Elicera Therapeutics AB (publ) Interim Report 1 January – 30 June 2023

 

Third quarter (July-September 2023)

• Operating profit/loss totaled SEK -5,149,440 (-7,028,100).
• Loss for the period totaled SEK -5,046,574 (-7,118,476).
• Cash flow from operating activities totaled SEK -14,243,671 (-4,875,926).
• Earnings per share before dilution totaled SEK -0.16 (-0.36). Earnings per share after dilution amounted to SEK - 0.16 (-0.36).

 

Period (January-September 2023)

• Operating profit/loss totaled SEK -11,881,583 (-15,410,951).
• Loss for the period totaled SEK -11,648,755 (-15,540,291).
• Cash flow from operating activities totaled SEK -18,425,660 (-14,087,125).
• Earnings per share before dilution totaled SEK -0.59 (-0.79). Earnings per share after dilution amounted to SEK - 0.59 (-0.79).

 

Key events during the third quarter

• Elicera  receives Notice of Allowance for European patent protecting the iTANK[TM] platform
• Elicera publishes a scientific article in Nature Communications about the CAR T construct in the ELC-401 program
• Elicera  receives Notice of Allowance for Chinese patent protecting the iTANK[TM] platform

 

Key events during the period

• Elicera continues Phase I/IIa trial with oncolytic virus as planned, following safety review in cohort 3.
• Elicera submits Clinical Trial Application to evaluate its CAR T-cell therapy in B-cell lymphoma.
• Elicera appoints Anna Koptina Gültekin as Head of Regulatory Affairs.
• Elicera hires Erik Penser Bank as market maker
• Elicera’s annual meeting re-elect the board of directors
• Elicera receives conditional approval from the Medical Products Agency on its CAR T-cell Clinical Trial Application to test ELC-301 (CARMA-study)
• Elicera, with its existing bank balances and estimated EU grant, has full financing for all activities through the end of  2024.

 

 

Key events after the end of the period

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

 

CEO Comments

The GMP validation of ELC-301 is progressing, and we expect to be able to treat the first patient in our CARMA clinical Phase I/II trial early next year.

 

The validation of the GMP procedure for ELC-301 is progressing as planned

In the spring, we received conditional approval from Läkemedelsverket, the

Swedish Medical Products Agency, for the start of the CARMA Phase I/IIa trial

with ELC-301, our iTANK-reinforced CAR T-cell therapy, in patients suffering from

difficult-to-treat or metastasized diffuse large B cell lymphoma (DLBCL), mantle

cell lymphoma or indolent lymphoma. The protocol permits the inclusion of

patients who previously stopped responding to approved CD19-targeted CAR

T-cell therapies, since our CAR T-cell therapy is directed at another target

(CD20) and is expected to initiate a parallel immune response to many different

targets in the tumor cells. The conditions for being able to start the trial is that

we can demonstrate that the manufacture of ELC-301 meets the established

framework for quality assurance in the drug industry: the Good Manufacturing

Process, or GMP. Validation takes place in partnership with a qualified consulting

partner who has lengthy experience in the manufacture of biological medical

products, and it is estimated that the process will be complete by the end of

the year. Assuming full approval, we expect to be able to treat the first patient in

the study in the first quarter of 2024. CARMA consists of two partial studies and

completion is expected in 2028 with two interim reports in 2025 and 2026. The

first interim report in 2025 will provide information on potential side effects and

tumor response for the first 12 patients treated in the dose escalation portion of

the trial. The second interim report in 2026 will provide similar kinds of data for

the remaining 6 patients, who will be given the maximum tolerable dose.

 

iTANK receives expanded commercial protection in key market

During the past quarter, we continued to expand the patent protection for our

in-house method, iTANK, which makes it possible to strengthen the efficacy of

CAR T-cell therapies in treating cancers. This strengthening comes from initiating a parallel immune response to most targets in cancer cells and by counteracting the otherwise highly immunosuppressive microenvironment in solid

tumors. In September, the China National Intellectual Property Administration

announced a Notice of Allowance for iTANK, which opens the way to new commercial possibilities in the region and at the same time is clear proof of the scientific value of our gene technology method. Together with the patent that was

previously granted in the European market, this approval is a key component

in our long-term effort to build up the value in iTANK, both through utilizing the

technology in our internal drug projects and by launching the technology for

other companies that are developing CAR T-cell therapies. At present there are

more than 400 active CAR T-cell projects in the preclinical phase – the phase

where the integration of iTANK is most suitable – and we are actively engaged

in addressing this well-defined market with the goal of signing non-exclusive

licensing agreements.

 

Preclinical analyses evaluate possible administration methods for ELC-401

The development of our other iTANK-reinforced CAR T-cell therapy, ELC-401 is

in the preparatory clinical phase ahead of a potential initial trial in patients

suffering from glioblastoma, an aggressive form of brain cancer. Since the

brain is protected by the blood-brain barrier, which efficiently blocks out large

molecules and cells, we are now conducting studies to identify the optimal

method for administering the treatment. At the same time, the production of

the virus vectors to be used in manufacturing the CAR T-cells is in progress.

The viruses are produced in a GMP lab, and carry the genetic code for the

synthetic receptor (CAR) that homes in on the tumor antigen we are targeting

in glioblastoma and incorporates itself into the patient’s own T cells during the

cancer treatment. We are also evaluating the possibilities of funding the clinical

development program through partnership or soft financing. In early November, the Swedish Research Council (Vetenskapsrådet) announced that Elicera’s

CEO, Magnus Essand, had been awarded a research grant linked to his role as

professor at Uppsala University. Even if the funds will not go directly to the company, the grant will finance the research group’s efforts at developing the same

CAR T-cell therapy as the one used in ELC-401.

 

Survey of priority indications for ELC-201

During the autumn, we concluded an extensive survey of possible indications for

ELC-201 based on both scientific and commercial considerations. Strategic efforts

are now underway ahead of the decision on which form or forms of cancer are

to be prioritized in the clinical development of this oncolytic virus therapy armed

with iTANK. After that, we will initiate dialogue as soon as possible with relevant

regulatory agencies while continuing to evaluate various financing alternatives

for the clinical trial program. As in our other internal development projects, routine activities are in progress to establish partnerships with drug companies that

have plenty of resources, in parallel with our search for soft financing.

 

The Phase I/IIa trial of ELC-100 (AdVince) will soon be fully recruited

In AdVince, the Phase I/IIa trial of ELC-100, the twelfth and final patient is currently being recruited, whom we hope can be included in the trial around the end

of the year. After that, a clinical follow-up will be conducted on the patient and

we expect to be able to present the preliminary trial data in the first half of 2024.

Based on the outcome of the study, we will be able to make a more detailed

plan for the next step in the clinical development program.

In summary, we are closing in on a number of important milestones in the

company’s development that, even in the short-term perspective, will increase

its value. Owing to a high rate of development in modern gene technology, increased interest in investments in cell therapy treatments from the drug industry and clearer regulatory frameworks from government agencies, conditions are continually being strengthened for both the commercialization of iTANK and the clinical development of our innovative therapies against difficult cancers.

 

 

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;11 CET on November 14, 2023.

 

Elicera Therapeutics AB’s interim report for January to September 2023 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
[email protected]

 

 

Certified Advisor

Erik Penser Bank

 

 

 

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.

 

For more information, please visit www.elicera.com