Immutep Limited (IMMP) regained compliance with Nasdaq’s minimum bid price requirement after the closing bid price of its American Depositary Shares was at or above US$1.00 per ADS for 10 consecutive business days, from September 28, 2026, through October 9, 2026. Nasdaq confirmed the matter is closed. To address the earlier deficiency, Immutep changed its ADS ratio effective September 28, 2026: one ADS represents 200 ordinary shares, compared with one ADS representing 10 ordinary shares previously. The company said the change did not affect its ordinary shares, which continue to trade on the ASX under IMM.
Immutep Limited (IMMP) is changing the ratio of its American Depositary Shares quoted on the Nasdaq Global Market to address a Nasdaq minimum bid price deficiency. Effective from the start of trading on September 28, 2026, the ADS ratio will change from 1 ADS = 10 ordinary shares to 1 ADS = 200 ordinary shares, which is equivalent in practice to a 1‑for‑20 reverse split of the ADSs.
After the change, Immutep expects the number of ADSs on issue to decrease from approximately 32.8 million to approximately 1.64 million, while the number of ordinary shares on issue remains 1,473,721,306. No ordinary shares are being issued or cancelled and shareholder and ADS holder proportional economic interests are unchanged, aside from cash in lieu for fractional ADS entitlements. The company states that the ratio was set to create a generous margin above Nasdaq’s US$1.00 minimum bid price requirement ahead of the current compliance deadline of October 26, 2026.
Immutep Limited (IMMP) outlines a revised development strategy for its lead immunotherapy eftilagimod alfa (efti) after the early discontinuation of the TACTI-004 trial. An ongoing root cause analysis has found structural differences between efti used in TACTI-004 and product used in earlier, more successful studies, including a subtle N-glycan variation, which may relate to the different immune activation profile seen in that trial.
Immutep has initiated a new 200 L manufacturing run of efti, consistent with ten prior GMP batches used in earlier Phase I/II studies, whereas TACTI-004 used only 2,000 L–manufactured product. The company plans to focus registration-directed development of efti on selected indications based on clinical data, FDA interactions and existing Fast Track and Orphan Drug designations, targeting trial starts in 2H CY2027, subject to strategy, regulatory, manufacturing, partnering and resource factors. Partner Dr. Reddy’s Laboratories supports the approach, and development of second program IMP761 for autoimmune disease continues as previously planned.
Immutep Limited (IMMP) reported its FY2026 results and operational review for the year ended June 30, 2026. Total revenue and other income rose to A$24.2 million, mainly from A$14.56 million of licensing revenue from Dr Reddy’s, but the loss after tax widened to A$79.3 million from A$61.4 million as research and development and IP expenses increased to A$91.9 million.
The company ended FY2026 with A$68.9 million in cash, cash equivalents and term deposits and expects this to fund operations well into the first half of CY2028. Net tangible asset backing per share declined to 4.1 cents from 9.3 cents. No dividends were paid.
Operationally, Immutep discontinued its pivotal TACTI‑004 Phase III lung cancer trial after a futility analysis showed underperformance versus control, and it repaid US$10 million of a US$20 million upfront from Dr Reddy’s. At the same time, it reported encouraging data from INSIGHT‑003, EFTISARC‑NEO and the IMP761 Phase I autoimmune program, and obtained FDA Orphan Drug Designation for efti in soft tissue sarcoma. Immutep also received a Nasdaq notice for non‑compliance with the US$1.00 minimum bid price requirement.
Immutep Limited reported mixed Q4 FY26 progress across its oncology and autoimmune pipelines alongside detailed cash flow data. A pooled analysis of five efti trials in 592 cancer patients showed increased absolute lymphocyte counts and a 7.7‑month median overall survival advantage for ALC responders.
The Phase III TACTI‑004 lung cancer trial was discontinued after an interim futility analysis, with objective response rates of 42.9% for efti versus 55.1% for control; a root cause review, including manufacturing aspects, continues. In contrast, INSIGHT‑003 showed median overall survival of 30.9 months, EFTISARC‑NEO met its primary immune‑activation objective and gained FDA orphan drug designation, and AIPAC‑003 in metastatic breast cancer completed follow‑up.
First‑in‑human IMP761 demonstrated favourable safety, pharmacodynamic activity and a pharmacokinetic profile supporting four‑weekly dosing. Cash, cash equivalents and term deposits were approximately A$68.87 million at 30 June 2026, about A$29.2 million above budget, and cost‑reduction measures are expected to support a cash runway extending well into H1 CY2028.
Immutep Limited reported mature results from the investigator-initiated INSIGHT-003 Phase I trial of eftilagimod alfa (efti) plus pembrolizumab and chemotherapy in first-line advanced non-squamous NSCLC. In 51 evaluable patients, median Overall Survival was 30.9 months in the overall population and in patients with PD-L1 TPS <50%, and 37.8 months in those with TPS ≥50%. These outcomes are described as comparing favourably with a 22.0‑month median Overall Survival reported for an anti‑PD‑1 plus doublet chemotherapy registrational trial, despite approximately 92% of INSIGHT-003 patients having TPS <50%.
Separately, Immutep previously decided to discontinue the TACTI-004 Phase III 1L NSCLC trial after a futility analysis recommended by the Independent Data Monitoring Committee. In 173 patients, objective response rate was 42.9% in the efti arm versus 55.1% in the placebo control arm, with no superiority seen in any TPS subgroup. By contrast, objective response rate in INSIGHT-003 has been 62.7%. A root cause analysis, including evaluation of distinct immune activation patterns and potential manufacturing factors, is ongoing with further results expected in Q3 CY2026.
Immutep Limited reported encouraging interim Phase I results for its lead autoimmune candidate IMP761, a first-in-class LAG-3 agonist antibody. In a randomized, placebo-controlled, double-blind first-in-human study in healthy volunteers using a KLH immune challenge model, IMP761 showed significant pharmacodynamic activity.
Doses from 0.9 mg/kg to 7 mg/kg reduced local inflammatory responses and attenuated T-cell activity versus placebo, with 7 mg/kg statistically significantly better for skin blood perfusion (p = 0.029). IMP761 was safe and very well tolerated at all dose levels, and the single ascending dose part met its primary endpoint. Pharmacokinetics support once-every-4-weeks dosing and the data support advancing IMP761 into Phase II studies in T cell–driven autoimmune diseases.
Immutep Limited ended its Phase III TACTI-004 lung cancer trial after an independent committee’s futility analysis showed the efti combination arm underperformed the control arm. The company is winding down the study and conducting a root cause analysis that may extend into Q3 CY2026.
Other efti programs continue, including encouraging INSIGHT-003 lung cancer data, the EFTISARC-NEO soft tissue sarcoma trial meeting its primary objective, and ongoing AIPAC-003 metastatic breast cancer follow-up. First-in-human Phase I testing of autoimmune candidate IMP761 progressed into a multiple ascending dose phase without safety concerns observed at doses up to 14 mg/kg.
Immutep reported cash, cash equivalents and term deposits of about A$110.6 million as of 31 March 2026, supported by A$28.85 million Q3 receipts mainly from a US$20 million upfront payment from Dr. Reddy’s. A US$10 million payment to Dr. Reddy’s is now due by June 2026 following the TACTI-004 discontinuation, and cost reductions are underway, with the cash runway expected to extend into H1 CY28.
Immutep Limited received a Nasdaq notice that its American Depositary Shares no longer meet the exchange’s minimum bid price requirement of US$1.00 per share, after trading below that level for 30 consecutive business days ended 24 April 2026. The notice has no immediate effect on Nasdaq listing or trading. Immutep has 180 calendar days, until 26 October 2026, to regain compliance by having its closing bid at or above US$1.00 for at least ten consecutive business days. The company plans to monitor its share price and consider options to restore compliance, while its ordinary shares continue to trade on the ASX.
IMMUTEP Ltd director Elisabeth Amanda Boyce reports direct ownership of 423,288 Ordinary Shares and several performance rights over additional shares. These performance rights have a $0.00 exercise price and, if vesting conditions are met, are scheduled to vest in tranches on December 1, 2026, December 1, 2027, and December 1, 2028, with expiration dates extending to November 23, 2028 and December 2, 2030.