Toleranzia (TOL) Q3 2024 earnings summary

Executive summary

• Submitted clinical trial application for TOL2 in myasthenia gravis to EMA in early October 2024, aiming for a multicenter, placebo-controlled phase I/IIa study in Sweden, Denmark, and Germany.

• Secured 71.14% subscription commitments for TO4 warrants, potentially raising SEK 43 million to support clinical trial activities.

• Appointed Ann-Sofie Taube as interim CFO during the regular CFO's leave.

• Scaled up TOL2 formulation, producing a large-scale test batch and building logistics for the clinical study.

Financial highlights

• Operating loss for Q3 2024 was KSEK -2,613, compared to KSEK -1,292 in Q3 2023; nine-month operating loss was KSEK -6,042, versus KSEK -5,770 year-over-year.

• Cash flow from operating activities for Q3 2024 was KSEK -1,931, down from KSEK 133 in Q3 2023; nine-month cash flow was KSEK -1,768, improved from KSEK -3,310 year-over-year.

• Investments in intangible assets for Q3 2024 totaled KSEK 10,684, up from KSEK 9,792 in Q3 2023; nine-month investments were KSEK 22,785, down from KSEK 39,583 year-over-year.

• Cash and bank balances at September 30, 2024, were SEK 1,042 thousand, compared to SEK 32,511 thousand a year earlier.

• Earnings per average share for Q3 2024 were SEK -0.01, unchanged from Q3 2023; nine-month EPS was SEK -0.03, improved from SEK -0.05 year-over-year.

Outlook and guidance

• Awaiting EMA decision on TOL2 clinical trial application, with study start anticipated following approval.

• TO4 warrant exercise in October 2024 could provide up to SEK 43 million in new funding.

• Loan agreement with Flerie Invest AB ensures financing for at least twelve months after the balance sheet date.