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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.
Immutep Limited reports that the U.S. FDA has granted Orphan Drug Designation to its immunotherapy candidate eftilagimod alfa (efti) for treating Soft Tissue Sarcoma, a rare cancer with significant unmet need. Orphan status can provide regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval.
The designation is supported by Phase II EFTISARC-NEO trial data in 38 evaluable patients, where efti with radiotherapy and KEYTRUDA achieved a median tumour hyalinization/fibrosis of 51.5%, beating the pre-set 35% target and historical ~15% with radiotherapy alone, with immune activation signals and a favourable safety profile.
IMMUTEP Ltd director and officer Marc Voigt has filed an initial ownership report showing substantial equity exposure to the company. He directly holds 14,791,695 Ordinary Shares, plus 450 additional Ordinary Shares, and 85,250 Ordinary Shares are held indirectly through JP Morgan Nominees Australia Limited.
Voigt also holds three tranches of performance rights over 1,200,000 underlying Ordinary Shares each, with a zero exercise price. According to the footnotes, 1,200,000 performance rights are scheduled to vest on December 1, 2026, and further 1,200,000-share tranches are scheduled to vest on December 1, 2027 and December 1, 2028, in each case subject to key performance indicators. The Ordinary Shares are represented by American Depositary Shares.
IMMUTEP Ltd Chief Operating Officer Deanne Diem Miller reported her initial ownership on a Form 3. She directly holds 2,867,305 Ordinary Shares. In addition, she holds 1,800,000 performance rights, each giving a right to receive Ordinary Shares at an exercise price of $0.0000 per share.
These performance rights are structured in three equal tranches of 600,000 underlying Ordinary Shares each, scheduled to vest on December 1, 2026, December 1, 2027, and December 1, 2028. Vesting of the later tranches depends on Ms. Miller achieving specified key performance indicators at the applicable vesting dates.