Stayble Therapeutics publishes half-year report for 2023

Stayble Therapeutics AB ("Stayble" or the "Company") hereby publishes its half-year report for 2023. The report is available as an attached document and on the Company's website, www.staybletherapeutics.com/en/investors/financial-reports/. Below is a summary of the report.

Summary

Highlights during the second quarter (April – June 2023)

• In April, positive interim data from the ongoing phase 2b study were presented, confirming safety and tolerability, as well as lower deviation in pain measurements compared to initial assumptions when analyzing blinded data from the six-month follow-up.
• In April, the subscription period in the rights issue ended. The rights issue was subscribed to a total of approximately 90 percent, including pre-subscription and underwriting commitments. The company received approximately SEK 31.7 million before issue costs. Proceeds will be used to finalize phase 2b and conduct a phase 1b targeting patients with disc herniation.
• In April, a directed offset issue of shares was carried out to the underwriters who chose to receive remuneration in the form of newly issued shares in Stayble. The subscription price was SEK 1.78 per share and payment was made in the form of an offset by the underwriter’s claim of remuneration.
• In April, Jarkko Kalliomäki was recruited as Chief Medical Officer (CMO). Jarkko is a specialist physician in rehabilitation medicine and pain management, a medical doctor in physiology and has extensive experience from the pharmaceutical industry.
• In April, Dr. Daisuke Sakai was introduced as a new scientific advisor. Dr. Sakai will bring expertise in the area of treating degenerative disc disease as well as herniated discs and experience from the Japanese market.
• In June, Stayble participated in the Bio International Convention in Boston. During the congress several meetings were held with potential partners.

Highlights after the end of the period

• No significant events after the end of the period.

Comment from the CEO – Progress according to plan

The second quarter began with an intense period for Stayble. In April, we successfully completed our rights issue, released interim data from the ongoing Phase IIb study, and made two strategically important recruitments. We are now well positioned for a continually eventful 2023.

At the start of the year, we received the approval to initiate the first clinical study with the drug candidate STA363 for herniated discs. This means that we now have two indications for STA363, enhancing the project's value and diversifying risk. The herniated disc study is ongoing with clinics already initiated, and we look forward to treating the first patients in Q3, as previously communicated. The Phase Ib study focuses primarily on investigating safety and tolerability, but also volume changes of the disc will be measured. This study involves patients experiencing pain due to herniated discs in the lumbar spine. Previous research has demonstrated the safety of the drug candidate STA363 through injection into patients' discs with degenerative disc disease. Building on the insights gained from prior Phase Ib and Phase IIb studies involving patients with degenerative disc disease, we anticipate an efficient process leading to results by the end of the first half of 2024.

Earlier this year (February), Stayble was able to secure all critical data to evaluate the primary endpoint of the Phase IIb study. Currently, over 90% of patients have completed the 12-month follow-up, significantly reducing the operational risk associated with the inability to draw conclusions from this follow-up period. The study is proceeding according to plan and we are approaching the time for obtaining top-line data, which is planned for the fourth quarter of this year.

Significant progress has been made through partnership efforts during the second quarter. Our participation at the BIO International Convention in Boston led to fruitful discussions. We have established several promising contacts with global companies with the necessary capacity to support a clinical phase III program with STA363, a regulatory process and future commercialization. During the meeting, we noted an increased interest in projects focused on long-term pain and in the outcome of our phase IIb study, where even a moderate effect on the pain scale is seen as highly interesting. The response we have received, together with the fact that our drug candidate STA363 now covers two indications, means that we look forward to further interesting discussions.

In summary, this quarter marks a period of significant progress for the Company. With the capital raised from the rights issue, we can drive our ongoing studies at the desired pace. I extend my gratitude to our existing and new shareholders for your continued support. Together, we look forward to continuing this exciting journey toward alleviating back pain and making a meaningful impact in people's lives.

For more information

Andreas Gerward, CEO 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 22nd, 2023.

About Stayble Therapeutics AB

Stayble is a clinical-stage pharmaceutical company developing the STA363 injection treatment for degenerative disc disease (DDD) and chronic disc herniation (LDH). Stayble's vision is to offer patients a simple and effective treatment that addresses the underlying cause of the patient's chronic pain and provides lasting pain relief and increased physical function. Aimed at patients who are not helped by physiotherapy and painkillers, the treatment is a single injection that is expected to last a lifetime and requires minimal rehabilitation. The company is now focused on clinical development and is currently conducting a Phase 2b clinical trial in DDD and a Phase 1b trial in LDH.

Svensk Kapitalmarknadsgranskning AB is the Company’s Certified Adviser.