Three months, October 1 - December 31
·         Operating profit/loss (EBIT) amounted to KSEK -2,121 (-2,181).
·         Cash flow from operating activities amounted to KSEK -2,895 (-510).
·         Investments in intangible assets amounted to KSEK 11,195 (13,089).
·         Earnings per share amounted to SEK -0.01 (-0.02).
 
Twelve months, January 1 – December 31
·         Operating profit/loss (EBIT) amounted to KSEK -7,891 (-8,639)
·         Cash flow from operating activities amounted to KSEK -6,323 (-7,199)
·         Investments in intangible assets amounted to KSEK 50,778 (35,095)
·         Earnings per share amounted to SEK -0.06 (-0.08)
 
The "Company" or "Toleranzia" refers to Toleranzia AB with organization number 556877-2866.
 
 
Significant events in the fourth quarter of 2023

• Final formulation and packaging started for the drug product TOL2
• Thomas Pålsson appointed as new CFO

Significant events after the reporting period

• The pivotal toxicology study of TOL2 provides full support for the submission of an application to initiate clinical trials in patients with myasthenia gravis
• The scientific advisory meeting with the Danish Medicines Agency, DKMA, provides broad support for the company's plans for the initial clinical phase I/IIa study of TOL2
• The Nomination Committee was presented ahead of the 2024 Annual General Meeting

Key financial data

  
Comments from the CEO
 
Key milestones achieved towards the clinical phase
2023 has been a great year as we have taken major steps towards a new drug for patients with a severe autoimmune disease with a high unmet medical need. Several critical milestones have been reached in our lead program TOL2 - a new drug for the treatment of the neuromuscular disease myasthenia gravis.
 
Completed production and optimized formulation
During the year, we finalized the production of the drug substance TOL2 for the upcoming clinical study by manufacturing three large-scale batches with GMP quality. To optimize stability and facilitate handling, we developed a new freeze-dried formulation which is expected to give the final drug product a shelf life of at least two years. With these two successfully achieved milestones, we could finally, at the end of the year, initiate the formulation of all GMP batches and the production of approximately 3,000 finished drug packages that will be sent to the clinics that will conduct the clinical study.
 
Successful tox program
A crucial milestone for the TOL2 project was the GLP toxicology study that we conducted during the fall. The study enabled us to show that the drug candidate is well tolerated and safe to use for clinical evaluation in humans. With the positive result from the toxicology program, work was started to develop and submit a clinical trial application. Once the application is approved, the clinical phase I/IIa study can be initiated, which we hope will happen in the second half of 2024.
 
Broad regulatory support for planned Phase I/IIa clinical study
A detailed clinical plan was developed during the year in collaboration with leading international clinical experts. Among others, Professor James Howard from the University of North Carolina, a prominent specialist in myasthenia gravis who has been a member of the company's Scientific Advisory Board since 2021, made crucial contributions to the plan.
In a scientific advisory meeting held during the fall with the Danish Medicines Agency, DKMA, we received broad support for the quality requirements set for the drug substance TOL2, the design of the recently completed toxicology study, and the company's plans for the initial clinical phase I/IIa study. This support is highly important to us as the study will partly be conducted in Denmark. We are primarily targeting Sweden, Denmark, and Germany, where there are several clinics with a good reputation in myasthenia gravis.
 
Research funds strengthen TOL3
In addition to the great successes in our main project, we have also received an important research grant from Vinnova for the continued development of TOL3 where we aim to treat the autoimmune disease ANCA vasculitis. The contribution to the project, which is a collaboration between several actors, amounts to SEK 2.9 million, of which SEK 1.7 million goes to Toleranzia.
 
Overall, we can put a productive and successful 2023 behind us and we are now focusing on taking TOL2 into clinical studies in patients with myasthenia gravis. Our hope is that TOL2 will represent a paradigm shift in the treatment of myasthenia gravis and offer patients a specific and effective treatment that will modify the disease itself and not just relieve the symptoms as current treatments do.
 
Charlotte Fribert
Executive Director
Gothenburg, February 23, 2024

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 shareholding
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. Nor does the company have any shareholdings in other companies.
 
Financial development and position
 
The period October - December
Other operating income amounted to KSEK 227 (39) during the quarter.
           
The company's operating expenses amounted to KSEK 13 543 (15 471) for the quarter, of which KSEK 1 518 (1 388) 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, KSEK 11 195 (13 251) refers to the development of the Company's project portfolio in myasthenia gravis and ANCA vasculitis, where the costs incurred are capitalized on an ongoing basis as own-account work.
 
The operating result during the quarter amounted to KSEK - 2 121 (-2 181).
 
The period January - December
Other operating income amounted to KSEK 489 (111) during the period and consists mainly of exchange rate differences and grants from Vinnova.
 
The company's operating expenses amounted to KSEK 59 158 (44 007) for the period, of which KSEK 5 589 (5 034) relates to personnel costs.
 
The costs for the Company's development work represent 87% (81%) of the total operating expenses. The cost of development work for the Company's project portfolio in myasthenia gravis and ANCA vasculitis amounted to KSEK 50 778 (35 095). The costs are capitalized on an ongoing basis as own-account work.
 
The operating result for the period amounted to KSEK -7 891 (-8 639).
 
Cash flow and liquidity
For the period October - December, cash flow from operating activities amounted to KSEK -2 895 (-510).
(-510). For the period January - December, cash flow from operating activities amounted to KSEK -6 323 (-7 199).
 
As of December 31, the Company's cash and bank amounted to KSEK 18 304 (33 937).
 
Investments
Total investments in intangible assets amounted to KSEK 11 195 (13 089) for the period October - December. Total investments in intangible fixed assets amounted to KSEK 50 778 (35 095) for the period January - December.
 
The investments relate to the development of the Company's project portfolio in myasthenia gravis and ANCA vasculitis and the costs are continuously capitalized as work for own account.
 
Human resources
Toleranzia is a development company where dedicated employees with solid experience and expertise are a prerequisite for commercial success and for achieving the Company's vision. The company had 12 full-time equivalent employees or contracted consultants as of December 31, 2023.
 
Financing
During the fall, the Company carried out a new share issue that provided the Company with capital and liquid funds of approximately SEK 43.4 million, before issue costs. Together with the shares, warrants (TO4) were issued with exercise during the period October 7 - 21, 2024, SEK 0.50 per share. Upon full subscription, the company will receive an additional SEK 43.4 million.
 
The company has a continuous focus on cash flow. The Board of Directors and management work continuously to ensure long-term and sustainable financing of ongoing and planned development projects and consider that there are several possible alternatives to ensure continued satisfactory financing of the Company.
 
In light of the above, the report has been prepared on a going concern basis.
 
Related party transactions
The company has related transactions regarding the purchase of services in process development for protein manufacturing from the company NorthX Biologics Matfors AB, which is partly owned by Flerie Invest AB, whose executive chairman, Thomas Eldered, is a member of Toleranzia's board of directors. In addition, related companies have individual agreements for consulting services with Björn Löwenadler (CBO), Vidar Wendel-Hansen (CMO) and Thomas Pålsson (CFO). Purchased services have been provided on market terms.
 
Shares
Toleranzia's shares are traded on Nasdaq First North Growth Market since October 15, 2020. The number of shares in Toleranzia amounted to 197 070 875 as of December 31, 2023. The share is traded with the short name TOL and with ISIN code SE0007438577. As of December 31, 2023, the share capital amounted to SEK 24 633 859. 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.
 
In addition to the share capital, 86 755 644 warrants have been issued that give the holder the right to subscribe to the same number of shares through exercise during the period October 7 - 21, 2024, at a price of SEK 0.50 per share.
 
On Toleranzia's website there is a list of the largest owners, a list that is continuously updated.
 
Mangold Fondkommission AB is the Company's Certified Adviser and can be reached at: ca@mangold.se.
 
Review by the auditor
This interim report has not been reviewed by the Company's auditors.
 
Financial calendar
Annual report for the financial year 2023              2024-04-30
Quarterly report 1, 2024              2024-05-20
Quarterly report 2, 2024              2024-08-23
Quarterly report 3, 2024              2024-10-24
 
Annual General Meeting 2024
The Annual General Meeting 2024 is planned to take place on June 19 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 2024.
 
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 23, 2024
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, 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 2024-02-23 08:00 CET.