Directors’ Report Annual Report 2022 9 The directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as the ‘consolidated entity’) consisting of Noxopharm Limited (referred to hereafter as the ‘company’ or ‘parent entity’) and the entities it controlled at the end of, or during, the year ended 30 June 2022. Directors The following persons were directors of Noxopharm Limited during the whole of the financial year and up to the date of this report, unless otherwise stated: • Mr. Frederick Bart, Non-Executive Chairman • Dr. Graham Kelly, Non-Executive Director (resigned executive positions 1 February 2022 and appointed Non-Executive Director 1 February 2022) • Mr. Peter Marks, Non-Executive Director and Deputy Chairman • Mr. Boris Patkin, Non-Executive Director • Dr. Gisela Mautner, Chief Executive Officer and Managing Director (appointed 1 February 2022) Principal activities The consolidated entity’s principal activity in the course of the current financial year continued to be drug development, with the primary focus being the clinical development of Veyonda® (Idronoxil) as an adjuvant therapy in chemotherapy and radiotherapy in the treatment of late-stage cancers. There were no significant changes in the nature of the Company’s principal activity during the financial year. Dividends There were no dividends paid, recommended or declared during the current or previous financial year. Review of operations The loss for the consolidated entity after providing for income tax amounted to $18,666,810 (30 June 2021: $9,346,749). During the financial year, the consolidated entity has achieved the following milestones: • The Clinical Development Program continues to make solid progress this year with three cancer trials underway: DARRT-2, CEP-2 and IONIC; • Regulatory: US FDA granted Investigational New Drug status for the use of Veyonda® in combination with doxorubicin for the treatment of Sarcoma (CEP-2 trial); and IND status was granted to Veyonda® in prostate cancer (and other solid tumours) for the DARRT-2 trial; • DARRT-2 Phase 2 Trial saw a second dose cohort of patients treated with 1200mg of Veyonda®, and the dose was found to be safe and well tolerated. Approval has been given to progress the study, and treatment of the third cohort of patients with a 1600mg dose of Veyonda® will commence. The trial is now open for enrollment in the US, Europe and Australia; • CEP-2 Phase 1 Trial saw the first dose cohort of patients enrolled, with recruitment ongoing. Orphan Drug Designation was granted to Veyonda® for the use in soft tissue Sarcoma by the US FDA in early 2022; • The IONIC Trial recruitment is progressing steadily, with the final site expected to be activated shortly; • LuPIN study completed during the year, with results published in the Journal of Nuclear Medicine in January 2022; • The pre-clinical drug platforms ChromaTM and SofraTM continue to mature with a growing pipeline of drug candidates as part of a strategy of expanding the portfolio of assets and the profile of the Company in the global pharmaceutical industry. Significant changes in the state of affairs There were no significant changes in the state of affairs of the consolidated entity during the financial year. Likely developments and expected results of operations Information on likely developments in the operations of the consolidated entity and the expected results of operations have not been included in this report because the directors believe it would be likely to result in unreasonable prejudice to the consolidated entity.
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