(Alliance News) - Evgen Pharma PLC on Thursday said interim loss widened, but noted the healthy volunteer study of its SFX-01 formulation remains on schedule.
The Cheshire, England-based clinical-stage drug development company said pretax loss in the six months that ended September 30 was GBP2.2 million, up 57% from GBP1.4 million a year earlier. Operating expenses were marginally above pretax loss at GBP2.2 million, up 47% from 1.5 million.
Evgen makes no revenue, as operations currently are at the stage of product development.
In October, it gained regulatory approval from the Medicines & Healthcare products Regulatory Agency for its pharmacokinetic and pharmacodynamic healthy volunteer study of SFX-01, which it expects will provide key insights into how this acts within the human body and in treating cases of glioblastoma, a type of brain cancer.
The study is now open for recruitment. The first eight subjects from an anticipated total of 24 entered the trial on schedule. The results are expected in the second quarter of 2023.
Evgen also reported progress in its Manchester University collaboration over SFX-01 in metastatic breast cancer patients. Since the start of the phase two trial, CDK4/6 inhibitors have grown in acceptance and are becoming standard of care in first line treatment.
However, patients invariably became resistant after an extended period of progression free survival, Evgen Pharma said. It is conducting further pre-clinical work with Manchester Breast Centre to assess the impact of SFX-01 in CDK4/6 resistance models.
"During the period the regulatory authorities have been highly supportive of our efforts through approvals for our clinical work and receipt of scientific advice, whilst our manufacturing effort is producing commercial grade tablets. Two new academic collaborations have been commenced, and we have seen pre-clinical progress in our key focus areas of breast cancer and glioblastoma," said Chief Executive Officer Huw Jones.
"We look forward to seeing clinical data on our new enteric coated tablet in the first half of next year and to seeing continued data flow from our numerous academic collaborations. Our cash runway is substantial at a turbulent time for our industry which sets a good foundation for the busy times ahead."
Shares in Evgen Pharma were down 5.7% to 5.52 pence in London on Thursday afternoon.
By Greg Rosenvinge, Alliance News reporter
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