[source: Avacta Group]
Avacta Group (AVCT ), a clinical stage oncology and diagnostics company, has described the year ending 31 December 2021 as “a period of transformation” for the business, highlighting to investors that it is very confident about the group’s immediate and long-term opportunities.
Chairman, Dr Eliot Forster and CEO, Dr Alastair Smith said transformational and significant progress had been made across Avacta’s Diagnostics and Therapeutics divisions in 2021.
In FY21, the Company’s Therapeutics Division transitioned to a clinical stage oncology drug business, “a significant step which is a value inflection point for a growing biotech,” it noted.
The successful submission of a CTA to the UK MHRA allowed it to initiate the ALS-6000-101 Phase I dose escalation and expansion trials in the UK while gaining approval from the US FDA for an IND meant patients could be dosed in the US as part of this ongoing clinical trial.
As a result, the first patient ever was dosed with a pre|CISIONTM FAPα-activated drug, AVA6000, in August 2021 and the dose has now been increased in the Phase Ia dose escalation part of the study following positive safety data from the first cohort of patients.
Avacta expects full read-out of the trial - a potentially pivotal moment - to occur this summer.
Meanwhile, the first ever CE marked in-vitro diagnostic product based on Affimer® technology was developed and brought to market, thereby ‘fully validating the platform’s potential to deliver a future pipeline of products for the Diagnostics division and its commercial partners.’
“Our Therapeutics Division has transitioned to being a clinical stage business through the dosing of the first patient in the Phase I study of AVA6000, increasing the division’s intrinsic value and attractiveness to specialist investors and pharmaceutical partners,” said Smith.
He said success in the ongoing study “will not only potentially create a valuable chemotherapy asset but will also be a first validation of the pre|CISION platform, highlighting a promising pipeline of chemotherapies with the potential to significantly improve patients’ lives.”
In addition, Avacta said its Diagnostics division is providing ‘a strong engine for growth and revenue generation’ through the development of market leading diagnostic tests. The division has established a fully integrated IVD product development capability and has a Quality Management System that complies with the diagnostics market standard of ISO13485.
It said the division is now developing its own products ‘and is positioned to deliver a pipeline of in-vitro diagnostic tests, including the re-development of its SARS-CoV-2 antigen test in the light of the emergence of highly mutated variants, to drive sales revenue and profitability.’
“Our Diagnostics division is ISO13485 certified and has established all the necessary product development functions in-house, removing the need to rely on multiple external partners. We are developing a pipeline of IVD products as well as improving the performance of our antigen test for COVID-19 to ensure it can be commercialised as soon as possible,” added Smith.
During FY21, Avacta reported group revenues of £2.9m, up from £2.1m in FY20. Revenues for its Therapeutics Division were £2.16m (FY20: £1.63 million), reflecting additional milestone payments from the LG Chem collaboration and a licensing agreement with POINT Biopharma, together with revenues from funded FTE development projects with LG Chem and AffyXell.
Pre-tax losses from continuing operations for the year were £29.19m compared to £18.86m in the year prior, with loss per ordinary share increasing to 10.55 pence (FY20: 8.37 pence). Cash and short-term deposit balances by period end stood at £26.2m compared to £47.9m.
In particular, increased R&D and manufacturing investment within the Diagnostics Division and clinical development costs in the Therapeutics Division, resulted in a reported loss from continuing operations of £26.4m compared to £16.4m in the year ended 31 December 2020.
The Board believes that the most significant near-term value driver for the Company is the clinical data from the Phase I study of AVA6000 which is expected in the middle of 2022.
It said a positive readout would create a significant commercial opportunity with a potentially safer form of Doxorubicin, while immediately opening up a large and very valuable pipeline of pre|CISIONTM chemotherapy FAPα-activated drugs for development and licensing.
Smith said the Company maintains a confident outlook “with both potential near-term value drivers relating to AVA6000's clinical trial progress, a pipeline of IVD products and a redeveloped SARS-CoV-2 antigen test offering immediate and long-term opportunities.”
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