Immutep Limited (IMMP) Bundle
When you look at Immutep Limited (IMMP), are you seeing just another clinical-stage biotech, or a pioneer in the Lymphocyte Activation Gene-3 (LAG-3) immunotherapy space that's now a Phase III company? This is a critical distinction, especially since the company reported $5.04 million in revenue for the 2025 fiscal year, marking a 31.28% jump, and has transitioned its lead candidate, eftilagimod alfa (efti), into a pivotal Phase III trial for first-line non-small cell lung cancer (1L NSCLC) that now spans over 24 countries. How does a company focused on activating the 'generals' of the immune system-the antigen-presenting cells-manage to generate such compelling clinical data, like the 81.0% 24-month overall survival rate seen in the INSIGHT-003 trial, and what does that mean for its A$448.9 million market capitalization today? Let's break down the history, the unique mechanism of action, and the financial reality of this late-stage immunotherapy player.
Immutep Limited (IMMP) History
You're looking for the story behind Immutep Limited, and honestly, the company's evolution is a classic biotech pivot. The direct takeaway is that the current company is a product of a crucial 2014 acquisition that shifted its entire focus from an older cancer vaccine (CVac) to the promising LAG-3 immune checkpoint platform, which is now driving its Phase III trial in lung cancer.
Given Company's Founding Timeline
The entity that became Immutep Limited started under the name Prima BioMed Ltd, a corporate shell that was repositioned into a biotechnology company to pursue early-stage research projects.
Year established
The company was originally incorporated as Prima BioMed Ltd in 2001, following the acquisition of rights to develop technologies from the Austin Research Institute in Melbourne, Australia.
Original location
Melbourne, Australia, served as the founding location for Prima BioMed.
Founding team members
While Prima BioMed was formed from licensed research, the core science that defines the current company originated with Professor Frédéric Triebel, who first discovered the Lymphocyte Activation Gene-3 (LAG-3) molecule in 1990 and later founded the French company Immutep SA.
Initial capital/funding
Initial funding for the biotech operations was secured by listing Prima BioMed on the Australian Securities Exchange (ASX) in 2001.
Given Company's Evolution Milestones
The company's trajectory is marked by a deliberate shift from its original assets to the LAG-3 platform, culminating in a pivotal Phase III trial in 2025. It's a clear path to commercialization. Exploring Immutep Limited (IMMP) Investor Profile: Who's Buying and Why?
| Year | Key Event | Significance |
|---|---|---|
| 2001 | Prima BioMed Ltd founded and listed on the ASX. | Established the corporate entity and secured initial public funding for operations. |
| 2014 | Acquisition of Immutep SA (France) for US$25 million. | Pivotal move securing the LAG-3 intellectual property and lead candidate, eftilagimod alpha (efti). |
| 2017 | Company officially renamed Immutep Limited. | Aligned the corporate identity with its core focus on the acquired LAG-3 technology platform. |
| 2024 (June) | Pivotal clinical trial collaboration agreement signed with MSD (Merck & Co., Inc.) for TACTI-004 Phase III trial. | Secured supply of KEYTRUDA® (pembrolizumab) for the registrational trial in first-line non-small cell lung cancer (1L NSCLC), while Immutep retained commercial rights to efti. |
| 2025 (March) | First patient dosed in the pivotal TACTI-004 Phase III trial. | Marked the transition to a Phase III biotech company and the start of the most significant program to date. |
| 2025 (October) | EFTISARC-NEO Phase II trial met its primary endpoint in soft tissue sarcoma. | Demonstrated clinical efficacy for efti in a new cancer indication, further validating the LAG-3 mechanism. |
Given Company's Transformative Moments
The acquisition of Immutep SA in 2014 was the single most transformative decision, shifting the company from a struggling cancer vaccine developer to a leader in the LAG-3 immune checkpoint space. This move completely redefined the pipeline and future potential.
Here's the quick math on their current commitment: Research and development expenses for the 2025 fiscal year were A$61.41 million, a sharp increase from A$41.55 million in FY2024, reflecting the cost of advancing multiple clinical trials, especially the Phase III TACTI-004 study. This is how you know they are all-in on the pipeline.
The company's financial position reflects this high-cost development stage. For the 2025 fiscal year, Immutep reported a net loss of A$61.4 million, up from A$42.7 million in the prior year, which is expected for a clinical-stage biotech scaling up a registrational trial. Their revenue, primarily from grants and interest income, was only A$5.04 million in FY2025.
The successful capital raise and strong cash management are key to mitigating the burn rate. As of March 31, 2025 (Q3 FY25), the company had a strong aggregate cash, cash equivalent, and term deposit position of approximately A$146.25 million, which management projects will fund operations to the end of calendar year 2026. That gives them a defintely solid runway.
- Secured the pivotal Phase III TACTI-004 collaboration with MSD, which positions eftilagimod alpha to target the broad first-line NSCLC market.
- Reported positive median Overall Survival (OS) of 17.6 months in May 2025 from the TACTI-003 trial in head and neck cancer patients with low PD-L1 expression (CPS <1), a group that typically responds poorly to anti-PD-1 monotherapy.
- Advanced the first-in-class LAG-3 agonist antibody, IMP761, into a Phase I trial for autoimmune diseases, diversifying the pipeline beyond oncology.
Immutep Limited (IMMP) Ownership Structure
Immutep Limited's ownership structure is typical of a late-stage biotechnology firm, heavily weighted toward institutional funds that finance its extensive clinical development, with a significant retail float.
This distribution of capital reflects a high-conviction bet by institutional players on the success of its Lymphocyte Activation Gene-3 (LAG-3) related immunotherapies, particularly its lead candidate, eftilagimod alfa (efti).
Immutep Limited's Current Status
Immutep Limited is a publicly traded, clinical-stage biotechnology company dual-listed on the Australian Securities Exchange (ASX: IMM) and the NASDAQ (NASDAQ: IMMP) in the United States. The company officially transitioned into a Phase III company in the 2025 fiscal year (FY25) following the initiation of its pivotal TACTI-004 trial for non-small cell lung cancer. As of November 2025, the company's market capitalization on the NASDAQ stands at approximately $270.83 million. While the company reported revenue of $5.04 million in FY25, up 31.28% from the prior year, it also recorded a net loss of -$61.43 million, which is common for a biotech in a major clinical phase. The company's cash position remains strong, with A$109.85 million available, which is projected to fund operations through the end of calendar year 2026.
Immutep Limited's Ownership Breakdown
The company's shareholder base is dominated by large institutional investors, many of whom hold American Depositary Receipts (ADRs) on the NASDAQ, alongside a broad base of retail and other institutional shareholders. The four largest substantial shareholders alone account for over 40% of the company's total shares.
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| The Bank of New York Mellon Corporation | 14.50% | Substantial holder, often associated with ADR holdings. |
| Regal Funds Management Pty Ltd | 13.91% | Major Australian-based investment fund. |
| Insignia Financial Ltd | 10.16% | Large financial services and wealth management group. |
| JP Morgan Chase & Co and its affiliates | 5.04% | Global financial institution with a significant stake. |
| Other Institutional & Retail Float (Approx.) | 56.38% | Includes other institutions like BlackRock, Inc. and Morgan Stanley, plus public float. |
| Insiders (Directors and Executives) | 0.01% | Represents the collective ownership of company insiders. |
Immutep Limited's Leadership
The leadership team blends deep scientific expertise with seasoned commercial and operational experience, which is defintely necessary for a company navigating the transition to Phase III. Marc Voigt, the Chief Executive Officer and Executive Director, has led the company since July 2014 and holds a direct stake of 1.01% of the company's shares. His long tenure provides critical stability. The board is overseen by Non-Executive Chairman Russell Howard, Ph. D. You can find more detail on the strategic direction in the Mission Statement, Vision, & Core Values of Immutep Limited (IMMP).
The key management personnel steering the company's clinical and commercial strategy as of November 2025 include:
- Marc Voigt: Chief Executive Officer & Executive Director.
- Frédéric Triebel, M.D., Ph. D.: Chief Scientific Officer & Executive Director, and the original founder of Immutep S.A. in 2001.
- Deanne Miller: Chief Operating Officer, General Counsel & Company Secretary.
- Christian Mueller: Chief Development Officer, focusing on pipeline advancement.
- Stephan Winckels, M.D., Ph. D.: Chief Medical Officer, appointed in 2025 to oversee clinical trials.
This structure ensures that the core scientific discovery is still represented at the executive and board level, while the operational roles are focused on the complex execution of global clinical trials. You need that scientific continuity in a biotech.
Immutep Limited (IMMP) Mission and Values
Immutep Limited's purpose extends beyond standard biotech returns, focusing on pioneering Lymphocyte Activation Gene-3 (LAG-3) immunotherapy to deliver novel, effective treatments for cancer and autoimmune diseases, while also ensuring Breaking Down Immutep Limited (IMMP) Financial Health: Key Insights for Investors is a priority for stakeholders.
The company is defintely a pioneer, leveraging its expertise to bring innovative options to patients in need and, at the same time, maximize value for shareholders. That's the core balance in a clinical-stage biotech.
Given Company's Core Purpose
Official mission statement
The mission is straightforward: develop innovative immunotherapies that offer new hope to patients with cancer and autoimmune diseases. This is a dual focus, which is unusual, but necessary given their proprietary LAG-3 technology, which can both stimulate the immune system (for cancer) and suppress it (for autoimmune disease).
- Develop innovative immunotherapies.
- Offer new hope to cancer and autoimmune disease patients.
- Maximize sustainable shareholder value.
Vision statement
Immutep Limited's near-term vision is anchored in the successful commercialization of its lead product candidate, eftilagimod alfa (efti), in a massive market. The successful dosing of the first patient in the pivotal TACTI-004 Phase III trial in first-line non-small cell lung cancer (1L NSCLC) in March 2025 was a key marker for this vision.
Here's the quick math: the total addressable market for 1L NSCLC is about $24 billion US, so a successful trial could catapult the company's valuation significantly. The vision is to set a new standard of care in this space by safely providing meaningful clinical benefits.
- Achieve marketing approval for eftilagimod alfa.
- Become a leader in LAG-3 immunotherapy.
- Safely provide meaningful clinical benefits for cancer patients.
Given Company slogan/tagline
While Immutep Limited doesn't use a short, punchy slogan in the traditional sense, their identity is clearly defined by their therapeutic focus and scientific leadership.
- LAG-3 Immunotherapy for Cancer & Autoimmune Disease.
- Global leader in LAG-3.
This focus drives operational decisions, like the prudent investment of surplus funds that saw interest income rise from A$3.88 million in FY2024 to A$5.29 million in FY2025, demonstrating a commitment to financial discipline alongside scientific progress. The core values of integrity, patient safety, and innovation are the bedrock of this dual pursuit.
Immutep Limited (IMMP) How It Works
Immutep Limited works by developing novel immunotherapy drugs that modulate the Lymphocyte Activation Gene-3 (LAG-3) immune checkpoint pathway, effectively training the body's immune system to fight cancer or, conversely, to dial down an overactive response in autoimmune disease.
The company's core value creation is in the clinical advancement of its first-in-class drug candidates, particularly its lead asset, eftilagimod alpha (efti), which is designed to activate antigen-presenting cells (APCs) to kick-start a stronger, more sustained anti-cancer T-cell response. It's a classic biotech model: invest heavily in research and development (R&D) to prove efficacy, then monetize through commercialization or lucrative licensing deals. Exploring Immutep Limited (IMMP) Investor Profile: Who's Buying and Why?
Immutep Limited's Product/Service Portfolio
The company's pipeline is centered on two main LAG-3-related product candidates, eftilagimod alpha (efti) and IMP761, plus out-licensed assets that offer potential milestone and royalty payments down the road. Efti is the primary near-term focus, now in a pivotal Phase III trial.
| Product/Service | Target Market | Key Features |
|---|---|---|
| Eftilagimod Alpha (Efti) | Oncology: First-Line Non-Small Cell Lung Cancer (1L NSCLC) | First-in-class soluble LAG-3Ig fusion protein; MHC Class II agonist; currently in global registrational Phase III trial (TACTI-004) in combination with KEYTRUDA® and chemotherapy. |
| Eftilagimod Alpha (Efti) | Oncology: Head and Neck Squamous Cell Carcinoma (HNSCC) | Fast Track designation from the FDA; Phase IIb trial (TACTI-003) showed a median Overall Survival (OS) of 17.6 months in the hard-to-treat PD-L1 negative (CPS <1) patient group. |
| IMP761 | Autoimmune Diseases (e.g., Rheumatoid Arthritis, Inflammatory Bowel Disease) | First-in-class LAG-3 agonist antibody; aims to suppress T-cell activity to treat conditions where the immune system is overactive; currently in a Phase I trial. |
Immutep Limited's Operational Framework
As a late-stage biotech, Immutep's operations are almost entirely focused on clinical trial execution and R&D investment, not commercial sales. Honestly, that's what you should expect from a company in this stage; they're building the product, not selling it yet.
The company's financial activity in the fiscal year ending June 30, 2025, reflects this intense R&D focus. Net cash used in operating activities was A$62.05 million, a significant increase from A$34.8 million in the prior year, mainly driven by the commencement of the pivotal Phase III TACTI-004 trial. The revenue is minimal, with licensing revenue being nil and research material sales at only A$0.06 million for FY2025. The company's total other income was A$10.3 million, with the largest component being A$5.3 million in interest income from its cash reserves. That's a solid buffer, but it's not a business model.
- Fund clinical trials: Finance the global Phase III TACTI-004 trial in 1L NSCLC, which enrolled and randomized over 170 patients as of October 2025.
- Manage cash runway: Maintain a strong cash and term deposit balance of approximately A$129.69 million at June 30, 2025, which is expected to fund operations until the end of calendar year 2026.
- Secure non-dilutive funding: Claim R&D tax incentives, such as the French Crédit d'Impôt Recherche, which provided A$4.13 million in grant income during fiscal year 2025.
- Advance pipeline: Progress the Phase I trial for IMP761 for autoimmune diseases, diversifying the company's therapeutic reach beyond oncology.
Immutep Limited's Strategic Advantages
The company's competitive edge comes from its leadership in the LAG-3 space and the strong clinical data that suggests efti can significantly enhance the effectiveness of established checkpoint inhibitors like KEYTRUDA® (pembrolizumab).
- First-Mover and LAG-3 Focus: Immutep is a leader in developing LAG-3-related immunotherapies, a next-generation immune checkpoint target, giving it a deep scientific and intellectual property (IP) advantage.
- Strategic Big Pharma Partnerships: Collaborations with Merck & Co., Inc. (MSD) on multiple trials, including the pivotal TACTI-004, not only validate the science but also provide access to a global clinical infrastructure and their blockbuster drug, KEYTRUDA®.
- Differentiated Mechanism of Action: Efti's unique role as an MHC Class II agonist activates the immune system's master switches (APCs) rather than just releasing the brakes (like PD-1 inhibitors), potentially creating a more robust and complete anti-cancer response.
- Compelling Clinical Data: Results from the INSIGHT-003 trial in 1L NSCLC showed a median Overall Survival of 32.9 months for the efti triple combination, substantially exceeding the historical 22.0 months for the standard-of-care combination alone, which is defintely a key selling point.
- Regulatory Tailwinds: Efti holds Fast Track designation from the U.S. Food and Drug Administration (FDA) for both 1L NSCLC and 1L HNSCC, which can expedite the development and review process.
Immutep Limited (IMMP) How It Makes Money
Immutep Limited, as a late-stage clinical biotechnology company, does not yet generate revenue from commercial product sales; instead, its income comes almost entirely from financing activities and government support for its research and development (R&D) efforts, primarily in Australia and France.
Immutep Limited's Revenue Breakdown
You need to understand that Immutep's business model is currently pre-commercial, meaning its financial health is measured by its cash runway-how long its cash reserves can fund its R&D-rather than profit. The revenue you see is 'Other Income,' which is crucial for offsetting the high costs of running pivotal Phase III clinical trials for its lead candidate, eftilagimod alfa (efti). Here's the breakdown of the A$10.3 million in total other income for the fiscal year ended June 30, 2025.
| Revenue Stream | % of Total | Growth Trend |
|---|---|---|
| Interest Income | 51.5% | Increasing |
| R&D Tax Incentives (Grant Income) | 40.8% | Stable/Increasing |
| Other/Miscellaneous Income | 7.2% | Increasing |
| Research Material Sales | 0.6% | Decreasing |
Business Economics
The core economic reality for Immutep is its high burn rate-the speed at which it spends its cash-which is typical for a biotech company advancing a product like efti into a registrational Phase III trial. The company's profitability is zero right now, but its value is tied to the clinical success of its pipeline, specifically the TACTI-004 trial in non-small cell lung cancer.
- Pricing Strategy: The future pricing strategy for efti will be based on its value proposition as a combination therapy with anti-PD-1 drugs like KEYTRUDA (pembrolizumab) and its ability to significantly improve overall survival rates over current standards of care.
- Cost Structure: R&D is the overwhelming cost driver. Net cash used in operating activities for FY2025 was A$62.05 million, a significant increase from the prior year, reflecting the costs of expanding the global Phase III TACTI-004 trial.
- Key Value Driver: The real money will come from a major pharmaceutical licensing deal or commercialization after regulatory approval. The current revenue streams are simply a bridge to that inflection point.
- Financial Cushion: The surge in Interest Income to A$5.3 million in FY2025 is a direct result of prudent investment of surplus funds and higher interest rates, which helps to slightly offset the R&D costs.
The company is defintely a high-risk, high-reward play tied to clinical data readouts.
Immutep Limited's Financial Performance
As of November 2025, Immutep's financial performance reflects its status as a late-stage R&D enterprise, prioritizing clinical advancement over near-term profit. The numbers show a company heavily invested in its future, which is exactly what you want to see at this stage.
- Cash Runway: The company reported a strong cash and term deposit balance of approximately A$109.85 million as of October 29, 2025 (Q1 FY26), which is projected to fund operations to the end of calendar year 2026.
- Net Loss: The net loss for the full year ended June 30, 2025, was A$61.43 million, a 43.8% increase from the previous year, directly correlating with the accelerated R&D spend on pivotal trials.
- R&D Investment: The increase in payments to suppliers and employees, mainly for R&D and clinical trial costs, rose by A$27.48 million during FY2025, showing a clear commitment to advancing efti.
- Market Valuation: The market capitalization stood at approximately A$397.42 million as of November 2025, with analysts projecting a significant upside based on the potential of the LAG-3 pipeline.
For a deeper dive into the balance sheet and cash flow, you should read Breaking Down Immutep Limited (IMMP) Financial Health: Key Insights for Investors. Finance: Monitor the TACTI-004 futility analysis, expected in Q1 CY2026, as this will be the next major financial catalyst.
Immutep Limited (IMMP) Market Position & Future Outlook
Immutep Limited is a high-risk, high-reward biotech play, currently positioned as a late-stage clinical company pioneering the Lymphocyte Activation Gene-3 (LAG-3) immunotherapy space, but still pre-revenue from its lead candidate. The company's future trajectory hinges on the pivotal Phase III TACTI-004 trial for eftilagimod alfa (efti) in first-line Non-Small Cell Lung Cancer (1L NSCLC), a market with a US total addressable value of approximately $24 billion. Analyst sentiment is strongly bullish, projecting a potential upside of over 430%, which reflects the market's belief in efti's unique mechanism of action as a soluble LAG-3 fusion protein.
Competitive Landscape
In the LAG-3 immunotherapy segment, Immutep's competitive position is defined by its pipeline status against the sole approved product. While Immutep's efti is a first-in-class LAG-3 soluble fusion protein that activates antigen-presenting cells (APCs), the primary commercial competition comes from the LAG-3 antibody class. This distinction is crucial; efti works differently than the antibodies. Exploring Immutep Limited (IMMP) Investor Profile: Who's Buying and Why?
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Immutep Limited | 0% | First-in-class soluble LAG-3 fusion protein (APC activator) |
| Bristol Myers Squibb | ~30% (1L Melanoma) | First-to-market approved LAG-3 antibody (relatlimab/Opdualag) |
| Regeneron Pharmaceuticals | 0% (Pipeline) | Late-stage clinical LAG-3 antibody (Fianlimab, Phase 3) |
Opportunities & Challenges
Honesty, the biggest opportunity is the sheer size of the target markets, but the biggest challenge is the capital burn required to reach them. Immutep's cash and term deposits totaled approximately A$109.85 million as of September 30, 2025, which provides runway, but the R&D costs are high. For the 2025 fiscal year, the company reported a loss after tax of A$61.4 million, up 43.8% from the previous year, showing the increased investment in clinical trials. Here's the quick math: you're betting on clinical success to capture a slice of those multi-billion-dollar markets.
| Opportunities | Risks |
|---|---|
| Pivotal Phase III TACTI-004 trial success in 1L NSCLC. | Clinical trial failure or unexpected safety signals. |
| LAG-3 agonist IMP761 for autoimmune disease; un-risked valuation estimated at A$5.9 billion. | Significant negative free cash flow, over $46 million in 2025. |
| Pipeline expansion into 1L Head and Neck Cancer (HNSCC) following constructive FDA feedback. | Intense competition from major pharma with approved LAG-3 antibodies. |
Industry Position
Immutep is a clinical-stage biotech focused on the Lymphocyte Activation Gene-3 (LAG-3) pathway, a next-generation immune checkpoint target. The company's position is unique because its lead candidate, efti, is a soluble molecule, not a monoclonal antibody like its competitors. This means it has a different mechanism of action, activating the immune system's APCs rather than just blocking an inhibitory signal. The Immune Checkpoint Inhibitors Market size is estimated at $50.29 billion in 2025, and the LAG-3 segment is projected to grow with a 17.81% Compound Annual Growth Rate (CAGR) through 2030, so the tailwinds are defintely strong. The company's forward-looking revenue growth is forecast at an impressive 104.1% per year, reflecting the anticipated near-term pipeline milestones.
- Lead the LAG-3 agonist space for autoimmune diseases with IMP761.
- Maintain strategic collaborations with Merck & Co. and Novartis, validating its technology.
- Capitalize on the large, unmet medical need in 1L NSCLC and HNSCC.
The entire LAG-3 market is still nascent, which is why Immutep is seen as a high-growth opportunity, even with a current market capitalization around $240 million.

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