Toleranzia AB: Interim report 2023-01-01 – 2023-03-31
3 May - 2023
First quarter, 2023
Three months, January 1 – March 31
· Net sales amounted to — KSEK (–)
· Profit after financial items amounted to KSEK -1,947 (-2,072).
· Cash flow from operating activities amounted to SEK -2,205 thousand (-2,395).
· Investments in intangible assets amounted to SEK 10,132 thousand (8,079).
· Earnings per share amounted to SEK -0.02 (-0.02).
The "Company" or "Toleranzia" refers to Toleranzia AB with organization number 556877-2866.
Significant events in the first quarter of 2023
- The composition of the Nomination Committee for the 2023 AGM was announced.
- A patent application was filed to protect combination therapy with the Company's tolerogens.
- A technical batch of TOL2 was produced for use in the upcoming GLP toxicology study.
- A financial contribution of approximately SEK 1.7 million was granted by the Swedish innovation agency Vinnova within the call "Swelife and Medtech4Health – Collaborative projects for better health".
Key financial data
|3 months||3 months||12 months|
|Net sales KSEK||–||–||–|
|Operating profit/loss KSEK||-1 988||-2 072||-8 639|
|Profit/loss for the period KSEK||-1 947||-2 072||-8 456|
|Total assets KSEK||123 084||131 537||125 632|
|Cash flow for the period KSEK||-12 337||-10 474||-42 341|
|Cash and bank balances KSEK||21 600||65 804||33 937|
|Equity KSEK||117 562||125 893||119 509|
|Earnings per share SEK||-0,02||-0,02||-0,08|
|Equity/assets ratio (%)||95,5||95,7||95,1|
|Number of shares at the end of the period (no.)||110 315 231||110 315 231||110 315 231|
|Avarage number of shares (no.)||110 315 231||110 315 231||110 315 231|
|Number of employees and consultans||10||6||8|
COMMENTS FROM THE CEO
2023 begins with several major achievements
In the first quarter of 2023, we took several major steps forward. We completed the manufacturing of a technical batch of TOL2 for the upcoming GLP toxicology study, which means we are another step closer to the first clinical trial in patients. We also strengthened the patent protection for our tolerance technology and were awarded a grant from Vinnova to start an expanded research project in ANCA vasculitis.
At the end of the quarter, a so-called technical batch of TOL2 was successfully produced – the second large-scale production. It gave the same high yield of purified TOL2 as the pilot batch that we produced at the end of 2022 and it is gratifying that we now have an efficient and robust manufacturing process for large-scale production in place. The material from the technical batch will be used in the upcoming GLP toxicology study. The next step will be to produce a GMP batch for use in the planned clinical trials in patients with myasthenia gravis. The work to develop a final formulation for the drug substance is ongoing and initial results indicate that it could be a freeze-dried product, which could provide significant benefits in terms of simplified storage and distribution as well as increased shelf life.
Following several preclinical studies with combination therapies, we have now filed a new patent application for the treatment of autoimmune diseases with tolerogens in combination with other immunomodulatory agents. Our drug development team made the surprising discovery that specific combinations of protein-based tolerogens and immunomodulatory agents provide synergies that can dramatically increase the therapeutic effect in the treatment of autoimmune diseases. The patent application covers this concept, and we see great potential for the discovery both in our current development programs and for our tolerance technology in general.
Before we rounded off the quarter, we were informed that we had been awarded a grant from Vinnova to start an expanded research project in the autoimmune blood vessel disease ANCA vasculitis. The project aims to use completely new technology to examine patients with ANCA vasculitis to increase detailed knowledge of the root cause of the disease. The knowledge can be directly used for the continued development of our drug candidate TOL3, which is based on the Company's tolerance technology. The project will be run by Toleranzia in collaboration with Lund University's Kidney Research Lab, Region Skåne and SciCross AB.
In February, we presented Toleranzia's development project at the 6th Antigen-Specific Immune Tolerance Summit in Boston, USA. The meeting highlighted the significant progress being made in the field of immune tolerance and tolerance induction right now, which makes it incredibly exciting to be a key player in this arena.
With great confidence in the future and the potential of our technology to change the lives of patients with autoimmune diseases, we look forward to completing the production process and the GLP toxicology study which are the final steps before we can initiate our first clinical study of TOL2 in patients with myasthenia gravis. In parallel, we are running the expanded project in ANCA vasculitis and continue to evaluate the possibilities of different combination therapies in our ongoing and future drug projects.
Gothenburg, May 2, 2023
General information about the business
Toleranzia AB (556877-2866) is a Swedish biotechnology company listed on Nasdaq First North. The Company develops drugs that harness the power of the immune system for the treatment of autoimmune orphan diseases (rare diseases). The drugs, which target the cause of the disease, can alleviate or cure the disease and not, like current treatments, merely reduce the symptoms. They have the potential to be the first long-acting or curative therapies that act specifically on the underlying cause of the autoimmune orphan disease for which they are being developed. Toleranzia's main focus is the autoimmune nerve and muscle disease myasthenia gravis, for which the Company is developing the drug candidate TOL2. In addition, Toleranzia is working on the autoimmune blood vessel disease ANCA-vasculitis, for which the Company is developing the drug candidate TOL3. Both diseases are so-called orphan diseases and there is a great medical need and market potential for both. For further information, please visit: www.toleranzia.com.
Company structure and shareholding
Toleranzia was founded by researchers at the University of Gothenburg. The company operates at the Biotech Center in Gothenburg. Toleranzia has no subsidiaries and is not part of any group. Nor does the company have any shareholdings in other companies.
Financial development and position
Period January – March
Net sales amounted to — KSEK (–) during the quarter.
Other income amounted to KSEK 47 (21) during the quarter and consists mainly of currency exchange rate gains.
The company's operating expenses amounted to KSEK 12,168 (10,172) for the quarter, of which KSEK 1,353 (1,037) relates to personnel costs.
The increased costs are in line with the Company's plan and expectations linked to the long-term strategy. The cost of personnel has increased compared to the previous year, as a result of an increase in the number of human resources compared to previous quarters.
Of the total cost, KSEK 10,132 (8,079) relates to the development of the company's project portfolio in myasthenia gravis and ANCA vasculitis, where the costs incurred are capitalized on an ongoing basis as own-account work.
The operating result during the quarter amounted to KSEK -1,989 (-2,072).
Cash flow and liquidity
For the period January – March 2023, cash flow from operating activities amounted to KSEK -2,205 (-2,395).
As of March 31, 2023, the Company's cash and bank balance amounted to KSEK 21,600 (65,804).
Total investments in intangible assets amounted to KSEK 10,132 (8,079) for the period January – March 2023.
The investments relate to the development of the Company's project portfolio within myasthenia gravis and ANCA vasculitis and the costs are capitalized on an ongoing basis as own-account work.
Toleranzia is a development company where dedicated employees with solid experience and expertise are a prerequisite for commercial success and for achieving the Company's vision. The Company had 10 full-time equivalent employees or contracted consultants as of March 31, 2023.
In the fall of 2021, the Company carried out a new share issue, raising capital and liquid funds totaling KSEK 69,532, before issue costs.
The company has a constant focus on cash flow and works continuously to secure financing. The Board of Directors and management have ongoing discussions with major shareholders and make the assessment that there are several possible alternatives and commitments to obtain long-term and sustainable financing of ongoing and future development projects and that the Company will continue to be satisfactorily financed.
In light of the above, the report has been prepared on a going concern basis as the management and Board of Directors believe that there are several options for obtaining long-term financing.
Related party transactions
The company has related party transactions regarding the purchase of services from the company NorthX Biologics Matfors AB in Matfors. Purchased services have been made on market terms.
Ongoing unrest in Europe
There is a general uncertainty in the market caused by the ongoing conflict in Ukraine. The uncertainty has so far not affected the company's operations and is not expected to affect operations in the coming months. Toleranzia has no operations in either the Russian or Ukrainian market. Raw materials and expertise are sourced from neither Russia nor Ukraine.
Toleranzia's shares are traded on Nasdaq First North Growth Market since October 15, 2020. The number of shares in Toleranzia amounted to 110,315,231 as of March 31, 2023. The share capital amounted to SEK 13,789,404 as of March 31, 2023. The Company has one class of shares, of which each share has a quota value of SEK 0.125 (SEK 0.125) and carries equal rights to participate in the Company's assets and earnings.
There are no ongoing option programs at the time of publication of this interim report.
Mangold Fondkommission AB is the Company's Certified Adviser and can be reached at: email@example.com.
Ownership per March 31, 2023
|Shareholder||Share of||Share of|
|FLERIE INVEST AB||47,4%||47,4%|
|FÖRSÄKRINGSAKTIEBOLAGET AVANZA PENSION||2,7%||2,7%|
|NORDNET PENSIONSFÖRSÄKRING AB||2,5%||2,5%|
|S & B CHRISTENSEN AB||2,0%||2,0%|
|NORDEA LIVFÖRSÄKRING SVERIGE AB||1,8%||1,8%|
|BERGSTRÖM, NIKLAS TOBIAS||1,4%||1,4%|
|NORDIC TENDER AB||1,4%||1,4%|
|KONSTRUKTIONS O FÖRSÄLJNINGSAKTIEBOLAGET KFAB||1,1%||1,1%|
Review by the auditor
This interim report has not been reviewed by the Company's auditors.
Annual General Meeting 2023, 2023-06-07
Interim report Q2 2023, 2023-08-25
Interim report Q3 2023, 2023-10-27
Year-end report 2023, 2024-02-23
The Board of Directors and the CEO hereby certify that the interim report gives a true and fair view of the Company's operations and financial position.
Gothenburg, May 2, 2023
The Board of Directors and CEO
The English version of the quarterly report is an internal translation. In case of any discrepancies, the Swedish text applies.