Abingdon Healt. Regulatory News (ABDX)

Half Year Trading Update

York, U.K. 26 January 2021:  Abingdon Health plc (AIM: ABDX) ("Abingdon" or "the Company"), a leading international developer and manufacturer of high quality and effective rapid tests, today provides a trading update for the six months ended 31 December 2020.

In line with Board expectations, revenues will be approximately £7.7m, (H1 2019/20: £1.5m) with second quarter revenue significantly ahead of the first quarter, highlighting the growth in activity in line with new product approvals and increased levels of manufacturing capacity. In December, the Company announced its IPO on the AIM market of the London Stock Exchange raising £22 million (before expenses). The cash position as of 31 December 2020 was £16.4m. 

Board Appointment

As separately announced today Melanie Ross has been appointed as Chief Financial Officer.

Department of Health and Social Care

Abingdon is pleased to report that it, along with UK-RTC consortium partners, completed the delivery of an order of 1 million AbC-19 anti-spike IgG devices to the Department of Health and Social Care (DHSC) on 8 January 2021. Regarding the current DHSC contract, as noted previously, this will expire on 14 February 2021 and, in-line with the Government's shift to a dynamic purchasing strategy, the Board expects that any future orders will be received via an application by the Company to future DHSC tender notices.

International approvals for the AbC-19TM Rapid Test

The Company is continuing to manufacture the AbC-19TM Rapid Test in anticipation of additional orders and to that end Abingdon's regulatory department is currently working with UK-RTC partners on regulatory approval in a total of 27 territories. As part of this regulatory approvals process, the Company continues to provide data to the US FDA ("Food and Drug Administration) to allow regulatory approval and in consultation with the FDA has provided additional performance data of the AbC-19TM Rapid Test versus PCR testing via a re-submission. The FDA has asked for additional data relating to PCR testing versus on-site finger-stick blood samples to allow focus on remote, or point-of-care testing which the Company expects to submit within four weeks.

AbC-19TM Rapid Test compatibility with vaccines

The Company believes that as an IgG neutralising antibody test, the AbC-19TM Rapid Test has a key role to play in mitigating the impact of the pandemic. The Company continues to work closely with commercial and academic partners to build the data set(s) around the use-case for the AbC-19TM Rapid Test alongside vaccines, and these will be published in due course.

Contract manufacturing for partners

Abingdon is pleased to report that one of its international contract service customers has received a CE mark for professional use for its COVID-19 lateral flow antigen test. The Company is now working closely with this partner regarding the scale-up of manufacturing to meet anticipated demand for this test. Furthermore, the Company continues to work with a number of other COVID-19 antigen test contract service partners with products in development.

The Company expects to complete delivery of an order for 1 million devices for its PCRD rapid test in February 2021. In this case, Abingdon's PCRD nucleic acid lateral flow immunoassay is being used alongside on-site isothermal amplification to create a near-patient testing molecular testing solution for the presence of the COVID-19 virus. Abingdon's partner is currently going through the FDA-EUA process.

We continue to support existing (non-COVID-19) manufacturing customers and we continue to work on a range of (non-COVID-19) development contracts.

Expansion of manufacturing operations

Further to our recent IPO, raising total proceeds of £22.2m, and in-line with stated strategy, Abingdon continues to invest further in its automated manufacturing capacity and is planning to expand both its York and Doncaster sites. The Company expects a number of key items of automated assembly equipment to come on-line over the coming months and these will increase significantly its automated manufacturing capacity.

Chris Yates, Chief Executive Officer of Abingdon Health, commented:

"I am pleased to report quarter-on-quarter revenue growth which has been driven by demand across a range of COVID and non-COVID products. As a result of ongoing investment in our facilities and the monies raised at our recent IPO, we will see our automated capacity increase significantly in the second half and into the next financial year, and we look forward to working with our customers to support their exciting growth plans.

"The AbC-19TM Rapid Test is an IgG neutralising antibody test and therefore we expect it will have a key role to play in mitigating the future impact of the pandemic. The Company is currently working closely with commercial and academic partners to build the data set(s) around the use-case for the AbC-19TM Rapid Test alongside vaccines and as an indicator of neutralising antibody production post infection."

Enquiries:

About Abingdon Health

Abingdon Health is a world leading developer and manufacturer of high-quality rapid tests across all industry sectors, including healthcare and COVID-19. Abingdon is the partner of choice for a growing global customer base and takes projects from initial concept through to routine and large-scale manufacturing and has also developed and marketed its own labelled tests.

The Company offers product development, regulatory support, technology transfer and manufacturing services for customers looking to develop new assays or transfer existing laboratory-based assays to a lateral flow format. Abingdon Health aims to support the increase in need for rapid results across many industries and locations and produces lateral flow tests in areas such as infectious disease, clinical testing including companion diagnostics, animal health and environmental testing. Faster access to results allows for rapid decision making, targeted intervention and can support better outcomes. This ability has a significant role to play in improving life across the world. To support this aim Abingdon Health has also developed AppDx®, a customisable image capturing technology that transforms a smartphone into a self-sufficient, standalone lateral-flow reader.

Founded in 2008, Abingdon Health is headquartered in York, England.

https://www.abingdonhealth.com/