp up BLA enabling activities as it currently anticipates a potential filing with the FDA in 2026, if the current ELPIS II trial is successful. The Company’s operating expenses and capital expenditure requirements are expected to accelerate in calendar year 2025 as a result of these activities, including CMC (Chemistry, Manufacturing, and Controls) and manufacturing readiness, and there will be a need to increase its current proposed spend and further increase its capital investments. The Company intends to seek additional financing and non-dilutive funding options to support these activities, and current cash projections may be impacted by these ramped up activities and any financing transactions entered into.
Conference Call and Webcast Details:

Conference Call Number: 1.877.407.0789
Conference ID: 13751432

Call me™ Feature: Click Here
Webcast: Click Here

An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ 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 Aging-related Frailty. Lomecel-B™ development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced