A report from Diamond Equity Research has detailed how Imugene Ltd (ASX:IMU, OTC:IUGNF) is bolstering its clinical-stage oncology pipeline with promising trial outcomes and a strategic financial position, valuing the company’s shares at 11 times (A$0.49) their current trading price (A$0.044).
The biotechnology firm’s efforts to advance innovative cancer immunotherapies, including its azer-cel CAR T-cell therapy and CF33 oncolytic virotherapy, are backed by a robust cash balance of A$54.26 million as of the first quarter of the financial year.
Complete responses in patients
The analysts believe Imugene’s azer-cel CAR T-cell therapy, developed for patients with diffuse large B-cell lymphoma (DLBCL), is shaping up as a strong contender in the fight against cancer.
They cite an ongoing Phase 1b trial in the US that has reported three complete responses – full recoveries – among 10 patients, including two in Cohort B, which combines azer-cel with lymphodepletion and interleukin-2 (IL-2) to enhance treatment durability.
These patients demonstrated extended response durations exceeding 90 days, underscoring the potential efficacy of this off-the-shelf, allogeneic CAR T-cell approach.
Following these positive interim results, Imugene is expanding patient enrolment and preparing for a pivotal Phase 2/3 trial submission with the US Food and Drug Administration (FDA).
VAXINIA shows potential
Imugene has initiated a Phase 1 expansion study for its CF33 oncolytic virotherapy, marketed as VAXINIA, at St Vincent’s Hospital in Melbourne.
This trial expansion follows Orphan Drug Designation by the FDA, which provides tax benefits and potential market exclusivity in treating cholangiocarcinoma, a rare but aggressive cancer type.
Previously, the FDA granted Fast Track Designation to VAXINIA, enabling an expedited review process.
VAXINIA’s early results indicate its potential in treating bile tract and gastrointestinal cancers, supporting Imugene’s push into novel cancer treatments.
Imugene’s financial update reflects strategic management, with a significant allocation of resources to research and development (71% of Q1 expenses).
Operating expenses for Q1 FY2025 amounted to A$24 million, including an A$14.4 million milestone payment to Precision Biosciences related to the azer-cel program.
With its current cash reserves, the company is positioned to support ongoing and upcoming trials across its immunotherapy portfolio.
In its wider pipeline, Imugene’s HER-Vaxx B-cell immunotherapy targets HER2-positive cancers, and recent clinical progress in immunotherapies provides a solid foundation for upcoming milestones.
The analysts have set a valuation target of A$0.49 per share, anticipating further value from clinical advances and regulatory support.
Collaborations on onCARlytics
In addition to its proprietary developments, Imugene has entered strategic partnerships with Eureka Therapeutics, Arovella Therapeutics and Celularity Inc, aimed at enhancing its onCARlytics platform.
These collaborations are expected to expedite trial processes and strengthen Imugene’s offerings within both allogeneic and autologous CAR T-cell applications.
With additional clinical milestones projected through 2026, Diamond Equity Research says Imugene is well-positioned to achieve regulatory progress, expand patient access and strengthen its market position in the competitive oncology space.