Stayble Therapeutics publishes half-year report for 2024

Stayble Therapeutics AB (“Stayble” or the “Company”) hereby publishes its half-year report for 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 (April – June 2024)

• In April, it was announced that the Company's scientific abstract regarding the treatment concept for herniated discs has been accepted for a poster presentation at the International Society for the Study of the Lumbar Spine (ISSLS) annual meeting in Milan, Italy.
• In June, the Company carried out a directed issue of 4,000,000 units, each consisting of three newly issued shares and two warrants of series TO2 in the Company, corresponding to a total of 12,000,000 shares and 8,000,000 warrants. Through the directed issue, the Company received approximately SEK 2.8 million after deduction for transaction costs.
• In June, it was announced that the Company reached the recruitment goal in the ongoing phase 1b study by having at least 18 patients complete their three-month visit. A total of 24 patients completed the visit. All essential data for evaluating the study's primary parameters have thus been secured. The company also presented interim results. The evaluation of the blinded results from the three-month follow-up showed safety and tolerability of both STA363 and placebo (primary study objective). The patients will be followed until they complete their six-month visit.

Highlights after the end of the period

• In July, the Company announced that Erik Kullgren has been appointed as the new CFO, effective August 1, 2024.

Financial information and commentary

No additional comments

Comment from the CEO

Our ongoing Phase 1 b study is progressing as planned, and we have achieved several significant milestones during the second quarter. We have strengthened our financial position through a targeted issue without a discount and presented interim data that increases the likelihood of positive results. The study evaluates our drug candidate STA363 in patients with pain caused by herniated discs. We are now entering the most exciting phase of the study, with the final patient follow-ups underway and results expected in Q4.

Interim data in the ongoing phase 1b study increase the likelihood of positive study results

We presented interim data from the three-month follow-up of all patients. The data show that our drug candidate STA363 is safe at three months, and no lasting side effects have been observed. This strengthens our hope of presenting positive results regarding the primary goal of the phase 1b study, which is to demonstrate safety and tolerability.

The final phase initiated in the Phase 1b study

Patient follow-up is progressing according to plan, and we are approaching when all patients have completed their last visit, including pain assessment and MRI examination. Once the last patient has completed their last visit, a more detailed time schedule will be presented. As previously communicated, the results, including interesting data regarding pain assessment and MRI examination, are expected to be presented during Q4 this year.

Secured financing

We are proud to have secured continued funding through a directed issue in a challenging market without a discount. The funds from the issue give Stayble good conditions to fully focus on delivering the upcoming results from the phase 1b study and to best prepare for partnership discussions at the end of the year and the beginning of 2025.

An exciting autumn

I look forward to an exciting fall for Stayble and actively working to raise awareness of how we can change future treatments for herniated disc pain. I want to take the opportunity to thank our existing and new shareholders for your support for our exciting development and for wanting to be part of the journey towards a completely new treatment for patients with herniated disc pain.

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 August 20, 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.