Toleranzia

Second quarter, 1 April – 30 June
·         Net sales 0 SEK (0 SEK).
·         Profit/loss after financial items -2 217 822 SEK (-1 576 639 SEK).
·         Results per share -0,02 SEK (-0,03 SEK).
First six months, 1 January – 30 June
·         Net sales 0 SEK (0 SEK).
·         Profit/loss after financial items -4 289 745 SEK (-2 999 195 SEK).
·         Results per share -0,04 SEK (-0,06 SEK).
 
Number within brackets: comparison to same period previous year.
Result per share: Result for the period divided with 110 315 231 shares as per 2022-06-30.
”Company” or ”Toleranzia” relates to Toleranzia AB with Swedish registration number 556877-2866.
 
Significant events during the second quarter 2022

• Toleranzia's groundbreaking results, demonstrating a therapeutic proof-of-concept in a preclinical disease model for the Company's most advanced drug candidate TOL2 for the autoimmune disease myasthenia gravis, were published in the scientific journal Frontiers in Immunology.

• A research consortium in which Toleranzia participates as an industrial partner was granted support from the Swedish Knowledge Foundation (KK-stiftelsen). The project will support Toleranzia's drug development by investigating basic mechanisms of vascular inflammation in the Company's autoimmunity models, as well as the effect of therapeutic intervention on markers of inflammation.

• Toleranzia participated in the 14th MGFA International Conference on Myasthenia And Related Disorders, organized every five years by the Myasthenia Gravis Foundation of America (MGFA).

Significant events after the reporting period

• Torbjörn Sannerstedt was appointed as new Chief Financial Officer (CFO).

 
Key financial information

Comments from the CEO
Toleranzia's concept attracts increasing attention on the international stage
 
During the second quarter of the year, Toleranzia published strong positive preclinical data on its drug candidate TOL2 for myasthenia gravis in a prestigious international scientific journal.  The same data were also presented at a leading international conference on myasthenia gravis, where they attracted considerable interest. At the same time, we continued our intensive work to scale up production of TOL2 in collaboration with our manufacturing partner 3P Pharmaceuticals and to prepare for the upcoming clinical trial of the drug candidate.
 
Strong interest in our potential disease-modifying treatment
In May, world-leading scientists gathered in Miami for the 14th edition of the Myasthenia Gravis Foundation of America's International Conference and our Chief Medical Officer, Vidar Wendel-Hansen, attended to spread the word about TOL2. During the meeting two new general symptom-relieving treatments were presented but specific treatments that can stop the progression of the disease are still lacking. As our concept has the potential to eliminate the cause of the disease, interest in TOL2 was very high. Toleranzia's preclinical results were presented by our research partner Konstantinos Lazaridis from the Hellenic Pasteur Institute in Athens, and it was clear to the audience that we are on the verge of the next big breakthrough if we can show similarly good results in future clinical trials. The results were also published in the prestigious scientific journal Frontiers in Immunology, further raising awareness of our treatment concept.
As myasthenia gravis is a rare disease, it is critical to find the right investigators and the most suitable clinical sites for the first clinical trial with TOL2. The growing interest in our concept puts us in a favorable position to conduct a good study and is a clear indication of the great need for a disease-modifying treatment.
 
Strengthened resources through research grants and new recruitment
Another external confirmation of the strength of our concept came when the Swedish Knowledge Foundation granted funding to a research consortium that will focus on anti-inflammatory drugs in areas such as vascular inflammation. Toleranzia's drug candidate TOL3 targets the autoimmune disease ANCA vasculitis and the consortium will provide us with valuable external expertise and resources to intensify our work in documenting the efficacy of our drug candidates in preclinical disease models.
At the same time, Toleranzia expanded its in-house organization during the quarter with two experienced cell biologists who are working to identify the mechanism of action behind the powerful tolerance induction provided by TOL2. After the reporting period, we also recruited a new CFO, who started on 15 August.
 
Continued intensive work to establish large-scale production of TOL2
Together with our manufacturing partner, we are making extensive efforts to establish large-scale production of TOL2 as quickly as possible. A shortage of certain necessary equipment and materials still remains in the wake of the covid pandemic, but, assuming key subcontractors can overcome supply issues, our goal remains to initiate the first clinical trial by the end of 2023 - a hugely important milestone in our efforts to bring a breakthrough treatment to critically ill patients while creating significant value for our shareholders.
 
Charlotte Fribert
CEO
Gothenburg, 26 August 2022

About Toleranzia
 
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.se.
 
Company structure
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. The Company has no shareholdings.
 
The share
Toleranzia's shares are traded on Nasdaq First North since 15 October 2020. The number of shares in Toleranzia as of 30 June 2022 is 110,315,231. The share capital as of 30 June 2022 amounts to SEK 13,789,404. The Company has one class of shares, each share having a quota value of SEK 0.125 (SEK 0.125) and carrying equal rights to participate in the Company's assets and profits.
 
Mangold Fondkommission AB is the Company's Certified Adviser and can be reached at: ca@mangold.se.
 
Financial development
During the first three months, the Company has mainly invested in the development of its project portfolio in myasthenia gravis and ANCA vasculitis. At the end of the second quarter, the Company had cash and cash equivalents of SEK 52.5 million (SEK 27.8 million) and an equity ratio of 96 % (92 %).
 
Principles for accounting and reporting
The interim report has been prepared in accordance with the Swedish Annual Accounts Act and the Swedish Accounting Standards Board’s general guidelines BFNAR 2012:1 on annual financial statements and consolidated financial statements (K3).
 
The cash flow statement is prepared using the indirect method. The reported cash flow includes only transactions involving receipts or payments.
 
In addition to cash and cash equivalents, the Company classifies as cash and cash equivalents available deposits with banks and other credit institutions and short-term liquid investments that are quoted in a marketplace and have a maturity of less than three months from the date of acquisition.
 
Otherwise, reference is made to the accounting policies set out in the 2021 Annual Report and applicable to the Company.
 
Review
This interim report has not been reviewed by the Company’s auditors.
 
Financial calendar
Interim report January-September                              2022-10-28
Year-end report 2022                              2023-02-24
 
The Board of Directors and the CEO hereby certify that this interim report gives a true and balanced view of the Company's operations and financial situation.
 
Gothenburg, 26 August 2022
Toleranzia AB
The Board of Directors and CEO