Indaptus Therapeutics (INDP) Q3 2024 earnings summary

Executive summary

• Focused on developing Decoy20, a novel anti-cancer and anti-viral immunotherapy, with ongoing Phase 1 clinical trials in advanced solid tumors after prior therapies have failed.

• Entered a clinical supply agreement with BeiGene to evaluate Decoy20 in combination with tislelizumab, aiming to start a combination study in 2025.

• Completed single-dose and initiated weekly dosing cohorts in the Phase 1 trial, with safety review authorizing unrestricted enrollment at the 3x10^7 Decoy20 dose.

• Decoy20 continues to be well tolerated, with further safety and efficacy data expected to guide future combination trials.

• Completed a $3 million registered direct offering and concurrent private placement, raising net proceeds of $2.5 million.

Financial highlights

• Cash and cash equivalents were $7.4 million as of September 30, 2024, down from $13.4 million at year-end 2023.

• Net loss for Q3 2024 was $3.1 million ($0.32 per share), a 22% improvement year-over-year; net loss for the nine months ended September 30, 2024 was $10.9 million, a 5% improvement year-over-year.

• Operating expenses for Q3 2024 decreased 26% year-over-year, primarily due to lower R&D and G&A costs.

• Research and development expenses for Q3 2024 were $1.5 million, down $0.7 million year-over-year; nine-month R&D expenses were $4.8 million, down $0.8 million year-over-year.

• Net cash used in operating activities for the nine months ended September 30, 2024 was $8.9 million.

Outlook and guidance

• Current cash is expected to fund operations into the first quarter of 2025; additional capital will be required to continue operations beyond this period.

• Plans to seek additional funding through equity or debt financings, collaborations, or licensing agreements.

• Plans to initiate a combination trial with BeiGene's tislelizumab and Decoy20 in 2025, pending further Phase 1 data.

• Research and development expenses are expected to increase as clinical development activities ramp up.