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 candidate, elraglusib, targets GSK-3β to disrupt tumor cell survival and enhance anti-tumor immunity.

• Elraglusib is being developed in both intravenous and oral forms for multiple cancer indications, including metastatic pancreatic cancer and pediatric cancers.

• Pipeline includes ongoing and planned trials in metastatic pancreatic cancer, Ewing sarcoma, melanoma, and colorectal cancer.

• Operates as a semi-virtual company, leveraging partnerships with academic institutions and contract research organizations.

Financial performance and metrics

• No product revenue to date; operations funded primarily through equity and convertible note financings.

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

• Accumulated deficit of $113.4 million as of March 31, 2024.

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

• Research and development expenses were $21.7 million in 2023 and $6.9 million for Q1 2024, reflecting increased clinical trial activity.

Use of proceeds and capital allocation

• Estimated net proceeds of $45.4 million from the IPO (or $52.4 million if the over-allotment is exercised), based on a $9.00 per share offering price.

• Proceeds prioritized to fund ongoing Phase 2 mPDAC trial, pediatric Ewing sarcoma trial, investigator-initiated studies, and development of oral elraglusib.

• Additional funds allocated to working capital, general corporate purposes, and obligations under license agreements.

• Proceeds expected to fund operations for at least 18 months; further capital will be needed for Phase 3 trials and broader development.