Investor Relations Newsletter

August 2024

CEO Update

Having entered the third quarter of 2024, I am very pleased to report on the substantial progress we have made across our business since our last update.

This year we have several major goals including: to advance our clinical trials in lung cancer; commercial launch of products in digestive health and liver disease; and to deliver on our strategic partner contracts.

  • Development of a test for the screening of early-stage lung cancer continues to progress on schedule and phase 2 of the Evolution trial is well underway, which we expect to complete this year.
  • In digestive health the OMED Health Breath Analyzer, having demonstrated excellent performance in validation studies, is now available through a limited commercial launch. Broader launch will take place this year in the U.S. and UK, and feedback from KOLs and potential partners has been very encouraging. The device has been registered with the FDA as a Class 1 medical device and there is reimbursement for hydrogen/methane breath testing in place in the UK and U.S. 
  • Clinical data from the study evaluating our LIBRA® test for the detection of liver disease in cirrhotic patients has been excellent, outperforming blood tests. We are on track to launch LIBRA® in the UK for this application by the end of the year.

Following on from the announcement last year of our partnership with the U.S. Defense Innovation Unit (DIU) to develop a solution for the early detection of infection on breath through a handheld device, we were excited in April to announce another major partnership with the Bill and Melinda Gates Foundation. The Foundation is investing $6.5 million in Owlstone, $5 million in equity to support advancements of the Breath Biopsy® platform including expansion of the Breath Biopsy VOC Atlas database and development of a remote-use real-time breath analyzer for infectious disease (highly complementary to the work being done with DIU), and $1.5 million in grant funding to support the identification of breath biomarkers and to develop diagnostic approaches for low-cost detection of tuberculosis and HIV.

It is worth highlighting that the Atlas is emerging as a key strategic asset for the business. This unique database played an important role in securing both the DIU and Foundation partnerships and is of significant interest to the FDA as they seek to establish best practices for the identification of breath biomarkers in support of the development of portable diagnostic devices.

Thank you for your ongoing support and we look forward to sharing additional updates soon.

Billy Boyle

Co-Founder and CEO

P.S. I recently ran 7 marathons in 7 days in support of Street Child in memory of my wife Kate, who passed away in 2014 from late-stage colon cancer. If you would like to support this cause, any donation would be kindly welcomed.

Program details:

Lung Cancer

As part of our mission to be the global leader in the early detection of disease through breath, cancer in general and lung cancer in particular are diseases where there is a clear clinical need. Lung cancer is the most common cancer in the world. In 2020 there were an estimated 2.3 million cases with an 85% mortality rate. Lung cancer also has one of the lowest 5-year survival rates of all cancers, at just 23.7% in the U.S., however early diagnosis can greatly improve the clinical outlook. Patients diagnosed at an early stage have a 5-year survival rate of 56%, compared to just 5% for late stage.

To address this need, we are developing tests for the early detection of lung cancer through the screening of individuals at a high risk of developing the disease, and to differentiate benign from malignant lung nodules identified through medical imaging such as low-dose CT.

Highlights

  • Having successfully concluded Phase 1 of our Evolution trial for development of our lung cancer screening test last year, which demonstrated that the probe used is safe in humans and provided insights into dosing, we are now in Phase 2.
  • We are in the process of recruiting up to 150 patients with lung cancer and up to 100 controls from clinical sites located in the UK and in Europe. We will be recruiting and performing data analysis throughout 2024 and expect to have final results later this year, which will guide the next stage of our development plan.
  • The Evolution trial to date has delivered the probe intravenously, however when the final test is launched it is intended that the probe will be delivered in an inhaled formulation. Development has proceeded on schedule, and we expect to start the in-human trial in Q4.  
  • We have also started development of a low-cost and simple to use single-use breath collection device that will allow patients to capture breath samples at-home following administration of the inhaled probe.

Digestive Health

Approximately 1 billion people worldwide suffer from digestive issues and in the U.S. alone 42 million people suffer from Irritable Bowel Syndrome (IBS), up to 70% of whom have Small Intestine Bacterial Overgrowth (SIBO). Despite this, overlapping symptoms and a lack of good diagnostic options makes diagnosis challenging and so many patients suffer for years without a treatment plan to help them. Digestive disease is also the leading cause of work absenteeism. In fact, overall annual healthcare expenditures for gastrointestinal disease total $136 billion – more than for heart disease, trauma, or mental health.

Fortunately, breath provides hope of a solution. Owlstone, under the OMED Health brand, has offered hydrogen/methane breath testing since mid-2021, and over 120,000 samples from patients from 15 NHS hospital trusts and many private clinics have been analyzed.

Now, we are launching the OMED Health Breath Analyzer, a handheld and portable device for the routine measurement of hydrogen and methane on breath over time, with an associated app to review immediate results and record dietary, symptom, and other information.

Highlights

  • The device is now on market, with the first units having been sold through a controlled launch to a number of individuals on the waitlist (currently at over 11k interested), enabling us to get detailed feedback prior to broader launch.
  • The OMED Health Breath Analyzer app is available for download by the general public in the UK and U.S. via the Apple Appstore and Google PlayStore in the UK and U.S.
  • Validation data on the OMED Health Analyzer shows that our device offers performance comparable to gold-standard benchtop instruments at 1/100th of the price. We have published a poster that shows how the device and algorithm were developed along with validation data.
  • A major milestone has been reached with the device now registered with the FDA, allowing it to be sold in the U.S. as a Class 1 medical device. Similar IVD self-test classification in the UK is in progress with a target of Q4 2024.
  • Feedback from key opinion leaders in digestive health has been very encouraging and we are in discussion with potential partners in the U.S. and elsewhere.

Liver Disease

Metabolic dysfunction-associated steatohepatitis (MASH) is becoming incredibly common. An estimated 25% of the global population have metabolic dysfunction-associated steatotic liver disease (MASLD). Approximately 20% of these cases progress to MASH, and in an estimated 112 million people their disease has progressed to compensated cirrhosis. In England alone, liver disease kills over 10,000 people each year and has increased by nearly 20% between 2016 and 2021. A major challenge is that liver disease is often detected late. In cirrhosis, progression is often asymptomatic with 75% of diagnoses occurring in the emergency room when due to the advanced nature of the disease treatment options are limited.

Our focus is on developing a test for both MASH and Cirrhosis, named LIBRA® (Liver Breath Analysis). The test when applied to cirrhosis is intended to be used in primary care, with samples collected either at-home of in the clinic, where imaging is generally not available and where blood tests have poor performance. In MASH, the intended use of the test is to stage liver disease to support the effective deployment of new drugs now reaching the market.

Highlights

  • Data generated to date on the potential for a breath test utilizing a EVOC® probes to be able to detect cirrhosis early has been very strong.
  • We are looking to launch the LIBRA® test for clinical use for this application initially in the UK and are on track to do so by the end of 2024.

Recent Press Releases

  • Owlstone Medical Secures $6.5 Million to Support Development of Breath-based Diagnostics for Infectious Disease. The full release can be found here and a brief video discussing the release here.

Recent Media Mentions

All of our news and media mentions can be found here.

Recent publications

All of our publications can be found here.

Recent Blogs

All Owlstone blogs can be found here, and OMED Health blogs here.

Events

Major conferences members of our management team have attended this year or will be attending in the coming months:

Our recent and upcoming events can all be found here

Webinars

  • The webinar ‘Real-time, home-based analysis of microbiome metabolites with the OMED Health Breath Analyser’ was run on 16 July 2024 and is available to watch on demand
  • Owlstone ran a webinar on ‘Next-Gen Breath Analysis to Accelerate Biomarker Research’ on April 03, which is available to watch on demand
  • The webinar ‘Breath as a Biomarker Matrix: A Case Study in Liver Disease’ was run on 13 February  2024 and is available to watch on demand

All our webinars can be watched here.

Videos

Developing volatile metabolites from exhaled breath as a biomarker platform video published

Infectious Disease 101 promo video published

Detection of Clostridioides difficile infection with breath analysis video published

Changes in exhaled breath compounds following iron supplementation video published

Additional selected website links

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