Three months,
· Net sales amounted to -- KSEK (--)
· Profit after financial items amounted to KSEK -2 503 (-2 218).
· Cash flow from operating activities amounted to
· Investments in intangible assets amounted to
· Earnings per share amounted to
Six months,
· Net sales amounted to -- KSEK (--)
· Profit after financial items amounted to KSEK -4 450 (-4 290)
· Cash flow from operating activities amounted to KSEK -3 442 (-4 095)
· Investments in intangible assets amounted to KSEK 29 792 (19 655)
· Earnings per share amounted to
The "Company" or "
Significant events in the second quarter of 2023
- Preparatory work for GMP manufacturing and GLP toxicology studies of the drug candidate TOL2
Significant events after the reporting period
- Decision to carry out an issue of units of approximately
SEK 55 million - Manufacturing steps of the GMP process for the drug substance TOL2 successfully completed
- Development of freeze-drying formulation of TOL2 drug candidate successfully completed
Key financial data
2023-04-01 | 2022-04-01 | 2023-01-01 | 2022-01-01 | 2022-01-01 | |
2023-06-30 | 2022-06-30 | 2023-06-30 | 2022-06-30 | 2022-12-31 | |
3 months | 3 months | 6 months | 6 months | 12 months | |
Net sales KSEK | - | - | - | - | - |
Operating profit/loss KSEK | - 2 489 | - 2 249 | - 4 478 | - 4 321 | - 8 639 |
Profit/loss for the period KSEK | - 2 503 | - 2 218 | - 4 450 | - 4 290 | - 8 456 |
Total assets KSEK | 121 959 | 128 880 | 121 959 | 128 880 | 125 632 |
Cash flow for the period KSEK | - 20 897 | - 13 276 | - 33 234 | - 23 750 | - 42 341 |
Cash and bank balances KSEK | 703 | 52 528 | 703 | 52 528 | 33 937 |
Equity KSEK | 115 059 | 123 674 | 115 059 | 123 674 | 119 509 |
Earnings per share SEK | - 0,02 | - 0,02 | - 0,04 | - 0,04 | -0,08 |
Equity/assets ratio (%) | 94,3 | 96,0 | 94,3 | 96,0 | 95,1 |
Number of shares at the end of the period (no.) | 110 315 231 | 110 315 231 | 110 315 231 | 110 315 231 | 110 315 231 |
Avarage number of shares (no.) | 110 315 231 | 110 315 231 | 110 315 231 | 110 315 231 | 110 315 231 |
Number of employees and consultans | 11 | 9 | 14 | 10 | 8 |
Comments from the CEO
Intensive work to reach key milestones
Production of GMP materials for clinical studies
There has been a high level of activity and work pace behind the scenes in
New freeze-dried formulation
After the end of the period, we have also completed the development of a new optimized drug formulation of TOL2. The new formulation, which consists of a freeze-dried drug product with excellent properties, can be stably stored and reconstituted to a high concentration of active drug.
Tox study to start shortly
In mid-September, we start the important GLP toxicology study of TOL2 with a batch of the drug candidate manufactured with the new freeze-drying formulation.
Rights issue strengthens cash position
The capital raise in the form of a rights issue of units of approximately
Ever closer to the clinical development phase
We look forward with confidence to the results from the GLP toxicology study and upcoming interactions with regulatory authorities - two important milestones in the development program of TOL2 as they represent the final steps before the submission of the clinical trial application. Recent progress brings us ever closer to our goal - to offer a completely new type of treatment for this rare but serious disease that currently lacks a safe, disease-specific and effective therapy.
Executive Director
About
General information about the business
Company structure and shareholding
Financial development and position
Period April - June
Net sales amounted to -- KSEK (--) during the quarter.
Other income amounted to KSEK 2 (--) during the quarter and consists mainly of currency exchange rate gains.
The company's operating expenses amounted to KSEK 22 150 (13 826) for the quarter, of which KSEK 1 505 (1 399) relates to personnel costs.
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 the previous year, as a result of an increase in the number of human resources compared to previous quarters.
Of the total cost, KSEK 19 659 (11 577) relates 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 -2 489 (-2 249).
The period January – June
Net sales amounted to -- KSEK (--) during the period.
Other income amounted to 49 KSEK (1) during the period and consists mainly of currency exchange rate gains.
Operating expenses for the Company amounted to 34 319 KSEK (23978) during the period, of which 2 859 KSEK (2 436) are costs for personnel.
The costs for the Company's development work represent 86% (82%) of the total operating costs. The cost of development work for the Company's project portfolio in myasthenia gravis and ANCA vasculitis amounted to KSEK 29,792 (19,656). The costs incurred are capitalized on an ongoing basis as own-account work.
Operating profit/loss for the period amounted to -4 478 KSEK (-4 321).
Cash flow and liquidity
For the period April - June, cash flow from operating activities amounted to KSEK -1 238 (-1 699). For the period January - June cash flow from operating activities amounted to -3 442 KSEK (-4 095).
As of
Investments
Total investments in intangible assets amounted to KSEK 19 659 (11 577) for the period April - June. Total investments in intangible assets amounted to KSEK 29 792 (19 655) for the period January - June.
The investments relate to the development of the Company's project portfolio within myasthenia gravis and ANCA vasculitis and the costs are capitalized on an ongoing basis as own-account work.
Human resources
Financing
The Rights Issue in brief
- The Board of Directors of
Toleranzia has, with authorization from the general meeting on7 June 2023 , resolved to carry out the Rights Issue of a maximum 110,315,231 units, corresponding to 110,315,231 shares and 110,315,231 warrants of series TO4. - If fully subscribed, the Rights Issue would provide
Toleranzia with approximatelySEK 55 million before issue costs. - In the event of full subscription and full exercise of all warrants of series TO4 in conjunction with offered units, the Company may be provided with an additional maximum of approximately
SEK 55 million . - The Rights Issue is covered to approximately 47 per cent by subscription commitments.
- All existing shareholders will receive one (1) unit right for each one (1) share owned on the record date,
25 August 2023 . One (1) unit right gives the right to subscribe for one (1) unit. One (1) unit consists of one (1) newly issued share and one (1) warrant of series TO4. The subscription price per unit isSEK 0.50 , corresponding toSEK 0.50 per share. The warrants are issued free of charge. - The subscription period for the Rights Issue will run from
30 August 2023 until13 September 2023 . - In addition, the board may decide on an over-allotment issue in the form of a directed new issue of a maximum 11,031,523 units, provided that the Rights Issue is fully subscribed. ("The Overallotment Issue")
Related party transactions
The company has related party transactions regarding the purchase of services from the company
Ongoing unrest in
There is a general uncertainty in the market caused by the ongoing conflict in
Shares
There are no ongoing option programs at the time of publication of this interim report.
Ownership
Shareholder | Share of | Share of |
capital | votes | |
47,4 % | 47,4 % | |
FÖRSÄKRINGSAKTIEBOLAGET AVANZA PENSION | 2,7 % | 2,7 % |
NORDNET PENSIONSFÖRSÄKRING AB | 2,5 % | 2,5 % |
2,0 % | 2,0 % | |
NORDEA LIVFÖRSÄKRING SVERIGE AB | 1,8 % | 1,8 % |
1,4 % | 1,4 % | |
KONSTRUKTIONS O FÖRSÄLJNINGSAKTIEBOLAGET KFAB | 1,1 % | 1,1 % |
KAUFMANN, JOHAN | 1,0 % | 1,0 % |
BERGSTRÖM, | 0,9 % | 0,9 % |
0,9 % | 0,9 % | |
OTHERS | 38,5 % | 38,5 % |
Total | 100,0 % | 100,0 % |
Review by the auditor
This interim report has not been reviewed by the Company's auditors.
Financial calendar
Interim report Q3 2023: 2023-10-27
Year-end report 2023: 2024-02-23
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.
The Board of Directors and CEO
The English version of the interim report is an internal translation. In case of discrepancies, the Swedish text applies.
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