Coiled Advances Next-Generation AO-252 Formulation

Coiled Therapeutics (AIM: COIL) (OTCQB: COTXF), the clinical-stage oncology company developing precision medicines for hard-to-treat cancers, announces the development of a next-generation oral formulation of AO-252, its first-in-class, brain-penetrant TACC3 inhibitor. First patient dosing with the new formulation is expected in July 2026, representing an important milestone in the execution of the Company's previously announced H2 2026 development roadmap.

Key Highlights

• A lipid-based softgel has been developed to deliver AO-252 in a pre-dissolved system, designed to achieve more consistent, dose-proportional absorption compared to the current tablet formulation.
• The current tablet formulation exhibits dose-dependent absorption limitations that constrain drug exposure at higher doses and reduces uptake consistency across dosing conditions. The new formulation is specifically designed to overcome this limitation.
• The formulation strategy follows a validated lipid-based softgel approach already used in approved oncology therapies, providing a well-characterised development and regulatory pathway.
• The most recent clinical data demonstrated an 80% Clinical Benefit Rate ("CBR") in patients receiving twice-daily ("BID") dosing n=5 versus 40% in patients receiving once-daily dosing n=5 in the ongoing Phase I study (NCT06136884), with tumour reductions observed in ovarian and endometrial cancer patients. This data relates to current tablet formulation and provides the rationale for the new softgel design.

The development of the next-generation softgel formulation reflects the Company's approach to optimising dosing ahead of expansion cohorts in July. By delivering AO-252 in a pre-dissolved lipid-based system, the Company expects to achieve more consistent absorption and improve drug exposure at higher dose levels.

The introduction of the next-generation formulation supports the Company's transition to targeted dose expansion cohorts in ovarian and prostate cancer, with an enrolment target of up to 30 patients by Q4 2026. The Company remains on track with its 2026 development roadmap, with comprehensive expansion cohort data readouts anticipated in H2 2026.

Sridhar Vempati, Chief Executive Officer of Coiled Therapeutics, commented:

"We are excited to dose our next patients with the new formulation which we expect to happen this month. It is a key step in our dose expansion programme in ovarian and prostate cancers and builds on the exposure-response signal we have already observed with AO-252. The softgel formulation is designed to address the absorption limitations in the current tablet. Combined with the clinical benefit data demonstrated by the current formulation, we believe the new formulation has the potential to further strengthens AO-252's potential to deliver meaningful clinical outcomes as we advance into dose expansion."

About AO-252

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