Stayble Therapeutics publishes interim report for the third quarter of 2024

Stayble Therapeutics AB (“Stayble” or the “Company”) hereby publishes its interim report for the third quarter of 2024. The report is available as an attached document and on the Company’s website: https://staybletherapeutics.com/investor-relations/financial-reports/. Below is a summary of the report.

Summary

Highlights during the second quarter (July – Septmeber 2024)

• July: Erik Kullgren was announced as the new CFO, effective August 1, 2024. 
• September: The South African Patent Office became the first authority to approve the Company's patent for the treatment of pain caused by herniated discs with STA363. 
• September: The last patient visit in the Company's Phase 1b study for patients with pain caused by herniated discs was completed. A total of 25 patients were included, and 22 of them completed their 6-month follow-up, meeting the goal of at least 18 evaluable patients in the study. 

Highlights after the end of the period

• October: The European Patent Office (EPO) issued an "Intention to Grant" for the Company's patent for the treatment of herniated discs with STA363. "Intention to Grant" implies that only a formal process remains before the Company can receive approved patents in the countries associated with the EPO.
• November: Positive results were announced from the Company's clinical Phase 1b study on pain caused by herniated discs. The study demonstrated good safety and tolerability of STA363, which was the primary objective. Additionally, patients treated with STA363 showed a statistically significant reduction in disc height compared to those treated with placebo.

Financial information and commentary

No additional comments

Comment from the CEO

We proudly and enthusiastically announced positive results from our Phase 1b study in November. The study demonstrated that STA363 is both safe and tolerable for patients with disc herniation and resulted in a statistically significant reduction in disc volume compared to placebo-treated patients. This reduction in disc volume is a prerequisite for alleviating pain caused by disc herniation. These findings provide us with great confidence in the future development of STA363. I now look forward to planning a Phase 2 study and intensifying ongoing and new partnership discussions. 

Positive Results from the Phase 1b Study – Established Safety and Disc Volume Reduction 

The study achieved its primary objective of demonstrating a favorable safety profile. Only a few adverse events (AEs) and no persistent serious adverse events (SAEs) related to STA363 were reported during the study. Additionally, we confirmed an important safety aspect, showing that STA363 has no adverse effects on the disc or the endplate (the surface between the disc and the vertebra), also known as Modic changes. This is a key differentiating factor compared to competing products under development. 

Data shows a statistically significant disc volume-reducing effect compared to placebo as early as one month, with maximum effect observed at three months and a sustained reduction at the six-month follow-up. These results align well with data from the Phase 2b study of STA363 in degenerative disc disease, providing valuable insights into the timing of volume changes. The reduction is comparable with what has been reported in other studies involving treatments that decrease disc volume, resulting in significant pain relief for disc herniation patients. This further strengthens the scientific rationale for STA363 and its potential as an effective pain treatment, given its similar impact on disc volume. 

Ongoing Partnering Activities – Key Meetings at the BioEurope Conference 

A critical factor in securing strategic partnerships is increasing our visibility on the global stage. During the reporting period, we participated in BioEurope, Europe’s largest partnering conference, where we held productive meetings with several pharmaceutical companies. Our primary focus is now to present the study results and intensify dialogue with these companies and others in the industry. 

Scientific Presence and Interest 

Visibility within the scientific community is a crucial component in developing new therapies. Our scientific advisor, Dr. Douglas Beall, recently published the article “Treatment Gaps and Emerging Therapies in Lumbar Disc Herniation,” highlighting STA363 as one of the groundbreaking treatments that could bridge the gap between conservative therapies and surgery. We have recently submitted two abstracts based on Phase 1b results to two scientific conferences scheduled for April and May 2025. We plan to continue active participation in other upcoming international scientific conferences and collaborate closely with our global scientific advisors. 

TO2 Secures Additional Working Capital for 2025 

The company previously issued the TO2 warrant to strengthen our cash position and enable full focus on preparing for Phase 2 and advancing our partnership discussions. The warrant is currently in the money at the highest possible strike price. The subscription period is set for late January, and a full subscription will provide the company with SEK 3 million before issuance costs. This capital will provide Stayble with sufficient runway into Q3 2025. 

An Exciting Time Ahead 

Encouraged by the promising results from Phase 1b, I look forward to an intense few weeks in the remaining of 2024 and a 2025 focusing on partnering efforts and Phase 2 planning. I am eager to drive our groundbreaking treatment forward in collaboration with prospective partners, scientific experts, and both new and existing shareholders.

For more information

Andreas Gerward, CEO of Stayble Therapeutics AB

Mail: andreas.gerward@stayble.se

Phone: +46 730 808 397

This information is the type of information that Stayble Therapeutics AB is obliged to publish pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on November 29, 2024.

About Stayble Therapeutics AB

Stayble is a clinical pharmaceutical company developing the injection treatment STA363 for chronic disc herniation (LDH). Stayble's vision is to offer patients a simple and effective treatment that targets the underlying cause of the patient's chronic pain and provides lasting pain relief and increased physical function. The treatment is aimed at patients who are not helped by physical therapy and painkillers and is a single injection that is expected to last a lifetime and requires minimal rehabilitation. After convincing data from previous pre-clinical and clinical studies (phase 1b and 2b) in degenerative disc disease, which show a volume reduction of the discs, the Company has successfully conducted a phase 1b study for the treatment of herniated discs.

The company's Certified Adviser is Svensk Kapitalmarknadsgranskning AB.