Three months, January 1 – March 31

• Operating profit/loss amounted to SEK -3 292 thousand (-1 641).
• Cash flow from operating activities amounted to SEK -3 190 thousand (-3 659)
• Investments in intangible assets amounted to SEK 5 171 thousand (4 687)
• Earnings per average share amounted to SEK -0,01 (0,00)

Significant events in the first quarter of 2025

• Toleranzia updated on the process for the Company's clinical trial application
• Toleranzia's clinical trial application for TOL2 was approved in Sweden and Germany but rejected in Denmark
• Toleranzia decided to apply for a scientific advice meeting with the Danish Medicines Agency
• Toleranzia and Flerie AB entered into a merger plan to delist Toleranzia
• The board of directors of Toleranzia unanimously recommended the shareholders of Toleranzia to vote in favor of the implementation of the proposed merger between Toleranzia and Flerie AB

Significant events after the reporting period

• Toleranzia called an Extraordinary General Meeting on May 7, 2025
• Toleranzia entered into a conditional loan agreement with Flerie AB including a credit facility of SEK 20 million provided that the merger plan is approved at the extraordinary general meeting on May 7, 2025
• Toleranzia brought forward the publication of its annual report for the financial year 2024 to April 23, 2025

Key financial data

[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
The first quarter of 2025 has been both dynamic and transformative for Toleranzia. We made important progress in the development of our lead drug candidate, TOL2, while also taking significant strategic steps toward securing the company’s long-term future.

In March, our clinical trial application for TOL2 received conditional approvals from the regulatory authorities in Sweden and Germany, which marks an important milestone in advancing our mission to provide new treatments for patients with myasthenia gravis. However, the application was rejected in Denmark. As immediate measures, we decided to increase the number of clinical centers participating in Germany and to request a scientific advisory meeting with the Danish Medicines Agency to address their comments and prepare for a possible resubmission.

In parallel with our clinical developments, Toleranzia entered a new strategic phase. In collaboration with our main shareholder, Flerie AB, we announced a proposed merger that would result in the delisting of Toleranzia from Nasdaq First North Growth Market. The Board of Directors has carefully evaluated the proposal and unanimously recommends that our shareholders vote in favor of the merger. We believe this step will strengthen our ability to fund and develop our pipeline over the long term. To formalize this process, we have called for an Extraordinary General Meeting on May 7, 2025, where shareholders will vote on the proposed transaction.

To support our operations during this transitional period, Toleranzia entered into a conditional loan agreement with Flerie AB, which includes a credit facility of SEK 20 million. This financing is contingent on the approval of the merger at the upcoming Extraordinary General Meeting and will provide essential support for our activities in the near term.

Operationally, intensive work is now underway in two main areas. First, we are finalizing the formulation of the previously produced GMP batch of drug substance into a lyophilized drug product. This work, which is ongoing in collaboration with our contract manufacturer, will provide the data required for regulatory authorities to grant final non-conditional approval to start the clinical trial. Second, we are putting a lot of focus on planning to ensure smooth logistics for the handling, transportation and analysis of patient samples from clinics participating in the trial.

We remain firmly committed to our vision of delivering breakthrough treatments in autoimmune diseases, and we continue to work diligently to initiate the clinical trial of TOL2 and to explore its promising potential to change the treatment landscape for patients with myasthenia gravis.

I would like to extend my sincere thanks to our shareholders, employees, and partners for the continued trust and support during this pivotal time.

Charlotte Fribert
Executive Director
Gothenburg, May 6, 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.com.

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 191 thousand (230) during the quarter and consists of foreign exchange gains and project support part of development projects.

Operating expenses amounted to SEK 8 654 thousand (6 559) during the quarter, of which SEK 1 951 thousand (1 567) relates to personnel costs.

Costs, excluding one-time costs related to merger preparations, are in line with the Company's plan and expectations linked to the long-term strategy. During the period, costs of SEK 762 thousand relate to work towards a merger with Flerie AB.

Of the total cost, SEK 5 171 thousand (4 687) 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 -3 292 thousand (-1 641) during the quarter.

Cash flow and liquidity
Cash flow from operating activities amounted to SEK -3 190 thousand (-3 659) during the quarter.

As of March 31, the Company's cash and bank balances amounted to SEK 5 417 thousand (9 747).

The Company will shortly need additional capital to prepare and conduct the planned clinical phase I/IIa trial. Initially, the conditional loan facility that the Company has signed with the main owner Flerie AB may enable the Company to fully carry out the clinical preparation activities, while the implementation of the clinical trial requires additional capital. See also the Financing section.

Investments
Total investments in intangible assets amounted to SEK 5 171 thousand (4 687) 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, 2025.

Financing
Toleranzia is a development company and has not yet generated any revenues. The company is in a very intensive phase with several ongoing pre-clinical activities prior to the start of the clinical phase I/IIa study of the drug candidate TOL2 for the treatment of myasthenia gravis. In order to complete the remaining preparations, a capital injection to the Company is required shortly. Furthermore, as a clinical trial should not be initiated before full funding is secured, additional - and not insignificant - capital injections will be needed.

The Board of Directors has evaluated several possible financing options and notes that, in the current market situation, it is challenging to raise capital in a listed environment. There is therefore a significant risk that the necessary capital cannot be obtained.

Toleranzia has received a merger offer from Flerie AB and the Board of Directors has, in light of the above, unanimously recommended the shareholders of Toleranzia to vote in favor of a merger with Flerie AB in accordance with the offer presented. Thomas Eldered, who is a member of the board of directors of Flerie and Toleranzia respectively, has not participated in the handling of matters relating to the merger or the preparation of the merger plan in Toleranzia's board of directors.

Toleranzia has also entered into a conditional loan agreement with Flerie AB including a credit facility of SEK 20 million. The agreement enters into force on May 7, 2025 and runs until September 15, 2025, provided that the merger plan is approved at Toleranzia's extraordinary general meeting on May 7, 2025.

In the event that the merger plan is approved at the Extraordinary General Meeting, the credit facility can ensure the Company's continued operational capacity and enable the Company to complete its clinic preparation activities until the completion of the merger while strengthening the Company's ability to secure long-term financing. Upon completion of the merger, Flerie will absorb Toleranzia, whereupon a combined company will be formed: New Flerie. After the completion of the merger, Toleranzia's operations will be transferred to a new subsidiary of Flerie Invest: New Toleranzia. The operation of the business of New Toleranzia will be the responsibility of Flerie Invest.

In the event that the merger plan is not approved at the Extraordinary General Meeting, there is significant uncertainty regarding the Company's future financing and continued ability to operate, which could have serious consequences for the Company's future development, financial results and financial position and ultimately adversely affect the Company's market value.

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 March, 2025. The share is traded with the short name TOL and with ISIN code SE0007438577. As of 31 March, 2025, 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

Quarterly reports and annual reports are published on the Company's website www.toleranzia.com.

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 6, 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