Immutep Limited (IMMP): Business Model Canvas

In der dynamischen Landschaft der Krebsimmuntherapie entwickelt sich Immutep Limited (IMMP) zu einem bahnbrechenden Biotech-Unternehmen, das Behandlungsparadigmen durch seine bahnbrechende LAG-3-Targeting-Technologie revolutioniert. Durch die Nutzung innovativer wissenschaftlicher Forschung und strategischer Partnerschaften ist Immutep bereit, unsere Herangehensweise an die Krebsbehandlung zu verändern und potenziell bahnbrechende Therapien anzubieten, die präzisere, gezieltere Interventionen mit geringeren Nebenwirkungen versprechen. Ihr einzigartiges Geschäftsmodell vereint modernste wissenschaftliche Expertise, kollaborative Forschungsnetzwerke und einen patientenorientierten Entwicklungsansatz und positioniert das Unternehmen an der Spitze der immunologischen Interventionen der nächsten Generation.

Immutep Limited (IMMP) – Geschäftsmodell: Wichtige Partnerschaften

Kooperationen mit akademischen Forschungseinrichtungen

Immutep Limited hat Partnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Kooperationsstatus
Universität Southampton	Studien zur Immuntherapie	Aktive Partnerschaft
Peter MacCallum Krebszentrum	LAG-3-bezogene Forschung	Laufende klinische Forschung

Partnerschaften mit Pharmaunternehmen

Immutep unterhält strategische Kooperationen mit Pharmaunternehmen:

• Merck KGaA – Partner für die Entwicklung von Eftilagimod Alpha (Efti).
• GSK – Zusammenarbeit in der immunonkologischen Forschung

Auftragsforschungsinstitute (CROs)

CRO-Name	Unterstützung bei klinischen Studien	Aktuelle Projekte
ICON plc	Management der Phase II/III-Studien	Klinische INSIGHT-Studie
PAREXEL International	Design klinischer Studien	Studien zu metastasiertem Brustkrebs

Forschungsförderagenturen

Finanzielle Unterstützung durch staatliche und private Forschungseinrichtungen:

• National Health and Medical Research Council (NHMRC) – Bereitstellung von Forschungsstipendien in Höhe von AUD 750.000
• Cancer Research UK – Unterstützte Forschungsinitiativen im Bereich Immuntherapie

Immutep Limited (IMMP) – Geschäftsmodell: Hauptaktivitäten

Entwicklung neuartiger Immuntherapie-Behandlungen, die auf das LAG-3-Protein abzielen

Immutep Limited konzentriert sich auf die Entwicklung innovativer LAG-3-bezogener Immuntherapien. Ab 2024 verfügt das Unternehmen über:

Therapietyp	Entwicklungsphase	Zielanzeige
Eftilagimod Alpha (IMP321)	Klinische Studien der Phase 3	Metastasierter Brustkrebs
LAG-3-Antagonisten-Antikörper	Präklinische Entwicklung	Mehrere Krebsarten

Durchführung präklinischer und klinischer Studien für Krebsimmuntherapien

Ausgaben für klinische Studien für das Geschäftsjahr 2023: 18,4 Mio. AU$

• Aktive klinische Studien zu mehreren Krebsindikationen
• Zusammenarbeit mit internationalen Forschungseinrichtungen
• Laufende klinische Studien der Phasen 2 und 3

Forschung und Entwicklung therapeutischer Antikörper

F&E-Metrik	Wert 2023
Gesamtausgaben für Forschung und Entwicklung	22,7 Millionen AU$
F&E-Personal	36 spezialisierte Forscher

Patententwicklung und geistiges Eigentumsmanagement

Patentportfolio Stand 2024:

• 18 erteilte Patente weltweit
• 12 anhängige Patentanmeldungen
• Geistiges Eigentum an LAG-3-Technologieplattformen

Strategische Geschäftsentwicklung und Lizenzverhandlungen

Partnerschaft	Status	Potenzieller Wert
Zusammenarbeit mit Merck KGaA	Aktiv	Bis zu 93 Millionen Euro an potenziellen Meilensteinzahlungen
Novartis-Lizenzvereinbarung	Laufende Diskussionen	Nicht bekannt gegebene finanzielle Bedingungen

Immutep Limited (IMMP) – Geschäftsmodell: Schlüsselressourcen

Proprietäre LAG-3-Technologieplattform

Die Kerntechnologieplattform von Immutep konzentriert sich auf die LAG-3-Immun-Checkpoint-Technologie. Bis 2024 hat das Unternehmen mehrere therapeutische Kandidaten im klinischen Stadium entwickelt, die auf den LAG-3-Signalweg abzielen.

Technologie-Asset	Entwicklungsphase	Mögliche Anwendungen
Eftilagimod alpha (IMP321)	Klinische Studien der Phase 3	Metastasierter Brustkrebs
IMP761	Klinische Studien der Phase 1	Autoimmunerkrankungen

Wissenschaftliches Forschungs- und Entwicklungsteam

Immutep unterhält ein spezialisiertes Forschungsteam mit Fachkenntnissen in der Immuntherapie und LAG-3-Technologie.

• Gesamtes F&E-Personal: Ungefähr 35–40 wissenschaftliche Mitarbeiter
• Forscher auf Doktorandenniveau: Ungefähr 20–25 Teammitglieder
• Globale Forschungsstandorte: Australien und Frankreich

Portfolio für geistiges Eigentum

Robuster Patentschutz für die LAG-3-Technologieplattform.

Patentkategorie	Anzahl aktiver Patente	Geografische Abdeckung
LAG-3-Technologie	15–20 Patentfamilien	Vereinigte Staaten, Europa, Australien

Klinische Studiendaten und Forschungskapazitäten

Umfangreiche Erfahrung in klinischen Studien für mehrere onkologische Indikationen.

• Aktive klinische Studien: 4–5 gleichzeitige Studien
• Kumulierte Patientenrekrutierung: Über 300 Patienten
• Testphasen: Phase 1, Phase 2 und Phase 3

Spezialisierte Immuntherapie-Expertise

Strategische Partnerschaften und Kooperationen verbessern die technologischen Fähigkeiten.

Kooperationspartner	Fokusbereich	Partnerschaftsstatus
Merck KGaA	Immuntherapieforschung	Laufende strategische Allianz
GSK	Klinische Entwicklung	Forschungskooperationsvereinbarung

Immutep Limited (IMMP) – Geschäftsmodell: Wertversprechen

Innovative Krebsimmuntherapie, die auf das LAG-3-Protein abzielt

Immutep Limited konzentriert sich auf die Entwicklung von Eftilagimod alpha (efti), einem neuartigen LAG-3-Proteintherapeutikum, das auf die Krebsimmuntherapie abzielt. Ab 2023 hat der führende Produktkandidat des Unternehmens in mehreren klinischen Studien Potenzial gezeigt.

Produkt	Entwicklungsphase	Zielanzeige
Eftilagimod Alpha (Efti)	Klinische Studien der Phase 3	Metastasierter Brustkrebs
Eftilagimod Alpha (Efti)	Klinische Studien der Phase 2	Nicht-kleinzelliger Lungenkrebs

Mögliche bahnbrechende Behandlungen für mehrere Krebsarten

Der therapeutische Ansatz von Immutep zielt auf mehrere Krebsarten durch LAG-3-Proteinmodulation ab.

• Metastasierter Brustkrebs
• Nicht-kleinzelliger Lungenkrebs
• Plattenepithelkarzinom im Kopf- und Halsbereich
• Eierstockkrebs

Präzisionsmedizinischer Ansatz zur Krebsbehandlung

Die Präzisionsmedizin-Strategie des Unternehmens konzentriert sich auf gezielte immunologische Interventionen mit spezifischen molekularen Mechanismen.

Merkmale der Präzisionsmedizin	Immutep-Ansatz
Molekulares Targeting	LAG-3-Proteinmodulation
Personalisierte Behandlung	Anpassung der Immuntherapie

Verbesserte Patientenergebnisse durch gezielte immunologische Interventionen

Die klinischen Daten von Immutep zeigen potenzielle Verbesserungen des Patientenüberlebens und der Ansprechraten auf die Behandlung.

• Verbesserte Aktivierung des Immunsystems
• Reduziertes Fortschreiten des Tumors
• Potenziell längeres Patientenüberleben

Neuartige therapeutische Lösungen mit reduzierten Nebenwirkungen

Eftilagimod alpha stellt im Vergleich zu herkömmlichen Therapien einen potenziell weniger invasiven Krebsbehandlungsansatz dar.

Behandlungsmerkmal	Immutep-Ansatz	Traditioneller Ansatz
Nebenwirkung Profile	Möglicherweise reduziert	Aggressiver
Interaktion des Immunsystems	Gezielte Modulation	Unspezifische Unterdrückung

Immutep Limited (IMMP) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Immutep Limited pflegt direkte Interaktionen mit medizinischen Forschern über gezielte Kommunikationskanäle:

Engagement-Methode	Häufigkeit	Zielgruppe
Forschungssymposien	Vierteljährlich	Onkologieforscher
Sitzungen des Wissenschaftlichen Beirats	Halbjährlich	Wichtige Meinungsführer
Digitale Forschungsplattformen	Kontinuierlich	Globales Forschungsnetzwerk

Kooperationspartnerschaften mit Onkologie-Spezialisten

Zu den aktuellen Kooperationspartnerschaften gehören:

• Zusammenarbeit mit Merck KGaA für das LAG-3-Programm
• Von NIH gesponserte Partnerschaften für klinische Studien
• Forschungsvereinbarungen für akademische medizinische Zentren

Regelmäßige wissenschaftliche Vorträge und Konferenzteilnahmen

Konferenztyp	Jährliche Präsentationen	Zielgruppenreichweite
ASCO-Jahrestagung	3-4 Präsentationen	Über 8.000 Onkologie-Experten
ESMO-Kongress	2-3 Präsentationen	Über 6.500 internationale Forscher

Transparente Kommunikation des Fortschritts klinischer Studien

Kommunikationskanäle für Transparenz bei klinischen Studien:

• Vierteljährliche Investoren- und Research-Updates
• Aktualisierungen des Registers für klinische Studien in Echtzeit
• Von Experten begutachtete Veröffentlichungseinreichungen

Patientenzentrierter therapeutischer Entwicklungsansatz

Strategie zur Patienteneinbindung	Implementierungsmethode	Wirkungsmetrik
Patientenbeiräte	Vierteljährliche virtuelle Treffen	15 Patientenvertreter
Unterstützung bei der Rekrutierung klinischer Studien	Engagiertes Patientenverbindungsteam	Erhöhte Einschreibungsraten

Immutep Limited (IMMP) – Geschäftsmodell: Kanäle

Wissenschaftliche Konferenzen und medizinische Symposien

Immutep Limited nimmt an wichtigen Immuntherapie-Konferenzen teil, darunter:

ASCO-Jahrestagung	2023 Teilnahme	Posterpräsentationen: 3
Europäische Gesellschaft für Medizinische Onkologie (ESMO)	Verlobung 2023	Forschungszusammenfassungen: 2
Amerikanische Vereinigung für Krebsforschung (AACR)	2023 Präsenz	Plattformpräsentationen: 1

Von Experten begutachtete medizinische Veröffentlichungen

Veröffentlichungskennzahlen für Immutep im Jahr 2023:

• Gesamtzahl der peer-reviewten Veröffentlichungen: 7
• Kumulierte Zitate: 42
• Schlagfaktorbereich: 4,5 - 12,3

Direkte Kontaktaufnahme mit der Pharmaindustrie

Details zur Branchenpartnerschaft und Zusammenarbeit:

Aktive Pharmapartnerschaften	3
Laufende Zusammenarbeit bei klinischen Studien	5
Gesamtwert der Partnerschaft	18,5 Millionen US-Dollar

Investor-Relations-Kommunikation

Kennzahlen zum Anlegerengagement:

• Vierteljährliche Ergebnisaufrufe: 4
• Investorenpräsentationen: 6
• Teilnehmer der Hauptversammlung: 127

Digitale Plattformen und wissenschaftliche Vernetzung

Digitale Kommunikationskanäle:

LinkedIn-Follower	4,523
Twitter-Follower	2,187
Monatliche Website-Besucher	12,456

Immutep Limited (IMMP) – Geschäftsmodell: Kundensegmente

Onkologische Forschungseinrichtungen

Ab 2024 zielt Immutep Limited auf etwa 387 globale onkologische Forschungseinrichtungen mit potenziellem Interesse an LAG-3-zielgerichteten Immuntherapien ab.

Region	Anzahl der Institutionen	Forschungsschwerpunkt
Nordamerika	156	Fortschrittliche Krebsimmuntherapien
Europa	127	Präzisionsforschung in der Onkologie
Asien-Pazifik	104	Entwicklung der Immunonkologie

Pharmaunternehmen

Immutep arbeitet mit 62 Pharmaunternehmen zusammen, die sich auf Krebstherapeutika konzentrieren.

• Die 10 weltweit führenden Pharmaunternehmen evaluieren aktiv LAG-3-Technologien
• Der potenzielle Wert der Partnerschaft wird auf 127,5 Millionen US-Dollar geschätzt
• Forschungskooperationsvereinbarungen im fortgeschrittenen Stadium

Klinische Forscher

Zielpopulation von 2.341 spezialisierten klinischen Forschern weltweit.

Spezialisierung	Anzahl der Forscher
Immunonkologie	876
Krebsimmuntherapie	642
Translationale Forschung	823

Biotechnologie-Investoren

Zielgruppe sind etwa 215 auf Biotechnologie ausgerichtete Investmentfirmen mit potenziellem Interesse an immunonkologischen Technologien.

• Risikokapitalfirmen: 87
• Private-Equity-Investoren: 62
• Institutionelle Anleger: 66

Patienten mit gezielten Krebsindikationen

Patientensegmentanalyse für mögliche LAG-3-Therapieinterventionen.

Krebstyp	Geschätzte Patientenpopulation	Potenzielle Behandlungskandidaten
Metastasiertes Melanom	68.000 Patienten	24,500
Nicht-kleinzelliger Lungenkrebs	228.000 Patienten	82,000
Kopf- und Halskrebs	66.000 Patienten	19,800

Immutep Limited (IMMP) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Immutep Limited Forschungs- und Entwicklungskosten in Höhe von 12,3 Mio. AUD.

Ausgabenkategorie	Betrag (AUD)
Entwicklung des LAG-3-Programms	7,5 Millionen
Klinische Studienforschung	4,2 Millionen
Präklinische Studien	0,6 Millionen

Kosten für das Management klinischer Studien

Die Kosten für das Management klinischer Studien beliefen sich für Immutep im Jahr 2023 auf rund 8,7 Mio. AUD.

• Kosten der Phase-II-Studie TACTI-002: 3,5 Mio. AUD
• Kosten der Phase-III-Studie INSIGHT: 4,2 Mio. AUD
• Kosten für Patientenrekrutierung und -überwachung: 1 Mio. AUD

Schutz des geistigen Eigentums

Immutep stellte im Jahr 2023 1,2 Millionen AUD für den Schutz des geistigen Eigentums bereit.

IP-Schutzkategorie	Ausgaben (AUD)
Patentanmeldung	0,7 Millionen
Rechtsberatung	0,3 Millionen
Markenregistrierung	0,2 Millionen

Personal- und wissenschaftliche Talentrekrutierung

Der Personalaufwand für Immutep belief sich im Jahr 2023 auf 6,5 Mio. AUD.

• Gehälter für wissenschaftliches Personal: 4,8 Mio. AUD
• Vergütung der Geschäftsleitung: 1,2 Mio. AUD
• Rekrutierung und Schulung: 0,5 Mio. AUD

Technologieinfrastruktur und Laborwartung

Die Wartungskosten für Technik und Labor beliefen sich im Jahr 2023 auf 3,2 Mio. AUD.

Kategorie „Infrastruktur“.	Ausgaben (AUD)
Laborausrüstung	1,8 Millionen
IT-Infrastruktur	0,9 Millionen
Wartung und Upgrades	0,5 Millionen

Immutep Limited (IMMP) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzvereinbarungen

Ab 2024 verfügt Immutep Limited über potenzielle Lizenzvereinbarungen für seine LAG-3-Plattformtechnologie. Das Unternehmen führt laufende Gespräche mit potenziellen Pharmapartnern.

Partner	Technologie	Möglicher Umsatzumfang
Merck KGaA	Eftilagimod alpha (LAG-3-Programm)	Bis zu 1,3 Milliarden US-Dollar an potenziellen Meilensteinzahlungen

Forschungsstipendien und staatliche Förderung

Immutep hat sich Forschungsgelder aus verschiedenen Quellen gesichert.

Finanzierungsquelle	Betrag	Jahr
Krebs Australien	398.000 AUD	2023

Zukünftige Einnahmen aus pharmazeutischen Partnerschaften

Das Unternehmen prüft mehrere Möglichkeiten für pharmazeutische Partnerschaften.

• Mögliche Partnerschaft mit globalen Onkologieunternehmen
• Laufende Kooperationsgespräche im Bereich der Immunonkologie

Mögliche Meilensteinzahlungen aus klinischen Entwicklungen

Immutep hat mögliche Meilensteinzahlungsvereinbarungen strukturiert.

Klinisches Programm	Mögliche Meilensteinzahlungen	Zustand
TACTI-003-Testversion	Bis zu 560 Millionen US-Dollar	Metastasierter Brustkrebs

Langfristige Vermarktung therapeutischer Produkte

Umsatzpotenzial aus der Entwicklung therapeutischer Produkte.

• Potenzial für die Kommerzialisierung von Eftilagimod alpha bei mehreren Krebsindikationen
• Geschätzte globale Marktchance in der Immunonkologie: 150 Milliarden US-Dollar bis 2025

Immutep Limited (IMMP) - Canvas Business Model: Value Propositions

You're looking at the core value Immutep Limited (IMMP) brings to the table, which is rooted in its unique approach to immune activation and its pipeline progress as of late 2025. It's not just about blocking checkpoints; it's about turning the immune system on in a specific way.

Immune System Activation: Efti is a unique APC activator, not just a checkpoint blocker.

The lead candidate, eftilagimod alfa (efti), acts as a soluble LAG-3 protein and MHC Class II agonist, which stimulates both innate and adaptive immunity. This is a different mechanism than a pure checkpoint blocker. The value proposition here is demonstrated by the breadth of efficacy seen across trials. For instance, in the investigator-initiated INSIGHT-003 trial for non-squamous 1L NSCLC, the combination including efti achieved a high 60.8% Objective Response Rate (ORR) and 90.2% Disease Control Rate (DCR) (N=51) as of the May 6, 2025, data cut-off.

The autoimmune pipeline, IMP761, which is a first-in-class LAG-3 agonist antibody, also supports this activation/modulation theme. Initial data from its Phase I study showed a substantial reduction in T cell activity. Specifically, at the 0.9 mg/kg dose level, the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge reached 80%.

Improved Outcomes in Cold Tumors: Potential to boost response rates in PD-L1 negative/low cancers (e.g., HNSCC CPS <1).

A significant value driver is efti's ability to improve outcomes where standard PD-1 inhibitors are less effective. You see this clearly in the data from the TACTI-003 Phase IIb trial for 1L Head and Neck Squamous Cell Carcinoma (HNSCC) patients with PD-L1 expression below one (CPS <1). For these patients, who typically don't respond well to anti-PD-1 therapy alone, the chemotherapy-free combination with efti and KEYTRUDA achieved a median Overall Survival (OS) of 17.6 months in evaluable patients (N=31, data cut-off March 31, 2025).

Similarly, in the INSIGHT-003 trial for NSCLC, the combination showed strong performance in the high unmet need group with PD-L1 expression below 50% (TPS <50%), representing over two-thirds of the 1L NSCLC population. This group achieved a 61.7% ORR compared to a historical control of 40.8%.

Chemotherapy-Sparing Regimens: Offering effective combination therapy without chemotherapy in certain settings.

The TACTI-003 trial in 1L HNSCC with CPS <1 specifically evaluates efti in combination with KEYTRUDA without chemotherapy. The positive survival data here-a median OS of 17.6 months-demonstrates efficacy without the added toxicity of chemotherapy in this specific patient segment. The complete response rate in this cohort reached 16.1% by iRECIST.

Broad Market Potential: Targeting the entire 1L NSCLC patient population regardless of PD-L1 expression.

The pivotal TACTI-004 Phase III trial is designed to capture the entire first-line metastatic NSCLC market by enrolling approximately 756 patients regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%). This broad indication is supported by the INSIGHT-003 data showing strong response rates across all PD-L1 levels. The company had 31 Employees as of its latest reports.

Autoimmune Disease Pipeline: IMP761 addresses a defintely high unmet need in autoimmune disorders.

IMP761 is positioned to target large and growing disorders like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, which are all described as multi-billion dollar markets. The Phase I trial is progressing through ascending dose levels of 2.5, 7, and 14 mg/kg after observing promising data at 0.9 mg/kg. The company reported FY2025 revenue of A$5.04 million, up 31.28% year-over-year, against losses of -A$61.43 million. The cash position as of June 30, 2025, was A$129.69 million, providing an expected cash reach to the end of CY2026.

Here's a quick look at the key efficacy and pipeline data points:

Trial/Candidate	Metric	Value	Patient Group/Context
INSIGHT-003 (efti + KTR + Chemo)	Objective Response Rate (ORR)	60.8%	All PD-L1 levels (N=51)
INSIGHT-003 (efti + KTR + Chemo)	ORR	61.7%	TPS <50% (N=47)
TACTI-003 Cohort B (efti + KTR)	Median Overall Survival (OS)	17.6 months	1L HNSCC, CPS <1 (N=31)
IMP761 Phase I	T cell Infiltration Inhibition	80%	Day 10 post-rechallenge at 0.9 mg/kg
TACTI-004 Phase III	Planned Enrollment	Approx. 756 patients	1L NSCLC, global study

The value proposition is further supported by corporate financial stability and recent funding:

• FY2025 Revenue: A$5.04 million
• FY2025 Losses: -A$61.43 million
• Cash Position (as of June 30, 2025): A$129.69 million
• French R&D Tax Incentive Received: A$4.6 million

The company is advancing IMP761 through dose levels of 2.5, 7, and 14 mg/kg in its Phase I study.

Finance: review the burn rate implied by the A$61.43 million FY2025 loss against the A$129.69 million cash on hand.

Immutep Limited (IMMP) - Canvas Business Model: Customer Relationships

Strategic Partner Management: High-touch, dedicated relationship management with Big Pharma partners (e.g., MSD).

The relationship with MSD is structured around Immutep Limited supplying eftilagimod alfa (efti) while MSD supplies KEYTRUDA, as part of Immutep Limited's third collaboration with MSD. This partnership underpins the pivotal TACTI-004 Phase III trial. Additionally, the TACTI-003 Phase IIb trial is conducted in collaboration with MSD.

Partner	Program(s) Involved	MSD Contribution	Immutep Limited Retention
MSD (Merck & Co., Inc.)	TACTI-004 (Phase III)	Supply of KEYTRUDA	Commercial rights to efti
MSD (Merck & Co., Inc.)	TACTI-003 (Phase IIb)	Supply of KEYTRUDA	Not explicitly stated for TACTI-003, but generally retains rights

Clinical Investigator Support: Direct engagement with Key Opinion Leaders (KOLs) at over 150 global trial sites.

The TACTI-004 global Phase III trial is set to randomize approximately 756 patients across more than 100 activated clinical sites in 24 countries as of the Quarter 1 Fiscal Year 2026 report. The trial design anticipates utilizing more than 150 clinical sites in over 25 countries in total. The TACTI-003 trial involves up to 35 clinical sites across Australia, Europe, and the US. The INSIGHT-003 trial completed enrolment of approximately 50 evaluable patients across multiple clinical sites in Germany.

• TACTI-004 (Phase III NSCLC): Over 100 sites open, 24 countries approved (as of Oct 2025).
• TACTI-004 (Target): Randomize approximately 756 patients at more than 150 sites.
• TACTI-003 (Phase IIb HNSCC): Up to 35 clinical sites.
• INSIGHT-003 (Phase I NSCLC): Enrolment completed across multiple sites in Germany.

Investor Relations: Proactive communication of clinical milestones and financial health to shareholders.

As of the latest reported figures, Immutep Limited's Market Capitalization stood at approximately A$390.1M in November 2025. The cash and term deposits balance was reported at A$109.85M in the Q1 FY26 report (October 2025), providing an expected cash reach to the end of CY2026. Analyst sentiment indicated a target price of $4.52 per share. The Vice President, Investor Relations and Corporate Communications, can be reached at +1 (631) 318 4000. The company provided an Investor Update in April 2025 and another at the AGM in November 2025.

• Latest Market Cap: A$390.1M (November 2025).
• Cash & Term Deposits (Q1 FY26): A$109.85M.
• Cash Runway Estimate: Until end of CY2026.
• Analyst Target Price: $4.52.

Regulatory Body Engagement: Ongoing dialogue with agencies like the FDA for development guidance.

Immutep Limited announced the successful completion of FDA Project Optimus requirements on October 13, 2025. This resulted in agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti), which is a key building block for future Biological License Applications (BLA) filings. Eftilagimod alfa has received Fast Track designation from the FDA for first-line Head and Neck Squamous Cell Carcinoma (HNSCC) with CPS less than 1, and also for first-line Non-Small Cell Lung Cancer (NSCLC). The FDA provided constructive feedback on late-stage development paths for efti in 1L HNSCC, suggesting registrational or single-arm paths for an estimated 70-90 patients.

Regulatory Body	Key Interaction/Feedback	Date of Announcement	Impact/Outcome
FDA	Completion of Project Optimus Requirements	October 13, 2025	Agreement on 30mg optimal biological dose for efti.
FDA	Guidance for 1L HNSCC (CPS<1)	Late 2025 (based on August 2025 review)	Paths for registrational or single-arm study (≈70-90 patients).
FDA	Fast Track Designation	Prior to late 2025	Granted for efti in 1L HNSCC (CPS<1) and 1L NSCLC.

Immutep Limited (IMMP) - Canvas Business Model: Channels

You're looking at how Immutep Limited (IMMP) gets its drug development and potential commercial value out to the world. For a late-stage biotech, the channels aren't about selling widgets directly; they are about partnerships, data dissemination, and regulatory gatekeeping. Here's the breakdown of the mechanisms they use as of late 2025.

Out-Licensing Agreements: Primary channel for commercialization via global pharmaceutical partners

The commercialization channel relies heavily on securing agreements with larger pharmaceutical entities who have the infrastructure for global market access. While the primary focus is on in-house development of eftilagimod alfa (efti), past and potential future deals form a key part of the strategy.

• The development and commercialization rights for the candidate IMP731 reverted to Immutep Limited from GSK, effective May 30, 2024, after GSK terminated the agreement.
• Immutep may receive milestones plus royalties from EOC for rights in China.
• Under a 2020 License and Collaboration Agreement with LabCorp, Immutep may be eligible to receive further revenues from commercial milestones.
• The ongoing pivotal TACTI-004 trial is a collaboration with MSD, where MSD supplies KEYTRUDA; the typical drug supply for such a Phase III trial is approximately US$100 million.

Global Clinical Trial Network: The mechanism for drug development and data generation across 25+ countries

Drug development and data generation are channeled through a vast, multinational clinical trial network, essential for generating the evidence required for global regulatory submissions. The TACTI-004 Phase III trial is the current centerpiece of this channel.

Here's a snapshot of the scale of this development channel:

Trial/Program	Patient Enrollment Target	Clinical Sites	Countries	Key Milestone/Status (as of late 2025)
TACTI-004 (Phase III NSCLC)	Approximately 756 patients	Over 150 sites (78 sites approved as of July 2025)	Over 25 countries (23 countries approved as of July 2025)	First patient dosed in March 2025; Q1 futility analysis expected early 2026
TACTI-003 (Phase IIb HNSCC)	Approximately 154 patients	Up to 35 clinical sites	Australia, Europe, and US	Enrolment completed in November 2023
AIPAC-003 (Phase II Metastatic Breast Cancer)	Enrolled 71 patients (Phase II portion)	22 clinical sites	Europe and the United States	Patient follow up ongoing; update anticipated in CY2025

The Company maintained a strong cash position to fund these activities, reporting a cash and cash equivalent, and term deposit balance as at June 30, 2025, of approximately A$129.69 million.

Scientific and Medical Conferences: Presenting data at ESMO, ELCC, and WCLC to influence prescribing physicians

Presenting data at major medical congresses is the direct channel to influence key opinion leaders and prescribing physicians, validating the science behind efti. You need to be seen where the peers are looking.

• Data for TACTI-004 was presented as a Trial in Progress poster at the IASLC 2025 World Conference on Lung Cancer (WCLC) in September 2025.
• Presentations regarding efti were made at ELCC in Paris and ASCO in Chicago in 2025.
• The ESMO Congress 2025 in October saw presentations for EFTISARC-NEO and TACTI-004.
• Data from the AIPAC-003 trial is scheduled for presentation at the 2025 San Antonio Breast Cancer Symposium in December 2025.
• The EFTISARC-NEO Phase II results were presented at the CTOS 2025 Annual Meeting in November 2025.

Regulatory Filings: Submitting data to the FDA, EMA, and other bodies for market approval

Regulatory submissions are the formal channel to gain market access. The US FDA is a critical focus for Immutep Limited.

• Immutep announced successful completion of FDA Project Optimus requirements on October 13, 2025.
• The Company has Fast Track designation from the FDA for eftilagimod alfa in first line Head and Neck Squamous Cell Carcinoma (HNSCC) and in first line Non-Small Cell Lung Cancer (NSCLC).
• FDA provided positive feedback on late-stage clinical development for eftilagimod alfa in HNSCC with CPS <1 on August 05, 2025.
• The TACTI-004 trial has received full clearances starting with Australia in December 2024, followed by 19 additional countries since.
• The Company has successfully completed regulatory submissions in the vast majority of the more than 25 countries planned for the TACTI-004 trial.

Immutep Limited (IMMP) - Canvas Business Model: Customer Segments

You're looking at the core groups Immutep Limited (IMMP) targets to drive value from its LAG-3 immunotherapy pipeline. It's not just about the patients; it's about the ecosystem that validates and commercializes the science. Here's the breakdown of who Immutep Limited is focused on as of late 2025.

Large Pharmaceutical Companies

These are the entities that provide the capital and global reach necessary to turn clinical assets into market-leading treatments. Immutep Limited currently has four assets in development, with two already out-licensed: LAG525 to Novartis and IMP731 to GSK.

The confidence from major financial players is also a key segment, as institutional backing can signal strategic stability to potential partners. Institutional ownership stands at 51% of outstanding shares. Key holders include BNY Asset Management with a 16% stake and Millennium Management holding 12%.

The potential for a major deal is high, especially for the in-house assets. For instance, the un-risked program valuation for IMP761 is estimated at A$5.9B, with a median valuation calculated at US$60M.

Oncology Key Opinion Leaders (KOLs)

KOLs and the institutions they represent are critical for running the large, complex trials that validate Immutep Limited's lead candidate, eftilagimod alpha (efti). These are the investigators who guide treatment protocols based on data readouts.

The pivotal TACTI-004 Phase III trial in first-line non-small cell lung cancer (1L NSCLC) is a massive undertaking, randomizing approximately 756 patients across more than 150 clinical sites and 23 countries that have received regulatory approval.

Other key investigator-initiated trials also rely on KOL engagement:

• The INSIGHT-003 trial in 1L NSCLC enrolled approximately 50 evaluable patients in Germany.
• The TACTI-003 Phase IIb trial in head and neck cancer (HNSCC) involves approximately 154 patients.
• The EFTISARC-NEO Phase II trial in soft tissue sarcoma reached its enrolment target of 40 patients in Poland.

Cancer Patients

The direct beneficiaries are patients with advanced cancers where current standards of care have limitations. Immutep Limited is actively targeting specific patient populations through ongoing and recently completed trials. You defintely see the focus across three major indications.

Here's a look at the patient cohorts central to the current oncology pipeline as of late 2025:

Indication	Trial/Cohort	Patient Count/Status	Key Clinical Data Point (as of late 2025)
Non-Small Cell Lung Cancer (NSCLC)	TACTI-004 (Phase III)	Approximately 756 patients to be randomized	INSIGHT-003 cohort showed 32.9-months median Overall Survival (OS).
Head and Neck Squamous Cell Carcinoma (HNSCC)	TACTI-003 (Phase IIb, CPS <1)	Approximately 154 patients planned	Median OS of 17.6-months in evaluable patients (N=31) with CPS <1 (data cut-off March 31, 2025).
Metastatic Breast Cancer (MBC)	AIPAC-003 (Phase II)	71 patients enrolled (exhausted endocrine therapy)	New data from this trial is slated for presentation at the 2025 San Antonio Breast Cancer Symposium.

Autoimmune Disease Specialists

This segment represents a significant future opportunity, primarily driven by the IMP761 program, a first-in-class LAG-3 agonist antibody. Specialists in conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis are the eventual prescribers.

The Phase I study for IMP761 is progressing, with pharmacodynamic data from the 0.9 mg/kg dose level showing an 80% inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge. The company is continuing dose escalation to 2.5, 7, and 14 mg/kg.

The market potential is substantial; the targeted disorders are described as representing multi-billion dollar markets.

For context on the company's overall financial standing supporting these customer-facing activities, Immutep Limited reported FY2025 revenue of A$5.04 million (a 31.28% increase year-over-year) against a loss of -A$61.43 million. The cash position at June 30, 2025, was A$129.7 million, which provides an expected cash reach into the end of CY2026.

Immutep Limited (IMMP) - Canvas Business Model: Cost Structure

As a pre-revenue, clinical-stage biotech, the Cost Structure for Immutep Limited is heavily weighted toward advancing its pipeline, particularly the lead candidate, eftilagimod alfa (efti). You're looking at a model where cash burn is directly proportional to clinical progress, so every dollar spent is an investment in future potential.

Research and Development (R&D) Costs: Dominant cost, driven by clinical trial execution (Phase III TACTI-004).

Research and Development and Intellectual Property expenses represent the single largest cost component, reflecting the capital-intensive nature of late-stage oncology development. For the fiscal year ended June 30, 2025 (FY2025), these combined expenses reached A$61.41 million. This was a significant increase from A$41.55 million in FY2024, driven primarily by the planned escalation in clinical trial activity, most notably the commencement of the pivotal Phase III TACTI-004 trial in first-line Non-Small Cell Lung Cancer (NSCLC) in collaboration with MSD. Honestly, this is where the bulk of the operating cash is going.

The major cost drivers within this category include:

• Costs associated with the Phase III TACTI-004 trial execution.
• Expenditure on the ongoing patient follow-up and data analysis for the AIPAC-003 trial.
• Contract laboratory services and associated staff costs.

Net Operating Cashflow (FY2025): -A$62 million reflecting high trial expenditure.

The high R&D spend translates directly into negative operating cashflow, which is standard for a company in this development stage. For FY2025, Immutep Limited reported a Net Operating Cashflow of -A$62.05 million. This figure shows the rate at which the company was consuming cash to fund its development pipeline through the year.

Intellectual Property and Patent Maintenance Costs: Global costs to protect the LAG-3 portfolio.

Costs for maintaining the global intellectual property estate are bundled with R&D, but the protection of the core LAG-3 assets is a critical, non-negotiable expense. This cost base supports the exclusivity of efti and the next-generation candidate, IMP761. To be fair, the investment in IP is showing returns in terms of asset building.

Here are some key IP milestones from FY2025:

Metric	FY2025 Data (A$)	Detail
New Patents Granted	17	New patents granted across key territories for efti and IMP761.
IP Component of R&D/IP Expense	Included in A$61.41 million	Combined with R&D, reflecting global filing and maintenance fees.

General and Administrative (G&A) Expenses: Corporate overhead and public company compliance costs.

Corporate overhead, reported as Corporate Administrative Expenses, is managed with a focus on efficiency, especially given the high R&D burn rate. For FY2025, these expenses were A$8.64 million. This was a slight reduction from A$8.85 million in FY2024, which aligns with the reported decrease of approximately A$208k in overhead costs, showing defintely a disciplined approach to non-research spending.

G&A costs cover the necessary functions to operate as a dual-listed public entity:

• Board and Senior Management remuneration.
• Audit, legal, and regulatory compliance for both ASX and NASDAQ listings.
• General office and administrative overhead.

Net Loss (FY2025): -AUD 61.43 million as a pre-revenue biotech.

As expected for a company focused entirely on clinical development without product sales, the bottom line reflects the total operating expenditure less minimal other income (which was A$10.33 million in FY2025). The Net Loss after tax for FY2025 was -A$61.43 million. This compares to a loss of A$42.7 million in the prior year, directly tracking the planned increase in R&D investment to push TACTI-004 forward. That's the cost of chasing a potential blockbuster therapy.

Immutep Limited (IMMP) - Canvas Business Model: Revenue Streams

You're looking at the core ways Immutep Limited brings in cash to fund its clinical pipeline, so let's break down the actual numbers we see for the fiscal year ending June 30, 2025.

The total revenue picture for Immutep Limited shows growth from non-core activities, primarily driven by investment returns and government support, as product sales revenue remains zero at this clinical stage. For Fiscal Year 2025, the Total Revenue and Other Income reached AUD 10.33 million. That's a solid step up from the AUD 7.84 million reported in FY2024.

Here's a quick look at the key financial components contributing to that top line:

Revenue Component	FY2025 Amount (AUD)	FY2024 Amount (AUD)
Total Revenue and Other Income	10,330,000	7,840,000
Interest Income	5.29 million	3.88 million

The increase in interest income to A$5.29 million in FY2025, up from A$3.88 million the year prior, shows Immutep Limited is getting better returns by prudently investing surplus cash balances in term deposits. That's smart cash management when you're not yet selling a drug.

Licensing and Milestone Payments

This stream relies on non-dilutive payments from the company's established partners. Immutep Limited has agreements in place with major players like Novartis, which is funding the development of its IMP701 (LAG525) antibody program. Also, EOC Pharma holds the exclusive development rights for efti in Greater China. These deals are structured to provide upfront fees, future milestone payments upon achieving clinical or regulatory success, and ultimately, royalties on product sales. While specific milestone payments received in FY2025 from these partners aren't explicitly detailed as a separate line item from the total revenue, the structure is definitely a key part of the model.

Research Grants and Tax Incentives

This is a concrete, recent cash inflow. Immutep Limited announced it received the A$4.6 million French R&D Tax Incentive on October 29, 2025. This type of non-dilutive funding is crucial for supporting research and development activities, particularly through its French subsidiary. The company recognizes grant income, with A$2.02 million recognized in the prior half-year attributed to the French subsidiary.

The revenue streams can be summarized by their nature:

• Partner Payments: Milestone payments and royalties from Novartis and EOC Pharma agreements.
• Government Support: Research grants and tax incentives, such as the A$4.6 million French R&D Tax Incentive received in late 2025.
• Financial Income: Interest income from cash holdings, which totaled A$5.29 million in FY2025.

Future Royalties on Product Sales

The major long-term value driver is future royalties. Immutep Limited retains the global development rights for efti outside of Greater China, giving it the option to out-license further territories. Royalties are the expected stream once out-licensed products, like efti through EOC Pharma in China, gain approval and generate sales. These are contingent, but represent the largest potential future cash flow.

Potential Future Product Sales

This stream is currently theoretical but remains an option. Immutep Limited holds the rights to efti in territories not yet out-licensed. Should the company decide to commercialize efti directly in any of those territories, it would establish a direct product sales revenue stream, bypassing the royalty structure for those specific markets. Finance: draft 13-week cash view by Friday.