Imugene (ASX: IMU) has received firm commitments for a $37.5 million capital raising to advance the development of off-the-shelf (allogeneic) CAR-T drug azer-cel for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

The company will raise an initial $22.5 million from the placement of 68.2 million shares priced at $0.33 each, a 22.4% discount to the last closing price of $0.425 and a 19.6% discount to the five-day volume weighted average price of $0.410 post the company’s recent 34-for-1 share consolidation.

Proceeds will place the company in a strong financial position to progress the azer-cel program towards a pivotal Phase 2 clinical trial in the new year.

Share Purchase Plan

Imugene will follow the placement with a $15 million share purchase plan to existing eligible shareholders at the same price, with applications up to a maximum of $100,000.

Participants in both raisings will be eligible to receive three free attaching listed options for every four new shares, at an exercise price of $0.43 per option and a March 2026 expiry date.

They will also receive a piggyback option (equating to one additional free option for every attaching option) at an exercise price of $0.86 each and a June 2028 expiry.

Phase 1b Responses

Imugene’s capital raising follows positive news this week from a Phase 1b clinical trial that showed a total of nine patients had achieved complete or partial responses in their DLBCL using azer-cel and interleukin 2.

The same trial previously reported that four out of seven patients had achieved a complete response (CR), which is defined as the disappearance of all signs of cancer in response to treatment.

The company today confirmed two more patients had achieved CR and three achieved partial response (where the cancer is reduced by at least 50%), bringing the best overall response rate to 75% and the total CR rate to 55%.

Improved Position

Imugene managing director Leslie Chong said the new data significantly improved the company’s position from a regulatory and commercial standpoint.

“We are very pleased with continued positive data from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients for whom previous lines of therapy have failed,” she said.

“These latest results have validated a separate trial for other niche blood cancer indications such as primary central nervous system lymphoma and subtypes of B-cell lymphoma in CAR-T naïve patients—it is an area with high unmet need which could expedite and expand the scope of azer-cel.”

Ms Chong said Imugene would present the Phase 1b data at a meeting with the US Food and Drug Administration to discuss designs for a registrational azer-cel trial.

R&D Tax Refund

Imugene has received a research and development tax refund for the 2024 financial year totalling $5.87 million, including interest of $84,990.

The refund is part of the Australian government’s tax incentive scheme, which provides certain companies with a refundable tax offset of up to 48.5%.

Ms Chong said the refund would enable further clinical development of the company’s immuno-oncology pipeline.