Investor Relations Newsletter

November 2023

Update from Billy

Since our last update in April, we have continued to make significant progress in our programs and I am excited to provide you with an update as we enter the final quarter of 2023.

Lung cancer has been an important area of focus for Owlstone Medical since its inception. With over 2.2 million new cases every year and 5-year survival rates at just 23.7% in the United States, the need for better tools for screening at-risk individuals remains acute. We are working hard to bring solutions to market to address this unmet clinical need: a screening test for the early detection of lung cancer and to differentiate benign from malignant lung nodules.

In June we attended the European Association of Cancer Research (EACR) meeting and presented results from Phase 1 of our EVOLUTION clinical trial in a poster. The data presented showed that our lead EVOC® probe had excellent safety and tolerability and demonstrated proof of mechanism by successfully measuring levels of D5-Ethanol in breath samples from lung cancer patients, including at very early stage. While the results are encouraging, we know that is no guarantee of success, and so we are also hard at work on a pipeline of alternate probes for lung cancer, one approach for which was also presented in poster form at EACR.

Phase 1 of EVOLUTION gave us the evidence we needed to proceed to Phase 2 of the study, which we have just initiated, and announced the recruitment of the first patient on October 5th. This phase will assess the diagnostic performance of the test in target patient groups and will enable refinement of the testing protocol. The study will recruit up to 150 cases and 200 controls from 3 sites in Europe and 6 sites in the U.K.

As was described last update we are working hard through OMED Health to transform how digestive disease is detected and addressed: we offer hydrogen/methane breath testing (HMBT) with interpretation in the UK, and have sent out over 14,500 kits since August 2021; we are developing a handheld device and app to enable patients and their doctors identify food-related and other triggers so that they can build a plan faster (our waitlist is rapidly growing and you can find it here); and through our Research Products and Services business we engage in projects in the gut microbiome to identify novel biomarkers related to digestive health.

On the OMED website we have published a number of blogs to help inform and educate on topics ranging from what is the gut microbiome, how breath testing can help those living with digestive conditions like IBS, and how SIBO can be treated. A list can be found further down in this newsletter, or you can explore on the website. We have also run two recent webinars in this area: Using Exhaled Breath to Analyze the Gut Microbiome, for which the recording is now available; and Proteomics and Metabolomics Symposium on October 11th. To learn more about the app associated with the OMED Health device, we have produced a video showing its design and functionality, and here is a video showing the device being paired with the app.

We have been attending conferences in digestive health to learn more and to engage directly with clinicians and potential partners, and to promote our current and upcoming offerings. These include Digestive Disease Week (DDW), the British Society of Gastroenterology (BSG), and the American College of Gastroenterology (ACG). At these events, in addition to exhibiting, we are presenting several posters related to hepatology and digestive health, including Gut Microbiome Phenotyping Using Dynamic Breath Analysis at ACG.

Beyond lung cancer and digestive disease, our strategy is to explore other areas of unmet clinical need through partnerships, engaging in paid-for product development and making select targeted investments only in areas that look particularly promising. As mentioned last update, our program to develop tests for the detection of liver cirrhosis and for the earlier detection of liver disease at NASH is an excellent example of this approach.

At the European Association for the Study of the Liver (EASL) meeting in June, we presented strong initial in-human trial results in a poster, which showed 83% sensitivity and 90% specificity (89% PPV, 84% NPV, 0.91 AUC) for the detection of cirrhosis using Limonene alone as an EVOC probe. The study also showed clear correlation between signal and disease severity, demonstrating the value of the approach as a tool for early-stage disease detection. This work has subsequently been published in the journal Biomedicines Special Issue “New Challenges in the Study of Liver Diseases: From Molecular Pathogenesis to Therapeutic Approaches 2.0”. We are now moving on to evaluate the impact of additional EVOC probes alongside limonene on test performance, in particular to confirm the ability to reliably detect earlier stages of liver disease.

Also in this area, we were very excited to announce in May that we had won an award from the U.S. Defense Innovation Unit (a division of the U.S. Department of Defense), to develop a handheld device capable of non-invasive detection of pre-symptomatic respiratory infectious disease. Owlstone is uniquely positioned to support this program as it incorporates our proprietary FAIMS technology, benefits from multiple studies in lung inflammation and bacterial and viral infectious disease (including COVID) we have performed with major pharma and academic partners through our Research Products and Services business, and builds on the work we have done to develop a handheld device for digestive health. The device will be developed over a two-year period, and if successful there is potential for a second phase to the project for further development of the device to the point of being ready for high-volume manufacturing by Owlstone.

Finally, the 2023 Breath Biopsy Conference took place online on 31st October-1st November. Sessions on the applications and advances in breath analysis, ask the expert sessions, poster presentations, and other content are all now available to watch on demand so please take a look!

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 publication of a peer-reviewed study in the journal Biomedicines – ‘Exogenous Volatile Organic Compound (EVOC®) Breath Testing Maximizes Classification Performance for Subjects with Cirrhosis and Reveals Signs of Portal Hypertension’. The results presented serve as proof of principle towards the development of a clinical test for the early detection of cirrhosis in primary care with at-home sample collection.

Owlstone announced recruitment of the first patient into its EVOLUTION Phase 2 clinical trial following successful achievement of key safety and proof of concept milestones in Phase 1. The trial has been designed to support development of a breath test to address the unmet clinical need for more effective early detection of lung cancer through the screening of high-risk asymptomatic individuals.

Owlstone presented new data on the development of novel tests for the detection of liver disease at the EASL Congress 2023, the annual meeting of the European Association for Study of the Liver. The poster ‘Dynamic Limonene Breath Testing Maximizes Classification Performance for Subjects with Cirrhosis’ described Owlstone’s research efforts to establish limonene as a non-invasive EVOC Probe for liver disease through a cross-sectional study run at the Facultad de Medicina Clínica Alemana Universidad del Desarrollo and Hospital Padre Hurtado, Santiago, Chile. 

Owlstone presented new data on the development of a screening test for the early detection of lung cancer at the EACR 2023 Congress, the annual meeting of the European Association for Cancer Research. The poster ‘Proof-of-mechanism study for a diagnostic probe compound generating D5-ethanol as an on-breath reporter molecule for lung cancer – Evolution phase 1’ described Owlstone’s efforts to establish D5-ethyl-β-glucuronide as a non-invasive EVOC® Probe for early cancer detection. The poster ‘Using exogenous volatile organic compound (EVOC) probes to target tumour-associated aldo-keto reductase activity: a potential tool to detect lung cancer’ described a complementary EVOC probe approach based on aldo-keto reductase (AKR) activity.

Owlstone announced that we had won an award from the U.S. Defense Innovation Unit (DIU), a division of the U.S. Department of Defense (DoD), for ‘Exhaled Breath Diagnostics’. The ‘EXHALE’ project, focused on the early detection of human infection using volatile organic compounds (VOCs) on breath, will develop a handheld device capable of non-invasive detection of pre-symptomatic respiratory infectious disease. The device, based on our FAIMS technology, will be developed over a two-year period supported by clinical studies to be performed at Duke University. If successful, there is potential for a second phase to develop the device to the point of being ready for high-volume manufacturing and global deployment.

Recent Blogs and Interviews.

As leaders in the breath research field, we know just how fast-paced this field can be, with many exciting advances made since our last edition. For this reason, we are delighted to announce that the fourth edition of The Breath Biopsy Guide is now available to download, where we explore the expanding applications of Breath Biopsy and highlight the new findings and innovations in breath research.

Breath is a complex medium that contains hundreds of volatile organic compounds (VOCs), primarily consisting of metabolites originating from a variety of physiological processes ongoing in the body. ReCIVA enables the simultaneous collection of replicate breath samples by directly capturing and pre-concentrating VOC biomarkers from breath onto multiple sorbent tubes. This allows for substantial enrichment of VOCs in breath, even those present in minimal quantities, by increasing the volume of breath collected.

The gut-liver axis refers to the bidirectional relationship between the gut microbiome and the liver. This relationship arises from the integration of signals produced by various factors such as diet, genetics, and the environment. Therefore, the gut microbiome plays an important role in the pathophysiology of many liver diseases.

It has been estimated that we take an average of 22,000 breaths daily (1), which equals about 11,000 liters of air leaving our body. Our breath is enriched with compounds that can originate from deeper in your body and the outside air in the environment around you. Biological processes within the body produce compounds that can be transported through the circulatory system. If these compounds are volatile – meaning that they are gaseous – they can launch from the blood vessel-rich alveolar membrane in the lungs and enter the air to be consequently breathed out.

Certain processes in the body produce volatile compounds which can diffuse away from their point of origin to the blood in nearby blood vessels. These volatile compounds are known as volatile organic compounds (VOCs) or volatile metabolites, and can be exhaled and detected in exhaled breath. Some gases are already measured in exhaled breath as part of diagnostic tests.

Breath contains many compounds of interest that can be used as biomarkers for clinical research and applications. It is specifically enriched for volatile organic compounds (VOCs) that can serve as biomarkers for a variety of potential clinical uses, including as diagnostic and monitoring metrics during clinical trials.

We have previously discussed why breath analysis can provide many unique advantages as a biological sample, what compounds can be found in the breath, and what processes they originate from, but how does breath analysis actually work? In this blog post, we will introduce how compounds in breath can be collected, analyzed, and measured for their use as biomarkers for clinical use.

Our introductory blog series has focused on why breath can be used as a unique biological sample for biomarker analysis, what compounds are found in the breath, what processes the volatile compounds originate from, and how they can be analyzed. The final blog in this series will run through three major case studies where breath biomarker analysis has been used, and where breath has the great potential to transform biomarker analysis. This will highlight what disease areas breath can be utilized within and give some scope to the breadth of potential applications of breath.

The gut-brain axis describes a bidirectional communication between the gut and the brain, bridging our cognition with the activity of the gastrointestinal tract through a complex network of pathways. As this link is bidirectional, the processes ongoing in the gut can also affect the brain, particularly the gut microbiome, coining the term “microbiota-gut-brain axis”.

Breath analysis has enormous potential to power microbiome research. For example, the microbiota in the gut produces volatile compounds such as short-chain fatty acids (SCFAs) that have an important role in health and disease. This lays the foundation for many potential research studies utilizing breath analysis of volatile metabolites to study the microbiome in many different contexts, in response to dietary changes, drug treatments, or in different disease contexts. 

The measurement of volatile organic compounds (VOCs) produced by metabolic activity in the body is a powerful approach for precision medicine and early detection across a wide variety of disease areas. But what is the definition of a VOC?

The gut-brain axis facilitates communication between the gut and the brain through a complex network of signaling molecules and pathways. Due to this intricate connection, it has the ability to influence various physiological processes, including digestion, metabolism, immune response, and mood. This has led to the suspicion that the gut-brain axis may play a role in these common diseases that have broad, but mostly unknown mechanisms behind them.

Cardiovascular and cardiometabolic diseases (CVMD) refer to a group of conditions affecting the heart, blood vessels, and metabolism, including diabetes, strokes, heart, liver, and kidney diseases. A growing body of literature highlights the potential mechanistic relationship between microbially-produced bioactive molecules and the development of CVMD. In this blog, we’ll discuss several microbially-derived molecules that may be implicated in CVMD pathophysiology and highlight how novel approaches, such as exploring the composition of exhaled breath, can support research into the relationship between CVMD and the gut microbiome.

Cancer is one of the most important global health issues. The discovery that the human body is colonized by microbial species of bacteria, fungi, and archaea has transformed how we think about the processes behind health and disease. This community of microbes – collectively referred to as the microbiota, or the microbiome – has been linked to the pathophysiology of many diseases including cancer, and therefore opens the door to a new category of potential biomarkers.

We were delighted to see an interview featuring Dr. Mariana Leal published with News Medical. Dr. Leal is a Lead Translational Scientist here at Owlstone Medical, and answered many questions about her role, and provided expert insight into our technology and upcoming projects.

We have also started producing a range of blogs related to digestive health through the OMED Health website:

Additional notable blogs:

All Owlstone Medical Blogs and Interviews can be found here.

Recent publications

A wide selection of Owlstone Medical papers, posters, case studies, and other resources can be found here.

Recent and upcoming events

All or our upcoming and recently past events can be found here.

Videos

Discover the OMED Health App

Breath Sampling with OMED Health

Breath Biopsy for Non-invasive Biomarkers

Owlstone Medical’s Breath Biopsy Laboratory

Owlstone Medical Mouthpiece Sampling Video

Breath Testing for Digestive Health with Functional Gut Diagnostics and Functional Gut Clinic

What happens after I purchase a breath testing kit?

Recent webinars

Notable mentions and other news

Media:

Awards:

All notable media mentions can be found here.

Additional selected website links

Investor Relations

About Owlstone Medical

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