REG - Ondine Biomedical - Ondine Biomedical Continues Growth in H1 2025

Ondine BiomedicalAnnouncement

26/09/2025 07:00

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RNS Number : 9074A  Ondine Biomedical Inc.  26 September 2025

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

Ondine Biomedical Continues Growth in H1 2025

 

Unaudited results for the six months to 30 June 2025

 

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial
therapies to prevent and treat hospital infections, is pleased to announce
continued commercial expansion and clinical progress in the first half of 2025
("H1 2025"). The Company invested significant time and resources into
strategic initiatives designed to drive long-term growth and value, including
advancing key clinical programmes, strengthening commercial channels, and
upgrading its product platform.

 

Financial figures throughout this interim report are in Canadian dollars
unless otherwise specified.

 

Operational Highlights

·    Commercial growth: Adoption of the Company's novel light-activated
antimicrobial, Steriwave(®), increased by 41% to 41 hospitals by the end of
H1 2025 (H1 2024: 29 Hospitals), including many of Canada's largest hospitals
and several NHS sites. Customer retention remained at 100%. Migration to the
second-generation, high-margin Steriwave Illuminator and Light Source was
completed across Canada, supporting further margin expansion. Distributor
channels were also strengthened, with partners such as Mölnlycke Health Care
and Kabla (Mexico) engaged in onboarding, training, and market development
activities to build momentum for future sales.

·     Growing Global Recognition: UK's First NHS hospital deployment
received global recognition for its 70% reduction in knee/hip arthroplasty
surgery infection reduction against another topical nasal antimicrobial agent.
On June 12, 2025, Mid Yorkshire Teaching NHS Trust was the recipient of the
International Photodynamic Association 2025 President's Award at the 18(th)
IPA World Congress in Shanghai China and was a Finalist in the prestigious HSJ
Patient Safety Innovation Award.

·     Clinical trial progress: Patient enrollment began at a single site
at the end of 2024 and expanded to 16 HCA Healthcare hospitals by the end of
H1 2025. This large, multi-center Phase 3 trial will dominate 2025
expenditures and is designed to support FDA submission for Steriwave and
represents a major milestone in bringing the Company's light-activated
antimicrobial technology to the U.S. market. Topline results are expected in
Spring 2026. In parallel, Steriwave is being evaluated in Europe, with a
clinical study at University Hospital Zurich, Switzerland's premier hospital,
to support regional validation and adoption.

·   Advancing into intensive care units (ICU): The first ICU-based Steriwave
trial was successfully completed at Royal Columbian Hospital in July 2025.
This is an important milestone for expanding Steriwave use into intensive care
settings where Steriwave has the potential to create significant impact. While
study results are expected to be available later this year, preliminary
indications are already shaping protocols in high-risk surgical specialties,
particularly cardiac surgery, where the mortality burden from post-surgical
infections can be as high as 15%. 1  (#_edn1) This trial seeks to demonstrate
Steriwave's ability to integrate into ICU workflow and highlights its
potential for broader clinical application in critical care. The Company
estimates that expansion into ICUs could represent a significant growth
opportunity.

·     Operational Progress: Ondine continues its strategic investment in
building the infrastructure necessary to support rapid growth and operational
excellence at scale. A key focus remains on talent planning and acquisition to
ensure the Company has the capacity, skills, leadership, and expertise
required for global expansion.

 

Financial Highlights

 

·      Revenue of $1.01 million, reflecting an 18% increase compared to
$0.86 million in H1 2024.

·   Gross margin at 65%, up 300 basis points from 62% in H1 2024, primarily
due to cost of materials reductions associated with our next generation
Steriwave illuminator.

·     Loss from operations of $12.5 million (H1 2024: $7.8 million) with
the increase reflecting costs associated with the U.S. clinical trial.

·     Cash and cash equivalents of $5.6 million as at 30 June 2025 (31
December 2024: $9.9 million).

·     Secured c.$5 million of capital in January 2025 and a further c.$19
million net proceeds from a fundraising post-period significantly
strengthening Ondine's financial position.

 

Chief Executive Officer's Statement

The first half of 2025 has been a period of important progress for Ondine
Biomedical. We advanced our largest clinical programme to date-the U.S. Phase
3 trial-while also completing the world's first ICU pilot of nasal
photodisinfection at Royal Columbian Hospital. These efforts, alongside data
collection from pilots and other clinical studies in leading hospitals in
Europe, the UK, Canada and Mexico, are helping to build the robust evidence
base required to establish Steriwave as a new standard in hospital infection
prevention.

Commercial adoption of Steriwave has continued to grow, with the technology
now in use across more than 40 hospitals and medical centres. Steriwave is
also being applied across a wide range of surgical specialties-including
neuro, cardiac, ENT, cosmetic, spinal, and orthopaedic procedures-reflecting
the breadth of its clinical utility. Looking ahead, the expansion we are
targeting from this foundation will require disciplined financial and
operational management. In support of our ambitious three-year sales growth
strategy, we are prudently building the organizational infrastructure,
processes, and talent necessary to enable sustainable growth and
profitability.

In addition to these operational and commercial efforts, we were proud to see
the Mid Yorkshire Hospitals NHS Trust recognized for its pioneering use of
Steriwave and resulting 70% reduction in surgical site infections compared
with a control group using a topical nasal antibiotic. The team received the
2025 IPA President's Award in Shanghai and was named a finalist in the 2025
HSJ Patient Safety Innovation Award in the UK. These honours recognize the
real-world clinical impact of our unique technology, especially in light of
the growing antimicrobial resistance crisis.

Looking ahead to the second half of 2025, our priorities include completing
enrollment in the U.S. Phase 3 trial, building on the results of the ICU
pilot, and supporting our distributors as they begin to introduce Steriwave
into new markets. We also remain focused on expanding our hospital footprint
in Canada while managing our resources carefully to ensure long-term
sustainability.

As a small, dedicated team, we have accomplished a great deal in the first
half of the year, strengthening our clinical, commercial, and operational
foundations. This continued progress would not be possible without the strong
support of our shareholders, team members, vendors, and hospital partners.
Together, we are generating the evidence and partnerships that will enable
Steriwave to deliver lasting value for patients, healthcare systems, and our
investors.

On behalf of the Board and the Ondine team, we extend our sincere gratitude to
all our stakeholders for their ongoing support of our efforts.

 

Investor Presentation

 

Ondine will be hosting a presentation to all existing and potential
shareholders today at 16:30 BST (08:30 Pacific time) held via the Investor
Meet Company platform. Questions can be submitted at any time during the
presentation.

 

Investors can sign up to Investor Meet Company for free and add to meet ONDINE
BIOMEDICAL INC. via:
https://www.investormeetcompany.com/ondine-biomedical-inc/register-investor
(https://www.investormeetcompany.com/ondine-biomedical-inc/register-investor)

 

Investors who already follow ONDINE BIOMEDICAL INC. on the Investor Meet
Company platform will automatically be invited.

 

 

A complete version of the interim report can be found here
http://www.rns-pdf.londonstockexchange.com/rns/9074A_1-2025-9-25.pdf
(http://www.rns-pdf.londonstockexchange.com/rns/9074A_1-2025-9-25.pdf)  and
is also being made available on the Company's website at:
 www.ondinebio.com/investors/reports-documentation/
(http://www.ondinebio.com/investors/reports-documentation/)

 

Enquiries:

 

 Ondine Biomedical Inc.                                           www.ondinebio.com
 Carolyn Cross, CEO                                               +1 604 669 0555

or via Vane Percy & Roberts
 Strand Hanson Limited (Nominated & Joint Financial Adviser)
 James Harris, Richard Johnson                                    +44 (0)20 7409 3494

 Peel Hunt LLP (Broker & Joint Financial Adviser)
 James Steel, Dr. Chris Golden                                    +44 (0)20 7418 8900

 Vane Percy & Roberts (Media Contact)
 Simon Vane Percy                                                 +44 (0)77 1000 5910

 

 

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader in
light-activated antimicrobial therapies ('photodisinfection') for the
prevention and treatment of infections, including those caused by
multidrug-resistant organisms. Ondine has a pipeline of investigational
products, based on its proprietary photodisinfection technology, in various
stages of development.

Ondine's nasal photodisinfection system is CE-marked in Europe and is approved
for nasal decolonisation in Canada, UK, Australia, Mexico, and several other
countries under the name Steriwave(®). In the US, it has been granted
Qualified Infectious Disease Product designation and Fast Track status by the
FDA and is currently undergoing clinical trials for regulatory approval.
Products beyond nasal photodisinfection include therapies for a variety of
medical indications such as chronic sinusitis, ventilator-associated
pneumonia, burns and other indications.

(#_ednref1)  1  Massart N, et al. Mortality due to hospital-acquired infection
after cardiac surgery. J Thorac Cardiovasc Surg. 2022;163(6):2131-2140.e3.
(link (doi:10.1016/j.jtcvs.2020.08.094) )

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