Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2023
Second quarter (April-June 2023)
- Operating profit/loss totaled SEK -4,466,286 (-3,641,800).
- Loss for the period totaled SEK -4,335,852 (-3,667,200).
- Cash flow from operating activities totaled SEK -2,146,178 (-3,877,975).
- Earnings per share before dilution totaled SEK -0.22 (-0.19). Earnings per share after dilution amounted to SEK - 0.22 (-0.19).
Period (January-June 2023)
- Operating profit/loss totaled SEK -6,732,143 (-8,382,851).
- Loss for the period totaled SEK -6,602,181 (-8,421,815).
- Cash flow from operating activities totaled SEK -4,181,989 (-9,211,200).
- Earnings per share before dilution totaled SEK -0.33 (-0.43). Earnings per share after dilution amounted to SEK - 0.33 (-0.43).
Key events during the second quarter
- Elicera receives conditional approval from the Medical Products Agency on its CAR T-cell Clinical Trial Application to test ELC-301 (CARMA-study)
- Elicera’s annual meeting re-elect the board of directors
Key events during the period
- Elicera continues Phase I/IIa trial with oncolytic virus as planned, following safety review in cohort 3.
- Elicera submits Clinical Trial Application to evaluate its CAR T-cell therapy in B-cell lymphoma.
- Elicera appoints Anna Koptina Gültekin as Head of Regulatory Affairs.
- Elicera recruits LifeSci Consulting as transaction advisor to assist the company in evaluating strategic partnering initiatives.
- Elicera hires Erik Penser Bank as market maker
- Elicera, with its existing bank balances and estimated EU grant, has full financing for various trials through the end of 2024.
Key events after the end of the period
- Elicera receives Notice of Allowance for European patent protecting the iTANK[TM] platform
- Elicera publishes a scientific article in Nature Communications about the CAR T construct in the ELC-401 program
- No key events that impact earnings or the financial position occurred after the end of the period
CEO Comments
The Swedish Medical Products Agency approves clinical trial application for the CARMA study after conditional validation of the GMP process
In late April, the Swedish Medical Products Agency (Läkemedelsverket) announced that it had approved our application to conduct clinical trials of our
CAR T-cell therapy, ELC-301, in the treatment of B-cell lymphoma. The clinical trial,
which we also call the CARMA study, is intended to evaluate the safety and efficacy of a dose of CD20-targeted CAR T-cells, armed with bystander immune-activating properties using the iTANK platform – in patients with B-cell lymphoma
relapsed and/or refractory B-cell malignancies, by studying tolerance, toxicity,
biological effects and anti-tumor responses. The approval is conditional on
Elicera conducting certain further validations of its GMP process, which was previously was expected to be completed and given final approval during the third
quarter of the year but which we now, after additional dialogue with the Agency,
is instead expected to be completed in the fourth quarter of the year. First patient is expected to be treated in the beginning of 2024.
Broad product portfolio yields many opportunities
We have made progress in our ongoing clinical phase I/IIa study with our oncolytic virus, ELC-100, in the treatment of neuroendocrine tumors and will shortly treat patient number 11. Thus, we only have one patient left to treat in the dose escalation phase, which we expect to be able to do by the turn of the year. We have numerous alternatives for action with ELC-201 that must be carefully considered before we make any final decisions on the continued development of this drug candidate. As also previously mentioned, we have completed our indication analysis together with an external party and identified several relevant forms of cancer where there is both robust scientific logic and good positioning for ELC-201. The issues we are currently examining include whether a clinical trial with ELC-201 is to be conducted in one cancer indication or several – known as a basket trial – and whether ELC-201 can and/or should be combined with other drugs. While we are engaged in responding
to these and other vital questions concerning the content of the programs,
GMP production of the oncolytic virus is taking place in parallel so that we – or a
potential future partner – can commence patient trials with ELC-201 as soon as
possible after decisions are made on the path ahead and financing is secured.
For ELC-401 – our CAR T program in glioblastoma – GMP production is also
occurring in parallel with the analysis of our treatment alternatives. In contrast
to ELC-201, the ELC-401 analysis partially entails preclinical trials for purposes
including being able to better determine how the CAR T-cell therapy is to be
administered. The objective for both ELC-201 and ELC-401 during the year is to
produce clinical development plans, including trial design and costs for the
forthcoming Phase I/II trials, and thereafter to decide how the programs should
best be advanced and financed – by Elicera alone or potentially together with a
partner. Having our efforts on the CAR T structure in ELC-401 recently accepted
for publication in the renowned journal Nature Communications is gratifying.
This is yet another sign that the work being pursued by our team of researchers
maintains a very high level of scientific quality.
Once again, I would like to thank our team who hard work, and a great deal of commitment, has successfully pursued the development of our various drug programs – and I would also like to thank our committed shareholders for your continued support and confidence.
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;10 CET on August 29, 2023.
Elicera Therapeutics AB’s interim report for January to June 2023 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
[email protected]
Certified Advisor
Erik Penser Bank
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 enhanced 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. In addition, Elicera has developed a technology platform called iTANK that can be used to optimize all CAR T-cells in development and activate killer T-cells against cancer. The company’s share (ELIC) is traded on Nasdaq First North Growth Market.
For more information, please visit www.elicera.com
