Q1 FY27 highlights: azer-cel responses build as cash outflow falls 19%
In its Q1 FY27 quarterly report for the period ended 30 September 2026, Imugene Limited (ASX: IMU) recorded an overall response rate (ORR) of 86% in Cohort 3 of its azer-cel Phase 1b trial, with updates reported after quarter end. The result comprised three complete responses (CRs) and three partial responses (PRs) among six of seven evaluable patients, all of whom had progressed on prior Bruton Tyrosine Kinase inhibitor (BTKi) therapy.
The clinical-stage cell therapy company also reported a Cohort 2 ORR of 81% (22 of 27 patients) and completed a placement of $11.12 million before costs. Net operating cash outflow fell 19% to $7.49m, and cash stood at $5.25m at quarter end.
Key points from the quarter:
- Cohort 3 ORR of 86%, with all seven enrolled patients previously progressed on a BTKi
- Cohort 2 ORR of 81% (22 of 27 evaluable patients)
- Two-tranche placement completed, raising $11.12 million before costs
- $2.1 million of existing CVI convertible notes redeemed and replaced with new notes maturing in January 2030
- Staff costs down 51%, with Leslie Chong stepping down as CEO and Managing Director and Dr John Le Gall appointed Chief Medical Officer after quarter end
When big ASX news breaks, our subscribers know first
Azer-cel Phase 1b delivers responses across three cohorts
Azer-cel (azercabtagene zapreleucel) is an off-the-shelf, allogeneic CD19-directed CAR T-cell therapy being developed for B-cell blood cancers. The Phase 1b trial in the US and Australia has three cohorts, covering patients who relapsed after CAR T therapy, patients who are CAR T-naïve, and patients who progressed on a BTKi.
Cohort 3: azer-cel with a BTKi
BTK inhibitors are a well-established standard of care across several B-cell malignancies, including chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL). Many patients eventually progress on them, and treatment options are limited. Cohort 3 gives azer-cel while patients continue BTKi therapy, with published studies combining a BTKi and approved autologous CD19 CAR T therapies in MCL and CLL providing the rationale.
Enrolment continued during the quarter across ten sites in the United States and five in Australia. As at 19 October 2026, response data were as follows:
| Tumour type | Evaluable patients | Responders | Result |
|---|---|---|---|
| Follicular lymphoma (FL) | 2 | 2 | 2 of 2 |
| Mantle cell lymphoma (MCL) | 3 | 2 | 2 of 3 |
| CLL | 1 | 1 | 1 of 1 |
| Richter’s transformation | 1 | 1 | 1 of 1 |
The responses built progressively:
- 30 June 2026: the first patient, with FL, achieved a CR
- 27 July 2026: an MCL patient achieved a CR and a second FL patient achieved a PR, both at the Day 28 assessment
- 5 October 2026: Day 28 assessments for four further patients showed a CR in a second MCL patient, a PR in a CLL patient, stable disease in a Richter’s transformation patient and progressive disease in a third MCL patient
- 19 October 2026: the Richter’s transformation patient improved from stable disease to a PR
Imugene described these as early results in a small number of patients, with most responses assessed at Day 28. Further follow-up is needed to establish durability and how the combination performs in a larger number of patients.
Cohorts 1 and 2
On 19 October 2026, the company reported a CR at Day 28 in a CAR T-naïve patient with marginal zone lymphoma (MZL). The Cohort 2 ORR is 81% (22 of 27 evaluable patients).
As of 5 October 2026, the ORR in Cohort 1 (CAR T-relapsed diffuse large B-cell lymphoma) was 68% across 22 evaluable patients. Imugene stated that the safety and tolerability profile of azer-cel across the Phase 1b trial remains manageable.
What an off-the-shelf allogeneic CAR T means for investors
CAR T therapies are made from T cells, a type of immune cell. Autologous products use the patient’s own cells and require a manufacturing period of three to six weeks. Azer-cel is allogeneic, meaning it is manufactured from healthy donor T cells, and is designed to be available within days.
Three response terms recur in the data. A CR means no detectable signs of cancer, while a PR typically means a reduction in tumour burden of at least 50%. ORR is the proportion of evaluable patients achieving a CR or PR.
For investors, Cohort 3 is testing whether azer-cel, given alongside continued BTKi therapy, can produce responses in patients who have progressed on a BTKi and have limited options. The data remain early and small, and durability is yet to be established.
Financial results: placement completed and costs cut
Cash flow and expenditure
Azer-cel Phase 1b activity continued to drive operating expenditure. Imugene said it continues to reduce its cost base and focus spending on the azer-cel program.
| Item | Q1 FY27 | Previous quarter |
|---|---|---|
| Net operating cash outflow | $7.49m | $9.21m |
| Staff costs | $1.91m | $3.90m |
| Direct research and development | $4.31m (57% of operating payments) | $4.26m (46%) |
| Administration and corporate costs | $1.33m | $1.07m |
| Cash and cash equivalents | $5.245m | $2.63m |
Staff costs fell 51%, reflecting reduced headcount. Administration and corporate costs rose 24%, primarily due to corporate activities associated with the July 2026 placement and the convertible note amendment.
Net cash from financing activities was $10.12 million. That comprised placement proceeds of $11.12 million, less transaction costs of $0.58 million, repayment of short-term financing of $0.23 million and other outflows of $0.19 million.
Quarter-end cash excludes the FY26 R&D tax incentive refund of approximately $2.1 million, which the company expects to receive in the December 2026 quarter.
Placement (Transaction 1)
During the quarter, Imugene completed a two-tranche placement of approximately 117.1 million new shares at $0.095 per share. The first tranche of around 73.7 million shares, totalling $7.0 million, included an international commercial-stage biopharmaceutical company, which accounted for approximately 14% of the total placement.
Shareholder approval for the second tranche was obtained at an Extraordinary General Meeting held during the quarter, where all resolutions passed on a poll. That tranche included shares issued to Executive Chairman Paul Hopper and former Chief Executive Officer Leslie Chong. Proceeds are being applied to azer-cel development, including Cohorts 2 and 3, and to regulatory planning.
CVI convertible note amendment (Transaction 2, separate from the placement)
On 21 August 2026, $2.1 million of existing notes held by CVI Investments, Inc. (CVI) were redeemed and cancelled, and replaced with new senior, unsecured, zero-coupon convertible notes maturing in January 2030 (TAR Notes). The TAR Notes carry an initial conversion price of $0.0664, equal to 80% of the reference price, with quarterly reset provisions subject to a floor price of $0.0398.
Repayments occur in four equal quarterly instalments, which the company can settle in cash at 110% or in shares, subject to conditions and CVI’s right to defer. On 8 September, 50% of the TAR Notes were redeemed in shares.
CVI also received 25,301,205 unlisted warrants exercisable at $0.0664 and expiring in August 2031, which would raise up to $1.68 million if exercised. Total convertible notes outstanding at quarter end had a face value of $10.525 million.
Leadership changes and what comes next
Leslie Chong stepped down as Chief Executive Officer and Managing Director for personal reasons after nearly 11 years of service. The senior leadership team will report to the Executive Chairman until new leadership commences with the company.
After quarter end, Dr John Le Gall MD MBA, former Vice President, Head of Clinical Development at Allogene Therapeutics, was appointed Chief Medical Officer. He replaces Dr John Byon, who stepped down by mutual agreement and will continue to support the organisation as a consultant, and no interruption to the azer-cel program is anticipated.
The Appendix 4C estimates 0.70 quarters of funding available. The Board is continuing to assess alternative capital sources, and the Directors believe the company can raise sufficient capital through equity financing and/or non dilutive inflows.
Upcoming items stated in the report:
- Annual General Meeting: the Notice was released after quarter end. Resolutions include adoption of the 2026 Remuneration Report, the election of directors Michael Kotsanis and Charmaine Gittleson, the re-election of director Kim Drapkin, approval of the employee incentive plan and additional 10% placement capacity under Listing Rule 7.1A, and ratification of the TAR Notes and warrants issued to CVI.
- R&D tax incentive refund: Imugene expects to receive approximately $2.1 million for FY26 in the December 2026 quarter.
- Cohort 3 data: the company will report further data as enrolment continues and the data mature.
- TAR Notes instalments: four equal quarterly instalments begin three months after the 21 August 2026 issue.
Curious About Imugene’s Azer-Cel Phase 1b Progress?
Imugene’s off-the-shelf CAR T therapy, azer-cel, delivered an 86% overall response rate in Cohort 3 and 81% in Cohort 2, while net operating cash outflow fell 19%. With a $11.12 million placement completed and further data expected as enrolment continues, the program remains the company’s central focus.
Investors seeking the full detail behind these results can visit the Imugene ASX announcements page to review the latest clinical updates and quarterly reporting. Explore the data to assess how azer-cel’s progress may shape the company’s investment potential.