First Patient Dosed with new Formulation of AO-252

Coiled Therapeutics PLC

03 August 2026

 

3 August 2026

Coiled Therapeutics plc

("Coiled Therapeutics" or the "Company")

First Patient Dosed with Optimised Lipid-Based 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."

Regulatory Information

This Announcement contains inside information for the purposes of the UK version of the market abuse regulation (EU No. 596/2014) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 ("UK MAR").

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Enquiries:

Coiled Therapeutics plc Sotirios Stergiopoulos (Chairman) Sridhar Vempati (CEO)	Via Burson Buchanan
SP Angel Corporate Finance LLP (Nominated Adviser & Joint Broker) David Hignell / Adam Cowl / Devik Mehta (Corporate Finance) Vadim Alexandre / Rob Rees (Corporate Broking)	[phone]
Shard Capital Partners LLP (Joint Broker) Damon Heath CPS Capital Group Pty Ltd (Joint Broker) Jason Peterson / David Valentino	[phone] [phone]
Burson Buchanan (Public Relations) Henry Harrison Topham / Jamie Hooper / Toto Berger	[phone]
Harbor Access (US Investor Relations) Matt Kelly / Jonathan Paterson	[phone]

About Coiled Therapeutics plc

Coiled Therapeutics (AIM: COIL) (OTCQB: COTXF) is an AIM-listed, clinical-stage precision oncology company advancing first-in-class small molecule therapies targeting validated cancer dependencies. Its lead programme, AO-252, is a novel TACC3 inhibitor currently being evaluated in a Phase I clinical trial in the U.S. (ClinicalTrials.gov ID: NCT06136884).  The Company's clinical development strategy is designed to generate the clinical evidence sought by potential pharmaceutical partners in selected tumour types, including ovarian and prostate cancer, while advancing a broader pipeline that includes a STAT6 siRNA programme for immunology indications.

About AO-252

AO-252 is a first-in-class, orally administered, brain-penetrant small molecule designed to selectively inhibit Transforming Acidic Coiled-Coil containing protein 3 (TACC3). TACC3 has emerged as a validated cancer dependency across multiple aggressive solid tumours and is largely dispensable in normal adult cells, supporting the potential for a broad therapeutic window.

By disrupting TACC3-driven protein interactions, AO-252 induces mitotic and replication stress, impairs DNA damage repair and promotes cancer cell death. Its ability to cross the blood-brain barrier is a key differentiator, supporting its potential to treat both primary brain tumours and brain metastases.

AO-252 is currently being evaluated in an ongoing Phase I open-label dose-escalation study. The Company plans to initiate Phase I/II dose-expansion cohorts in ovarian and prostate cancer in H2 2026.

For more information, please visit: www.coiledplc.com and follow us on LinkedIn.

 

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