First Patient Dosed with new Formulation of AO-252

Refined oral formulation designed to optimise drug exposure ahead of planned Phase I/II dose expansion in ovarian and prostate cancer

Coiled Therapeutics (AIM: COIL) (OTCQB: COTXF), the clinical-stage precision oncology company developing differentiated small molecule therapies for genetically defined cancers, announces that the first patient in the United States has been dosed with the Company's optimised lipid-based oral formulation of AO-252. Initial post-dose safety monitoring identified no treatment-related adverse safety findings.

AO-252 is Coiled Therapeutics' first-in-class, brain-penetrant small molecule inhibitor of TACC3, currently in Phase I clinical development in the U.S. for patients with advanced solid tumours (NCT06136884).

The new lipid-based softgel formulation delivers AO-252 in a pre-dissolved system, and is designed to provide more consistent, dose-proportional absorption than the previous tablet formulation, which showed dose-dependent absorption limitations.

This new formulation follows results from the ongoing Phase I trial twice-daily ("BID") dosing cohort using the tablet formulation, which achieved an 80% Clinical Benefit Rate (n=5) in patients with an average of five prior lines of therapy, compared with 40% in the once-daily dosing cohort (n=5), as previously announced on 7 July 2026, including tumour reductions in patients with ovarian and endometrial cancer. The Company's Directors believe the improved pharmacokinetic profile may support evaluation at higher dose levels while building on the clinical activity observed in the BID cohort.

Dosing of the first patient under the new formulation marks a step towards the Company's planned dose-expansion cohorts in ovarian and prostate cancer, targeting up to 30 patients by Q4 2026. Both indications have attracted commercial interest from large pharmaceutical companies.

Coiled Therapeutics expects initial safety and pharmacokinetic data from the new formulation in Q4 2026. Subject to positive results, the Company expects these data sets to support continued engagement with pharmaceutical companies that have previously expressed interest in AO-252.

Sridhar Vempati, Chief Executive Officer of Coiled Therapeutics, commented: "Dosing the first patient with our optimised lipid-based softgel formulation of AO-252 marks an important milestone in the development of AO-252. The new formulation was specifically engineered to improve drug exposure by addressing absorption limitations observed with the tablet formulation and is intended to achieve a more consistent, dose-proportional absorption profile.

"By optimising systemic drug exposure, we aim to build on the 80% Clinical Benefit Rate we have already demonstrated in our BID cohort. This transition strengthens our clinical pathway as we prepare to initiate our targeted dose-expansion cohorts in ovarian and prostate cancers later this year, keeping us on track with our 2026 clinical roadmap."

Brian Orr, M.D., MS, Medical Oncologist and one of the principal investigators in the Phase I study, commented: "TACC3 is a compelling target in chromosomally unstable tumours, and the early clinical activity we have observed with AO-252 is encouraging. Moving to a pre-dissolved lipid-based system directly addresses the absorption limitation seen with the tablet formulation and, importantly, gives us a stronger platform from which to explore higher dose levels. I am optimistic that this improved formulation will allow us to fully characterize the potential of AO-252 in the patients who need new options most."

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