iX Biopharma Makes Significant Strides In Drug Development In FY16
? Expands number of products under development
? Ends FY16 in stronger financial position
Singapore, 25 August 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) made significant strides in the development of the products in its product pipeline during the year ended 30 June 2016 (“FY16”).
In FY16, the Group completed a Phase 2 multi-dose clinical study for its lead product, Wafermine, an oral-sublingual analgesic using ketamine. The study confirmed its safety and tolerability when administered alone and in combination with opioids in three different dosing regimens in subjects undergoing bunionectomy. The next step in development for Wafermine is to conduct a Phase 2 efficacy study with a larger population to determine the optimal dose and dosing interval.
The Group has previously completed pilot bioavailability studies for PheoniX, a drug for erectile dysfunction. In FY16, it had completed a pivotal bioequivalence study of the same drug, and is awaiting the results of the study. Following which, the Group will file PheoniX with the relevant country’s regulatory authority for commercialisation.
The Group also introduced two new products from its research & development (“R&D”) efforts during the year: BnoX, a pain management drug incorporating buprenorphine as the active ingredient, and WafeRest, a melatonin wafer supplement for the alleviation of jet lag. BnoX will help meet a global need for a viable alternative to opioids, while WafeRest will offer an effective solution for those suffering from flight dysrhythmia.
WafeRest will be the first health supplement in the Group’s pipeline of products. As a health supplement, the drug is not subject to in-human clinical studies, and the time-to-market for this product is expected to be relatively shorter. The Group has commenced stability testing for WafeRest and, upon successful completion, intends to file the product for export listing with the Australian Therapeutic Goods Administration for sale.
In the fourth financial quarter ended 30 June 2016 (“4Q16”), the Group has reported a net profit of S$0.4 million, on revenue of S$1.7 million, compared to a loss of S$2.9 million, on revenue of S$2.2 million for the corresponding period a year ago (“4Q15”). The 4Q16’s net contribution included an R&D tax incentive of S$3.1 million. Also, there were S$1.3 million one-off expenses incurred in 4Q15 made up of share-based payments and listing expense.
For the full financial year ended 30 June 2016 (“FY16”), the Group reported a narrowing of net loss to S$7.7 million, versus the S$10.6 million recorded for the full financial year ended 30 June 2015 (“FY15”). Revenue for FY16 was S$5.8 million, while that for FY15 was S$7.4 million. The FY16’s lower net loss included an R&D tax incentive of S$3.9 million. Also, there were S$3.2 million one-off expenses incurred in FY15 made up of share-based payments and listing expense.
Lower full-year revenue was mainly due to a lower level of essential similarity (“ES”) testing activity in the Chemical Analysis (“CA”) business segment, which came off from a higher-than-usual ES activity level in FY2015 when a large number of molecules (oral dosage form) came off patent. The excess testing capacity and resources in our CA business had been utilised by our R&D that otherwise needed to be procured externally.
R&D expenses were higher in FY16, reflecting investments made in later-stage clinical studies for Wafermine and PheoniX, as well as the preclinical development of new products, including BnoX and WafeRest.
Since its initial public offering, iX Biopharma further boosted its cash balance through the addition of an aggregate of S$9.8 million in net proceeds from a private share placement in April 2016 and a rights issue in July 2016.
? Ends FY16 in stronger financial position
Singapore, 25 August 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) made significant strides in the development of the products in its product pipeline during the year ended 30 June 2016 (“FY16”).
In FY16, the Group completed a Phase 2 multi-dose clinical study for its lead product, Wafermine, an oral-sublingual analgesic using ketamine. The study confirmed its safety and tolerability when administered alone and in combination with opioids in three different dosing regimens in subjects undergoing bunionectomy. The next step in development for Wafermine is to conduct a Phase 2 efficacy study with a larger population to determine the optimal dose and dosing interval.
The Group has previously completed pilot bioavailability studies for PheoniX, a drug for erectile dysfunction. In FY16, it had completed a pivotal bioequivalence study of the same drug, and is awaiting the results of the study. Following which, the Group will file PheoniX with the relevant country’s regulatory authority for commercialisation.
The Group also introduced two new products from its research & development (“R&D”) efforts during the year: BnoX, a pain management drug incorporating buprenorphine as the active ingredient, and WafeRest, a melatonin wafer supplement for the alleviation of jet lag. BnoX will help meet a global need for a viable alternative to opioids, while WafeRest will offer an effective solution for those suffering from flight dysrhythmia.
WafeRest will be the first health supplement in the Group’s pipeline of products. As a health supplement, the drug is not subject to in-human clinical studies, and the time-to-market for this product is expected to be relatively shorter. The Group has commenced stability testing for WafeRest and, upon successful completion, intends to file the product for export listing with the Australian Therapeutic Goods Administration for sale.
In the fourth financial quarter ended 30 June 2016 (“4Q16”), the Group has reported a net profit of S$0.4 million, on revenue of S$1.7 million, compared to a loss of S$2.9 million, on revenue of S$2.2 million for the corresponding period a year ago (“4Q15”). The 4Q16’s net contribution included an R&D tax incentive of S$3.1 million. Also, there were S$1.3 million one-off expenses incurred in 4Q15 made up of share-based payments and listing expense.
For the full financial year ended 30 June 2016 (“FY16”), the Group reported a narrowing of net loss to S$7.7 million, versus the S$10.6 million recorded for the full financial year ended 30 June 2015 (“FY15”). Revenue for FY16 was S$5.8 million, while that for FY15 was S$7.4 million. The FY16’s lower net loss included an R&D tax incentive of S$3.9 million. Also, there were S$3.2 million one-off expenses incurred in FY15 made up of share-based payments and listing expense.
Lower full-year revenue was mainly due to a lower level of essential similarity (“ES”) testing activity in the Chemical Analysis (“CA”) business segment, which came off from a higher-than-usual ES activity level in FY2015 when a large number of molecules (oral dosage form) came off patent. The excess testing capacity and resources in our CA business had been utilised by our R&D that otherwise needed to be procured externally.
R&D expenses were higher in FY16, reflecting investments made in later-stage clinical studies for Wafermine and PheoniX, as well as the preclinical development of new products, including BnoX and WafeRest.
Since its initial public offering, iX Biopharma further boosted its cash balance through the addition of an aggregate of S$9.8 million in net proceeds from a private share placement in April 2016 and a rights issue in July 2016.