Fortacin(TM) To Undertake Phase III Clinical Trials in the United States
Disposal of Listed Securities of VXR Shares for A$5 million Net Proceeds
HONG KONG, Aug. 6, 2021 /PRNewswire/ — Endurance RP Limited’s ("Endurance Longevity" or the "Company" and together with its subsidiaries, the "Group"; stock code: 0575.HK) is pleased to announce a positive profit alert for the interim results 2021 for the six month period ended 30 June 2021. The alert was followed by positive market reaction with the share price up by 18.7% to an intra-day high of HK$0.184 on the following day. The Company expects profit attributable to shareholders for the six months ended 30 June 2021 will reach approximately US$0.5 – 4 million (approximately HK$3.9 – 31.2 million), compared to a loss of approximately US$27.16 million (approximately HK$212 million) for the same period in 2020.
According to the announcement, the reason for the significant improvement in the financial situation was mainly due to the unrealized market value of financial assets at fair value in the statement of profit and loss, which recorded a gain of about US$12.18 million (approximately HK$95 million), compared with a loss of about US$1.1 million (approximaely HK$8.58 million) in the same period last year. In addition, the Company received a milestone payment of US$3.2 million (approximately HK$24.96 million) for development of Fortacinä (the PE prevention drug), compared with zero in the same period last year. And lastly, the Company recorded a reversal of impairment loss of approximately US$20,000 (approximately HK$160,000) for the preliminarily estimated FortacinTM intangible assets during the reporting period, compared with an impairment loss of US$13.3 million (approximately HK$104 million) in the same period last year.
The company has also announced on 15 July that FortacinTM has received strong positive results for its US Phase II patient reported outcome (PRO) Validation Study. Prespecified data analysis from the 16 centre United States study undertaken to validate the US Food and Drug Administration (FDA) mandated PRO for PE has been successfully completed as the key final step for assessment of efficacy ahead of the Phase III randomised clinical trial (RCT),which is already planned for the US. It is expected that the Phase III clinical trials will begin in the second half of 2021, and a new drug application will be submitted by the end of 2022.
On July 28, the company announced that Fortacinä received a detailed market assessment by MME, one of the leading global market research companies for health care in the United States. According to the study, 71% of the respondents felt there was a significant unmet need for the treatment for PE and existing treatments were not particularly successful. When presented with Fortacinä, 90% of physicians felt that Fortacinä would be valuable as front-line therapy and would certainly prescribe as it will be well received by their patients. At the same time, price sensitivity is also tested in the US in the range of US$90 to US$150 per month. This range was confirmed as easily achievable even as a "cash pay" a market launch price.
Jamie Gibson, Chief Executive Officer of the company said, "The data confirms the scale of the business opportunities in the United States. This indicates that an approved prescription product is needed, and Fortacinä should meet these needs at an attractive price.The Company expects that Fortacinä will become a market leader within one to two years after its launch. It can be seen from various clues that the positive momentum of Fortacinä in the first half of the year contributes to the positive profit alert of the Company. The commercialization of Fortacinä in the U.S. market is also proceeding step by step with more good news coming.
The Company also announced today that the Group disposed an aggregate of 7,224,755 VXR shares . The Group is expected to generate a net recognised gain of approximately A$5.04 million (approximately US$3.73 million or HK$29.09 million) and will be recognised in the Group’s final results for the year ending 31 December 2021. Following the Disposal, the Company’s interest in VXR has been reduced from approximately 4.26% to approximately 3.19% of VXR’s existing total issued share capital.
A$5 million (or approximately US$3.70 million or HK$28.86 million) of the net proceeds of the salel will be applied to discharge the remaining amount outstanding in respect of the settlement of the Australian taxation litigation. The remaining A$0.92 million (or approximately US$0.68 million or HK$5.30 million) will be used by the Company to meet its general corporate purposes and for working capital.
The Disposal is consistent with the Group’s stated strategy of disposing of non-core assets and represents a good opportunity for the Group to realise its investment in the Disposed Shares at a time of historically heightened valuation of VXR Shares.
About Endurance Longevity (Stock code: 0575.HK)
Endurance Longevity is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness, and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 21 years of financial reporting since its initial public offering.
About VXR (ASX: VXR)
VXR (ASX: VXR), an ASX-listed company is incorporated and domiciled in Australia. The principal activities of VXR are resources exploration, focusing on base metals, and the progression towards the development of VXR’s Sulphur Springs Copper – Zinc Project.
The net asset value of VXR was approximately A$24.79 million (or approximately US$18.32 million or HK$142.90 million) as at 31 December 2020, as set out in VXR’s last published interim report for the six months ended 31 December 2020.
The English version of this press release shall prevail in case of any discrepancy or inconsistency between English version and its Chinese translation.