Stayble Therapeutics publishes interim report for the third quarter 2022

Stayble Therapeutics AB ("Stayble" or the "Company") hereby publishes the interim report for the third quarter of 2022. The report is available as an attached document and on the Company's website.

Highlights during the third quarter (July – September 2022)

• Stayble announces that the last patient has been enrolled in the ongoing Phase 2b clinical trial of STA363 for chronic disc-related low back pain. This completes patient enrolment, and the study will be completed once all patients have been followed up for 12 months. Top-line results are expected to be presented in Q4 2023.
• Stayble announces that the Company's CEO Andreas Gerward has purchased 15,000 shares in the Company with a total value of SEK 73,350. The shares were purchased in the open market at a price of SEK 4.89 per share. Following the transaction, Andreas owns a total of 360,000 shares in Stayble.

Highlights after the end of the period

• Stayble provides an update on the ongoing Phase 2b study and reports that the Company continues to see good adherence and that approximately 70% of all patients have completed their 6-month follow-up, which is the primary objective of the study.

CEO comment

Patient recruitment completed - study continues with high quality

We end the third quarter with a positive outlook. Our efforts to increase patient recruitment paid off and we saw a dramatic increase in recruitment rates. The last patient was treated in the end of August and the study is therefore fully in line with our communicated timeline. The study is now entering a follow-up phase where patients will be followed for 12 months after their treatment. During October we were able to announce that 70% of patients completed their 6-month visit, which is the most important visit for the evaluation of the study. Once all patients have completed their 6-month visit, all data to analyse primary endpoint of the study will have been collected. Patients are then followed for an additional 6 months and once all patients have completed their 12-month visit, the data set will be unblinded and we will know which patients that received active substance or placebo, after which the top-line data can be presented.

Stepping up partnering activities

With a fully recruited study and, hence a defined timetable to results, Stayble is focusing on increasing the interest from potential partners. Over the past few weeks, we have participated in several partnering conferences. At the end of October, we attended BIO-Europe in Leipzig - Europe's largest partnering congress in life science, and prior to that we attended the LSX Nordic Congress in Copenhagen and the Nordic Life Science Days in Malmö. The conferences gave us the opportunity to strengthen existing as well as to create new strategic business contacts. Potential collaborators associate STA363 with several benefits as it fills a major medical need and the interest in the treatment concept is high. The fact that Stayble is in Phase 2b is also an optimal time to initiate collaborations.

Furthermore, Stayble has had an abstract accepted for a poster presentation at the 4th European Congress on Clinical Trials in Pain (SOPATE2022). The congress will take place on 7-8 December 2022 in Vienna, Austria. We look forward to presenting STA363 and our clinical trial to experts in the field.

Looking ahead

In conclusion, I would like to thank my colleagues and our collaborators for outstanding work with our Phase 2b study and I look forward to a strong finish. With all patients enrolled, we look forward to achieving new milestones. The short-term focus revolves around continuing to engage in partner discussions while also following up our patients and preparing for the next stage of development through key regulatory interactions.

For more information

Andreas Gerward, CEO Stayble Therapeutics AB

Mail: andreas.gerward@stayble.se

Phone: +46 730 808 397

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 and can be reached at +46 (0) 11 32 30 732 or e-mail ca@skmg.se