NurExone Biologic Inc. (TSXV: NRX,OTC:NRXBF) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical company developing exosome-based regenerative therapies for central nervous system injuries, today announced results from an independent proteomic analysis conducted at the Technion – Israel Institute of Technology. which evaluated multiple production batches of NurExone’s exosomes. The results support the Company’s Chemistry, Manufacturing and Controls (“CMC”) readiness by strengthening evidence of repeatable manufacturing and quality testing and represent an important step toward a potential Investigational New Drug (“IND”) application, the regulatory filing required to begin human clinical trials.
Batch-to-batch consistency is a core factor in biological production for clinical manufacturing. Four independent NurExone exosome production batches showed a highly consistent protein “fingerprint,” demonstrating the robustness and reproducibility of the Company’s manufacturing process.
The evaluation also included a reference comparison to commercial exosomes. The analysis detected several therapeutically potential proteins in NurExone samples, not seen in the commercial reference, supporting differentiation and a distinct biological profile linked to inflammation control, cellular resilience, and nerve repair support.
Dr. Lior Shaltiel, Chief Executive Officer of NurExone, said, “Each step towards the clinic is a de-risking step. Consistent exosome production is a core bioengineering milestone that underpins clinical-grade manufacturing. This independent assessment provides additional evidence of our manufacturing process control.”
NurExone’s near-term development focus includes execution milestones designed to reduce technical and regulatory risk. In parallel, the Company continues to advance operational initiatives that may support clinical execution and longer-term platform optionality. These initiatives include progress toward establishing small-scale clinical manufacturing capability in Israel as a bridge from research-scale material to clinical-grade production under controlled conditions and evaluating potential steps for U.S. operational development through Exo-Top Inc., the Company’s wholly owned subsidiary, subject to financing and timing considerations.
Figures 1A-1B – The graphs below represent the unique proteins contained in exosomes produced by NurExone
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Figure 1A. Protein fingerprints from four independent NurExone EV/exosome production batches, grouped by functional category and plotted as mean log2 intensity (n=4), with error bars representing standard deviation across batches. Categories shown include EV identity / biogenesis, ECM / guidance / neurite environment, antioxidant / stress protection, anti-inflammatory / immune modulation, and trophic / growth-factor signaling. The category-level profile indicates reproducible enrichment across batches, with the strongest signal in ECM / guidance / neurite environment and robust representation of EV identity / biogenesis markers, supporting batch-to-batch consistency of both exosome identity and functional protein cargo.
Figure 1B. This figure highlights proteins detected in NurExone EV/exosome batches but not detected in the commercial EV reference samples used in the comparison. Protein abundance is presented as mean log2 intensity (n=4) with error bars (SD) reflecting across-batch variability. The proteins shown are: PDGFRB, LAMA4, ARHGEF1, PEX19, TPST1, BDH2, GALK1, CARS1, PACSIN3, CD320, and IL1R1. Bar colors correspond to the functional categories shown in the legend.
Extension of Russo Engagement
Subject to TSX Venture Exchange (“TSXV“) approval, NurExone has reengaged Russo Partners LLC, a New York-based strategic communications firm, (“Russo“) for an additional 3-to-6-month term, to provide public and investor relations related services. NurExone will pay Russo US$15,000 per month for services rendered.
After the initial engagement period, either party has the right to terminate the agreement upon providing 30-days’ notice. Russo does not currently have a direct or indirect interest in the securities of the Company. While Russo has no intention of acquiring any additional securities of the Company at this time, it may do so in the future in compliance with applicable securities laws and TSXV policies.
About Russo
For more than 35 years, Russo Partners has provided public and investor relations support for healthcare companies and the technologies behind them. As an early specialist agency in biotechnology, we’ve supported communications around developments in areas like genomics, personalized medicine, gene therapy, regenerative medicine, and more. We help companies define and communicate what matters across four areas: positioning and messaging, corporate and product communications, media and investor engagement programs, and social media and editorial support. For more information, visit www.russopartnersllc.com.
About NurExone
NurExone Biologic Inc. is a TSXV, OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsi . 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. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
FORWARD-LOOKING STATEMENTS
This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. 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. Forward-looking statements in this press release include, but are not limited to, statements relating to: the Company’s CMC activities and manufacturing/quality readiness; potential IND-enabling steps and the timing/commencement of clinical trials; manufacturing scale-up and establishment of small-scale clinical manufacturing capability in Israel; evaluation of potential U.S. operational development through Exo-Top Inc.; and the TSXV approval and scope of services of Russo; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.
These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: the ability to execute planned CMC work as designed; the availability of capital, talent and third-party vendors on commercially reasonable terms; that preclinical and analytical data will continue to support advancement toward IND-enabling steps; that regulatory interactions occur on expected timelines; that manufacturing technology transfer/scale-up proceeds as planned; that operational steps in Israel and the U.S. advance as contemplated; that the Russo engagement receives TSXV approval on substantially the terms described; and the NurExone platform technology has the ability to offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.
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: early-stage development risk; the risk that preclinical/analytical results do not predict clinical outcomes; regulatory review timing and outcomes; manufacturing scale-up and CMC risks; financing and market conditions; dependence on third-party collaborators and suppliers; IP protection; competition and technological change; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca. 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.
Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.
i Spinal cord injury, Glaucoma
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