() intends to transition from research & development (R&D) to a commercialisation phase as it prepares the trial design for a phase 2A study of its cannabinoid development therapeutic CPAT-01 in animals.
The well-capitalised, Sydney-based company released its quarterly cashflow report and market update for December quarter 2018 earlier today.
READ: CannPal Animal Therapeutics concludes successful phase 1B cannabinoid study in dogs
CannPal highlighted its $4.55 million cash balance at the end of the December quarter, comparing it with the $510,000 quarterly cash burn which had primarily related to its R&D costs.
During the quarter, the diligent budget manager received a $297,299 R&D tax refund from the Australian Government and attributed its increase in legal costs and fees in part to collecting the refund.
CannPal confirmed it was fully-funded up to its phase II pilot studies for CPAT-01 and other milestones it has communicated to market, including the commercialisation of its lead nutraceutical product DermaCann.
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CannPal founder and managing director Layton Mills told the market: “I am very excited about the progress that we’re making across our entire portfolio.
“Our work so far continues to build confidence that CannPal will be able to develop and commercialise compliant and evidence-based products for companion animals in the areas of pain and osteoarthritis, as well as skin and joint health.
“I’m looking forward to commencing our Phase 2 pilot studies for CPAT-01 and the potential to explore commercialisation opportunities for our nutraceutical products in 2019.”
CannPal chairman Geoff Star highlighted the team’s momentum, saying “I’m extremely happy with the progress that CannPal has made in the December quarter, and particularly the company’s progress with our nutraceutical program, while maintaining focus on our lead pharmaceutical.
“Our strategy has been to remain focused and diligent in the development of compliant animal health products and that work is beginning to pay off as we’re getting closer towards getting CannPal in a position to explore commercialisation opportunities in 2019.
“I’m looking forward to the team continuing with the same momentum throughout the new year.”
Phase II pilot studies
This quarter, the protocol for the highlighted first study in its phase II program, a phase 2A pilot clinical study of CPAT-01 in client-owned animals with the arthritic bone condition OA, is being worked on.
CannPal will draw on its results from phase I (A&B) studies completed last year, including its phase 1B study of CPAT-01 in more than 48 dogs completed last month, which evaluated the development drug for pain and inflammation control in dogs.
Gene expression studies have revealed clear cannabinoid impact in important pain and inflammatory pathways, supporting proposed pain and inflammatory control claims for CPAT-01.
A Melbourne-based integrated medical lab has been helping CannPal identify the drug’s effects on key chemokine and cytokines associated with the activated pain and inflammatory genes highlighted in the phase I studies.
A kick-off of the study is now expected in the June half-year 2019.
Neutraceutical products
On the nutraceuticals front, CannPal’s New Zealand-based manufacturing partner Jaychem Industries Ltd is also expected to start a canine study of DermaCann, which is being developed as a CBD (cannabidiol)-derived oral skin supplement for dogs.
Auckland-based Jaychem completed laboratory formulation work in the December quarter and will manufacture a batch of formula in the June half for the study, in a start to the formulation stability program.
NSW biotech CannPal will add the safety data from development work and the upcoming skin study results to a dossier for complementary animal health product approval (CAHP) with Australian Pesticides and Veterinary Medicines Australia (APVMA).
CAHP approval would allow animal owners in Australia to buy DermaCann through Australian veterinarians and would represent a significant milestone for the animal pharmaceuticals company.
READ: CannPal Animal Therapeutics caps off busy September quarter
CannPal also worked with the Australian Government’s independent science agency CSIRO last quarter, backed by a $500,000 CSIRO grant, and this is expected to generate additional commercialisation opportunities for CannPal.
The collaborators claimed success from their first phase of study in evaluating the feasibility of using CSIRO’s food-producing technologies to turn CannPal’s oil-based formulations into a powdered product.
CannPal hopes to identify opportunities to use the delivery mechanism for animal nutraceuticals in its pipeline.
Significant shareholders
The tightly-held company’s top 20 shareholders had 68.18% of the company on September 17, with The Trust Company (Australia) Limited <MOF A/C> leading the pack with a 15.8% stake.
CannPal’s other significant shareholders were Gemelli Nominees Pty Ltd, with 9.32%, Pepaanne Pty Ltd <The Chapman Family A/C> (8.23%), founder Layton Patrick Mills <DJS Family A/C> (7.39%) and Tania Maree Vidovic <Star V Family A/A> (7.39%).