Immutep Quarterly Activities Report Q1 FY27
Lower operating cash outflows and research tax rebates support an expected cash runway well into H1 CY28.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Immutep (NASDAQ: IMMP) is refocusing cancer drug efti’s potential registration-directed development on selected head and neck cancers and presurgical soft tissue sarcoma. Study starts are targeted for H2 CY27, subject to strategy, regulatory interactions, manufacturing, partnering and resources. Autoimmune candidate IMP761 is now a co-priority.
Following the discontinued TACTI-004 trial, an ongoing analysis identified structural differences between manufacturing scales; a new 200 L manufacturing run has been contracted. EFTISARC-NEO met its primary endpoint, while IMP761’s initial single-dose study met its safety endpoint in healthy volunteers. Cash and term deposits were approximately A$48.50 million at 30 September 2026; the company expects runway well into H1 CY28. Quarterly operating cash outflow fell to A$19.1 million from A$38.9 million. Nasdaq bid-price compliance was restored, but audit committee composition does not meet ASX requirements.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointEFTISARC-NEO met its primary endpoint: median tumour tissue change of 51.5% versus a 35% target, N=38, p<0.001.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Efti development preparations target H2 CY27 study starts in head and neck cancer with CPS <1 and presurgical sarcoma.
- Moderate pointEfti manufacturing restart has been contracted at 200 L, the scale used in earlier successful trials.
- Moderate pointIMP761’s single ascending dose study met its safety and tolerability primary endpoint in healthy volunteers.
- Moderate pointCost reductions, including targeted headcount cuts, largely took effect from the start of FY27.
- Moderate point. Forward-looking: it has not happened yet and may not happen.TACTI-004 payments are expected to decline significantly in subsequent quarters as trial activity winds down.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Cash and term deposits of approximately A$48.50 million support expected runway well into H1 CY28.
15 minor points
- Minor pointCompleted INSIGHT-003 reported median overall survival of 30.9 months in advanced or metastatic non-squamous first-line lung cancer.
- Minor pointINSIGHT-003 identified no new safety signal since the previous data cut-off.
- Minor pointEFTISARC-NEO showed statistically significant increases in blood cytokines and chemokines, indicating immune activation.
- Minor pointEfti received FDA Orphan Drug Designation for the presurgical soft tissue sarcoma setting in April 2026.
- Minor pointEFTISARC-NEO quality of life remained stable during presurgical treatment, without statistically significant deterioration on any measured scale.
- Minor pointPostsurgery quality-of-life summary scores improved 6.0 points; fatigue fell by up to 14.2 points versus baseline.
- Minor point. Forward-looking: it has not happened yet and may not happen.IMP761 is now a co-priority, with further Phase I updates expected at ACR Convergence in November 2026.
- Minor pointIMP761 reduced inflammatory responses and T-cell activity versus placebo; 7 mg/kg significantly inhibited skin blood perfusion, p=0.029.
- Minor pointIMP761’s pharmacokinetic profile supports once-every-four-weeks dosing.
- Minor pointPatent protection expanded with three grants covering an efti combination, IMP761 and an IMP761 potency assay.
- Minor pointResearch tax rebates supplied A$0.86 million during the quarter and €1.36 million after quarter-end.
- Minor pointGeneral and administrative cash use fell to A$1.2 million from A$1.5 million in Q4 FY26.
- Minor pointResearch and development cash use fell to A$16.5 million from A$22.0 million in Q4 FY26.
- Minor pointStaff payments declined to A$2.4 million from A$2.5 million in Q4 FY26.
- Minor pointNasdaq confirmed restored minimum bid price compliance; the matter is closed.
Negative
- Major pointTACTI-004 was discontinued early following a Phase III futility outcome.
- Moderate pointOngoing root cause analysis identified structural differences between 2,000 L TACTI-004 material and earlier 200 L material.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Targeted H2 CY27 study starts depend on strategy, trial design, regulatory interactions, manufacturing, partnering and resources.
- Moderate pointAIPAC-003, the Phase II metastatic breast cancer trial, closed effective 30 June 2026.
- Moderate pointProposed early-stage breast cancer Phase II study remains on hold pending root cause analysis and strategic decisions.
- Moderate pointAudit committee membership fell to two after Pete Meyers’ resignation, leaving noncompliance with ASX Listing Rule 12.7.
- Minor pointADS ratio change had a 1-for-20 reverse-split effect on 28 September 2026 following Nasdaq’s bid-price deficiency notice.
News Explained
Effective
Details
Market Reaction – IMMP
On Oct 29, the day this news came out, the latest delayed price for IMMP is 2.60% below the previous close. The latest delayed price is $3.23.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
- Tumour hyalinization/fibrosis
- 51.5% vs 35% prespecified target; p<0.001
- EFTISARC-NEO evaluable population (N=38); primary endpoint
- Median overall survival
- 30.9 months
- INSIGHT-003 overall study population; 51 evaluable patients
- Cash and term deposits
- A$48.50 million
- As at 30 September 2026
- Expected cash runway
- Well into H1 CY28
- Company expectation at the time of the report
- Australian R&D tax rebate
- A$0.86 million
- Received for eligible FY2025 R&D activities
- French R&D tax incentive payment
- €1.36 million (approximately A$2.16 million)
- Received after quarter-end for eligible CY2025 R&D activities
Key Terms
n-glycan structure technical
objective response rates (orr) medical
pharmacodynamic activity medical
pharmacokinetic profile medical
lag-3 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Media Release
- Immutep intends to focus the registration-directed clinical development of efti on HNSCC in patients with CPS <1 and the neoadjuvant setting of STS, with preparations for future clinical trials underway and study start targeted for H2 CY27.
- IMP761, the Company's agonist anti-LAG-3 antibody for autoimmune diseases, is now a co-priority alongside efti and will be the subject of a late breaking poster at the American College of Rheumatology (ACR) Convergence in November 2026.
- The ongoing root cause analysis following the discontinuation of TACTI-004 has identified structural differences between the 2000 L scale efti used in TACTI-004 and the 200 L scale efti used in earlier successful clinical studies. A new manufacturing run of efti at 200 L scale has been contracted.
- The Company received an A
$0.86 million cash rebate under the Australian Government’s R&D Tax Incentive for eligible FY2025 R&D activities and, subsequent to the end of the quarter,€1.36 million (approximately A$2.16 million ) from the French Government under its Crédit d’Impôt Recherche (CIR) program for eligible CY2025 R&D activities. - Cash and term deposits of A
$48.50 million at 30 September 2026, with cash runway expected to extend well into H1 CY28.
SYDNEY, AUSTRALIA, Oct. 29, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, provides an update on its activities for the quarter ended 30 September 2026 (Q1 FY27).
EFTILAGIMOD ALFA DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC
Following the early discontinuation of the TACTI-004 study, Immutep has been conducting a detailed root cause analysis.
In September, Immutep announced that the ongoing root cause analysis identified structural differences between the efti used in TACTI-004 and the efti used in earlier successful clinical studies. These differences (e.g. a subtle difference in N-glycan structure) are considered potentially relevant given the markedly different immune activation profile observed in TACTI-004 compared to previous trials and the unexpected clinical outcome of the study.
Based on the currently available data from the root cause analysis to date, Immutep believes that the unexpected outcome of TACTI-004 cannot be explained by clinical factors (e.g. suboptimal protocol, substantial imbalance between treatment arms or safety findings) or trial execution factors (e.g. invalid randomisation pattern or general clinical trial conduct).
The Company will provide a further update on the root cause analysis at its Annual General Meeting on 27 November 2026.
New Manufacturing Run
Based on the findings from the root cause analysis to date, Immutep has contracted a manufacturing run of efti at 200 L scale. Ten GMP batches of efti have previously been manufactured at 200 L scale and used in successful Phase I and Phase II clinical studies of efti, including TACTI mel, TACTI-002 and INSIGHT-003. In contrast, TACTI-004 was conducted exclusively with efti manufactured at 2,000 L scale.
Future Clinical Development Focus
Immutep currently intends to focus the potential registration-directed clinical development of efti on:
- HNSCC in patients with CPS <1; and
- the neoadjuvant setting of STS.
This focus reflects the compelling clinical data generated to date, the Company's interactions with the FDA, regulatory designations obtained, unmet medical need and substantial market potential in these indications.
Preparations for the next phase of clinical trials have commenced. Subject to final decisions on strategy and trial design, regulatory interactions, manufacturing timelines, partnering and resources, Immutep is targeting study start during H2 CY27.
Immutep’s licensing partner, Dr. Reddy's Laboratories (“DRL”), has been consulted on and is supportive of this approach. The Company is also in preliminary discussions with other parties regarding the proposed development pathway.
INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
The investigator-initiated INSIGHT-003 Phase I trial has been completed.
In this study, the combination of efti with KEYTRUDA® and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.
As previously announced, mature overall survival (OS) results from INSIGHT-003 (data cut-off 27 March 2026) demonstrated a median overall survival (mOS) of 30.9 months in the overall study population.1
These results compare favourably with historical benchmarks. No new safety signal was identified since the previous data cut-off.
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
Immutep announced in September that one of the two indications in which it intends to focus the registration-directed clinical development of efti is the neoadjuvant setting of soft tissue sarcoma (STS).
The investigator-initiated EFTISARC-NEO Phase II trial evaluating efti in combination with radiotherapy and KEYTRUDA® in the neoadjuvant setting for resectable STS has met its primary endpoint, with a median
Immutep also received Orphan Drug Designation for efti in this setting from the FDA in April 2026.
Subsequent to the end of the quarter, on 23 October 2026, Immutep announced health-related quality of life (HRQoL) data from the EFTISARC-NEO trial, presented in an ePoster at the ESMO Congress 2026 in Madrid. HRQoL, a secondary endpoint, remained stable during neoadjuvant treatment, with no statistically significant deterioration in any measured scale. After surgery, patients reported statistically significant improvements in the QLQ-C30 summary score (6.0 points; p=0.008) and in role and social functioning, and reported significantly lower fatigue than at baseline (by up to 14.2 points; p=0.001).
AIPAC-003 – Phase II Trial in Metastatic Breast Cancer
The AIPAC-003 Phase II trial evaluated efti in combination with chemotherapy in hormone receptor positive (HR+), HER2 negative/low metastatic breast cancer that is resistant to endocrine-based therapy, as well as in metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy. As previously announced, the trial closed effective 30 June 2026.
Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-Negative Breast Cancer
As previously announced, a proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer remains on hold pending completion of the root cause analysis related to TACTI-004 and further strategic decisions.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
IMP761 – Phase I Trial
Development of IMP761, the Company's agonist anti-LAG-3 antibody for autoimmune diseases, continues in line with previously disclosed plans and is now a co-priority alongside efti.
In June 2026, Immutep presented positive interim data from its placebo-controlled, double-blind, randomized, first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody, at the EULAR 2026 Congress in London.
The single ascending dose part of the study met its primary endpoint, demonstrating favourable safety and tolerability in healthy volunteers, with IMP761 well tolerated across all dose levels tested.
The data also showed statistically significant pharmacodynamic activity, including reduced local inflammatory responses and attenuated T-cell activity compared to placebo, with the 7 mg/kg dose achieving a statistically significant inhibition in skin blood perfusion (p = 0.029).
The pharmacokinetic profile supports once-every-four-weeks dosing. These encouraging results support further clinical evaluation of IMP761 in autoimmune diseases driven by T-cell-mediated inflammation, such as rheumatoid arthritis or type 1 diabetes, with additional trial updates expected at the American College of Rheumatology (ACR) Convergence 2026, taking place from 6 to 11 November 2026 in Orlando, Florida, USA. As announced on 19 October 2026, a late-breaking abstract on IMP761 has been accepted for poster presentation at the conference on 10 November 2026.
INTELLECTUAL PROPERTY
During the quarter, Immutep continued to build its patent estate and was granted three new patents.
In particular, as announced in July, Immutep was granted its fourth United States patent directed to efti in combination with a PD-1 pathway inhibitor.
The Company was also granted a Russian patent directed to IMP761 and an Australian patent directed to an assay used to measure the potency of IMP761 as part of a quality control step in the production of the agonist LAG-3 antibody.
CORPORATE AND FINANCIAL SUMMARY
Change to American Depositary Share Ratio
Following the Nasdaq minimum bid price deficiency notification announced on 30 April 2026, Immutep announced on 21 September 2026 a change to the ratio of its American Depositary Shares (ADSs), effective 28 September 2026 (US Eastern time), from one ADS representing 10 ordinary shares to one ADS representing 200 ordinary shares.
For holders of ADSs, the change has the same practical effect as a reverse split of the ADSs on the basis of one new ADS for every 20 ADSs held. The Company's ordinary shares quoted on the ASX are not affected, the number of ordinary shares on issue does not change, and the change does not alter the proportionate economic interest of any shareholder or ADS holder in the Company.
Subsequent to the end of the quarter, on 13 October 2026 Immutep announced that it had received written notification from Nasdaq confirming that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5450(a)(1), following a closing bid price at or above US
Board and Audit and Risk Committee
Subsequent to the end of the quarter, Pete Meyers resigned as a Non-Executive Director effective 2 October 2026. As announced on 9 October 2026, following Mr Meyers’ resignation the Audit and Risk Committee comprises two members and the Company is not currently in compliance with ASX Listing Rule 12.7. The Board has commenced a search for an additional independent non-executive director with financial and accounting expertise who, once appointed, is intended to join the Audit and Risk Committee and be invited to chair it. The Company expects to complete the appointment during the financial year ending 30 June 2027. In the interim, Lis Boyce is acting as Chair of the Audit and Risk Committee. The Committee’s recommendations on financial reporting, accounting judgements and external audit continue to be referred to the full Board.
Cash Flow Summary
During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.
In September, Immutep announced it had received an A
Subsequent to the end of the quarter, on 28 October 2026, Immutep announced it had received a cash payment of
The non-dilutive funding from both incentives will be applied to Immutep's current R&D activities for its product candidates, efti and IMP761. Immutep's expected cash reach extends well into the first half of CY28.
The net cash used in G&A activities in the quarter was A
In Q1 FY27, cash receipts from customers were A
Payment for staff costs was A
Total net cash inflow received in investing activities for the quarter was A
As at 30 September 2026, Immutep had total cash and term deposits of approximately A
Payments to related parties and their associates of A
After the TACTI-004 Phase III futility outcome, the Company has initiated cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions, most of which took effect from the start of FY27. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend well into H1 of CY28.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases. The Company is a pioneer in the understanding and advancement of therapeutics related to the Lymphocyte Activation Gene-3 (LAG-3)/MHC Class II immune control mechanism, and its diversified product portfolio harnesses the ability of this mechanism to stimulate or suppress the immune system. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Forward Looking Statements
This announcement contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995, including statements regarding the ongoing root cause analysis relating to TACTI-004; the manufacture of efti at 200 L scale; Immutep’s intended clinical development focus for efti in HNSCC and STS, including the design, regulatory interactions and targeted start of future clinical trials; partnering discussions, including with DRL and other parties; the anticipated timing of further clinical updates for IMP761; expected reductions in TACTI-004 payments and other operating costs; and Immutep’s expected cash runway. Forward-looking statements can be identified by words such as “anticipate”, “believe”, “expect”, “intend”, “plan”, “target”, “potential”, “may”, “will”, “should” and similar expressions.
Forward-looking statements are based on Immutep’s current expectations and assumptions as at the date of this announcement and are subject to known and unknown risks, uncertainties and other factors, many of which are beyond Immutep’s control, that could cause actual results to differ materially from those expressed or implied. These include: the findings and timing of the root cause analysis, which is not complete and may not identify a conclusive cause for the outcome of TACTI-004; whether efti manufactured at 200 L scale will be comparable to efti used in earlier clinical studies, and the timing and success of the new manufacturing run; the results of ongoing and future clinical trials, which may not replicate earlier results; the requirements of the FDA and other regulators for future trials; Immutep’s ability to enter into partnering arrangements and the terms of any such arrangements; the actual timing and amount of TACTI-004 wind-down costs and other expenditure; the timing and amount of R&D tax incentives; Immutep’s ability to obtain additional funding; and the other risks described in Immutep’s filings with the ASX and the US Securities and Exchange Commission, including its most recent Annual Report on Form 20-F.
Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this announcement. Except as required by law or the ASX Listing Rules, Immutep undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
- Immutep press release - 13 July 2026
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
U.S. Investors/Media:
Matthew Beck
Ph: +1 (917) 415-1750; matthew.beck@astrpartners.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Which cancer indications is Immutep prioritizing for efti, and when could new trials start?
Immutep intends to focus potential registration-directed development on head and neck squamous cell carcinoma with CPS <1 and soft tissue sarcoma treatment before surgery, targeting study starts during H2 CY27. Timing remains subject to strategy and trial design decisions, regulatory interactions, manufacturing timelines, partnering and resources.
How much cash does Immutep have and how long is its expected runway?
Immutep held approximately A$48.50 million in cash and term deposits at 30 September 2026 and expects its cash runway to extend well into H1 CY28. The balance excludes the subsequent French research tax incentive payment of €1.36 million, approximately A$2.16 million.
When will Immutep provide another TACTI-004 root cause analysis update?
Immutep plans to provide a further root cause analysis update at its Annual General Meeting on 27 November 2026. The analysis remains ongoing; the identified manufacturing-scale structural differences are considered potentially relevant to the trial’s different immune activation profile and unexpected outcome.
How does Immutep plan to address its audit committee compliance issue?
Immutep is searching for an additional independent non-executive director with financial and accounting expertise and expects an appointment during the financial year ending 30 June 2027. The appointee is intended to join and be invited to chair the committee. Lis Boyce is acting chair, and financial reporting, accounting judgement and external audit recommendations continue to go to the full Board.