Three months, October 1 - December 31
- Operating profit/loss amounted to KSEK -4 206 (-2 122).
- Cash flow from operating activities amounted to KSEK -8 513 (-2 895)
- Investments in intangible assets amounted to KSEK 7 242 (11 195)
- Earnings per average share amounted to SEK -0,02 (-0,01)
Twelve months, January 1 - December 31
- Operating profit/loss amounted to KSEK -10 248 (-7 891).
- Cash flow from operating activities amounted to KSEK -10 281 (-6 323)
- Investments in intangible assets amounted to KSEK 30 026 (50 778)
- Earnings per average share amounted to SEK -0,04 (-0,06)
Significant events in the fourth quarter of 2024
- A clinical trial application for the drug candidate TOL2 was submitted to the EMA
- The Company received approximately SEK 37 million through the warrants of series TO4
- A new Certified Adviser was appointed (Svensk Kapitalmarknadsgranskning AB)
- The composition of the Nomination Committee for the 2025 Annual General Meeting was announced
Significant events after the reporting period
- Toleranzia updated on the process for the Company's clinical trial application
- The clinical trial application for TOL2 was approved in Sweden and Germany
Key financial data
| 2024-10-01 | 2023-10-01 | 2024-01-01 | 2023-01-01 | |
| 2024-12-31 | 2023-12-31 | 2024-12-31 | 2023-12-31 | |
| 3 months | 3 months | 12 months | 12 months | |
| Operating profit/loss (EBIT) KSEK | - 4 206 | - 2 122 | - 10 248 | - 7 891 |
| Profit/loss for the period KSEK | - 4 224 | - 1 909 | - 9 436 | - 7 458 |
| Total assets KSEK | 186 474 | 160 427 | 186 474 | 160 427 |
| Cash flow for the period KSEK | 17 172 | - 14 207 | 7 408 | - 15 633 |
| Cash and bank balances KSEK | 13 777 | 18 304 | 13 777 | 18 304 |
| Equity KSEK | 180 073 | 153 518 | 180 073 | 153 518 |
| Earnings per average share SEK | - 0,02 | - 0,01 | - 0,04 | - 0,06 |
| Equity/assets ratio (%) | 89 | 95 | 89 | 95 |
| Number of shares at the end of the period | 270 962 006 | 197 070 875 | 270 962 006 | 197 070 875 |
| Avarage number of shares (no.) [1] | 254 095 552 | 133 133 154 | 211 404 947 | 133 133 154 |
| Number of employees and consultans | 10 | 12 | 10 | 12 |
[1] 86,755,644 warrants converted into an equal number of shares, SEK 0.50 per share. Warrants issued September 2023, subscription period 7 - 21 October 2024. Subscription of 73 891 131 shares was made.
COMMENTS FROM THE CEO
As we conclude 2024, I am pleased to reflect on a year of significant progress and strategic milestones for Toleranzia. Our dedicated efforts have brought us closer to our goal to develop innovative life-changing therapies for patients with autoimmune diseases, with a particular focus on our lead drug candidate, TOL2, for myasthenia gravis.
Important Regulatory Achievements
In the first quarter, we achieved a pivotal milestone by successfully completing the regulatory Good Laboratory Practice (GLP) toxicology study for TOL2. The results demonstrated that TOL2 was well-tolerated at high doses, with no adverse events observed during treatment or follow-up periods - strongly supporting its advancement into clinical development.
Building on this momentum, we engaged in a scientific advisory meeting with Germany's Paul Ehrlich Institute (PEI) in January. Their feedback was broadly supportive of our development plan and the design of our planned Phase I/IIa clinical trial. This endorsement, alongside positive feedback from regulatory authorities in Sweden and Denmark, reinforced our clinical strategy.
Clinical Trial Application (CTA)
Through the second and third quarters, we finalized the CTA for TOL2. All preclinical studies were completed, and data was compiled for submission. A key step in this process was a unique preclinical study in May, where TOL2 was exposed to blood samples from myasthenia gravis patients. The study confirmed that TOL2 did not induce inflammatory immune activation or adversely affect blood cells, further strengthening its safety profile.
In October, we took a major step forward by submitting the CTA for TOL2 to the European Medicines Agency (EMA). In February, we were delighted to announce that the CTA was approved in Sweden and Germany. The clinical trial will be a double-blind, randomized, placebo-controlled, first-in-human (FIH) Phase I/IIa trial in patients with generalized myasthenia gravis receiving single or multiple doses of increasing amounts of TOL2 to assess its safety, tolerability, and preliminary efficacy.
Strengthening Our Financial Position
To support our endeavors, we successfully completed the exercise of series TO4 warrants in October, securing approximately SEK 37 million. The high participation rate of around 85 percent underscores strong investor confidence in Toleranzia's vision and strategy. This capital provides a financial foundation as we advance into clinical development. Additional capital injections will however be required to fully fund the Phase I/IIa trial.
Looking Ahead
Operationally, two main areas of intensive work are underway. First, we are finalizing the formulation of the previously produced Good Manufacturing Practice (GMP) batch of drug substance into a lyophilized drug product. This work, currently ongoing with our contract manufacturing partner, will provide the necessary data for regulatory authorities to grant a final non-conditional authorization to begin the clinical trial. Second, we are dedicating significant planning efforts to ensure seamless logistics for handling, transporting, and analyzing patient samples from clinics participating in the trial.
Our focus remains steadfast on diligently initiating the TOL2 clinical trial and exploring its promising potential to transform the treatment landscape for patients with myasthenia gravis.
Charlotte Fribert
Executive Director
Gothenburg, February 21, 2025
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 orphan 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 orphan 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 orphan diseases for which 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 October-December
Other operating income amounted to SEK -175 thousand (227) during the quarter and consists of foreign exchange gains and project support part of development projects.
Operating expenses amounted to SEK 11 272 thousand (13 543) during the quarter, of which SEK 1 877 thousand (1 518) 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 7 242 thousand (11 195) 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 -4 206 thousand (-2 122) during the quarter.
Period January - December
Other operating income amounted to SEK 1 123 thousand (489) during the period and consists of foreign exchange gains and project support part of development projects.
Operating expenses amounted to SEK 41 397 thousand (59 158) during the period, of which SEK 6 776 thousand (5 589) relates to personnel costs.
The costs are in line with the Company's plan and expectations linked to the long-term strategy.
The cost of the Company's development work represents 73% (86%) of the total operating cost. The cost of development work related to the Company's project portfolio in myasthenia gravis and ANCA vasculitis, amounted to SEK 30 026 thousand (50 778), where the costs incurred are capitalised on an ongoing basis as own-account work.
The operating result amounted to SEK -10 248 thousand (-7 891) during the period.
Cash flow and liquidity
Cash flow from operating activities amounted to SEK -8 513 thousand (-2 895) during the quarter. Cash flow from operating activities amounted to SEK -10 281 thousand (-6 323) during the twelve months.
As of December 31, the Company's cash and bank balances amounted to SEK 13 777 thousand (18 304).
Investments
Total investments in intangible assets amounted to SEK 7 242 thousand (11 195) during the quarter. The corresponding investment for the period Januari-December amounted to SEK 30 026 thousand (50 778)
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 December 31, 2024.
Funding and financing
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.
During the second quarter of 2024, Toleranzia entered into a loan agreement of SEK 20 million with the Company's main owner, Flerie Invest AB. The loan commitment came into effect on May 1, 2024, with a term of 12 months, thereby ensuring satisfactory financing for going concern until the balance sheet date. The loan was utilized during 2024; however, as of December 31, 2024, it was not utilized in any part.
During the fourth quarter of 2024, the subscription warrants of series TO4 ("TO4"), which were issued in connection with the Company's rights issue of units in the second quarter of 2023, were exercised at approximately 85 percent. The exercised TO4 were converted into 73 891 131 new shares, providing Toleranzia with SEK 35 991 thousand after issuance costs.
The Phase I/IIa trial entails a not insignificantly increased capital requirement for the Company. Considering this, the Board of Directors is monitoring the situation and evaluating various financing options including the timing and scope of capital raising that may be beneficial to the Company.
Shares
Toleranzia's shares are traded on Nasdaq First North Growth Market since October 15, 2020. The number of shares in Toleranzia amounted to 270 962 006 as of 31 December, 2024. The share is traded with the short name TOL and with ISIN code SE0007438577. As of 31 December, 2024, the share capital amounted to SEK 33 870 251. 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.
Toleranzia's website contains a list of the largest owners, which is continuously updated.
Svensk Kapitalmarknadsgranskning AB, ca@skmg.se, is the Company's Certified Adviser.
Review by auditor
This interim report has not been reviewed by the Company's auditors.
Financial calendar
| Annual report for the financial year 2024 | 2025-04-30 |
| Quarterly report 1, 2025 | 2025-05-06 |
| Quarterly report 2, 2025 | 2025-08-20 |
| Quarterly report 3, 2025 | 2025-11-11 |
Quarterly reports and annual reports are published on the Company's website www.toleranzia.com.
Annual General Meeting 2025
The Annual General Meeting 2025 is planned to take place on June 5th, with time and place to be announced in the notice of the meeting. Publication of the annual report will take place in connection with the notice of the AGM. The annual report will be published on the Company's website www.toleranzia.com.
The Board of Directors does not intend to propose any dividend at the AGM 2025.
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, February 21, 2025
Toleranzia AB (publ)
The Board of Directors and CEO
The English version of the financial report is an internal translation. In case of any discrepancies, the Swedish version shall prevail.
For further information, please contact
Charlotte Fribert, VD
Phone: +46 763 19 98 98
Email: charlotte.fribert@toleranzia.com
This information is information that Toleranzia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-02-21 09:33 CET.
