The US Healthcare market is the largest in the world and within this the cancer diagnostics market is estimated at USD 56.5bn in 2022 and expected to grow at a compound annual growth rate (CAGR) of 8.4% until 2030 (Source; Precedence Research).
Early detection and good treatment are considered critical in the fight against cancer. Against this backdrop, Oxford BioDynamics PLC, has the potential to be a huge success over the coming years. This week they announced a £5.6m placing and up to a further £2m raise through a PrimaryBid offer open until 4.30pm on Thursday 3 August.
Taking a step back, Oxford BioDynamics was founded in 2007 as a spin-out from the University of Oxford by a team including its Chief Scientific Officer Dr Alexandre (“Sasha”) Akoulitchev. Oxford BioDynamics is a global leader in the field of 3D genomics, interrogating the 3D structure of the genome to reveal critical health information. The genome’s 3D architecture is as important as the genetic code it contains: it is key to the regulation (turning on and off) of genes.
Building on over 16 years of research, Oxford BioDynamics is now successfully commercializing their world-leading understanding of 3D genomics, using their proprietary automated fast turnaround blood testing technology platform, EpiSwitch®, to develop and launch validated, commercial, smart clinical tests. The technology is fully developed and protected by 18 patent families. Tests developed using EpiSwitch can be used for prediction of response to therapy, patient prognosis, disease diagnosis and disease monitoring. There is a more detailed explanation with some great videos on the Oxford Biodynamics website here.
The company strategy is centred on the development and commercialisation of precision medicine tests for cancer and other life-changing diseases.
The company launched their flagship product, the EpiSwitch CiRT (Checkpoint Inhibitor Response Test) for cancer in February 2022 and their next commercial product will be the Prostate Screening Episwitch (PSE) test for prostate cancer, which is planned to be launched in Q4 2023. The most likely next tests to follow these are a diagnostic test for the early detection of colorectal cancer and, in veterinary medicine, a diagnostic/prognostic test for various canine cancers. All of these have large potential end markets.
The EpiSwitch CiRT, which predicts a patient’s likely response to immune checkpoint inhibitor (ICI) therapies, offers significant potential benefits to patients, doctors and healthcare payors alike. ICIs are a relatively new class of drugs that work by “taking the brakes off” the body’s immune system to allow it to find and kill cancer cells. ICI therapy can have striking results, but only about one-third of patients typically show positive response and many will experience significant side effects whilst on these expensive treatment regimes. It is estimated that over $10bn is spent annually on ineffective ICI therapy in the US alone, so improving the effective use of ICI’s could save significant sums. The test has demonstrated best-in-class performance in the prediction of cancer patient response to ICIs, with high sensitivity (93%), specificity (82%), and accuracy (85%) across the most widely used ICIs from multiple pharmaceutical companies, in 15 key oncological indications.
CiRT orders from US oncologists have shown positive growth since its launch in February 2022. As shown on the chart below, the first 100 CiRT orders took around 9 months, with successive 100-test milestones reached after a further 4.5 months, less than 3 months and just over 1 month. In June 2023, CiRT orders reached an average of over 4 per day, taking the total to almost 100 orders in a month. The test has a unique CPT-PLA code, allowing for reimbursement by US insurers. The average amount reimbursed under this code to date is over $2400, against a list price of $4,950. During 2023, more than 45 doctors have ordered the CiRT. There are estimated to be 13,416 oncologists in the US (2021 ASCO snapshot) and if only 1% of them ordered 2 tests a week, revenues of $25m+ could be achieved per year.
The PSE test which is expected to launch in Q4 of 2023 will be aimed at larger addressable markets than CiRT and could therefore generate significantly higher revenues, even at a lower average selling price. PSE is a simple blood test that combines the widely used prostate specific antigen (PSA) test with an EpiSwitch prostate cancer classifier developed by the Company. Positive results from PSA tests are known to be unreliable, with a positive predictive value in some studies as low as 14-25% (meaning 3 in 4 men with a raised PSA level will not have cancer). This results in many men without prostate cancer being referred for expensive follow-on screening, including invasive biopsies that often lead to complications. In stark contrast, in data from the PROSTAGRAM NHS study published in the journal Cancers, PSE demonstrated a positive predictive value of 93% and overall accuracy of 94%. Following publication of the PROSTAGRAM study results the company experienced an unprecedented level of interest in the test and decided to expedite final product development and validation work in order to launch PSE as a commercial test this year. Already they have set up a clinical lab in the US which has been successfully registered under the Clinical Laboratory Improvements Act (CLIA). Staff have been trained, tech transfer has been completed and an application made for a CPT-PLA payor code for the test has been filed.
In the US there are approximately 47 million men aged between 50 and 74, with 25 million PSA tests performed annually (2021 figures). There are approximately 10 million men in the same age bracket in the UK. OBD believe the test has significant value. Pricing is yet to be determined, but at $400 (which is not thought unreasonable), eventually achieving volumes of 1% of the PSA tests currently performed in the US each year could generate revenues of the order of $100 for the company.
The recent fundraise will provide the working capital to support the continued development of the EpiSwitch product line starting with the already launched CiRT and the soon to be launched PSE test. Achieving small market shares in both of these tests will generate revenues many times the size of the current market cap of Oxford BioDynamics. Beyond these two tests there is a pipeline of deployable tests for other large addressable markets, including colorectal cancer and canine cancer as referenced above. This fundraise could provide the springboard for the next phase of growth.