In recent months Imugene (IMU: $0.30) has been generating very encouraging data from its Azer-Cel immunotherapy program. However its high cash burn with a falling market capitalisation has seen the company reduce internal funding on other programs to focus on the Azer-Cel technology.
Strong Results in Car-T Naïve Patients
In July this year Imugene opened up the Azer-Cel program to include patients with different types of B-cell lymphomas who had not previously received any CAR-T therapies. However these patients had been heavily pretreated with other therapies.
From the first six patients, there was a response in five patients, which were three complete responses and two partial responses (83% response).
This follows the study in 16 patients with DLBCL (Diffuse Large B-cell Lymphoma) who had all failed CAR-T therapy. In that patient population, a response rate of 81% was achieved, made up of seven complete responses and six partial responses. Three of the complete responses have extended out beyond six months so far.
Imugene intends to meet with the FDA this quarter to discuss the regulatory path to market in DLBCL in patients who have failed CAR-T therapies. It is also plans to continue recruiting CAR-T treatment naïve patients for treatment.
Funding Constraints
In the September quarter the company's cash burn was $12.6 million, which was down 48% from the previous corresponding period. Imugene finished September with $32 million in cash, which is just over six months of cash. The company also has $20 million in debt in the form of Convertible Notes.
Progressing to FDA discussions around a pivotal study in DLBCL (in patients who have failed CAR-T) has also triggered a milestone payment to Precision Biosciences, from whom the company acquired the technology. Imugene will pay Precision US$3 million and around $6 million in IMU shares. Precision has become a substantial shareholder in Imugene with a 6.2% stake as a result.
Securing an out-licensing deal for Imugene for one of its now non-core technologies has become a priority. The technologies that may be monetised include its oncolytic virus CF33, CF33-CD19, and its antibody immunotherapy program, PD1-Vaxx.
The Azer-cel technology is an allogeneic approach that combines IL-2 as a non-personalised therapy.
Imugene is capitalised at $89 million.
Bioshares recommendation: Speculative Hold Class B
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