- Paradigm Biopharmaceuticals (PAR) deepened its loss for the first half of the 2021 financial year as it takes on some crucial anti-arthritis clinical trials
- The drug manufacturing revealed in its latest half-year report a $20.7 million net loss after tax — over 300 per cent more than the $5.1 million loss from the same period in 2019
- Revenue for the six months to the end of 2020 came in at around $254,000 — almost 70 per cent lower than the $571,000 over the same time the year before
- However, the heavier spending comes from major investment into some key clinical trials for Paradigm’s osteoarthritis and mucopolysaccharidosis treatments
- Paradigm plans to submit an investigational new drug application with the U.S. FDA by the end of the March 2021 quarter
- As such, the company is launching a phase-three trial for its flagship Zilosul product during the second quarter of 2021
- At the end of December 2020, Paradigm had $85.2 million worth of cash and cash equivalents on hand to continue developing its treatments
- Shares in PAR closed 4.44 per cent higher this afternoon at $2.59 per share
Paradigm Biopharmaceuticals (PAR) deepened its loss for the first half of the 2021 financial year as it takes on some crucial anti-arthritis clinical trials.
The drug manufacturer revealed in its latest half-yearly report a net loss after tax of $20.7 million — over four times the $5.1 million loss from the same half-year in 2019.
Revenue for the half-year came in at $254,475 — almost 70 per cent lower than the $571,478 over the previous corresponding period.
However, while losses are typically a negative thing, Paradigm said the increased loss is a reflection of the “significant progress” made in clinical trials for the treatment of osteoarthritis and mucopolysaccharidosis (MPS).
Over the half-year, Paradigm majorly progressed its clinical program for OA as it works to submit an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) by the end of the March 2021 quarter.
As such, around $11.6 million was spent on pre-clinical and clinical activities for a phase-3 trial to begin during the second quarter of 2021. Paradigm said it has contracted Premier Research as the Clinical Research Organisation (CRO) for the third-phase clinical program and contracted Cytel to help with statistical and data management services.
Importantly, the company said it has manufactured a new batch of Zilosul — its key OA-treatment drug — to ensure there is enough of the product to complete the trials.
Paradigm Chief Medical Office Dr Donna Skerret said the company has worked hard to make sure it has all necessary data ready to go for its upcoming IND submission.
“During CY2020, Paradigm conducted a number of non-clinical and clinical studies to provide updated information regarding drug characteristics, pharmacokinetics, and non-clinical toxicity as requested by the FDA in the company’s first meeting with the Agency in February 2020,” Dr Skerret said.
As well as the third-phase trial for Zilosul, Paradigm has also kicked off a phase-two trial to understand the ability of its products to treat chronic pain associated with MPS.
It seems investors are happy to forgive Paradigm’s steeper losses given the progress of the company’s clinical trials. At the end of December 2020, Paradigm had $85.2 million worth of cash and cash equivalents on hand to continue developing its treatments.
Shares in PAR closed 4.44 per cent higher this afternoon at $2.59 per share.