Earlier in the year the company reported that, from seven patients treated, a complete response had been achieved in four patients (57% response). This month the company announced that, from an additional five patients treated, two achieved a complete response and three a partial response. This brings the complete response rate to 55% (six of the 11 evaluable patients).
The appealing aspect of this technology is that it is an allogeneic (off-the-shelf) CAR T therapy, not requiring reprocessing of a patient’s own T-cells (autologous). Also very encouraging is that the complete responses, albeit in a small patient population, are similar to those achieved with the more complicated and expensive autologous CAR T therapies such as Yescarta (54%), Breyanzi (53%) and Kymriah (40%) in patients with DLBCL who had also failed at least two lines of therapy.
The focus now for Imugene is to progress this therapy into a pivotal study next year. The company has received Fast Track Designation from the FDA for this program.
Capital Raising
To support the pivotal study, the company is raising up to $37.5 million through a placement ($22.5 million) and a share purchase plan (up to $15 million). Imugene recently conducted a share consolidation on a 1 for 34 basis. The capital raise is being conducted at $0.33 per share (or $0.01 per share on an unconsolidated basis), representing a 30% discount to the 20-day VWAP.
There are also options attached to the newly issued shares, which could raise additional significant funds if the share price moves higher. Following the raise, Imugene will have a pro forma cash balance at June 30 of $64 million.
Summary
The Azer-cel technology was acquired by Imugene in 2023, with prior data from the treatment of 84 patients. Imugene is seeking for its therapy to become the first allogeneic CAR T therapy to reach the market.
Key upcoming milestones include outcomes from dialogue with the FDA regarding the pivotal study, additional Phase Ib data from the current DLBCL study, and treatment and results from applying the technology to CAR T-naïve patients in similar niche blood cancers to DLBCL.
With the company developing a suite of immuno-oncology treatments, it is positive to see Imugene focus now on a path to market for arguably its most promising therapy. On an undiluted basis, Imugene is capitalized at $81 million.
Bioshares recommendation: Speculative Buy Class A
Disclaimer:
Information contained in this newsletter is not a complete analysis of every material fact respecting any company, industry or security. The opinions and estimates herein expressed represent the current judgement of the publisher and are subject to change. Blake Industry and Market Analysis Pty Ltd (BIMA) and any of their associates, officers or staff may have interests in securities referred to herein (Corporations Law s.849). Details contained herein have been prepared for general circulation and do not have regard to any person’s or company’s investment objectives, financial situation and particular needs. Accordingly, no recipients should rely on any recommendation (whether express or implied) contained in this document without consulting their investment adviser (Corporations Law s.851). The persons involved in or responsible for the preparation and publication of this report believe the information herein is accurate but no warranty of accuracy is given and persons seeking to rely on information provided herein should make their own independent enquiries. Details contained herein have been issued on the basis they are only for the particular person or company to whom they have been provided by Blake Industry and Market Analysis Pty Ltd. The Directors and/or associates declare interests in the following ASX Healthcare and Biotechnology sector securities: Analyst MP: 1AD, ACR, AVR, CGS, CUV, CYC, DXB, IMM, LBT, MX1, OPT, NEU, PAB, PXS,RNO,SOM. These interests can change at any time and are not additional recommendations. Holdings in stocks valued at less than $100 are not disclosed.
