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ProQR plans AX-0810 Phase 1 data for December 9

Initial AX-0811 Phase 1 data in healthy volunteers are expected in early January 2027.

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Form Type
6-K

Rhea-AI Filing Summary

ProQR Therapeutics N.V. (PRQR) announced upcoming presentations on AX-0810, AX-0811 and its Axiomer RNA-editing platform. At The Liver Meeting 2026, two AX-0810 Phase 1 posters are scheduled to cover study design and previously disclosed safety, pharmacokinetic and target-engagement findings; one is a late-breaking poster on proof-of-concept data. A TIDES Europe presentation on November 3 will review previously presented AX-0810 findings and preclinical work on AX-0811.

At a December 9 conference, ProQR plans to present Cohort 3 data and the 12 week follow up from the AX-0810 Phase 1 study, alongside new preclinical proof-of-concept data for AX-0811. AX-0811, an NTCP-targeting RNA-editing oligonucleotide being evaluated in a Phase 1 study in healthy volunteers, has initial data expected in early January 2027. ProQR describes its preclinical findings as showing greater potency and durability.

AX-0810 poster presentations 2 presentations The Liver Meeting 2026
AX-0810 follow-up 12 week follow up Scheduled for presentation on December 9, 2026
TIDES Europe presentation November 3, 2026 Plenary presentation
Expected initial AX-0811 data Early January 2027 AX-0811 Phase 1 study in healthy volunteers
ADAR technical
"molecular machinery ... called ADAR (Adenosine Deaminase Acting on RNA)"
Editing Oligonucleotides technical
"Axiomer™ “Editing Oligonucleotides”, or EONs"
NTCP target engagement medical
"NTCP target engagement findings from the study"
pharmacokinetics medical
"safety, pharmacokinetic, and target engagement findings"
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
proof-of-concept medical
"new preclinical proof-of-concept data for AX-0811"
A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What will PRQR present about AX-0810 at The Liver Meeting 2026?

ProQR plans two AX-0810 Phase 1 poster presentations covering study design and previously disclosed safety, pharmacokinetic and target-engagement findings. One poster is a late-breaking presentation on proof-of-concept data.

When are initial AX-0811 Phase 1 data expected?

Initial AX-0811 Phase 1 data are expected in early January 2027. The study is evaluating AX-0811 in healthy volunteers.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates

 

 

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 of

the Securities Exchange Act of 1934

 

For the month of October, 2026

 

Commission File Number: 001-36622

 

PROQR THERAPEUTICS N.V.

 

Zernikedreef 9

2333 CK Leiden

The Netherlands

Tel: +31 88 166 7000

(Address, Including Zip Code, and Telephone Number,
Including Area Code, of Registrant’s Principal Executive Offices)

 

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

 

Form 20-F x Form 40-F ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

 

 

 

On October 28, 2026, ProQR Therapeutics N.V. (“ProQR”) issued a press release entitled “ProQR to Present Clinical and Preclinical Progress from AX-0810 and AX-0811 at Upcoming Conferences.” A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

ProQR hereby incorporates by reference the information contained herein into ProQR’s registration statements on Form F-3 (File No. 333-282419, File No. 333-270943, File No. 333-263166, File No. 333-285767 and File No. 333-297272).

 

 

 

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.

 

  PROQR THERAPEUTICS N.V.
   
   
Date: October 28, 2026 By:  /s/ Dennis Hom
    Dennis Hom
    Chief Financial Officer

 

 

 

INDEX TO EXHIBITS

 

Number   Description
     
99.1   Press Release of ProQR Therapeutics N.V. on October 28, 2026.

 

 

Exhibit 99.1

 

ProQR to Present Clinical and Preclinical Progress from AX-0810 and AX-0811 at Upcoming Conferences

 

·ProQR to present its ADAR-mediated RNA editing approach and progress toward next-generation editing oligonucleotides at TIDES Europe plenary session
·AX-0810 Phase 1 data to be featured in two poster presentations at AASLD, The Liver Meeting® 2026, including one late-breaking poster
·Cohort 3 data and the 12 week follow up from the AX-0810 Phase 1 study along with new preclinical proof-of-concept data for AX-0811 to be presented at Nature Conferences RNA at the Bench and Bedside V in December 2026
·Next-generation AX-0811, an NTCP-targeting RNA editing oligonucleotide generated using ProQR’s AI-enabled discovery engine is being evaluated in a Phase 1 study in healthy volunteers, with initial data expected in early January 2027

 

LEIDEN, Netherlands & CAMBRIDGE, Mass., October 28, 2026 – ProQR Therapeutics N.V. (Nasdaq: PRQR) (ProQR), a clinical-stage company dedicated to changing lives through transformative RNA therapies based on its proprietary ADAR-mediated Axiomer™ RNA editing technology platform, today announced upcoming presentations highlighting clinical and preclinical progress with AX-0810 and AX-0811 and the broader Axiomer RNA editing platform at TIDES Europe, The Liver Meeting 2026, Nature Conferences RNA at the Bench and Bedside V.

 

Upcoming Presentations

 

TIDES Europe 2026

 

Gerard Platenburg, ProQR’s chief scientific officer, will deliver a plenary presentation reviewing previously presented clinical findings from AX-0810, including a favorable safety and tolerability profile and NTCP target engagement that demonstrate successful translation. The presentation will also highlight AI-enabled advances in the discovery of AX-0811, a next-generation Axiomer RNA editing oligonucleotide with preclinical data demonstrating greater potency and durability, underscoring the potential of ProQR’s Axiomer platform.

 

Plenary session title: “Clinical Validation of ADAR RNA editing and translation to AI-driven next-generation EONs”
Presenter: Gerard Platenburg, Chief Scientific Officer
Date and time: November 3, 2026, 16:25 CET
Location: Amsterdam, Netherlands

 

 

 

AASLD The Liver Meeting® 2026

 

The AX-0810 Phase 1 study will be featured in two poster presentations at The Liver Meeting® 2026, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 5–9, 2026. The presentations will focus on study design, as well as previously disclosed safety, pharmacokinetic, and target engagement findings from the study.

 

Poster presentation
Title: Safety, pharmacokinetics and target engagement of AX-0810 a first-in-class RNA editing therapy designed to modulate bile acid transport for cholestatic disease
Abstract number: 1156
Presenter: R. Bart Takkenberg, MD, PhD, Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam
Date and time: November 5, 2026, 12:00pm-1:00pm MT
Location: Denver, CO

 

Late-breaking poster presentation
Title: First-in-person evidence of in vivo Axiomer RNA Editing of NTCP for the treatment of cholestasis: Proof of concept data from the AX-0810 Phase 1 Trial
Late-breaking abstract number: 5032
Presenter: R. Bart Takkenberg, MD, PhD, Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam
Date and time: November 8, 2026, 1:00pm-2:00pm MT
Location: Denver, CO

 

Nature Conferences RNA at the Bench and Bedside V

 

Cohort 3 data and the 12 week follow up from the AX-0810 Phase 1 study and new preclinical proof-of-concept data for AX-0811 will be presented at Nature’s RNA at the Bench and Bedside V in December 2026.

 

Presentation title: From clinical validation to next-generation ADAR RNA editing: Advancing NTCP modulation with AX-0810 and AX-0811 for cholestatic disease
Presenter: Gerard Platenburg, Chief Scientific Officer
Date and time: December 9, 2026, 2:30-3:00pm PT
Location: La Jolla, California

 

Building on the clinical experience with AX-0810 and encouraging preclinical proof-of-concept findings, AX-0811, a next-generation NTCP-targeting RNA editing oligonucleotide designed with improved potency and durability is being evaluated in a Phase 1 study in healthy volunteers with initial data expected in early January 2027.

 

 

 

The presentations and posters will be made available on the Publications and Presentations section of ProQR’s website following their presentation, subject to applicable conference policies.

 

About Axiomer™

 

ProQR is pioneering a next-generation RNA base editing technology called Axiomer™, which could potentially yield a new class of medicines for diverse types of diseases. Axiomer™ “Editing Oligonucleotides”, or EONs, mediate single nucleotide changes to RNA in a highly specific and targeted way using molecular machinery that is present in human cells called ADAR (Adenosine Deaminase Acting on RNA). Axiomer™ EONs are designed to recruit and direct endogenously expressed ADARs to change an Adenosine (A) to an Inosine (I) in the RNA – an Inosine is translated as a Guanosine (G) – correcting an RNA with a disease-causing mutation back to a normal (wild type) RNA, modulating protein expression, or altering a protein so that it will have a new function that helps prevent or treat disease.

 

About ProQR

 

ProQR Therapeutics is a clinical-stage company dedicated to changing lives through the creation of transformative RNA therapies. ProQR is pioneering a next-generation RNA technology called Axiomer™, which uses a cell’s own editing machinery called ADAR to make specific single nucleotide edits in RNA to reverse a mutation or modulate protein expression and could potentially yield a new class of medicines for both rare and prevalent diseases with unmet need. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.

 

Learn more about ProQR at www.proqr.com.

 

Forward Looking Statements

 

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will,” “would” and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding the timing and content of ProQR’s upcoming presentations at TIDES Europe, The Liver Meeting 2026, and Nature Conferences RNA at the Bench and Bedside V, as well as ProQR’s participation in these conferences; the availability of ProQR’s presentations and posters on its website; the planned presentation of Cohort 3 data and 12 week follow up from the AX-0810 Phase 1 study and new preclinical proof-of-concept data for AX-0811; the continued development and advancement of the Axiomer platform and ProQR’s NTCP-targeting programs; the potential for greater potency and durability of AX-0811 observed preclinically to translate into humans; the Phase 1 clinical development of AX-0811 in healthy volunteers, including enrollment of the trial and the anticipated timing of initial clinical data in early January 2027; the therapeutic potential of Axiomer EONs and ProQR’s product candidates; and the anticipated benefits of ProQR’s AI-enabled discovery engine.

 

 

 

Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Actual results could differ materially from those expressed or implied by these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described in ProQR’s filings with the Securities and Exchange Commission, including certain sections of its most recent annual report on Form 20-F. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities; the risk that preclinical or early clinical data may not be predictive of future results or clinical benefit; the likelihood that ProQR’s programs may not advance on the timelines currently anticipated; reliance on contract research organizations, contract manufacturers and other third parties; the ability to recruit and retain employees and consultants, including members of management and scientific advisors; the ability to integrate and realize the anticipated benefits of AI, machine learning and proprietary data in discovery and development; the unpredictability of regulatory requirements and the duration and results of regulatory review; possible safety or efficacy concerns that may emerge as additional data are generated; the possible impairment of, inability to obtain or costs to obtain intellectual property rights; the ability to secure, maintain and realize the intended benefits of collaborations and partnerships; risks related to cybersecurity and data privacy; general business, operational, financial and accounting risks; and risks related to macroeconomic conditions, market volatility, geopolitical events, international trade restrictions and other developments affecting ProQR’s business. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. ProQR assumes no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

 

ProQR Therapeutics N.V.

 

Investor and media contact:
Sarah Kiely
ProQR Therapeutics N.V.
T: +1 617 599 6228
skiely@proqr.com
or
Investor contact:
Peter Kelleher
LifeSci Advisors
T: +1 617 430 7579
pkelleher@lifesciadvisors.com

 

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