This material has been prepared for marketing purposes and is not and shall not be considered to constitute a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and further information about the company have been set out in an information memorandum which was published and published on lipum.se on 30 June 2023.
Lipum sees an opportunity to complete the ongoing clinical phase I study with the drug candidate SOL-116 earlier than planned. To enable this, the company is conducting a rights issue of approximately SEK 26,4 million with a subscription period of July 4-18. BioStock contacted Lipum's CEO Einar Pontén to find out more.
Lipum is a clinical-stage biopharmaceutical company specializing in the development of a novel treatment for chronic inflammatory diseases. The company has developed the drug candidate SOL-116 which is an antibody with a fully human structure that blocks Bile Salt-Stimulated Lipase (BSSL), a previously overlooked target molecule in the immune system.
The company's primary focus is on treatment of rheumatoid arthritis (RA), but it also sees opportunities for SOL-116 in other inflammatory diseases such as Crohn's disease, ulcerative colitis and systemic lupus erythematosus (SLE).
First-in-Human study continues as planned
Lipum is currently conducting a Phase I study with SOL-116 that has so far included five dose groups with healthy subjects and will conclude with one dose group with RA patients. The safety evaluations between each dose group have shown that SOL-116 is safe and well tolerated.
Can start the second part of the study earlier
The first part of the study is a Single Ascending Dose (SAD) study where each subject receives a single dose of SOL-116. The study has progressed well, leading the company to aim to advance the second part of the study where healthy subjects receive repeated doses of SOL-116.
The company plans to start the repeated dose part after the summer, which is significantly earlier than the original plan. In parallel, the company will conduct the final part of the SAD part where a group of RA patients will receive a dose of SOL-116.
Once the study is completed, the next step is to move on to a clinical phase II study, which Lipum estimates will be possible in 2024. In preparation for this, the company recently had an advisory meeting with Läkemedelsverket where they received good feedback on the curriculum.
Capital raising
By advancing faster with the clinical phase I study, time and cost savings are achieved until the next development stage, but at the same time an earlier capital need arises. Therefore, Lipum has decided to carry out a rights issue that, if fully subscribed, will provide the company with approximately SEK 26,4 million before deduction for transaction costs.
Approximately 60 percent of the net proceeds are intended to be used to complete the ongoing Phase I clinical study, approximately 20 percent is intended for preclinical studies, and the remaining 20 percent will be used to finance other ongoing costs.
The rights issue is supported by major shareholders
A number of major shareholders, including Flerie Invest and The Crafoord Foundation, has undertaken to subscribe for its shares in the issue. Furthermore, Christian von Koenigsegg, and the company's CEO Einar Ponten and founder Olle Hernell and Susanne Lindquist has undertaken to subscribe for shares in the issue. In total, the issue is covered by subscription commitments in an amount of approximately SEK 14,0 million, corresponding to approximately 53,1 percent of the rights issue.
CEO Einar Pontén comments
BioStock spoke with Lipum's CEO Einar Ponten about the issue and progress in the Phase I study with SOL-116.
First of all, why could SOL-116 be a valuable addition in the treatment of RA and other chronic inflammatory diseases?
– With SOL-116, we will offer a new mechanism of action for the treatment of RA. This is due to the fact that the antibody blocks the unique target molecule BSSL, which no other drug for RA does.
»With SOL-116, we will offer a new mechanism of action for the treatment of RA. This is due to the fact that the antibody blocks the unique target molecule BSSL, which no other drug for RA does.«
– Despite great progress, today's drugs are associated with significant side effects, partly due to the fact that they suppress the immune system. The largest share of the market is held by TNF-alpha inhibitors, despite the fact that they have no or insufficient effect in approximately 30 percent of patients. Another third terminate treatment within 2-3 years due to transient effects or side effects. A similar and large medical need is considered to exist for several other chronic inflammatory diseases.
You are now conducting a rights issue to complete the clinical study with SOL-116 earlier than planned. What does the new schedule look like?
– We originally planned to conduct the two stages of the phase I study in series one after the other. However, during the first so-called SAD part, we have received excellent results on SOL-116's pharmacokinetics, i.e. when measuring how the antibody is metabolized in the body. Therefore, we have concluded that the second part to study safety at multiple doses can start earlier than planned. We therefore expect the entire phase I study to be completed during the first quarter of 2024.
»During the first so-called SAD part, we have obtained excellent results on SOL-116's pharmacokinetics, i.e. when measuring how the antibody is metabolized in the body. Therefore, we have concluded that the second part to study safety at multiple doses can start earlier than planned.«
What do the data from the first dose levels in the study show?
– At this stage, only healthy subjects have received one dose each of SOL-116 and the study is still blinded. The most important conclusion is that the antibody is considered safe and that it has been well tolerated and that the turnover in the body (pharmacokinetics) has been as expected. The final group that receives a single dose includes RA patients and we look forward to being able to compare data from these with healthy subjects.
You have big names such as Flerie Invest and Christian von Koenigsegg among the owners who are also subscribing to the issue. How significant is that?
– All shareholders are important and my task is to deliver results that in the long term give them a good return on invested capital. Then it is of course very good to have owners who understand the life science industry and that there are many capital-intensive milestones that must be achieved along the way to a major deal.
How long is the capital injection expected to finance the business?
– The capital will cover our needs until we have completed and evaluated Phase I so that we can present and finance the plans for an impact study in Phase II.
Finally, where do you hope to be in 3 years?
– If I take the word “hopefully,” my vision is that the combination of a completed phase I study with data also from RA patients will lead to continued effective, perhaps in collaboration with a larger pharmaceutical company, clinical development and verified efficacy with SOL-116 for the treatment of chronic inflammatory diseases.