Celecoxib

Three-part program - AI-enabled characterization of PrimeC's formulation advantage, an active-comparator trial against edaravone, and a streamlined pivotal pathway - is designed to strengthen PrimeC's differentiation, shorten the time to potential commercialization, and significantly reduce overall development costs, complemented by a parallel regulatory pathway in Canada. CAMBRIDGE, Mass., Aug. 31, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company's previously planned development path. ALS drug development has been shaped by a single model: large, long, expensive confirmatory trials that few companies can fund and that people with ALS wait years to read out. NeuroSense's plan replaces that single large commitment with three shorter, focused studies, each designed to answer a specific question that regulators, physicians, partners or payers routinely ask. The redesigned strategy builds on the totality of evidence generated in NeuroSense's Phase 2b PARADIGM study, including clinically meaningful effects on functional decline, statistically significant modulation of extracellular vesicle-associated TDP-43, consistent findings across multiple disease-related biomarkers, and encouraging long-term survival results. NeuroSense has already received FDA clearance to initiate its pivotal Phase 3 PARAGON trial. Together, these clinical, biomarker and regulatory advances provide the foundation for a more focused and capital-efficient development pathway. AI-enabled characterization of PrimeC's formulation advantage. PrimeC is an extended-release fixed-dose combination engineered to synchronize the pharmacokinetic profiles of its two active components. In a completed clinical pharmacokinetic study, PrimeC produced a synchronized exposure profile that was not reproduced when the individual components were administered together. NeuroSense is now applying AI-enabled modeling to these clinical data to quantify the magnitude of that difference, assess its consistency across individual patients and further characterize the contribution of PrimeC's proprietary formulation. This work builds upon PrimeC's established intellectual property position and is intended to support potential additional patent protection while providing clinicians, payers and prospective partners with an objective basis for distinguishing PrimeC from any co-administration of its individual components. A direct comparative study against edaravone. NeuroSense plans to conduct an active-comparator clinical study designed to evaluate PrimeC directly against edaravone, an established ALS therapy. Head-to-head trials are not common in ALS, and differentiated results could provide people with ALS, clinicians, payers and prospective partners with compelling evidence of PrimeC's relative clinical value and commercial potential. A streamlined pivotal pathway. NeuroSense is evaluating an optimized design for its planned Phase 3 study (PARAGON) that would be substantially smaller and shorter in duration than previously planned, enriched for participants earlier in their disease course and intended to support an earlier regulatory submission. Any such pivotal design remains subject to alignment with FDA. The Company plans to discuss with the FDA whether its existing data may support full approval or, alternatively, an Accelerated Approval pathway, with an additional study conducted post-approval as required. A parallel path to earlier access in Canada. NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to target for December 2026. If accepted and ultimately approved, this pathway has the potential to make PrimeC available to Canadian patients on the strength of data already generated. "One of the hardest constraints in ALS is not scientific - it is that the standard development path takes longer than patients have," said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. "We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package - pharmacology, comparative clinical context, and a pivotal dataset - than the single-trial approach would have." About NeuroSense NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. The Company's lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism. NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, with results published in JAMA Neurology showing slowing of functional decline relative to placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC's multi-target mechanism of action. NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. As described above, the Company is working with FDA on an optimized design for the study. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. About PrimeC PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation, with the potential to inhibit disease progression. About ALS Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 3 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU. Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the potential benefits of the Company's redesigned development strategy for PrimeC. Further, certain forward-looking statements, including statements regarding the potential regulatory pathways for PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These risks include the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; potential delay in the Canadian New Drug Submission; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that the strategic opportunities described will not materialize or result in the anticipated benefits to the Company; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; timing for reporting data, including from the study of PrimeC in Alzheimer's disease; that the study will not be successful; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law. For further information: Email: [email protected] | Tel: +972 (0)9 799 6183 Logo - SOURCE NeuroSense 21% more press release views with Request a Demo

WILMETTE, Ill., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the appointment of Jeffrey D. Kent, M.D., FACP, FACG, as Executive Vice President, Head of Medical Affairs, effective September 1, 2026. The Company also announced that two abstracts on ALXN1840 (tiomolibdate choline, TMC), its late-stage candidate for the treatment of Wilson disease, have been accepted for presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting ® 2026, taking place November 5-9, 2026, in Denver, Colorado. Appointment of Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs Upon joining Monopar, Dr. Kent will lead the Company’s medical affairs organization as Monopar prepares for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840, its first-in-class albumin tripartite complex (ATC) activator drug candidate for the treatment of Wilson disease. “Dr. Kent’s training as a gastroenterologist and hepatologist, combined with his deep experience in rare disease, regulatory strategy, and product launches, makes him an exceptional fit for Monopar as we prepare to bring ALXN1840 to patients with Wilson disease,” said Chandler Robinson, M.D., Chief Executive Officer of Monopar. “The novel mechanism of action and compelling data package of ALXN1840 have the potential to meaningfully change how Wilson disease is treated,” said Dr. Kent. “I look forward to helping realize that potential for patients.” Dr. Kent brings more than 20 years of biopharmaceutical leadership experience across medical affairs, clinical development and regulatory strategy, with expertise spanning rare diseases, hepatology and gastroenterology, immunology and specialty therapeutics. Most recently, he served as Chief Medical Officer of Sling Therapeutics, where he led the Phase 2b clinical program evaluating linsitinib in thyroid eye disease. Previously, Dr. Kent spent more than a decade at Horizon Therapeutics, including serving as Executive Vice President, Medical Affairs, and as a member of the Executive Committee. During his tenure, he built and scaled Horizon’s global medical affairs organization and supported key programs, including the KRYSTEXXA franchise and the TEPEZZA Biologics License Application (BLA) and its successful FDA Advisory Committee meeting. Earlier in his career, Dr. Kent led global medical affairs for HUMIRA at Abbott Laboratories and served on the CELEBREX clinical development team at Searle/Pharmacia. AASLD – The Liver Meeting ® 2026 Presentations The abstract, titled “Residual hepatic, neurologic, and psychiatric disease burden in treatment-experienced patients with Wilson disease: baseline findings from the FoCus Phase 3 trial,” was selected for an oral presentation, a distinction reserved for a small share of accepted abstracts. Frederick K. Askari, M.D., Ph.D., lead author of the abstract and Associate Professor of Internal Medicine and Director of the Wilson Disease Program at the University of Michigan Health System, will present the findings on Sunday, November 8, 2026, from 12:15 p.m. to 12:30 p.m. MT. The presentation will highlight the significant unmet need that persists despite years of treatment with currently available therapies, underscoring the importance of novel treatment options in Wilson disease. Additionally, a second abstract, titled “Neutral molybdenum balance and lack of molybdenum toxicity in subjects treated with tiomolibdate choline supports safety pro TMC,” was selected for a poster presentation. Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Consultant Hepatologist at The Roger Williams Institute of Liver Studies, King’s College London, and King’s College Hospital, London, will present the poster during the Metabolic and Genetic Disease poster session on Thursday, November 5, 2026, from 12:00 p.m. to 1:00 p.m. MT. The abstracts are scheduled to be released publicly by AASLD on October 5, 2026, and will be published in the October supplement of Hepatology . Presentation materials will be made available on the Monopar website concurrently with each presentation. About Wilson Disease Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. Caused by mutations in the ATP7B gene, the disease impairs the body’s ability to excrete copper, resulting in toxic copper accumulation in the liver, brain, and other organs and potentially fatal outcomes if untreated. About ALXN1840 ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. Clinical data demonstrate that ALXN1840 improves copper balance by increasing fecal copper excretion. In the Phase 3 pivotal trial, ALXN1840 met the primary endpoint by demonstrating rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability pro observed across 645 patient-years of follow-up in 266 patients. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage candidate ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers. For more information, visit: Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning the following: that Dr. Kent will lead the medical affairs organization in preparation for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840; that Monopar is preparing to bring ALXN1840 to patients with Wilson disease; and that the novel mechanism of action and compelling data package of ALXN1840 have the potential to meaningfully change how Wilson disease is treated. The forward-looking statements involve risks and uncertainties including, but not limited to: the risk that Dr. Kent does not commence employment as expected or that the anticipated benefits of his appointment are not realized; uncertainties related to the regulatory process, including the rolling NDA submssion, that Monopar has initiated for ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CONTACT: Monopar Therapeutics Inc. Investor Relations Quan Vu Chief Financial Officer vu@monopartx.com Follow Monopar on social media for updates: X: @MonoparTx LinkedIn: Monopar Therapeutics Source: Monopar Therapeutics Inc.