A Flip Through Imugene’s December 2019 Quarterly 4C Report

Australia-headquartered clinical stage immuno-oncology player, Imugene Limited (ASX:IMU) has recently released its Quarterly 4C report on the ASX, highlighting its key activities undertaken during December 2019 quarter. Imugene continued to focus on its product pipeline during the quarter, which includes an oncolytic virotherapy (CF33) and a range of B-cell immunotherapies.

Imugene’s novel therapies have the potential to:

• Combine with standard of care drugs without increasing toxicity.
• Combine with minimal cost increase.
• Combine for better response rates and efficacy.

Let us take a quick glance over the key activities reported by the Company during the quarter:

Completed Oversubscribed Placement to Fund Clinical Programs

In December 2019, the Company successfully completed the oversubscribed placement of up to ~683 million new shares at an issue price of $0.036 per new share (and 1 New Option for every 3 New Shares issued) to raise approximately $24.6 million (before the exercise of any New Options).

The funds were raised for the following purposes:

Completed Acquisition of Oncolytic Virus Platform

The acquisition of the oncolytic virus platform developed at the prestigious City of Hope Cancer Research and Treatment Centre was completed during the quarter, following the completion of Extraordinary General Meeting (EGM) held on 18^th November 2019.

Subsequent to the EGM, the Company finalised the acquisition of Vaxinia Pty Ltd and City of Hope licence of CF33, which comes with long patent life and robust intellectual property, compelling pre-clinical safety and efficacy, and is expected to enter two Phase 1 clinical trials this year.

Three Presentations Presented at the Annual ESMO Congress

In October 2019, three presentations were presented on the Company’s B-cell immunotherapy programs (HER-Vaxx, B-Vaxx and PD1-Vaxx) at the Annual ESMO (European Society of Medical Oncology) Congress in Barcelona , Spain.

Professor Dr. Ursula Wiedermann from the Medical University Vienna, Austria, presented comprehensive clinical data results of HER-Vaxx’s Phase 1b clinical study at the ESMO. She is also the lead-inventor of the HER-Vaxx vaccine.

The Company is progressing with HER-Vaxx’s Phase 2 clinical trial with the dosing of further HER-2+ gastric cancer patients with its HER-Vaxx (IMU-131) cancer immunotherapy.

ALSO READ: A Smash Hit by Imugene: Received Core US Patent for HER-Vaxx

Moreover, two leading medical investigators, Dr Tanios Bekaii-Saab and Dr Joshua Tobias presented presentations demonstrating that combining the Company’s HER2 vaccines with PD1 vaccines have reduced cancer growth in a several standard preclinical models.

The Company’s anti PD-1 B cell immunotherapy, the PD1-Vaxx, is expected to enter into Phase 1 trials in 2020.

ALSO READ: Imugene Announced Completion of GMP manufacturing and Toxicology Studies for PD1-Vaxx

In addition, a presentation on the Company’s HER-Vaxx was presented at the ESMO World Congress Asia in November 2019 in Singapore.

Appointed Professor Yuman Fong as Chairman of Oncolytic Virotherapy SAB

During the quarter, the Company appointed Professor Yuman Fong to lead its Scientific Advisory Board (SAB) of oncolytic virotherapy (OV).

Professor Fong is a Managing Director, Chair of the Department of Surgery, at City of Hope based near Los Angeles, which is an internationally recognised independent research and treatment center for life-threatening like cancer and diabetes.

Subsequent to his appointment, the Company strengthened its OV SAB with the hiring of Professor Prasad S. Adusumilli and Dr Rebecca Auer.

Provided a GMP Manufacturing Update for CF33

The Company provided a GMP manufacturing update for CF33 in November 2019, notifying that GMP manufacture of two oncolytic virus constructs (CheckVacc and Vaxinia) has been completed for Phase 1 clinical trials, scheduled to begin this year.

The company has planned to undertake Phase 1/2 Vaxinia MAST (Mixed Advanced Solid Tumours) study and Phase 1 CheckVacc Triple Negative Breast Cancer Study in 2020.

Financial Updates of December 2019 Qtr

In November 2019, the Company received an R&D tax refund worth $4.13 million under the Australian Government’s R&D tax incentive program.

This added to the Company’s bank balance, that stood at $36.8 million as at 31^st December 2019. Moreover, the inflow from the tax incentive took its net cash from operating activities for the quarter to $0.4 million.

With four promising assets in the clinic, the Company expects to see a rise in expenditures in coming quarters. The Company has estimated its cash outflows for this quarter at ~$6.5 million, with ~$5.4 million likely to be spent on research and development.

The Company’s management is well-positioned to control ongoing operating costs effectively.

In a nutshell, Imugene has a robust balance sheet and is well-financed to achieve its clinical and commercial milestones. It is imperative to note that the Company’s clinical programs are progressing well through their respective development pathways for potential next generation of immunotherapies.

IMU ended the day’s trading session at $0.032 on the ASX on 5^th February 2020.