Tillkännagivande • Jul 02
NurExone Biologic Inc. announced that it has received CAD 0.627795 million in funding NurExone Biologic Inc. announced a non-brokered private placement of 1,012,573 units of the company at a price per unit of CAD 0.62 for gross proceeds of CAD 627,795.26 on June 30, 2026. Each Unit consists of one common share and one Common Share purchase warrant. Each Warrant entitles the holder thereof to purchase one Common Share at a price of CAD 0.78 per Common Share for a period of 36 months from the closing date. Closing of the offering is subject to receipt of all necessary regulatory approvals, including approval of the TSXV, and all securities issued under the offering are subject to a statutory hold period of four months and one day from the closing date of the offering. No insiders participated in this offering and no finder’s fees were paid in connection with this offering.
The company has received $ 441,779 from 2 investors pursuant to Regulation D. Tillkännagivande • Mar 11
NurExone Biologic Inc. announced that it has received CAD 0.880751 million in funding NurExone Biologic Inc. announced a private placement of 1,295,222 units of the company at a price per unit of CAD 0.68 for gross proceeds of CAD 880,750.96 on March 11, 2026. Each Unit consists of one common share and one Common Share purchase warrant. Each Warrant entitles the holder thereof to purchase one Common Share at a price of CAD 0.85 per Common Share for a period of 36 months from the closing date. Closing of the offering is subject to receipt of all necessary regulatory approvals, including approval of the TSXV, and all securities issued under the offering are subject to a statutory hold period of four months and one day from the closing date of the offering. No insiders participated in this offering and no finder’s fees were paid in connection with this offering. Tillkännagivande • Feb 28
Nurexone Biologic Inc. Announces Step Down of Jacob Licht as Chief Executive Officer of Exo-Top Inc NurExone Biologic Inc. announced that Jacob Licht will be stepping down from his roles as Chief Executive Officer of Exo-Top Inc. at the end of March 2026 for personal reasons. Tillkännagivande • Jan 31
NurExone Biologic Inc. Announces Board Changes, Effective January 30, 2026 NurExone Biologic Inc. announced changes to its board of directors. Effective January 30, 2026, Eyal Gabbai has been appointed to the Board replacing Dr. Gadi Riesenfeld, who has resigned from the Board. Dr. Riesenfeld will continue to support NurExone as a member of the Company’s Scientific Advisory Board. Mr. Gabbai brings extensive healthcare and international capital markets experience. Eyal Gabbai is the Chairman of Meuhedet Health Fund, Israel’s third largest health maintenance organization, with approximately 1.4 million members and annual turnover exceeding USD 3 billion. He is also Chairman of Medica Excel, a private hospital network. He previously served as Director-General of Israel’s Prime Minister’s Office, overseeing policy coordination across infrastructure, capital markets, communications and housing, with engagement across government, international counterparts, and the private sector. From 2002 to 2007, he was Director General of Israel’s Government Companies Authority, leading major privatization and capital markets transactions with aggregate proceeds exceeding USD 5 billion through initial public offerings and strategic sales. Tillkännagivande • Dec 20
NurExone Biologic Inc. Reports Anti-Inflammatory Activity of Its Exosomes in Lab Analysis NurExone Biologic Inc. announced new laboratory data demonstrating that its proprietary exosomes can significantly reduce inflammatory activity compared to untreated cells and cells treated with a commercially available exosome product. For TNF-alpha, another central inflammatory signal, NurExone's exosomes demonstrated a clear concentration-dependent response, as concentration increased, inflammatory signaling decreased further, reaching reductions of over 60% compared to the untreated inflamed control at the highest concentration tested. In contrast, commercially available exosome product showed little to no meaningful reduction in either inflammatory signal in the concentration analysed. INR 264.7 macrophages were stimulated with LPS (Lipopolysaccharide) to induced inflammation and treated with NurExone BM-MSC extracellular vesicles ("EVs") or commercial BM-MSC EVs at the indicated concentrations. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. Tillkännagivande • Dec 13
NurExone Biologic Inc. Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for Future First in Human Use Pathways NurExone Biologic Inc. announced meaningful progress in its long-term clinical-readiness strategy. In parallel, NurExone reported new scientific data showing strong biological activity in its exosomes compared with commercially available exosomes, reinforcing confidence in the platform as the Company advances toward human studies. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. These risks and uncertainties include, but are not limited to risks related to: the Company's early stage of development; lack of revenues to date; the inherent uncertainty of preclinical drug development, including challenges in identifying, engaging or retaining qualified manufacturing partners, achieving and maintaining GMP compliance, and producing consistent batches of ExoPTEN; the Company will not file for compassionate-use; the Master Cell Bank will no longer meet quality, consistency and/or supply requirements; the engagement of Russo will not be approved; the Company will not yield the intended benefits from their engagement of Russo; the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company's products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company's technologies; the Company's dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company's ability to protect its intellectual property; the possibility that the Company's technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications such as spinal cord injury, optic nerve repair, or other therapeutic areas; failure to meet planned development milestones or achieve commercial breakthroughs; the Company will not advance the ExoPTEN's manufacturing processes and/or analytical methods; the Company will not prepare regulatory submissions; the Company will not launch first compassionate-use nor first-in-human programs; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications. Tillkännagivande • Oct 10
NurExone Biologic Inc. Announces New Preclinical Results Showing That Its Lead Candidate ExoPTEN Produces A Producing, Dose-Dependent Therapies in an Eye Model of Glaucoma NurExone Biologic Inc. announced new preclinical results showing that its lead candidate ExoPTEN produces a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma. The study was conducted in collaboration with Prof. Ygal Rotenstreich team at the Goldschleger Eye Institute at Sheba Medical Center, one of the world’s leading hospitalsi. It demonstrated that ExoPTEN’s biological activity increases with higher dosing levels in animals with optic nerve injury, resulting in consistent and measurable recovery of visual function. The findings show that ExoPTEN’s regenerative effect is reproducible, quantifiable, and scales with dose. This dose-response study, the third independent investigation of ExoPTEN’s activity in optic nerve injury, complements the previously announced results from June 2024 and December 2024, which showed structural preservation and survival of retinal ganglion cells. The optic nerve crush (‘ONC’) model used in these experiments mimics the nerve damage that occurs in glaucoma, one of the leading causes of irreversible blindness. The researchers led by Prof. Rotenstreich, tested low and high doses of ExoPTEN delivered by extrachoroidal injection directly to the eye. Functional measurements of retinal activity using scotopic threshold response electroretinography (STR-ERG) showed that both ExoPTEN doses improved visual signal strength in animals with optic nerve injury, with the high-dose group achieving response amplitudes comparable to those of uninjured eyes. This result demonstrates substantial functional recovery and provides clear evidence of a dose-dependent therapeutic effect that aligns with ExoPTEN’s proposed biological mechanism. Tillkännagivande • Sep 12
NurExone Biologic Inc. announced that it has received CAD 0.632656 million in funding NurExone Biologic Inc. announced a non-brokered private placement to issue 930,376 units at an issue price of CAD 0.68 for gross proceeds of CAD 632,655.68 on September 11, 2025. Each unit consisted of one common share in the capital of the company and one-half of one common share purchase warrant. Each warrant entitles the holder thereof to purchase one common share at a price of CAD 0.88 per common share for a period of 36 months, subject to acceleration. Jay Richardson participated in the offering and acquired 24,854 units. The transaction is subject to TSX Venture Exchange approval. Closing of the offering is subject to receipt of all necessary regulatory approvals, including the TSXV, and all securities issued under the offering are subject to a statutory hold period of four months and one day from the closing of the offering. The offering was approved by the members of the board of directors of the company. Tillkännagivande • Sep 09
NurExone Biologic Inc. Receives U.S. Patent Allowance for Exosome Manufacturing, Strengthening Supply Chain Readiness NurExone Biologic Inc. announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent covering the Company’s proprietary process for producing exosomes, natural cell-free nanoparticles derived from stem cells. The patent is part of an extensive international patent family, securing broad global protection and strengthening the company’s worldwide market position. The patent secures exclusive rights to NurExone’s 3D scaffold and shear-stress based bioreactor system, enabling scalable, reproducible exosome production. Together with the GMP-grade Master Cell Bank acquired in December 2024, this milestone establishes a robust foundation for NurExone’s clinical supply chain and the planned launch of Exo-Top Inc.’s commercial-scale production and business-to-business supply of naïve exosomes. The patented manufacturing process is under an exclusive worldwide license to NurExone from the Technion Research and Development Foundation Ltd. Tillkännagivande • Jul 09
NurExone Biologic Inc. Announces New ExoPTEN Preclinical Study Indicates Significant Improvement in Walking Quality in Spinal Cord Injury Model NurExone Biologic Inc. announced new preclinical results demonstrating that 100% of small animals treated with a higher dose of ExoPTEN regained motor function after spinal cord injury. The results of the preliminary, dose-ranging study were confirmed using precise measurements using the CatWalk XT system. Using the CatWalk XT system, researchers assessed ExoPTEN’s effect on the animals’ ability to walk. All animals (100%) in the higher-dose group demonstrated measurable gait recovery, in contrast to one animal in the untreated group which exhibited minimal stepping. In the study, researchers compared medium and high single doses of ExoPTEN, administered minimally-invasively on the day of spinal cord compression surgery, to a control group that received injection of the vehicle only. Medium and high doses used in this study refer to escalating dose levels used to explore potential therapeutic effects and tolerability in animals. The treatment demonstrated a dose-dependent effect, with 100% of animals in the high-dose group regaining walking ability in both hind limbs, compared to 50% in the medium-dose group, and only 1 out of 6 rats in the untreated control group. The gait analysis data also showed dose-dependent improvement in walking function. Animals treated with higher dose of ExoPTEN displayed larger paw print areas, greater maximal contact area of their hind paws, a wider base of support, and an extended duration of the paw contact with the walkway. These indicators reflect improved balance, strength, coordination and weight bearing during walking. Evaluation of additional study parameters is ongoing. Notably, the high dose was well tolerated, with no observed side effects. As part of this ongoing work, the Company plans to initiate additional studies to explore alternative dosing regimens, while also advancing the optimization of ExoPTEN’s manufacturing processes and analytical methods. These efforts aim to refine the drug’s therapeutic profile and facilitate engagement with regulatory authorities. The CatWalk XT system, developed by Noldus Information Technology, is widely considered a leading tool for studying animal movement. It uses an illuminated glass walkway to capture footprints and movement patterns, allowing researchers to collect precise, objective data on an animal’s motor function. NurExone continues to advance its research and development efforts, optimizing ExoPTEN’s dosing strategies and manufacturing processes, and preparing for regulatory submissions as it aims to launch first-in-human clinical trials. The Company remains committed to developing treatments that bring new hope to people who suffer nervous system injuries. Tillkännagivande • Jun 05
NurExone Strengthens Path to Clinical Trials for ExoPTEN with New Manufacturing Process Validation NurExone Biologic Inc. announced that on May 22, 2025, it presented new manufacturing process data at the 4th annual meeting of the Israeli Society for Extracellular Vesicles Research (‘ISEVR’), a conference dedicated to cutting-edge exosome science. The Company’s presentation showcased promising early data on the viability and potency of cells from its proprietary Master Cell Bank (‘MCB’). The MCB represents a valuable and key strategic asset in advancing good manufacturing practices (‘GMP’)-compliant manufacturing of exosomes for the Company’s lead therapeutic candidate, ExoPTEN, as well as for its subsidiary, Exo-Top Inc. (‘Exo-Top’). ‘The findings suggest strong economic potential, indicating that the MCB may support an extended number of production batches maximizing its value and utility’, commented Dr. Dr. Tali Kizhner, Research and Development Director of NurExone. In addition to confirming the robust growth performance of the mesenchymal stem cells (‘MSCs’), Cells exhibit population doubling time (PDT) of 20.4hr±1.56 for up to 9 passages. The PDT of cells, which refers to the time it takes for the number of cells to double, utilized to investigate cell growth dynamics, and serves as a measure for assessing MSCs’ proliferative capacity (Sci Rep. 2021;11(1):3403). The shorter the population doubling time, the stronger the proliferative capacity of the cells. the new data highlights recent advancements in both upstream and downstream manufacturing processes, demonstrating consistent exosome yields and preserved biological potency across multiple production runs. NurExone intends to transfer the manufacturing process to its wholly owned U.S.-based subsidiary, Exo-Top, who will be responsible for establishing GMP-compliant MSC driven exosome production to support both clinical trials and future commercial supply. ExoPTEN is being developed as a first-in-class, exosome-based therapy targeting high-impact neurological indications, including acute spinal cord injury, optic nerve damage, facial nerve injury, and additional conditions such as traumatic brain injury. NurExone expects to initiate a first in human clinical trial of ExoPTEN in 2026 and is continuing to expand its manufacturing capabilities to support broader development of exosome-based regenerative therapies. Tillkännagivande • May 31
NurExone Announces Clinical Trial Plans for Acute Spinal Cord Injury Therapy At Annual Meeting of American Spinal Injury Association NurExone Biologic Inc. announced that Professor Nahshon Knoller M.D., senior clinical advisor to the Company, will be presenting at the prestigious annual meeting of the American Spinal Injury Association (“ASIA”), where he will discuss the Company’s plans for future clinical trials in 2026 in the field of acute spinal cord injuries (“SCI”) for ExoPTEN, a first-in-class exosome-based therapy, as well as results from the Company’s preclinical studies.NurExone expects to initiate a Phase 1/2a clinical trial in 2026 (“2026 SCI Trial”) marking a major milestone in the advancement of regenerative therapies for central nervous system injuries.Adult patients with traumatic SCI between spinal levels C5 and T10, classified as ASIA Grade A or B, will be enrolled in the 2026 SCI Trial. These patients will be treated within 3 to 7 days post-injury. Phase 1 will be a dose-escalation study evaluating safety in up to 18 patients, followed by a Phase 2a randomized, double-blind, placebo-controlled trial measuring functional recovery in 10–15 patients. At the 2025 ASIA meeting, Professor Knoller, a renowned neurosurgeon and former Director of the Spinal Trauma Unit at Sheba Medical Center, the Middle East’s largest hospital and ranked by Newsweek as one of the ten leading hospitals in the world, will provide updates on the 2026 SCI Trial, as well as results from the Company’s other preclinical studies. ExoPTEN is based on mesenchymal stem cell-derived exosomes loaded with siRNA targeting PTEN, a molecular inhibitor of neural regeneration through the mTOR pathway. Delivered via intranasal and intrathecal routes, ExoPTEN is designed to reduce cell death and promote axonal regrowth in the acute post-injury phase. The therapy has been granted Orphan Drug Designation by both the United States Food and Drug Administration and European Medicines Agency.Preclinical studies to be presented by Professor Knoller at ASIA showed robust recovery of motor, sensory, and structural function in rat models of complete spinal cord transection and compression. MRI, BBB scoring, von Frey testing, and histology have confirmed the therapeutic effects of ExoPTEN. Fluorescent labeling has shown that exosomes effectively homed to the injury site for up to seven days post-injury. Being invited to present these findings at ASIA underscores the Company’s emergence as an innovator in neuroregeneration. Tillkännagivande • May 28
NurExone Biologic Inc. announced that it has received CAD 0.137769 million in funding NurExone Biologic Inc. announced a private placement that it has issued 393,625 warrants at an issue price of CAD 0.35 per warrant for the gross proceeds of up to CAD 137,768.75 on May 27, 2025. Tillkännagivande • May 09
NurExone Biologic Inc. Advances Vision Restoration Strategy with Preclinical Data Presentation at the Association for Research in Vision and Ophthalmology 2025 NurExone Biologic Inc. announced that its preclinical data on optic nerve regeneration study was presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology in Salt Lake City Utah, the world's largest and most respected vision science conference. In developing the forward-looking statements in this press release, have applied several material assumptions, including: the Company will realize on the benefits of exosome loaded drugs in regenerating or repairing damaged nerves; the ability of the Company's products to be used for patient treatment; the Company will fulfill its intended future plans and expectations; there being growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas; the Company will carry out its pre-clinical trials and realize upon the benefits of the pre-clinical trials; the Company having the ability to maintain its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and cell therapy applications; the Company will receive all regulatory approvals; the Company will have clinical and commercial breakthroughs in regenerative medicine; the Company will be able to realize its future development plans, operational initiatives, and strategic objectives; the Company's ability to advance its therapeutic programs and clinical milestones; the results of the Company's preclinical trials and its ability to be a promising treatment pathway for SCI; the Company's ability in advancing toward clinical translation in several high-impact indications; the results of the Company' preclinical trials and its suggest of a promising treatment pathway for glaucoma; the Company developing groundbreaking therapies for regenerative medicine in several indications; ExoPTEN having the ability to address vision loss and improve patient lives; the Company having the able to advance toward clinical translation in several high -impact indications; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications, including recovery of optic nerve function and overall visual health. Tillkännagivande • Apr 25
NurExone Biologic Inc. to Showcase Breakthrough in Facial Nerve Regeneration at ISEV 2025 NurExone Biologic Inc. is presenting new data at the 2025 International Society for Extracellular Vesicles (ISEV) Annual Meeting being held in Vienna April 24-27. In developing the forward-looking statements in this press release, the company maintaining its ongoing commitment to using its ExoTherapy platform to advance the field of regenerative medicine and cell therapy applications; the Company will receive all regulatory approvals; the Company will have clinical and commercial breakthroughs in regenerative medicine; the Company will be able to realize its future development plans, operational initiatives, and strategic objectives; the Company's ability to advance its therapeutic programs and clinical milestones; the Company's ability to present its preclinical findings at ISEV, as outlined herein; the results of the Company's preclinical trials and its ability to be a promising treatment pathway for SCI; the Company's ability in advancing toward clinical translation in several high-impact indications; and the NurExone platform technology will offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications. These risks and uncertainties include, but are not limited to risks related to: the Company's early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; dependence on the Company's strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertainty clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the inability to obtain or maintain regulatory approval of the drug product candidates of the company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the inability to obtain or maintaining intellectual property protection for the drug product candidates of theCompany; risks that the Company's intellectual property and technology won't have the intended impact on the Company and/or its business; the ability to carry out its pre-clinical trials and realize upon the stated benefits of the pre-clinical trials; the inability of the Company to produce and/or supply exosomes for a wide range of applications; the inability of the Company's products to be used for patient treatment; there not being broader adoption in the field and/or cell therapy applications; the inability of the company to fulfill its intended future plans and expectations; there not being growing clinical demand for innovative treatments in spinal cord, optic nerve, and/or other therapeutic areas; the inability of the Company will not have clinical and/or commercial breakthroughs in regenerative Medicine; the Company will be unable to fulfill its intended future plans, operational initiatives, and clinical milestones. Tillkännagivande • Apr 23
Exo-Top Inc. Appoints Jacob Licht as Chief Executive Officer NurExone Biologic Inc. announced the appointment of Jacob Licht as Chief Executive Officer of Exo-Top Inc. (“Exo-Top”), a wholly owned subsidiary of the Company, and as Vice President, Corporate Development at NurExone. Exo-Top is a U.S.-based GMP-compliant exosome manufacturing site and will be the pillar of the Company’s global supply chain and commercialization strategy.Mr. Licht’s new roles will include leading the establishment of Exo-Top’s manufacturing capabilities, developing strategic partnerships, and developing corporate initiatives aligned with NurExone’s path toward clinical readiness and future fundraising. Mr. Licht brings more than 20 years of experience in manufacturing-intensive biotech and specialty pharmaceuticals companies. He has led transactions totaling $1 billion across mergers and acquisitions, licensing, and asset sales. His previous leadership roles include Vice President of Business Development at Lantheus Medical Imaging and Vice President of Corporate Development at Bavarian Nordic and Emergent BioSolutions, where he was instrumental in driving strategic acquisitions and commercial partnerships. Tillkännagivande • Apr 15
NurExone Biologic Inc., Annual General Meeting, Jun 18, 2025 NurExone Biologic Inc., Annual General Meeting, Jun 18, 2025. Location: ontario, toronto Canada Tillkännagivande • Apr 04
NurExone Biologic Inc. announced that it has received CAD 2.303105 million in funding NurExone Biologic Inc announced a non brokered private placement of 3,543,238 units at a price of CAD 0.65 per Unit for aggregate gross proceeds of CAD 2,303,104.7 on April 4, 2025. Each Unit consisted of one common share and one Common Share purchase warrant. Each Warrant entitles the holder thereof to purchase one Common Share at a price of CAD 0.85 per Common Share for a period of 36 months. Closing of the Offering is subject to receipt of all necessary regulatory approvals, including TSXV, and all securities issued under the Offering are subject to a statutory hold period of four months and one day from the closing of the Offering and applicable U.S. legends. Tillkännagivande • Mar 15
NurExone Biologic Inc. Completes an Important Preclinical Study Towards Its Investigational New Drug Submission NurExone Biologic Inc. announced that it has successfully completed an important preclinical study towards its Investigational New Drug submission. The new study, which advances the Company's path towards first-in-human trials, demonstrated that ExoPTEN treatment with different dose regimens led to both motor function recovery and significant improvements in blood flow at the site of spinal cord injury--an essential factor in tissue healing and functional recovery. Regulatory milestones, including Orphan Drug Designation, facilitate the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. Tillkännagivande • Jan 23
NurExone Biologic Inc. announced that it has received CAD 0.479918 million in funding NurExone Biologic Inc announced a non-brokered private placement of 856,996 units at an issue price of CAD 0.56 per unit for the gross proceeds of CAD 479,917.76 on January 21, 2025. Each Unit consisted of one common share and one Common Share purchase warrant. Each Warrant entitles the holder thereof to purchase one Common Share at a price of CAD 0.70 per Common Share for a period of 36 months, subject to acceleration. Closing of the Offering is subject to receipt of all necessary regulatory approvals, including TSXV, and all securities issued under the Offering are subject to a statutory hold period of four months and one day from the closing of the Offering. The company has received $434,512 (CAD 624,209.1653498061) from 6 investors pursuant to exemption provided under Regulation D. Tillkännagivande • Jan 22
Nurexone Biologic Inc. Appoints Dr. Tali Kizhner as its New Director of R&D NurExone Biologic Inc. has appointed Dr. Tali Kizhner as its new Director of R&D, reinforcing the Company’s leadership as it advances toward clinical trials. With over 15 years of R&D and chemistry, manufacturing and controls expertise, Dr. Kizhner has led initiatives in therapeutic protein development and dietary supplements. She joins NurExone from Biond Biologics, where she specialized in intracellular delivery of biologics, and previously led global R&D efforts at International Flavors & Fragrances. At Protalix Biotherapeutics, she played a pivotal role in developing biologics, including FDA- and EMEA-approved treatments for Fabry disease. Dr. Kizhner, who holds a Ph.D. in Biotechnology and Food Engineering from the Technion – Israel Institute of Technology, brings expertise and leadership to guide NurExone’s promising therapies through the upcoming stages of development and approvals. Tillkännagivande • Dec 07
NurExone Biologic Inc. Announces Preclinical Results in Restoring Vision After Optic Nerve Damage NurExone Biologic Inc. has announced significant findings from an expanded preclinical study of the potential of its portfolio drug, ExoPTEN, for repairing optic nerve damage. Conducted in collaboration with the Goldschleger Eye Institute at Sheba Medical Center, consistently ranked one of the top ten hospitals in the world, the study builds on previously announced preliminary results on June 28, 2024 and strengthens the suggestion of a promising treatment pathway for glaucoma, the leading cause of irreversible blindness globally. Researchers utilized a rodent model of optic nerve crush (ONC) to simulate the damage associated with conditions like glaucoma. After inducing injury, ExoPTEN was administrated via direct injection into the eyes. The study expanded on earlier findings which indicated that eyes treated with ExoPTEN regained nearly normal retinal activity, as evidenced by electrical tests. Expanded analyses of the study data showed clear recovery of signal transmission in treated eyes compared to untreated controls, which showed no significant response. Additionally, imaging results by optical coherence tomography (OCT) scans indicates and validates that in all of treated eyes (naïve exosome treatment or ExoPTEN treatment) a successful ONC procedure has been performed. The study also showed that ExoPTEN treatment significantly enhanced the survival of retinal ganglion cells - key neurons responsible for transmitting visual information to the brain. Detailed analysis of retinal flat-mounts confirmed this effect, with treated eyes exhibiting substantially higher counts of these cells compared to untreated or control-treated eyes. Tillkännagivande • Sep 27
NurExone Biologic Inc. announced that it expects to receive CAD 2 million in funding NurExone Biologic Inc. announced a non-brokered private placement of up to 3,636,363 units at an issue price of CAD 0.55 per Unit for aggregate gross proceeds of up to CAD 1,999,999.65 on September 26, 2024. Each Unit will consist of one common share and one Common Share purchase warrant. Each Warrant will entitle the holder thereof to purchase one Common Share at a price of CAD 0.70 per Common Share for a period of 36 months, subject to acceleration. Closing of the Offering is subject to receipt of all necessary regulatory approvals, including TSXV, and all securities issued thereunder will be subject to a statutory hold period of four months and one day from the closing of the Offering.
On the same date, the company announced that it has issued 2,927,541 Units at an issue price of CAD 0.55 per unit for the gross proceeds of CAD 1,610,147.55 in first tranche. Tillkännagivande • Aug 16
NurExone Biologic Inc. Announces Significant Advancements in Their Manufacturing Process of Exosomes NurExone Biologic Inc. announced significant advancements in their manufacturing process of exosomes. Exosomes, which are naturally released by cells, hold immense promise for regenerative medicine and they are at the heart of the Company’s innovative ExoPTEN product, which is being developed for the treatment of acute spinal cord injury and glaucoma. In a recent study, NurExone focused on ensuring that the Company’s exosome production process could consistently deliver reliable products. The study compared exosomes produced from bone marrow-derived mesenchymal stem cells (MSCs) from two different donors. Despite a natural variability in the starting material, the exosomes showed consistent yields measured in concentration of exosomes and similar size distribution, demonstrating the reliability of NurExone's production methods. To ensure the exosomes are not only consistent but also effective at targeting damaged tissue, NurExone conducted further tests using an advanced animal model of spinal cord injury. Exosomes from the different donors were administered to rats with spinal cord compression injuries and compared with an untreated control group. The newly produced exosomes demonstrated excellent and comparable homing abilities to the injured area. NurExone also investigated the effectiveness of exosomes produced using different culture methods, comparing 2D culture conditions with NurExone’s scalable 3D culture systems. Testing showed that both methods produced exosomes with similar homing and targeting capabilities. NurExone’s patented 3D culture is expected to facilitate commercial mass production of exosomes. Tillkännagivande • Jul 30
NurExone Biologic Inc. Announces Further Expansion of ExoPTEN Patent Coverage NurExone Biologic Inc. announced that the Israel Patent Office recently issued a Notice of Allowance for an ExoPTEN patent, covering innovative Extracellular Vesicles (EVs) comprising a phosphatase and tensin homolog ("PTEN") inhibitor and their application use. The Company's ExoPTEN drug, currently under development, aims to promote nerve growth and regeneration after acute spinal cord injury by inhibiting the PTEN protein. The patent, titled “Vesicles Comprising a PTEN Inhibitor and Uses of Same”, was originally submitted by the Technion Research and Development Foundation Ltd. (“Technion”) and Ramot at Tel Aviv University Ltd. It is the first patent licensed by NurExone from Technion and describes a fundamental element of the Company’s ExoPTEN nanodrug under development for acute spinal cord injury. Tillkännagivande • Jul 18
NurExone Biologic Inc. Announces Promising Preliminary Results in Optic Nerve Recovery Study of NurExone’s First Product ExoPTEN for Glaucoma NurExone Biologic Inc. announced the preliminary results from a small-scale controlled study exploring the use of its nanodrug, ExoPTEN, for optic nerve recovery in a rat model at Sheba Medical Center. This study marks a second clinical indication being investigated for ExoPTEN. The study was initiated by Professor Michael Belkin, following the success of ExoPTEN in nerve regeneration in the spinal cord indication in preclinical models. An Optic Nerve Crush (“ONC”) model was used to simulate conditions like glaucoma, where the optic nerve is crushed, resulting in impaired vision. Glaucoma is a common eye condition, particularly in older adults typically caused by optic nerve compression and pressure in the eye. The prevalence of glaucoma in the Western world is generally estimated to be around 2-3% in people aged 40 and older. The risk increases with age, and the prevalence can be higher in populations over 60. Estimated Number of People Affected in the United States alone, is over 3 million people, with many more cases likely undiagnosed. The study carried out under Prof. Ygal Rotenstreich and Dr. Ifat Sher of Sheba Medical Center explored the therapeutic effects of ExoPTEN on retinal function after ONC compared to healthy baseline levels, an untreated ONC control and ONC treated with naïve exosomes. Importantly ExoPTEN was administered minimally-invasively using suprachoroidal injection in a delivery system invented by Prof. Rotenstreich. As expected, the post-ONC control eyes exhibited a marked decline in retinal functionality, as evidenced by the lack of a peak (Fig. A – red graph). Experimental treatments with ExoPTEN (“ONC+PTEN"), showed promising results, with treated eyes exhibiting a peak similar to the healthy eye in the same animal indicating recovery of retinal response following optical nerve compression (Fig. B – green graph). The naïve exosome-treated rats (“ONC+EXO”) showed a lower peak and increased latency indicating a weaker response (Fig. C – brown graph). The results presented are from just 18 days following the ONC damage. These treatment findings suggest potential pathways for recovery of optic nerve function and overall healthy vision. Positive impact of specific treatments on retinal health: Graphs A-C show Electroretinogram (ERG) measurements of dark-adapted (scotopic) threshold retinal response (STR, in microvolts, mV) at -36 dB of three representative rats. In each rat, one eye was left intact as a healthy control (“Healthy”, gray). Rat A had ONC in one eye (red) with no treatment, which resulted in a flat, near-zero retinal response. Rat B had ONC in one eye and was treated with ExoPTEN (green, ONC+PTEN), resulting in a retinal response similar to the healthy intact contralateral eye. Rat C had ONC in one eye and was treated with naïve exosomes (brown, ONC+EXO), resulting in a recordable but delayed and smaller retinal response compared to the healthy control contralateral eye. The results are following the minimally-invasive administration of two treatment cycles (one post-operation and the other in the subsequent week), with a volume of 20µL per eye in the treated and the control rats (naïve exosomes). Tillkännagivande • Mar 26
NurExone Biologic Inc., Annual General Meeting, Jun 03, 2024 NurExone Biologic Inc., Annual General Meeting, Jun 03, 2024. Tillkännagivande • Feb 21
NurExone Biologic Inc. Expands Intellectual Property Portfolio NurExone Biologic Inc. underscored its expanding Intellectual Property (IP) portfolio, which will serve as the foundation for its strategic goal of licensing the innovative ExoTherapy platform to interested biotech companies. NurExone’s Intellectual property portfolio describes the ExoTherapy platform’s comprehensive technology and processes for the production of nanodrugs including large scale production of exosomes, loading of active molecules and the composition of the exosomes themselves. The Company is highlighting its innovative bioreactor and biological processes for: High yield repeatable production of exosomes and Production of natural and potent exosomes (not synthetically engineered). Scientific results and initiatives have demonstrated efficiency of the Company’s large-scale production process, its effectiveness of the Company’s proprietary small-interfering RNA (siRNA) sequences as therapeutic agent and the technology for loading veracity of therapeuticmolecules into exosomes. Aspects of the company’s platform which relate to Extracellular Vesicles (EVs) production are described in a growing intellectual property portfolio with two PCT applications currently in National Phases. The first application disclosed unique three-dimensional (3D) porous scaffold that induce physiological changes in the cells, which result in enhanced secretion of EVs and in improved biological effect of the Evs on mammalian cells. This international patent application is currently pending in US, EU, AU, SG and IL. The second international patent application further elaborate the EV composition produced by the 3D system as well as the treatment of diseases and disorders associated with such composition. This international patent application is currently pending in US, EU, AU, IL and IN. Both applications, once granted, will provide NurExone patent protection over unique and effective platform that will maximize EVs quality. These EVs will be used for the development and manufacturing of diverse medicament for various diseases as will be developed by the NurExone team. Such developments are the basis of additional patent families. NurExone has an exclusive license from the Technion (Israel Institute of Technology) over novel patent family that claim a system and method for producing Extracellular Vesicles (EVs) from stem cells for other types of indications as well. Professor Shulamit Levenberg, Director of the Technion Center for 3D Bioprinting and Chief Scientific Advisor at NurExone, and her team lab is behind this technology. This patent family bundled together two international patent applications. Tillkännagivande • Jan 05
NurExone Biologic Inc. announced that it has received CAD 1.985758 million in funding NurExone Biologic Inc. announced it has completed a non-brokered private placement of a minimum of 7,091,993 units at a price of CAD 0.28 per unit for gross proceeds of CAD 1,985,758.04 on January 05, 2024. Each Unit consists of one common share in the capital of the Company, and one Common Share purchase warrant. Each Warrant entitles the holder thereof to purchase one Common Share at a price of CAD 0.35 per Common Share for a period of 36 months from the closing of the Private Placement. The Warrants are subject to accelerated expiration whereby if the daily volume weighted average trading price of the Common Shares on the TSX Venture Exchange for any period of 20 consecutive trading days equals or exceeds CAD 0.80. All securities issued under the Private Placement are subject to a statutory hold period of four months and one day from the closing of the Private Placement. The Private Placement is subject to final approval of the TSXV. Tillkännagivande • Nov 25
NurExone Biologic Inc. Appoints Eran Ovadya as Secretary NurExone Biologic Inc. announced the appointment of Eran Ovadya, the existing chief financial officer of the Company, to also serve as secretary.