Following a strong 2024, this year has started on a positive note for cell- and gene company Elicera Therapeutics. In January, the company announced that the first patient treated in a study of the CAR T-cell therapy ELC-301 is now tumour-free. Elicera is now focusing on strengthening its financial position through the ongoing subscription period of TO2. BioStock reached out to CEO Jamal El-Mosleh to learn more. 
– We have several important and potentially value-driving milestones to present throughout the year from both of our clinical programs, says El-Mosleh.

Using its commercially available immune-enhancing technology platform, iTANK (Immunotherapies Activated with NAP for Efficient Killing), Elicera Therapeutics armours its drug candidates with immune-activating properties. This aims to increase the effectiveness of treatments and trigger a parallel immune response, resulting in a dual attack on tumor cells.

Entering 2025 after a strong 2024

Elicera enters 2025 in a strengthened position after a successful 2024. Last year began with a successful capital raise of SEK 27.6 million and was marked by increased international presence, with participation in several key events, including CICON24, one of the world’s largest cancer immunotherapy conferences. 

A major milestone in the company’s history was reached in November 2024 when the first patient was enrolled in the phase I/IIa CARMA study, evaluating the CAR T-cell therapy ELC-301 for B-cell lymphoma. ELC-301, enhanced with the iTANK platform, showed early promising results, and in January 2025, it was reported that the first treated patient had become tumour-free. 

Strengthening the finances

In a previous interview with BioStock, Elicera’s CEO Jamal El-Mosleh described 2025 asa key year for the company as it advances the clinical development. Currently, Elicera aims to strengthen its financial position through the ongoing TO 2 subscription period, which could contribute approximately SEK 22 million to its coffers if all subscription warrants are exercised. 

BioStock reached out to 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 four drug candidates – two within oncolytic viruses and two within CAR T-cell therapies. Can you give us a status update on the CAR T-cell projects?

– Absolutely! Regarding our CAR T-cell therapies, we have two exciting programs: ELC-301 and ELC-401.

– ELC-301 is currently undergoing a clinical trial involving a total of 18 planned patients with B-cell lymphoma, known as the CARMA study. The study aims to determine the optimal dose of the CAR T-cell therapy ELC-301, armed with the iTANK platform, in patients who have received at least two prior standard treatments and now lack curative options. The purpose of arming ELC-301 with iTANK is to activate a broad and highly potent parallel immune response against cancer to ensure the most effective anti-tumor response possible – particularly relevant for treating 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 (tumour-free) at the first follow-up one month after treatment, with no severe side effects observed. These results were recently presented by our Chief Scientific Officer, Professor Magnus Essand, at the Cancer Crosslinks scientific conference.

– The study is now continuing with two additional patients in Cohort 1 at the lowest dose level. After that, the dose will be escalated in Cohort 2 with three patients, eventually reaching the planned optimal treatment dose in Cohort 3 with six patients. If no severe dose-limiting side effects are observed, the study will transition into a phase IIa stage, including an additional six patients. A total of 18 patients are planned to be treated in the phase I/IIa CARMA study.

– We plan to present ongoing results from each dosing group at scientific conferences in 2025 and 2026. We are pleased to announce that we have been accepted to present an abstract at the prestigious International Society for Cell & Gene Therapy (ISCT) Meeting 2025 in New Orleans, USA, from May 7–10. At this conference, we plan to present initial data from the first cohort in the CARMA study, assuming patient recruitment and follow-up proceed as planned.

– Over the past year, we have advanced the planning of a clinical study for ELC-401. We have been working closely with key opinion leaders and potential investigators to design a carefully crafted clinical trial. Our goal is to secure soft funding or enter a partnership to start treating patients. We see significant 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 undergoing an ongoing clinical dose-escalation study for the treatment of neuroendocrine tumours, where we have recently completed the full enrollment of all 12 patients in the study. We expect to report data from the study by the summer. Given the relatively heterogeneous patient population, we will then carefully analyse the data package and determine the best path forward for advancing the program in clinical development.

– Earlier this year, we also announced that we have received Orphan Drug Designation (ODD) for ELC-100 in the treatment of neuroendocrine tumours of the pancreas. This is an important milestone, as it provides certain advantages during the development phase, such as tax incentives for clinical trials in the U.S. At a later stage, ODD also offers the possibility to waive fees associated with regulatory approval applications, as well as up to seven years of market exclusivity if the drug is approved. These benefits enhance our competitiveness and long-term commercial value.

– ELC-201, our “next-generation” oncolytic virus, is armed with the iTANK platform and is currently in the preclinical development phase. Our goal is to advance this program into clinical development, either through soft funding or partnerships with other stakeholders. We see great potential in ELC-201 and are actively working to establish strategic collaborations to accelerate its clinical development.

– In summary, we have an exciting pipeline with significant potential in oncolytic viruses and are working with a strong focus to ensure that our candidates reach patients in need of new and effective treatment options. 

You are currently in the subscription period for TO2, which can be exercised until March 11. Can you tell us a bit about the terms?

– The subscription price is 1.85 SEK per share, and the exercise period runs from February 26, 2025, to March 11, 2025. This means that holders of TO2 have the opportunity to subscribe for new shares at this attractive price during this period.

– We have a total of 11,908,764 outstanding TO2 series warrants, meaning that an equal number of new shares can be issued upon full exercise. If all warrants are exercised, this would provide the company with approximately 22.0 MSEK before issuance costs, strengthening our cash position to advance our clinical programs.

– The last day for trading the TO2 series warrants is March 7, 2025, meaning that investors who wish to buy or sell TO2 must do so by this date. 

Why should one exercise their warrants?

– Given the current stock price level, exercising warrants of series TO2 presents a highly attractive opportunity to increase ownership in Elicera at a lower cost.

– Additionally, we have several important and potentially value-driving milestones to present throughout the year from both of our clinical programs, particularly from the CARMA study, where we plan to release two reports during the year. These reports could provide significant insights into the ELC-301 program and the iTANK platform and potentially increase interest from both investors and potential partners.

– Beyond this, Elicera has a broad portfolio of well-diversified drug development programs, including another valuable asset in the iTANK platform. This platform can be used to arm CAR T-cells “universally”, making it highly relevant for multiple potential partnerships and licensing deals.

– Taken together, this positions Elicera as a company with multiple opportunities to create shareholder value in the long term, and we eagerly look forward to the developments in the coming year. 

The warrants are 100% secured through a number of guarantee commitments. Would you like to comment on this?

– That is correct. The warrants are 100% secured through a series of guarantee commitments, providing us with a strong financial foundation to build upon. Subscription commitments total approximately 2.4 MSEK, corresponding to 11.0% of the warrants. These commitments have been made by myself, all members of the company’s board, and several members of the company’s management team and larger warrant holders. This demonstrates strong commitment and confidence from our leadership and board in the company’s future.

– The guarantee commitments total approximately 19.6 MSEK, corresponding to 89.0% of the warrants. This ensures that the entire issuance volume is guaranteed, providing us with financial stability and security in a currently challenging financial climate. 

The rationale behind securing the warrant program is to minimize the risk of it not being fully subscribed, given the difficult market conditions. The board has prioritised strengthening the cash position to enable the company to report preliminary data from all 18 planned patients in the CARMA study. We believe this will create the most shareholder value in the long run, as it allows us to achieve key value-driving milestones in the development of our pipeline. 

– We are grateful for the strong support and confidence we have received from our investors and stakeholders, and we are convinced that this will provide us with 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 scope of the secured proceeds; instead, the funds will be used to sustain operations into the second half of 2027. As mentioned earlier, this gives us the opportunity to pass several important and potentially value-driving milestones. This means that we can continue our clinical development at a pace that maximises value creation while maintaining a stable financial foundation over an extended period. 

We are confident that this strategy will provide us with greater flexibility and resilience in a challenging market environment and ultimately create the most shareholder value. 

What are the most critical milestones in 2025?

– The most critical milestones in 2025 are related to our ongoing clinical studies. For ELC-100, we will finalise the dose-escalation study by the summer, representing a significant milestone in the program’s development and providing valuable data to inform our next steps. For the CARMA study, we plan to report data from both cohort 1 and cohort 2 during the year. These reports are crucial for demonstrating study progress and assessing the treatment’s safety and efficacy. 

– At the same time, we are actively seeking soft funding and/or partnerships for our other programs, including establishing collaborations for our iTANK platform. This is a key 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. Nevertheless, this remains a priority in our strategic efforts, and we are dedicating significant resources to 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 our progress throughout the year. 

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