CannPal Animal Therapeutics Releases Quarterly Report

CannPal updates the market on the company's progress.

Animal health company CannPal Animal Therapeutics Limited (ASX: CP1) is pleased to update the market on its progress in the March 2020 quarter and attaches its Appendix 4C Quarterly Cash Flow Report for the period.

The Company had a cash balance of $2.42m with operating outflows totalling $594k for the quarter, with $489k related to the costs associated with the research and development of the Company's lead pharmaceutical and nutraceutical drug candidates.

In response to COVID-19, CannPal has adapted its research programs to minimise the impact of coronavirus across its program of works, allowing the Company capacity to complete the milestones it has previously communicated to the market.

While it is a challenging environment at present, the Company remains capitalized to reach our major milestones, and remains committed to maximising shareholder capital, while placing added focus on activities that can provide CannPal with near term commercial outcomes.Layton Mills CannPal Managing Director

CPAT-01

The Company continued to make progress across all key milestones for CPAT-01, the Company's lead drug candidate in development for the control of pain and inflammation associated with osteoarthritis, and is pleased to announce the successful completion of the live phase of its Phase 2B Target Animal Safety Study in Canada.

The TAS study was a 3-month clinical trial evaluating high dose ranges of CPAT-01 to confirm a broad safety profile for the drug candidate, which was hypothesised from the Company's earlier pharmacokinetic and safety studies completed in 2019.

20 Dogs were dosed twice daily in groups with either 0, 1, 2.5 or 5 times the planned treatment dose for a period of 90 days, to determine an appropriate margin of safety for the drug. Outcomes from initial TAS studies are expected to provide good indications of the outcome from a pivotal six-month study. Results are expected in June 2020.

Recruitment for the Phase 2A pilot dose determination study continued during the quarter, reaching more than 80% of planned enrolment. So far, 71 dogs have been screened for the Phase 2A pilot study in osteoarthritic dogs, and 46 dogs have either completed or currently remain on treatment.

However, recent substantial slowing in enrolment due to the impact of COVID-19, and the social distancing measures implemented by the State and Federal governments in Australia, has led CannPal to the decision to complete the study after the 46th dog finishes treatment.

This remains one of the largest randomised, double-blind, placebo-controlled trials in osteoarthritic dogs, using both THC and CBD, firmly establishing CannPal as a leader in the cannabinoid-derived animal health industry. Results from this study are expected to be available by Q3 2020.

The data generated will provide key insights into the effects of CPAT-01 for the symptoms associated with osteoarthritis, which will be used to determine the next steps for the ongoing pilot and pivotal research programs.

CannPal has continued with its regulatory preparations for an upcoming pre-submission conference with the Food and Drug Administration, Centre for Veterinary Medicine.

The PSC will be an opportunity for CannPal to start sharing data for the ongoing development of CPAT-01 with the regulatory agency. The PSC was intended to take place in the USA in Q2 2020 but will now be held virtually due to the restrictions placed on international travel.

Nutraceuticals

Recruitment for the DermaCann® pilot field study has also been impacted by the challenges associated with COVID-19.

While recruitment had continued during the period, with 13 dogs either completed or currently remaining on treatment (up from 5 in Q4 2019), the social distancing measures implemented by the State and Federal governments in Australia have made it particularly challenging for this trial.

Due to the interactions required between the specialist dermatologists, contract research organisation, pets and their owners, there has been a substantial slowing in enrolment which has led CannPal to the decision to finalise the study after the 13th dog completes treatment.

CannPal will proceed with testing for anti-inflammatory and inflammatory biomarkers using the blood samples taken from the currently enrolled dogs to support its commercialisation strategy. These research activities will be completed in laboratories that are capable of continuing work during this period and are expected to commence in early H2 2020.

CannPal will proceed with its planned Target Animal Safety study for DermaCann®, which is also now expected to commence in H2 2020.

The Company is well capitalised to complete the remaining research activities for the program.

Pilot Launch of Joint Health Supplement

During the quarter, CannPal was granted the global exclusive rights to commercialise patented MicroMAX® microencapsulation technology by The Commonwealth Scientific and Industrial Research Organisation (CSIRO) for use in the field of Animal Therapeutics.

MicroMAX® is CSIRO's patented encapsulation technology platform designed to encapsulate microscopic droplets of oil in a special food-grade material, to protect bioactive ingredients from oxidation, and help deliver them to the gastrointestinal tract for better absorption.

CannPal is pleased to announce that it has progressed its pilot launch for a new Joint Health Supplement containing the formulation that was central to the 18-month evaluation of MicroMAX®, under a new direct to consumer brand, max by CannPal.

The supplement contains a proprietary hemp-derived oil formulation which was part of an in-vitro canine inflammation research model to evaluate the anti-inflammatory effects of various CannPal formulations. Data from the research model confirmed the formulation significantly (p-value <0.0001) reduced the expression of pro-inflammatory biomarkers when compared to control.

CannPal has now entered into a manufacturing agreement with leading Australian pet food Company, Next Generation Pet Foods, to produce a pilot batch of the product for market evaluation in the United States, using the Amazon platform.

Amazon provides the Company with a cost-effective platform to access consumers in the United States to market test the product, via the FBA distribution channel. Amazon is one of the leading distribution channels for pet supplements in the United States.

The product contains natural anti-inflammatory compounds from hemp and other plants that act to support the endocannabinoid and immune system in the dog. The recognised safety profile of the ingredients allows the Company capacity to commercialise the product without the approvals that would be required for a veterinary prescription product.

CannPal Managing Director, Layton Mills

"Despite the challenges associated with COVID-19, CannPal made positive progress with the CPAT-01 research program and has implemented changes to the DermaCann® development plan that will allow the Company capacity to complete the program with minimal impact on time and budget.

Disclaimer: Past performance is not an indicator of future performance.

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Casey Peternell
Casey Peternell

Casey is a media and content creator with a keen eye for creativity. Casey is currently in the process of obtaining a double bachelors degree in Media & Communications and Business from Swinburne University in Melbourne.

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