Why IMU is a multi multi bagger, page-25989

Imugene Limited – Quarterly Report Highlights Significant Progress in Multiple Candidates, Strong Balance Sheet, and Numerous Upcoming Potential Clinical Catalysts

Investment Highlights

• Initiation of Phase 1 Bile Tract Cancer Trial with VAXINIA:
Imugene has initiated the Phase 1 trial for bile tract cancer, with the first patient now dosed at St. Vincent’s Hospital in Melbourne.

This trial expands the MAST (Metastatic Advanced Solid Tumours) program to specifically target cholangiocarcinoma (bile tract cancer) with the oncolytic virus CF33 (VAXINIA), following promising results in gastrointestinal cancers.

The trial has witnessed significant outcomes, including a complete response in a patient who has been in the study for over 620 days, and stable disease in another patient for more than four months.

With the FDA’s Fast Track Designation for VAXINIA facilitating an expedited review and potential approval, the trial aims to enroll 10 patients and is testing higher doses to further confirm the treatment’s efficacy.

Additionally, the Cohort Review Committee has approved the commencement of the fifth cohort for both intratumoral (IT) and intravenous (IV) administration arms, and the sixth cohort is now actively enrolling, all without any safety concerns noted to date. This progress marks a pivotal phase in evaluating VAXINIA’s effectiveness in treating this challenging cancer.

• First Patient Dosed in Intravenous (IV) Combination Arm of Imugene's Phase 1 onCARlytics Trial:
Imugene has achieved a significant milestone by dosing the first patient in the intravenous (IV) combination arm of its Phase 1 onCARlytics clinical trial, known as OASIS.

This trial explores the innovative CD19 oncolytic virotherapy drug candidate, onCARlytics (CF33-CD19),
in adult patients with advanced or metastatic solid tumours.

The trial is currently conducted at three prominent U.S. sites: City of Hope, University of Cincinnati, and MD Anderson Cancer Center, with potential expansion up to 10 sites.
It aims to recruit approximately 40-45 patients.

OASIS is designed to evaluate the safety and efficacy of onCARlytics administered either by intratumoural (IT) injection or IV infusion, alone or in combination with the CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto®, which is already approved for certain blood cancers.

This strategic combination seeks to exploit CD19, a marker primarily effective in blood cancer therapies, by enabling solid cancer cells to present CD19 on their surface, thus making them susceptible to existing CD19-targeting therapies.

This innovative approach could potentially open up 90% of the cancer market, which is currently not addressable by CD19 therapies. With the first patient already dosed in the IV monotherapy arm in February at City of Hope in California, early combination data from the trial are anticipated by the fourth quarter of 2024, aiming to potentially establish a new paradigm for treating solid tumors with a market potential valued at approximately USD $532 billion by 2032.

• Valuation:
The company concluded FY 2024 with cash reserves amounting to A$93.1 million, which excludes an anticipated R&D tax incentive of approximately A$11 million.

Operating cash burn during the year was A$95.5 million, with direct research and development expenditure accounting for 52.5% of total operating burn. These funds are projected to support the company's clinical pipeline and operations through late 2025.

The company has made significant strides in advancing its pipeline toward late-stage clinical trials, with several major milestones potentially expected in the second half of 2024 and into 2025.
With the potential for multiple positive data readouts and the initiation of a registrational Phase 2/3 clinical trial, we anticipate a re-rating of the company's valuation.

We have revised our financial model, incorporated updated cash reserves, and reassessed our comparable company analysis, resulting in a valuation of $0.49 per share, contingent upon the company's successful execution.