Highlights

  • Shares surged 26.19% to A$0.027 on 9 November 2026, lifting Market Capitalisation to about A$39.06 million.
  • Cash of A$48.50 million at 30 September 2026 is expected to fund operations into the first half of 2028.
  • Root cause analysis of the failed TACTI-004 trial points to efti manufacturing-scale differences, with further findings due 27 November.
  • IMP761, a LAG-3 agonist for autoimmune disease, now ranks alongside efti, with a late-breaking ACR poster due 10 November.

A 26.19% rally to A$0.027 on 9 November 2026 has given Immutep Limited (ASX:IMM) some relief after a punishing year in which the shares fell almost 90%. The clinical-stage biotechnology company used its first-quarter FY27 update to lay out a leaner cost base, a narrower cancer strategy and a growing autoimmune program, all while explaining what went wrong in its failed Phase III trial.

Leaner Spending Extends the Runway

Net operating outflow fell to A$19.1 million in the September quarter from A$38.9 million in the prior quarter, as Research and Development cash use dropped to A$16.5 million with the TACTI-004 wind-down. Cash and term deposits closed at A$48.50 million. Management expects the balance to last into the first half of calendar 2028 after cost reductions, although the Appendix 4C calculation showed 2.53 quarters because the period included large trial close-out payments.

Immutep also received about A$2.16 million from the French research tax incentive after quarter end, plus A$0.86 million from the Australian incentive during the period.

Explaining the TACTI-004 Setback

The Phase III trial in first-line non-small cell lung cancer was stopped early after a futility outcome. The company's root cause analysis found structural differences, including a subtle N-glycan difference, between efti produced at 2,000-litre scale, used only in TACTI-004, and the 200-litre scale used in earlier studies. Immutep said current data do not point to clinical or trial-execution factors, though the analysis is incomplete. It has contracted a new 200-litre Manufacturing run.

A Narrower Efti Pipeline

Registration-directed work now centres on head and neck cancer with a PD-L1 combined positive score below one, and neoadjuvant soft tissue sarcoma. The Phase II EFTISARC-NEO trial met its primary endpoint, with median tumour hyalinisation or fibrosis of 51.5% in 38 patients against a 35% target, and the FDA granted Orphan Drug designation in April 2026. The INSIGHT-003 study reported median overall survival of 30.9 months in 51 evaluable patients.

IMP761 Steps Forward

IMP761, a first-in-class LAG-3 agonist antibody, is now a co-priority. Interim Phase I data presented in June showed the single-ascending-dose part met its primary endpoint with favourable safety. Dosing every four weeks is supported by pharmacokinetics. A late-breaking poster is scheduled at ACR Convergence on 10 November 2026.

What Comes Next

Immutep targets the start of its next efti trial in the second half of calendar 2027, subject to strategy, regulatory, manufacturing and partnering factors. The AGM on 27 November 2026 will include a further root cause update. The company also regained Nasdaq compliance on 13 October after changing its ADS ratio, and expects to appoint an independent director to its Audit and Risk Committee during FY27.