Toleranzia AB: Interim Report 2022-01-01 – 2022-03-31

First quarter 2022

First quarter, 1 January – 31 March
·         Net sales 0 SEK (0 SEK).
·         Profit/loss after financial items -2 071 922 SEK (-1 422 555 SEK).
·         Results per share -0,02 SEK (-0,03 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 2022-03-31.
”Company” or ”Toleranzia” relates to Toleranzia AB with Swedish registration number 556877-2866.
 
Significant events during the first quarter 2022

• Toleranzia announced that the Company has taken steps to secure access to the purification material required to complete the scale-up of production and large-scale manufacturing of its TOL2 drug candidate. The shortage of material, caused by the production of the Covid-19 vaccine, previously led to significant uncertainty as to when the first batch of TOL2 for the clinical trial could be produced. Now that the Company has found an additional supplier and ordered, on behalf of its manufacturing partner 3P Biopharmaceuticals, all the purification material needed for the large-scale production, the prospects for starting the study in the second half of 2023 according to the communicated timetable are strengthened.

 
Key financial information

Comments from the CEO
Process equipment and purification materials secured for large-scale production of TOL2
During the first quarter of the year, we have continued to drive Toleranzia forward in an efficient and systematic way, taking important steps towards the first clinical trial of our lead drug candidate TOL2 in myasthenia gravis.

Toleranzia's current focus is on scaling up manufacturing of the TOL2 drug candidate. In March, after intensive work to evaluate options to address the shortages and delays in the supply of manufacturing materials caused by the production of Covid-19 vaccines, we were able to secure delivery of all purification materials for large-scale manufacturing. This was achieved through a supply agreement with a new supplier of biomolecule purification materials.

Once the purification material is delivered, our manufacturing partner 3P Biopharmaceuticals is fully equipped to establish the large-scale manufacturing process. Because TOL2 is protein-based, this process is much more technically complex and time-consuming than it is for conventional chemical drugs. The establishment of a well-functioning large-scale production process will therefore be a major value-creating step forward for the project.

In addition to the production work, the Company is also focusing on the next important steps in the development of TOL2. To this end, we are currently procuring a CRO to conduct the additional toxicology studies required to bring the drug candidate into clinical trials. At the same time, preparations for a scientific advisory meeting with the EMA ahead of the first clinical trial have begun, with the aim of paving the way for obtaining regulatory approvals in time to start the clinical trial as planned, in the second half of 2023.

Every five years, the Myasthenia Gravis Foundation of America holds an International Conference to bring together all those working with myasthenia gravis, and in mid-May the 14th edition of this conference will be held in Miami, USA. Our CMO Vidar Wendel-Hansen will attend the meeting and take the opportunity to present and discuss our unique tolerance technology with leading myasthenia gravis experts. In addition, our research collaborator Konstantinos Lazaridis from the Hellenic Pasteur Institute in Athens will present our preclinical data from the TOL2 project. The meeting is well timed for Toleranzia as we are currently optimising the upcoming clinical trial, together with clinical trial design experts, and selecting the best clinical research sites to streamline patient recruitment.

Toleranzia is looking forward to an exciting year with important milestones ahead, both in the preparation for our clinical trial of TOL2 in myasthenia gravis and the development of TOL3 in ANCA vasculitis. All with the overall goal of developing treatments that can dramatically improve the quality of life and outlook for patients with serious autoimmune diseases who currently lack well-functioning treatment options. I want to thank all shareholders who are helping us make this possible.
 
Charlotte Fribert
CEO
Gothenburg, 6 May 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. Previously, the shares were traded on Spotlight Stock Market. The share has ISIN code SE0007438577 and short name TOL. The number of shares in Toleranzia as of 31 March 2022 is 110,315,231. The share capital as of 31 March 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 first quarter, the Company had cash and cash equivalents of approximately SEK 65.8 million (SEK 35.5 million) and an equity ratio of 95.7% (93.1%).
 
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). For more detailed information on the accounting principles, refer to the Company’s 2021 Annual Report.
 
Review
This interim report has not been reviewed by the Company’s auditors.
 
Next reports
Interim report January-June 2022-08-26
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, 6 May 2022
Toleranzia AB
The Board of Directors and CEO