(Alliance News) - Evgen Pharma PLC on Wednesday said it would begin a trial to test a new medicinal product later this year and said its results for the most recent financial year are in line with expectations.
The Cheshire, England-based drug development company said it expects to start its healthy volunteer trial in the fourth quarter of 2022 with the new SFX-01 formulation, targeted at treating cancer patients who have become resistant to the widely used class of CDK4/6 inhibitor drugs.
The company said the trial will be a placebo-controlled, dose-escalating trial that will assess how a drug is absorbed and circulates in the body, and how a drug engages with our target molecules.
Evgen Pharma's SFX-01 is a composition of synthetic sulforaphane and alpha-cyclodextrin and has undergone clinical trials for oestrogen-positive metastatic breast cancer. It will be entering the clinic in glioma/glioblastoma later in 2022. In September last year, the US Food and Drug Administration granted Orphan Drug status to SFX-01 in malignant glioma.
Turing to results, for the financial year ended on March 31, Evgen Pharma reported no revenue, compared to GBP194,000 a year ago. Pretax loss remained largely flat at GBP3.2 million.
The company said it does not have any approved or revenue generating products due to significant losses since its inception. "The group expects to incur losses for the foreseeable future, and there is no certainty that the business will generate a profit", it noted.
The firm suffered a total loss of GBP2.7 million including a charge for share-based compensation of GBP0.1 million, same as the year before.
Operating expenses amounted to GBP3.0 million, lower from GBP3.5 million, excluding share-based compensation. This reflected reduced manufacturing technology transfer costs, offset in part by an increase in payroll costs with the recruitment of additional senior staff and preparatory work for the forthcoming clinical trials.
Chief Executive Officer Huw Jones said: "Our focus during the year has been on achieving the objectives set at our 2021 fundraise, particularly around manufacturing, formulation and clinical trials preparation. With this groundwork now complete, we are pleased to have achieved very visible progress in each of our development programmes and we are anticipating another busy year."
Cash and short-term deposits at March 31 stood at GBP9.0 million, down from GBP11.6 million a year ago.
Looking ahead, the firm hopes to be advancing preclinical studies and its business development strategy, alongside the commencement of two clinical trials by the end of 2022.
Evgen Pharma shares were down 4.7% at 3.67 pence each on Wednesday afternoon in London.
By Xindi Wei; xindiwei@alliancenews.com
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Evgen Pharma (EVG)