Stayble Therapeutics publishes year-end report for 2022

Stayble Therapeutics AB ("Stayble" or the "Company") hereby publishes its year-end report for 2022. 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.

Financial information and commentary

Stayble Therapeutics AB reported operating expenses of KSEK 4,642 (4,594) for the period October-December 2022.

The company had increased costs in the period 1 January to 31 December compared to the previous year. This is directly linked to the positive increase in patient recruitment that occurred during the period.

Highlights during the fourth quarter (October - December 2022)

• Approximately 70% of all patients had completed their 6-month follow-up by October in the ongoing Phase IIb study, which is the primary endpoint of the trial.
• A poster on the ongoing Phase IIb study was accepted for presentation at the 4th European Congress on Clinical Trials in Pain (SOPATE2022), Austria, on 7-8 December 2022.

Highlights after the end of the period

• The company's Phase IIb study has reached the follow-up target of 100 patients completing its 6-month follow-up. All critical data to evaluate the study's primary endpoint have thus been secured. All patients will continue to be followed until they complete their 12-month visit prior to code break. Of these, approximately 50% of patients have completed their 12-month visit. Top-line data is expected to be presented in Q4 2023.

CEO comment

It is with pleasure that I sum up 2022 and acknowledge that it has been a successful year for Stayble. The highlight of the year was in August when we were able to announce that the last patient had been enrolled in our Phase IIb study. An important milestone that makes 2023 a very important and exciting year in the Company's development as we look forward to the results of the study.

All key data secured from ongoing phase IIb study with STA363

Achieving this milestone in our Phase IIb means that we have secured all the necessary data to evaluate the study's primary endpoint (pain). This required 100 patients, each of whom underwent pain measurement six months after treatment. Furthermore, approximately 50% of patients have now completed their 12-month visit. I would also like to highlight the hard work and dedication of the medical staff and research team who have ensured that the study has been conducted with high quality and good adherence.

STA363 and its potential yielded great interest among experts

In December, our Chief Scientific Officer, Anders Lehmann presented a poster at SOPATE2022, a congress on clinical trials in pain. Experts in the field have shown great interest in the new therapeutic opportunity, STA363, for the treatment of disc-related chronic low back pain and our clinical program.  

Upcoming meetings with FDA and MPA

The US and Europe are two of the most important markets and therefore during the first quarter we will initiate dialogues with both the US (FDA) and Swedish (MPA) regulatory authorities. How authorities view previously generated data, regulatory issues and plans on how to design a Phase III clinical program are important for the future development of STA363 and questions that partners are interested in getting answers to.

Looking forward

With interest already high from previous partner discussions, we look forward to continuing more detailed discussions throughout the year. We will also actively work to introduce STA363 to multiple new potential partners. This to ensure that as many relevant stakeholders as possible are interested in learning about the upcoming results from our Phase IIb study and then continue with more in-depth discussions.

Thank you for your continued support in Stayble, 2023 will be an exciting year!

For more information

Andreas Gerward, CEO Stayble Therapeutics AB

Mail: andreas.gerward@stayble.se

Phone: +46 730 808 397

This is information that Stayble Therapeutics AB is obliged to make public according to the EU Market Abuse Regulation. The information was made publicly available by the Company’s contact person set out above on 21 February 2023 08.00 CET.

About Stayble Therapeutics AB

Stayble is a clinical stage pharmaceutical company developing the injection treatment STA363 for disc-related low back pain. The treatment is aimed at patients whose back pain persists after physiotherapy and painkillers. The injection is given once and the effect is expected to remain throughout the entirety of the patient’s life and to require minimal rehabilitation. The Company’s focus is set upon the continued clinical development and is currently conducting a clinical phase 2b. Stayble’s vision is to develop STA363 as a new standard treatment for patients suffering from chronic disc-related low back pain.

Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.