The biopharmaceutical company is progressing on numerous clinical trials.
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The Dimerix Ltd (ASX: DXB) share price is skyrocketing in late morning trade, up 50% to 35 cents per share.
First, let’s look at the results for the year ended 30 June.
Dimerix share price soars despite operating losses
Revenues from ordinary activities decreased 44% year-on-year
Loss after providing for income tax of $6.37 million, up from a loss of $4.49 million in FY20
Cash reserve of $5.3 million
No dividends paid during FY21
What happened in FY21 for Dimerix
Dimerix reported it demonstrated “favourable clinical efficacy and strong safety profiles” across a number of its Phase 2 renal clinical studies
In the United States, the Food and Drug Administration (FDA) gave clarity to the company’s Focal Segmental Glomerulosclerosis (FSGS) and Orphan Drug Designation, accelerating the approval pathway. Similar approvals were granted by the United Kingdom and European Union medical authorities.
The company also has 2 independent Phase 3 clinical studies currently underway in patients with COVID-19 respiratory complications.
Additionally, Dimerix reported its DMX-200 manufacturing process was optimised to improve commercial scalability and global logistics.
What did management say?
Dimerix’s CEO Nina Webster said:
We faced a year of challenges and opportunities in 2020. I am enormously proud of how adaptive and resilient our employees were in the face of a global pandemic and am grateful for their unwavering commitment to deliver on strategy and further strengthen the pipeline.
Research & development director Robert Shepherd added:
It has been a very exciting and rewarding year, with our Phase 2 studies in FSGS and diabetic kidney disease providing robust data to progress into a global Phase 3 study that may provide a much-needed therapeutic option for patients with FSGS. The outcomes from our DMX-200 studies have supported inclusion into two COVID programs and I am pleased to be in a position support the global effort in treating the effects of this disease.
What’s next for Dimerix
Looking ahead, the company plans include:
Global FSGS Phase 3 clinical study initiation
REMAP-CAP Phase 3 study in intensive care COVID-19 patients conclusion
CLARITY 2.0 Phase 3 study in hospitalised COVID-19 patients conclusion
DMX-700 pre-clinical study initiation
DMX-200 in diabetic kidney disease longer term study initiation
Today’s capital raising announcement
Circling back to the cap-raise, which could also be influencing the Dimerix share price lift today, the company said it has received firm commitments to raise $20 million via a 2-tranche placement of some 100 million new shares.
Commenting on the capital raising, Webster said:
The company will emerge from this capital raise with a substantially strengthened balance sheet, putting us in a great position to deliver on the Dimerix pipeline, including the Phase 3 programs in FSGS as well as in COVID-19 patients with respiratory complications. We look forward to reporting on our progress in due course.
The Dimerix share price is up 38% in 2021.
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The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.