Fourth quarter (October-December 2021)
* Operating loss totaled SEK -2,142,267 (-2,596,526).
* Loss for the period totaled SEK -2,142,267 (-2,596,256).
* Cash flow from operating activities totaled SEK -879,846 (-782,625).
* Earnings per share before dilution totaled SEK -0.11 (-0.22). Earnings per share after dilution amounted to SEK -0.11 (-0.22).
* Proposed dividend of SEK 0.00 per share (0.00 for the preceding year)
Period (January-December 2021)
* Operating loss totaled SEK -13,119,368 (-2,828,545).
* Loss for the period totaled SEK -13,120,443 (-2,823,127).
* Cash flow from operating activities totaled SEK -14,293,102 (-905,251).
* Earnings per share before dilution totaled SEK -0.82 (-0.23). Earnings per share after dilution totaled SEK -0.82 (-0.23).
Key events during the fourth quarter
* Elicera appoints professor Gunilla Enblad, Key Opinion Leader within the fields of CAR T-cells and B-cell lymphoma, as scientific advisor.
* Elicera presented the results of its research at the European Society of Gene & Cell Therapy (ESGCT) 2021 Virtual Congress on October 19-21, and at the 13th Annual Protein & Antibody Engineering Summit (PEGS) Europe Summit on November 2-4.
* Elicera Therapeutics enters agreement with BioNTech for contract manufacturing of viral vectors for CAR T-cell therapy.
Significant events during the period
* The Board of Directors was expanded with the addition of cell therapy specialist Karin Hoogendoorn.
* Elicera conducted a new share issue that attracted a great deal of interest and generated proceeds of SEK 55.1 million net after costs.
* Elicera was listed on Nasdaq First North Growth Market on 11 June.
* Elicera submitted a patent application for development of ELC-201, the next generation of oncolytic viruses.
* Elicera received ATMP classification from the EMA for the oncolytic virus ELC-100.
* The Board of Directors and executive management of Elicera Therapeutics increased their holdings and purchased shares.
Key events after the end of the period
* Elicera strengthens IP protection for ELC-100 through acquisition of patent from Immunicum.
* Elicera Therapeutics secures 5 million SEK in funding from Vinnova to develop an automated CAR T-cell manufacturing process
* No other key events that impact earnings or the financial position occurred after the end of the period
We are fighting cancer with the next generation of cell and gene therapies and a universally compatible CAR T-cell technology platform.
With 2021 now behind us, we can look back over an extremely eventful year for Elicera in which we made important advances as a company and in our pipeline. A successful listing on First North Growth Market and an oversubscribed new share issue that netted sufficient capital to pursue operations up until the second half of 2023. The listing involved significant effort in corporate governance and due diligence, and is therefore a stamp of quality for the company.
Our fully-developed iTANK technology platform has obtained key scientific validation
We presented important proof-of-concept data on iTANK at two scientific conferences, most recently at the European Society of Cell and Gene Therapy Congress in October, the largest European congress in the field. This data shows that the iTANK platform boosts the effect of CAR T-cell treatments for cancer regardless of the choice of CAR molecule, tumor type or animal model, which indicates that it is universally compatible with other CAR T-cell therapies. The technology can solve two of the largest challenges faced by CAR T-cell therapies in the treatment of solid tumors, and we therefore see good opportunities to find several licensees for the technology. In conjunction with the imminent publication of the data in a respected scientific journal, we expect that this will send a strong signal to both academic and commercial players.
Reinforced patent protection for ELC-100
We were recently able to report that our IP protection for ELC-100 had been further reinforced through our buy-back of a patent from Immunicum. The acquisition also meant that all previous agreements with Immunicum concerning any royalties and milestone payments were no longer valid, which we believe overall will facilitate future dialogues with potential partners for ELC-100. Finally, the patent also provides us with a future opportunity to develop new oncolytic viruses based on the same technology.
To date, seven patients have been treated in the first part of the ongoing Phase I/II trial with ELC-100, our oncolytic virus. The patients were treated at the University Hospital in Uppsala, and we are also investigating the possibility of starting up yet another clinic abroad in order to accelerate patient recruitment. The safety data will be reported after each patient group - or cohort - has been fully treated in the study. In 2021, we also announced that ELC-100 had obtained ATMP classification from the European Medicines Agency (EMA), which is important in that it provides us with a clear regulatory path for the drug candidate up to market approval.
Further partnership with Baylor College of Medicine in the US
In April 2021, we submitted a patent application for ELC-201, the next generation of oncolytic virus, with three combined mechanisms of action against cancer. The drug candidate has the potential to treat most forms of cancer, and our primary indication for ELC-201 will be evaluated during the year. To begin clinical trials as quickly as possible after having determined the priority indication for ELC-201, we have already initiated GMP production of the oncolytic virus together with the Baylor College of Medicine in Houston, Texas (US). This is our second partnership with BCM, and it is gratifying to further strengthen our links with the US in this manner.
Preclinical efforts with ELC-301 continue
For our most advanced CAR T project, ELC-301 for the treatment of B cell lymphoma, we have begun GMP production of what are known as vectors for the manufacture of CAR T cells. It is estimated that production will be completed before summer this year. We were also recently able to report that Vinnova has awarded a grant of approximately 5 million SEK to develop an automated process for manufacturing our CAR T-cells. The manufacture of CAR T-cells is extremely complex. Our aim is to establish an automated production process in order to reduce manufacturing time, improve robustness and decrease production failure. If we are successful, we expect to be able to add yet another important asset to our portfolio of intellectual property by filing for a patent application to protect 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. We are also in the final phase of deciding on the design of our initial patient study with ELC-301, which will subsequently be discussed with Läkemedelsverket, the Swedish Medical Products Agency. The aim is to be able to start the clinical study without a pre-clinical toxicological study, which is technically challenging and doubtfully relevant when working with CAR-T cells.
Contract manufacturing agreement with BioNTech
ELC-401 is our CAR T-cell therapy whose mechanism of action can be utilized in the treatment of a range of different solid tumors, and initially we will be treating patients with cancer of the brain (glioblastoma). To confirm the potential in other indications of solid tumors as well, we will survey different tumor cells to find the target that ELC-401 is directed against, an effort that will be completed during 2022. In 2021, we also signed a contract manufacturing agreement with the German company BioNTech for production of the virus vectors that will subsequently be used when we construct our CAR T-cells for use in future clinical studies. It is estimated that the initial study will begin in 2023 at the earliest.
I would like to extend my sincerest thanks to the Elicera team for their hard work during the year, and to our new shareholders for their trust. I look forward to continuing Elicera's vital efforts in the fight against cancer through developing the next generation of cell and gene therapies, and through expanding awareness of our universally compatible CAR T-cell technology platform.
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;04 CET on January 25, 2022.
Elicera Therapeutics AB's interim report for January to December 2021 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
About Elicera Therapeutics AB
Elicera Therapeutics AB is a clinical phase cell and gene therapy company that develops the next generation of immuno-oncology 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-cell therapies under development and activate killer T-cells against cancer. Elicera's share (ELIC) is listed on the Nasdaq First North Growth Market. G&W Fondkommission has been appointed the Company's Certified Adviser. E-mail: firstname.lastname@example.org,tel: +468-503 000 50.
For more information, please visit www.elicera.com