Immutep Quarterly Activities Report Q2 FY25
Immutep (ASX: IMM; NASDAQ: IMMP) reported significant progress in Q2 FY25, marking its transition to a Phase III biotech company. Key highlights include:
The company's TACTI-004 Phase III trial in first-line non-small cell lung cancer received its first regulatory approval. Mature data from INSIGHT-003 showed impressive results with 32.9-month median overall survival and 81.0% 24-month OS rate. The TACTI-003 trial in head & neck cancer demonstrated promising outcomes with 67% 12-month OS rate.
The Phase II soft tissue sarcoma trial showed a three-fold increase in tumor hyalinization compared to historical data. The company's IMP761 Phase I trial reported favorable initial safety results.
Financially, Immutep maintains a strong position with A$159.26 million in cash, cash equivalents, and term deposits, providing an expected cash reach until the end of CY2026. The quarter saw increased R&D spending of A$16.2 million, primarily due to the Phase III trial commencement.
Immutep (ASX: IMM; NASDAQ: IMMP) ha riportato progressi significativi nel secondo trimestre del FY25, segnando la sua transizione a una società biotech di Fase III. I punti salienti includono:
La trial di Fase III TACTI-004 dell'azienda nel trattamento del carcinoma polmonare non a piccole cellule in prima linea ha ricevuto la sua prima approvazione normativa. I dati maturi provenienti da INSIGHT-003 hanno mostrato risultati impressionanti con una sopravvivenza globale mediana di 32,9 mesi e un tasso di sopravvivenza globale a 24 mesi dell'81,0%. La trial TACTI-003 nel carcinoma testa-collo ha dimostrato risultati promettenti con un tasso di sopravvivenza globale a 12 mesi del 67%.
La trial di Fase II sul sarcoma dei tessuti molli ha mostrato un incremento triplo nell'iperalinizzazione tumorale rispetto ai dati storici. La trial di Fase I IMP761 dell'azienda ha riportato risultati iniziali di sicurezza favorevoli.
Dal punto di vista finanziario, Immutep mantiene una posizione forte con A$159,26 milioni in cassa, equivalenti di cassa e depositi a termine, fornendo una copertura di cassa prevista fino alla fine del CY2026. Il trimestre ha visto un incremento della spesa in R&S di A$16,2 milioni, principalmente a causa dell'inizio della trial di Fase III.
Immutep (ASX: IMM; NASDAQ: IMMP) informó sobre un progreso significativo en el segundo trimestre del FY25, marcando su transición a una empresa biotecnológica de Fase III. Los aspectos más destacados incluyen:
La prueba de Fase III TACTI-004 de la empresa para el cáncer de pulmón de células no pequeñas en primera línea recibió su primera aprobación regulatoria. Los datos maduros de INSIGHT-003 mostraron resultados impresionantes con una supervivencia global mediana de 32.9 meses y una tasa de supervivencia global a 24 meses del 81.0%. La prueba TACTI-003 en cáncer de cabeza y cuello demostró resultados prometedores con una tasa de supervivencia global a 12 meses del 67%.
La prueba de Fase II de sarcoma de tejidos blandos mostró un aumento de tres veces en la hialinización tumoral en comparación con los datos históricos. La prueba de Fase I IMP761 de la empresa reportó resultados iniciales de seguridad favorables.
Desde el punto de vista financiero, Immutep mantiene una posición fuerte con A$159.26 millones en efectivo, equivalentes de efectivo y depósitos a plazo, proporcionando una cobertura de efectivo esperada hasta finales de CY2026. El trimestre vio un aumento del gasto en I+D de A$16.2 millones, principalmente debido al inicio de la prueba de Fase III.
Immutep (ASX: IMM; NASDAQ: IMMP)는 FY25 2분기에 중요한 진전을 보고했으며, 이를 통해 3상 생명공학 회사로의 전환을 알렸습니다. 주요 사항은 다음과 같습니다:
회사의 TACTI-004 3상 임상시험이 비소세포폐암 1차 치료제로서 첫 번째 규제 승인을 받았습니다. INSIGHT-003의 성숙한 데이터는 32.9개월의 중앙 전체 생존 기간과 81.0%의 24개월 생존율로 인상적인 결과를 보여주었습니다. 두경부암에 대한 TACTI-003 임상시험은 67%의 12개월 생존율로 유망한 결과를 나타냈습니다.
2상 연조직 육종 임상시험에서는 역사적 데이터에 비해 종양의 비후화가 3배 증가한 것으로 나타났습니다. 회사의 IMP761 1상 시험은 초기 안전성 결과가 긍정적이라고 보고했습니다.
재무적으로 Immutep은 A$159.26 백만의 현금, 현금성 자산 및 정기예금으로 강력한 입장을 유지하고 있으며, CY2026년 말까지의 현금 유지 기간을 기대하고 있습니다. 이번 분기에는 3상 임상시험 시작으로 인해 R&D 지출이 A$16.2 백만 증가했습니다.
Immutep (ASX: IMM; NASDAQ: IMMP) a fait état de progrès significatifs au deuxième trimestre de l'exercice 2025, marquant sa transition vers une entreprise biopharmaceutique de phase III. Les points clés incluent :
La nouvelle étude de phase III TACTI-004 de l'entreprise sur le cancer du poumon non à petites cellules en première ligne a reçu sa première approbation réglementaire. Les données consolidées de l'étude INSIGHT-003 ont montré des résultats impressionnants avec une survie médiane globale de 32,9 mois et un taux de survie globale de 81,0 % à 24 mois. L'essai TACTI-003 sur les cancers de la tête et du cou a démontré des résultats prometteurs avec un taux de survie globale de 67 % à 12 mois.
L'essai de phase II sur le sarcome des tissus mous a montré un triplement de l'hyalinisation tumorale par rapport aux données historiques. L'essai de phase I IMP761 de l'entreprise a rapporté des résultats initiaux de sécurité favorables.
Sur le plan financier, Immutep maintient une position solide avec A$159,26 millions en liquidités, équivalents de liquidités et dépôts à terme, offrant une couverture de trésorerie attendue jusqu'à la fin de l'exercice 2026. Le trimestre a vu une augmentation des dépenses de R&D de 16,2 millions de dollars australiens, principalement en raison du lancement de l'étude de phase III.
Immutep (ASX: IMM; NASDAQ: IMMP) berichtete über bedeutende Fortschritte im 2. Quartal FY25, was seinen Übergang zu einem Biotech-Unternehmen der Phase III markiert. Zu den wichtigsten Höhepunkten gehören:
Die TACTI-004 Phase-III-Studie des Unternehmens zur Erstlinienbehandlung von nicht-kleinzelligem Lungenkrebs erhielt ihre erste regulatorische Genehmigung. Reife Daten aus der INSIGHT-003-Studie zeigten beeindruckende Ergebnisse mit einer medianen Gesamtüberlebenszeit von 32,9 Monaten und einer Gesamtüberlebensrate von 81,0% nach 24 Monaten. Die TACTI-003-Studie bei Kopf-Hals-Krebs zeigte vielversprechende Ergebnisse mit einer Gesamtüberlebensrate von 67% nach 12 Monaten.
Die Phase-II-Studie zu Weichgewebesarkomen zeigte einen dreifachen Anstieg der Tumorhyalinisation im Vergleich zu historischen Daten. Die Phase-I-Studie IMP761 des Unternehmens berichtete über günstige anfängliche Sicherheitsdaten.
Finanziell hält Immutep eine starke Position mit A$159,26 Millionen in Bargeld, Bargeldäquivalenten und Termingeldern, was eine erwartete Liquidität bis Ende CY2026 gewährleistet. Im Quartal gab es einen Anstieg der F&E-Ausgaben von A$16,2 Millionen, hauptsächlich aufgrund des Beginns der Phase-III-Studie.
- Transition to Phase III company with TACTI-004 trial approval
- Exceptional INSIGHT-003 trial results with 32.9-month median overall survival
- Strong cash position of A$159.26M with runway through end of 2026
- Triple improvement in tumor hyalinization in Phase II sarcoma trial
- Favorable safety results from IMP761 Phase I trial
- Increased R&D cash burn to A$16.2M from A$9.5M in previous quarter
- Higher total net cash outflows of A$19.0M vs A$8.6M in Q1
- Departure of Chief Medical Officer announced for April 2025
Insights
The Q2 FY25 report marks a transformative period for Immutep, highlighted by three important developments that significantly enhance its market position:
- The transition to Phase III status with TACTI-004 represents a critical milestone, placing Immutep among a select group of biotechs with late-stage oncology assets. The trial's global scope across 25+ countries suggests strong commercial potential and increases the likelihood of successful patient recruitment.
- The INSIGHT-003 data in 1L NSCLC is particularly compelling, with a
81.0% 24-month OS rate substantially outperforming historical controls. This exceptional survival benefit could position efti as a potential game-changer in the lucrative NSCLC market. - The company's financial position is robust with
A$159.26M in cash and investments, providing runway through CY2026. The increased R&D spend ofA$16.2M (up fromA$9.5M QoQ) reflects the strategic acceleration of clinical programs, particularly TACTI-004.
The breadth of positive clinical data across multiple indications (NSCLC, HNSCC, sarcoma) demonstrates efti's versatility and potential broad applicability. The favorable safety profile across all programs enhances the probability of regulatory success. The publication in Science Immunology adds scientific credibility and could facilitate future partnership discussions.
The financial analysis reveals a well-capitalized biotech executing a strategic acceleration of its clinical programs:
- The
A$159.26M cash position is strategically allocated between liquid cash (A$73.89M ) and term deposits (A$85.37M ), optimizing interest income while maintaining operational flexibility. - The increased quarterly R&D spend of
A$16.2M reflects planned Phase III expansion, while reduced G&A expenses (A$566k vsA$961k QoQ) demonstrates operational efficiency. - With an average quarterly burn rate of approximately
A$19M , the current cash position provides about 8 quarters of runway - sufficient to reach significant Phase III milestones and maintain a strong negotiating position for potential partnerships.
The company's disciplined financial management, evidenced by the
Media Release
- Marking Immutep’s transition to a Phase III biotech, the Company’s pivotal TACTI-004 trial in first-line non-small cell lung cancer (1L NSCLC) received first regulatory approval
- Mature data from INSIGHT-003 in 1L NSCLC demonstrates an excellent 32.9-month median overall survival (OS) and
81.0% 24-month OS rate, significantly outperforming historical controls - Promising new results in first line head & neck cancer with PD-L1 CPS <1 reported at ESMO IO 2024, with median OS not reached and
67% 12-month OS rate well above historical controls - Phase II in soft tissue sarcoma shows three-fold increase in tumour hyalinization (trial’s primary endpoint, also associated with survival) compared to historical data from radiotherapy
- Phase I trial of IMP761 reported favourable initial safety results advancing the first-in-class agonist LAG-3 antibody program
- Publication in Science Immunology by Monash University & Immutep first to resolve how human LAG-3 binds to MHC II and show crystal structure human LAG-3/MHC II complex
- Strong aggregate cash, cash equivalent and term deposit position of A
$159.26 million , providing Immutep with an expected cash reach to the end of CY2026
SYDNEY, AUSTRALIA, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 31 December 2024 (Q2 FY25).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-004 – Start of Phase III Trial in 1L NSCLC
In December 2024, Immutep initiated its pivotal TACTI-004 Phase III clinical trial of eftilagimod alfa (“efti”) for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). The receipt of regulatory approval from the Australian Therapeutic Goods Administration means that Immutep has transitioned into a Phase III company; a significant milestone for the Company.
Immutep has successfully completed regulatory submissions in the vast majority of the more than 25 countries that will be part of the global TACTI-004 trial. Additional approvals from multiple countries are expected in the weeks and months ahead. The Company expects to enrol the first patient in Q1 of CY2025.
TACTI-003 (KEYNOTE-C34) – Phase IIb Trial in 1L HNSCC
In December 2024, Immutep reported further positive results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. Cohort B is evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with PD-L1 negative tumours (CPS <1) who typically do not respond well to anti-PD-1 therapy alone. The results were presented by Martin Forster, M.D., Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024.
Adding to the high response rates and favourable safety data previously reported in July 2024, the new data showed that, encouragingly, median overall survival (OS) has not yet been reached and the 12-month OS rate is
AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer
In October 2024, Immutep completed patient enrolment in the Phase II portion of the AIPAC-003 trial. The randomised Phase II portion of the trial enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. Data cleaning and analysis is ongoing.
INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC
In November 2024, first overall survival results were reported from the investigator-initiated INSIGHT-003 trial evaluating efti in combination with KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
Mature data from patients with a minimum follow-up of 22 months (N=21) demonstrated results significantly exceeding historical controls and expectations. Data included a median OS of 32.9 months, median PFS of 12.7 months, and a 24-month OS rate of
Subsequent to quarter end, patient enrolment was completed for INSIGHT-003 in January 2025. The trial reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF. Additional data updates are expected in 2025 and beyond.
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
Also in November, new data from the EFTISARC-NEO Phase II investigator-initiated trial of efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS) were presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting.
Based on preliminary analysis, the triple combination therapy demonstrates significant efficacy in the neoadjuvant setting for resectable STS. The combination achieved a greater than three-fold increase in tumour hyalinization/fibrosis (median
The EFTISARC-NEO trial, with a data cut-off of 20 October 2024, also showed
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
IMP761 is a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.
In December 2024, Immutep reported favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. There have been no treatment related adverse events in the first three of five single ascending dose cohorts in healthy participants. Additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships to follow in the first half of CY2025.
PARTNER ACTIVITY
Collaboration with Monash University
In December 2024, new findings that resolve how human lymphocyte activation gene 3 (LAG-3) binds to its main ligand MHC Class II (MHC-II), also known as HLA Class II (HLA-II) in humans, were published in Science Immunology. The work by Monash University and Immutep, is also the first to show the crystal structure of a human LAG-3/MHC-II complex and provides a better foundation for development of blocking LAG-3 therapeutics, including Immutep’s anti-LAG-3 small molecule program.
INTELLECTUAL PROPERTY
During the quarter, Immutep was granted three new patents for efti and IMP761 in various territories. In particular, Immutep was granted a new patent for efti in combination with a PD-1 pathway inhibitor for the treatment of infection from the Brazilian Patent Office and a new patent for the same combination for the treatment of cancer or infection by the Japan Patent Office. In addition, a new patent was granted for IMP761 by the Malaysian Patent Office.
CORPORATE & FINANCIAL SUMMARY
Board & Senior Management Changes
Independent Non-Executive Director, Anne Anderson, tendered her resignation from the role, effective from 4 October 2024. The Board thanked her for her contribution to Immutep and wished her every success with her next endeavours.
As Immutep’s efti program has advanced into Phase III development, the Company has continued to grow and evolve its team. As part of this, Christian Mueller, who has been with Immutep for over eight years, most recently as SVP Regulatory and Strategy has been promoted to Chief Development Officer. In addition, Dr Florian Vogl, Immutep’s Chief Medical Officer will depart the Company in April 2025. The Company’s current Medical Affairs Advisor, who has been working in different roles closely with Immutep for over nine years, Dr Stephan Winckels, has been appointed acting CMO and taken over all related responsibilities.
Cash Flow Summary
During the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash, cash equivalent and term deposit balance as at 31 December 2024 of approximately A
In Q2 FY25, cash receipts from customers were A
The net cash used in R&D activities during the quarter was A
Total net cash outflows used in operating activities in the quarter were A
Total cash flow used in investing activities for the quarter was A
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Sodali & Co
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
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