REG - Oxford BioDynamics - Commercial update for FY24

Oxford BiodynamicsAnnouncement

14/10/2024 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241014:nRSN9695Ha&default-theme=true

RNS Number : 9695H  Oxford BioDynamics PLC  14 October 2024

Oxford BioDynamics
("OBD" or the "Company" and, together with its subsidiaries, the "Group")

 

Commercial update on financial year ended 30 September 2024

Growth in test sales over the year, new sales model initiated and resources
focused on PSE. Business restructured to maximise runway, with a material
reduction in costs.

Oxford, UK - 14 October 2024 - Oxford BioDynamics, Plc (AIM: OBD, the
Company), a precision clinical diagnostics company bringing specific and
sensitive tests to the practice of medicine based on OBD's EpiSwitch® 3D
genomics platform today issues a commercial update following its financial
year ended 30 September 2024. The Company has also commenced steps to reduce
the cost base and maximise the cash runway through a comprehensive review of
the strategic options open to the Company.

EpiSwitch® CiRT

CiRT orders in the second half of the financial year were 25% increased on the
first half. The final financial quarter ended with 95 tests for September,
bringing the total number of tests ordered since launch to 1,266. A total of
671 tests were ordered in the financial year.

Following the launch of the PROWES Registry Study - a prospective
observational study - at up to 12 sites across the US, with up to 2,500
patients to expedite the inclusion of CiRT into the National Comprehensive
Cancer Network (NCCN) Guidelines - three regional study sites have been
onboarded to date. CiRT tests carried out in the study are being run on normal
commercial terms through our CLIA-accredited labs.

By the end of August, it was evident that the majority of CiRT orders were now
coming through the PROWES initiative and that the CiRT test would need to be
included in NCCN Guidelines before we could expect significant traction from
oncologists. Consequently, the Company has been able to reallocate its field
sales resources to growing orders for the PSE test, without increasing the
cost base.

In the next financial year, the main focus of the Group's CiRT team will be on
completion of patient enrolment into PROWES, alongside continuing to support
those oncologists already using the test in their day-to-day practice.

The Group will also shortly begin running CiRT tests on blood samples from
patients enrolled in a clinical trial of an immune checkpoint inhibitor in
endometrial cancer, for a top 10 pharma company.

EpiSwitch® PSE

PSE has grown steadily with orders in the second half of the year increased by
86% to 483 tests (H1: 259 tests) and more than 90 tests ordered in each month
in the last quarter to the end of September. Total tests ordered since launch
to the end of the financial year were 747. The recent redeployment of sales
resources from the CiRT vertical to the PSE vertical has increased the number
of salespersons dedicated to PSE five-fold, without increasing costs.
Retraining of sales staff began in the first week of September, with the
expanded and newly focused PSE sales team deployed in the field in the first
week of October.

Compared to CiRT, PSE has a much lower barrier to entry, because it already
fits the American Urological Association (AUA)/NCCN guideline definition for
prostate cancer screening. The expanded team, led by Dr Steve Arrivo, will
focus on building on the traction gained so far for PSE in the concierge
medicine space. Concierge practitioners are entrepreneurial, focused on
patient outcomes and able to embrace innovation. Sales to such clinics are
typically on a cash-pay basis. There are approximately 2,000 concierge clinics
in the US which converts to an addressable market for this segment of circa
150,000 cash-pay tests per annum.

In addition, we have been reimbursed for PSE tests under our existing CPT/PLA
code (0433U) by several US insurers including Humana, UHC, Medicare and Optum
Health. In the UK, sales of the test have come through the Company's
partnership with the Goodbody Clinic and from private clinics such as The
London Clinic.

PSE has received a high level of attention within the industry because of its
accuracy and ease of use. This has led to ongoing discussions with two of the
leading diagnostic services companies in the US for a distribution deal that
would widen access to the test and have the potential to add significant
volume.

Strategy and funding

The Board acknowledges that access to capital in the UK market is limited and
the burn rate of the Company has been high in order to get to its current
position. In this context, the Board and management recognises the need to
maximise the Company's cash runway, both in the short and longer term, and is
initiating a series of cost-saving actions that will materially reduce the
business's monthly cash cost base, whilst maintaining support for both CiRT
and PSE as set out above.

The management team remains wholly confident in the inherent value of the
Company's test products and its EpiSwitch platform and therefore, as part of
these plans, directors, PDMRs and certain other senior staff have agreed to
take 25% of their net pay in newly issued shares for the foreseeable future.
Chief Executive Officer, Dr Jon Burrows will take 35% of his net pay in newly
issued shares.

Notwithstanding the measures being taken to reduce the cost base, the Company
will require additional cash resources by early Q1 of 2025. The Board has
therefore launched a comprehensive review of the strategic options open to the
Company. In addition to exploring available funding options, the review will
consider a range of potential actions, including but not limited to a
licensing or sale of Company assets - such as the EpiSwitch NST and EpiSwitch
SCB tests - and a possible hive-off of the Company's US business into a
separately funded entity. Currently, the strategic review does not envisage an
offer for the Company under the City Code of Takeovers and Mergers. A further
announcement regarding the outcome of the review will be provided in due
course.

The Company expects to publish preliminary results for the year ended 30
September 2024 in January 2025, following the financial audit. A further
commercial update on the first quarter of the 2025 financial year will be
provided at that time.

-Ends-

For more information:

 Oxford BioDynamics Plc                  +44 (0)1865 518910

 Jon Burrows, CEO

 Paul Stockdale, CFO

 Shore Capital                           +44 (0)20 7408 4090

(Nominated Adviser and Broker to OBD)

 Stephane Auton

 Lucy Bowden

 WG Partners                             +44 (0)20 3705 9330

 (Joint Broker to OBD)

 David Wilson / Claes Spång /

Satheesh Nadarajah / Erland Sternby

 Vigo Consulting                         +44 (0)20 7390 0230
 (Media / Analyst enquiries for OBD)

Rozi Morris                            obd@vigoconsulting.com

 

Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is an international biotechnology company,
advancing personalized healthcare by developing and commercializing precision
clinical diagnostic tests for life-changing diseases.

Currently OBD has two commercially available products: the EpiSwitch® PSE
(https://url.avanan.click/v2/___http:/www.94percent.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjphZTRmOjE1ZmE3ZTA1NmFmMzlmYjIzZmFhOGU1NTc5MWI0OTdiODZmMjVmOTFlOWQ2YjBiZTM3YmNmMTMxMGYxOTcxMjI6cDpU)
(EpiSwitch Prostate Screening test) and EpiSwitch® CiRT
(https://url.avanan.click/v2/___https:/www.mycirt.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjpjZGI4OjQ3ZWJmMjU3YzNhNjYzYzNiYWVjZGNlMTJjZDM5ZGZkYzBlNmQyNTc0OTdlZWU4ZGI4ODFlYzU1OWZmN2JmMWE6cDpU)
(Checkpoint Inhibitor Response Test) blood tests. PSE boosts the predictive
accuracy of a PSA test from 55% to 94% when testing the presence or absence of
prostate cancer. CiRT is a highly accurate (85%) predictive response test to
immuno-oncology checkpoint inhibitor treatments.

The tests are based on OBD's proprietary 3D genomic biomarker platform,
EpiSwitch® which enables screening, evaluation, validation and monitoring of
biomarkers to diagnose patients or determine how individuals might respond to
a disease or treatment.

OBD's clinical smart tests have the potential to be used across a broader
range of indications, and new tests are being developed in the areas of
oncology, neurology, inflammation, hepatology and animal health.

The Group's headquarters and UK laboratories are in Oxford, UK. Its US
operations and clinical laboratory are in Maryland, USA, along with a
reference laboratory in Penang, Malaysia.

OBD is listed on the London Stock Exchange's AIM (LSE: OBD). For more
information, please visit the Company's website, www.oxfordbiodynamics.com
(https://url.avanan.click/v2/___http:/www.oxfordbiodynamics.com___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6Njo3YmRiOmUxODM2ZWZhYmIxNjdhMjFiNTMxOThjNjE0YzMwYzg5YzA1MjI2MmYxMGY0ZTU1MzdjYzdlYzg1NDA5ZTcyOWU6cDpU)
, X (@OxBioDynamics) or LinkedIn
(https://url.avanan.click/v2/___https:/www.linkedin.com/company/oxford-biodynamics___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjozM2I4OmVmNzdkN2M0NmYxZDg3ODc0MWQ1NDEyMGQ4MjAxOWVmMTg4ZTMzNWY4MTA5NGE3NTE5ZDdlNWIwNjI5MTRhMTM6cDpU)
.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCFLFVAIDLVLIS