Announcement • Aug 15
NurExone Biologic Announces New Preclinical Tissue-Analysis Data Supporting Potential Neuroprotective Effect Of ExoPTEN In Acute Spinal Cord Injury Animal Model NurExone Biologic announced new preclinical tissue-analysis results that provide additional biological support for ExoPTEN’s potential neuroprotective effect in an animal model of traumatic spinal cord injury. NurExone has previously reported improved functional recovery in animals treated with ExoPTEN. In the current analysis, spinal cord tissue collected from those same animals and evaluated to assess biological markers associated with neurons and supporting structures. Two months after injury, ExoPTEN-treated animals showed significantly higher numbers of cells positive for Myelin Basic Protein (MBP), a key component of the protective coating surrounding nerve fibers, compared with controls in regions on both sides of the injury site. These data further inform NurExone’s understanding of ExoPTEN’s potential mechanism of action and contribute to the scientific and regulatory foundation supporting the program as it advances through preclinical development toward potential clinical development. Acute spinal cord injuries can trigger a cascade of biological processes beyond the initial trauma that can contribute to further damage to nerve cells and their supporting structures. Protecting surviving neural tissue and the structures needed for nerve signaling is therefore an important therapeutic objective. To study ExoPTEN’s mechanism of action within the injured spinal cord, the Company performed a broad immunohistochemical analysis using target tissues collected from a previously reported efficacy study. Three areas of the spinal cord were assessed independently: the injury area itself and regions rostral (toward the head) and caudal (toward the tail) to the injury site. Researchers examined several markers associated with neurons and their supporting structures: NeuN, a marker associated with neuronal nuclei and cell bodies; NF200, a marker of neuronal axons and cell bodies; and MBP, a major component of myelin and a marker used to identify the myelin sheaths that insulate nerve fibers. Two months after spinal cord injury, ExoPTEN-treated animals showed significantly higher numbers of MBP-positive cells compared with controls in regions on both sides of the injury. The differences were statistically significant in both the rostral region (p=0.01) and caudal region (p=0.04). These findings provide additional preclinical evidence supporting ExoPTEN’s potential neuroprotective effect and may help biologically explain the functional improvement previously observed in treated animals. ExoPTEN is NurExone’s lead exosome-based therapeutic candidate for acute spinal cord injury. ExoPTEN uses bone marrow-derived naïve exosomes loaded with proprietary siRNA targeting PTEN and is being developed as a minimally invasive therapeutic approach intended to promote recovery following nerve injury. Announcement • Jul 29
NurExone Biologic Inc. Announces Board Changes NurExone Biologic Inc. announced the appointment of Mr. David Stolick to its Board of Directors, effective July 28, 2026. Mr. Stolick succeeded the late James "Jay" Richardson, whose leadership helped shape NurExone during its formative years. Mr. Stolick brings extensive finance, capital markets, M&A, and healthcare company leadership experience. He previously served as VP of Finance at V-Wave Ltd., a U.S.-Israeli medical device company acquired by Johnson & Johnson in October 2024. He also previously served as CFO of Exalenz Bioscience and BrainStorm Cell Therapeutics, and as Corporate Controller at M-Systems. Mr. Stolick holds a B.A. in Economics and Accounting from Ben-Gurion University and is a Certified Public Accountant. Announcement • Jul 20
NurExone Biologic Inc., Annual General Meeting, Sep 15, 2026 NurExone Biologic Inc., Annual General Meeting, Sep 15, 2026. Location: ontario, toronto Canada Announcement • 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. New Risk • Jun 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$4.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$4.8m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 5.0% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (€37.1m market cap, or US$43.2m). Board Change • May 20
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Jay Richardson was the last independent director to join the board, commencing their role in 2011. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Announcement • Apr 15
NurExone Biologic Inc., Annual General Meeting, Jun 18, 2025 NurExone Biologic Inc., Annual General Meeting, Jun 18, 2025. Location: ontario, toronto Canada Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Board Change • Dec 30
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 5 new directors. 5 experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). Independent Director Jay Richardson is the most experienced director on the board, commencing their role in 2011. Independent Director Gadi Riesenfeld was the last independent director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Announcement • 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. New Risk • Nov 14
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 53% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Shareholders have been substantially diluted in the past year (53% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (€29.9m market cap, or US$31.6m). Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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). New Risk • May 30
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$3.9m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$3.9m free cash flow). Share price has been highly volatile over the past 3 months (31% average weekly change). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (57% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$4.7m net loss next year). Market cap is less than US$100m (€24.0m market cap, or US$26.0m). New Risk • Mar 29
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 53% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (47% average weekly change). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (53% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$4.5m net loss next year). Market cap is less than US$100m (€34.2m market cap, or US$36.9m). Announcement • Mar 26
NurExone Biologic Inc., Annual General Meeting, Jun 03, 2024 NurExone Biologic Inc., Annual General Meeting, Jun 03, 2024. Announcement • 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. Announcement • 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. Announcement • 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. New Risk • Nov 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$3.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$3.1m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Less than 3 years of financial data is available. Currently unprofitable and not forecast to become profitable next year (US$4.5m net loss next year). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (€10.0m market cap, or US$11.0m). Announcement • Oct 31
Nurexone Biologic Receives FDA Orphan-Drug Designation, Accelerating Development of Exopten Therapy for Acute Spinal Cord Injury Treatment NurExone Biologic Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for its ExoPTEN therapy, recognizing the potential of this regenerative therapy for acute spinal cord injury, a condition where effective treatments are limitedi. The orphan drug designation provides significant benefits to pharmaceutical companies developing drugs for rare diseases, i.e. those impacting fewer than 200,000 people in the United Statesii. These benefits include market exclusivity, financial incentives, regulatory assistance, and support with drug development. Overall, the designation incentivizes and supports the development of certain treatments, increasing access to therapies for patients. Earning orphan-drug designation is a significant milestone for the Company. The designation covers the use of mesenchymal stem cell (MSC) derived small extracellular vesicles (EVs) loaded with short and modified interfering RNA (siRNA) targeting the phosphatase and tensin homolog (PTEN) protein for acute spinal cord injury, as implemented in the Company's ExoPTEN drug under development. Announcement • Oct 20
Nurexone Biologic Inc. Appoints Teodoro Forcht Dagi to Scientific Advisory Board and Advisory Committee NurExone Biologic Inc. appointed Professor Teodoro Forcht Dagi, a renowned neurosurgeon, life science venture capitalist and professor at the Mayo Clinic Alix School of Medicine as well as at Queen’s University Belfast, to its esteemed Scientific Advisory Board and Advisory Committee. Announcement • Oct 12
NurExone Biologic Inc. Secures Eureka Grant for Collaborative Partnership to Expand to Chronic Spinal Cord Injury Therapy NurExone Biologic Inc. announced that the Company has been awarded a ILS 1 million (CAD 350,00) grant by the Israel Innovation Authority as part of the Israel-Canada bilateral Eureka program. The grant is for a collaboration with Canada-based Inteligex Inc. to develop an innovative hybrid therapy tailored for the complex chronic spinal cord injury market. This endeavor combines Inteligex's established expertise in stem cell treatments with NurExone's ExoTherapy drug delivery platform. Currently, NurExone is in the process of developing the ExoPTEN product specifically for acute spinal cord injuries. This collaborative effort opens the possibility for the Company to expand its focus to chronic spine injuries. In acute injuries, immediate cell damage occurs, while chronic injuries trigger a secondary injury cascade in the days, weeks, and months following the initial injury. Chronic injuries involve inflammation, cell death, and the formation of a cavity within the spinal cord, encased by scar tissue that disrupts nerve signal flow. Consequently, recovering motor function after paralysis induced by chronic injury is exceptionally challenging, and a hybrid therapy may have potential for a significant step forward in this field. The ILS 1 million grant for the first year is expected to cover a significant part of the Company's total first year project budget of ILS 2.45 million (CAD 850,000). The two-year collaborative partnership with Inteligex has an overall budget of EUR 1.69 million. Announcement • Sep 14
NurExone Biologic Inc. Moves Forward Towards Human Clinical Trials, Completes Pre-IND Meeting with FDA for Proprietary ExoPTEN Drug NurExone Biologic Inc. announced that the Company has completed a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in connection with the manufacturing, preclinical and clinical development plan of ExoPTEN, NurExone’s first ExoTherapy product, after receiving a written response from the FDA on August 29, 2023. A Pre-IND meeting offers open communication between applicants and the FDA, enabling the applicants to receive information regarding the preparation of an IND application and guidance for the clinical studies of the Company’s ExoPTEN drug. The FDA provided clear and valuable guidance on the chemistry manufacturing and controls and agreed that the company's proposed ExoPTEN release testing strategy would be expected to adequately control for safety of the ExoPTEN product for use in the planned first-in-human clinical trial. The FDA’s response to the Company indicated that the planned toxicity study strategy is acceptable under FDA guidelines and large-scale animal studies will not be required. Based on the FDA’s feedback, the Company plans to submit an IND application regarding the development of ExoPTEN by fourth quarter, 2024, and expects to initiate Phase 1/2 human clinical studies in 2025. ExoPTEN is being developed to be a minimally invasive ExoTherapy for spinal cord injuries administrated intranasally and yielding neuron regeneration and rewiring in traumatically damaged spinal cords. The drug is being developed using NurExone’s proprietary ExoTherapy platform for producing and loading exosomes with pharmaceutical cargo targeting central nervous system injuries. Announcement • Sep 07
NurExone Biologic Inc. announced that it has received CAD 1.483501 million in funding On September 6, 2023, NurExone Biologic Inc., closed the transaction. The company issued 750,000 units at a price of CAD 0.275 per unit for the gross proceeds of CAD 206,250 in the second and final tranche closing. The company issued and sold 5,394,548 Units at a price of CAD 0.275 per unit for aggregate proceeds of CAD 1,483,500.70 under the Private Placement. New Risk • Sep 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 12% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€7.14m market cap, or US$7.64m). Minor Risks Less than 3 years of financial data is available. Currently unprofitable and not forecast to become profitable next year (US$3.5m net loss next year). Shareholders have been diluted in the past year (12% increase in shares outstanding). New Risk • Aug 30
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€6.38m market cap, or US$6.97m). Minor Risks Less than 3 years of financial data is available. Currently unprofitable and not forecast to become profitable next year (US$3.5m net loss next year). Announcement • Aug 30
NurExone Biologic Inc. Announces Board Changes NurExone Biologic Inc. added Dr. Gadi Riesenfeld as an independent director to the Company’s Board, replacing Mr. Ron Mayron, a member of the Board since 2021, effective July 6, 2023. Mr. Riesenfeld was the former president of Pharmos Corporation, a publicly traded biotech company listed on NASDAQ, and president of several bio-pharmaceutical companies, including Kamapharm Ltd., Galisar Ltd., and OticPharma. New Risk • Aug 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 7.5% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€7.74m market cap, or US$8.47m). Minor Risks Less than 3 years of financial data is available. Currently unprofitable and not forecast to become profitable next year (US$3.3m net loss next year). Shareholders have been diluted in the past year (7.5% increase in shares outstanding). Announcement • Aug 10
NurExone Biologic Inc. announced that it expects to receive CAD 1.4 million in funding NurExone Biologic Inc. announced a non-brokered private placement of a minimum of 2,727,272 units and a maximum of 5,090,909 units at a price of CAD 0.275 per unit for minimum gross proceeds of CAD 750,000 and maximum gross proceeds of CAD 1,400,000 on August 9, 2023. Each unit will consist of one common share, one-half of one class A common share purchase warrant and one-half of one class B common share warrant. Each class A warrant will entitle the holder thereof to purchase one common share at a price of CAD 0.34 per common share for a period of 24 months from the closing of the transaction. Each class B warrant will entitle the holder thereof to purchase one common share at a price of CAD 0.48 per common share for a period of 36 months from the closing of the transaction. The transaction is subject to the approval of the 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 transaction. The company may pay finder’s fees in connection with the transaction, all in accordance with the policies of the TSXV and applicable securities laws. Announcement • Jul 23
NurExone Biologic Inc. Announces Advancements in Extracellular Vesicles Functionality with Enhanced Potency and Cellular Uptake for potentially better drug delivery NurExone Biologic Inc. announced significant advancements in extracellular vesicles (EVs) functionality. Leveraging its proprietary and patented 3D-Flow production, the Company has achieved significantly enhanced EV functionality. These achievements include an amplified immuno-modulatory response which means helping the immune system to respond to injury and reducing the inflammation activity and in parallel, significantly improved cellular uptake, allowing NurExone's EVs better cell penetration, holding great promise for the Company's future EVs-based therapies. Through production methodologies, NurExone aims to unlock the full potential of EVs as powerful therapeutic tools. The Company's exclusive and unique 3D-Flow process involves culturing EVs on a 3D "scaffold" and subjecting the stem cells to flow-induced shear stress stimulation during production. This innovative technique, which was developed in the lab of Professor Shulamit Levenberg at the Technion (Haifa) and exclusively licensed to the Company, has already demonstrated increased yield in production1. The current study, performed by the Company, assessed functional properties of EVs, cultured using different production techniques. The EVs derived from Human Bone Marrow Mesenchymal Stem Cells (hBM-MSC) and produced via 3D-Flow demonstrated a superior ability to decrease the inflammatory response of cells compared with a standard control and other production techniques, suggesting effectiveness in decreasing inflammation. Furthermore, the groundbreaking 3D-Flow production has led to EVs with significantly improved cellular uptake, compared with EVs produced by other production techniques. This is critical to ensure targeted delivery of therapeutic cargo to specific cell types, maximizing the potential of EVs as drug delivery vehicles. EVs have gained considerable attention in recent years due to their potential as natural therapeutic carriers. Demonstrating modulation of immune response, and superior uptake of EVs in the target cells will assist in moving from the laboratory to the clinical setting. NurExone is committed to further exploring the potency and therapeutic benefits of EVs produced through the 3D-Flow process using rigorous preclinical and clinical studies. The Company's wholly-owned subsidiary, NurExone Biologic Ltd. has obtained an exclusive worldwide license from the Technion to develop and commercialize the production process for use for additional indications. Based on the study results, the Company is pursuing a patent application in the United States and other key markets under the Patent Cooperation Treaty (PCT). Once the production process is finalized, NurExone intends to monetize this technology by licensing it to other companies within the global biopharmaceutical industry in addition to implementing it within its proprietary drug platform. Announcement • Jul 08
Nurexone Biologic Inc. Announces Board Changes NurExone Biologic Inc. announced that, effective July 6, 2023, Dr. Gadi Riesenfeld has been appointed to the board of directors of the Company replacing Mr. Ron Mayron, who resigned for personal reasons. Dr. Riesenfeld has served on the board of directors and as president of several bio-pharmaceutical companies, including Kamapharm Ltd., Galisar Ltd., and OticPharma. Moreover, he was previously the president of Pharmos Corporation, a publicly traded biotech company listed on NASDAQ. Dr. Riesenfeld holds a Ph.D. degree from the Faculty of Agriculture of the Hebrew University of Jerusalem and held a scientific position, as a post doctorate, at the Cedars Sinai Medical Center in Los Angeles, California. Announcement • Jun 23
Nurexone Biologic Inc. Reports Positive Imaging Results from an Internal Preclinical Study of Its Investigational Drug ExoPTEN NurExone Biologic Inc. reported positive imaging results from an internal preclinical study of its investigational drug ExoPTEN. The image analysis and measurements confirmed successful nerve regeneration following traumatic transection of the spinal cord in rats. These imaging results align with previous results showing a remarkable recovery of motor function in 75% of paralyzed rats suffering from spinal cord injuries and treated with the new therapy. During a recent internal preclinical trial, the company's ExoPTEN drug caused 75% of rats to regain hind limb reflex, some motor function, and sensory control. Subsequently, the spinal cords of rats from the study were subjected to advanced Diffusion Tensor Imaging (DTI) to assess the structural integrity of the spinal cord. ExoPTEN is being developed to be a minimally invasive ExoTherapy for spinal cord injuries (SCI) administrated intranasally and yielding neuron regeneration and rewiring in traumatically damaged spinal cords. The drug is being developed using NurExone's proprietary ExoTherapy platform for producing and loading exosomes with pharmaceutical cargo targeting central nervous system injuries. To assess the structural integrity of the spine cord, 9.4T conventional MRI and diffusion tensor imaging (DTI) was performed in control-treated (IN) SCI animals, ExoPTEN-treated (IN)SCI animals, and intact rats. In the control-treated SCI animals, caudal nerve tracts were completely severed at the epicenter indicated, leaving the caudal spinal cord de-innervated and atrophied. ExoPTEN promoted reinnervation and nourishment to the caudal spinal cord. Announcement • May 09
NurExone Biologic Inc. Resignation of Eyal Flom from Board of Directors NurExone Biologic Inc. announced the resignation of Eyal Flom from the board of directors of the Company for personal reasons, effective immediately. Announcement • Feb 18
NurExone Announces Interim Positive Results of Internal Preclinical Study of Proprietary ExoPTEN Drug NurExone Biologic Inc. announced the interim results of an internal, preclinical study of its ExoPTEN drug. ExoPTEN is being developed by NurExone as a minimally invasive drug, aimed at capitalizing on the $2.9 billion market for acute Spinal Cord Injuries (SCI). The current study was designed to assess the impact of ExoPTEN on the motor, reflex, and sensory recovery of rats, following full transection (i.e. complete severing) of the spinal cord. The interim results, four weeks post-transection, showed that: In the ExoPTEN treated group comprising four rats that received intranasal administration of ExoPTEN, 75% of the rats responded to treatment and recovered hind limb reflex, rehabilitated some motor function, and recovered sensory control. In the exosome only treated group and in the therapeutic PTEN siRNA molecule only treated group, comprising four rats each, 25% of the rats responded to treatment and recovered hind limb reflex, motor function, and recovered sensory control. In a control group, comprising six rats that received a (non-therapeutic) saline solution, none of the rats demonstrated any sensory or reflex recovery or motor rehabilitation. ExoPTEN is based on the company’s proprietary ExoTherapy platform, in which exosomes are produced and loaded with therapeutic molecules for delivery to damaged cells in the body. The current study assessed ExoPTEN with an improved and modified siRNA (small interfering RNA) sequence as its therapeutic cargo. ExoPTEN, as an ExoTherapy-based drug, is designed to promote neuron regeneration and rewiring in traumatically damaged spinal cords, while being an "off-the-shelf" drug with minimally invasive administration. Announcement • Jan 13
United States Patent Office Allows Patent to NurExone Biologic Inc NurExone Biologic Inc. has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application NO. 17/042,44 (the Patent). The Patent covers and protects NurExone Exo-PTEN technology, and its drug composition as well as methods for non-invasive intranasal administration of exosome-based treatment. The Patent discloses and claims ground-breaking inventions and methods in exosome technology, such as the pharmaceutical compositions comprising extracellular vesicles including exosomes, loaded with an exogenous inhibitor of phosphatase and tensin homolog (PTEN) inhibitor as well as a method for treating neuronal injury or damage, including intranasal administration. The Company intends to file additional patent applications with the USPTO as well as additional international patent applications (PCT) in order to further strengthen NurExone's intellectual property portfolio. The Patent was submitted by the Technion-Israel Institute of Technology and Ramot, a Tel Aviv University's technology transfer company and is part of NurExone's licensed intellectual property portfolio. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 6 non-independent directors. Independent External Director Oded Orgil was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.