Oxford Biodynamics PLC is a global biotechnology company leading the world in the study and commercialisation of Epigenetics, the 3D analysis of the genome. The company is listed on the AIM market and has a market cap of £25m.
Following the publication of the half year results on 30 May, CEO Jon Burrows and Chair Matthew Wakefield, gave an update on corporate performance, the company strategy and the opportunities ahead. A recording of the webinar is available here.
Oxford Biodynamics was founded in 2007 and listed on the AIM market in 2016. The company is the global leader in 3D Genomics and is developing diagnostic blood tests for large addressable healthcare markets. The flagship Checkpoint Inhibitor Response Test (CiRT) was launched in early 2022, has had considerable early sales success and the company plans to launch a Prostate Specific Episwitch (PSE) test for the diagnosis of prostate cancer by the end of 2023. Progress has also been made in the validation of an ALS (Motor Neurone Disease) test in clinical trials.
Oxford Biodynamics success and future potential is based around its leadership position in 3D genomics, where the regulation of genotype and epigenetics intersect, and where they have developed a world leading understanding of the 3D structure of the genome. This knowledge is protected by 18 patent families and is enabling precision blood tests for the detection of life-changing diseases. Industry recognition has come in OBD’s membership of the National Institute of Healthcare (NIH) Biomarker Steering Committee (OBD is the only diagnostic company represented) and from the award of 2 PACT grants to help develop the Episwitch platform as the industry standard for 3D genomics. OBD already has the largest curated 3D genomics database and has worked on 10,000+ samples across 30+ diseases.
Getting to the personalised tests that can be commercialised and sold into the market involves a four step process which has taken 10 years to build and the last 3 years to fine tune. 1) The 3D genome has been mapped and the 1.2m critical regulatory anchor points recorded; 2) A custom chip based on Agilent array technology was built which interrogates the 3D genome and enables it to be profiled; 3) Data is fed into a database to create the world largest 3D genomics database; and 4) diagnostic tests are built that can be applied precisely to different diseases. From blood sampling to clinical reports can take 3 days, a great benefit to doctors and patients to have such a fast-turnaround blood test.
In addition to the CiRT which was launched in early 2022 there are 5 other tests currently in development. The PSE test for prostate cancer, the next test to be launched, will come to market in the US and UK before the end of the year. After this follow tests for ALS, Colorectal/bowel cancer, , Rheumatoid Arthritis and veterinary medicine. Following these five tests are a large pipeline of further blood tests that cover a wide range of medical areas and large addressable markets.
Commercial progress has been led by CiRT which has seen steady growth in orders and this momentum has continued as we move through 2023. The test tells oncologists which patients will respond to checkpoint inhibitors. It is fast, accurate and easy to order. The first 100 orders took 9 months from launch; the second 100 orders took about 4.5 months and the latest 100 orders have taken less than 3 months. A record 51 tests were sold in April and they are on track for another strong month in May. Initial sales took time as this was a new market which needed educating about the CiRT. There are now 30 doctors regularly ordering tests. A single sales representative has built credibility and “early adopter” doctors have grown their understanding of the benefits as they have used the test with their patients. There are now 4 sales representatives covering the US with a focus on the Eastern seaboard.
With over 300 tests ordered, OBD is now activating the next stage of the sales channel which is leveraging peer to peer sales. Here an oncologist using the CiRT invites 6-10 of their network to hear more about the test. Representatives from OBD educate about the science and the doctor presents 3 or more case studies of how using the test has benefitted their patients. Three of these peer to peer events have now taken place and many more are planned as more doctors use and gain understanding of the benefits of the CiRT. This is a well proven pharmaceutical growth strategy as one doctor can influence many more of their peers and the company is confident this will have a positive impact on CiRT sales going forward. Insurance reimbursements for these tests are being received within a range of $2,000 to $2,500.
The PSE test for prostate cancer is the next test to be launched and has the potential to make a significant impact on patient health and be a major revenue generator for the company. Initial research was carried out as part of the Prostagram trial over a four year period which is seeking to find better diagnosis and treatment of prostate cancer in conjunction with Imperial College London and the University of East Anglia. The study results were peer reviewed in “Cancers”, an open access journal of oncology, and published in February 2023. OBD’s PSE Test for prostate cancer was found to have Positive Predictive Value of 0.93 and a Negative Predictive Value of 0.95. These results are substantially better than the existing widely used PSA test which has a Positive Predictive Value of only 0.14 and a Negative Predictive Value of 0.93. In practice this means that for those taking the PSA and getting a positive result, for 86% of them the diagnosis is incorrect. OBD’s test saves men and their families the worry of an intrusive biopsy and saves the healthcare system a considerable amount of money.
The publication of this peer reviewed paper led to a huge amount of interest from physicians and hospital groups wanting to use the test. Plans are currently underway to launch the test in the US and UK by the end of the year. Laboratory space in the US has been leased, equipment has been installed, staff hired and the necessary tech transfer has begun. The process to have the lab CLIA certified has also started and is on track to be up and running by the end of the year. Work has also started on obtaining a unique CPT/PLA code for reimbursement by payor groups and OBD expect to receive this relatively quickly. The test does not need FDA approval for launch as this is diagnostic test.
The PSE test is a great test to launch because it will be selling into a large and well understood market. There are 25m PSA tests conducted in the US every year and 25% of them are sent forward for intrusive follow up work. That’s a huge number of expensive MRI scans and biopsies, with 86% of them completely unnecessary. OBD are targeting a minimum market share of 1% (250,000 tests) and believe the economic value of each test is in excess of $400, which if achieved would equate to revenue of $100m per year. The test has already generated a lot of interest from prospective users and sales will initially be generated through 2 established clinician channels and 1 hospital network channel in the US. With such a significantly more accurate test the question might be why wouldn’t this be the standard of care across the whole industry? In addition there are 11m men in the UK aged between 50 and 80 who need a PSE test. This is without doubt a very large market and revenues from the PSE test are potentially transformational for the company.
OBD also has a test for ALS which they are developing as part of a study carried out by Massachusetts General Hospital and Mitsubishi Tanabe Pharma. The test has been validated in a clinical trial and the appropriate next steps for commercialisation are being considered.
At the end of March the company reported net cash of £3.6m. Post that date they have announced the award of a PACT grant of close to £1m and that they received an R&D tax credit of £0.9m in April.
In summary there is a lot going on at Oxford Biodynamics, spearheaded by the accelerating sales of CiRT and the launch of the PSE test for Prostate Cancer later this year. Management is very upbeat about prospects and its easy to understand why.
A recording of the webinar is available here.