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ONDINE BIOMEDICAL INC. AIM: OBI LANTERN Phase 3 Positive Topline Results Investor & Analyst Webcast | 10 Sept 2026
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IMPORTANT NOTICE Disclaimer & Investigational Status The information contained in this presentation is being supplied and communicated to you solely for your information and may not be reproduced, further distributed to any other person or published, in whole or in part, for any purpose . All financial figures presented in Canadian dollars, unless otherwise noted . The distribution of this presentation in certain jurisdictions may be restricted by law, and persons into whose possession this presentation comes should inform themselves about, and observe, any such restrictions . Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, the contents of this presentation have not been verified by Ondine Biomedical Inc . (the “Company”) or any other person . Accordingly no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information and opinions contained in this presentation and no reliance should be placed on such information or opinions . None of the Company, or any of its respective members, directors, officers or employees nor any other person accepts any liability whatsoever for any loss howsoever arising from any use of such information or opinions or otherwise arising in connection with this presentation . No part of this presentation, or the fact of its distribution, should form the basis of or be relied upon in connection with any contract or commitment or investment decision whatsoever . This presentation does not form part of any offer of securities, or constitute a solicitation of any offer to purchase or subscribe for securities or an inducement to enter into any investment activity . Recipients of this presentation are not to construe its contents, or any prior or subsequent communications from or with the Company or its representatives as investment, legal or tax advice . In addition, this presentation does not purport to be all - inclusive or to contain all of the information that may be required to make a full analysis of any transaction . Further, the information in this presentation is not complete and may be changed . Recipients of this presentation should each make their own independent evaluation of the information and of the relevance and adequacy of the information in this document and should make such other investigations as they deem necessary . By participating in this presentation and/or accepting any copies hereof you agree to be bound by the foregoing restrictions and the other terms of this disclaimer . Forward - Looking Statements This presentation contains forward - looking statements, including regarding LANTERN’s full data analysis, regulatory submissions and timing, and Ondine’s commercial plans, which are subject to risks and uncertainties that could cause actual results to differ materially. Investigational Product – Not Approved in the U.S. Ondine’s nasal photodisinfection technology is not approved by FDA and is not commercially available for sale in the United States. In the United States, it is limited by federal law to investigational use only. Topline / Preliminary Data Results presented today are topline findings from a preliminary analysis of LANTERN. The Company's full analysis is ongoing; final results, once available, may differ from the topline findings presented. No Promotion This presentation is intended solely to inform existing and prospective shareholders, analysts, and the investment community of study results. It is not intended to promote the sale or use of an unapproved product.
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OVERVIEW Ondine Biomedical & the case for non-antibiotic SSI prevention 300M+ surgical procedures performed globally each year 1 Rising antimicrobial resistance is increasing the need for practical, non-antibiotic infection- prevention strategies. Patented, broad - spectrum light - activated antimicrobial Clinical use today in Canada, Europe & Mexico Pre - surgical nasal treatment designed to reduce microbial burden without antibiotics QIDP designation + Fast Track status for SSI prevention 35M+ major surgeries performed annually in the U.S. 2 Sources: 1BIS Research, Global Surgical Procedure Volume Database, 2024. 2LSI, U.S. Surgical Procedure Volumes (SPV) Database, 2025.
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Two simple steps at the point of care… NASAL PHOTODISINFECTION Five minutes. Clinician controlled. No antibiotics 1 APPLY Formulation binds to microbes 2 ACTIVATE Red light triggers antimicrobial action 3 RAPID EFFECT Immediate broad-spectrum microbial reduction MRSA Aspergillus fumigatus Candida auris + = Representative in vitro examples Investigational product, not for use or sale in the U.S.
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STUDY DESIGN LANTERN: Large-scale Pivotal Phase 3 study 18 USA: 14 HCA Healthcare hospitals CAN: 4 hospitals 5,188 USA: 4,787 patients enrolled CAN: 401 patients enrolled Cluster - randomised, standard - of - care - controlled crossover design Hospital Group A Hospital Group B Standard of Care (SoC) Nasal Photodisinfection + SoC Standard of Care (SoC) Nasal Photodisinfection + SoC Period 1 Period 2 SoC included permitting nasal mupirocin
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Preoperative ASA Score 26.3% 48.9% 16.0% 6.4% Procedure Category 38.1% 19.1% 5.3% ASA 1 121 2.3% ASA 2 1,398 26.3% ASA 3 2,604 48.9% ASA 4 853 16.0% ASA 5 4 0.1% Unclassified 342 6.4 % 15.6% 7.7% 6.7% Ortho 2,028 38.1% Cardiac 1,014 19.1% Neuro 831 15.6% Breast 412 7.7% Spine 359 6.7% Other 345 6.5 % Vascular 174 3.3 % General 152 2.9 % Clean trauma 7 0.1 % 2.3% STUDY DESIGN Total intent - to - treat (ITT) population ASA score is a standard preoperative rating of overall patient health; higher scores indicate greater illness and surgical risk: 1 = healthy vs. 5 = critically ill.
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Distribution of Procedure Lengths STUDY DESIGN Total ITT population
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Primary Efficacy Endpoint Rate of surgical site infections (SSIs) compared to standard of care alone within 30 days post - surgery. STUDY DESIGN Primary outcomes Safety Profile Percentage of participants with treatment - related adverse events within 30 days after surgery. EFFICACY SAFETY
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Ideal for sparse outcomes in a heterogenous background population Incorporates prior data from substantial evidence base (250,000+ prior patient-treatments outside U.S.) Consistent with evolving FDA guidance on the use of Bayesian methodology in clinical trials Fully pre - specified approach including operating characteristics per FDA guidance STATISTICAL APPROACH Pre - specified Bayesian analysis Prior evidence Current trial data + Posterior probability Estimates the likelihood that a real treatment benefit exists Combines trial data with pre - specified prior evidence. FDA Draft Guidance issued Jan. 2026: www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products
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TOPLINE RESULTS Primary efficacy endpoint met Topline findings from the pre-specified primary efficacy analysis. Full study analysis is ongoing. 98.2 % 0 100 59.5 0 25 50 75 100 100 0 25 50 75 100 Standard of care (SoC) alone Nasal photodisinfection + SoC 40.5% lower risk of 30 - day SSI Posterior probability of reduced 30 - day SSI risk Posterior probability that nasal photodisinfection reduced 30 - day SSI risk vs. standard of care alone 1.8% 30 - day SSI risk (relative to standard of care) Relative 30-day SSI risk (SoC = 100)
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All three supportive frequentist analyses reached conventional statistical significance and were consistent with the primary Bayesian result TOPLINE RESULTS Exploratory frequentist analyses 0 0.2 0.4 0.6 0.8 1 1.2 Mixed - effects logistic model Firth penalized logistic regression Generalized estimating equations 1 2 3 0.465 0.475 0.465 Odds ratio (95% confidence interval) Odds ratio below 1.0 favours nasal photodisinfection + SoC p = 0.019 p = 0.016 p = 0.022 Topline findings. Full study analysis is ongoing. | P-value < 0.05 indicates statistical significance. 0.25 0.88 0.26 0.87 0.27 0.82
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Consistent with more than a decade and 250,000+ patient-treatments of prior clinical experience Topline findings. Full study analysis is ongoing. TOPLINE RESULTS Safety profile consistent with prior clinical experience Only mild, transient treatment - related adverse events No treatment - related serious safety concerns identified
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REGULATORY PATHWAY From topline data to NDA submission Topline findings. Full study analysis is ongoing. 1 Complete Full Analysis 2 Share Results with FDA, P ublish & Present 3 Pre - NDA Meeting 4 NDA Submission
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BEYOND THE DATA Preparing for the next phase In the U.S., nasal photodisinfection remains investigational and is not approved, cleared, commercially available, or offered for sale. Manufacturing Scale - Up Expanding manufacturing capacity to support demand in approved markets and readiness for future regulatory milestones. Supply Chain Strengthening Building supply chain resilience to continued growth in approved markets and potential future U.S. requirements. Commercial Readiness Advancing operational capabilities to support future market access, subject to regulatory approval.
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Bringing the LANTERN Phase 3 study to a successful conclusion represents the culmination of years of hard work, scientific validation, and dedicated clinical execution. The LANTERN trial findings mirror clinical observations over a decade of real-world use outside the U.S., reinforcing our confidence in nasal photodisinfection as we prepare for upcoming pre-NDA discussions with the FDA. Topline findings. Full study analysis is ongoing. Carolyn Cross CEO
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Thank you for joining us