Third quarter (July-September 2024)
- Operating profit/loss amounted to SEK -2,697,267 (-5,149,440).
- Loss for the period amounted to SEK -2,514,629 (-5,046,574).
- Cash flow from operating activities totalled SEK -2,233,409 (-2,243,671).
- Earnings per share before and after dilution totalled SEK - 0.07 (-0.26).
Period (January-September 2024)
- Operating profit/loss amounted to SEK -13,972,098 (-11,881,583).
- Loss for the period amounted to SEK -13 507,085 (-11,648,755).
- Cash flow from operating activities totalled SEK -19,231,075 (-18,425,660).
- Earnings per share before and after dilution totalled SEK -0.45 (-0.59).
Key events during the third quarter
- Elicera participated and presented poster in the annual conference organized by the scientific network International Society for Gene & Cell Therapy (ISCT) September 4.
- Elicera Therapeutics' 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 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/II-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 receive SEK 27.6m before costs.
- Elicera changes Certified Adviser and Liquidity provider to Mangold Fondkommission AB.
- Nomination committee proposes CMC specialist Sharon Longhurst to Elicera's board of directors.
- Elicera board was re-elected at the annual general meeting and Sharon Longhurst 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.
Key events after the end of the period
- Elicera recruits the last patient in the ongoing clinical phase I/II-study with ELC-100 in treatment of neuroendocrine tumors.
- Elicera Therapeutics includes the first patient in the Phase I/II clinical study CARMA targeting B-cell lymphoma.
- No other key events that impact earnings or the financial position occurred after the end of the period.
CEO Comments
Elicera Therapeutics advances the clinical development of its oncolytic therapy ELC-100 and its CAR T-cell candidate ELC-301
First patient enrolled in CARMA, the company's Phase I/IIa study
In early November, we were pleased to announce that the first patient had been enrolled in CARMA, the company's clinical Phase I/IIa study that aims to study the safety and treatment profile of our most advanced CAR T-cell candidate, ELC-301. The start of the study is an important milestone since it is also the first time that iTANK, our patented gene technology, will be evaluated in patients. The findings
from the study will thus not only play a key role in the continued development of ELC-301 but will also constitute a crucial validation of iTANK.
The ongoing CARMA study comprises two parts: a dose escalation study in a total of 12 patients in order to identify the optimal dosing range, followed by a dose expansion study in an additional six patients in order to evaluate the treatment efficacy of the maximum tolerable dose. The dose escalation study will be conducted in four dose groups of three patients each.
After the first patient group has received their doses, we will conduct a safety evaluation before moving to the second cohort. The outcome of which is expected in the first half of 2025.
Final patient enrolled in the clinical Phase I/II study with ELC-100
In parallel, the final patient has been enrolled in the ongoing dose escalation trial with ELC-100 in 12 patients who are suffering from neuroendocrine tumors. ELC-100 is based on a virus that is gene engineered to locate and selectively infect neuroendocrine cancer cells. Once in the cancer cell, the virus replicates to such an extent that the cancer cell bursts and dies.
In the first stage of the study, we evaluate the safety of the treatment and identify the maximum tolerated dose that can be administered without causing serious side effects. Moreover, the potential treatment efficacy of ELC-100 is evaluated, including its impact on tumor growth.
Presentation of the preliminary findings from the first part of the study is planned for the first half of 2025. Based on the findings from the study, the company will formulate a strategy for the continued development of ELC-100.
Elicera participates in key industry and investor conferences
International interest in the company's technology and treatments is significant, and we see clear value in participating in the relevant industry meetings and conferences. For example, we recently attended BIO-EUROPE and ATMP Sweden 2024, where we had exciting discussions with various stakeholders. During the autumn, Elicera's co-founder and head of research, Magnus Essand, also spoke at CICON24 and the Miltenyi Cell and Gene Therapy Summit 2024. These opportunities were important platforms for providing information and conversing with other key global figures and opinion leaders in the fields of oncology and cell therapy.
In summing up the quarter, we noted clear advances in our pipeline and participated in public forums to position our groundbreaking immuno-oncology candidates as potential treatments on the leading edge of cancer care. Our intense efforts are continuing, with the long-term goal of offering new and efficacious treatment alternatives for patients with needs for complex medical care.
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;15 CET on November 28, 2024.
Elicera Therapeutics AB's interim report for January to September 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
