First quarter (January-March 2022) Operating profit amounted to SEK -4,741,051 (-2,404,551) Profit for the period amounted to SEK -4,754,615 (-2,404,489) Cash flow from operating activities amounted to SEK -5,333,226 (- SEK 3,481,034) Earnings per share before dilution amounted to SEK -0.24 (-0.20). Earnings per share after dilution amounted to SEK -0.24 (-0.20). Significant events during the first quarter Elicera Therapeutics secures SEK 5 million in grant financing from Vinnova to develop an automated manufacturing process of CAR T-cells The Annual General Meeting will be held on 7 March. The board is re-elected in addition to Karin Hoogedoorn, who declined re-election. Elicera Therapeutics publishes a scientific article in Nature Biomedical Engineering on the mechanism of action of the iTANK platform and data indicating its universal compatibility with other CAR T cell therapies. Significant events after the end of the period No events have occurred after the end of the period that affect earnings and position. CEO words Publishing iTANK data in one of the world’s highest ranked scientific journals sends important signals to potential partners. iTANK generates interest from potential partners We were recently able to report that proof-of-concept data for the iTANK platform have been published in the scientific journal Nature Biomedical Engineering. With an Impact Score of 25.7, Nature Biomedical Engineering is one of the most influential scientific journals in its field, which means that it is one of the two percent highest ranked scientific journals in the world (+10 Impact score). The publication is therefore a significant feather in the cap and scientific validation for Elicera’s clinical development work and will form a very important part of the marketing of iTANK as we now increase our focus on securing our first commercial partnership. Enhanced patent protection for ELC-100 At the beginning of the year, we were able to report that our IP protection for our oncolytic virus and most advanced candidate ELC-100 has been further strengthened through the repurchase of a patent from Immunicum. The acquisition also means that all previous agreements with Immunicum regarding any royalties and payments for achieved goals no longer apply, which we overall believe will facilitate future talks with potential partners to ELC-100. Finally, the patent also gives us a future opportunity to develop new oncological viruses based on the same technology. To date, seven patients have been treated in the first part of the ongoing Phase I / II study with ELC-100. The patients are treated at the University Hospital in Uppsala and we are also investigating the possibility of starting up another clinic abroad to speed up the recruitment of patients. Safety data will be reported after each fully treated patient group (cohort) in the study. In 2021, we also announced that ELC-100 has received a so-called Advanced Therapy Medicinal Products (ATMP) classification from the European Medicines Agency (EMA), which is important as it gives us a clear regulatory path for the drug candidate until market approval. Preclinical studies for ELC-201 on the way to conclusion ELC-201 is the next generation of oncolytic virus with three combined mechanisms of action against cancer. The drug candidate has the potential to treat most cancers and our primary indication for ELC-201 will be evaluated this year. We have made great progress in the preclinical development during the quarter and expect to be able to conclude and report on this important phase in the development shortly. ELC-301 approaches clinical trials For our most advanced CAR-T project, ELC-301 for the treatment of B-cell lymphoma, we have started Good Manufacturing Practice (GMP) production of so-called vectors for the production of CAR-T cells which are expected to be ready before the summer of this year. We were also recently able to report that Vinnova has granted a grant of approximately SEK 5 million to automate the manufacturing process of our CAR T cells. CAR T-cell therapies are very complex to manufacture. Our goal is therefore to establish an automated production process to reduce production time, improve robustness and reduce production errors. If we succeed, we can add another important asset to our intellectual property portfolio by applying for patent protection for the automated manufacturing process. We will be able to use this process not only for ELC-301 but also for our CAR T cell therapy in solid tumors, ELC-401. Many highlights to look forward to in 2022 Looking ahead, a number of important milestones are at the door for both oncolytic viruses and CAR T cells. We have several ongoing partner talks with both smaller and larger pharma companies and have an ambition to conclude our first commercial agreement on the iTANK platform already in 2022. The forthcoming conclusion and reporting of preclinical studies for ELC-201, as well as already secured contract manufacturers for GMP production, means that the candidate can soon start planning for clinical studies. We are also in the final stages of deciding on the study design for our first CAR T-cell patient study with ELC-301, which we then plan to discuss with the Medical Products Agency. In conclusion, I would like to thank my colleagues for fantastic efforts and the shareholders for continued confidence during the quarter. I look forward to a very exciting 2022.
CEO and co-founder These interim financial statements have been approved by the Board of Directors and the President for publication. The information was submitted, through the care of the above contact person, for publication on April 26, 2022 at 08.02 CET.
Elicera Therapeutics AB’s interim financial statements for January to March 2022 are available on the company’s website: https://www.elicera.com/investors-2/financial-reports.
For further information contact:
Jamal El-Mosleh, CEO, Elicera Therapeutics AB (publ) Phone: +46 (0) 703 31 90 51
About Elicera Therapeutics AB
Elicera Therapeutics AB is a cellular and gene therapy company in the clinical phase that develops the next generation of immunooncological treatments. The company has four drug candidates in development, two CAR T cells and two oncolytic viruses, which are based on research conducted by Professor Magnus Essand’s research group at Uppsala University. In addition, Elicera has a fully developed technology platform, iTANK, which can be used to optimize the effect of all CAR T cells under development and activate killer T cells against cancer. Elicera’s share (ELIC) is listed on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission, e-mail: [email protected] tel .: 08‑503 000 50. For more information, please visit www.elicera.se The following appendices are available for download:
Elicera Q1 SW Press release
Elicera Q1 2022 EN See the full press release and other news from this company on Cision News.
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