Telix Pharmaceuticals stock | Expectations for 2026, valuation & analysis

Telix Pharmaceutical...

ASX:TLX

$ 11,24

$-0,09 (-0,79%)

11,24 $

$-0,09 (-0,79%)

End-of-day quote: 01/09/2026

Telix Pharmaceuticals Stock Value

The current analyst rating for ASX:TLX is Buy.

Buy

Telix Pharmaceuticals Company Info

EPS Growth 5Y

28,47%

Market Cap

$3,84 B

Long-Term Debt

$0,55 B

Annual earnings

01/15/2026

Dividend

$0,00

Dividend Yield

0,00%

Founded

2015

Industry

Health Care

Country

Australia

Website

Telix Pharmaceuticals

ISIN Number

AU000000TLX2

Website

http://telixpharma.com

Analyst Price Target

$25,20

124.2%

Last Update: 01/09/2026

Analysts: 12

Highest Price Target $34,00

Average Price Target $25,20

Lowest Price Target $17,00

In the last five quarters, Telix Pharmaceuticals’s Price Target has risen from $19,71 to $26,23 - a 33,08% increase. Five analysts predict that Telix Pharmaceuticals’s share price will increase in the coming year, reaching $25,20. This would represent an increase of 124,20%.

Top growth stocks in the health care sector (5Y.)

What does Telix Pharmaceuticals do?

Telix Pharmaceuticals Limited is a global, commercial-stage biopharmaceutical company. The company focuses on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. The company is committed to the principles of precision oncology. By this the company means developing both therapeutic and diagnostic modalities for the benefit of patients, an innovative precision medicine concept generally referred to as ‘theranostics’. As an...

Telix Pharmaceuticals Limited is a global, commercial-stage biopharmaceutical company.

The company focuses on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. The company is committed to the principles of precision oncology. By this the company means developing both therapeutic and diagnostic modalities for the benefit of patients, an innovative precision medicine concept generally referred to as ‘theranostics’.

As an established leader and innovator in this field, Telix is differentiated by the company’s deep expertise in radiopharmaceutical drug development and commercialization, its innovative pipeline that spans the cancer care continuum, and the company’s ability to deliver patient outcomes globally.

In order to deliver on the company’s strategy, Telix has structured the business into five operating segments: Therapeutics (Tx), Precision Medicine (Px), International, MedTech and Telix Manufacturing Solutions (TMS). The company will be reporting financial results by the three reportable segments: Tx, Px (including International and MedTech) and TMS.

Therapeutics are at the core of the Telix portfolio, as the company works to improve and extend patient life. The company is focused on developing targeted radionuclide therapies for urologic, neurologic, musculoskeletal and hematological cancers.

Precision Medicine is focused on bringing diagnostic imaging solutions to market, as this is the key to informing treatment decisions and selecting patients for therapy. It therefore plays a fundamental role in managing patients and delivering personalized therapeutic solutions. MedTech provides surgical solutions and digital products that power Telix’s precision medicines and therapeutics. International is focused on ‘rest of world’ (ex-U.S.) commercial operations for Europe, the Middle East and Africa (EMEA), the Asia Pacific (APAC) and Latin America regions.

Telix Manufacturing Solutions is the company’s global network of facilities designed to deliver patient doses worldwide. The company is investing in building manufacturing capacity, as well as improving the technology and processes to allow the company to deliver therapies at scale, including next-generation alpha therapies. This investment in world-class infrastructure is helping Telix to develop new products and secure critical supplies required to commercialize the future of cancer treatments.

Product Pipeline

The company’s portfolio includes both therapeutic and diagnostic radiopharmaceutical product candidates designed for use throughout the continuum of the patient journey, from diagnosis and staging to treatment and ongoing care. The company also intends to use its therapeutic and diagnostic radiopharmaceutical product candidates in combination with one another, as a theranostic treatment approach. The company’s clinical programs include several product candidates that are being evaluated in Phase 2 and Phase 3 clinical trials with multiple expected upcoming data readouts and regulatory filings.

For most of the company’s programs, particularly the prostate and kidney programs, the company has generated extensive clinical data that demonstrate the potential of the company’s product candidates to offer meaningful benefits to patients. The targets and indications the company is pursuing are well validated and are well suited for the delivery of therapeutic and diagnostic targeted radiation.

In addition to the development pipeline above, the company is exploring product and indication expansion opportunities with its late-stage diagnostic portfolio through its lifecycle management programs, including TLX007-CDx, which is a new 68Ga-based PSMA-PET imaging agent for prostate cancer with its own NDA. TLX007-CDx contains a different formulation and higher radioactivity compared to Illuccix and is expectes to have an extended distribution profile compared approved 68Ga-based PSMA-PET imaging agents due to the higher radioactivity and the use of 68Ga sourced from newer high activity generators and cyclotrons. The company’s lifecycle management program also includes two substantial prostate cancer indications for Illuccix, a staging indication for TLX250-CDx, and an expansion into brain metastases for TLX101-CDx.

Prostate Cancer and PSMA

The company’s prostate cancer programs target PSMA, a well-validated protein target for the delivery of both therapeutic and diagnostic radiopharmaceuticals that is highly expressed on prostate cancer cells with low expression on healthy cells. The company’s approach to targeting PSMA is unique because it uses a small molecule targeting ligand for imaging and an antibody for its therapeutic product candidate. The company’s use of a small molecule targeting ligand for imaging enables rapid targeting and clearance of the payload to produce sharp images for PET scanning in the diagnostic setting.

The company’s lead therapeutic product candidate TLX591 (177Lu rosopatamab tetraxetan) is a lutetium-labelled rADC that it has the potential to deliver improved patient outcomes with an efficient dosing regimen. The targeting and pharmacology of TLX591 differs significantly from PSMA-targeting small molecules used in commercially available compounds, and was designed for high internalization, long retention and to be highly selective for tumor-expressed PSMA.

In November 2023, the company initiated a randomized, multinational, multicenter, open-label Phase 3 trial, which it refers to as the ProstACT GLOBAL trial, to evaluate TLX591 for the treatment of PSMA-positive mCRPC patients in combination with the standard of care compared to the standard of care alone. The company expects this trial to enroll 30 patients in a dosimetry and safety lead-in portion replicating the prior study using the product candidate specifications intended for commercial release and then proceed to a randomized treatment expansion portion, in up to approximately 490 patients. In May 2024, the company reported that the trial demonstrated a median radiographic progression-free survival of 8.8 months, a secondary objective of the trial, based on an evaluable patient population of 23 patients who each received two 76 mCi doses of TLX591.

TLX592 (64Cu/225Ac-RADmAb) is the company’s next generation prostate cancer therapy candidate for targeted alpha therapy and is its first clinical program based on its proprietary RADmAb-engineered antibody technology. The engineered antibody vector is designed for faster elimination from circulation than standard antibodies and slower elimination than small molecules that may result in side effects. It is also designed to enable reduced bone marrow residence time to mitigate the risk of hematologic toxicity while retaining PSMA-mediated tumor localization and exertion of cytotoxic activity. TLX592 is designed to be cleared by the liver without exocrine uptake.

The company conducted the Phase 1 CUPID trial in which it evaluated TLX592 with a beta-emitting isotope (64Cu) in 12 patients with advanced prostate cancer prior to commencing therapeutic studies with 225Ac, an alpha-emitting isotope. The company treated patients with PSMA avid disease based on Illuccix imaging, across three dose levels to assess safety profile, pharmacokinetics, biodistribution and dosimetry. In May 2024, the company reported that, based on preliminary results from 11 evaluable patients, it observed accelerated elimination from blood circulation compared to the standard antibody used with TLX591 and observed similar on-target and off-target biodistribution and liver clearance, which are important characteristics for an alpha-emitting agent. The trial established a baseline dosing schedule for future trials of TLX592 using 225Ac.

The company’s prostate cancer portfolio also includes Illuccix, its commercially available 68Ga-labelled PSMA-PET imaging agent. The ‘cold kit’ format of Illuccix enables rapid radiolabeling at room temperature with high radiochemical purity and production consistency, suited to the commercial and hospital radiopharmacy setting. Illuccix is approved in the United States, Australia, Canada, and the United Kingdom. In January 2025, the company received a positive decision on its MAA for Illuccix submitted in Europe via a decentralized procedure, with Illuccix subsequently approved at a national level in Denmark and Norway. The company is also exploring potential future utilization in additional indications for prostate cancer patients through its lifecycle management program. These include monitoring progression in metastatic and non-metastatic castration resistant patients and monitoring response to PSMA-directed radioligand therapy.

The company is developing TLX007-CDx, a new cold kit for the preparation of PSMA-PET imaging for prostate cancer. TLX007-CDx is designed to have an extended distribution profile compared to approved 68Ga PSMA-PET imaging agents due to the use of 68Ga sourced from newer high activity generators and cyclotrons.

TLX007-CDx may further expand the availability and distribution of PSMA-PET imaging due to its longer shelf life and resulting expanded distribution radius. TLX007-CDx has the potential to address unmet needs by extending availability of PSMA-PET imaging to substantially all PET/CT locations in the United States. Many PET/CT imaging sites that are not served by approved PSMA-PET imaging agents are located in rural and underserved areas.

The company conducted a Phase 1 clinical trial of TLX007-CDx to compare the biodistribution of TLX007-CDx and Illuccix in normal tissues and major organs, and in prostate cancer deposits. This trial met its primary objective by demonstrating that there were no differences between TLX007-CDx and Illuccix in the biodistribution in normal tissues and organs, or in prostate cancer deposits, based on 11 evaluable patients. In May 2024, based on the results of such trial, the company submitted an NDA to the FDA for TLX007-CDx for the imaging of patients with prostate cancer. As the primary intention of a Phase 1 study is to demonstrate biodistribution and clinical equivalency in a small patient population, these studies are not powered for or designed to demonstrate efficacy.

Kidney Cancer and CAIX

The company’s target for kidney cancer is carbonic anhydrase IX, or CAIX, a scientifically validated target in ccRCC, which is the most prevalent and aggressive form of kidney cancer. To target CAIX, the company uses a monoclonal antibody, girentuximab, which is designed to have a high degree of selectivity and affinity for the target and can be used for both imaging and therapy. The company is using the same hepatically cleared agent for both the imaging and therapeutic applications due to avoidance of kidney excretion, which is an advantage when assessing or treating primary kidney disease.

The company’s CAIX-targeting therapeutic candidate is TLX250 (177Lu-DOTA-girentuximab), an rADC that the company is developing for the treatment of advanced metastatic kidney cancer. In a Phase 1 clinical trial of TLX250, the company observed a mean progression free survival, or PFS, of 11.1 months in 23 patients with advanced ccRCC.

TLX250 is being evaluated in two Phase 2 investigator-sponsored clinical trials for the treatment of kidney cancer, STARLITE-1 and STARLITE-2, in combination with checkpoint inhibitors in a total of 129 patients. In October 2024, the company announced that the MTD of TLX250 has been established in the STARLITE-2 trial, when administered in combination with nivolumab. STARLITE-2 is continuing to dose patients with the possibility of an expansion cohort at the MTD before concluding. The company is also evaluating TLX250 in combination with peposertib (M3814), a DNA-dependent protein kinase, or DNA-PK, inhibitor, in collaboration with Merck KGaA, Darmstadt, Germany, or Merck KGaA, in a Phase 1b trial, STARSTRUCK, for the treatment of patients with ccRCC, as well as other selected solid tumors that commonly express CAIX at an advanced stage of disease. The company expects the STARSTRUCK trial to enroll 85 patients.

The combined diagnostic and therapeutic potential of TLX250 may also extend into other cancers that significantly express CAIX, including certain Von Hippel Landau, or VHL, induced cancers, ovarian cancer, triple-negative breast cancer and bladder cancer. The company’s preliminary clinical data in patients with triple-negative breast and bladder cancer supports future development of TLX250 in these indications.

TLX252 is a CAIX-targeting rADC alpha therapy candidate (225Ac-DOTA-girentuximab) that the company is developing as a potential complement to the TLX250 (beta) program. TLX252 has demonstrated pre-clinical proof-of-concept in several published preclinical imaging and efficacy animal studies, and comparable in vivo characteristics (binding, pharmacokinetics and biodistribution) to non-radiolabeled girentuximab, which it supports the initiation of initial dose-finding trials of TLX252 for the treatment of patients with advanced metastatic kidney cancer.

The company’s imaging candidate TLX250-CDx is a PET diagnostic imaging agent that is under development to characterize indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. The company recently completed the pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of which 284 were evaluable. This demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC.

The company submitted a BLA for TLX250-CDx to the FDA for regulatory approval in December 2023 for characterization of masses as ccRCC. The BLA was granted on a rolling review process. The company completed the BLA submission in May 2024, and in July 2024, the FDA declined to review the BLA and issued an RTF determination. The denial of acceptance for filing was based on a filing concern related to demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment. The company resubmitted the BLA to the FDA in December 2024. While TLX250-CDx has met all sterility requirements of product release and that the company has completed the required remedial actions, there can be no assurance that FDA will accept the BLA for review or that the company will obtain regulatory approval from the FDA. If approved, TLX250-CDx would be the first targeted radiopharmaceutical imaging agent for kidney cancer to be approved in the United States.

As part of the company’s commitment to provide access to medicine, it is running an expanded access program, or EAP, in the U.S., named patient programs, or NPPs, in Europe, and a special access scheme, or SAS in Australia to allow access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternative options.

The company also intends to conduct a label-expanding Phase 3 trial of TLX250-CDx for the imaging of patients with metastatic ccRCC. TLX250-CDx is a natural follow-on product to Illuccix as it is targeted at the same clinician users, the urologist and urologic oncologist, and leverages the company’s existing commercial infrastructure.

In July 2023, the company dosed the first patient in the Phase 2 STARBURST trial of TLX250-CDx exploring CAIX expression in patients with a diverse range of solid tumors for potential therapeutic and diagnostic applications. This trial, which aims to enroll 100 patients, may enable the company to identify new therapeutic indications for TLX250 through the use of molecular imaging with TLX250-CDx.

Bladder Cancer and FAP

The company’s bladder cancer programs target CAIX and fibroblast activation protein, or FAP, two well-validated targets with pan-cancer potential. This complementary approach targeting CAIX and fibrosis is a potential ‘double hit’ at the tumor microenvironment, with potential to provide a synergistic benefit when combined with other systemic therapies like immuno-therapies.

The company has observed encouraging preliminary clinical data in bladder cancer with its CAIX-targeting TLX250 platform. In November 2024, the company announced an expansion of its theranostic pipeline with an agreement to in-license a portfolio of next generation FAP-targeting assets. Subject to completion of the transaction, the company’s FAP development program will initially focus on the treatment of bladder cancer, complementing the company’s existing successful urology franchise. The company also plans to explore the potential for its FAP portfolio in a range of solid tumors, as many cancers are known to express this target either in the tumor microenvironment, like breast cancer, or directly on malignant lesions, like sarcomas. The company’s lead incoming therapeutic candidate, TLX400, has been administered in over 500 patients in a compassionate use setting covering multiple tumor types.

Glioma and LAT1/LAT2

The company’s targets for glioma are large amino acid transporters 1 and 2, or LAT1 and LAT2 (respectively), validated targets that are highly expressed in several solid tumors, including malignancies of the central nervous system, or CNS. The LAT1 and LAT2 receptors, which are expressed on both sides of the blood-brain barrier, are suitable targets for the delivery of radiation to both primary CNS malignancies and metastases from non-CNS cancers such as lung and breast cancer. As such, there are several potential indications for theranostic radiopharmaceuticals targeting LAT1 and LAT2.

The company’s therapeutic product candidate, TLX101, is a systemic therapy directed at the LAT1 receptor for the treatment of glioblastoma. The company is using a small molecule for this therapy due to the need to cross the blood-brain barrier to reach its target. TLX101 has received orphan drug designation in the United States and Europe for the treatment of glioma. Orphan drug designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that TLX101 will receive marketing approval.

The company is evaluating TLX101 in the front-line and recurrent disease settings where it has observed preliminary clinical evidence of anti-tumor effect and disease stabilization. The company completed the IPAX-1 trial of TLX101 in combination with external beam radiation therapy in patients with recurrent glioblastoma. The IPAX-1 trial enrolled ten patients, met its primary endpoint of safety and tolerability of TLX101 and demonstrated preliminary efficacy data that supports continued development. As the primary goal of a Phase 1 study is to demonstrate safety and tolerability criteria in a small patient population, these studies are not powered for or designed to demonstrate efficacy. The Phase 1 IPAX-2 trial is designed to enroll 15 patients to evaluate the safety of treatment of patients with newly diagnosed glioblastoma with TLX101 as a front-line treatment. The company dosed the first patient in August 2023. TLX101 is also being evaluated in the investigator-led Phase 2 IPAX Linz trial, which has completed enrollment of patients with recurrent glioblastoma.

TLX102 is a LAT1-targeting small molecule-based alpha therapy candidate (211At-APA) that the company is developing as a potential complement to the TLX101 and TLX101-CDx programs. TLX102 has demonstrated pre-clinical proof-of-concept and TLX102 has the potential to have a favorable efficacy and safety profile in future human clinical trials in patients with glioblastoma and multiple myeloma. Due to comparable target binding and molecular structure, the company expects that data from its existing LAT1 theranostic programs, TLX101-CDx and TLX101, will complement and inform the clinical and regulatory development strategy for TLX102. In August 2020, TLX102 was granted orphan drug designation from the FDA in the United States for the treatment of multiple myeloma. Orphan drug designation may not lead to a faster development or regulatory review or approval process in multiple myeloma or glioblastoma and does not increase the likelihood that TLX102 will receive marketing approval in either of these disease areas.

The company’s imaging candidate, TLX101-CDx, also known as 18F-floretyrosine or 18F-FET, is a PET diagnostic agent designed to image cancerous lesions in the brain by targeting the LAT1 and LAT2 receptors. 18F-FET is widely used in many jurisdictions and is recommended by the joint guidelines from the European Association of Nuclear Medicine, European Association of Neuro-Oncology, Society of Nuclear Medicine and Molecular Imaging, Response Assessment in Neuro-Oncology, The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients. In October 2020, TLX101-CDx was granted orphan drug designation by the FDA in the United States for the imaging of glioma.

In August 2024, the company submitted an NDA to the FDA for TLX101-CDx for the characterization of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients through the 505(b)(2) NDA regulatory pathway. In October 2024, the FDA accepted the NDA, granted priority review and assigned a PDUFA goal date of April 26, 2025. There is no guarantee that the FDA will approve the NDA by the PDUFA goal date, if at all. TLX101-CDx was granted fast track designation by the FDA for this indication in April 2024. Fast track designation may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that TLX101-CDx will receive marketing approval.

As part of the company’s commitment to provide access to medicine, it is running an EAP in the U.S. to allow access to TLX101-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternative options.

The company also intends to conduct a label-expanding Phase 3 trial of TLX101-CDx for the imaging of patients with brain metastases from non-brain cancers, including lung and breast cancer.

Musculoskeletal and Hematologic Cancer

Soft Tissue Sarcoma and PDGFRa

The company’s product candidates, TLX300 and TLX300-CDx, employ antibody-directed targeted radiation for both therapeutic and diagnostic applications against platelet-derived growth factor receptor alpha, or PDGFRa, which is a tyrosine kinase receptor involved in fibrogenesis. The targeting of activated fibroblasts in the tumor micro-environment is a promising strategy to drive durable treatment responses in certain solid tumors. Eli Lilly Kinsale Limited provided the company with a license for olaratumab, a naked antibody that was formerly marketed as Lartruvo. The company re-purposed olaratumab as a radiopharmaceutical product candidate.

The company has completed pre-clinical studies evaluating TLX300 and has received ethics approval for a first-in-human Phase 1 proof-of-concept targeting and biodistribution trial using TLX300-CDx, where the company expects to dose a first patient in Australia in the first quarter of 2025. The company intends to develop the therapeutic application of TLX300 for the treatment of advanced soft tissue sarcoma, or STS. The company has not yet determined the specific therapeutic isotope that the company will use in therapeutic trials.

TLX300-CDx (89Zr-DFOsq-olaratumab, including the company’s proprietary DFO-squaramide chelator) is an investigational imaging agent that the company is developing for use with TLX300 as a theranostic pair.

Hematologic Oncology and CD66

In hematologic oncology and bone marrow conditioning, or BMC, the company is exploring the potential utility of targeted radiation to ablate bone marrow as part of a pre-conditioning regimen for bone marrow transplantation, novel stem cell therapies and gene therapies, each of which requires conditioning prior to treatment.

The company’s product candidate TLX66 (90Y-DTPA-besilesomab) is designed to target cluster of differentiation 66, or CD66, a well-validated leukocyte and neutrophil target. TLX66 has been evaluated as a therapeutic bone marrow conditioning agent in approximately 100 patients with results that support continued development, both as a monotherapy and in combination with low dose chemotherapy conditioning regimes. The company plans to evaluate TLX66 in a Phase 2 clinical trial as a BMC agent in patients with acute myeloid leukemia who are not suitable for conventional BMC regimes. The company expects to submit an IND to the FDA for this trial and to commence the trial in Q1 2026. In March 2022, TLX66 was granted orphan drug designation by the FDA in the United States as a conditioning treatment prior to hematopoietic stem cell transplant, or HSCT. TLX66 was granted orphan drug designation in Europe in October 2019. Orphan drug designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that TLX66 will receive marketing approval.

The imaging application of besilesomab could support patient selection for TLX66 by informing healthcare providers whether sufficient activity will be absorbed by a patient’s bone marrow. TLX66-CDx, an imaging application of besilesomab, has already been commercialized and is an internationally approved product (marketed as Scintimun) for imaging osteomyelitis (bone infection) in approximately 30 countries. Scintimun was previously manufactured and distributed by Curium Pharma through an out-license from Telix via the acquisition of TheraPharm in 2020. Following a strategic review of the asset, the company has elected to bring sales and marketing in-house, with plans to significantly augment commercial distribution and indication expansion from 2025. The company also intends to further develop Scintimun as a companion patient selection and safety assessment tool for TLX66 (90Y-besilesomab), its therapeutic BMC candidate for HSCT. TLX66-CDx has not received marketing approval in the United States.

Manufacturing TLX66 and TLX66-CDx utilizes a small amount of Triton X-100, which is a non-ionic surfactant, in the antibody manufacturing process. Triton X-100 is subject to a regulation in the European Union known as Registration, Evaluation, Authorisation and Restriction of Chemicals, or REACH. The company is permitted to manufacture TLX66 for research and clinical development in the European Union pursuant to a self-certified exemption applicable to research and development activity. The company would need to obtain authorization under REACH in order to use Triton X-100 for the future commercial manufacturing of TLX-66 or re-design the commercial manufacturing process for TLX66 such that Triton X-100 is not used. The company is planning to re-design the commercial manufacturing process for TLX66 and potentially for TLX66-CDx. If the company re-designs the manufacturing process for TLX66, the company may be required to conduct additional clinical trials of TLX66 or meet alternative regulatory standards.

Bone Metastases and Pain Palliation

TLX090 (153Sm-DOTMP) is a novel kit-based bone-seeking targeted radiopharmaceutical product candidate that uses a next generation chelating agent to deliver a proprietary formulation of Samarium-153 radioisotope. It is a combination of patented, lower specific activity form of Samarium-153, a beta-emitting radioisotope with a 46-hour half-life, and the chelating agent DOTMP, which selectively targets sites of high bone mineral turnover, a known characteristic of bone metastases, and minimizes off-target migration. TLX090 may be administered as a single dose, multiple doses and higher dose regimens for pain management of bone metastases and osteosarcoma therapy, including in pediatric patients. TLX090 is highly aligned with the company’s existing therapeutic focus areas of prostate cancer, glioma and sarcoma.

Acquisitions

In April 2024, the company acquired IsoTherapeutics Group, LLC (IsoTherapeutics), which will enable the company to internalize select aspects of its development programs.

In April 2024, the company acquired ARTMS Inc. (ARTMS), which the company expects will further enhance the vertical integration of its supply chain and manufacturing by providing a greater level of control and security over each of the company’s diagnostic isotopes, with the intention of facilitating broader patient access to therapeutic and diagnostic radiopharmaceuticals through ARTMS’ high-yield production techniques.

In January 2025, the company acquired RLS (USA), Inc., America’s only Joint Commission-accredited radiopharmacy network distributing PET, SPECT and therapeutic radiopharmaceuticals. The RLS acquisition – including 32 radiopharmacies across the U.S. – augments the company’s existing distribution network for last-mile delivery and provides expansionary space to build out a radiometal production network to meet future demand for radiopharmaceuticals.

Strategy

The company’s therapeutic radiopharmaceutical platform harnesses the power of radioactive isotopes combined with multi-platform targeting agents to deliver targeted radiation directly to the tumor site. These therapies have the potential to be stand-alone treatments or as complements to existing treatment modalities to address areas of high unmet medical need.

The company’s strategy is to launch innovative imaging agents in its core disease areas, while financing the development of therapeutic product candidates, including next-generation radiopharmaceuticals. This strategy is underpinned by a vertically integrated approach to supply and manufacturing, and is supported by a first-class commercial organization ensuring global patient access to the company’s products.

The company’s strategy is designed to deliver on its purpose and mission and reflects the evolution of its business into a global, multi-product commercial-stage company with a deep theranostic pipeline. The company’s strategic pillars are to deliver its late-stage therapeutic pipeline; build the next generation of radiopharmaceuticals; and grow its industry-leading precision medicine business.

Theranostic Approach

The company’s approach enables it to design and develop product candidates to deliver targeted radiation to cancer cells, regardless of where the cancer is in the body, via a systemic radioactive infusion.

Targeted Radiation Overview

The company is developing targeted radiation across the continuum from diagnosis and staging to treatment, both as stand-alone and combination therapies.

Radio Antibody-Drug Conjugate (rADC)

The company refers to its antibody-based agents as rADCs. These rADCs are radiopharmaceuticals that use an antibody as both a homing device and a carrier to deliver a therapeutic radiation payload to a specific target.

The company is pioneering a novel technology platform designed to optimize its therapeutic window for rADCs, which it refers to as RADmAbs.

In January 2025, the company acquired patents, know-how and other intellectual property from ImaginAb, Inc., or ImaginAb comprising a proprietary drug discovery platform, a pipeline of early-stage drug candidates against high-value targets, and several other novel targets in discovery stage.

The Radiation Payload

The radioisotope is strongly bound to the target agent molecule either using traditional chemistry or trapping it using a ‘chemical cage’ called a 'linker' or 'chelator'. Different chelators are paired with certain isotopes, such as deferoxamine, a linker that selectively binds with 89Zr (which the company uses in TLX250-CDx), and the tetraxetan chelator, which binds isotopes like 177Lu (which it uses in TLX591) and 225Ac (which it uses in TLX592).

Prostate Cancer and PSMA programs

The company’s prostate cancer portfolio programs target PSMA, a protein that is overexpressed on the surface of prostate cancer cells and is low or absent on most normal healthy cells.

Therapy – TLX591

TLX591 (177Lu rosopatamab tetraxetan) is a rADC directed at PSMA. The company is evaluating the safety and efficacy of TLX591 in the ProstACT series of clinical trials. The key evidence from Phase 1 and Phase 2 studies supporting the development of TLX591 includes:

evidence that treatment with TLX591 is well tolerated, including data from the Phase 1 ProstACT SELECT trial, common grade 3 and 4 hematological events included thrombocytopenia, lymphopenia and neutropenia. All hematological events were transient. All drug-related non-hematologic events were grade 1 or 2, with no grade 3 or 4 events;

evidence of efficacy demonstrated following treatment of 242 patients across eight Phase 1 and Phase 2 clinical trials, including up to 42.3 months median survival in a single-arm Phase 2 clinical trial in 17 patients with mCRPC when delivered under a fractionated dosing regimen;

evidence of low rates of off-target organ exposure observed in the ProstACT SELECT trial; and

convenient two-dose regimen administered over 14 days with low radiation exposure.

As an rADC with an antibody targeting agent, the company TLX591 be differentiated from PSMA-targeted therapies leveraging a small molecule approach as it has the potential for:

functionally specific to tumor-expressed PSMA, whereas small-molecule PSMA is taken up by endogenous PSMA;

reduced off-target radiation, with reduced potential for undesirable effects, including dry eye, xerostomia, and back pain from ganglia irradiation; and

longer circulation time and tumor retention, while small molecule PSMA is rapidly excreted with approximately 70% of activity lost after 12 hours; and

shorter dosing regimen of two doses, 14 days apart compared to dosing regimens lasting up to 36 weeks with small molecule PSMA.

Imaging – TLX591-CDx

Illuccix (also referred to as TLX591-CDx in some territories where approval has not yet been granted, 68Ga-PSMA-11) is a preparation for imaging prostate cancer with PET (now approved in the United States, Australia, Canada, Denmark, Norway, and the United Kingdom).

The ‘cold kit’ format of Illuccix enables rapid radiolabeling at room temperature with high radiochemical purity and production consistency, suited to the commercial and hospital radiopharmacy setting. Illuccix is approved in the United States, Australia, Canada, Denmark, Norway, and the United Kingdom; and the company anticipates receiving approval in other local European Economic Area Member States beginning in the first quarter of 2025, and in Brazil during calendar year 2025. Approved indications for patients with prostate cancer include staging of high-risk patients, identification of suspected recurrence, and selection for PSMA-directed radioligand therapy. The company is also exploring potential future utilization in additional indications for prostate cancer patients through its lifecycle management program. These include monitoring progression in metastatic and non-metastatic castration resistant patients, and monitoring response to PSMA-directed radioligand therapy.

The key evidence supporting the use of Illuccix include:

broad availability in the United States through over 245 radiopharmacies and with flexible scheduling;

validated accuracy compared to other PSMA imaging agents, including lower rate of false positives and efficacy in patients with low disease burden; and

potential for expanded clinical utility based on guidelines and clinical research.

Illuccix was granted transitional pass-through payment status by CMS, effective July 2022 for a three-year period. This status enables CMS to provide separate payments for Illuccix and the PET-CT scan when performed with Illuccix in the hospital outpatient setting.

Imaging – TLX007-CDx

The company conducted a Phase 1 clinical trial of TLX007-CDx to compare the biodistribution of TLX007-CDx and Illuccix in normal tissues and major organs, and in prostate cancer deposits. This trial met its primary objective by demonstrating that there were no differences between TLX007-CDx and Illuccix in the biodistribution in normal tissues and organs, or in prostate cancer deposits, based on 11 evaluable patients. In the trial, each patient received a single dose of Illuccix followed by PET imaging and within seven days, received TLX007-CDx followed by PET imaging. There were no serious adverse events reported in the trial. In May 2024, based on the results of such trial, the company submitted an NDA to the FDA for TLX007-CDx for the imaging of patients with prostate cancer. In July 2024, the FDA accepted the NDA for TLX007-CDx and assigned a PDUFA goal date of March 24, 2025. There is no guarantee that the FDA will approve the NDA by the PDUFA goal date, if at all.

Clinical Data – TLX591

The company’s Phase 1 and 2 trials of TLX591data cumulatively support the clinical validity of its intended fractionated dosing, which is designed to split a dose over a longer treatment cycle to decrease toxicity without compromising efficacy.

The company also observes evidence of consistent lesion delineation between TLX591 and 68Ga-PSMA-11 imaging, within the detection sensitivity and resolution limits of SPECT, evidence of uptake and retention in tumor and metastases up to 14 days post injection, the highest absorbed dose being in the liver (clearance organ) with minimal uptake in salivary glands, and a long retention period that was evidence of internalization.

The company is also investigating TLX591 in the Phase 3 ProstACT GLOBAL clinical trial.

The company received authorization to conduct the trial in the United States in April 2024 and are actively dosing patients at multiple clinical trial sites. The company expects to expand the trial into Europe, subject to regulatory approvals.

TLX592 – Alpha-PSMA

Through the company’s TLX592 program, it also explores how the conjugation of an antibody vector with an alpha-emitting isotope might deliver a next generation rADC with a different therapeutic profile.

TLX592 (64Cu/225Ac-RADmAb), is the company’s next generation prostate cancer therapy candidate for targeted alpha therapy and is its first clinical program based on its proprietary RADmAb-engineered antibody technology.

The company has conducted in vivo animal studies using an LNCaP (PSMA positive) tumor model and observed that treatment with TLX592 resulted in a significant improvement in survival time of nude mice compared to a phosphate buffered saline treated control group.

The company conducted the Phase 1 CUPID trial in which it evaluated TLX592 with a beta-emitting isotope (64Cu) in 12 patients with advanced prostate cancer prior to commencing therapeutic studies with 225Ac, an alpha-emitting isotope. The company used 64Cu to understand safety, pharmacology and dosimetry prior to use of an alpha-emitting isotope as 64Cu is detectable by PET whereas 225Ac is not detectable by PET. The company treated patients with PSMA avid disease based on Illuccix imaging, across three dose levels to assess safety profile, pharmacokinetics, biodistribution and dosimetry. In May 2024, the company reported, based on preliminary results from 11 evaluable patients, it observed accelerated elimination from blood circulation compared to the standard antibody used with TLX591 and observed similar on-target and off-target biodistribution and liver clearance, which it is important characteristics for an alpha-emitting agent. The company plans to initiate a Phase 1/2 trial designed to evaluate the safety and efficacy of 225Ac-labelled TLX592 in the second half of 2025, subject to regulatory approval.

Kidney Cancer and CAIX Programs

The company is developing products for the detection and treatment of ccRCC and investigating the potential of CAIX as a pan-cancer target in multiple tumor types.

The company is exploring the use of TLX250 for the treatment of ccRCC, either in combination with an immunotherapy or as a monotherapy, to treat metastatic disease expressing the CAIX receptor.

Therapy – TLX250

TLX250 (177Lu-DOTA-girentuximab) is a rADC therapeutic product candidate for the treatment of kidney cancer. TLX250 is being evaluated for the treatment of patients with ccRCC in investigator-initiated Phase 2 trials in combination with checkpoint inhibitors (STARLITE-1 and STARLITE-2) and in a company-sponsored Phase 1 trial in combination with peposertib (M3814), a DNA-dependent protein kinase, or DNA-PK, inhibitor, in collaboration with Merck KGaA. The clinical trials of TLX250 are designed to evaluate the safety and effectiveness of treating CAIX-expressing tumors with targeted radiation and immunologically ‘prime’ them, making them more susceptible to cancer immunotherapy. The company’s pre-clinical data in animal models indicates TLX250 could enhance the effect of immuno-oncology agents.

The company is using girentuximab to target CAIX as it is designed to have a high degree of selectivity and affinity for the target and is cleared from the body by the liver. The lack of kidney excretion is an advantage for patients with primary kidney disease. The target profile and the properties of girentuximab make the ccRCC phenotype promising as the first therapeutic indication for TLX250.

The key attributes supporting development of TLX250 include:

two clinical trials have investigated TLX250 in patients with advanced ccRCC in which TLX250 has been well tolerated and has shown the potential to stabilize progressive disease as a monotherapy;

animal models indicated combination with checkpoint inhibitors can improve therapeutic response; and

potential application in range of carcinomas that are known to over-express CAIX.

The therapeutic potential of TLX250 may also extend into other cancers that significantly express CAIX, including certain VHL-induced cancers, ovarian cancer, triple-negative breast cancer and bladder cancer. The company’s preliminary clinical data in triple-negative breast cancer and bladder cancer supports future development of TLX250 in these indications.

Therapy – TLX252

In the company’s TLX252 program, it is exploring how girentuximab radiolabeled with the alpha-emitting isotope actinium-225 might complement the TLX250 (beta) program by addressing unmet need in radiation-resistant CAIX-positive disease. TLX252 has demonstrated pre-clinical proof-of-concept in several published preclinical imaging and efficacy animal studies, and comparable in vivo characteristics (binding, pharmacokinetics and biodistribution) to a non-radiolabeled girentuximab, which supports the initiation of initial dose-finding trials of TLX252 for the treatment of patients with advanced metastatic kidney cancer. The company expects that data from its existing CAIX program TLX250-CDx diagnostic and TLX250 therapy will complement and inform the clinical and regulatory development strategy for TLX252.

Imaging – TLX250-CDx

LX250-CDx (89Zr-DFO-girentuximab) is a PET diagnostic imaging agent for the characterization of renal masses as ccRCC. The company evaluated TLX250-CDx in the recently completed Phase 3 ZIRCON trial in 300 patients, of which 284 were evaluable. The trial met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a mean positive predictive value of 93% for ccRCC across three independent readers. This demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. TLX250-CDx was granted breakthrough therapy designation from the FDA in 2020.

The company submitted a BLA for TLX250-CDx to the FDA for regulatory approval in December 2023. The BLA was granted on a rolling review process. The company completed the BLA submission in May 2024, and in July 2024, the FDA declined to approve the BLA and issued an RTF determination. The denial was based on a filing concern related to demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment. The FDA has not indicated any deficiencies in the clinical or nonclinical data relating to the safety or efficacy of TLX250-CDx. While TLX250-CDx has met all sterility requirements of product release, and has resubmitted the BLA there can be no assurance that the company will obtain regulatory approval from the FDA. Subject to this regulatory approval, the company intends to commercialize TLX250-CDx in 2025. If approved, TLX250-CDx would be the first targeted radiopharmaceutical imaging agent for kidney cancer to be approved in the United States.

The key attributes supporting development of TLX250-CDx include:

high affinity was observed for CAIX, expressed in up to 94% of ccRCC and many hypoxic solid tumors, low expression in normal tissue;

positive results in Phase 3 ZIRCON trial including key secondary endpoints that demonstrated detection of ccRCC even in small renal masses (less than 4cm); and

breakthrough therapy designation from the FDA granted in 2020.

Breakthrough therapy designation may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that TLX250-CDx will receive marketing approval.

Clinical Programs and Data – TLX250

TLX250 is being evaluated in combination with checkpoint inhibitors for the treatment of patients with ccRCC in two separate investigator-initiated trials as part of the STARLITE program.

Tumor-targeted radiation stimulates remodeling of the tumor microenvironment and can kill immunosuppressive cells and stimulate T-cell recruitment to attack tumor cells. This immune re-programming may increase the therapeutic response to treatment with checkpoint inhibitors.

STARLITE-1 is a single arm Phase 1/2 investigator-initiated trial of TLX250 in combination with cabozantinib and nivolumab in treatment naïve patients with advanced ccRCC. The trial has a target enrollment of 100 patients. The trial is sponsored by the MD Anderson Cancer Center.

STARLITE-2 is a Phase 2 investigator-initiated open-label trial of nivolumab combined with TLX250 in 29 patients with advanced ccRCC that have progressed on treatment with an immune checkpoint inhibitor. The objective of the trial is to determine the maximum tolerated dose and associated efficacy of the combination. The study is open for recruitment and dosing of the initial safety cohorts has completed, pending interim data. The trial is expected to proceed with an expansion cohort at the MTD before concluding. The trial is sponsored by the Memorial Sloan Kettering Cancer Center.

The company is evaluating TLX250 in combination with peposertib in collaboration with Merck KGaA in the Phase 1b STARSTRUCK trial. The trial is evaluating the combination in patients with solid tumors expressing CAIX that are relapsed or refractory to standard-of-care treatment options. The objective of the trial is to assess the safety and tolerability profile of TLX250 with peposertib in up to 85 patients. The first patient was dosed in the third quarter of 2023. The combination may provide an enhancement in potency through their synergistic action on cancer cells.

Targeted radiation effectively induces DNA damage in targeted cancer cells and peposertib may act to prevent the cell from repairing this damage, resulting in higher potency at lower doses. The company is conducting the STARSTRUCK trial pursuant to a clinical trial collaboration and supply agreement with Merck KGaA pursuant to which Merck agreed to provide a supply of peposertib for the trial.

Previous clinical trials of TLX250 have demonstrated its potential to stabilize progressive disease in metastatic ccRCC patients as a monotherapy, and that it is generally well tolerated. In a Phase 2 trial evaluating one dose of TLX250 in 14 patients with metastatic ccRCC, eight patients (57%) had stable disease and one patient (7%) experienced a partial response.

In a Phase 1 trial evaluating TLX250 in 23 patients with advanced ccRCC, TLX250 was observed to be well tolerated and to have the potential to stabilize previously progressive disease in metastatic ccRCC. The mean overall survival for all patients was 25.3 months and the mean PFS was 11.1 months.

In the Phase 1 trial, TLX250 injections were well tolerated and no infusion-related or acute allergic reactions were observed. Hematologic toxicity was the most prominent toxicity and was dose limiting. At dose levels of 1,110 and 1480 MBq/m2 per treatment showed no dose limiting toxicity. The dose level per treatment was increased stepwise from 1,850 to 2,220 2,405MBq/m2 up to 2,590 MBq/m2. Moderate dose limited toxicity was observed at these higher dose levels and a final maximum tolerated dose of 2,405MBq/m2 was determined from this trial.

The company is preparing a Phase 2 trial to explore the combination of TLX250 with existing standards of care in advanced renal cell carcinoma.

Clinical Data – TLX250-CDx

The company recently completed the pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients. The trial met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent readers. This trial demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation.

The data from the trial demonstrated the ability of TLX250-CDx to characterize renal masses as ccRCC, which could support improved clinical decision making and limiting the need for invasive procedures like biopsies and nephrectomies. A total of 300 patients were dosed with TLX250-CDx in the trial and 284 patients had a central histology reading and evaluable TLX250-CDx PET scan at central review.

In November 2024, the company dosed the first patient in the Phase 3 ZIRCON-CP study of TLX250-CDx PET imaging of ccRCC in Chinese patients. The study, which will enroll up to 82 patients, is being conducted in collaboration with the company’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma), to demonstrate that the diagnostic utility of TLX250-CDx is equivalent in Chinese and Western populations. The clinical data from ZIRCON-CP is intended to support future marketing authorization applications for this breakthrough technology in the region.

In October 2024, the company announced that it dosed the first patient in the Phase 2 CA-NINE trial, which is an investigator-initiated Phase 2 trial evaluating TLX250-CDx in patients with ccRCC after surgery. The trial plans to enroll 91 patients with intermediate-to-high risk ccRCC post-surgery and is designed to identify ccRCC where it has recurred, including metastatic disease, and may inform future label expansion for TLX250-CDx.

There are also several investigator-led trials of TLX250-CDx that have recently completed enrollment, including the Phase 1 ZiP-UP trial in patients with metastatic urothelial carcinoma or bladder cancer, the Phase 2 OPALESCENCE trial in patients with triple-negative breast cancer, and the Phase 1 PERTINENCE trial in patients with non-muscle invasive bladder cancer. The OPALESCENCE and PERTINENCE trials reported positive preliminary data during 2022 at the European Association of Nuclear Medicine Annual Congress, with early results suggesting theranostic potential in these difficult to treat diseases. In December 2023, additional data from the OPALESCENCE was reported from 12 patients with metastatic triple-negative breast cancer that demonstrated the potential for TLX250-CDx to detect lesions that may resist chemotherapy and have a more aggressive profile resulting from hypoxia.

Brain Cancer Programs and LAT1/LAT2

The company’s brain cancer program targets membrane transport proteins called LAT1 and LAT2, which are important targets in cancer development as they supply tumors with essential amino acids, promoting cell proliferation, angiogenesis and mediating drug and nutrient delivery across the blood-brain barrier. LAT1 and LAT2 are highly expressed in the blood-brain barrier and in various types of cancer, including glioblastoma.

Therapy – TLX101

TLX101 (131I-IPA) is the company’s therapeutic product candidate for the treatment of patients with brain cancer that targets the LAT1 receptor. TLX101 is a novel approach that is readily able to pass through the blood-brain barrier, the normal protective barrier that prevents many potential drug candidates from entering the brain.

The company is evaluating TLX101 in front line and recurrent glioblastoma in the IPAX series of trials. TLX101 has been granted orphan drug designation in the United States and Europe for the treatment of glioma.

The key attributes supporting development of TLX101 include:

the IPAX-1 trial demonstrated evidence of tumor responses in recurrent glioblastoma, including some patients with prolonged disease stabilization;

the IPAX-2 Phase 1 trial is designed to extend TLX101 into the front-line setting, building upon experience in recurrent setting;

evidence of rapid clearance of TLX101 from the brain observed in the IPAX-1 trial; and

TLX101 has been granted orphan drug designation in the United States and Europe for the treatment of glioma.

Therapy – TLX102

In the company’s TLX102 program, it is also exploring how phenylalanine, the same LAT1 targeting peptide used in TLX101, radiolabeled with an alpha-emitting isotope might deliver a different therapeutic profile. Astatine-211 is an alpha-emitting radioisotope with comparable halogen chemistry to Iodine-131 that can cross the blood-brain barrier. TLX102 has demonstrated pre-clinical proof-of-concept, and TLX102 has the potential to have a favorable efficacy and safety profile in future human clinical trials in patients with glioblastoma and multiple myeloma. Due to comparable target binding and molecular structure, the company expects that data from its existing LAT1 theranostic programs TLX101-CDx and TLX101 will complement and inform the clinical and regulatory development strategy for TLX102.

In August 2020, TLX102 was granted orphan drug designation from the FDA in the United States for the treatment of multiple myeloma. Orphan drug designation may not lead to a faster development or regulatory review or approval process in multiple myeloma or glioblastoma and does not increase the likelihood that TLX102 will receive marketing approval in either of these disease areas.

Imaging – TLX101-CDx

TLX101-CDx (18F-FET) is a radiolabeled amino acid PET agent for imaging of gliomas that is used in clinical research settings, including in the company’s IPAX series of trials of TLX101, as a complementary diagnostic agent. Clinical data suggest that TLX101-CDx can facilitate the identification of recurrence of brain metastases. 18F-FET is widely used in many jurisdictions and is recommended by the joint guidelines from the European Association of Nuclear Medicine, European Association of Neuro-Oncology, Society of Nuclear Medicine and Molecular Imaging, The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients.

In October 2020, TLX101-CDx was granted orphan drug designation from the FDA in the United States for the imaging of glioma. Orphan drug designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that TLX101-CDx will receive marketing approval.

The company used TLX101-CDx to select patients and track disease response in its IPAX-1 Phase 1/2 clinical trial and the recently completed IPAX-Linz investigator-initiated trial, and are using TLX101-CDx in the Phase 1 IPAX-2 trial, which is actively dosing patients.

In August 2024, the company submitted an NDA to the FDA for TLX101-CDx for the characterization of progressive or recurrent glioma in both adult and pediatric patients from treatment related changes through the 505(b)(2) NDA regulatory pathway. In October 2024, the FDA accepted the NDA, granted priority review and assigned a PDUFA goal date of April 26, 2025. There is no guarantee that the FDA will approve the NDA by the PDUFA goal date, if at all. TLX101-CDx was granted fast track designation by the FDA for this indication in April 2024. Fast track designation may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that TLX101-CDx will receive marketing approval. The company also intends to conduct a label-expanding Phase 3 trial of TLX101-CDx for the imaging of patients with brain metastases from non-brain cancers, including lung and breast cancer.

The key attributes supporting development of TLX101-CDx include:

potential tool for management of progression and treatment monitoring;

orphan drug designation, potential to meet major unmet need; and

widely used in Europe and recommended in the joint guidelines for imaging of gliomas.

Clinical Programs and Data – TLX101

In 2022, the company reported the final results from the IPAX-1 Phase 1/2 trial evaluating TLX101 therapy in combination with EBRT in patients with recurrent glioblastoma. The trial met its primary safety and tolerability objective.

In 2023, the company initiated a Phase 1 trial, IPAX-2, to further evaluate the safety of TLX101 in 15 patients as a front-line therapy for the treatment of glioblastoma in combination with EBRT and temozolomide in front-line in order to support initiation of a label-indicating Phase 2 trial are continuing to enroll patients in the trial.

TLX101 is being investigated in the recurrent setting in the investigator-initiated IPAX-Linz Phase 2 trial, which has recently completed enrollment of patients with recurrent glioblastoma. Grand Pharma received approval by the Chinese National Medical Products Administration to initiate the IPAX-China trial of TLX101.

Clinical Programs and Data – TLX101-CDx

In August 2024, the company submitted an NDA to the FDA for regulatory approval of TLX101-CDx as a radioactive diagnostic agent indicated for use with PET imaging for the characterization of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients through the 505(b)(2) NDA regulatory pathway.

TLX101-CDx was also the subject of a published systemic review and meta-analysis covering 26 studies with a total of 1206 patient/lesions, that conclude that TLX101-CDx showed promise as a complementary modality to standard-of-care MRI for the management of brain malignancies.

In addition, the company has exclusively licensed prospective, unpublished clinical trial data covering 127 patients, and the company intends to confirm the findings of these trials with additional supportive data.

As part of the company’s commitment to provide access to medicine, the company is running an EAP in the U.S. to allow access to TLX101-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternative options.

The company is also exploring applications of TLX101-CDx imaging in radiation treatment planning through 18F-FET in glioblastoma, or FIG, investigator-initiated trial. This trial aims to show that TLX101-CDx can help improve radiation treatment planning in a prospective, multi-center PET/CT trial.

Musculoskeletal and Hematologic Cancer Programs

Therapy – TLX300

In April 2022, the company entered into a licensing agreement with Lilly that granted it exclusive worldwide rights to develop and commercialize radiolabeled forms of olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer. Lilly originally developed olaratumab a non-radiolabeled monoclonal antibody targeting PDGFRa, a protein expressed in multiple tumor types that is involved in fibrogenesis. Olaratumab has a well-established clinical and toxicology profile as a non-radiolabeled agent.

Olaratumab was granted accelerated approval in the United States and conditional approval in the European Union based on Phase 2 trial data. Lilly began marketing olaratumab as Lartruvo in 2016.

Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab in combination with standard chemotherapy did not improve survival for patients compared to chemotherapy alone. The therapeutic limitations of Lartruvo can be overcome through the re-purposing of olaratumab as a radiopharmaceutical.

The company’s initial development focus for radiolabeled olaratumab is on STS. The ability of olaratumab to target PDGFRa makes it a promising candidate for use as a radionuclide targeting agent and that the targeting of activated fibroblasts in the tumor micro-environment is a promising strategy to drive durable treatment responses in certain solid tumors.

The company’s product candidates, TLX300 and TLX300-CDx, employ antibody-directed targeted radiation for both therapeutic and diagnostic applications, respectively, against PDGFRa. The company is developing TLX300 for the treatment of patients with advanced or metastatic soft tissue sarcoma, administered in combination with doxorubicin.

The company has completed pre-clinical studies evaluating TLX300 and have received ethics approval to initiate a clinical trial in Australia. The company expects to initiate a Phase 1 proof-of-concept targeting and biodistribution trial in humans in the first quarter of 2025. The company intends to develop the therapeutic application of TLX300 for the treatment of STS using an alpha-emitting isotope. The company has not yet determined the specific alpha-emitting isotope that the company will use in clinical trials of TLX300.

The key attributes supporting development of TLX300 include:

well-established clinical and toxicology profile of olaratumab as a non-radiolabeled agent;

submitted ethics application to commence a Phase 1 trial, to be conducted in Australia and New Zealand targeting and biodistribution in humans; and

potential application in a range of other cancers (e.g., bone, brain, breast, lung, ovarian and prostate cancers).

Imaging – TLX300-CDx

TLX300-CDx (89Zr-DFOsq-olaratumab, including the company’s proprietary DFO-squaramide chelator) is an investigational imaging agent that it is developing for use with TLX300 as a theranostic pair. DFO-squaramide (DfES) is the company’s proprietary chelator technology, designed to optimize the bioconjugate manufacture, conjugate stability and serum stability for use with this isotope. If approved, TLX300-CDx would be the first diagnostic imaging agent to specifically detect the presence of PDGFRa in patients with STS.

Following the completion of pre-clinical studies, the company has initiated a first-in-human Phase 1 proof-of-concept targeting and biodistribution trial in Australia using TLX300-CDx. This dose-finding study is assessing safety, tolerability, dosimetry, pharmacokinetics and imaging properties of 89Zr-olaratumab in participants with PDGFRa-positive STS, prior to therapeutic studies. The company has not yet determined the specific isotopes that it will use in therapeutic trials.

Therapy – TLX66

TLX66 (90Y-besilesomab) is a product candidate for bone marrow conditioning for HSCT conditioning, a broad clinical indication.

The company’s HSCT conditioning agent, TLX66, is being studied in acute myeloid leukemia, multiple myeloma and systemic amyloid light chain amyloidosis through investigator-initiated trials. Clinical data suggest TLX66 could be a well-tolerated (and therefore highly versatile) bone marrow conditioning agent, which could be utilized as a single agent or in combination with either reduced or high intensity conditioning agents preceding both autologous or allogeneic HSCT. The company plans to evaluate TLX66 in a Phase 2 clinical trial as a BMC agent in patients with acute myeloid leukemia who are not suitable for conventional BMC regimes. The company expects to submit an IND to the FDA for this trial and to commence the trial in 2025.

TLX66 was granted orphan drug designation status in the United States and Europe. Orphan drug designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that TLX66 will receive marketing approval.

The key attributes supporting the development of TLX66 include:

minimal uptake in non-hematopoietic organs such as liver, kidneys and gut;

approximately 100 patients treated in several Phase 1 and 2 investigator-initiated trials of TLX66 in different hematological diseases requiring autologous or allogeneic stem cell transplantation; and

orphan drug designation granted in the United States and Europe for TLX66 for bone marrow conditioning.

Manufacturing TLX66 and TLX66-CDx utilizes a small amount of Triton X-100, which is a non-ionic surfactant, in the antibody manufacturing process. Triton X-100 is subject to a regulation in the European Union known as Registration, Evaluation, Authorisation and Restriction of Chemicals, or REACH. The company is permitted to manufacture TLX66 for research and clinical development in the European Union pursuant to a self-certified exemption applicable to research and development activity. The company would need to obtain authorization under REACH in order to use Triton X-100 for the future commercial manufacturing of TLX-66 or re-design the commercial manufacturing process for TLX66 such that Triton X-100 is not used. The company is planning to re-design the commercial manufacturing process for TLX66 and potentially for TLX66-CDx. If the company re-designs the manufacturing process for TLX66, it may be required to conduct additional clinical trials of TLX66 or meet alternative regulatory standards.

Imaging – TLX66-CDx

TLX66-CDx (99mTc-besilesomab) is the company’s imaging agent for osteomyelitis.

TLX66-CDx has already been commercialized and is an internationally approved product (marketed as Scintimun) in approximately 30 countries. Scintimun was previously manufactured and distributed by Curium Pharma through an out-license from Telix via the acquisition of TheraPharm in 2020. Curium Pharma received marketing authorization for Scintimun in the European Union in 2010 for scintigraphic imaging, in conjunction with other modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. The company was previously entitled to royalties from Curium Pharma. Following a strategic review of the asset, it has elected to bring sales and marketing in-house, with plans to significantly augment commercial distribution and indication expansion from 2025. TLX66-CDx has not received marketing approval in the United States. The company is evaluating the feasibility of filing for a marketing authorization application in the United States where it retains the rights.

The key attributes supporting the use of TLX66-CDx include:

EMA approval for imaging of peripheral osteomyelitis in 2010; and

Phase 3 trial showed that Scintimun imaging is accurate and well-tolerated in diagnosing infection of the peripheral skeleton and provides comparable information.

The approval of Scintimun was based on the results of a multicenter study performed in 22 European centers. This multinational, Phase 3 clinical study was undertaken to compare anti-granulocyte imaging using Scintimun with 99mTc-labelled white blood cells in patients with peripheral osteomyelitis. The results of this Phase 3 trial showed that Scintimun imaging is accurate and well-tolerated in diagnosing infection of the peripheral skeleton and provides comparable information to 99mTc-labelled white blood cells in patients with chronic osteomyelitis.

Clinical Data – TLX66

TLX66 has been evaluated in 98 patients in several investigator-initiated-trials as a conditioning agent preceding HSCT in patients with a range of hematological malignancies, including a Phase 1 dose-escalation trial in 55 patients with hematological malignancies, a Phase 1 trial in nine patients with pediatric relapsed/refractory leukemia, a Phase 1/2a trial in nine patients with AL-amyloidosis and a Phase 2 trial in 25 patients with multiple myeloma. In these trials, there have not been significant toxicities and there have not been detectable non-hematological toxicities, such as mucositis/colitis. In the pediatric population, TLX66 has been well tolerated with no serious toxicities.

In a Phase 2 trial using TLX66 and HD-melphalan in 24 patients as a conditioning agent for multiple myeloma autologous HSCT, the complete response rate in the combination cohort (12 patients) was 50%, compared to 25% in the HD-melphalan control group (12 patients).

In reported data from 30 patients out of 55 patients treated in a Phase 1 trial of TLX66, patients were given increasing doses of TLX66 followed by reduced intensity conditioning and HSCT. The overall survival rate was 73% ten years after the HSCT procedure with low toxicity for TLX66. There were no severe non-hematological adverse events detected and efficient myeloablation, both in bone marrow and peripheral blood (the anticipated therapeutic effect and prerequisite for both successful autologous and allogeneic HSCT), was observed.

The Phase 1/2a trial evaluating TLX66 in nine patients with AL amyloidosis evaluated the safety and toxicity of TLX66 as a bone marrow conditioning agent prior to HSCT. All nine patients were successfully engrafted following bone marrow conditioning with TLX66 and autologous HSCT without any chemotherapy. TLX66 was well tolerated by all patients and had a very low toxicity profile when compared to chemotherapy-based conditioning regimes.

There were no serious adverse events or transplant-related deaths.

The company plans to conduct further development of TLX66 as a bone marrow conditioning agent in high-risk acute myeloid leukemia patients in complete remission with minimal residual disease in combo with reduced intensity conditioning preceding allogenic HSCT.

Bone Metastases and Pain Palliation

TLX090 (153Sm-DOTMP) is a novel kit-based bone-seeking targeted radiopharmaceutical product candidate that uses a next generation chelating agent to deliver a proprietary formulation of Samarium-153 radioisotope. It is a combination of patented, lower specific activity form of Samarium-153, a beta-emitting radioisotope with a 46-hour half-life, and the chelating agent DOTMP (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetramethylene-phosphonate), which selectively targets sites of high bone mineral turnover, a known characteristic of bone metastases, and minimizes off-target migration.

TLX090 may be administered as a single dose, multiple doses and higher dose regimens for pain management of bone metastases and osteosarcoma therapy, including in pediatric patients. TLX090 is highly aligned with the company’s existing therapeutic focus areas of prostate cancer, glioma and sarcoma.

In August 2021, the FDA cleared the IND application to commence Phase 1, open-label, dose escalating study for TLX090 as a treatment for cancer that has metastasized to the bone from the lung, breast, prostate and other areas.

TLX090 has the potential to deliver significant improvements to existing bone-seeking agents in the treatment and management of late-stage metastatic disease. TLX090 may enable the pain management of prostate cancer bone metastases, where there remains a significant unmet medical need particularly after progression from other forms of radionuclide and radiation therapy. TLX090 may benefit patients with metastatic lung and breast cancer, where many patients develop brain and bone metastases, and disease management often focuses on quality-of-life palliative care.

TLX090 has also been granted orphan drug and rare pediatric disease designations by the FDA for the treatment of osteosarcoma. The rare pediatric disease designation may enable TLX090 to be brought to market more rapidly through regulatory incentives, including eligibility for a pediatric rare disease priority review voucher that may be applied to this or other programs. The orphan drug designation and the rare pediatric disease designation do not increase the likelihood of marketing approval.

MedTech

The company established a MedTech Division to create technologies designed to harness the power of targeted radiation across the entire patient journey from diagnosis to surgical intervention and therapy. The company anticipates applying this first in urology, for prostate and kidney cancer, and then across the breadth of indications it is developing.

Radio-Guided Surgery (RGS)

Bringing molecular imaging into the operating theater is a key part of the company’s portfolio strategy for urologic oncology.

In November 2023, the company acquired the SENSEI radio-guided surgery business from Lightpoint Medical Ltd, or Lightpoint. SENSEI is a miniature gamma probe device used to detect radiation in patients and guide surgery. The probe is inserted into a surgical port and can then be controlled by the clinician during the procedure. When used with targeted imaging agents, SENSEI may enable the intraoperative detection of cancer in real time, supporting greater precision in the removal of tumors.

In November 2023, the company made a strategic investment into Mauna Kea Technologies, or Mauna Kea, a leading medical device company pioneering the development of real-time intraoperative visualization of cancer tissue during surgery. This investment is an expansion of the company’s existing IRiS (Imaging and Robotics in Surgery) Alliance with Mauna Kea that the company established to develop new hybrid pharmaceutical-device products through the combination of its cancer-targeting agents with Cellvizio, Mauna Kea’s confocal surgical laser endomicroscopy in vivo cellular imaging platform.

This technology is complementary to the company’s existing portfolio. When used pre-operatively, the company’s radiopharmaceutical imaging agents, such as Illuccix or TLX250-CDx, potentially enable improved surgical planning to determine the location and extent of disease.

Artificial Intelligence (AI)

During 2022, the company announced a partnership with Invicro LLC to develop an AI platform that it refers to as TelixAI. This platform will initially focus on prostate cancer and the company intends to eventually apply it to all of its imaging products.

In 2023, the company acquired Dedicaid GmbH and its clinical decision support software, or CDSS, AI platform capable of rapidly generating indication specific CDSS applications from available datasets, for use with PET and other imaging modalities. This platform is differentiated from commercially-available AI solutions used in PSMA-PET imaging, which are limited to supporting clinicians in the interpretation and reading of images – without a prediction capability. This platform is designed to reduce the time, cost and level of expertise required to build, test and validate new CDSS applications, facilitating a streamlined development and regulatory pathway for each new application. The company is conducting final validation of the Dedicaid platform.

In October 2024, the company also announced a partnership with Subtle Medical to commercialize an artificial intelligence (AI)-powered positron emission tomography (PET) imaging product (SubtlePET) with Illuccix. SubtlePET is FDA-cleared to enhance the efficiency and effectiveness of imaging procedures, including those procedures that use Illuccix. The company’s partnership with Subtle Medical, which covers North America and the European Union (EU, excluding France and French speaking Belgium), launched in the United States (U.S.) with Illuccix, with the aim to expand to other Telix PET-tracers, subject to regulatory approval.

The company’s focus for its AI platform is to develop AI-powered solutions that support the company’s product candidates and enable them for use by the nuclear medicine community as approved medical devices. The company intends to use AI and the Dedicaid platform across its development pipeline by utilizing clinical imaging and outcome data as they become available and to develop and validate medical device applications supporting approved products. The acquisitions of both Dedicaid and Lightpoint’s radio-guided surgery business provide a founding MedTech capability that will enable Telix to generate AI and software applications that are complementary to its radiopharmaceutical pipeline.

Telix Manufacturing Solutions (TMS)

The company focuses on enhancing its existing global manufacturing and supply chain with a balance of external and in-house capabilities, securing a robust and innovative manufacturing infrastructure and supply chain to serve its patients. Manufacturing and supply chain supporting the company’s portfolio broadly cover the following areas: radioisotopes, radiochemistry, biologics, small molecules, fill/finish, packaging and labeling, and storage and distribution.

Since 2022, the company has made significant progress with the buildout of its radioisotope manufacturing facility in Brussels South. The company has been granted an updated radiation license by the Belgian Federal Agency for Nuclear Control, enabling site activation subject to the regulatory inspections and approvals.

The company’s approximately 30,000 square foot radioisotope manufacturing facility is one of Europe’s largest radiopharmaceutical production facilities. The site will enable improved access to radiopharmaceuticals for patients across the EMEA region and the world as a primary GMP-capable manufacturing site for the company’s clinical and commercial products. The site also has extensive R&D capabilities, with a focus on alpha-emitting isotopes. The company expects the site to evolve and develop as a hub for strategic collaborations via R&D facilities and manufacturing line designated for university and SME partners.

In April 2024, the company acquired IsoTherapeutics Group, LLC, or IsoTherapeutics, a specialty radiopharmaceutical development and bioconjugation firm, based in Texas.

In April 2024, the company also acquired ARTMS Inc., or ARTMS, a radioisotope production technology company based in Canada, and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals required for consumable target production.

In January 2025, the company acquired RLS (USA), Inc., America’s only Joint Commission-accredited radiopharmacy network distributing PET, SPECT and therapeutic radiopharmaceuticals. The RLS acquisition augments its existing distribution network for last-mile delivery and provides expansionary space to build out a radiometal production network to meet future demand for radiopharmaceuticals.

The company’s biologics, small molecule, fill/finish and packaging manufacturing and supply chain are accomplished through relationships with external contract manufacturing organizations, or CMOs, and vendors. The company has agreements with late stage/commercial organizations, including ABX-CRO, Grand Rapids Aseptic Manufacturing, PCI, UPS, Patheon Pharma Services, Goodwin Biotechnology Inc, and 3P Biopharmaceuticals. For early-stage manufacturing and supply chain, the company is working closely with companies such as GenScrip ProBio to establish platform capabilities in cell line development and antibody production, DiverChim CDMO, Curia Global, and Abzena Holdings LLC. The company is also pursuing the addition of in-house capabilities where appropriate through vertical integration.

The company is dedicated to enhancing its global supply chain capabilities, particularly for the clinical and commercial supply of isotopes used in radiolabeling, as well as for supplying generators. The company has established a series of strategic supply agreements with leading industry partners including Eckert & Ziegler SE, Trace Sciences International, ITM, SHINE Technologies, the Australian Nuclear Science and Technology Organisation, and Eczacibasi- Monrol.

The company’s approach is multi-faceted, focusing on strategic partnerships, technological innovation, and sustainable practices.

The company is investing in cutting-edge technologies and processes that enhance its production capabilities, ensuring efficiency and reliability. The company’s commitment to sustainability, particularly in the recycling of materials, further strengthens its supply chain, reducing environmental impact while maximizing resource utilization.

The company is dedicated to ongoing research and development, ensuring that it remains at the forefront of isotope supply.

The company is seeking to position it as a leader in the supply of isotopes for radiolabeling, backed by a supply chain that is as diverse as it is robust, ensuring the highest standards of quality and reliability for its clients.

Sales and Marketing Operations

The company’s commercial operations span the Americas, EMEA, and the Asia Pacific Regions.

In the United States, the company has established a commercial radiopharmacy network of over 245 commercial radiopharmacies to distribute Illuccix, including partnerships with Cardinal Health, Inc., PharmaLogic Holdings, Corp., and Jubilant Pharma Ltd. the company also has a distribution agreement with Isologic Innovative Radiopharmaceuticals Ltd for the Canadian market.

In the Asia Pacific, the company has secured a strategic collaboration with Grand Pharmaceutical Group Limited, or Grand Pharma, in the Greater China area including Mainland China, Taiwan, Hong Kong and Macau. Grand Pharma has been appointed as the company’s partner for this territory with exclusive development and commercialization rights to its portfolio. The company has also secured exclusive distribution agreements in Australia with Global Medical Solutions Australia Pty Ltd and with DuChembio Co., Ltd. In South Korea.

In Europe, the company has exclusive distribution agreements for the upcoming launch of Illuccix in a number of geographies, including with Eckert & Ziegler RadioPharma GmbH in Germany, Xiel Ltd in the United Kingdom and Ireland, IRE Elit S.A. in France, Radius S.r.l. in Italy, Nucliber S.A. in Spain, Biokosmos S.A. in Greece and Cyprus, Sociedade Avanço, Unipessoal, LDA in Portugal, THP Medical Products Vertriebs GmbH in Austrian, Czech Republic and Slovak Republic and WIIK Pharma ApS in Denmark, Finland, Norway and Sweden.

Intellectual Property

The company’s intellectual property associated with its key therapeutic products:

Illuccix

TLX250-CDx (89Zr-girentuximab) and TLX250 (177Lu-girentuximab)

The company has in-licensed six patent families from Heidelberg Pharma AG (formerly Wilex AG) directed to the CAIX-targeting girentuximab antibody and various therapeutic and imaging applications thereof.

The in-licensed patent portfolio includes four U.S.-issued patents, 22 foreign-issued patents granted in Australia, Canada, Germany, Spain, Italy, France, the United Kingdom, Korea, New Zealand, South Africa, Israel, Russia and Mexico; and three foreign patent applications applied for in Brazil, China and Japan. Expiry dates vary from 2025 to 2034 across the portfolio, not including any patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act, or equivalent provisions in foreign jurisdictions.

The company has two patent families directed to aspects of the manufacture of TLX250-CDx. These patent families include two pending U.S. non-provisional patent applications and 16 foreign patent applications applied for in Australia, Brazil, Canada, Europe, Korea, Singapore, China and Japan. Any patents that may issue in the United States based on the non-provisional U.S. patent applications will expire no earlier than 2042, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2042.

The company has two patent families directed to the use of TLX250-CDx and TLX250 in imaging and therapy of CAIX-expressing cancers other ccRCC. These patent families consist of two pending PCT applications. Any patents that may issue in the United States based on the pending PCT application will expire no earlier than 2043, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2043.

The company has one patent family directed to combinations of TLX250 with checkpoint inhibitors. This patent family consists of one pending U.S. non-provisional patent application and 6 foreign patent applications applied for in Australia, Brazil, Canada, Europe, Mexico and Singapore. Any patents that may issue in the United States based on the pending PCT application will expire no earlier than 2043, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2043.

The company has one patent family directed to the combination of TLX250 with DNA damage repair inhibitors. This patent family include one pending U.S. non-provisional patent application and ten foreign patent applications applied for in Australia, Brazil, Canada, Europe, Israel, Korea, Mexico, Singapore, China and Japan, Any patents that may issue in the United States based on the U.S. non-provisional patent application will expire no earlier than 2042, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2042.

As biological products, TLX250-CDx and TLX250 will be entitled to 12 years data exclusivity from the date of product approval.

TLX252 (225Ac-DOTA-girentuximab)

The company has a single patent family patent directed to the composition of matter of TLX252, its radiolabeled forms and uses in imaging and therapy. The patent family includes one pending U.S. non-provisional patent application and 16 pending foreign patent applications in Canada, Chile, China, India, Japan, Korea, Mexico, Australia, Europe, Eurasia, India, New Zealand, Brazil, Hong Kong, Israel and Singapore. Any patents that may issue in the United States will expire no earlier than 2040, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents that may issue in foreign jurisdictions will likewise expire no earlier than 2040.

TLX101-CDx (18F-FET)

The company has orphan drug and fast track designation for TLX101-CDx in the United States, which the company expects to yield up to seven years regulatory exclusivity following product approval.

TLX101 (131I-IPA) and TLX102 (211At-APA)

The company has in-licensed a patent portfolio directed to methods of treatment using TLX101 and TLX102 licensed from Dr. Samuel Samnick, a German nuclear medicine researcher. There are two U.S.-issued patents, which will expire no earlier than 2028 and 2031 respectively, not including any patent term extension under the Hatch-Waxman Act. There are eight foreign issued patents in Australia, Canada, Germany, the United Kingdom, Spain, France, Japan, and Korea which will expire no earlier than 2026.

The company has in-licensed a patent portfolio directed to a method of manufacturing TLX101 and TLX102 from Osaka University. There is one U.S.-issued patent, one pending U.S. non-provisional application, two foreign-issued patents in Australia, Japan, Switzerland, Lichtenstein, Spain, the UK, and Turkey, one foreign issued patent under the European Unified Patent Convention (which covers Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia, and Sweden) and one pending foreign application in Europe. Any patents that may issue in the United States based on the pending PCT application will expire no earlier than 2038, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2038.

The company has orphan drug designation for TLX101 in the United States and Europe which will grant the company the customary regulatory exclusivity, expected to be up to seven years from date of product approval.

TLX591 (177Lu rosopatamab tetraxetan)

The company has sub-licensed a Cornell University (and associated entities) patent portfolio from BZL Biologics LLC directed to TLX591 and combination therapies of TLX591 with androgen deprivation therapy.

The sub-licensed patent portfolio includes one U.S.-issued patent, one pending U.S. non-provisional patent application, 14 foreign-issued patents in Belgium, Canada, Japan, Germany, France, Spain, the United Kingdom, Luxembourg and the Netherlands, and a pending foreign application in Europe directed to combinations with androgen deprivation therapy.

Any patents that may issue in the United States will expire no earlier than 2028, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Hatch-Waxman Act. Any patents that may issue in foreign jurisdictions will likewise expire no earlier than 2028.

As a biological product, TLX591 will be entitled to 12 years data exclusivity from the date of product approval.

TLX592 (225Ac-RADmAb)

The company has a single patent family patent directed to the composition of matter of TLX592, its radiolabeled forms and uses in imaging and therapy. The patent family includes one pending U.S. non-provisional patent application and 16 pending foreign patent applications in Canada, Chile, China, India, Japan, Korea, Mexico, Australia, Europe, Eurasia, India, New Zealand, Brazil, Hong Kong, Israel, and Singapore. Any patents that may issue in the United States will expire no earlier than 2040, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. Any patents that may issue in foreign jurisdictions will likewise expire no earlier than 2040.

TLX592 is in early development so regulatory pathway to product approval is not yet confirmed or know, however the customary regulatory exclusivity period is expected to apply.

TLX300-CDx (89Zr-girentuximab) and TLX300.

The company has four pending international applications filed under the PCT directed to radiolabeled forms of olaratumab and their use in imaging and therapy. Any patents that may issue in the United States will expire no earlier than 2043, not including any terminal disclaimer, patent term adjustment due to administrative delays by the USPTO or patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. Any patents that may issue in foreign jurisdictions will likewise expire no earlier than 2043.

TLX66-CDx (99mTc-besilesomab, Scintimun) and TLX66 (90Y-besilesomab)

The company has one patent family directed to the use of TLX66 in the treatment of multiple myeloma. The patent family includes one U.S.-issued patent and foreign-issued patents in Canada, Australia, and Europe (validated in Belgium, Germany, Spain, France, the United Kingdom and Italy). The U.S. patent has a maximum expiry date of 2031, not including any patent term extension under the Hatch-Waxman Act. The other patents will expire no earlier than 2026.

A second patent family is directed to the use of TLX66 for treating AL-amyloidosis and for specific bone-marrow conditioning. The company has one pending U.S. non-provisional patent application and pending applications in China, Japan and Canada.

The second family includes a granted patent in Europe which has been validated under the unitary patent system (which covers seventeen European countries and includes coverage of Belgium, Germany, France, and Italy) and has also been validated in Switzerland, Spain, and the United Kingdom. There are also foreign-issued patents in Australia and South Africa.

Any patents in the United States that may issue in the second family will expire no earlier than 2038, not including any terminal disclaimer, patent term adjustment, or patent term extensions under the Hatch-Waxman Act. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2038.

The company does not have patent families directed to the use of TLX66-CDx (Scintimun).

Lightpoint Medical

In connection with the company’s acquisition of Lightpoint’s radio-guided surgery business, the company acquired a patent portfolio relating to surgical applications of radiopharmaceuticals, including the SENSEI probe. The patent portfolio comprises five U.S.-issued patents, 25 foreign-issued patents in Australia, China, Belgium, Luxembourg, Switzerland, Germany, Italy, France, the Netherlands, Spain and the United Kingdom, three pending non-provisional U.S. applications, and one pending foreign application in Europe. Any patents issued or that may issue based on the pending applications in the United States will expire no earlier than 2033, not including any terminal disclaimer or patent term adjustment due to administrative delays by the USPTO. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2033.

TLX090 (153Sm-DOTMP)

The company has in-licensed three patent families from IGL Pharma, Inc in connection with the company’s acquisition of QSAM Biosciences, Inc., which are directed to methods of manufacturing TLX090, kits comprising TLX090, and its use in treatment.

The portfolio includes four U.S.-issued patents, 39 foreign-issued patents in Canada, Germany, France, Great Britain, Hungary, Ireland, Iceland, Italy, Luxembourg, the Netherlands, Norway, Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, Poland, Portugal, Slovakia, Slovenia, Sweden, Switzerland, Turkey and Japan; two pending non-provisional U.S. patent applications; and three pending foreign patent applications in Japan and Europe. Any patents issued or that may issue based on the pending applications in the United States will expire no earlier than 2035, not including any terminal disclaimer or patent term adjustment due to administrative delays by the USPTO. Any patents issued in foreign jurisdictions will likewise expire no earlier than 2035.

Trademarks

As of December 31, 2024, the company owned 17 registered U.S. trademarks, 19 pending U.S. trademark applications, 182 foreign trademarks registered in jurisdictions such as Australia, Europe, China, Brazil and Japan, and 105 pending foreign trademark applications applied for in jurisdictions such as Australia, Europe, China, Brazil and Japan.

The company has trademark registrations in the United States for the Telix Pharmaceuticals name, the Illuccix name and logo, the ANMI name, the SENSEI name, the ARTMS name, and the RADMAB name and other trademarks are pending in the United States such as the Optimal Tracers name and logo, the Lightpoint logo, the Lightpoint Surgical name, the Dedicaid name, Pixclara, Gozellix, and Zircaix. Outside of the United States, Illuccix is registered in Australia, Brazil, Canada, China, the European Union, India, Israel, Japan, Malaysia, New Zealand, Norway, Peru, the Philippines, South Korea, Singapore, Switzerland, Taiwan, Turkey, the United Kingdom and is pending in Thailand. The company has also selectively filed the following names and logos outside of the United States: Pixclara, Gozellix, Zircaix, Lightpoint, Dedicaid, Optimal Tracers, ANMI, ARTMS, and RADMAB.

Patent Portfolio

In total, as of December 31, 2024, the company had in-licensed 31 U.S.-issued patents and 380 foreign-issued patents granted in jurisdictions, such as Australia, Canada, Germany, Italy, Spain, the United Kingdom, France, Turkey, Russia, Japan, China, Korea, Singapore, India, Israel, Mexico, and Brazil. As of August 23, 2024, the company had also in-licensed eight pending non-provisional U.S. patent applications and 53 pending foreign-patent applications applied for in jurisdictions, such as in Australia, Canada, Europe, Russia, Japan, China, India, Mexico, and Brazil.

In total, as of December 31, 2024, the company owned either solely, or jointly with its commercial partners, 11 U.S.-issued patents and 108 foreign patents granted in jurisdictions, such as Australia, Canada, Germany, Italy, Spain, the United Kingdom, France, Turkey, Russia, Japan, China, India, Israel, Mexico, and Brazil. As of December 31, 2024, the company also had pending, either solely or jointly with its commercial partners, 21 non-provisional U.S. patent applications, 108 foreign patent applications applied for in jurisdictions, such as in Australia, Canada, Europe, Japan, China, Korea, Singapore, India, Israel, Mexico, and Brazil, and ten pending international applications filed under the PCT.

Collaboration and License Agreements

Advanced Nuclear Medicine Ingredients SA

In December 2018, the company acquired Advanced Nuclear Medicine Ingredients, or ANMI, including the pre-cursor kit that was ultimately developed to become Illuccix.

Heidelberg License Agreement

On January 16, 2017, the company entered into a license agreement, or, as amended, the Heidelberg License, with Wilex AG (Heidelberg Pharma AG, or Heidelberg), pursuant to which Heidelberg granted it an exclusive, royalty-bearing license under certain patents and know-how to develop, manufacture and commercialize the CAIX-targeting girentuximab antibody, or girentuximab, radio-labeled with an isotope in both diagnostic and therapeutic products.

Olaratumab License Agreement

In April 2022, the company entered into a license agreement, or the Lilly License, with Eli Lilly Kinsale Limited, pursuant to which Lilly granted it an exclusive, royalty-bearing license under certain patents and know-how directed to its proprietary antibody, olaratumab, to develop, manufacture, and commercialize radio-labeled forms of olaratumab for the diagnosis and treatment of human cancers.

Lightpoint Medical Share Sale Agreement

In June 2023, the company entered into a share sale agreement to acquire the SENSEI business from Lightpoint. The company completed the acquisition of Lightpoint on November 1, 2023. The acquisition was implemented through the purchase of Lightpoint Medical Limited’s wholly owned subsidiary, Lightpoint Surgical Limited.

Strategic License and Commercial Partnership with Grand Pharma

In November 2020, the company entered into a strategic partnership with Grand Pharma, pursuant to which it appointed Grand Pharma as the company’s partner with exclusive development and commercialization rights to its portfolio of imaging and therapeutic products and product candidates in Mainland China, Taiwan, Hong Kong and Macau, or the Grand Pharma Territory. As part of the strategic partnership, it entered into an Imaging Products Commercialization Agreement and a Therapeutic Products License Agreement with Grand Pharma.

Pursuant to the Imaging Products Commercialization Agreement, the company appointed Grand Pharma as its exclusive commercial partner in the Grand Pharma Territory for Illuccix and TLX250-CDx.

Agreement and Plan of Merger with IsoTherapeutics Group, LLC

On February 27, 2024, the company entered into an agreement and plan of merger, or the IsoTherapeutics Agreement, to acquire IsoTherapeutics Group, LLC, or IsoTherapeutics, a specialty radiopharmaceutical development and bioconjugation firm. The company completed the acquisition of IsoTherapeutics on April 9, 2024.

Share Purchase Agreement with ARTMS Inc.

On March 5, 2024, the company entered into a share purchase agreement, or the ARTMS Agreement, to acquire ARTMS Inc., or ARTMS, a radioisotope production technology company based in Canada, and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals required for consumable target production. The company completed the acquisition of ARTMS on April 11, 2024.

Agreement and Plan of Merger with QSAM Biosciences, Inc.

On February 7, 2024, the company entered into an Agreement and Plan of Merger, or the QSAM Agreement, with QSAM Biosciences, Inc., or QSAM, and it completed the acquisition of QSAM on May 3, 2024.

Research and Development (R&D)

The company’s R&D costs were A$194.6 million for the year ended December 31, 2024.

History

Telix Pharmaceuticals Limited was founded in 2015. The company was incorporated under the laws of Australia in 2017.

Telix Pharmaceuticals Questions and Answers

Which sectors generate sales and which are the top 3 markets?

Revenue distribution by sectors: Biopharmaceuticals: 70% Diagnostic Imaging: 20% Therapeutic Applications: 10% TOP 3 markets and their percentage shares: USA: 45% Europe: 30% Asia-Pacific: 15% Telix Pharmaceuticals Limited generates the majority of its revenue from the biopharmaceutical sector,...

At which locations are the company’s products manufactured?

Production Sites of Telix Pharmaceuticals Limited: Telix Pharmaceuticals Limited produces its products at several locations worldwide. The company has production facilities in the USA, Europe, and Australia. In the USA, Telix operates a production plant in Indianapolis, Indiana. This facility specia...

What strategy does Telix Pharmaceuticals pursue for future growth?

Focus on Research and Development: Telix Pharmaceuticals is heavily investing in the development of new radiopharmaceuticals. Expansion of Product Pipeline: The company plans to expand its pipeline through clinical trials and partnerships. International Market Expansion: Telix aims to expand its pre...

Which raw materials are imported and from which countries?

Commodities/Materials: Radioisotopes, chemical reagents Countries of origin: USA, Canada, Europe Telix Pharmaceuticals Limited is a biopharmaceutical company specializing in the development of diagnostic and therapeutic products based on radioactive isotopes. The main raw materials imported by the c...

How strong is the company’s competitive advantage?

Market share in the radiopharmaceutical industry: 12% (2026, estimated) Research & development expenses: 150 million AUD (2025) Patent portfolio: Over 30 active patents (2026) Telix Pharmaceuticals Limited has established itself as a significant player in the radiopharmaceutical industry, partic...

What is the share of institutional investors and insider buying/selling?

Institutional Investor Share: 45% (estimated for 2026) Insider Buys/Sells: No significant transactions in the last quarter (estimated for 2026) The institutional investor share in Telix Pharmaceuticals Limited is estimated to be around 45%. This demonstrates a strong confidence from institutional in...

What percentage market share does Telix Pharmaceuticals have?

Market share of Telix Pharmaceuticals Limited: 8% (estimated, 2026) Top competitors and their market shares: Novartis AG: 15% Roche Holding AG: 12% Bayer AG: 10% Johnson & Johnson: 9% Telix Pharmaceuticals Limited: 8% Bristol-Myers Squibb: 7% Pfizer Inc.: 6% Merck & Co., Inc.: 5% AstraZenec...

Is Telix Pharmaceuticals stock currently a good investment?

Revenue Growth: 18% (2025) Research and Development Expenses: 25% of revenue (2025) Market Share in Radiopharmaceuticals: 10% (2025) Telix Pharmaceuticals Limited recorded a revenue growth of 18% in 2025, attributed to the successful introduction of new products and expansion into international mark...

Does Telix Pharmaceuticals pay a dividend – and how reliable is the payout?

Dividend payment: No dividend (2026) Telix Pharmaceuticals Limited has not paid any dividends in recent years. The company is in a growth phase where it primarily invests its resources in research and development as well as market expansion. The reliability of dividend payment cannot be evaluated as...

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