Stayble Therapeutics publishes interim report for the first quarter of 2024

Stayble Therapeutics AB (“Stayble” or the “Company”) hereby publishes its interim report for the first 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 first quarter (January – March 2024)

• In January, the final data analysis of the phase IIb study with STA363 against degenerative disc disease was announced. Consistent with the preliminary topline analysis communicated in November 2023, the subgroup analyzes corroborate previous results where no difference in pain between placebo and active groups could be detected. The company will now concentrate on the phase Ib project in disc herniation, where the company is strengthened by the results from the phase IIb study.
• In March, it was announced that the last patient had been included in the ongoing phase Ib clinical study with STA363 against herniated discs. No significant side effects have been reported. Results from the study are expected to be available in Q4 2024.

Highlights after the end of the period

• In April, it was announced that the Company's scientific abstract regarding the treatment concept against herniated discs had been accepted for a poster presentation at the International Society for the Study of the Lumbar Spine (ISSLS) annual meeting in Milan, Italy.

Financial information and commentary

No additional information

Comment from the CEO

With ten years of experience in drug development, I strive to create companies that give good returns to investors and develop ground-breaking treatments for patients. STA363, for the treatment of pain caused by disc hernia, represents exactly the kind of potential I'm passionate about. With a project based on a well-known and favorable safety profile and a study with a well-defined endpoint, we have the opportunity to alter the game plan and truly make a difference for patients suffering from this painful condition.

During the first quarter, we achieved a significant milestone by successfully including all patients in our phase 1b clinical study. This accomplishment reduces the risk associated with the study. We now eagerly await the results, which are expected in Q4, marking t an important milestone for us.

Our effort to raise awareness among partners and physicians about Stayble and STA363 is also progressing. Through approved abstracts and presentations by our scientific advisors, our research has received valuable attention from experts both in the scientific sphere and within companies. This strengthens our credibility and our ability to attract partners to our project.

It is important to emphasize that STA363 has a scientific basis, as it has previously been shown that reduced disc volume leads to reduced pain in herniated disc patients. We already have convincing results from patients in previous studies in degenerative disc diseases that demonstrate that treatment with STA363 produces just such changes to the disc, i.e. reduced volume and water content. Thus, STA363 has the potential to alleviate pain and improve the quality of life of those affected.

In conclusion, we have results from patients that strengthen the concept, a safe product, and a scientific basis for our project. The Phase 1b study has completed recruitment according to plan and we are now looking forward to sharing the results during the fourth quarter.

I would like to warmly thank our existing and new shareholders for your continued support of our exciting development and for sharing our vision of making a real difference to patients with herniated disc pain.

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 May 21st, 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 is currently conducting a phase 1b study for the treatment of herniated discs.

The company's Certified Adviser is Svensk Kapitalmarknadsgranskning AB.