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2022-11-18

Elicera Therapeutics AB (publ) Interim Report 1 January - 30 September 2022

Third quarter (July-September 2022)

  • Operating profit/loss totaled SEK -7,028,100 (-6,753,799).
  • Loss for the period totaled SEK -7,118,476 (-6,753,799).
  • Cash flow from operating activities totaled SEK -4,875,926 (-13,418,888).
  • Earnings per share before dilution totaled SEK -0.36 (-0.34) Earnings per share after dilution amounted to SEK -0.36 (-0.35).

Period (January-September 2022)

  • Operating profit/loss totaled SEK -15,410,951 (-10,977,101).
  • Loss for the period totaled SEK -15,540,291 (-10,978,176).
  • Cash flow from operating activities totaled SEK -14,087,126 (-13,413,256).
  • Earnings per share before dilution totaled SEK -0.79 (-0.75) Earnings per share after dilution amounted to SEK -0.79 (-0.75).

Key events during the third quarter

  • Elicera Therapeutics attended the Cell Therapy Durability Response Summit in Boston, MA (US)

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.
  • 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.
  • 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 after the end of the period

  • Elicera Therapeutics' co-founders receive additional grants totalling 7,65 MSEK from the Swedish Cancer Society to support CAR T research.
  • Elicera employees awarded "Doctoral Thesis of the Year" in Sweden (in gene and cell therapy research) for their description of the iTANK platform.
  • Agreements were signed with Erik Penser Bank AB, which will assume Certified Adviser duties on January 10, 2023.
  • Elicera Therapeutics enters first international collaboration involving the iTANK platform with a Spanish research institution
  • Nomination Committee for Elicera Therapeutics appointed
  • No key events that impact earnings or the financial position occurred after the end of the period

CEO Comments

The first of what we hope will be several international partnerships on iTANK has been established

Elicera reached a key milestone in its business development in October through entering its first iTANK platform partnership agreement with the Josep Carreras Leukemia Research Institute (JCLRI) in Spain. More specifically, we have signed a material transfer agreement (MTA) to facilitate the successful development of JCLRI's CAR T-cell treatments for Ewing sarcoma, a solid tumor that at present has limited alternatives for treatment. This difficult-to-treat cancer indication is characterized by immunologically "cold" solid tumors that additionally contain an abundance of immunosuppressive cells. That is why we are pleased that research groups have noticed the potential of the iTANK platform to increase the efficacy of the CAR T-cells, even for solid tumors that are difficult to treat. Some of the advantages of the partnership are that also going forward, Elicera will retain the rights to iTANK and that any new patents arising from the project will be the joint property of Elicera and the JCLRI. This is a keystone in our strategy of entering partnership and licensing agreements for the iTANK platform. The collaboration with the JCLRI is therefore significant since it represents the first of several agreements that we hope to establish.

Our message reaches international partnering conferences

As we announced in the preceding interim report, Elicera attended several international conferences during the quarter for the purpose of pursuing our strategy of entering several partnerships concerning the iTANK platform. The dialogues that we conducted during the conferences indicated significant interest in the platform, and I feel that our message regarding how it will solve the challenges of T-cell receptors and CAR T-cells in the treatment of solid tumors is really being heard. In August, Elicera attended the Cell Therapy Durability Response (CTDR) summit in Boston, Massachusetts as a sponsor and presented the iTANK platform. We attended the Nordic Life Science Days in Malmö in September, BIO Europe in Lepizig in October and the Onco Cell Therapy Summit Europe in Amsterdam in November. These conferences were valuable opportunities for networking with potential partners across the globe and for speaking about Elicera and the iTANK platform to the public.

The ELC-301 trial ready ahead of its launch, and focus is on recruiting the final patients in the ELC-201 trial

Preparations continue for the Phase 1/2a trial with CAR T candidate ELC-301 in B-cell lymphoma. The meeting with the Swedish Medical Products Agency to discuss the final design of the trial was delayed to shortage of personnel and took place in November. After dialogue with Swedish Medical Products Agency, we will submit the application for clinical testing at our earliest opportunity. Depending on how long the government agencies take to approve the application, we expect to be able to treat the first patient by early spring of 2023 at the latest.

Our other programs are also proceeding in accordance with plans. Previously, we announced that patient recruitment for the ongoing Phase 1/2a trial with the ELC-100 oncolytic virus in neuroendocrine tumors was progressing slowly as a result of the pandemic and due to the fact that it is a relatively rare form of cancer. In the third quarter, we took measures to accelerate patient recruitment, which has already yielded results: two new patients were recruited and treated. The next communication regarding the trial will take place once we have safety data from the ninth patient treated in the third patient cohort. The plan thereafter is that we will announce when the patients in each cohort have finished treatment.

As regards Elicera's other programs that are investigating the efficacy of our ELC-201 oncolytic virus, the current analysis to determine which cancer indication to treat and evaluate first continues. Completion is estimated for the end of the year, and we believe that clinical trials can be initiated in 2024 at the earliest. For both ELC-201 and our other CAR T candidate, ELC-401, fully financed Good Manufacturing Practice (GMP) production is under way and we expect to conclude this in 2023, in accordance with plans.

Three priorities in the immediate future

As a result of Elicera having the financing required to carry out all programs at full speed until the first half of 2024, we feel safe in putting all our energy into prioritizing the following initiatives in the near future: signing more partnership agreements around the iTANK platform, commencing treatments in the 301 trial, and concluding patient recruitment for the 100 trial. My colleagues have done an excellent job during the quarter to make progress in relation to these three priorities, and for that they deserve high praise.

I would also like to extend my sincerest thanks to Elicera's shareholders for their continued confidence during the quarter. Our new partnership with Erik Penser Bank will be initiated in January 2023 and will help to promote exciting new opportunities to present and speak about Elicera's operations for existing and potential new shareholders. After a difficult year, the biotech sector in the US has staged a good recovery since May. My hope is that the Swedish biotech sector will also follow along, and Elicera will then be well positioned to benefit from this based on our robust pipeline an

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;07 CET on November 18, 2022.

Elicera Therapeutics AB's interim report for January to September 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 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. 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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