Welcome to our dedicated page for Immutep SEC filings (Ticker: IMMP), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Immutep Limited filings document foreign-private-issuer disclosures for a clinical-stage biotechnology company whose ADRs trade on Nasdaq and whose ordinary shares trade on ASX. Recent Form 6-K reports furnish ASX releases, quarterly activities reports and half-year financial information covering research and development spending, cash resources, clinical trial expenses and operating results.
The filings also record program-specific disclosures for eftilagimod alfa and IMP761, including TACTI-004, INSIGHT-003 and EFTISARC-NEO updates, FDA orphan drug designation in soft tissue sarcoma, development collaborations, and Nasdaq minimum-bid-price compliance notices. These documents describe clinical, regulatory, liquidity and capital-market matters for Immutep's LAG-3 immunotherapy portfolio.
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.
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.