With a strong IP portfolio, deep clinical-stage pipeline, global collaborations and an experienced leadership team, Invion is poised for transformative value creation as it enters the next phase of clinical and commercial growth.
Invion Limited (ASX:IVX) is a clinical-stage Australian life sciences company focused on transforming photodynamic therapy (PDT) into a next-generation solution for treating cancer and infectious diseases. The company’s core value lies not just in preclinical promise, but in real-world clinical validation.
At the heart of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively target diseased cells and, upon light activation, induce a precise oxidative stress response to destroy them. Unlike conventional PDTs that suffer from toxicity and off-target effects, Photosoft compounds are engineered for enhanced safety, specificity, immune activation, and theragnostic utility. INV043, Invion’s lead cancer drug candidate, has demonstrated up to 80 percent tumor control in combination with immune checkpoint inhibitors, and is now in human trials.The company is actively progressing a broad pipeline across multiple indications, including:
These trials signal a critical shift for Invion from preclinical research to meaningful clinical validation, spanning both systemic and topical formulations. The safety data from the NMSC trial is expected to support accelerated development of the anogenital cancer program, given both use the same topical compound.
The clinical results so far have been consistent with the findings from the preclinical studies – showing INV043 to be very safe with promising efficacy signals. The next set of trials aim to further solidify the potential for the technology, where the one drug can treat multiple cancers, improve patient outcomes when using checkpoint inhibitors in combination with INV043 and demonstrate its diagnostic and theragnostic potential.
Beyond internally funded trials, Invion is strategically expanding its clinical and commercial footprint through non-dilutive, global partnerships. In South Korea, Hanlim Pharm is funding the preclinical development of Photosoft for glioblastoma multiforme — a highly aggressive brain cancer — and oesophageal cancer, both of which present major unmet needs. These programs are fully financed by Hanlim, with Invion retaining all intellectual property
Similarly, Dr. I&B Co. (Dr.inB), another South Korean group, is backing the development of Photosoft for human papillomavirus (HPV) in a new proof-of-concept trial. This collaboration not only funds a novel therapeutic area outside of oncology but underscores the versatility of Photosoft as a multi-indication, platform technology. Invion bears none of the clinical trial costs and maintains all rights to future commercialization.
In parallel, Invion is expanding the Photosoft platform into infectious diseases, where preclinical studies have demonstrated broad-spectrum antimicrobial activity. The compound has proven effective in vitro against:
These results reflect Invion’s long-term vision of developing a scalable, accessible and affordable therapy platform that addresses both high-burden cancers and the growing global threat of antimicrobial resistance. With Photosoft, the company is building a foundation not just for treating disease — but for reshaping therapeutic accessibility and patient outcomes worldwide.
Invion’s leading active trial is a Phase I/II adaptive clinical study targeting non-melanoma skin cancer — a condition that represents 98 percent of all skin cancers and constitutes a substantial public health burden in Australia. Using a topical formulation of INV043, the trial is designed with a 3+3 structure allowing real-time protocol optimization for safety and efficacy. The formulation offers significant cosmetic and pain-reduction benefits over existing approved PDT treatments like Metvix (by Galderma S.A.) and excisional surgery, both of which have limitations related to scarring and pain. Dosing of the first patient commenced in December 2024, with ongoing recruitment and interim data expected in the second half 2025 or early 2026. The skin cancer program not only represents a potentially fast path to market but also supports downstream programs, such as the anogenital cancer study, through shared formulation and safety data.
The anogenital cancer program is a major upcoming milestone for Invion, developed in collaboration with the prestigious Peter MacCallum Cancer Centre in Melbourne, Australia, one of the leading oncology research centres in the world. Utilizing the same topical INV043 formulation as the non-melanoma skin cancer trial, this Phase I/II study will leverage safety data from the trial to accelerate approval timelines. The anogenital trial targets high-risk lesions and cancers with limited therapeutic options, and benefits from the scientific and operational expertise of Peter Mac. Preclinical data showed exceptional synergy when INV043 was used in combination with immune checkpoint inhibitors (anti-PD-1), achieving up to 80 percent tumor-free responses in models of anal squamous cell carcinoma, compared with a circa 12 percent response rate with aniti-PD-1 alone. This program exemplifies Invion’s theragnostic strength, where the compound also enables fluorescent visualization of tumor margins to aid surgical decision-making.
INV043 has completed a Phase II investigator-led clinical trial in prostate cancer, funded by the RMW Cho Group. The trial involved sublingual systemic administration of the compound followed by targeted light therapy. Following COVID-related disruptions, a second cohort of 16 patients was successfully treated and evaluated using PSMA-PET scans and RECIST criteria. Results were compelling: 44 percent of patients showed no detectable cancer via PSMA-PET scan three months post-treatment, while 40 percent demonstrated partial or stable response by MRI. The therapy was extremely well-tolerated, with no serious adverse events and only mild treatment-emergent side effects. These findings serve as clinical proof-of-concept for systemic delivery of INV043, highlighting its potential for deeper-seated cancers and reinforcing its safety and scalability.
Through a strategic partnership with South Korean pharmaceutical company Hanlim Pharma, Invion is advancing preclinical programs for two highly aggressive and deadly cancers: glioblastoma multiforme and oesophageal cancer. Hanlim is funding both programs entirely, allowing Invion to retain all IP and avoid capital outlay. These programs are exploring INV043’s efficacy in some of the most treatment-resistant solid tumors, with early-stage studies underway and updates expected in 2025. If successful, this collaboration could lead to regional licensing or joint ventures in Asia, significantly expanding Invion’s global footprint.
Dr.inB, a leading PDT innovator in South Korea, is partnering with Invion to develop Photosoft-based treatments for HPV-related conditions, including genital warts and potentially HPV-linked cancers. The program, which includes proof-of-concept human trials, is entirely funded by Dr.inB, and Invion retains all IP and commercialization rights. Beyond HPV, Photosoft has demonstrated broad-spectrum antimicrobial potential against antibiotic-resistant bacteria, fungi and viruses, including SARS-CoV-2. This opens the door to applications in periodontal disease, peri-implant mucositis, and other infectious conditions. PDT’s unique mechanism of action — using light to generate oxidative stress — renders it immune to resistance development, making it an ideal candidate for combatting antimicrobial resistance, one of the top 10 threats to humanity identified by the World Health Organization.
Thian Chew brings over two decades of executive and advisory experience in healthcare and finance. He is the co-founder of Chronic Airway Therapeutics and a board advisor at Stanford Medicine’s Center for Asian Health Research and Education (CARE). Formerly an executive director at Goldman Sachs and director at KPMG Consulting, Chew combines strategic vision with operational rigor. He is an adjunct professor at the University College London and associate professor at HKUST, holding dual an MBA from Wharton School (Palmer Scholar) and an MA from the Lauder Institute, University of Pennsylvania.
A world-renowned expert in immunotherapy and translational cancer biology, Robert Ramsay is a senior scientist at Peter MacCallum Cancer Centre and has over 30 years of oncology research experience. He was instrumental in demonstrating the synergy between INV043 and checkpoint inhibitors, leading to his appointment as a key advisor. Ramsay also served as president of the Australian Society for Medical Research.
Scott Carpenter brings cross-functional expertise in regulatory affairs, business development and stakeholder engagement. He previously held leadership roles at Starpharma, AusBiotech and Bayer CropScience and holds an MBA from Melbourne Business School.
The co-inventor of Invion’s PDT patents, Sebastian Marcuccio is the founder of Advanced Molecular Technologies and has a deep background in pharmaceutical R&D, including with CSIRO. He is currently adjunct professor at La Trobe University and holds a PhD in organic chemistry.
With more than 18 years of experience managing global Phase I-IV drug and device trials across 14 countries, Kim Steel has worked with Novotech and Pacific Clinical Research. She is managing director of SAPRO Consulting, leading operational delivery for Invion’s ongoing trials.
A veteran of scientific instrumentation development, Alexander Bennett brings 35+ years of experience designing medical and forensic light systems. He led PDT light source trials at Peter MacCallum Cancer Centre and ensures the clinical precision of INV043’s light activation protocol.
Revolutionizing Photodynamic Therapy (PDT) for cancer and infectious diseases
On track to complete enrollment of first two cohorts of RAD204 following positive recommendation from DSMC to escalate dose to 60mCi of Lu177
On track to complete enrollment of the first cohort of Phase 1 ‘HEAT' trial of RAD202 for treatment of advanced HER2-positive solid tumors
U.S. FDA granted Fast Track Designation for RAD101 to distinguish between recurrent disease and the treatment effect of brain metastases
Confirmed guidance of Cash Runway through to mid-2026
Radiopharm Theranostics (ASX: RAD,OTC:RDPTF, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced financial results for the fiscal year ended June 30, 2025, and provided a corporate update.
"During the last quarter, we continued to execute with discipline and momentum across our pipeline, advancing key milestones within both our therapeutic and diagnostic radiopharmaceutical programs," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We are encouraged by the pace and efficiency of our development efforts. Notable achievements this quarter include the FDA's Fast Track Designation for RAD101, DSMC clearance to proceed with higher dosing of RAD204, procurement of multiple supply agreements for key radioisotopes and meaningful clinical progress across our clinical pipeline. These milestones reflect our unwavering commitment to delivering precise, targeted radiopharmaceutical solutions that have the potential to transform cancer care. Looking ahead, we anticipate a number of important clinical and corporate milestones throughout the remainder of 2025."
Program and Business Updates
177Lu-RAD204 – Nanobody targeting PD-L1 radiolabeled with Lutetium 177
177Lu-RAD202 – Nanobody targeting HER2 radiolabeled with Lutetium 177
18F-RAD101 – Small molecule targeting fatty acid synthase radiolabeled with Fluorine-18
Ga68-RAD301 – Peptide targeting αvΒ-integrin radiolabeled with Gallium 68
Preclinical Assets
Business Updates
Financial update
The following is a summary of the Appendix 4C Cash Flow Report:
In compliance with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding reimbursements for out-of-pocket expenses.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com .
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
News Provided by GlobeNewswire via QuoteMedia
Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3
On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25
Radiopharm Theranostics (ASX: RAD,OTC:RDPTF, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.
"FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center," said Riccardo Canevari, CEO and Managing Director. "RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year."
"Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity," noted Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.
"The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation," noted David Piwnica-Worms, M.D., Ph.D., Professor, MD Anderson Cancer Center, and scientific co-founder of Radiopharm Ventures.
B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors.
About RV-01
RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com .
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
News Provided by GlobeNewswire via QuoteMedia