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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 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 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 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.
IMMUTEP Ltd director Pete A. Meyers filed an initial ownership report showing both ordinary shares and performance rights. He holds 4,052,173 Ordinary Shares directly. In addition, he holds performance rights over blocks of 388,889, 758,631, 650,000, and 650,000 underlying Ordinary Shares at an exercise price of $0.0000 per share.
The footnotes state these performance rights were granted on December 16, 2022 and December 2, 2025. Vesting dates run from October 1, 2026 through December 1, 2029, and each grant is dependent on Mr. Meyers meeting specified vesting conditions, with expiration dates extending to December 2, 2030.
IMMUTEP Ltd Chief Medical Officer Stephan Karel Gerard Winckels filed an initial ownership report showing his equity position. He directly holds 92,935 Ordinary Shares and three blocks of 221,708 performance rights each over Ordinary Shares, with vesting dates in 2026, 2027 and 2028 and an exercise price of $0.0000. The vesting of these performance rights depends on achieving specified key performance indicators and they expire in 2030.
IMMUTEP Ltd director Dr. Russell Howard has filed an initial Form 3 showing his equity interests in the company. The filing reports performance rights over 50,000 Ordinary Shares granted on November 23, 2023, which may vest on December 1, 2026 if vesting conditions are met. Additional performance rights granted on December 2, 2025 cover 400,154 Ordinary Shares scheduled to vest on December 1, 2026, and two further tranches of 461,746 performance rights each that may vest on December 1, 2027 and December 1, 2028, all subject to specified vesting conditions. The Form 3 also reports 1,717,977 Ordinary Shares held indirectly through Regulus Star Pty Ltd.