2025 after a successful 2024. The year 2025 has begun in the same positive spirit when it was announced in January that the first treated patient in a study of The CAR T-cell therapy ELC-301 is now tumor-free. At the same time, Elicera is now focusing on strengthening its financial position through the ongoing TO2 utilization period. BioStock contacted CEO Jamal El-Mosleh to find out more.
- We have several important and potentially value-driving milestones to be announced during the year from both of our clinical programs., says El-Mosleh.
Elicera Therapeutics focuses on developing cancer treatments based on oncolytic viruses and CAR T cells. Using the company's immune-enhancing technology platform iTANK (Immunotherapies Activated with NAP for Efficient Killing), which is commercially available, equips its drug candidates with immune-activating properties. This aims to both increase the effectiveness of the treatments and at the same time trigger a parallel immune response, resulting in a two-pronged attack on tumor cells.
Entering 2025 after a successful 2024
After a successful 2025, Elicera Therapeutics enters 2025 strengthened. Last year began with a successful capital raising of SEK 27,6 million and was marked by increased international presence, where the company participated in several important events, including CICON24, one of the world's largest conferences for cancer immunotherapy. One of the biggest milestones in the company's history was reached in November when the first patient was included in the phase I/IIa study CARMA, which evaluates the CAR T-cell therapy ELC-301 against B-cell lymphoma. ELC-301, enhanced with the iTANK platform, showed promising early results, and in January 2025, it was reported that the first treated patient had become tumor-free.
Financial strengthening
In a previous interview with BioStock, Elicera's CEO described Jamal El-Mosleh 2025 as a key year for the company as it advances clinical development. Right now, the aim is to strengthen the cash flow through the current subscription period in TO2, which could bring the company approximately SEK 22 million if all warrants are exercised. BioStock contacted El-Mosleh for a status update and to learn more about TO2.
Jamal, let's start with an update on Elicera's pipeline. You have 4 drug candidates. Two of them in oncolytic viruses, two in CAR T-cell therapies. Can you give us a status update on the CAR T-cell projects?
– Absolutely! When it comes to our CAR T-cell treatments, we have two exciting programs: ELC-301 and ELC-401.
– ELC-301 is currently undergoing a clinical trial, in a total of 18 planned patients with B-cell lymphoma, which we call the CARMA study. The goal of the study is to determine the optimal dose of the CAR T-cell therapy ELC-301, which is armed with the iTANK platform, in patients who have received at least two prior standard therapies and are now without curative treatment options. The purpose of arming via the iTANK platform is to activate a broad and highly potent parallel immune response against cancer to ensure the most effective anti-tumor response possible, which is particularly relevant in the treatment of solid tumors.
– The CARMA study has had a very encouraging start. The first patient, treated with the lowest dose level (1/10 of the planned maximum dose), showed a complete response (tumor-free) already at the first follow-up one month after treatment, without any serious side effects being observed. These data were recently presented by our research director, Professor Magnus Essand, at the scientific conference Cancer Crosslinks.
– The study will now continue to treat two additional patients in cohort 1 at the lowest dose level. The dose will then be escalated in cohort 2 of three patients, ultimately reaching the planned optimal treatment dose in cohort 3 of six patients. If no serious dose-limiting adverse events are noted, the study will transition into a phase IIa part that includes six additional patients. A total of 18 patients are planned to be treated in the phase I/IIa CARMA study.
– We plan to present continued results from each dosing group at scientific conferences in 2025 and 2026 and can already announce that we have been accepted for presentation of an abstract at the prestigious International Society for Cell & Gene Therapy (ISCT) Meeting 2025 in New Orleans, USA, which takes place May 7–10. At the conference, we plan to present initial data from the first cohort of the CARMA study, assuming patient recruitment and follow-up go according to plan.
– Regarding our second CAR T program, ELC-401, which targets glioblastoma (brain tumor), we have advanced the planning of a clinical trial over the past year. We have worked closely with key opinion leaders and prospective trial leaders to plan a well-thought-out clinical trial where we hope to be able to secure soft funding, or enter into partnerships, to be able to start treating patients. We see very great potential in ELC-401.
And what is the status of your oncolytic virus programs?
– Within our oncolytic virus programs, we currently have two drug candidates: ELC-100 and ELC-201.
– ELC-100 is in an ongoing clinical dose escalation study for the treatment of neuroendocrine tumors, where we have recently fully recruited all 12 patients to the study. We expect to be able to report data from the study by the summer. Given the relatively heterogeneous patient population, we will then analyze the data package carefully and make decisions on how best to advance the program further in clinical development.
– Earlier this year, we were also able to announce that we have received Orphan Drug Designation (ODD) for ELC-100 in the treatment of neuroendocrine tumors of the pancreas. This is an important milestone, as it already provides certain benefits during the development phase, such as tax breaks for clinical trials in the US. At a later stage, ODD also provides the opportunity to avoid fees associated with the application for regulatory approval, as well as up to seven years of market exclusivity if the drug is approved. These benefits strengthen our competitiveness and our long-term commercial value.
– ELC-201, our “next generation” oncolytic virus, is armed with the iTANK platform and is currently in preclinical development. The goal is to advance this program into clinical development either through soft funding or through partnerships with other players. We see great potential in ELC-201 and are actively working to find strategic collaborations to accelerate clinical development.
– In summary, we have an exciting pipeline with great potential in oncolytic viruses and are working purposefully to ensure that our candidates reach patients who need new and effective treatment options.
You are currently offering a subscription period in TO2 that can be used until March 11. Can you tell us a little about the terms?
– The subscription price is SEK 1,85 per share, and the exercise period extends from February 26, 2025 to March 11, 2025. This means that holders of TO2 have the opportunity to subscribe for new shares at this advantageous price during this period.
– We have a total of 11 series TO908 warrants outstanding, which means that an equal number of new shares can be issued upon full exercise. If all options are exercised, this would provide the company with approximately SEK 764 million before issuance costs, giving us a stronger cash position to drive our clinical programs forward.
– The last day for trading in the TO2 series warrants is March 7, 2025, which means that investors who want to buy or sell TO2 must do so by this date.
Why should you exercise your warrants?
– Given the current level of the share price, the exercise of series TO2 warrants represents a very attractive opportunity to increase ownership in Elicera at a lower cost.
– We also have several important and potentially value-driving milestones that will be presented during the year from both of our clinical programs, not least from the CARMA study, where we plan two interim reports during the year. This can not only provide significant insights into the ELC-301 program and the iTANK platform, but also potentially further strengthen interest from both investors and potential partner candidates.
– In addition, Elicera has a broad portfolio of well-diversified drug programs in development, including an additional valuable asset in the iTANK platform. This platform can be used to “universally” arm CAR T cells, making it highly relevant for several potential partnerships and licensing deals.
– Overall, this makes Elicera a company with multiple opportunities to create shareholder value in the long term, and we look forward to developments in the coming year.
The warrants are 100 percent secured by a number of guarantee commitments. Would you like to comment on this?
– That's right. The warrants are 100 percent secured by a number of guarantee commitments, which gives us a strong financial foundation to build on.
– The subscription commitments total approximately SEK 2,4 million, corresponding to 11,0 percent of the Warrants. These have been submitted by myself, all members of the Company's Board of Directors, as well as by a number of members of the Company's management and major warrant holders. This demonstrates a strong commitment and confidence from our management and Board of Directors in the future of the Company.
– The guarantee commitments total approximately SEK 19,6 million, corresponding to 89,0 percent of the Warrants. This ensures that the entire issue volume is guaranteed, providing us with financial stability and security in a currently tough financial climate.
– The rationale behind securing the option program is to minimize the risk that the program would not be fully subscribed, given the challenging market conditions. The Board has prioritized strengthening the cash position to enable the company to report preliminary data from all 18 planned patients in the CARMA study. We believe that this will create the most shareholder value in the long term, as it allows us to achieve important value-driving milestones in the development of our pipeline.
– We are grateful for the strong support and trust we have received from our investors and stakeholders, and we are convinced that this will give us the best conditions to continue delivering value to our shareholders.
How do you plan to use the proceeds?
– No new clinical studies are planned within the framework of the secured cash flow, but it will be used to drive the business into the second half of 2027. This gives us the opportunity to pass several important and potentially value-driving milestones, as I mentioned earlier.
– This means that we can continue our clinical development at a pace that maximizes value creation, while maintaining a stable financial foundation for an extended period of time.
– We are convinced that this strategy will give us greater flexibility and resilience in a challenging market environment, and that in the long term it will create the most shareholder value.
What are the most critical milestones in 2025?
– The most critical milestones in 2025 are linked to our ongoing clinical studies. For ELC-100, we will finalize the dose escalation study report by the summer, which represents a significant milestone in the program's development and will provide us with valuable data to make decisions about the next steps.
– For the CARMA study, we plan to report data from both cohort 1 and cohort 2 during the year. These interim reports are crucial to show the progress of the study and to assess the safety and efficacy of the treatment. In parallel, we are actively working to seek soft funding and/or partnerships for our other programs, including establishing collaborations for our iTANK platform. This is an important part of our strategy to ensure long-term development and value creation.
– However, I want to be clear that I cannot guarantee success this year in securing soft funding or partnerships. However, it is a prioritized part of our strategic work, and we are investing significant resources in achieving success in these areas.
– In summary, these critical milestones will have a major impact on the company's future development and value creation, and we look forward to reporting on progress throughout the year.