Imugene (IMU: $0.22) has announced it intends to raise $80 million through a private placement that includes two specialist biotech investment funds with commitments secured. The funds to be raised will support the company's portfolio of immuno-oncology drug development assets. Imugene will have a proforma (June 30) cash balance of $175 million.
Every two shares issued under the raise will come with an option to purchase shares at $0.33 by the end of March 2026, which has the potential to raise an additional $67 million.
Platform 1 - B Cell Immunotherapy
Imugene has three core technologies with multiple therapeutic applications. The first of these is the B-cell therapy, where the first two therapies are HER-Vaxx and PD1-Vaxx. The concept of these programs is to stimulate the body to develop its own antibodies against HER2 and PD1 respectively rather than receiving an injection of monoclonal antibody drugs such as Avastin and Keytruda respectively to bind to these targets.
In a Phase II study in 36 patients with gastric cancer, there was a 5.6 month benefit in overall survival when the HER-Vaxx therapy was added to the treatment (13.9 months compared to 8.3 months for chemotherapy alone). A second Phase II study has started in patients with gastric cancer who have failed treatment with Herceptin, and a Phase II study in patients with resectable gastric cancer is planned.
A Phase II study is expected to start in coming months with the PD1-Vaxx therapy in patients with lung cancer (NSCLC) who have high PD-L1 expression levels (more than 50%) and who have progressed whilst receiving checkpoint inhibitor therapy.
Platform 2 - CF33 Oncolytic Virus
In October last year Imugene commenced a study using its novel oncolytic virus, CF33, which has been armed to inhibit PD-L1 as well. That study, in patients with the difficult to treat metastatic triple negative breast cancer, is about to move into the fourth cohort where CEO Leslie Chong expects to see some positive efficacy data emerge.
A Phase I study started in May this year with just the CF33 virus (called Vaxinia) in patients with metastatic and advanced solid tumours. It will enrol between 51-100 patients. Two delivery forms will be explored, intravenous and directly into the tumour, as well as investigating CF33 as a monotherapy and in combination with Keytruda.
Platform 3 - onCARlytics
Chong says the jewel in the crown for Imugene is the onCARlytics program, which is a combination of three technologies in one. The approach is to use the CF33 virus to infect cancer cells, insert the CD19 transgene, and then use CAR T cell therapy to destroy the tumours. CAR T has been successful in blood-based cancers where CD19 is expressed, but it is not expressed in solid tumours. Over the next 12 months the company is seeking to move this into clinical studies under an IND.
Summary
Imugene has 10 clinical studies underway or planned for the treatment of 10 different cancers using its three novel oncology platforms. With the latest capital raise the company is well positioned to advance its clinical pipeline and move closer to registration studies.
Imugene will be capitalised at $1.4 billion at the completion of the capital raise underway.
Bioshares Recommendation: Speculative Buy Class A
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