OS Therapies (OSTX) Q2 2026 earnings summary

Executive summary

• Focused on developing OST-HER2 for osteosarcoma, with positive Phase IIb results showing improved survival rates, including statistically significant 2.5-year overall survival data (75% vs. 47%, p=0.003), and strong biomarker data supporting efficacy.

• Engaged in regulatory interactions with FDA, EMA, MHRA, and TGA, with BLA and MAA submissions planned for late 2026 and early 2027.

• Expanded pipeline includes OST-tADC platform for solid tumors and advanced next-generation ADC and DC platforms with proprietary linker technology.

• Reported second quarter 2026 financials and provided business and regulatory updates, focusing on OST-HER2 for metastatic osteosarcoma.

Financial highlights

• Net loss of $19.0 million for the six months ended June 30, 2026, compared to $8.4 million for the same period in 2025.

• Net operating loss of $8.576 million for Q2 2026, compared to $4.839 million in Q1 2025.

• Research and development expenses rose to $13.4 million (six months), mainly due to vendor and clinical trial costs, partially offset by a $1.96 million VAT receivable.

• Over $3 million in VAT refunds receivable at Q2 end, with an additional $1 million VAT and at least $4.2 million R&D tax credits expected by Q3 end.

• Cash and cash equivalents were $205,035 as of June 30, 2026.

Outlook and guidance

• Substantial doubt exists about the ability to continue as a going concern due to insufficient cash to fund operations for 12 months.

• Management is pursuing additional capital through equity and debt financings; $4.7 million raised in August 2026 with up to $5 million more available.

• Financial roadmap expected to extend into 2027, supported by tax refunds and minimally dilutive capital.

• Regulatory submissions for OST-HER2 in the U.S., U.K., and Europe targeted for completion by 2027.