(Image Credit - Idaho National Laboratory)
After the close of North American trading yesterday, Intec Pharma Ltd. (TASE:NTEC)(NASDAQ:NTEC) announced the company's financial results for the six months ended June 30, 2017. Like most other clinical stage biopharmaceutical companies, Intec has no commercialized products and therefore no revenues. This shifts the focus of their earnings release from well...earnings, to things like cash, research & development expenses and any updates on the company's pipeline. That being taken into account, here are 7 things that current and prospective investors should pay attention to from Intec's recent earnings release.
Related: Inside Intec Pharma's Accordion Pill Technology
As of June 30, 2017, Intec Pharma had $16.1 million in cash and cash equivalents. Based on their cash used in operating activities in the first half of '17, of $9.4 million, this gives the company approximately 1.7 years before they may need to raise capital, find a partner for one of their drugs, or generate revenue from the commercialization of one or more products.
Research and development expenses were approximately $9.5 million in H1'17, up $4.1 million, or 76% from the comparable period last year. This increase in R&D expenses can be attributed to expenses related to the company's Phase III clinical trial for AP-CDLD, increases in payroll and compensation expenses and a decrease in the Israeli National Authority for Technological Innovation's (NATI) participation in research and development expenses. The company's NATI grant was put on hold as a result of a condition requiring that AP-CDLD be manufactured in Israel. Intec is currently evaluating if it is possible to manufacture the drug in Israel.
Intec's general and administrative expenses increased approximately 40% from the first half of 2016 to $2.1 million in the six-month period ended June 30, 2017. This increase can be attributed to an increase in share-based compensation to employees and professionals.
For the first half of 2017, loss and comprehensive loss was approximately $11.2 million, an increase of $4.8 million, or approximately 75% compared to the first half of last year. This increase primarily resulted from an increase in expenses related to the Phase III clinical trial for AP-CD/LD, higher payroll expenses, increased share-based compensation and NATI's decreased participation in research and development expenses.
In March 2017, Intec completed a $10 million private placement, strengthening the company's balance sheet and giving them a longer 'runway' in the form of a higher cash position.
Recently, Intec reported topline data from their phase 1 clinical trial of AP-CBD/THC, the company's cannabidiol (CBD) and tetrahydrocannabinol (THC) accordion pill. The results showed that compared to GW Pharma's Sativex, AP-CBD/THC showed significant improvements in exposure of CBD and THC, a longer median time of peak concentration, and significantly higher absorption. Additionally, the study showed that CBD/THC was found to be safe and well tolerated. Intec plans on developing AP-CBD/THC for indications that include low back neuropathic pain and fibromyalgia.
Intec also advanced enrollment in the ACCORDANCE study, their phase three clinical trial of AP CD/LD, the company's accordion pill with a combination of Carbidopa/Levodopa for the treatment of symptoms associated with advanced Parkinson's disease. Based on this, the company expects to complete enrollment during the fourth quarter of 2017 or the first quarter of 2018.
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