TOLERANZIA AB Three months,
· 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
The "Company" or "
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 shareholderFlerie Invest AB .
Key financial data
| 2024-01-01 | 2023-01-01 | 2023-01-01 | |
| 2024-03-31 | 2023-03-31 | 2023-12-31 | |
| 3 months | 3 months | 12 months | |
| Operating profit/loss (EBIT) KSEK | -1 641 | -1 988 | -7 891 |
| Profit/loss for the period KSEK | -786 | -1 947 | -7 459 |
| Total assets KSEK | 156 600 | 123 084 | 160 427 |
| Cash flow for the period KSEK | -8 557 | -12 337 | -15 633 |
| Cash and bank balances KSEK | 9 747 | 21 600 | 18 304 |
| Equity KSEK | 152 732 | 117 562 | 153 518 |
| Earnings per average share SEK | -0,00 | -0,02 | -0,06 |
| Earnings per share at full dilution [1] | -0,00 | -0,02 | -0,03 |
| Equity/assets ratio (%) | 97,5 | 95,5 | 95,7 |
| Number of shares at the end of the period | 197 070 875 | 110 315 231 | 197 070 875 |
| Number of shares at full dilution [1] | 197 070 875 | 110 315 231 | 283 826 519 |
| Avarage number of shares (no.) | 197 070 875 | 110 315 231 | 133 133 154 |
| Number of employees and consultans | 10 | 10 | 12 |
| [1] 86,755,644 warrants converted into an equal number of shares, | |||
Vd har ordet
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,
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.
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
Executive Director
Om
Verksamhet
Company structure and shareholding
Financial development and position
Period January - March
Other operating income amounted to
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,
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
As of
Investments
Total investments in intangible assets amounted to
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
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
Shares
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
Toleranzia’s website contains a list of the largest owners, which is continuously updated.
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.
The Board of Directors and CEO
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