Rights Issue 2023
“By broadening the usage of our candidate STA363 to include the treatment for lumbar disc herniation, we will not only be able to help even more people with chronic pain, but also increase our market potential and diversify the risk for the Company. With growing market potential, and the positive results from earlier trials, we believe we have even greater opportunities to increase the value for our shareholders. Hence, we welcome more investors to share our vision of helping millions of people to a better life”, Stayble CEO Andreas Gerward says.
- Stayble’s Board of Directors has today decided on the Rights Issue. The decision by the Board is subject to the approval of an extraordinary general meeting of shareholders, planned for March 16th 2023.
- The Rights Issue, if fully subscribed, will provide Stayble with approximately 35,2 MSEK, before issuing costs.
- The subscription period of the Rights Issue will be March 24th 2023 up to and including April 12th 2023.
- Those who on the record date of March 21st 2023 are registered as shareholders in Stayble own preferential right to subscribe to shares in the current Rights Issue. For each existing share, one (1) subscription right is received. Seven (7) subscription rights entitle the holder to subscribe for ten (10) new shares.
- The subscription price has been determined to SEK 1.78 per new share.
- Approximately 11.7 percent of the Rights Issue are covered by pre-subscription commitments, approximately 38.2 percent by so-called bottom-up underwriting commitments and approximately 38.3 percent by so-called top-down underwriting commitments. Hence, the Rights Issue has commitments up to 80 percent.
- A number of members of the Board of Directors and management of the Company have together, through a so-called lock-up agreement, undertaken not to sell any existing shareholdings or such shareholdings that are received through subscription in the Rights Issue during a period of six months from the announcement of the Rights Issue.
Background, motive and milestones
Stayble is a clinical pharmaceutical company, developing the candidate drug STA363 for the treatment of chronic disc related back pain. According to the Board of Directors, STA363 has a competitive edge by being based on a body specific and well documented molecule, lactic acid, combined with a contrast agent in order to provide a safe and reliable injection. The treatment consists of a one-time injection with effects calculated to be lifelong and demanding minimal rehabilitation in comparison to surgical procedures.
The Company currently focuses on further clinical development of STA363 and is at the moment conducting a clinical phase 2b study of the indication degenerative disc disease (DDD). In August of 2022 the phase 2b study was fully recruited and all patients have gone through the three month and six months follow-ups. Currently the focus of Stayble is thus to secure that all patients complete their twelve-month follow-ups and meanwhile intensifying dialogues with potential partners for an upcoming phase 3 clinical study. Topline results of the phase 2b study are expected to be presented during Q4 of 2023.
In order to broaden the activities of the Company, Stayble intends to initiate another project utilizing STA363, directed towards the indication lumbar disc herniation (LDH). There are approximately 2.3 million chronic cases of lumbar disc herniation in EU4 (Germany, France, Italy and Spain), Great Britain, the US and Japan. Additionally, another 10 million patients are diagnosed with LDH annually in the same geographical areas, of which 1.5 million cases are classified as chronic. Based on the level of disc degeneration and the type of hernia, the Company assesses that approximately 60 percent of these are treatable by STA363. The Company intends to initiate a clinical phase 1b study for the LDH treatment during the first half of 2023.
Adding a second indication is an important addition to Stayble’s vision to establish itself as a major player among companies treating pain. With a second indication added to the portfolio, the Board considers Stayble better equipped for upcoming dialogues of partnership regarding upcoming studies and market launch, since the second indication both provides the opportunity to reach a larger market and spreads the risk related to the development of pharmaceuticals. As the treatment is based on a well-documented and body specific molecule, lactic acid, the Board both sees a competitive advantage as well as a low risk during development by utilizing this molecule.
Currently, the working capital is not estimated by the Board to be sufficient to cover the demands of the upcoming twelve-month period. The motive of the Rights Issue is to provide working capital in order to finance operating costs up to and including the first half of 2024. The proceeds of the Rights Issue are also intended to finance the initiation of a phase 1b study within the indication of LDH, concluding the current phase 2b study within the indication of DDD and prepare the organization for partnerships.