Pasithea Therapeutics (KTTA) Q4 2024 earnings summary

Executive summary

• Clinical-stage biotech focused on CNS disorders and RASopathies, with lead candidate PAS-004, a next-generation MEK inhibitor, advancing through Phase 1 trials for MAPK pathway-driven tumors and NF1-PN.

• Discontinued non-core clinic operations in the UK and US to focus on therapeutics; pipeline includes PAS-003 (ALS) and PAS-001 (schizophrenia) in early development.

• Completed long-term toxicology studies and advanced PAS-004 into multiple dosing cohorts with favorable safety and PK data; orphan drug designation received for NF1.

Financial highlights

• Net loss for 2024 was $13.9 million, an improvement from $16.0 million in 2023.

• Research and development expenses decreased 11.1% to $7.2 million, while general and administrative expenses fell 10.5% to $7.1 million.

• Cash and cash equivalents at year-end 2024 were $6.9 million, down from $16.3 million in 2023.

• Working capital decreased to $6.2 million from $14.1 million year-over-year.

• No revenue generated; accumulated deficit reached $49.6 million.

Outlook and guidance

• Management expects research and development expenses to increase in 2025 due to expanded clinical activity for PAS-004.

• General and administrative expenses are expected to decrease slightly in 2025.

• Company will require additional capital to fund operations beyond the next twelve months; ongoing efforts to raise funds through equity and warrant offerings.

• FIH Phase 1 Dose Escalation Study for PAS-004 expected to complete in 2026; Phase 1/1b trial in adult NF1-PN patients to launch in 2025.