Three months, January 1 - March 31
·         Operating profit/loss amounted to KSEK -1,641 (-1,988).
·         Cash flow from operating activities amounted to KSEK -3,659 (-2,205)
·         Investments in intangible assets amounted to KSEK 4,687 (10,132)
·         Earnings per share amounted to SEK -0,00 (-0,02)
 
The "Company" or "Toleranzia" refers to Toleranzia AB with organization number 56877-2866.
 
 
Significant events in the first quarter of 2024

• The pivotal GLP toxicology study of TOL2 was successfully completed and provided full support for the submission of a clinical trial application in patients with myasthenia gravis.
• The scientific advisory meeting with the German Medicines Agency Paul Ehrlich Institut was conducted and provided broad support for the company's planned initial Phase I/IIa clinical trial of TOL2.

Significant events after the reporting period

• A loan agreement of SEK 20 million was signed with the Company's main shareholder Flerie Invest AB.

Key financial data

Comments from the CEO
 
2024 starts with important milestones achieved
In the first quarter of 2024, we took several major steps forward in our main project TOL2. In the GLP toxicology study, which is crucial to the project, we were able to establish in January, in a preliminary report from our contracted partner, that the drug candidate was well tolerated at the high dose tested. No adverse events were observed during either the treatment or follow-up periods following intravenous administration of the drug candidate. The positive result fully supports the further development of TOL2 and the submission of a clinical trial application in patients with myasthenia gravis. The outcome of the study means that during the quarter we took a critical step closer to the first clinical trial in patients with this autoimmune disease.
 
At the end of January, Toleranzia held a scientific advisory meeting with the Paul Ehrlich Institute (PEI), Germany's medical regulatory authority. In March, a generally positive final report was received from the meeting. The PEI's response means that Toleranzia has received positive feedback on the TOL2 program from the authorities in Sweden, Denmark and Germany, the three countries where the clinical trial in patients with myasthenia gravis is planned to be conducted. Like the Swedish and Danish regulatory authorities, the PEI provided broad support for the TOL2 program development plan and the planned Phase I/IIa clinical trial. In addition to valuable advice on the clinical trial, the PEI provided valuable input on the design of the clinical trial application that is currently being prepared.
 
In parallel, work is ongoing to scale up the formulation process to produce approximately 3,000 packs of sterile, GMP-grade lyophilized TOL2 for the upcoming clinical trials. The collaboration with the contract manufacturer, which started at the end of 2023, is progressing according to plan.
 
Toleranzia recently received a loan commitment of SEK 20 million through an agreement with Flerie Invest AB. The agreement, which entered into force on May 1 with a term of 12 months, was signed on market terms and runs without collateral with an interest rate amounting to a maximum of nine hundred and ninety thousand SEK.
 
With important milestones achieved during the period, in particular the positive result from the GLP toxicology study and the favorable regulatory interactions, we are soon ready to initiate our first clinical study of TOL2 in patients with myasthenia gravis. The loan commitment of SEK 20 million is a significant addition that reassuringly strengthens the capital base for the start of the study.
 
Charlotte Fribert
Executive Director
Gothenburg, May 20, 2024

About Toleranzia
 
General information about the business
Toleranzia AB (publ) (556877-2866) is a Swedish biotechnology company listed on Nasdaq First North. The company develops drugs that harness the power of the immune system to treat rare autoimmune diseases. The drugs, which target the cause of the disease, can alleviate or cure the disease and not, like current treatments, just reduce the symptoms. They have the potential to be the first long-acting or curative treatments that act specifically on the underlying cause of the rare autoimmune disease they are developed for. 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 rare diseases where so-called orphan drugs can be developed and where there is a great medical need and a large market potential. For further information, please visit: www.toleranzia.se.
 
Company structure and shareholding
Toleranzia does not have any subsidiaries. Flerie Invest AB owns more than 50% of the shares, which means that Toleranzia is a subsidiary of Flerie Invest AB. The company owns no shares.
 
Financial development and position
 
Period January - March
Other operating income amounted to SEK 230 thousand (47) during the quarter.
 
Operating expenses amounted to 6,559 KSEK (12,167) during the quarter, of which 1,567 KSEK (1,353) relates to personnel costs.
 
The costs are in line with the Company's plan and expectations linked to the long-term strategy.
 
Of the total cost, SEK 4,687 thousand (10,132) relates to the development of the Company's project portfolio in myasthenia gravis and ANCA vasculitis, where the costs incurred are continuously capitalized as work for own account.
 
The operating result amounted to SEK - 1,641 thousand (-1,988) during the quarter.
 
Cash flow and liquidity
Cash flow from operating activities amounted to SEK -3,659 thousand (-2,205) during the quarter.
 
As of March 31, the Company's cash and bank balances amounted to SEK 9,747 thousand (21,600).
 
Investments
Total investments in intangible assets amounted to SEK 4,687 thousand (10,132) during the quarter.
 
The investments relate to the development of the Company's portfolio of projects in myasthenia gravis and ANCA vasculitis and the costs are capitalized on an ongoing basis as work for own account.
 
Human resources
Toleranzia is a development company where committed employees with solid experience and cutting-edge 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, 2024.
 
Funding and financing
During the period, negotiations were concluded regarding conditional loans from 2013/2014 that related to completed projects. The project support in the form of loans from VGR/Tillväxtverket was finalized through repayment remission and simultaneous payment of accrued interest. The interest was paid during the first quarter and since then the Company has no interest-bearing liabilities.
 
The Board of Directors and management have a continuous focus on cash flow and work continuously to ensure long-term and sustainable financing of ongoing and planned development projects and assess that there are several possible options to secure the financing of the Company.
 
Related party transactions
The company has related party transactions regarding the purchase of services in process development for protein production from the company NorthX Biologics Matfors AB, which is partly owned by Flerie Invest AB and whose executive chairman of the board, Thomas Eldered, is a board member of Toleranzia. Furthermore, related companies to Björn Löwenadler (CBO), Vidar Wendel-Hansen (CMO) and Thomas Pålsson (CFO) each have agreements for consulting services. Purchased services have been made on market terms.
 
Shares
Toleranzia's shares are traded on Nasdaq First North Growth Market since October 15, 2020. The number of shares in Toleranzia amounted to 197 070 875 as of March 31, 2023. The share is traded with the short name TOL and with ISIN code SE0007438577. As of March 31, 2023, the share capital amounted to SEK 24 633 859. 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, earnings and votes.
 
In addition to the share capital, 86 755 644 warrants have been issued that give the holder the right to subscribe to the same number of shares through exercise during the period October 7 - 21, 2024, at a price of SEK 0.50 per share.
 
Toleranzia’s website contains a list of the largest owners, which is continuously updated.
 
Mangold Fondkommission AB is the Company's Certified Adviser and can be reached at: ca@mangold.se.
 
Review by auditor
This interim report has not been reviewed by the Company's auditors.
 
Financial calendar
Annual General Meeting 2024                              2024-06-19
Quarterly report 2, 2024                          2024-08-23
Quarterly report 3, 2024                          2024-10-24
 
Quarterly reports and annual reports are published on the Company's website www.toleranzia.se.
 
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 20, 2024
Toleranzia AB
The Board of Directors and CEO