Investor Relations Newsletter
May 2023
Update from Billy
Last update, I covered our key strategic areas for the business. Now, following on from a successful 2022 where we made tremendous progress across the company, I wanted to share with you our goals for 2023 and progress thus far.
Owlstone Medical is developing two tests to address the unmet clinical needs in this area:
- A screening test for the early detection of lung cancer for asymptomatic people with a high risk of developing lung cancer (50 years+ of age, have smoked 20 years); and
- A test to differentiate benign from malignant lung nodules that have been identified through incidental findings or as a result of screening using LDCT where a relatively low specificity is leading to a large number of false positives.
To power these tests, Owlstone has pioneered the use of Exogenous VOC (EVOC®) Probes to investigate the onset, progression, and treatment of disease, with the Company’s lead EVOC Probe for the early detection of lung cancer now in clinical trials with promising early results. The first phase of our clinical trials (Evolution) is drawing to a close, and we plan to start our second phase very shortly, recruiting patients from clinical sites across the UK and in Europe. Our most recently published data can be seen in poster format and I hope to be able to share more on our progress later in the year.
As a source of additional EVOC probes for future development in oncology, we recently announced a Research Agreement with Bicycle Therapeutics plc to investigate the potential of developing antigen-targeted diagnostic probes that use bicyclic peptides as their targeting mechanism linked with Owlstone’s EVOC probes. Work will initially focus on lung cancer screening as the first proof of principle, but may be applied to other cancers in future.
The gut is the site of a wide range of illnesses including Irritable Bowel Syndrome (IBS), Small Intestine Bacterial Overgrowth (SIBO), carbohydrate malabsorption issues, Inflammatory Bowel Disease (IBD), and many others. Over 1 billion people worldwide suffer from digestive disease, however as symptoms overlap considerably diagnosis is challenging and many suffer for years without a clinical plan to help them.
Through our partnership with Functional Gut Diagnostics, Owlstone has been providing simple at-home hydrogen/methane breath test (HMBT) for small bacterial intestinal overgrowth (SIBO) and Food Intolerance testing in the U.K. for more than 18 months. Now with volumes and revenues from tests ordered by clinicians growing, we are broadening our reach by starting to offer HMBT testing directly to patients.
Supporting that effort, Owlstone recently press released and launched OMED Health, a dedicated, patient-centric brand and website to offer patients and clinicians access to breath-based diagnostic tests and resources for a range of conditions. While initially focused on digestive disease to help individuals with gut health issues enjoy an improved quality of life, OMED Health will eventually support other indications as well.
As part of the OMED Health offering, a portable breath analyzer that can monitor gut health over time is being developed. The device, along with a mobile app that allows viewing of results and tracking of symptoms and other potential triggers, will be available later in 2023, and a waitlist is now open.
In addition to the programs described above, Owlstone has a rich pipeline of opportunities in areas of significant unmet need that in themselves may not justify our sole investment to bring Breath Biopsy tests to market, but still present an opportunity for shared development and commercialization.
The source of these opportunities include internal market research, large customer-funded development partnerships, external in-licensing of existing well validated biomarkers, and in particular opportunities from our Research Products and Services (RPS) business. The RPS business has a substantial number of active customer paid-for service projects focused in the diagnostic space, covering a diverse range of areas including respiratory disease, cancer and infectious disease. Each of these has the potential to identify new intellectual property capable of being commercialized with external support. Of note, if these projects had been resourced by Owlstone alone, the total cost to the business would be in excess of $8.5 million.
Our strategy therefore is to leverage these customer-funded partnerships to explore whether we can identify biomarkers in that area, and if the market opportunity is sufficiently attractive, to make selective investments to advance these programs. Our liver program is a perfect example of this. Originally kick-started through an academic research project, certain chemicals with the potential to be used as probes to explore liver function were identified. This was encouraging enough for direct Owlstone investment, and now following promising early clinical trial results [press release/paper, poster] we are working to identify strategic partners to support further development of the test. Beyond liver we are working hard to enter into partnerships in other indications, which we expect to be able to share more on throughout the year.
Thank you for your ongoing support and we look forward to sharing additional updates soon.
Billy Boyle
Co-Founder and CEO
Key recent press releases and other news
Owlstone announced the launch of OMED Health, a dedicated, patient-centric brand and digital platform that will offer patients and clinicians access to breath-based diagnostic tests, point-of-care (PoC) devices and support resources for a range of conditions. Initially focused on digestive disease, OMED Health will help individuals with gut health issues have an improved quality of life by enabling better, and faster, understanding and management of their conditions.
Owlstone announced that it has entered into a Research Agreement with Bicycle Therapeutics plc (NASDAQ: BCYC, “Bicycle”), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology to develop antigen-targeted diagnostic probes that use bicyclic peptides as their targeting mechanism linked with Owlstone’s Exogenous Volatile Organic Compound (EVOC®) probes.
06 February 2023: Owlstone Medical Publishes Data on the Use of Exhaled Volatile Organic Compounds as Biomarkers for Liver Disease Detection
Owlstone announced the publication of a peer-reviewed study in the Journal of Clinical and Translational Hepatology, “Breath Biopsy to identify exhaled volatile organic compounds as biomarkers for liver cirrhosis detection”. The study identifies a set of volatile organic compounds (VOCs) that can identify patients with liver disease and separate them based on severity.
07 December 2022: Owlstone Medical Launches Breath Biopsy VOC Atlas
Owlstone announced the launch of the Breath Biopsy VOC Atlas, a catalogue of validated and quantitated volatile organic compounds (VOCs) found on breath. The Atlas provides insight and scientific context into these molecules, supporting biomarker discovery through incorporation into Owlstone’s Breath Biopsy OMNI® platform.
All Owlstone Medical press releases can be found here.
BBCon 2022: The Breath Biopsy Conference 2022 brought the global breath research community to discuss and celebrate the exciting progress being made around the world in our field. More than 600 people registered to join us from over 70 countries, building upon the success of previous year’s Breath Biopsy Conferences. Recordings of the presentations and the posters presented are on our website, and selected highlights can be found here.
Recent Blogs and Interviews
Top Breath Research Papers Published in 2022
The use of breath analysis in research is a rapidly advancing field, and 2022 brought with it some exciting papers. Now that we’ve reached the end of the year and are into 2023, we’ve curated a list to highlight some of the most important papers published last year that significantly advanced our knowledge of breath testing.
Introducing the Breath Biopsy VOC Atlas
There are over 1000 different volatile organic compounds (VOCs) found on the breath, however the variability of VOCs in a natural human population is not well described. Establishing the composition of normal breath is an essential foundational step toward improving breath biomarker research. To address this crucial need for improved biomarker discovery we have developed the Breath Biopsy VOC Atlas, the largest available dataset of validated VOCs on the breath, identified in a group of diverse, healthy volunteers.
Understanding Gut Health Through Breath and Fecal Headspace VOC Analysis
Many factors can impact the composition of the gut microbiome, and the loss of balance has been known to associate both directly and indirectly with various diseases, including but not limited to irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) and colorectal cancer. In the last decade, with the advancement of -omics data analysis, volatile organic compounds (VOCs) have received more interest as a novel, efficient and non-invasive method for disease diagnosis.
Breath Biopsy for Identification of VOC Biomarkers for Liver Cirrhosis
Lifestyle related factors have led to a rapid rise in the prevalence of liver diseases, with as many as 3 in 10 adults affected in some countries, alongside an increasing number of children. Early detection of liver diseases, such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and cirrhosis, remains a significant clinical challenge, however a non-invasive approach that can be offered as part of a screening program represents an ideal solution, and we are developing Breath Biopsy® to meet this need.
What is Breath Biopsy useful for?
Human breath is a rich source of biological information, capable of revealing general insights into a subjects’ overall health as well as specific indicators of disease onset and progression. While a few breath tests are in clinical use, many studies have demonstrated the potential to develop novel tests based on breath biomarkers for early detection, precision medicine and treatment monitoring in areas including respiratory, cardiovascular and digestive diseases, and cancer.
Unlock the secrets of the gut microbiome with breath testing
The last twenty years have seen significant growth in both breath research and research into the human microbiome. The recent overlap of these fields has been especially beneficial and has the potential to usher in a new era of personalized medicine. Much of the progress in breath research over recent years has focused on the identification of volatile organic compounds (VOCs) on exhaled breath.
Top breath research papers – as selected by the experts
At the Breath Biopsy Conference, the round table panel discussion is always one of the most popular sessions. Last year, on the 2nd of November, we asked our expert panellists about some of the biggest unanswered questions in breath research and enjoyed the resulting lively discussion, including some great contributions from the audience.
In vitro analysis could help you identify prospective VOC biomarkers
Analyzing VOCs produced by in vitro models of disease or drug response can demonstrate mechanistic links between disease biology and biomarker candidates. These can subsequently be verified in clinical studies sampling the same VOCs on breath, providing vital evidence that could bring diagnostic breath tests into clinical practice.
Breath Analysis for Non-Invasive Exposure Research
The World Health Organization reports that 1 in 4 global deaths are due to an unhealthy living or working environment and environmental risk factors. Discovering biomarkers that act as early indicators of hazardous exposures or pre-clinical signs of elevated disease risk could make it possible to move beyond diagnosis and treatment of exposure-related diseases into actual prediction and prevention of adverse outcomes. VOCs in breath include a number commonly related to hazardous exposure.
The potential role of VOCs in detecting and treating lung cancer
Lung cancer is the leading cause of cancer-related deaths, accounting for 12.9% of all new cancer cases in the United States, and outcomes are strongly linked to stage of diagnosis. Unfortunately, there are significant shortcomings in the current screening methods for early lung cancer detection. Breath testing is much more suited to early-stage testing than LDCT or an invasive tissue biopsy and Owlstone is working to develop a breath-screening test now.
Examining candidate breath biomarkers for kidney disease
Kidney disease, though common, is often diagnosed by routine blood or urine tests that a patient is undergoing for a different reason. Development of a non-invasive breath test could allow for cheaper screening and earlier intervention, when damage is less severe and treatment simpler. Recent studies have proposed a number of potential breath biomarkers that warrant further investigation.
Paul Brinkman on bringing breath tests into the home
We spoke to Paul Brinkman, Research Associate in the field of Pulmonology at the Amsterdam UMC. With a background in biomedical engineering, Paul’s been working on breathomics for over a decade.
Additional notable blogs:
Building consensus on breath tests for digestive diseases
Enhancing Biomarker Analysis with the Breath Biopsy HRAM Library
Your Questions Answered: Biomarker Analysis
Progressing from Biomarker Discovery to Breath Biopsy Tests
OMNI: Reproducible Non-invasive Global VOC Analysis of Breath
Designing Studies to Standardize Breath Biomarker Discovery
What is the Best Method for Breath Biomarker Discovery?
All Owlstone Medical Blogs and Interviews can be found here.
Recent publications
Key Owlstone-led publication in the Journal of Clinical and Translational Hepatology, which identifies a set of seven VOCs that can identify patients with liver disease and separate them based on severity, showing promise as a panel for liver disease detection and monitoring. This published results were generated through efforts under Owlstone’s liver test development program.
Paper: VOCs from Exhaled Breath for the Diagnosis of Hepatocellular Carcinoma
Study published in the Journal of Clinical and Translational Hepatology that demonstrates that alterations in breath VOCs can be used to differentially identify liver disease on breath. The study builds upon a previous Owlstone publication identifying limonene as a breath biomarker to measure liver function and stage liver disease and supports our development of breath-based diagnostic screening and staging tests for liver disease.
Paper published in Science Translational Medicine that collected (by ReCIVA®) and analyzed exhaled breath samples from 277 participants presenting acute cardiorespiratory exacerbations and demonstrated good diagnostic sensitivity and specificity using VOC biomarkers of acute cardiorespiratory disease.
Study in the Journal of Personalized Medicine that collected exhaled breath samples using ReCIVA on 5 consecutive days in 14 subjects with severe asthma who had undergone extensive clinical characterization. The research was able to demonstrate the short-term repeatability of breath samples in a severe asthma population and corroborate its sensitivity to airway inflammation.
Paper: A deep learning approach for detecting liver cirrhosis from volatolomic analysis of exhaled breath
Publication in Frontiers in Medicine that explored the diagnosis of liver cirrhosis from breath samples collected by ReCIVA and analyzed by FAIMS from 46 individuals, 35 with cirrhosis and 11 healthy controls. The study was able to demonstrate the ability to predict the presence of cirrhosis based on a full volatolomics profile of patient breath samples.
Poster: Breath-based detection of lung cancer using Exogenous Volatile Organic Compound targeting β-glucuronidase in the tumour microenvironment
Poster: Identifying and characterizing VOCs in exhaled breath from SARS-CoV-2 positive individuals
Poster: Changes in exhaled volatile organic compounds following iron supplementation in self-reported healthy adults
Poster: Using chemical ionisation in the identification of volatile organic compounds (VOCs) on breath
Poster: Targeting tumour-associated aldo-keto reductase activity with exogenous volatile organic compound (EVOC) Probes to detect lung cancer
Poster: Pre-clinical exogenous volatile organic compounds (EVOC®) Probes screening and optimization for chronic liver diseases detection
Recent Case Studies and White Papers
Case study: Identifying pathogens on breath via the lung microbiome
Ventilator associated pneumonia (VAP) is the most common secondary infection in critically ill hospitalized patients. Ideally, rapid identification of the actual strain would allow prescription of targeted anti-microbial therapy, however current techniques can be invasive and time consuming. Ahmed et al. have carried out a translational study attempting to compare and unify results from both in vitro and in vivo work in order establish strong prospective biomarkers of a number of pathogenic strains associated with VAP.
Case study: Is breath acetone too ubiquitous to be a good biomarker of heart failure?
Heart Failure (HF), as a consequence of cardiovascular disease, is the main cause of hospitalization in the USA, Europe and Japan. Biomarkers of cardiac disease have the potential to be of great benefit clinically, unfortunately biomarkers in clinical use require invasive procedures. A number of clinical studies have investigated breath biomarkers, specifically breath acetone, as one possible solution. Gouzi et al. conducted a meta-analysis of studies which have considered acetone as a potential biomarker of heart failure and summarized the findings.
White Paper: Breath Biopsy® OMNI®: Data Normalization Project
This whitepaper explores one of the key analytical processes underpinning Breath Biopsy OMNI, the most advanced service for global breath VOC analysis.
A wide selection of Owlstone Medical papers, posters, case studies, and other resources can be found here.
Recent and upcoming events
ERS International Congress, Sept 4-6
BMSS, Sept 13-15
Early Detection of Cancer Conference 2022, Oct 18-20
Jefferies London Healthcare Conference, Nov 15-17
J.P. Morgan Health Care Conference, Jan 9-12
5th Markets and Markets Next Gen Microbiome and Probiotics Conference, Feb 8-9
Biomarkers UK, Feb 27-28
Pittcon, Mar 20-22
AACR, Apr 14-19
Digestive Disease Week, May 6-9
ATS 2023, May 19-23
ASMS 2023, Jun 4-8
EACR 2023, Jun 12-15
All or our upcoming and recently past events can be found here.
Videos
Breath Biopsy for Non-invasive Biomarkers
Owlstone Medical’s Breath Biopsy Laboratory
Owlstone Medical’s digestive health Breath Biopsy tests feature on BBC News
Owlstone Medical Mouthpiece Sampling Video
Breath Testing for Digestive Health with Functional Gut Diagnostics and Functional Gut Clinic
Recent webinars
Webinar: Non-invasive Functional Assessment of the Microbiome from Exhaled Breath
A webinar introducing breath biomarkers originating from the microbiome, and Breath Biopsy technology and its capabilities. A recording is available for viewing.
Webinar: Breath Biopsy® OMNI® for comprehensive and reliable detection of VOC biomarkers in breath
A webinar introducing breath biomarkers, and Breath Biopsy technology and its capabilities. A recording is available for viewing.
Webinar: Identifying Translational Biomarkers for Diagnostics and Drug Development using Breath Biopsy In Vitro Headspace Analysis. A webinar highlighting the use of translational biomarkers for diagnostics and drug development. A recording is available for viewing.
Notable media mentions and other news
Media:
Drug Discovery News, Don’t Hold Your Breath (9 Mar 2023)
Frontline Genomics, Liquid Biopsy – A Non-Invasive Approach To Health And Disease (31 Jan 2023)
Cambridge Independent, How Owlstone’s HR rolled out an award-winning suite of enterprise skills on Cambridge Science Park (cambridgeindependent.co.uk) (3 Nov 2022)
Cambridge Independent, Billy Boyle celebrates the teamwork at the heart of Owlstone Medical’s success (cambridgeindependent.co.uk) (7 Nov 2022)
Awards:
Finalist for Employer of the Year, 2023 Cambridge Independent Science and Technology Awards
Shortlisted as a finalist for the Medtech of the Year in the European Lifestars Awards
Winner of the Enterprise Skills Award at the Cambridge Independent Science and Technology Awards 2022
All notable media mentions can be found here.