Immutep Limited (IMMP) Business Model Canvas

Immutep Limited (IMMP): Business Model Canvas [Dec-2025 Updated]

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You're digging into a late-stage biotech like Immutep Limited (IMMP), trying to see past the R&D burn to the potential payoff. Honestly, this company is all about one thing: pushing its lead asset, eftilagimod alfa, through the pivotal Phase III TACTI-004 trial in lung cancer. As of November 2025, they're sitting on A$129.7 million in cash equivalents to fund this, even though their FY2025 net loss hit -AUD 61.43 million on revenue of AUD 10.33 million. Their value proposition hinges on being a unique immune system activator, not just another checkpoint blocker, which is why their partnerships with giants like MSD are so critical. To see exactly how they plan to turn this high-stakes science into shareholder value-from their IP estate to their out-licensing strategy-you need to look at the full Business Model Canvas below.

Immutep Limited (IMMP) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that fuel Immutep Limited's pipeline progression, especially as they transition into a Phase III company. These aren't just handshake agreements; they involve significant clinical execution and financial structuring. Honestly, these partnerships are where a lot of the near-term value is locked in.

Clinical Trial Collaboration and Supply Agreements

The relationship with MSD (known as Merck & Co., Inc. in the US and Canada) is central to advancing eftilagimod alfa (efti) into registrational studies. This is a big deal for Immutep Limited, as it validates the combination approach.

  • Clinical trial collaboration and supply agreement signed with MSD for the pivotal Phase III TACTI-004 study in first-line metastatic non-small cell lung cancer (1L NSCLC).
  • TACTI-004 is a globally conducted, 1:1 randomised, double-blind, multinational, controlled study enrolling approximately 750 NSCLC patients across both squamous and non-squamous subtypes.
  • This follows two prior collaborations (TACTI-002 Phase II and TACTI-003 Phase IIb) which collectively treated over 350 patients.
  • The combination of efti with KEYTRUDA® and standard chemotherapy in INSIGHT-003 (a related trial concept) delivered a 61.7 per cent objective response rate in patients with low or no PD-L1 expression (TPS <50 per cent).
  • Under the agreement, Immutep Limited will conduct the registrational TACTI-004 study, and MSD will supply KEYTRUDA®.
  • Immutep Limited retains full commercial rights to efti and freedom to operate.

Immutep Limited also has a history of collaboration with Merck KGaA, Darmstadt, Germany, focusing on efti in combination with their investigational agent, bintrafusp alfa (M7824), in the INSIGHT-005 Phase I/IIa trial. Furthermore, a separate second agreement with Merck KGaA, Darmstadt, Germany, and Pfizer concerned efti in combination with avelumab for urothelial cancer, announced in November 2022. Immutep Limited financially supports the trial run by IKF, and Merck KGaA, Darmstadt, Germany, contributes financially to the biomarker-related work for INSIGHT-005.

Out-Licensed Assets and Regional Agreements

Managing out-licensed assets provides Immutep Limited with non-dilutive funding potential through milestones and royalties. Here's a breakdown of the key deals:

Partner Asset/Territory Immutep Limited Entitlement Key Detail/Status
Novartis LAG525 (leramilimab) - Global Rights ex-China Development-based milestone payments and royalties on sales Novartis has conducted five separate clinical trials with LAG525. The patent expires on 13 March 2035.
EOC Pharma Eftilagimod alfa (efti) - Greater China Undisclosed milestones plus royalties on net sales EOC Pharma's Phase II trial in China involved up to 152 patients and was fully funded by EOC Pharma.

Research and Early-Stage Collaborations

Academic ties are crucial for validating the science behind the LAG-3 mechanism. These collaborations often lead to foundational IP.

  • Monash University: Collaboration published findings in Science Immunology in December 2024, resolving the crystal structure of a human LAG-3/MHC-II complex.
  • Cardiff University: License Agreement grants Immutep Limited exclusive rights to develop and commercialize next-generation anti-LAG-3 small molecules identified through the collaboration.

The financial foundation supporting these ongoing partnership activities is solid; Immutep Limited reported an aggregate cash, cash equivalent, and term deposit position of approximately A$146.25 million as at 31 March 2025. This provides an expected cash reach to the end of CY2026. Finance: draft 13-week cash view by Friday.

Immutep Limited (IMMP) - Canvas Business Model: Key Activities

You're looking at the core engine driving Immutep Limited's value right now-the clinical execution and IP management. It's all about hitting those data milestones, and as of late 2025, they're deep in the execution phase across their pipeline.

Executing the pivotal Phase III TACTI-004 trial in 1L Non-Small Cell Lung Cancer (NSCLC)

The TACTI-004 trial, which tests eftilagimod alfa (efti) with KEYTRUDA® and chemotherapy, is the main focus. This registrational study plans to randomize approximately 756 patients across more than 150 clinical sites in over 24 countries globally. As of October 29, 2025, Immutep Limited had enrolled and randomized over 170 patients, which is above the threshold needed for the planned futility analysis. That analysis by the Independent Data Monitoring Committee (IDMC) is still on track for completion in the first quarter of CY2026.

Conducting Phase II trials for eftilagimod alfa in Head and Neck Squamous Cell Carcinoma (HNSCC) and metastatic breast cancer

The data coming out of the Phase II programs is informing late-stage strategy. For HNSCC patients with low PD-L1 expression (CPS <1), the FDA has provided constructive feedback suggesting registrational pathways involving a single-arm study of about 70 to 90 patients. This follows the TACTI-003 Phase IIb trial, where Cohort B achieved a median Overall Survival (OS) of 17.6 months (N=31) as of March 31, 2025. Anyway, the metastatic breast cancer trial, AIPAC-003, has defined the Optimal Biological Dose (OBD).

Here's the quick math on the AIPAC-003 dosing levels from the data cut-off of September 15, 2025, in the evaluable population (N=64):

Dosing Level Objective Response Rate (ORR) Disease Control Rate (DCR)
30 mg efti + paclitaxel 41.9% 87.1%
90 mg efti + paclitaxel 48.5% 78.8%

The 30 mg dose was confirmed as the OBD, which is relevant for future Biological License Applications (BLA).

Advancing the first-in-class LAG-3 agonist, IMP761, for autoimmune disease into Phase I

The push into autoimmune disease with IMP761 is showing early promise. Initial data from the first-in-human Phase I study, announced June 23, 2025, showed a substantial pharmacological effect at the 0.9 mg/kg dose level, achieving 80% inhibition of T cell infiltration in the skin following rechallenge. Immutep Limited is continuing to escalate single ascending doses to 2.5, 7, and 14 mg/kg, with additional data expected in the second half of CY2025. This is a defintely high-potential asset.

Managing and expanding the global Lymphocyte Activation Gene-3 (LAG-3) IP portfolio

The company's strategy relies heavily on its intellectual property surrounding LAG-3. Immutep Limited has four assets under development, including two that are out-licensed: LAG525 to Novartis and IMP731 to GSK. The un-risked program valuation for IMP761 alone has been estimated at A$5.9B. Furthermore, the IP base expanded during Q4 FY25 (ending June 30, 2025), with the granting of four new patents.

  • Eftilagimod alfa (efti)
  • IMP761
  • LAG525 (out-licensed to Novartis)
  • IMP731 (out-licensed to GSK)

Securing regulatory designations like FDA Fast Track for expedited development

Regulatory momentum is key for expediting market access. Eftilagimod alfa has already secured Fast Track designation from the US FDA for both first-line HNSCC and first-line NSCLC. More recently, on October 13, 2025, Immutep Limited received positive and straightforward feedback from the FDA confirming the successful completion of Project Optimus requirements, which resulted in agreement on 30mg as the optimal biological dose for efti. This agreement is directly relevant to potential future BLAs.

To be fair, the financial foundation supporting these activities is solid; the cash, cash equivalent, and term deposit balance as at June 30, 2025, was A$129.69 million, which provides an expected cash reach to the end of CY2026.

Immutep Limited (IMMP) - Canvas Business Model: Key Resources

You're looking at the core assets that power Immutep Limited's engine right now, late in 2025. These aren't just ideas; they are the tangible and intangible things the company owns and uses to create value.

Eftilagimod alfa (efti), the lead asset, is a first-in-class soluble LAG-3 protein acting as an MHC Class II agonist. This molecule is central to all near-term value drivers. Data from the investigator-initiated INSIGHT-003 trial in non-squamous first-line NSCLC showed a high 62.7% objective response rate and a 90.2% disease control rate across all PD-L1 expression levels. Furthermore, for the AIPAC-003 trial in metastatic breast cancer, the 30 mg dose was determined as the optimal biological dose for efti.

The protection around efti is deep, built through an extensive Intellectual Property (IP) estate. Immutep Limited maintains broad protection for efti across a total of nine patent families covering the molecule. The company secured several new patents in Fiscal Year 2024, including six for efti in combination with a PD-1 pathway inhibitor.

Financially, the company is well-capitalized to fund its ongoing development strategy. As of 30 June 2025, the balance sheet showed a strong position, which the company stated provides a cash runway through calendar year 2026.

The Key Resources can be summarized like this:

Resource Category Specific Asset/Metric Value/Status (Late 2025 Context)
Lead Product Candidate Eftilagimod alfa (efti) First-in-class soluble LAG-3 protein; Optimal dose determined at 30 mg
Financial Capital Cash, cash equivalents, and term deposits A$129.69 million as at 30 June 2025
Intellectual Property Efti Patent Families Nine patent families providing broad protection
Out-Licensed Asset LAG525 (Ieramilimab) Out-licensed to Novartis; eligible for milestones plus royalties
In-House Capability Scientific Expertise Specialized in-house team focused on LAG-3 biology and clinical development

The specialized in-house LAG-3 scientific expertise and clinical development team is a critical human capital asset, driving the progression of efti through pivotal trials like TACTI-004.

Regarding the out-licensed assets, the arrangement with Novartis for LAG525 (ieramilimab) remains a source of future optionality. For Novartis' global rights, Immutep Limited is eligible to receive development-based milestone payments plus royalties on sales following commercialization. The company also has royalty potential from its China rights for efti through its partner, EOC Pharma.

Further detail on the IP protection includes:

  • The IP estate covers efti across various combination settings, including with PD-1 pathway inhibitors.
  • One patent family protects efti in combination with a chemotherapy agent, with expiry dates extending into the 2030s.
  • The company also holds IP around its second in-house asset, IMP761, an agonist LAG-3 antibody for autoimmune disease.

The EFTISARC-NEO trial data, presented in late 2025, showed a median 51.5% tumour hyalinization/fibrosis in soft tissue sarcoma patients treated with efti, radiotherapy, and KEYTRUDA.

The company also received a A$4.6 million French R&D Tax Incentive in November 2025, which supports R&D activities via its French subsidiary.

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.


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