Fourth quarter 2022
Fourth quarter, 1 October – 31 December
·         Net sales amounted to -- KSEK (--)
·         Profit after financial items amounted to KSEK -2,181 thousand (-1,758)
·         Cash flow from operating activities amounted to KSEK -507 (-4,079)
·         Investments in intangible assets amounted to KSEK 13,090 thousand (5,753)
·         Earnings per share amounted to SEK -0.02 (-0.02)
Twelve months, 1 January – 31 December
·         Net sales amounted to -- KSEK (--)
·         Profit after financial items amounted to KSEK -8,639 (-62852)
·         Cash flow from operating activities amounted to KSEK -7,196 (-6,850)
·         Investments in intangible assets amounted to KSEK 35,096 (26,314)
·         Earnings per share amounted to SEK -0.08 (-0.06)
 
”Company” or ”Toleranzia” relates to Toleranzia AB with Swedish registration number 556877-2866.
 
Significant events during the fourth quarter 2022

• Toleranzia entered into an agreement with Charles River Laboratories to conduct a GLP toxicology study of TOL2, the company's drug candidate for the autoimmune disease myasthenia gravis.

• Toleranzia and 3P Pharmaceuticals, the company's contract manufacturing partner, successfully manufactured the first pilot batch of TOL2 with all process steps completed on a large scale.

• Flerie Invest announced a mandatory bid to the shareholders of Toleranzia, which Toleranzia's Board of Directors recommended the shareholders of Toleranzia not to accept.

Significant events after the reporting period

• Toleranzia announced the composition of the Nomination Committee for the 2023 Annual General Meeting.

 
Key financial data

Comments from the CEO
Several important advances in the development of TOL2
2022 ended with an intense quarter in which we successfully produced a large-scale pilot batch of TOL2 while completing the procurement of a partner for the conduct of our upcoming GLP toxicology study. It is satisfying to sum up the year's successes while looking forward to 2023 where we expect an even faster pace.
 
Large-scale process yields large amounts of TOL2
At the end of 2022, we reached a very important milestone when we succeeded in producing a pilot batch of TOL2 at 1000 L scale at our contract manufacturer 3P Biopharmaceuticals (3P) in Pamplona, Spain. The production resulted in a much higher yield of pure TOL2 than we had dared to hope for and the material in the pilot batch is now being further validated. We will soon begin the next stage of the process where two more large-scale batches of TOL2 will be produced. First a technical batch for the regulatory GLP toxicology study, then a GMP batch for the clinical trial in patients.
 
Key partnership launched
Just before the turn of the year, after a thorough evaluation, we were able to select Charles River Laboratories (CRL) as our partner in the conduct of the GLP toxicology study of TOL2. CRL is a well-established global contract research organisation with both expertise and experience in the study of biological drug candidates with immunomodulatory properties such as TOL2. They therefore have all the systems and methods needed for the documentation of TOL2's safety profile. The results of the GLP toxicology study will form a key part of Toleranzia's application to conduct a clinical trial in patients with myasthenia gravis.
 
Good market prospects for a truly disease-modifying therapy like TOL2
During the year, we have seen an ever-increasing international interest in TOL2. Several partnership dialogues intensified after our preclinical data became visible thanks to the fact that Toleranzia, together with our partners at the Hellenic Pasteur Institute in Greece, both published the results in a scientific journal during the summer and presented them at the largest international conference on myasthenia gravis. The hallmark of TOL2 is that we see a clear differentiation from existing therapies both in terms of safety and magnitude and long-term impact on therapeutic efficacy in our preclinical model. Based on our preclinical results, we hope to offer a breakthrough, truly disease-modifying treatment for patients suffering from the often severe effects of myasthenia gravis as opposed to currently approved therapies, all of which are only symptom relieving.
 
Focus on the final pieces of the puzzle for our first clinical trial
In addition to making significant progress in production, we have also worked during the year to evaluate biomarkers for clinical efficacy, select study sites and design an optimal study design for the upcoming TOL2 clinical trial to deliver high quality data.
 
As we look ahead, we have several value-enhancing milestones in sight. The next step is the production of the technical batch followed by the GLP toxicology study. In parallel, we will complete the production of a GMP batch and apply for approval to conduct our first clinical trial. As the trial will be conducted directly in patients, it will allow us to demonstrate, already in a first study, not only the safety of TOL2 but also the treatment effect. We are now working to leverage the progress we have made in 2022 to achieve our goal of starting to evaluate TOL2 in patients for the first time.
 
Gothenburg, February 24, 2023
Charlotte Fribert
Chief Executive Officer

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.com
 
Company structure and shareholdings
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.
 
Financial development and position
The period October – December 2022
Net sales amounted to -- KSEK (--) during the period.
 
Other income amounted to 39 KSEK (112) during the period and consists of currency exchange rate gains.
 
Operating expenses for the Company amounted to 15,471 KSEK (7,622) during the period, of which 1,388 KSEK (1,095) is costs for personnel.
 
The increased costs are in line with the Company's plan and expectations linked to the long-term strategy. The cost of personnel has increased compared to last year, as a result of the increase in the number of human resources compared to previous quarters.
 
Of the total cost 13,251 KSEK (5,752) relates to development of the Company product portfolio within myasthenia gravis and ANCA vasculitis and the costs incurred are capitalized on an ongoing basis as own-account work.
 
Operating profit/loss during the period amounted to 2,181 KSEK (1,758).
 
The period January – December 2022
Net sales amounted to -- KSEK (--) during the period.
 
Other income amounted to 111 KSEK (578) during the period and consists of currency exchange rate gains, together with contributions from Vinnova.
 
Operating expenses for the Company amounted to 44,007 KSEK (33,976) during the period, of which 5,034 KSEK (4,149) is costs for personnel.
 
In 2022, the company has added human resources equivalent to three positions to the organization - one protein chemist and two cell biologists.
 
Of the total cost 35,257 KSEK (27,116) relates to development of the Company product portfolio within myasthenia gravis and ANCA vasculitis and the costs incurred are capitalized on an ongoing basis as own-account work. Development work costs correspond to 80% (80%) of the Company's total operating expenses.
Operating profit/loss for the period amounted to -8,639 KSEK (-6,282).
 
Cash flow and liquidity
Cash flow from operating activities for the fourth quarter 2022 amounted to -507 KSEK (-4,079). For the period January - December 2022 cash flow from operating activities amounted to -7,196 KSEK (-6,850).
 
As of December 31, 2022, the cash balance amounted to 33,937 KSEK (76,278).
 
Investment
Total investments in intangible assets amounted to KSEK 13,090 (5,753) in the fourth quarter of 2022. Total investments in intangible assets amounted to KSEK 35,096 (26,314) for the period January - December 2022.
 
The investments relate to the development of the Company's project portfolio in myasthenia gravis and ANCA vasculitis and the costs are capitalized on an ongoing basis as own-account work.
 
Personnel resources
Toleranzia is a development company where dedicated employees with solid experience and excellence are a prerequisite for commercial success and for achieving the company's vision. In 2022, the company recruited three new people and the company had nine full-time equivalent employees or contracted consultants as of 31 December 2022.
 
Financing
During the autumn of 2021, the company carried out a new share issue, raising capital and cash of SEK 69 532 thousand in total, before issue costs.
 
The company has a continuous focus on cash flow and has ongoing discussions with its major shareholders to ensure sustainable financing of ongoing and future development projects. The existing working capital is, in the opinion of the Board of Directors, sufficient for the current needs according to the business plan for the next five months. The Board works continuously to secure the Company's financing and believes that the Company will continue to be adequately financed.
 
In light of the above, the report has been prepared on a going concern basis as it is the assessment of management and the Board that there are a number of options available to obtain long-term financing.
 
Related party transactions
The company has related transactions concerning the purchase of administrative services from the company GU Ventures AB in Gothenburg. The services purchased have been made on market terms.
 
Ongoing unrest in Europe
There is a general uncertainty in the market caused by the ongoing conflict in Ukraine. The uncertainty has so far not affected the company's operations and is not expected to affect operations in the coming months. Toleranzia has no operations in either the Russian or Ukrainian markets. Incoming raw materials and expertise are sourced from neither Russia nor Ukraine.
 
Share
Toleranzia's shares have been traded on Nasdaq First North since 15 October 2020. The number of shares in Toleranzia as of 31 December 2022 was 110,315,231. The share capital amounted to SEK 13,789,404 as 31 December 2022. The Company has one class of shares, each share having a quotient value of SEK 0.125 (0.125 SEK) and carrying equal rights to participate in the Company's assets and profits.
 
There are no outstanding option plans at the time of issuance of this interim report.
 
Mangold Fondkommission AB is the Company's Certified Adviser and can be reached at: ca@mangold.se.
 
Ownership per December 31, 2022

 
Review
This interim report has not been reviewed by the Company’s auditors.
 
Financial calendar

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, 24 February 2022
Toleranzia AB (publ)
The Board of Directors and CEO 

The English version of the quarterly report is an internal translation. In case of any discrepancies, the Swedish text applies.
 
For further information, please contact:
Charlotte Fribert, CEO, Mobile: +46 76 319 98 98, Email: charlotte.fribert@toleranzia.com
Torbjörn Sannerstedt, CFO, Mobile: +46 708 66 22 55, Email: torbjorn.sannerstedt@toleranzia.com