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Ondine Biomedical Raises £8.5M to Fund Steriwave Phase 3 Clinical Trial in the US

• Ondine Biomedical is raising £8.5 million through a share placing and subscription to fund the US Phase 3 clinical trial of its Steriwave nasal photodisinfection system. • The trial, in partnership with HCA Healthcare, will enroll approximately 5,000 patients across 14 hospital sites to evaluate infection prevention methods. • Initial patient recruitment is expected by the end of the year, with early data anticipated next autumn, and the funds will support operations into early H2 2025. • Ondine is also in discussions for a potential $4 million investment to extend its financial runway to early Q2 2026, covering the trial's conclusion and NDA submission.

Ondine Biomedical has announced a proposed minimum £8.5 million fundraising through a placing and subscription of new shares, priced at 8.5p each, to support the US Phase 3 clinical trial of its nasal photodisinfection system, Steriwave. The AIM-traded firm is collaborating with HCA Healthcare for this trial, which aims to enroll around 5,000 patients across 14 hospital sites to assess infection prevention methods. Initial patient recruitment is expected by the end of the year, with early data anticipated next autumn.

Trial Details and Funding

The Phase 3 trial is designed to evaluate the efficacy of Steriwave in preventing infections. The funding secured will ensure Ondine has adequate resources to complete the trial, advance commercialization efforts, and maintain operations into the early second half of 2025. The majority of Ondine's directors intend to participate in the fundraising, contributing approximately £0.21 million.
In addition to the current fundraising, a separate private placing announced in September is expected to settle by November 8, potentially bringing in an additional CAD 5 million (£2.8 million). Together, these efforts aim to secure at least £11.3 million.

Potential Further Investment

Ondine is also in advanced discussions with a major US healthcare group regarding a possible investment of up to $4 million. If successful, this could extend the company's financial runway to early in the second quarter of 2026, covering the trial's conclusion and the new drug application (NDA) submission. Should these discussions not result in an agreement, Ondine's board will explore alternative funding routes to support operations beyond mid-2025.
The placing is managed by RBC Capital Markets, Orana Corporate, and Oberon Capital and is not underwritten, taking place on a non-preemptive basis. Further announcements regarding the final allocation and total size of the placing will follow its conclusion.

Market Reaction

Following the announcement, shares in Ondine Biomedical experienced a positive market reaction, rising 8.78% to 9.11p at 0957 GMT.
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Reference News

[1]
Ondine raising £8.5m to fund US clinical trial - Sharecast.com
sharecast.com · Nov 1, 2024

Ondine Biomedical plans £8.5m fundraising for US phase three trial of nasal photodisinfection system, 'Steriwave', with ...

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