Ann: Imugene AGM Presentation, page-115

What I have taken out of the above:

1. Early-Stage Trials:

• Imugene’s novel treatments (VAXINIA, onCARlytics, and azer-cel) are mostly in Phase 1 and Phase 1b trials, meaning efficacy and safety data are still preliminary and limited. This restricts conclusions about long-term effects and survival benefits

Small Sample Sizes and Patient Diversity:

• The Phase 1 trials, especially for the azer-cel and onCARlytics therapies, involve small cohorts, which may not capture broader efficacy and safety profiles across diverse populations. This limits generalizability until larger Phase 2 or Phase 3 trials are conducted

Limited Comparative Analysis:

• While complete responses have been reported in some cases, a more comprehensive comparative analysis against existing FDA-approved treatments (e.g., traditional CAR T-cell therapies for blood cancers) is lacking. This absence of head-to-head trials limits the understanding of Imugene's therapies’ relative efficacy and cost-effectiveness

Focus on Novel Mechanisms:

• Imugene’s approach to using oncolytic viruses (VAXINIA) and CD19-targeted onCARlytics therapy to make solid tumors resemble blood cancer cells is innovative. However, these mechanisms are complex and unproven in solid tumors. The transition from preclinical models to human trials for such approaches can often reveal unforeseen biological challenges

Regulatory Hurdles and Uncertain Timelines:

• Despite FDA designations for faster review (e.g., Fast Track and Orphan Drug Designations), Imugene's path to market is unclear given their heavy reliance on Phase 1 results. It may take years before obtaining FDA approval if Phase 2 and Phase 3 results are required, impacting short-term valuation

Potential and Valuation

1. Market Demand for Novel Cancer Therapies:

• Imugene’s focus on CAR T-cell and oncolytic virus therapies addresses a high-demand area in oncology. The potential for an allogeneic (off-the-shelf) CAR T-cell treatment could significantly lower costs and increase accessibility compared to autologous (patient-specific) therapies. If successful, azer-cel could attract considerable market interest in diffuse large B-cell lymphoma (DLBCL) and potentially expand into other blood cancers

Differentiated Mechanisms with Broad Applications:

• The onCARlytics platform uniquely targets solid tumors by making them appear as CD19-positive cells, theoretically expanding CAR T-cell applications beyond hematologic malignancies. If this approach proves effective, it could open new therapeutic options for cancers that are less responsive to current immunotherapies

Intellectual Property and Competitive Position:

• Imugene’s patents, particularly in regions like the U.S. and China, provide a competitive moat if they progress to advanced trial stages. Additionally, they are positioned to license or partner with larger pharmaceutical companies, which could enhance their market access and reduce financial risk associated with late-stage trials

FDA Fast Track and Orphan Drug Designations:

• These designations for VAXINIA in bile tract cancer allow for expedited regulatory processes, possibly accelerating Imugene's path to commercialization and improving short-term valuation. However, these designations will only convert to market value if subsequent trials affirm safety and efficacy

Strategic Pathways for Commercialization:

• Imugene’s flexibility in pursuing partnerships, out-licensing, or independent commercialization provides multiple options to realize value. This reduces financial risk and allows Imugene to leverage the expertise and distribution networks of established pharmaceutical companies for scaling

In summary, while Imugene's cancer therapies show potential due to novel approaches and differentiated mechanisms, limitations such as early-stage data, small sample sizes, and lengthy regulatory timelines could impact valuation and speed to market. Broader comparisons with FDA-approved treatments and robust Phase 2/3 data will be essential for confirming therapeutic viability and solidifying Imugene’s market position.