Telix Pharmaceuticals (NASDAQ:TLX) executives highlighted commercial momentum in prostate cancer imaging and outlined multiple clinical programs in oncology during an H.C. Wainwright discussion featuring CEO Chris Behrenbruch and CMO David Cade.
Company overview and 2026 revenue outlook
Behrenbruch described Telix as a “fully vertically integrated radiopharma company specializing in oncology,” with a portfolio focus in urologic oncology and neuro-oncology. He said the company is commercial-stage and generated “just over $800 million in sales” in 2025, driven primarily by its U.S. prostate cancer imaging franchise, which includes two FDA-approved products.
PSMA imaging growth drivers and the BiPASS Phase III study
In discussing the PSMA imaging opportunity, Behrenbruch outlined three primary business drivers:
- Baseline market growth: He said Telix expects ongoing growth in PSMA imaging of about 5% to 7% annually as “white spaces” remain and some referring physicians continue to use CT and bone scans.
- Second product and reimbursement segmentation: Behrenbruch said having a second product with pass-through creates a segmentation strategy for targeting payers in different settings, which he expects to translate into revenue. He also noted the product offers clinical and distribution benefits.
- Potential label expansion via BiPASS: Telix is running a Phase III trial called BiPASS that could expand the total addressable market (TAM) for PSMA imaging.
Cade emphasized the clinical rationale behind BiPASS by pointing to the volume and limitations of prostate biopsies in the U.S. He said there are “north of 1 million biopsies” performed annually, but a significant portion—he estimated “somewhere between 750,000” and “maybe 800,000”—do not yield definitive results. He also cited an estimated 200,000 to 250,000 men who decline biopsy despite needing evaluation.
According to Cade, the study examines whether adding a gallium PSMA PET scan to MRI can better direct biopsies—potentially reducing the need for extensive template biopsies—or allow some patients to avoid biopsy altogether if PSMA PET is negative. He summarized the patient benefit as “one and done or none and done” and said the evolving clinical pathway could represent “an estimated 750,000-800,000 scans” over time.
Therapeutics update: ProstACT Global (TLX591) and U.S. enrollment plans
Behrenbruch and Cade also reviewed Telix’s therapeutics pipeline, including TLX591 in metastatic castration-resistant prostate cancer (mCRPC). Behrenbruch said ProstACT Global is a randomized Phase III trial evaluating standard of care plus TLX591 versus standard of care alone across three cohorts combining TLX591 with enzalutamide, abiraterone, or docetaxel.
He explained that Part 1 of the program was initiated after the FDA requested additional combination data with androgen receptor pathway inhibitors (ARPIs). The company reported Part 1 results focused on safety and dosimetry. Behrenbruch said the main toxicity observed was hematologic adverse events, but characterized them as transient, self-limiting, and rapidly reversible, including at higher grades. He contrasted this with what he described as benign patient-centric adverse events, stating the treatment does not have salivary gland uptake and does not rely on renal excretion.
Regarding next steps, Behrenbruch said Telix plans to take the Part 1 package to the FDA and seek an IND amendment to enroll U.S. patients into Part 2, which is already enrolling globally. He said the study has regulatory approval in “seven or eight countries,” with recruitment underway in Canada, Australia, and New Zealand, and the U.K. “just coming online.” He expected U.S. patients could enter Part 2 around mid-year or early Q3, with the U.S. accounting for about 20% of enrollment.
Telix also discussed an event-driven interim futility analysis in Part 2 at approximately 25% of events (around 80 patients). Behrenbruch said timing is uncertain but estimated it could occur around Q4 or Q1 next year.
Alpha strategy (TLX592) and pipeline approach
Behrenbruch said Telix is still evaluating its PSMA-targeted alpha strategy and described TLX592 as an early-stage asset. He said the company used copper-64 PET imaging as a surrogate to assess targeting and biodistribution because actinium is difficult to image, and Telix is preparing for first-in-human actinium studies in late-stage patients who have typically progressed on lutetium therapy.
He said TLX592’s value proposition includes avoiding exocrine gland uptake—an issue that can lead to salivary and lacrimal gland damage in some alpha programs—and minimizing renal exposure, noting recent discontinuations in the field related to renal toxicity for renally excreted alphas.
More broadly, Behrenbruch said Telix aims to match radionuclides to the biological problem, noting work across multiple alpha and halogen isotopes, including lead-212, actinium, and astatine. He also pointed to efforts in smaller engineered formats between small molecules and full-length antibodies to improve tissue penetration while maintaining favorable clearance characteristics.
Brain and kidney programs: TLX101 and TLX250
In neuro-oncology, Cade discussed TLX101 in the IPAX BrIGHT Phase III trial for recurrent glioblastoma. He referenced earlier Phase I findings that he said showed meaningful tumor control and extended survival, citing survivals “in the range of 23-32 months” from diagnosis compared with median survivals he described as typically “nine to 15 months” in that population. He said IPAX BrIGHT includes a Part 1 Bayesian design to optimize dosing of TLX101 and lomustine, followed by a randomized Phase III Part 2 comparing lomustine alone versus lomustine plus TLX101, with overall survival as the primary endpoint. Behrenbruch added that Telix has monotherapy dose-escalation experience and compassionate-use experience in Europe, and the company expects to begin rolling the study out to U.S. patients this year.
In renal cancer, Behrenbruch said the TLX250 program has been challenging due to rapidly evolving standards of care. He said Telix has decided to focus on an unmet need in last-line, rapidly progressing metastatic clear cell renal cell carcinoma, acknowledging belzutifan as an emerging option but not describing it as an “overwhelming solution.” He said Telix is pursuing a “VISION trial style” approach in later-line patients while also exploring combinations with immunotherapy, including a study at MD Anderson combining checkpoint inhibitors with targeted radiation.
Behrenbruch also reiterated expectations to launch Zircaix this year, calling it the “true companion imaging agent” to TLX250 and noting it uses the same targeting agent. He said the zirconium imaging agent enables predictive dosimetry for the lutetium therapy candidate and highlighted the value of hepatic excretion for renal imaging to avoid urinary tract signal during primary staging.
About Telix Pharmaceuticals (NASDAQ:TLX)
Telix Pharmaceuticals (NASDAQ: TLX) is a clinical-stage biopharmaceutical company focused on the development and commercialization of molecularly targeted radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging expertise in radiochemistry, nuclear medicine and oncology, Telix aims to address unmet clinical needs across a range of tumor types by pairing diagnostic imaging agents with therapeutic radionuclides.
The company’s pipeline spans both imaging and therapeutic candidates.
