Highlights:
Unrealised Gain in Venturex Resources Limited
- Regent Pacific’s investment in Venturex Resources Limited has increased significantly to US$10.74 million (approximately HK$83.77 million) and a marked to-market value of US$13.13 million (approximately HK$102.41million) on its VXR shareholding, representing a 450% increase from 31 December 2020.
- Venturex Resources Limited (“VXR”), Regent Pacific’s investment announced a recapitalisation plan which aims at resetting the company for growth as a supplier of new-generation energy and technology materials and to advance the funding and development of its fully owned flagship Sulphur Springs copper-zinc project in Western Australia’s Pilbara region.
- Highly regarded mining executive Bill Beament will join VXR and will lead the new management team.
- Upon approval by VXR’s shareholders, funding of A$18.80 million at A$0.08 per share by way of a A$14 million placement to investors, of which Mr Beament will subscribe for A$8.90 million, and a fully underwritten one-for-seven entitlement offer to existing shareholders.
- An option structure to source additional the funding of A$39.60 million, increasing the total value of the strategic funding package to A$58 million, putting VXR in a strong position to fast-track the development of Sulphur Springs.
- Existing VXR’s shareholders will be offered a one-for-seven underwritten entitlement offer, through which they will also receive one free attaching option for every two shares subscribed for exercisable at A$0.135 within 24 months.
Approval and Commercialisation Progress on Fortacin™ / Senstend™
China
- The start day of the clinical study for seeking approval of an import licence for Senstend™ (the marketing name of Fortacinä in China) from the National Medical Products Administration (“NMPA”) of the PRC moved to Q4 2021.
- Two ingredients for the placebo for the commencement of the clinical trial will only be in stock earliest by July 2021 due to the disruptive impact of COVID-19 on the supply chain.
United States
- Medical Marketing Economics (“MME”) announced that patients in the US are willing to pay Fortacinä for US$90 to US$150 after the completion of the survey.
- The Group remains on target to submit the study to the US Food and Drug Administration (“FDA”) at the end of June 2021 depending on the results of the study.
HONG KONG, May 12, 2021 /PRNewswire/ — Regent Pacific Group Limited (“Regent Pacific” or the “Company” and together with its subsidiaries, the “Group”; stock code: 0575.HK), a specialist healthcare, wellness and life sciences investment group is pleased to announce several operational updates regarding its investment in Venturex Resources Limited (“VXR”, ASX: VXR) and the approval and commercialisation progress of Fortacinä.
The Group’s investment in Venturex Resources Limited has increased significantly to US$10.74 million (approximately HK$83.77 million) and a marked to-market value of US$13.13 million (approximately HK$102.41million) on its VXR shareholding, representing a 450% increase from 31 December 2020.
For the benefit of shareholders, VXR announced an extensive recapitalisation plan which aims at re-set the company for growth as a supplier of new-generation energy and technology materials and to advance the funding and development of its 100% owned flagship Sulphur Springs copper-zinc project in Western Australia’s Pilbara region.
Mr Bill Beament, a veteran with a strong track record of success in the international mining industry will join VXR and will lead the new board and management team.
Upon approval by VXR’s shareholders, the funding package under the recapitalisation introduces:
(a) funding of A$18.80 million at A$0.08 per share by way of a A$14 million placement to sophisticated investors, of which Mr Beament will contribute A$8.90 million, and a fully underwritten one-for-seven entitlement offer to existing shareholders; and
(b) an option structure to source additional funding of A$39.60 million, increasing the total value of the strategic funding package to A$58 million, putting VXR in a strong position to fast-track the development of Sulphur Springs.
VXR’s shareholders will have the opportunity to participate in the funding package via the fully underwritten one for seven entitlement offer, through which they will also receive one free attaching option for every two shares subscribed for, exercisable at A$0.135 within 24 months.
Regent Pacific also announced that Wanbang Pharmaceutical Group Co., Ltd. (“Wanbang Pharmaceutical”), has ordered clinical supplies (both active and placebo) from Pharmaserve (North West) Limited (“PSNW”), the manufacturer of Fortacin™ for the purpose of clinical trial. However, PEG/Povidone, the two ingredients for the placebo will only be in stock earliest by July 2021 due to the disruption of the supply chain of PSNW under the COVID-19 pandemic.
In respect of the commercial scale up to increase the current batch size per each manufacturing run to 50,000 units from 15,000 units, the development work will commence in June 2021 after the latest commercial batch has been manufactured in May 2021. This is designed, if successful, to meet Wanbang Pharmaceutical’s requirements for China and the over-the-counter’s requirements of Recordati S.p.A. in the European Union and the United Kingdom (the “UK”).
In addition, Medical Marketing Economics (“MME”), a leading global marketing consulting firm engaged by the Group announced that a price of US$90 to US$150 is sustainable for Fortacinä to be sold in the US after a comprehensive analysis of patients, physicians and healthcare providers across the US. In addition, over 80% would to consider Fortacin™ as an effective treatment.
In respect of the US Phase II validation study, the clinical research organisation has “locked” the data base with top line results expected in June 2021. The Group remains on target to submit the study to the US Food and Drug Administration (“FDA”) at the end of June 2021 depending on the results of the study. On the assumption that the trial is sufficient to convince the FDA that the Premature Ejaculation Bothersome Evaluation Questionnaire serves as an appropriate measure for support of a label claim, the pivotal Phase III study could commence in the latter half of 2021, with New Drug Application submi
ssion possible in late 2022, giving a Prescription Drug User Fee Act date at the end of 2023.
Jamie Gibson, Chief Executive Officer of the Company, said, “This extensive recapitalisation plan will help to fast track the development of Sulphur Springs into a producing copper and zine mine and enhance the competitiveness, operations and the development of the Company’s business in the new-generation energy industry under the leadership of Mr Beament, a veteran in the resource sector. It also enables VXR’s shareholders and its financial stakeholders to benefit from the strategy and will be offered the chance to acquire further shares and options in VXR on the same terms to tape into the high-growth industry.”
Together with the promising commercialisation progress of Fortacin™ in the US, Taiwan, Hong Kong and Macau, the Company is poised to capture significant market share through its premature ejaculation treatment around the world in the coming years.”
About Regent Pacific (Stock code: 0575.HK)
Regent Pacific 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 23 years of financial reporting since its initial public offering in May 1997.
About Fortacin™ / Senstend™
Fortacin™ is the first solution to PE that does not act on the central nervous system and offers bona fide therapeutic efficacy that has been validated through extensive clinical trials in Europe, with over 23,500 doses delivered to trial participants. The solution is a topical spray containing low doses of lidocaine and prilocaine that take effect almost immediately upon application, giving users more control without reducing pleasure. Fully approved by the European Medicines Agency (EMA), Fortacin™ is now available in France, Germany, Italy, Portugal, Spain and the UK.