Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2024

Second quarter (April-June 2024)

• Operating profit/loss amounted to SEK -5,841,409 (-4 466 286).
• Loss for the period amounted to SEK -5,622,779 (-4,335,852).
• Cash flow from operating activities totalled SEK -7,733,270 (-2,146,178).
• Earnings per share before and after dilution totalled SEK -0.16 (-0,22).

Period (January-June 2024)

• Operating profit/loss amounted to SEK -11,274,831 (-6,372,143).
• Loss for the period amounted to SEK -10,992,456 (-6,602,181).
• Cash flow from operating activities totalled SEK -16,997,666 (-4,181,989).
• Earnings per share before and after dilution totalled SEK -0.39 (-0,33) ).

Key events during the second quarter

• 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 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.
• Eliceras co-founder Magnus Essand invited to present the company's CAR T-cell projects at the world's largest cancer immunotherapy conference, CICON.
• 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 abstract on the iTANK platform's potential to enhance CAR T-cell treatment of solid tumors accepted for presentation at ISCT 2024.
• 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 to Elicera’s board of directors.

Key events after the end of the period

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

CEO Comments

Elicera Therapeutics launches its first clinical CAR T-cell study for treatment of lymphoma and signs agreements in China and the US to advance the company’s full portfolio of products.

The final preparations are under way ahead of the start of CARMA

Soon, we expect to be able to initiate our first clinical CAR T-cell study with the company’s in-house candidate ELC-301. The study will include patients who have progressed after standard treatment and who no longer have any curative treatment options. With ELC-301, we hope to offer these patients an effective treatment that is not only life-prolonging but also has curative potential.

The final preparations for enrolling the first patients in the autumn are presently under way, and we believe that we will be able to report interim data from the first dosage group in early 2025. The results from the dose-escalation study will then be expected in the second half of 2025, depending on how patient recruitment progresses. The results from the second part of the study will be expected 6 to 12 months later, also depending on how quickly we can include patients in the study. There will be a follow-up period of at least two years after the treatment phase, during which the long-term effects of the treatment will be evaluated. We have high hopes for the study, and we are looking forward to presenting an initial report once we have concluded treatment of the first dosage group.

Elicera Therapeutics signs preclinical collaboration agreement with Fourth China Medical University

In mid-June, we announced that Elicera Therapeutics had entered into a preclinical research collaboration agreement with the Fourth Affiliated Hospital of China Medical University (CMU4). The collaboration, which will take place with the Biomedical Innovation Center, gives CMU4 the rights to evaluate our oncolytic treatment, ELC-201, in preclinical proof-of-concept studies against several different solid forms of cancer. ELC-201 is an iTANK-armed oncolytic virus and has the ability to selectively infect and kill cancer cells from the inside. Areas that the researchers at CMU4 will focus on include analyzing the safety profile and treatment efficacy of ELC-201 against aggressive forms of cancer: pancreatic cancer (PDAC), gastric cancer (GI), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), and non-muscle invasive bladder cancer (NMIBC). The studies are being conducted in organoids – simplified three-dimensional versions of organs – that are isolated from patient samples, which makes rapid collection of data possible. The findings will provide guidance in the choice of indication ahead of the forthcoming clinical development of ELC-201. In parallel with this initiative, we are seeking soft financing and/or commercial partnerships that could cover the cost of the clinical development program.

Partnership on iTANK in the US

Earlier this year, we announced a similar agreement with a prominent US cancer research center, with iTANK in focus. Through entering into this type of strategic development partnership, we lower the costs for producing crucial data that supports the commercial development of our technology and our treatment candidates. The partnership with several academic parties also increases the dissemination of the available scientific evidence for our products, which over the long term promotes awareness and acceptance of our innovations among researchers and clinicians.

Developments in Elicera Therapeutic’s pipeline are progressing

ELC-401 is an iTANK-armed CAR T-cell therapy that is being developed against glioblastoma, a severe – and relatively common – form of brain cancer. In the US alone, approximately 15,000 people a year develop this form of cancer, and the expected survival after diagnosis is very brief: approximately 15 months. This is attributable to the lack of approved efficacious therapies and limited success in the development of new treatments. Owing to its location, glioblastoma is protected by the blood-brain barrier, which makes it difficult for drugs to reach the tumor tissue. In addition, glioblastoma is characterized by an extremely high mixture – heterogeneity – of tumor targets. This complicates treatment with traditional CAR T-cells, whose effect is isolated to one or maybe sometimes two individual tumor targets. In preclinical studies, ELC-401 has been shown to have a good effect on glioblastoma, which is attributed to iTANK. Through the release of NAP, iTANK facilitates a broad activation of the immune system, which has the ability to identify a broad set of tumor targets. We recently announced that our head of research, Magnus Essand, had been awarded a research grant of approximately SEK 4 million to conduct further preclinical studies with ELC-401. As with ELC-201, we are currently seeking soft financing and/or commercial partnerships to cover the costs of the clinical development of this cell therapy candidate.

Given that the last patient in the AdVince-study still has to be identified, we aim to report the final study results in second half of 2025.

CAR T-cell therapies celebrated at the 10th anniversary at Uppsala Castle, with participation from Elicera’s co-founders

Early this summer, we celebrated the tenth anniversary of the first clinical trial with CAR T-cells in Europe, in 2014. Attending the event were Elicera Therapeutics’s co-founder and head of research, Magnus Essand, as well as Gunilla Enblad, principal investigator in the first CAR T-cell study in 2014 and also the principal investigator in the CARMA study. In conjunction with the celebration, Gunilla was interviewed on Sweden Radio (SR P1) about the potential of CAR T-cell therapies and their role in the future treatment of cancer. We are thrilled to be able to partner with such knowledgeable and experienced people in the development of the company’s innovative therapies, and we are continuing in our ambition to be able to offer revolutionary treatments for patients who otherwise have few alternatives available. And finally, we are looking forward in September to having the opportunity to participate in CICON24, the world’s largest conference in cancer immunology and immunotherapy. Our head of research, Professor Magnus Essand, will present iTANK and our CAR T-cell program in glioblastoma to some of the world’s leading shapers of public opinion in the field, which will be a fantastic opportunity for us to reach out with Elicera’s message and forge crucial new contacts. With the global partnerships that commenced in China and the US in 2024 and the start of a further clinical trial, it is with pride and confidence that I look to the future of both Elicera and the patients who it is our ambition to help.

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;14 CET on August 29, 2024.

Elicera Therapeutics AB’s interim report for January to June 2024 is available at the company home page : https://www.elicera.com/investors-2/financial-reports.