ASX-listed biotech trailblazer, PharmAust’s efforts to assist man’s best friend to battle cancer have been given a significant boost after the company was deemed eligible for research and development tax rebates worth $1.452 million over three years by the Australian Government.
Importantly, the Perth-based company may also soon be able to claim on overseas expenditures after receiving a positive finding regarding pre-approvals for related off-shore R&D activities.
A favourable assessment by the Australian Government’s Department of Industry, Innovation and Science has found that the first two phases of PharmAust’s clinical trials that are testing the effects of Monepantel as a treatment for canine cancer, constituted R&D activities under the R&D Tax Incentive, also known as the “RDTI”.
This was despite the fact that the trials cannot be conducted domestically, due to the unavailability of drug development, manufacturing facilities and dog cancer research services in Australia.
Typically, R&D activities must be conducted in Australia to be eligible for the grants, however, due to the unavailability of certain facilities in Australia, the company said that its payments to overseas service providers in current and future applications for the incentive would most likely be eligible for the grant.
Upon review and assessment of the company’s application, the department issued certificates to PharmAust under sections of the Industry Research and Development Act that confirm its eligibility for the grant.
According to management, the pre-approvals relate specifically to expenses incurred whilst conducting and supporting the clinical trials in Australia, that are testing the effects of Monepantel on dogs with cancer.
They also cover overseas supporting activities such as the reformulation programs and taste tests conducted with BRI in Canada, the scaled tablet manufacturing carried out with Catalent in the US and the Phase I dog trials in healthy canines managed with another US-based research organisation.
The findings and confirmation will enable PharmAust to claim a total eligible R&D expenditure within Australia of $2.215 million and an overseas amount of $1.123 million over the specified three-year period.
Ultimately, this represents total refundable tax credits of around $1.452 million to PharmAust at the current rate of 43.5% on eligible activities during this same timeframe.
To date, PharmAust has manufactured enough tablets to conduct its first Phase II trial, testing the effects of Monepantel in dogs with B cell lymphoma.
The pre-approval further paves the way for R&D tax rebate eligibility so that the company may, for example, undertake supplementary tablet manufacture to explore the long-term effects for periods beyond 12 months and widen the scope of treatments to dogs with other types of cancer.
PharmAust Chief Scientific Officer Dr Richard Mollard said: “Having certainty over the R&D tax rebate for the next three years greatly assists PharmAust accelerate its work.”
“PharmAust is pleased to be developing Monepantel as an anti-cancer agent for pet dogs in Australia and also developing Monepantel as an Australian export product for overseas markets.”
The news has come at a good time for PharmAust, which last month saw its subsidiary Epichem, win the 2019 WA Industry and Export Award and the Women in International Business Award, which was presented to Epichem’s Chief Executive Officer, Dr Martine Keenan.
Early in September, PharmAust made another significant step in its fight against canine cancer by finalising the contractual arrangements with the University of Melbourne’s U-Vet Werribee Animal Hospital for its Monepantel Phase II clinical trials.
Is your ASX-listed company doing something interesting? Contact : matt.birney@businessnews.com.au