OncoSil Medical Limited (ASX: OSL), based in North Sydney, Australia is a medical device company engaged in advancing breakthrough treatments for pancreatic and liver cancer. Its flagship product is OncoSil, a targeted radioactive isotope (Phosphorous-32), implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.
On March 25th, 2019, the company announced that it had received advice from the British Standards Institute (BSI) Clinical Oversight Committee that has reviewed the OncoSil™ CE Mark file. According to BSI, there is insufficient clinical benefit determined from the examination to recommend approval. The recommendation will now be forwarded to BSI’s Medical Device Group for final determination.
OncoSil Medical is assessing the feedback to layout the subsequent steps. However, the company is quite disappointed with the determination received for its initial assessment, given the strong data package that was presented. It intends to clarify the issues with BSI and then announce the course of action as soon as it is decided.
Oncosil has a market valuation of over AUD 100 million with ~ 630.71 million outstanding shares. With the end of the market trading on March 25th, 2019, the OSL stock closed at the price of AUD 0.049, crashing by AUD 69.38%, indicating a steep intra-day fall of AUD 0.111.
In February 2019, the company released its financial report for the half-year ended December 31st, 2018, also highlighting the key developments and operational activities that were undertaken.
During the period, various milestones were achieved, including significant advancements to accelerate OncoSil’s early commercialisation strategy and clinical progress in the US. The US FDA confirmed that the PanCO (ex-US) clinical study safety data meets the Investigational Device Exemption (IDE) requirement, providing the Company with a heads up to proceed to a full-scale US pivotal study without further US patient data. The 10th patient underwent surgical resection for PanCO clinical study, for which the rate of resection stood at 24% as on February 20th, 2019. Besides, eight out of the 10 resections had reported R0 surgical margins which are a strong predictor of improved survival.
As per the financial results, the revenue from ordinary activities was recorded at around AUD 1.94 million, reflecting a rise of 6.3% over the previous corresponding period (PCP) ended December 31st, 2017. The loss for the half-year attributable to the owners of the company also increased by 13.6% and amounted to approximately AUD 5.15 million.
At the end of the six months as of December 31st, 2018, the net cash and cash equivalents stood at around AUD 13.04 million, up on circa AUD 5.19 million as of December 31st, 2018. The operating activities resulted in cash outflows of approximately AUD 2.21 million due to large payments of around AUD 6.61 million to the suppliers and employees. Besides, the investing activities further contributed AUD 14,828 to cash outflows on account of payments for property, plant and equipment. On the contrary, the financing activities generated net cash inflows of AUD 60,452 during the period.
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