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NeuroSense (Nasdaq: NRSN) secures South Korean patent protection for ALS therapy PrimeC

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Form Type
6-K

Rhea-AI Filing Summary

NeuroSense Therapeutics reported that the Korean Intellectual Property Office granted Korean Patent Number 10-2969898 covering the composition of PrimeC, its lead drug candidate for amyotrophic lateral sclerosis (ALS). The patent covers PrimeC’s proprietary tablet formulation, manufacturing process, pharmacokinetic profile, and its use in treating ALS, and is expected to protect these aspects in South Korea through 2042.

The company describes this as strengthening its global intellectual property around PrimeC and aligning with its plan to advance into a pivotal Phase 3 PARAGON trial in ALS, for which it has already received U.S. FDA clearance. PrimeC is a novel oral combination of ciprofloxacin and celecoxib designed to target multiple ALS-related disease mechanisms, and earlier Phase 2b data showed slowing of disease progression, biomarker activity, and a reported survival benefit.

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Insights

New South Korean patent extends PrimeC protection and supports NeuroSense’s ALS strategy.

The Korean Intellectual Property Office has issued a patent covering PrimeC’s composition, formulation, manufacturing process, pharmacokinetics, and ALS use, with protection in South Korea expected through 2042. This adds another jurisdiction to NeuroSense’s growing patent estate.

PrimeC is an oral combination of ciprofloxacin and celecoxib aimed at multiple ALS mechanisms, including neuroinflammation, oxidative stress and iron dysregulation. NeuroSense cites Phase 2b data showing slowing of disease progression, biomarker changes and a survival signal, and has FDA clearance to begin the pivotal Phase 3 PARAGON study.

The filing links this patent to long-term development and potential commercialization plans for PrimeC. Actual commercial impact will depend on future Phase 3 outcomes, regulatory decisions, and market adoption in South Korea and other regions.

Patent jurisdiction South Korea Korean Intellectual Property Office grant for PrimeC
Patent number 10-2969898 Korean patent covering PrimeC composition and use
Patent protection horizon Through 2042 Expected duration of PrimeC patent protection in South Korea
ALS annual disease burden $1 billion Estimated yearly ALS burden in the United States
ALS incidence More than 5,000 people Annual ALS diagnoses in the United States
Projected ALS population growth 24% Increase in people living with ALS by 2040 in U.S. and EU
Phase 3 trial size Approximately 300 participants Planned enrollment for pivotal Phase 3 PARAGON ALS study
Korean Intellectual Property Office regulatory
"the Korean Intellectual Property Office (KIPO) has issued Korean Patent Number 10-2969898"
Phase 3 PARAGON study financial
"as we advance toward Phase 3 development” and later “pivotal Phase 3 PARAGON study in ALS"
microRNAs technical
"significant biological activity across multiple ALS-related biomarkers, including microRNAs"
microRNAs are tiny pieces of genetic material that act like dimmer switches for genes, turning down the production of specific proteins inside cells. Investors pay attention because microRNAs can be used as diagnostic markers or drug targets—meaning discoveries can create new tests, treatments, or business opportunities, and progress or setbacks in that research can materially affect a company’s clinical prospects and valuation.
forward-looking statements regulatory
"This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
extended-release oral formulation technical
"PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination"
biomarkers technical
"significant biological activity across multiple biomarkers associated with ALS, including microRNAs"
Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

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FAQ

What did NeuroSense Therapeutics (NRSN) announce in its June 2026 6-K?

NeuroSense announced that the Korean Intellectual Property Office granted a patent covering PrimeC’s composition, formulation, manufacturing process, pharmacokinetics, and ALS treatment use in South Korea, with protection expected through 2042, strengthening the company’s intellectual property around its lead ALS candidate.

What is covered by NeuroSense’s new South Korean patent for PrimeC?

The South Korean patent covers key aspects of PrimeC, including its proprietary tablet formulation, manufacturing process, pharmacokinetic characteristics, and pharmaceutical use for treating ALS, providing expected patent protection in South Korea through 2042 and reinforcing NeuroSense’s PrimeC-related intellectual property position.

How does the South Korean patent relate to NeuroSense (NRSN) PrimeC development plans?

NeuroSense states that the Korean patent further strengthens its global intellectual property estate around PrimeC and supports long-term development and commercialization plans, as the company advances toward a pivotal Phase 3 PARAGON study in ALS following U.S. FDA clearance to initiate that trial.

What clinical data has NeuroSense reported for PrimeC in ALS?

NeuroSense reports compelling Phase 2b data for PrimeC, including meaningful slowing of ALS disease progression, significant biological activity across multiple ALS-related biomarkers such as microRNAs, and long-term follow-up indicating a meaningful survival benefit, supporting a multi-target mechanism of action.

What are NeuroSense’s planned Phase 3 activities for PrimeC in ALS?

NeuroSense has received U.S. FDA clearance to initiate the pivotal Phase 3 PARAGON clinical trial in ALS. The company indicates this Phase 3 study is expected to enroll approximately 300 participants, primarily in the United States, to further evaluate PrimeC’s safety and efficacy.

How large is the ALS disease burden mentioned by NeuroSense Therapeutics (NRSN)?

NeuroSense notes that more than 5,000 people are diagnosed with ALS annually in the United States, with an annual disease burden of about $1 billion. It also cites expectations that the number of people living with ALS will grow by 24% by 2040 in the U.S. and EU.
 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of June 2026

 

Commission File Number: 001-41084

 

NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)

 

NeuroSense Therapeutics Ltd.

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9-7996183
(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒           Form 40-F ☐

 

 

 

 

 

 

Explanatory Note

 

On June 11, 2026, NeuroSense Therapeutics Ltd. issued a press release entitled “NeuroSense Granted South Korean Patent Covering PrimeC Composition for ALS.” A copy of the press release is furnished herewith as Exhibit 99.1.

 

The first three paragraphs of the press release attached hereto as Exhibit 99.1 are hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480 and 333-289658) and Form F-3 (File No. 333-269306, 333-260338, 333-283656, 333-284051, 333-291122 and 333-293060) to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1

 

 

Exhibit Index

 

Exhibit No.   Description
99.1   Press Release dated June 11, 2026

 

2

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NeuroSense Therapeutics Ltd.
     
Date: June 11, 2026 By: /s/ Alon Ben-Noon
    Alon Ben-Noon
    Chief Executive Officer

 

3

 

Exhibit 99.1

 

NeuroSense Granted South Korean Patent Covering PrimeC Composition for ALS

 

Patent claims cover PrimeC’s proprietary formulation, manufacturing process and use in ALS

 

Expands intellectual property protection in one of the world’s leading pharmaceutical markets, following recent patent advancements in Japan, Brazil, Australia and the United States

 

Further strengthens global patent portfolio as NeuroSense prepares to initiate Phase 3 development of PrimeC

 

CAMBRIDGE, Mass., June 11, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”  or the “Company”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Korean Intellectual Property Office (KIPO) has issued Korean Patent Number 10-2969898 covering the composition of PrimeC, the Company’s lead drug candidate for the treatment of amyotrophic lateral sclerosis (ALS).

 

 

The granted patent claims cover key aspects of PrimeC, including its proprietary tablet formulation, manufacturing process, pharmacokinetic characteristics, and pharmaceutical use for the treatment of ALS.

 

The patent is expected to provide patent protection for such aspects of PrimeC in South Korea through 2042.

 

“This patent grant further strengthens our growing global intellectual property estate surrounding PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “South Korea is an important pharmaceutical market, and this milestone reflects the continued recognition of the novelty and proprietary nature of PrimeC as we advance toward Phase 3 development.”

 

The South Korean patent grant follows patent grants received in other major jurisdictions, further expanding NeuroSense’s global intellectual property portfolio and supporting the long-term development and commercialization strategy for PrimeC.

 

PrimeC is a novel oral therapy designed to simultaneously target multiple biological mechanisms associated with ALS progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

 

NeuroSense previously reported compelling results from its Phase 2b PARADIGM study, including meaningful slowing of disease progression, significant biological activity across multiple ALS-related biomarkers, including microRNAs, and long-term data demonstrating a meaningful survival benefit. The Company has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 PARAGON study in ALS.

 

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 generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

 

 

 

 

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

 

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 synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

 

About ALS

 

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 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. Further, certain forward-looking statements, including statements regarding the benefits of the Korean patent, development, regulatory progress and potential commercialization of 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 uncertainty regarding the benefits of the Korean patent; outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; 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: info@neurosense-tx.com, Tel: +972 (0)9 799 6183

 

 

 

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