Calgary, Alberta--(Newsfile Corp. - August 9, 2022) - NurExone Biologic Inc. (TSXV: NRX) (formerly, EnerSpar Corp.) (the "Company" or "NurExone"), a biopharmaceutical company developing biologically-guided exosome therapy for patients with traumatic spine injuries, released excerpts from a letter uploaded to Sedar today from Mr. Jay Richardson, Former CEO of EnerSpar and current director of NurExone to EnerSpar's shareholders. In the letter, Mr. Richardson thanked EnerSpar's shareholders for their support during his tenure as CEO and during the RTO process that began in August 2021 and was recently completed resulting in the listing of NurExone Biologic Inc on the TSXV.
The letter noted Mr. Richardson's enthusiasm for NurExone's growth outlook and his intention to continue with NurExone as a director for the immediate future. Mr. Richardson highlighted certain aspects of NurExone's market drivers as follows:
The Company is developing exosome-based technology and products.
NurExone has the technology and know-how necessary to produce exosomes and load them with therapeutic molecules creating ExoTherapies that are biologically guided to select anatomies. ExoTherapies are expected to be suited for wide patient populations due to their immune evasion, off-the-shelf use, and intranasal administration.
Exosomes have the potential to emerge as a strong drug delivery system.
The global exosome market alone is expected to reach US$2.28 billion by 2030; North America accounts for the largest portion of the share.1 NurExone are the developers of the first intranasal and "off-the-shelf" exosome-based product to treat trauma to the spinal cord, brain and other central nervous system indications.
Target unmet need for functional-recovery based treatment for acute spinal cord injuries
NurExone's first product ExoPTEN is largely set to capitalize on the tremendous need for functional-recovery based spinal cord treatment. Between 250,000 and 500,000 people suffer from traumatic spinal cord injuries each year. Depending on the type and severity of the spinal injury, the current costs of treatment can be over US$1.5 million/patient in direct medical costs.2 Beyond this, there are significant indirect costs due to loss of patient mobility. NurExone's ExoTherapy is targeted at recovering functionality thus reducing the life-altering loss of mobility and accompanying economic impact of these injuries.
Advancement in the field of exosomes is immense and drawing significant investments
While there are currently no exosome-based therapeutics approved by the FDA, the current advancement in the field is immense. Biotech companies around the world with the capability of producing exosomes have received major investments to develop exosome treatments. Notably, Evox Therapeutics Ltd., an exosome biotech firm, signed a US$1.2 billion deal with pharmaceutical giant Eli Lilly.3 There is no company except for NurExone that is currently known to be developing exosome-based treatments for SCI.4
He also noted upcoming Company milestones as follows:
Preparations for Phase 1 clinical trials (in humans)
As NurExone is moving forward with its pre-clinical study, it is gearing up for a meeting with the FDA to receive needed guidelines for preparations to start Phase 1 clinical trials. NurExone plans to finalize the product characterization of its innovative biologically-guided ExoTherapy and to scale up the production of ExoPTEN, its first ExoTherapy product.
Enter to a state-of-the-art facility to accelerate R&D activities
Growing IP portfolio
NurExone's R&D team submitted three new provisional patent applications in Q2 of 2021 and Nurexone intends to file more patents in the future to expand its competitive moat. A new Sponsor Research Agreement has also been extended with Technion University until the end of Q3 of 2023 to continue existing developments.
Strategic partnerships/ collaborations towards transition of ExoTherapy to humans
The Company recently signed a Collaboration Agreement with Polyrizon Ltd, a leading clinical development stage biotech company based in Israel and hold partly by Medigus Ltd. in order to develop an effective and tailored intranasal delivery formulation for the administration of their exosome-based drug platform in people.
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided ExoTherapy to be delivered non-invasively to patients who have suffered traumatic spinal cord injuries. ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. Nurexone is transferring the treatment to humans, and the company holds an exclusive worldwide license from the Technion for development and commercialization of the technology. For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
This press release contains certain forward-looking statements, including statements about the Company's future plans and intentions, the ability to produce exosomes and load them with therapeutic molecules creating ExoTherapies that are biologically guided to select anatomies, the potential size of the global exosome market, the ability of ExoTherapy to recover functionality from, and reduce the life-altering loss of mobility and accompanying economic impact of, spinal cord injuries, the ability of the Company to move forward with its pre-clinical studies or obtain a meeting with the FDA, the ability of the Company to finalize its product characterization and scale up its production, obtain a state of the art facility to accelerate R&D activities, the growth of the Company's IP portfolio or the filing of additional patent applications by the Company and additional developments that may arise from the Company's collaboration activities and strategic partnerships with third parties. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. 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, protection of the Company's intellectual property and dependence on the Company's strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/133194