Imugene Ltd (ASX:IMU, OTC:IUGNF) has made significant progress in multiple candidates, has a strong balance sheet and numerous upcoming potential clinical catalysts, according to Diamond Equity Research.
VAXINIA cynical trial
Imugene made substantial strides in its clinical pipeline during the June quarter, highlighted by the initiation of the Phase 1 bile tract cancer trial with its oncolytic virus CF33, VAXINIA and the first patient dosed at St Vincent’s Hospital in Melbourne.
This trial expands the MAST (Metastatic Advanced Solid Tumours) program to specifically target bile tract cancer with the oncolytic virus CF33 (VAXINIA), following promising results in gastrointestinal cancers.
The trial has shown promising early results, including a complete response in one patient and stable disease in another. Facilitated by the US Food and Drug Administration’s (FDA) Fast Track Designation, the trial aims to enrol 10 patients and is testing higher doses to further confirm the treatment’s efficacy.
The fifth cohort for intratumoral (IT) and intravenous (IV) administration arms have also been approved to commence and the sixth cohort is actively enrolling, all without any safety concerns noted to date. Diamond Equity Research says this progress marks a pivotal phase in evaluating VAXINIA’s effectiveness in treating this challenging cancer.
onCARlytics OASIS trial
Imugene has also commenced dosing in the intravenous (IV) combination arm of its Phase 1 onCARlytics trial, branded as OASIS, which explores the CD19 oncolytic virotherapy candidate onCARlytics (CF33-CD19). This trial, conducted at prominent US sites, targets advanced or metastatic solid tumours, with early data expected by the fourth quarter of 2024.
Financially, Imugene concluded FY 2024 with A$93.1 million in cash reserves, which would be bolstered by an anticipated A$11 million R&D tax incentive. Operating cash burn for the year was A$95.5 million, with 52.5% of that spent on research and development. These funds are expected to support operations through late 2025.
Attractive valuation
Diamond Equity Research has provided a valuation of $0.49 per share, contingent on the successful execution of upcoming clinical milestones. This presents significant upside potential to the company’s current share price of around $0.053.
The research group recognised IMU’s “significant strides” made in advancing its pipeline toward late-stage clinical trials, with several major milestones potentially expected in the second half of 2024 and into 2025.