Novakand Pharma (NOVKAN) Q4 2023 earnings summary

Executive summary

• FRACTAL phase IIa met its safety/tolerability objective and showed signals of cardioprotection; next cardiovascular study planned as combined phase IIb/III pivotal study.

• KANDOVA ovarian cancer trial expanded to five Nordic sites; KAND145 phase I began, with single-dose escalation completed after period end.

Financial highlights

• Q4 net sales SEK 0; operating income SEK -19.0m, net income SEK -18.5m and EPS SEK -0.23, versus SEK -14.0m, SEK -14.0m and SEK -0.22, respectively, in Q4 2022.

• FY net sales SEK 0; operating income SEK -65.0m and net income SEK -64.9m, versus SEK -51.9m and SEK -52.5m in FY 2022; EPS SEK -0.81 versus SEK -0.90.

• FY operating expenses SEK 66.1m, including R&D costs of SEK 58.0m; excluding SEK 3m FRACTAL license fee and SEK 3m ROR1 impairment, expenses were SEK 60.1m and R&D costs SEK 52.0m.

Outlook and guidance

• KANDOVA phase Ib completion targeted for Q2 2024, with top-line results before end-2024; 3 of the anticipated 6–12 patients recruited as of the CEO statement.

• KAND145 multiple-ascending-dose phase ongoing; top-line results planned for Q2 2024. Single-dose results showed expected conversion to KAND567, comparable pharmacokinetics, and safety/tolerability at the expected therapeutic concentration.

• Next cardiovascular study planned as a combined phase IIb/III pivotal study; design work and partnership discussions underway.