IMMUTEP Ltd

Immutep Limited is a development stage biotech company focused on the development of immunotherapeutic products for the treatment of cancer and autoimmune diseases, with its product candidates all related to lymphocyte activation gene 3, or LAG-3, a gene linked to the regulation of T cells in immune responses. The company has four LAG-3 product candidates or programs: eftilagimod alfa (also known as efti or IMP321), IMP701 (also known as LAG525 or ieramilimab), IMP731 (previously also known as GSK'781), and IMP761. Of these, efti and IMP761 are the subject of active programs. The company has no medicinal products approved for commercial sale and no source of consistent material revenue, and it currently generates modest income from sales of LAG-3 research reagents. The company operates in the pharmaceutical and biotechnology industries, which are subject to rapid and significant technological change, and competition among biotechnology and pharmaceutical companies for qualified employees is intense.

Immutep's most advanced product candidate is efti, a recombinant protein typically used in conjunction with other therapies such as chemotherapy or other immunotherapy to amplify a patient's immune response. The company has entered into three clinical trial collaboration and supply agreements with Merck & Co., Inc., Rahway/Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of efti with MSD's anti-PD-1 therapy pembrolizumab in Phase II and Phase III clinical trials. It has also entered into two clinical trial collaboration and supply agreements with Merck KGaA, Darmstadt, Germany, and Pfizer for Phase I clinical trials to evaluate the combination of efti with avelumab, a PD-L1 blocking antibody. In China, Hong Kong, Macau and Taiwan, the exclusive development and commercialization rights to efti are held by licensee EOC Pharma. IMP701 was fully licensed to CoStim Pharmaceuticals, which was subsequently acquired by Novartis; in August 2026, the exclusive license and collaboration agreement was terminated on notice from Novartis, and Novartis will assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S. IMP731 was licensed to a major pharmaceutical company and has been transferred back to Immutep. IMP761 is a clinical-stage product candidate being developed as the company's first agonist antibody of LAG-3 for application in autoimmune disease. The company has discontinued its early-stage small molecule anti-LAG-3 research program, although its exclusive license agreement with Cardiff University has not been terminated. Immutep has a dedicated R&D laboratory close to Paris with ongoing research capabilities as well as external research collaborations.

Immutep's business model centers on the development and potential commercialization of its LAG-3 related product candidates, with revenue generation dependent on successfully completing preclinical and clinical development, receiving regulatory approval, setting acceptable prices, obtaining adequate coverage and reimbursement from third-party payors, obtaining commercial and clinical quantities of products at acceptable cost levels, and successfully marketing and selling products. The company has historically devoted most of its financial resources to research and development, including pre-clinical and clinical development and manufacturing activities, and has financed a significant amount of its operations through public and private financing. The company has no in-house manufacturing capability for its product candidates and is dependent on third parties for cost effective manufacture and manufacturing process development. It relies on WuXi Biologics, a China-based contract manufacturer, to manufacture efti. The company also depends on collaborations and strategic alliances with third parties for developing, manufacturing and commercializing its product candidates.

Immutep's most advanced product candidate, efti, is a recombinant protein used in conjunction with other therapies to amplify a patient's immune response. The company has entered into three clinical trial collaboration and supply agreements with Merck & Co., Inc. (MSD) to evaluate efti in combination with pembrolizumab in Phase II and Phase III clinical trials, and two agreements with Merck KGaA and Pfizer for Phase I clinical trials combining efti with avelumab. In China, Hong Kong, Macau and Taiwan, exclusive development and commercialization rights to efti are held by licensee EOC Pharma. During fiscal year 2026, Immutep entered into a strategic licensing agreement with Dr. Reddy's Laboratories, under which Dr. Reddy's has the exclusive right to develop and commercialize efti in all markets worldwide excluding the Immutep Territory, which consists of the United States, Canada, Europe (excluding the Russian Federation and the Commonwealth of Independent States), Japan and Greater China. Immutep is entitled to potential regulatory, development and commercial milestone payments of up to US$349.5 million ¹ and royalties on net commercial sales in the licensed territories, and retains the global manufacturing rights to efti.

Immutep's second LAG-3 product candidate, IMP701 (ieramilimab, also known as LAG525), is an antagonist antibody that acts to stimulate T cell proliferation in cancer patients. IMP701 was fully licensed to CoStim Pharmaceuticals, which was subsequently acquired by Novartis. In August 2026, the exclusive license and collaboration agreement was terminated on notice from Novartis, and Novartis will assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S. The third LAG-3 product candidate, IMP731, is a depleting antibody that could remove T cells involved in autoimmunity; it was licensed to a major pharmaceutical company and has been transferred back to Immutep. The fourth LAG-3 product candidate, IMP761, is a clinical-stage product candidate being developed as the company's first agonist antibody of LAG-3 for application in autoimmune disease. The company has discontinued its early-stage small molecule anti-LAG-3 research program, although its exclusive license agreement with Cardiff University has not been terminated. Immutep also has a dedicated R&D laboratory close to Paris with ongoing research capabilities as well as external research collaborations, and currently generates modest income from sales of LAG-3 research reagents.

During fiscal year 2026, Immutep entered into a strategic licensing agreement with Dr. Reddy's Laboratories, granting Dr. Reddy's the exclusive right to develop and commercialize efti in all markets worldwide excluding the Immutep Territory, which consists of the United States, Canada, Europe (excluding the Russian Federation and the Commonwealth of Independent States), Japan and Greater China. Immutep is entitled to potential regulatory, development and commercial milestone payments of up to US$349.5 million and royalties on net commercial sales in the licensed territories, and retains the global manufacturing rights to efti. In March 2026, following a planned interim futility analysis, the company discontinued TACTI-004 (NCT06726265; KEYNOTE-F91), its registrational Phase III trial of efti in combination with an anti-PD-1 therapy and chemotherapy in 1st line non-small cell lung cancer (NSCLC), and commenced an orderly wind-down of the trial together with a comprehensive root cause analysis, which remains ongoing. In fiscal 2026, the company recorded an A$3.1 million ² non-cash impairment charge on the intellectual property intangible asset relating to the patents held on efti from the acquisition of Immutep S.A. (now Immutep S.A.S.) in 2014, following the discontinuation of TACTI-004. TACTI-004 was conducted exclusively with efti manufactured at 2,000L scale, and the ongoing root cause analysis following its discontinuation has identified subtle structural differences between that efti and the efti manufactured at 200L scale which was used in earlier positive clinical studies. The company has contracted a new manufacturing run of efti at 200L scale. In the last quarter of fiscal 2026, the company undertook cost reduction initiatives, including a targeted reduction in headcount.

For the fiscal years ended June 30, 2026, and 2025, Immutep had net losses of A$79.3 million ³ and A$61.4 million ⁴, respectively. The company has experienced significant recurring operating losses and negative cash flows from operating activities since inception. It expects to continue to incur losses from operations for the foreseeable future and expects the costs of drug development to increase in the future as more patients are recruited to its clinical trials. The company anticipates that its expenses will increase substantially for the foreseeable future if, and as, it continues research and preclinical and clinical development of its product candidates, expands the scope of current proposed clinical studies, initiates additional preclinical, clinical, or other studies, changes or adds additional manufacturers or suppliers or the manufacturing process, seeks regulatory and marketing approvals, seeks to identify and validate additional product candidates, acquires or in-licenses other product candidates and technologies, maintains, protects, and expands its intellectual property portfolio, attracts and retains skilled personnel, creates additional infrastructure to support its operations as a publicly quoted company and its product development and planned future commercialization efforts, adds an internal sales force, and experiences any delays or encounters unexpected issues which necessitate a change in planned expenditure.

Immutep's growth vectors center on the continued development of its LAG-3 product candidates, particularly efti and IMP761. The company has entered into a strategic licensing agreement with Dr. Reddy's Laboratories, under which Dr. Reddy's has the exclusive right to develop and commercialize efti in all markets worldwide excluding the Immutep Territory, which consists of the United States, Canada, Europe (excluding the Russian Federation and the Commonwealth of Independent States), Japan and Greater China. Immutep is entitled to potential regulatory, development and commercial milestone payments of up to US$349.5 million and royalties on net commercial sales in the licensed territories, and retains the global manufacturing rights to efti. The company has also entered into three clinical trial collaboration and supply agreements with Merck & Co., Inc. (MSD) to evaluate efti in combination with pembrolizumab in Phase II and Phase III clinical trials, and two agreements with Merck KGaA and Pfizer for Phase I clinical trials combining efti with avelumab.

A second growth vector is the development of IMP761, a clinical-stage product candidate being developed as the company's first agonist antibody of LAG-3 for application in autoimmune disease. The company has a dedicated R&D laboratory close to Paris with ongoing research capabilities as well as external research collaborations. The company has discontinued its early-stage small molecule anti-LAG-3 research program, although its exclusive license agreement with Cardiff University has not been terminated. In August 2026, the exclusive license and collaboration agreement for IMP701 was terminated on notice from Novartis, and Novartis will assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S. IMP731 was licensed to a major pharmaceutical company and has been transferred back to Immutep.

Immutep's margin and cost outlook reflects its status as a development stage biotech company with no products approved for commercial sale and no source of consistent material revenue. The company expects to continue to incur losses from operations for the foreseeable future and expects the costs of drug development to increase in the future as more patients are recruited to its clinical trials. In the last quarter of fiscal 2026, the company undertook cost reduction initiatives, including a targeted reduction in headcount. The company anticipates that its expenses will increase substantially for the foreseeable future if, and as, it continues research and preclinical and clinical development of its product candidates, expands the scope of current proposed clinical studies, initiates additional preclinical, clinical, or other studies, changes or adds additional manufacturers or suppliers or the manufacturing process, seeks regulatory and marketing approvals, seeks to identify and validate additional product candidates, acquires or in-licenses other product candidates and technologies, maintains, protects, and expands its intellectual property portfolio, attracts and retains skilled personnel, creates additional infrastructure to support its operations as a publicly quoted company and its product development and planned future commercialization efforts, adds an internal sales force, and experiences any delays or encounters unexpected issues which necessitate a change in planned expenditure.

Immutep's operational outlook is shaped by its reliance on third-party manufacturing and supply partners. The company has no manufacturing capabilities and is dependent on third parties for cost effective manufacture and manufacturing process development of its product candidates. It currently relies on WuXi Biologics, a contract development and manufacturing organization headquartered in China, to manufacture efti. TACTI-004 was conducted exclusively with efti manufactured at 2,000L scale, and the ongoing root cause analysis following its discontinuation has identified subtle structural differences between that efti and the efti manufactured at 200L scale which was used in earlier positive clinical studies. The company has contracted a new manufacturing run of efti at 200L scale. The company is a small company, with few internal staff and limited facilities, and is and will be required to rely on a variety of contractors to manufacture and transport its products, to perform clinical testing and to prepare regulatory dossiers.

Immutep's capital allocation priorities are focused on funding its research and development programs. The company has historically devoted most of its financial resources to research and development, including pre-clinical and clinical development and manufacturing activities, and has financed a significant amount of its operations through public and private financing. The company anticipates that its expenses will increase substantially for the foreseeable future if, and as, it continues research and preclinical and clinical development of its product candidates. The company will require additional financing and may be unable to raise sufficient capital, which could have a material impact on its research and development programs or commercialization of its products or product candidates. Any additional equity fundraising in the capital markets may be dilutive for shareholders and any debt-based funding may bind the company to restrictive covenants and curb its operating activities and ability to pay potential future dividends even when profitable.

Immutep faces structural headwinds and execution risks to its growth plan. The company has a history of operating losses and may not achieve or maintain profitability in the future, with net losses of A$79.3 million and A$61.4 million for the fiscal years ended June 30, 2026, and 2025, respectively. The company has no medicinal products approved for commercial sale and no source of consistent material revenue. In March 2026, following a planned interim futility analysis, the company discontinued TACTI-004, its registrational Phase III trial of efti in combination with an anti-PD-1 therapy and chemotherapy in 1st line non-small cell lung cancer (NSCLC), and commenced an orderly wind-down of the trial together with a comprehensive root cause analysis, which remains ongoing. In fiscal 2026, the company recorded an A$3.1 million non-cash impairment charge on the intellectual property intangible asset relating to the patents held on efti from the acquisition of Immutep S.A. (now Immutep S.A.S.) in 2014, following the discontinuation of TACTI-004.

A further constraint is the regulatory and legislative environment affecting the company's supply chain. On December 18, 2025, the National Defense Authorization Act for Fiscal Year 2026 was signed into law, including Section 851, commonly referred to as the BIOSECURE Act. Once implemented, the BIOSECURE Act will restrict U.S. federal agencies from procuring biotechnology equipment or services produced or provided by a "biotechnology company of concern," from contracting with entities that use such equipment or services in performing a federal contract, and from using federal loan or grant funds for such equipment or services. WuXi Biologics is not currently designated as a biotechnology company of concern. However, earlier legislative versions of the BIOSECURE Act expressly named WuXi Biologics, members of Congress have urged the Department of Defense to add WuXi Biologics to the 1260H List, and in June 2026 the Department of Defense added WuXi AppTec, a separate company, to the 1260H List. If WuXi Biologics is included on the initial OMB list of biotechnology companies of concern, the applicable prohibitions could become effective as early as approximately Q3 2028, based on the statutory implementation timetable. Qualifying contracts or agreements entered into before the applicable effective date may benefit from a five-year grandfathering period, which could expire approximately in Q3 2033.

Immutep faces material risks specific to its business model and current situation. The company has a history of operating losses and may not achieve or maintain profitability, with net losses of A$79.3 million and A$61.4 million for the fiscal years ended June 30, 2026, and 2025, respectively. It has no medicinal products approved for commercial sale and no source of consistent material revenue. In March 2026, following a planned interim futility analysis, the company discontinued TACTI-004, its registrational Phase III trial of efti in combination with an anti-PD-1 therapy and chemotherapy in 1st line non-small cell lung cancer (NSCLC), and commenced an orderly wind-down of the trial together with a comprehensive root cause analysis, which remains ongoing. In fiscal 2026, the company recorded an A$3.1 million non-cash impairment charge on the intellectual property intangible asset relating to the patents held on efti from the acquisition of Immutep S.A. (now Immutep S.A.S.) in 2014, following the discontinuation of TACTI-004. The company relies on WuXi Biologics, a China-based contract manufacturer, to manufacture efti, and U.S. restrictions on dealings with certain biotechnology companies, including under the BIOSECURE Act, could disrupt its supply of efti and adversely affect its relationships with current or prospective U.S. partners. If WuXi Biologics is included on the initial OMB list of biotechnology companies of concern, the applicable prohibitions could become effective as early as approximately Q3 2028, based on the statutory implementation timetable. Qualifying contracts or agreements entered into before the applicable effective date may benefit from a five-year grandfathering period, which could expire approximately in Q3 2033. The company will require additional financing and may be unable to raise sufficient capital, which could have a material impact on its research and development programs or commercialization of its products or product candidates.

Management's message to shareholders emphasizes the company's focus on advancing its LAG-3 product candidates, particularly efti and IMP761, while navigating the challenges of a development stage biotech company with no approved products and no consistent material revenue. The company has entered into a strategic licensing agreement with Dr. Reddy's Laboratories, under which Dr. Reddy's has the exclusive right to develop and commercialize efti in all markets worldwide excluding the Immutep Territory, which consists of the United States, Canada, Europe (excluding the Russian Federation and the Commonwealth of Independent States), Japan and Greater China. Immutep is entitled to potential regulatory, development and commercial milestone payments of up to US$349.5 million and royalties on net commercial sales in the licensed territories, and retains the global manufacturing rights to efti. In March 2026, following a planned interim futility analysis, the company discontinued TACTI-004, its registrational Phase III trial of efti in combination with an anti-PD-1 therapy and chemotherapy in 1st line non-small cell lung cancer (NSCLC), and commenced an orderly wind-down of the trial together with a comprehensive root cause analysis, which remains ongoing. In fiscal 2026, the company recorded an A$3.1 million non-cash impairment charge on the intellectual property intangible asset relating to the patents held on efti from the acquisition of Immutep S.A. (now Immutep S.A.S.) in 2014, following the discontinuation of TACTI-004. In the last quarter of fiscal 2026, the company undertook cost reduction initiatives, including a targeted reduction in headcount. The company's strategic priorities for the period ahead include continuing the development of efti and IMP761, managing its cost structure, and securing additional funding to support its research and development programs. The company anticipates that its expenses will increase substantially for the foreseeable future if, and as, it continues research and preclinical and clinical development of its product candidates.