Fourth quarter (October-December 2024)

• Operating profit/loss amounted to SEK -2,911,958 (-5,212,694).
• Loss for the period amounted to SEK -2,603,242 (-4,749,222).
• Cash flow from operating activities totalled SEK -4,232,090 (3,503,148).
• Earnings per share before and after dilution totalled SEK -0.07 (-0.24).
• Proposed dividend of SEK 0.00 per share (0.00 for the preceding year)

Period (January-December 2024)

• Operating profit/loss amounted to SEK -16,884,056 (-17,096,277).
• Loss for the period amounted to SEK -16,110,327 (-16,397,977).
• Cash flow from operating activities totalled SEK -23,463,165 (-14,922,512).
• Earnings per share before and after dilution totalled SEK -0.51 (-0.83).

Key events during the fourth quarter

• Elicera enrolls the last patient in the clinical phase I/IIa trial with oncolytic virus ELC-100.
• Elicera includes the first patient in the phase I/IIa clinical study CARMA targeting B-cell lymphoma.

Key events during the period  

• Elicera participates in a collaborative project for the development of improved

CAR T-cell production that has been awarded research support of SEK 850

thousand.

• Elicera's Board of Directors proposes a rights issue of units of approximately SEK 64 million that was approved at the general meeting.
• Elicera receives approval to initiate clinical phase I/IIa-study CARMA with CAR T-cell therapy ELC-301 in B-Cell lymphoma
• Elicera enters agreement with prominent US Cancer Center to evaluate the use of iTANK in T-cell receptor therapies.
• Eliceras right issue subscribed at 43 % and Elicera receives SEK 27.6m before costs.
• Elicera changes Certified Adviser and Liquidity provider to Mangold Fondkommission AB.
• Elicera board was re-elected the annual general meeting and Sharon Longhurst, CMC specialist was elected new to the board as Jan Zetterberg denied re-election.
• Elicera enters a preclinical collaboration agreement with China Medical University for the development of ELC-201.
• Elicera participated and presented a poster in the annual conference organized by the scientific network International Society for Gene & Cell Therapy (ISCT) September 4.
• Elicera co-founder and CSO, Magnus Essand, was invited to present iTANK and the company's development of CAR T-cell therapies at CICON24 (Eighth International Cancer Immunotherapy Conference), September 8.

Key events after the end of the period

• Elicera Therapeutics' drug candidate ELC-100 receives Orphan Drug Designation in the U.S. for the treatment of pancreatic neuroendocrine tumors
• Elicera Therapeutics presents first clinical results from iTANK-armed CAR T-cell therapy at scientific conference: The first patient was tumor free at the first follow-up, one month after completing treatment, with no serious side effects observed.
• No other key events that impact earnings or the financial position occurred after the end of the period.

CEO Comments

Elicera Therapeutics' clinical phase I/IIa study with ELC-301 is making significant progress and is expected to report preliminary data in the coming year.

First Patient Successfully Treated in the Clinical Phase I/IIa CARMA Study

patient enrolled in CARMA

In early November, we were delighted to announce that the first patient had been included in CARMA, the company's clinical phase I/IIa study aimed at documenting the safety and efficacy of our CAR T-cell candidate, ELC-301, in patients with B-cell lymphoma. The study consists of two parts: a dose-escalation phase (phase I) involving 12 patients and a dose-expansion phase (phase IIa) with 6 patients. The cell therapy ELC-301 incorporates our proprietary iTANK platform technology, which is intended to initiate a parallel immune activation to enable a broader and more effective attack against cancer cells.

At the end of January, Elicera Therapeutics presented observational data from CARMA at the scientific conference Cancer Crosslinks in Oslo, Norway. It was revealed that the first patient treated with ELC-301 in the study had achieved a complete response at the one-month follow-up after treatment, with no severe side effects. These are promising initial results and we now continue recruiting more patients to generate more robust clinical data.

We plan to report structured and consolidated results from the study as each dosing group is completed. These results are expected to be presented at scientific conferences in 2025 and 2026. The exact timing of our data reporting will depend on the pace of the study and the scheduling of relevant conferences.

Elicera Therapeutics Participates in Several Strategic Meetings

In December, Elicera Therapeutics was invited to present its technology and commercial projects at the Innovation and Entrepreneurship Exchange and Cooperation Forum. This high-profile event brought together representatives from governmental and scientific institutions as well as commercial players in the life science industry in both China and Sweden. The meeting provided a valuable opportunity to highlight the therapeutic potential of the company's gene and cell therapies, as well as to emphasize the rapidly growing global development of cell therapies.

Our co-founder and Chief Scientific Officer, Magnus Essand, was invited to participate in Cancer Crosslinks 2025, an annual scientific meeting in Oslo, Norway, aimed at bridging the gap between research and clinical oncology. There, he presented our initial observational data from the CARMA study. This highly regarded event, which gathers global scientific experts and commercial stakeholders, highlights the latest advancements in cancer diagnostics and the treatment of both solid and hematological cancers.

We look forward to an intense conference schedule in 2025, which, as noted earlier, includes participation in scientific conferences where we can present summarized data from each cohort in the CARMA study.

Key Milestone for ELC-100: Orphan Drug Designation from the FDA

Finally, in January, we announced that the company's drug candidate ELC-100 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine tumors in the pancreas. This designation provides benefits during the program's continued development and potential market approval, including seven years of market exclusivity in the US. Neuroendocrine tumors represent a highly heterogeneous condition, and in our ongoing phase I clinical study, severely ill patients can be categorized into several subgroups, even based on their treatment history. This diversity necessitates the development of new therapeutic solutions with a broad understanding of the specific needs of different patient groups. We look forward to analyzing and reporting final data from the phase I study around mid-2025, after which we will announce how we plan to proceed with the program's development.

In Summary

All the above demonstrates the significant progress Elicera Therapeutics has made as we enter an exciting 2025. I would like to extend a heartfelt thanks to our team and partners for their outstanding work and support that has brought us this far. I also wish to express my gratitude to our shareholders for their continued support and confidence in our journey!

Jamal El-Mosleh

CEO and co-founder

The interim report has been approved by the board and the CEO for publication. The information was submitted for publication distributed through the contact person below at 08;16 CET on February 3, 2025.

Elicera Therapeutics AB's Year-end report for January to December 2024 is available at the company home page : https://www.elicera.com/investors-2/financial-reports.

For further information please contact:

Jamal El-Mosleh, CEO, Elicera Therapeutics AB

Phone: +46 (0) 703 31 90 51
jamal.elmosleh@elicera.com

Certified Advisor

Mangold Fondkommission AB

About the iTANK platform

The iTANK- (immunoTherapies Activated with NAP for efficient Killing) platform is the company's own fully developed commercially available technology platform for arming and enhancing CAR T-cells to meet two of the major challenges CAR T-cell therapies face in the treatment of solid tumors: tumor antigen heterogeneity and a hostile tumor microenvironment. The technology is used to incorporate a transgene into CAR T-cells encoding a neutrophil activating protein (NAP) from the bacterium Helicobacter pylori. Upon activation, NAP secreted from the CAR(NAP) T-cells has been shown to be able to enhance the function of the CAR T-cell in addition to activating a parallel immune response via CD8+ killer T-cells. This is expected to lead to a broad attack against most antigen targets on cancer cells. The iTANK-platform is used to enhance the company's own CAR T-cells but can also be universally applied to other CAR T-cell therapies under development. More information about iTANK-platform is available here: https://www.elicera.com/technology

About Elicera Therapeutics AB

Elicera Therapeutics AB is a clinical stage cell and gene therapy company that develops next generation immuno-oncology treatments based on iTANK-armed oncolytic viruses and CAR T-cells. The work is based on high-profile long-standing research conducted by Professor Magnus Essand's research group at Uppsala University and has resulted in the development of four drug candidates, including two CAR T-cells and two oncolytic viruses. The iTANK-technology platform can be used to arm any CAR T-cell therapy in development and activate killer T-cells against cancer. The company addresses an international billion-dollar market in cell therapy development by offering out-licensing of iTANK to the majority of players in the pharmaceutical industry. The company's share (ELIC) is traded on Nasdaq First North Growth Market. For more information, please visit www.elicera.com