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Biotech Pharma Ondine Biomedical

Ondine Biomedical launches £10m placing to fund US regulatory push

by tickstock newsroom · Editor JMA

Ondine Biomedical (AIM:OBI) has launched a equity funding effort, to raise around £10 million (C$18.88 million) before expenses.

The AIM-listed company, which develops light-activated antimicrobial therapies to prevent hospital-acquired infections, is issuing new common shares at 10p each, a premium of roughly 3% to the 9.75p closing price on 29 September, the last trading day before shares entered the Capital Access Window.

The fundraising follows positive topline results from Ondine's Phase 3 pivotal LANTERN trial, announced last month, which reported an estimated 40% relative reduction in 30-day surgical site infections using Steriwave nasal photodisinfection versus standard care.

With the trial complete, the company said it is shifting from peak clinical trial spending toward commercial execution and regulatory submission.

Proceeds are earmarked across four areas: circa 35% for commercial expansion in markets where Steriwave is already authorised, including Canada, the UK, Europe and Mexico; circa 20% for US regulatory activities supporting a planned New Drug Application submission in mid-2027; circa 20% for production, operations and quality systems; and circa 25% for general and administrative costs, including strengthening the senior management team and board.

Ondine is targeting a pre-NDA meeting with the US Food and Drug Administration in the first quarter of 2027, building on the Qualified Infectious Disease Product and Fast Track designations it already holds, which carry an expedited six-month review goal.

Net proceeds are expected to extend the company's cash runway into early 2028, with research and development spending and operating losses forecast to narrow materially now that LANTERN trial costs have passed their peak.

The company plans to recruit a chief commercial officer and a permanent chief financial officer, alongside adding US market expertise to its board, as it ramps up commercial capability through the end of 2027.

Read more about Ondine Biomedical

Ondine added that its manufacturing infrastructure can absorb significant production increases through fuller use of existing capacity and additional shifts, without requiring new facilities, while a planned 2027 rollout of its in-house Formulation Applicator is expected to improve consumables margins.

And, it expects to need further funding for a US commercial launch, subject to FDA approval, and intends to pursue non-dilutive sources such as bank debt or partnering proceeds for that stage.

Chief executive Carolyn Cross intends to subscribe for roughly 10.59 million subscription shares for cash, contributing gross proceeds of approximately £1.06 million (C$2 million). Other directors have indicated they will take up a combined 1.14 million subscription shares at the issue price, settled against amounts the company owes them rather than new cash.

by tickstock newsroom