Stayble Therapeutics publishes year-end report for 2024

February 2025 Regulatorisk

Summary

 

Highlights during the fourth quarter (October – December 2024)

• In October, the European Patent Office (EPO) announced an “Intention to Grant” for the Company’s patent for treating disc herniation with STA363. “Intention to Grant” means that only a formal process remains before the Company can obtain approved patents in countries linked to the EPO.
• In November, the Company announced positive results from its clinical phase 1b study on patients with disc herniation. The study achieved its primary objective regarding safety and tolerability. Additionally, patients treated with STA363 showed a statistically significant reduction in disc volume compared to patients treated with placebo.
• In December, the Company announced that it was intensifying partnering activities regarding the drug candidate STA363 in collaboration with a renowned transaction advisor.

 

Highlights after the end of the period

• In January, it was announced that a scientific abstract regarding STA363’s effect on disc volume reduction was accepted for an oral presentation at the International Society for the Study of the Lumbar Spine (ISSLS) annual meeting in Atlanta, USA, on May 12-16, 2025.
• In January, the outcome of the exercise of series TO2 warrants was published. A total of 8,000,000 shares were subscribed for through the warrants, representing a 100% exercise rate. The Company raised approximately SEK 2,640,000 before transaction costs.
• In February, an update was provided on the ongoing work to establish partnerships for the pain project STA363. The Company views the significant interest shown by several pharmaceutical companies positively. The board and management assess that there are good opportunities to enter into a partnership agreement based on the results from Phase 1b.

Financial information and commentary

After the period ended, the Company completed the subscription period for the series TO2 warrants. The warrants were exercised 100% by the holders, raising a total of SEK 2.64 million before transaction costs. This capital provides the Company with working capital for continued efforts in ongoing partnership discussions and preparations for phase 2b. The Board continuously works on partnerships and strategic financing alternatives to ensure long-term liquidity.

Comment from the CEO

Stayble is in an exciting development phase where the need for new, safe, and effective treatment alternatives for patients suffering from pain caused by disc herniation is high. We are currently working intensively toward our goal of finding a licensee or partner with the right expertise and financial resources to drive the continued clinical development, commercialization, and launch of STA363. We are engaged in ongoing partnership discussions with several pharmaceutical companies that have shown significant interest. I see good opportunities to finalize a deal or strategic collaboration during the year.

 

Clear interest from potential partners

An intensive effort is underway with our transaction advisor to advance the partnering process. Their experience, expertise, and network provide us with excellent opportunities to identify the right partner to develop STA363 further. We are engaged in discussions with several potential partners, ranging from non-confidential talks to more in-depth discussions where we share detailed confidential information about STA363.

 

Positive results from phase 1b study – Established safety and disc volume reduction

The clinical study has been completed and demonstrated a favorable safety profile without adverse effects on the disc or endplate. Data also shows a significant volume reduction as early as one month after treatment, with maximum effect observed at three months and a sustained reduction at six months. This strengthens the scientific rationale for STA363’s potential as an effective treatment.

 

Confirmed scientific interest

Visibility in the scientific community is another crucial component in drug development. Stayble has previously submitted two scientific abstracts based on phase 1b data, one to ISSLS (International Society for the Study of the Lumbar Spine) and one to USASP (United States Association for the Study of Pain). Both abstracts have been accepted, and we look forward to presenting our groundbreaking research at these conferences in the spring. Having abstracts accepted at scientific congresses is a mark of quality that supports our ongoing partnership discussions.

 

Strengthened intellectual property protection

With the positive news that the European Patent Office (EPO) has issued an “Intention to Grant” for our patent concerning the treatment of disc herniation, only a formal process remains before we receive approved patents in Europe. Patents are crucial in drug development, and this approval strengthens our intellectual property protection and competitiveness. The patent is valid at least until 2040 and can be extended in certain markets until 2045.

 

TO2 secures additional working capital

The fully subscribed TO2 warrant issuance raised approximately SEK 2.64 million, providing us with continued financial flexibility for partnership discussions and phase 2b preparations. I would like to take this opportunity to thank warrant holders for their continued support.

 

An exciting time ahead

Bolstered by promising phase 1b results, strong interest from potential partners, and strengthened financial resources, I look forward to advancing our groundbreaking treatment together with potential partners, scientific experts, and both new and existing shareholders.

 

Gothenburg, February 25, 2025

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 25, 2025.

 

About Stayble Therapeutics AB

Stayble is a clinical pharmaceutical company developing the injection treatment STA363 for lumbar 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 has successfully completed a phase 1b study for the treatment of herniated discs.

The company’s Certified Adviser is Svensk Kapitalmarknadsgranskning AB.