Actuate Therapeutics (ACTU) Registration filing summary

Company overview and business model

• Clinical-stage biopharmaceutical company developing therapies for difficult-to-treat cancers by inhibiting glycogen synthase kinase-3 (GSK-3).

• Lead product, elraglusib, is an ATP-competitive small molecule targeting GSK-3β, with potential applications across multiple cancer types.

• Pipeline includes intravenous and oral formulations, with ongoing trials in metastatic pancreatic cancer (mPDAC) and pediatric cancers.

• Operates as a semi-virtual company, leveraging third-party partnerships for research, manufacturing, and clinical development.

Financial performance and metrics

• No revenue generated to date; accumulated deficit of $113.4 million as of March 31, 2024.

• Net loss of $24.7 million in 2023 and $8.3 million for the three months ended March 31, 2024.

• Cash and cash equivalents of $2.1 million as of March 31, 2024; working capital deficit of $12.5 million.

• Research and development expenses were $21.7 million in 2023 and $6.9 million for Q1 2024.

• Substantial doubt exists regarding ability to continue as a going concern without additional capital.

Use of proceeds and capital allocation

• Estimated net proceeds of $23.2 million from the IPO, or $27.0 million if the over-allotment is exercised.

• Proceeds prioritized to fund and complete ongoing Phase 2 mPDAC trial, pediatric Ewing sarcoma trial, investigator-initiated studies, and license obligations.

• Remaining funds allocated to working capital and general corporate purposes; additional funding required for further development.