Stayble Therapeutics publishes year-end report for 2023

Stayble Therapeutics AB (“Stayble” or the “Company”) hereby publishes its year-end report for 2023. 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 fourth quarter (October – December 2023)

• In November, top-line data from the phase IIb study with STA363 against chronic disc-related back pain was announced. The randomized, double-blind study did not achieve the primary objective. According to the pre-specified statistical criteria, STA363, compared to the placebo, did not show a statistically significant reduction in pain at six months.
• In December, additional analyses from the phase IIb study on degenerative disc disease and its impact on the Company's other project on disc herniation were announced. In patients who received the higher dose of STA363, a statistically significant difference was observed in disc intensity and disc height, which are clear signs of reduced disc volume. These effects should result in reduced herniated disc volume and, thus, reduced pressure on the nerve root, and reduced pain in herniated disc patients.

Highlights after the end of the period

• In January, the final data analysis of the phase IIb study with STA363 against chronic disc-related back pain was announced. Consistent with the preliminary topline analysis communicated in November 2023, the subgroup analysis corroborates 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 results from the phase IIb study strengthen the company.

Financial information and commentary

During quarter 4, Stayble Therapeutics AB reported operating costs of SEK 6,595,000, which included all closing costs for the Phase IIb study in degenerative disc diseases (DDD).

Comment from the CEO

2023 was one of the most exciting years in Stayble's development journey. Especially when we could present the results from the phase IIb study against chronic disc-related back pain at the end of the year. However, the study did not demonstrate the results on pain that we had hoped for, but the results show that treatment with STA363 affects the disc in line with our concept. A statistically significant difference in disc intensity and disc height was observed in the phase IIb study in degenerative disc diseases, and this supports the hypothesis in our project within disc hernia.

Data from phase IIb provide support for treatment efficacy in pain caused by herniated discs

In patients from phase IIb who received the higher dose of STA363 (the same used in the herniated disc study), a statistically significant difference in disc intensity and disc height was found, which are clear signs of reduced disc volume. A correlation between treatment resulting in reduced disc and hernia volume and its effect on herniation-induced nerve root pain is the basis for the treatment principle, supported by scientific literature. Therefore, we are shifting the focus to our ongoing phase Ib study in disc herniation. We align with the development plan and will complete patient recruitment in Q1 2024. After that, patients will be followed for six months with follow-ups at one week, one week, three months, and six months. The primary focus of the study is safety and tolerability, and we will communicate preliminary results in the first half of this year. As previously communicated, the final results from the study will be presented in the second half of this year.

Secured financing until the end of 2024

As a consequence of the results from the phase IIb study, we have reviewed our expenses and taken steps to reduce costs to extend the time we have funding. Among other things, we have limited rental costs, as well as limited company analysis and external support. We have also reduced the number of employees from January 1, 2024. This gives us funds until the final results from phase Ib in disc herniation. In parallel with the development, we continue our dialogues with potential partners.

I look forward to 2024 and continuing to develop STA363 towards disc hernia

Over the years, we have gained significant experience in conducting pain studies, from design to implementation and follow-up. With our experience, strong scientific support, and an apparent demand for a product like STA363, we look forward to continuing our development in an area with a significant medical need.

We look forward with confidence to the next steps and results from our study in 2024.

Andreas Gerward, CEO

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 February 20th, 2024.

About Stayble Therapeutics AB

Stayble is a clinical pharmaceutical company developing the injection treatment STA363 for degenerative disc disease (DDD) and 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 Ib and IIb) 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.