The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is enjoying a day in the green today after the company announced its yearly financial results for FY22.
Shares in the ASX biotech company are up 2.34% at $1.31 in early afternoon trade.
Let's go over the highlights of the report.
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What did Paradigm report?
- Revenue from continuing activities down 1.72% year-over-year (YoY) to $8.78 million
- Net loss for the period attributable to members up 14.4% YoY to $39.24 million
- Diluted earnings per share (EPS) down 13.06% YoY to negative 16.87 cents
- Net tangible asset backing per share down 48.35% YoY to 16.92 cents
Paradigm Biopharmaceuticals gave investors an update on the clinical trials currently in its pipeline. These included receiving regulatory approval for its PARA_OA_002 study that will be conducted in Australia and key parts of the Commonwealth.
Another achievement for the year was the company receiving fast track designation from the United States's Food and Drug Administration (FDA) for its Zilosul medication, which is intended for treating knee osteoarthritis via the pentosan polysulfate sodium (PPS) compound.
Two phase-two studies are also in the works for treating the disease mucopolysaccharidosis (MPS) by comparing the effects of a placebo and PPS in a 2:1 randomisation study.
What else happened in FY22?
Paradigm Biopharmaceuticals initiated a capital raise in August, which comprised $45.7 million from institutional investors and a $20.3 million rights entitlement at $1.30 per share. The total value of the raise was $66 million.
After the company received FDA approval for its Zilosul medication, it engaged with a market research firm to get feedback from how physicians and the general public perceived the product.
The results were reportedly positive, with Paradigm interim CEO and chief medical officer Donna Skerrett commenting:
Assuming sustained efficacy and robust safety data, physicians and payers consider Zilosul will provide high value to the treatment of osteoarthritis of the knee by covering a number of important unmet needs by providing an alternative treatment to reduce pain and improve function in these patients.
Skerrett continued:
Fast Track Designation allows Paradigm the opportunity to interact and collaborate with the FDA more frequently during the development stage, enabling a stronger overall program in line with the FDA's expectations and provides opportunity for shorter review timelines.
What's next?
The biotech's focus for FY23 and beyond will be on progressing the clinical trials in its pipeline, particularly for its Zilosul medication. Recruitment activities are expected to ramp up on this front, with testing sites activated in the United Kingdom, Europe, and Canada.
The Paradigm board also declared environmental, social, and governance (ESG) policies were "at the forefront of our strategic thinking" in the future. It expects to provide updates to investors on its ESG activities in FY23.
Paradigm share price snapshot
The Paradigm share price is currently down 31.48% year to date. This is significantly below the S&P/ASX 200 Index (ASX: XJO), which is tracking 6.34% lower over the same period.
Paradigm Biopharmaceuticals' market capitalisation is $294.12 million from today's price action.
