Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2022

August 22, 2022

 

Second quarter (April-June 2022)

  • Operating profit/loss totaled SEK -3,641,800 (-1,818,751).
  • Loss for the period totaled SEK -3,667,200 (-1,818,888).
  • Cash flow from operating activities totaled SEK -3,877,975 (3,486,666).
  • Earnings per share before dilution totaled SEK -0.19 (-0.15) Earnings per share after dilution amounted to SEK -0.19 (-0.15).

 

Period (January-June 2022)

  • Operating profit/loss totaled SEK -8,382,851 (-4,223,302).
  • Loss for the period totaled SEK -8,421,815 (-4,224,377).
  • Cash flow from operating activities totaled SEK -9,211,200 (5,631).
  • Earnings per share before dilution totaled SEK -0.43 (-0.35) Earnings per share after dilution amounted to SEK -0.43 (-0.35).

 

Key events during the second quarter

  • Elicera Therapeutics successfully concluded preclinical proof-of-concept studies for oncolytic virus ELC-201 con­firming the mechanism of action.
  • Elicera Therapeutics received EUR 2.5 million in EU funding to fully finance a clinical phase I/II-trial with its CAR T-cell therapy, ELC-301.
  • Elicera Therapeutics, with its cash and bank balances and EU support, has full financing for various trials through the first half of 2024.

 

Key events during the period

  • Elicera Therapeutics boosted IP protection for ELC-100 through the acquisition of patents from Immunicum.
  • Elicera Therapeutics secured SEK 5 million in grant financing from Vinnova to develop an automated manufacturing process of CAR T-cells.
  • Annual General Meeting held on March 7. The Board of Directors was re-elected except for Karin Hoogendoorn, who declined re-election.
  • Elicera Therapeutics published a scientific article in Nature Biomedical Engineering on the iTANK platform’s mechanism of action, and data indicating its universal compatibility with other CAR T-cell therapies.

 

Key events after the end of the period

  • No key events that impact earnings or the financial position occurred after the end of the period

 

 

CEO Comments

 

EUR 2.5 million secured in EU funding for ELC-301

In June, we announced that Elicera had secured EUR 2.5 million in funding from the EIC Accelerator Fund. EIC is the European Innovation Council, which is part of Horizon Europe, the EU’s largest funding program. The EIC Accelerator Fund supports small and medium-sized companies that have developed scalable innovations with breakthrough poten­tial. Our innovative research and development in CAR T-cell therapy and oncolytic viruses, as well as the research funding we previously received, show that we have done just this. Despite extremely fierce competition, we have now secured approximately SEK 40 million in total funding for the ELC-301 program. According to our estimates, this means that the im­pending clinical Phase I/IIa trial has now been fully financed.

We believe that with our existing cash and bank balances, the EU grant and other grants, we have the financing to carry out all our programs at full speed until the first half of 2024.

With the downturn in today’s finance market, securing financ­ing may prove to be a challenge. Owing to the decision by the EIC, which is based on the scientific level and possibilities for scalability of ELC-301, we have the opportunity to reach significant value-creating milestones without having to initiate procedures for raising capital in the immediate future. We are also continually review­ing alternate solutions for financing in order to ensure in the best manner possible that all programs have opti­mal conditions for reaching patients and the market as quickly as possible.

 

Increased focus on partnering activities

Our ambition is to enter into several partnerships around the iTANK platform, and the company is in ongoing dialogue with players outside Sweden. We believe in the platform’s great potential for facilitating CAR T-cell treatment of solid tumors, and we therefore look forward to future opportunities to in­crease exposure to, and initiate further dialogues concerning, Elicera and iTANK.

This includes Elicera’s participation in several conferences during the second half of the year. This August, Elicera will take part as a sponsor and exhibitor at the Cell Therapy Dura­bility Response (CTDR) Summit in Boston, MA. The conference will focus on how to best solve the problems, observed over the past year, with allogenic CAR T-cell treatments in the form of short-term therapeutic effects, primarily in solid tumors – problems that Elicera’s iTANK platform was specifically devel­oped to solve. Beyond CTDR, we will also exhibit the company at the Onco Cell Therapy Summit i Amsterdam, in november and at the Oncolytic Virotherapy Summit – also in Boston – in December 2022.

Partnering activities will also take place as part of the Nordic Life Science Days in September, and BIO-Europe in November.

 

The development programs are proceeding in accordance with plans, with a focus on solving the challenges of patient enrollment for ELC-100.

Patient enrollment for the ongoing clinical Phase I/II trial with ELC-100 has been slow over the year as a result of the pandemic, and due to the fact that it is a relatively rare form of cancer. We believe it unlikely that the trial will reach full enrollment before the end of the year, but we recently received approval from the Swedish Medical Products Agency for updated inclusion criteria and we are also reviewing other measures to facilitate patient enrollment.

Apart from having secured financing for the impending Phase I/IIa trial with ELC-301 for treatment of B-cell lymphoma, the preparations ahead of the patient study are proceeding in accordance with plans. We are meeting with the Swedish Medical Products Agency in September to discuss the final structure of the study, and our ambition is to commence the study around the start of the new year.

For our other programs – ELC-201 and ELC-401 – fully-fi­nanced Good Manufacturing Practice (GMP) production is proceeding in accordance with plans and we expect to conclude this in 2023. Late in the autumn, we are planning to conclude our indication analysis for ELC-201 for the purpose of determining an indication for evaluation and/or study of the candidate. We expect to commence clinical trials for the two aforementioned programs by 2024 at the earliest.

 

In summary, I would like to thank my colleagues for their fan­tastic efforts – especially relating to the tremendous success with the EU funding – and Elicera’s shareholders for their continued confidence during the quarter. I look forward to the rest of a very exciting 2022.

 

 

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;06 CET on August 22, 2022.

 

Elicera Therapeutics AB’s interim report for January to June 2022 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

 

 

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: ca@gwkapital.se, tel: +468-503 000 50.

 

 

For more information, please visit www.elicera.com

 

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