Successful Enrolment Completed Across Two Cohorts

Coiled Therapeutics (AIM: COIL) (OTCQB: COTXF), the clinical-stage precision oncology company developing differentiated small molecule therapies for genetically defined cancers, provides an update on the clinical development of its next-generation, lipid-based formulation of AO-252, its first-in-class, brain-penetrant small molecule inhibitor of TACC3. Following the dosing of the first patient with the new formulation, announced on 3 August 2026, the Company has successfully enrolled patients across two distinct escalation cohorts: a twice-daily ("BID") 120mg cohort (n=3) and a once-daily ("QD") 160mg cohort (n=3). All patients are progressing as planned through the assessment period, in accordance with the study protocol.

Key Highlights

• Patients successfully enrolled across two initial cohorts (120mg BID, n=3; 160mg QD, n=3) evaluating the new lipid-based softgel formulation of AO-252.
• All patients are progressing through the protocol-specified assessment period in the ongoing Phase I study (NCT06136884).
• The new softgel formulation is designed to achieve more consistent, dose-proportional absorption, building on the 80% Clinical Benefit Rate (CBR) signal observed in earlier twice-daily tablet dosing (n=5).
• The Company remains confident of dosing up to 30 patients with the new formulation by the end of 2026, as the trial advances towards Phase I/II planned dose-expansion cohorts in ovarian and prostate cancer.

The 120mg BID and 160mg QD dose levels were selected to optimise systemic drug exposure based on encouraging clinical activity observed with the original tablet formulation. As previously announced, the tablet formulation demonstrated an 80% Clinical Benefit Rate ("CBR") in patients receiving twice-daily dosing (n=5), compared with 40% in patients receiving once-daily dosing (n=5). The new pre-dissolved, lipid-based softgel system was specifically designed to reduce absorption variability, enhance bioavailability and deliver a more predictable, dose-proportional exposure, supporting evaluation of AO-252 at sustained dose levels.

Enrolment across these cohorts marks continued progress towards the Company's planned Phase I/II dose-expansion cohorts in ovarian and prostate cancer, with an enrolment target of up to 30 patients with the new formulation by the end of 2026. The Company continues to expect initial safety and pharmacokinetic ("PK") data readouts by the end of 2026, in line with its previously stated development roadmap.

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

"We have now enrolled patients across both our 120mg BID and 160mg QD cohorts with the new formulation, and they are progressing well through their assessment period in line with protocol. The new formulation was specifically designed to enhance bioavailability and deliver more consistent drug exposure, building on the encouraging 80% clinical benefit rate signal we observed with twice-daily dosing in earlier cohorts. This is an important step in de-risking our dose-escalation strategy and keeps us firmly on track to dose up to 30 patients by the end of the year, as we advance towards our planned expansion cohorts in ovarian and prostate cancer."

Regulatory Information

About AO-252

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