Optic Nerve Injuries

Sept. 26, 2024 -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”), a biopharmaceutical company developing exosome-based therapies for the multi-billion dollar regenerative medicinei market, is pleased to announce a non-brokered private placement of up to 3,636,363 units (“Units”) at a price of $0.55 per Unit for aggregate gross proceeds of up to $2,000,000 (the “Offering”) and will, on acceptance of the TSX Venture Exchange (“TSXV”), close on a first tranche of the Offering for gross proceeds of $1,610,147.55. The Company intends to use the proceeds of the Offering for working capital purposes. Dr. Lior Shaltiel, Chief Executive Officer of the Company noted that, “we appreciate the continued support of our existing shareholders, who recognize the milestones we’ve achieved as we advance toward the use of loaded exosomes as regenerative therapy for the multi-billion-dollar markets of acute spinal cord injuries and optic nerve damage. Their participation in the Offering reflects confidence in our strategic direction and long-term growth potential, as we move ahead on the path to our clinical and commercial goals.” Each Unit will consist of (i) one common share in the capital of the Company (each, a “Common Share”), and (ii) one Common Share purchase warrant (each, a “Warrant”). Each Warrant will entitle the holder thereof to purchase one Common Share at a price of $0.70 per Common Share for a period of 36 months, subject to acceleration. If the daily volume weighted average trading price of the Common Shares on the TSXV for any period of 10 consecutive trading days equals or exceeds $1.05, the Company may, upon providing written notice to the holders of the Warrants (the “Acceleration Notice”), accelerate the expiry date of the Warrants to a date not less than 30 days following the date of the Acceleration Notice. If the Warrants are not exercised by the applicable accelerated expiry date, the Warrants will expire and be of no further force or effect. 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. The Offering may constitute a “related party transaction”, as such term is defined in Multilateral Instrument 61-101 – Protection of Minority Shareholders in Special Transactions (“MI 61-101”) as certain insiders of the Company may subscribe in the Offering, and would require the Company to receive minority shareholder approval for, and obtain a formal valuation for the subject matter of, the transaction in accordance with MI 61-101, prior to the completion of each such transaction. However, the Company expects such participation would be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as the fair market value of the Units subscribed for by the insiders, nor the consideration for the Units paid by such insiders, would exceed 25% of the Company's market capitalization. The Company is also pleased to announce the closing of the first tranche of the Offering for gross proceeds of $1,610,147.55 from the issuance of 2,927,541 Units. All securities issued pursuant to the first tranche of the Offering are subject to a statutory hold period of four months and one day. This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described in this news release in the United States. Such securities have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and, accordingly, may not be offered or sold within the United States, or to or for the account or benefit of persons in the United States or “U.S. Persons”, as such term is defined in Regulation S promulgated under the U.S. Securities Act, unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from such registration requirements. NurExone Biologic Inc. is a TSXV, FSE and OTCQB listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications. i https://www.novaoneadvisor.com/report/us-regenerative-medicine-market The content above comes from the network. if any infringement, please contact us to modify.

Harvard University researchers launched a single-center study after noticing incidents of nonarteritic anterior ischemic optic neuropathy among semaglutide users in clinical practice. Novo Nordisk’s massively successful GLP-1 analog semaglutide, the active ingredient in the popular diabetes and obesity meds Ozempic and Wegovy, may be linked to a vision loss disorder, a new study suggests. But one team of analysts cautioned against reading too much into the analysis. The study found that people taking semaglutide were four to nearly eight times more likely to develop nonarteritic anterior ischemic optic neuropathy (NAION) than their peers on other non-GLP-1 meds for diabetes and weight loss. The study was conducted by researchers at Harvard University and published last week in JAMA Ophthalmology. NAION is an eye condition that’s marked by decreased blood supply to the optic nerve, causing vision loss. It’s the second most common form of optic nerve damage, with an annual incidence rate estimated at around 2.3 to 10.2 per 100,000 among people over 50 years of age in the U.S., according to the American Academy of Ophthalmology. The study raises questions, but a Leerink Partners team led by David Risinger said in a Thursday note that they “do not expect this single analysis to impact prescribing trends” of Ozempic and Wegovy. That’s because, as the study authors themselves noted, the analysis was designed to report an “association” but not to establish a causal relationship. “Larger retrospective studies, post-marketing analyses of GLP-1s, and/or prospective clinical trials would be required to confirm the findings,” the analysts wrote. The Harvard researchers launched the study after noticing cases of NAION among semaglutide takers in clinical practice. So they evaluated nearly 17,000 patients seen by neuro-ophthalmologists at Massachusetts Eye and Ear between December 2017 and November 2023. Patients who were taking either Ozempic or Wegovy were matched with non-takers by various baseline characteristics, including comorbidities related to NAION. Among 710 patients with Type 2 diabetes, the cumulative NAION incidence over a 36-month period was 8.9% for users of semaglutide compared with 1.8% in the non-GLP-1 cohort. Among 979 individuals who were overweight or obese, the 36-month rates were 6.7% and 0.8% for the users of Novo’s med and other non-GLP-1 treatments, respectively. As the authors noted, Massachusetts Eye and Ear clinic includes a specialized neuro-ophthalmology service that evaluates a large proportion of the Boston area’s NAION cases. “[T]herefore, our findings may not be fully generalizable to other settings,” they wrote in the study. The best approaches to confirm the findings, the researchers noted, would be to conduct a much larger retrospective, multicenter population-based study, a prospectively designed randomized clinical trial or a postmarket analysis of all GLP-1 receptor agonists. But large studies may be difficult to run, because there isn’t a specific diagnostic code for NAION, the authors said. For this study, the researchers manually reviewed records and found that 40% of cases marked as ischemic optic neuropathy, the closest code relevant to NAION, were actually not NAION. NAION is currently not listed as a side effect in the labels of Ozempic or Wegovy. The increasing use of GLP-1 meds has spurred multiple population-based studies exploring their potential risks and benefits. Previous anecdotal reports of suicidal thoughts related to the use of semaglutide were recently refuted by a large Nature Medicine study involving 1.8 million patients. The FDA and the European Medicines Agency later found no association between the Novo drug and suicidal thoughts or actions. Other studies appeared to link the GLP-1 med to some unexpected benefits. A new JAMA Network Open study published on Friday involving 1.6 million patients with Type 2 diabetes found that compared with insulin, GLP-1 meds were associated with a significant risk reduction in 10 obesity-related cancers, including gallbladder cancer, liver cancer, ovarian cancer and colorectal cancer. In that same study, GLP-1 drugs were not associated with a decreased risk of any of the 13 cancers examined when compared with metformin but, instead, an increased risk of kidney cancer. Meanwhile, Novo Nordisk and its GLP-1 rival Eli Lilly have been busy confirming their offerings’ efficacy in various conditions beyond diabetes and weight loss. Lilly’s GIP/GLP-1 dual agonist Zepbound recently aced a phase 3 study in obese patients with obstructive sleep apnea. Novo’s semaglutide has also shown a benefit in slowing kidney disease progression in diabetic patients with chronic kidney disease. And Wegovy earlier this year secured an FDA approval to reduce the risk of cardiovascular-related events in patients who are overweight or obese with cardiovascular disease.

Neurotrophins are proteins involved in the development, function and survival of neurons discovered 70 years ago by Italian Nobel Rita Levi Montalcini with the identification of Nerve Growth Factor (NGF). The first NGF-based therapy was approved by the U.S. Food and Drug Administration (FDA) in 2018 to treat a rare ocular disorder and today in Rome researchers are discussing the potential of neurotrophins including NGF, Brain Derived Neurotrophic Factor (BDNF) and other molecules for the treatment of various eye and brain disorders, paving the way for innovative therapeutic strategies for unmet patient needs. Potential indications include: corneal neurosensorial abnormalities, retinal diseases, optic neuropathies, traumatic brain damage, axon regeneration, dementia, Alzheimer’s and Parkinson’s disease. Clinical studies aimed at expanding the research and knowledge of potential applications of NGF in both eye and brain disorders are being evaluated for launch in 2025. ROME--(BUSINESS WIRE)-- Nature Conferences has convened a meeting of leading global scientists to discuss the state of the art and future lines of research on neurotrophins. The event, From the Eye to the Brain, will focus on the potential new applications of neurotrophins in therapeutic areas including ophthalmology and the central nervous system. The program takes place in Rome June 11-12 and is sponsored by Dompé farmaceutici. This press release features multimedia. View the full release here: From the Eye to the Brain: World’s Top Scientists Gather in Rome to Discuss Future of Neurotrophins in Eye and Brain Research (Photo: Business Wire) Neurotrophins were discovered by Italian Nobel laureate Dr. Rita Levi-Montalcini and her colleague Dr. Stanley Cohen in the early 1950s. Drs. Levi-Montalcini and Cohen uncovered that NGF plays a crucial role in the proliferation, differentiation and survival of sympathetic and sensory neurons. The past decade saw a key breakthrough with the first successful therapeutic application of a neurotrophin. The first NGF treatment was approved in 2018 by the U.S. FDA for the treatment of a rare corneal disease. From the Eye to the Brain will feature global experts in the fields of neuroscience and ophthalmology discussing the first potential therapeutic applications of neurotrophins in the treatment of optic nerve and retinal damage in glaucoma and central nervous system disorders including pediatric and adult traumatic brain injuries, Parkinson’s disease, dementia and depression. “Research on neurotrophins is becoming increasingly important for understanding several brain diseases for which we currently have no effective therapies,” said Elliott Mufson, professor of neurobiology and Alzheimer's disease researcher at Barrow Neurological Institute in Phoenix, Arizona, and speaker at the conference. “For example, there is a disconnect between the NGF and its receptors, which leads to the death of key neurons, causing dementia in people with Alzheimer’s disease, Parkinson’s disease, and Down syndrome. Potential approaches to rescue these neurons exist and we will discuss how NGF could be used to track the progression of Alzheimer's Disease in people affected by the disease.” “The discovery of neurotrophins in the 50s was a truly paradigm-shifting, revolutionary discovery. It was a brilliant piece of work that changed how we thought about our brain’s functions.” said Thomas Südhof, M.D., Nobel Prize in Physiology or Medicine 2013. “Today neurotrophins are under-researched but there are enormous opportunities. These opportunities will be realized once we actually have a better insight into what neurotrophins do.” Key Sessions Thomas C. Südhof, M.D., Nobel Prize in Physiology or Medicine 2013 How to build and renew synapses: from molecules to memory mechanisms This presentation will focus on the significant progress made in understanding synaptic transmission and its implications for treating neurological diseases such as Alzheimer’s and Parkinson’s. Elliott Mufson, Ph.D., Barrow Neurological Institute Neurotrophins in Neurological Disease Dr. Mufson will discuss the role that nerve growth factor (NGF) plays in the maintenance of a group of cholinergic cells located deep within the brain that make a key neurotransmitter that contributes to cognition and how their degeneration plays a role in the onset of dementia in people with Alzheimer’s disease, Parkinson’s disease and Down syndrome. Barbara L. Hempstead, Dean of Weill Cornell Graduate School of Medical Sciences Impact of Neurotrophins on the Development of Social Behavior Circuits Dr. Hempstead’s research will be presented on neurotrophins and pro-neurotrophins, exploring their dual role in promoting neuronal survival and causing neuronal dysfunction post-injury, which has important implications for stroke and seizure-related conditions. Baoji Xu, Professor UF Scripps, University of Florida BDNF-TrkB signaling and the regulation of appetite and body weight Dr. Xu will discuss his research on the role of neurotrophins in cerebral cortex development and weight control, contributing to a deeper understanding of the connection between neurobiology and metabolic regulation, offering insights into potential treatments for obesity and related disorders. Elizabeth Coulson, Ph.D., Queensland Brain Institute Targeting the p75 neurotrophin receptor to stop neurodegeneration in dementia Dr. Coulson will present her research on neuronal cell death mechanisms in neurodegenerative diseases, focusing on the amyloid precursor protein associated with Alzheimer’s disease and her work to identify therapeutic targets to address this condition. Zhigang He, Ph.D., B.M., Harvard Medical School Neurotrophins-based strategies for promoting neuronal survival and axon regeneration Dr. He will present advancements in axon regeneration and functional restoration following central nervous system injuries, addressing spinal cord and optic nerve injuries. Additional From the Eye to the Brain sessions will focus on potential applications for corneal neurosensorial abnormalities, retinal diseases, optic neuropathies, traumatic brain damage, axon regeneration, and dementia. For more detailed information about the conference and to view the complete agenda, visit: . About Nature Conferences: Nature Conferences brings together experts from various scientific fields to discuss the latest research and innovations. Our events provide a platform for collaboration and knowledge exchange, driving scientific advancements across the globe. For more information visit . About Dompé: Dompé is a privately-held biopharmaceutical company founded in Milan, Italy, with a 130-year legacy of R&D and medical innovation. Today, headquartered Dompé employs more than 900 employees worldwide and maintains a U.S. commercial operations hub in the San Francisco Bay Area as well as an R&D presence in Boston. For more information visit . Forward Looking Statements This press release refers to certain information that may not coincide with expected future results. Dompé firmly believes in the soundness and reasonableness of the concepts expressed. However, some of the information is subject to a certain degree of indetermination in relation to its research and development activities and the necessary verifications to be performed by regulatory bodies. Therefore, as of today, Dompé cannot guarantee that the expected results will be consistent with the information provided above. View source version on businesswire.com: Contacts Michael Szumera Senior Director, Head of US Corporate Communications Mobile: +1 650 445 3735 michael.szumera@dompe.com Source: Dompé farmaceutici Smart Multimedia Gallery Photo From the Eye to the Brain: World’s Top Scientists Gather in Rome to Discuss Future of Neurotrophins in Eye and Brain Research (Photo: Business Wire) Photo Elliott Mufson, professor of neurobiology and Alzheimer's disease researcher at Barrow Neurological Institute in Phoenix, Arizona (Photo: Business Wire) Photo Thomas Südhof, M.D., Nobel Prize in Physiology or Medicine 2013 (Photo: Business Wire) View this news release and multimedia online at: