Ondine Biomedical Launches £8.5 Million Fundraising Effort for U.S. Phase 3 Clinical Trial

3 min read | November 01, 2024 07:22 AM GMT | By Team Kalkine Media

Highlights

  • Fundraising targets at least £8.5 million to fund a U.S. Phase 3 clinical trial for Ondine’s nasal photodisinfection technology.
  • A 36% increase in issued share capital is anticipated, with New Common Shares priced at 8.5 pence each.
  • Additional negotiations could secure US$4 million, potentially extending Ondine’s financial stability into Q2 2026.

Ondine Biomedical Inc. (LSE:OBI), a Canadian life sciences company, has unveiled a comprehensive fundraising initiative to secure no less than £8.5 million (C$15.3 million) from both new and existing shareholders. The fundraising will involve issuing common shares at 8.5 pence per share through a combination of a placing and subscription. This fundraising effort aims to fund a critical U.S. Phase 3 clinical study of the company’s nasal photodisinfection technology, branded as Steriwave® outside of the United States.

Details of the Fundraising and Director Participation
The proposed issuance will see at least 100 million New Common Shares offered, representing approximately 36% of Ondine’s current issued share capital. The share price represents a 1.5% premium over the 31 October closing price of 8.375 pence. The majority of Ondine’s directors, referred to as the "Participating Directors," plan to contribute approximately £0.21 million (C$0.38 million) as part of the subscription, subject to regulatory compliance under Canadian prospectus rules. These directors’ participation is structured as a related party transaction under AIM regulations.

Clinical Trial and Funding Utilization
The primary goal of the funds is to support the U.S. Phase 3 trial for Ondine’s nasal photodisinfection system, which will be conducted in collaboration with HCA Healthcare. The trial, set to begin patient recruitment by the end of 2024, will involve around 5,000 patients across 14 HCA hospital sites. The study will compare standard infection prevention methods against those supplemented with nasal photodisinfection, with early results expected in Autumn 2025.

Private Placement and Potential Investments
Alongside the main fundraising, Ondine announced a private placement disclosed on 24 September, expected to raise an additional C$5 million (approximately £2.8 million) by 8 November 2024. Combining the private placement with the main fundraising, Ondine aims to secure a total of at least £11.3 million (C$20.4 million), sufficient to complete the Phase 3 trial and support commercialization in approved markets, extending its cash runway into early H2 2025.

Moreover, Ondine is negotiating with a major U.S. healthcare group for an additional investment of up to US$4 million (£3.1 million). If successful, this investment would further extend the company's financial stability into early Q2 2026, covering anticipated Phase 3 results and a potential New Drug Application (NDA) submission. Should these talks not result in an agreement, Ondine’s Board will explore alternative funding routes.

Non-Underwritten Fundraising and Allocation
The allocation and final number of placing shares will be decided by RBC Capital Markets, Orana Corporate LLP, and Oberon Capital, in agreement with Ondine. Notably, the offering is non-pre-emptive and not underwritten, with results to be announced promptly.


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