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RAD 402 preclinical data package complete; demonstrates safety and promising biodistribution profile
Ethics approval and Phase 1 clinical trial start in prostate cancer anticipated in 2H 2025
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Radiopharm Theranostics
Investor Insight
Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.
Overview
Radiopharm Theranostics (ASX:RAD) is an innovative biopharmaceutical company specializing in the development of radiopharmaceutical products for both diagnostic and therapeutic applications. Founded with a mission to address significant unmet medical needs, particularly in oncology, the company has positioned itself at the forefront of the rapidly evolving field of precision medicine.
Radiopharm Theranostics presents a compelling value proposition for investors, characterized by several key factors:
- Strategic Partnerships
- Lantheus’ strategic investment in Radiopharm Theranostics, committing up to AU$18 million, strengthens Radiopharm's financial position and supports the advancement of its projects.
- Radiopharm owns 75 percent interest in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center, to develop novel radiopharmaceutical products for cancer treatment.
- Market Positioning: Radiopharm is strategically positioned to capture a significant share of the expanding theranostics market.
- Diverse Product Pipeline: The company boasts a robust pipeline of radiopharmaceutical products targeting various oncological diseases, which diversifies risk and increases potential revenue streams.
- Innovative Technology: Radiopharm's focus on leveraging technological advancements in radiopharmaceuticals, particularly in treating oncological diseases, positions it at the cutting edge of medical innovation.
Lantheus’ investment in Radiopharm marks a pivotal moment for both companies and holds substantial implications for the field of theranostics. The funding will facilitate Radiopharm's research and development efforts, accelerating its product pipeline and market presence. Under the agreement, Radiopharm will transfer two early preclinical assets to Lantheus for a further AU$3 million, fostering a collaborative relationship focused on radiopharmaceutical development. The collaboration positions Radiopharm to capitalize on the increasing demand for theranostic solutions, aligning with trends in personalized medicine. Moreover, this financial backing will support clinical trials and operational needs, while also aiming for the commercialization of their products.
Company Highlights
- Radiopharm Theranostics is focused on developing and commercializing radiopharmaceutical products and nuclear medicines for both therapeutic and diagnostic applications in precision oncology.
- Radiopharm has four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb) – with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development.
- The company has received clearance from the US Food and Drug Administration for an investigational new drug application with two INDs (one for RAD 301 and one for RAD 101). Phase 1 for RAD 301 and for RAD 204 is in progress.
- The company aims to commercialize its pipeline for possible licensing and distribution agreements and has secured four platform technologies, which it is seeking to develop for the diagnosis and treatment of certain cancers.
- Radiopharm owns 75 percent interest in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center.
Technology and Clinical Pipeline
Radiopharm has four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb) – with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development.
Radiopharm’s clinical stage development in the pipeline include:
- PD-L1 (non-small cell lung cancer indication) - currently in phase 1 in Australia;
- HER2 (breast/gastric cancer indication) - will begin phase 1 trials this year;
- Integrin VB6 (pancreatic cancer indication) - now in Phase I imaging in pancreatic cancer.
- Fatty Acid Synthase (brain METS indication) - preclinical has been completed and with IND approval for Phase IIb Imaging
The company recently received FDA approval for its investigational new drug application for 18-Pivalate (RAD 101). Labelled with the radioisotope F18, Pivalate is a small molecule that targets fatty acids synthase, which is overexpressed in brain tumours but not in normal cells.
Positive data from the company’s Phase 2 imaging trial of 17 patients with brain metastases has shown significant tumour uptake. Radiopharm holds an exclusive global license for the Pivalate platform.
Radiopharm highlights that Pivalate is potentially a new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients a better option in relation to current imaging technology, which has many limitations.
Management Team
Paul Hopper – Executive Chairman
Paul Hopper is the founder of Radiopharm Theranostics. He has over 25 years of experience in the biotech, healthcare and life sciences. Focused on start-up and rapid-growth companies, he has served as the founder, chairman, non-executive director or CEO of more than 15 companies in the US, Australia and Asia. Previous and current boards include Imugene, Chimeric Therapeutics, Viralytics, Prescient Therapeutics and Polynoma. His experience covers extensive fund raising in US, Australia, Asia and Europe, and he has deep experience in corporate governance, risk management, and strategy.
Riccardo Canevari – Managing Director and Chief Executive Officer
Riccardo Canevari has broad and deep experience across specialty pharma, oncology and radiopharmaceuticals. He was most recently chief commercial officer of Novartis Advanced Accelerator Applications, one of the leading radiopharmaceutical and nuclear medicine companies, globally. He was responsible for global commercial strategy and country organizations in ~20 countries across North America, Europe and Asia. He was responsible for Lutathera’s in-market growth strategy and execution to build a blockbuster asset and for the pre-launch plan for Lu-PSMA 617 in metastatic prostate cancer. Prior to this, Canevari was senior vice-president and global head, breast cancer franchise for Novartis Oncology since 2017, overseeing the launch of major breast cancer products, including KISQALI and PIQRAY. He also held various management roles with Novartis Pharma and Ethicon/Johnson & Johnson.
Dr. Sherin Al-Safadi - Vice-president, Medical Affairs
Dr. Sherin Al-Safadi is an accomplished industry leader with many years of experience in pharmaceuticals and biotech. Most recently she was vice-president – medical affairs at POINT Biopharma, where she led the strategic and tactical planning for Phase III support and launch preparation of radiopharmaceuticals. She also provided strategic input and leadership for business development and licensing opportunities. She currently serves as co-founder and president at Foundation Amal (Canada-USA), overseeing an executive leadership team of 12 directors and members, who led the successful 2021 cross-border expansion into the USA and spearheaded the development of a successful branding and communication strategy. Al-Safadi holds a PhD in neurobiology from Concordia University, an MBA in entrepreneurship & management from the John Molson School of Business, and a MSc in pharmacology (oncology drug development) from McGill University.
Vimal Patel - Vice-president, CMC
Vimal Patel joins RAD from Orum Therapeutics where he was vice-president, head of CMC and supply chain. He was responsible for all CMC functions including process and analytical development, manufacturing, quality control, quality assurance, regulatory and supply chain. He led the successful manufacture of two ADCs and contributed to filing an IND leading to a Phase-I trial. Prior to Orum, Patel held roles of increasing responsibility in process development and manufacturing sciences at several companies, including Actinium Pharmaceuticals. Patel also held a position at Pfizer where he contributed to the refiling of Mylotarg and the filing of Besponsa BLAs. He also developed manufacturing processes for various ADCs. He also held roles at Daiichi Sankyo, Progenics Pharmaceuticals and SibTech in various capacities. Patel has MS in biotechnology from University of Connecticut and B.S. in chemical engineering from Sardar Patel University.
Noel Donnelly - Non-executive Director
Noel Donnelly brings more than 25 years of leadership experience in finance, strategy and operations within the biopharmaceutical and biotechnology industries. He has a distinguished track record of building and leading cross-functional teams, driving corporate governance and executing complex financial strategies that support rapid company. growth. Donnelly is current the chief financial officer of PepGen, where he oversaw the company's financial strategy through its successful IPO, raising U$120 million and leading subsequent financial efforts that secured an additional US$90 million. Donnelly was previously the CFO of EIP Pharma (now, CervoMed), where he led the company's IPO plannig phase. He had a 15-year tenure at Takeda/Shire PLC, in various senior roles, where he led critical R&D integrations and oversaw more than US$160 billion in integration planning and execution. He was instrumental in shaping the company's portfolio management strategy.
Developing innovative radiopharmaceuticals for a highly underserved oncology sector
Radiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for ¹?¹Tb-KLK3-mAb Phase I Clinical Trial in Australia
Radiopharm Theranostics (ASX: RAD, 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 the signing of a supply agreement with Cyclotek to radiolabel RAD 402 with Terbium-161 ( 161 Tb) in Australia, which supports the initiation of a Phase 1 clinical trial. RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic labelled with the radionuclide 161 Tb for treatment of prostate cancer.
"This agreement is an important milestone for the development of RAD 402 and is the last step needed to submit for ethics approval and begin our Phase 1 clinical trial in prostate cancer," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We are very appreciative of the entire team at Cyclotek for their support as we work together to bring an innovative new treatment option to patients battling prostate cancer."
RAD 402 has been designed to target KLK3, which is highly expressed in the prostate, with very limited/no expression in other tissues and organs. Compared to 177 Lu, 161 Tb emits additional Auger and conversion electrons alongside its β-radiation, which can lead to potentially improved antitumoral therapeutic efficacy. 161 Tb-RAD 402 is the first company-sponsored Phase I trial in prostate cancer using 161 Tb.
Under the agreement, Cyclotek will produce and provide doses of 161 Tb-labeled RAD 402 to support Radiopharm's upcoming Phase 1 clinical trial in prostate cancer in Australia. The Phase 1 trial is anticipated to start in the second half of 2025.
"We are pleased to partner with Radiopharm to facilitate the development of their innovative radiotherapeutic, RAD 402, for the treatment of prostate cancer," stated Greg Santamaria, CEO of Cyclotek. "Our mission at Cyclotek is to improve the accessibility of radiopharmaceuticals to enhance patient outcomes. As we support the Radiopharm Theranostics team, we look forward to RAD402 advancing toward market approval while demonstrating the value radiotherapeutics can bring to patients."
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 .
About Cyclotek
Cyclotek is the leading radiopharmaceutical manufacturer in Australia and New Zealand. We manufacture diagnostic and therapeutic radiopharmaceuticals for supply into clinical trials and for clinical use.
At Cyclotek, we are committed to improving patient outcomes by making diagnostic and therapeutic radiopharmaceuticals accessible. PET tracers provide patient specific insights into their disease state, leading to earlier diagnosis, more accurate assessment of disease extent, and improved treatment planning and monitoring. Paired with radionuclide therapies, these products offer a comprehensive, non-invasive disease management option.
Our dedication to innovation drives our continuous development of new radiopharmaceuticals.
This helps provide our customers a growing range of tools that enhance the understanding of each patient's health, contributing to more cost-effective healthcare solutions.
At Cyclotek, we are not just a manufacturer, we are a hub of innovation. Our commitment to quality, safety, supply and customer service ensures that healthcare providers have the best tools available for precise diagnostics and therapies, fostering improved patient care.
Through our unwavering focus on excellence, we aim to make a lasting, positive impact on healthcare.
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/
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Radiopharm Theranostics Granted U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain Metastases
Radiopharm Theranostics (ASX:RAD, "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 granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.
RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastases.
"The FDA's Fast Track Designation for RAD101 highlights the seriousness of recurrent brain metastases as a condition and the unmet medical need for innovative products that can differentiate between tumor recurrence and radiation necrosis or pseudprogression," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "RAD101 represents a promising advancement in improving diagnostic precision for brain metastases, offering hope for more effective clinical decision-making in the over 300,000 patients diagnosed annually in the U.S. We are excited to advance our Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025."
The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. A Sponsor that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. A Sponsor's drug receiving Fast Track designation also may be eligible for Priority Review if relevant criteria are met.
About the Phase 2 Clinical Trial of RAD101
The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases.
About RAD101
RAD101 is the Company's novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.
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 metastases. Learn more at radiopharmtheranostics.com .
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
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
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
News Provided by GlobeNewswire via QuoteMedia
Radiopharm Theranostics Doses First Patient in Phase 1 'HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors
Phase 1 1 First-In-Human study designed to assess safety , tolerability , right dose for Phase 2 and early signs of efficacy of 177Lu-RAD20 2 in individuals with advanced HER2-positive solid tumors
Previous clinical proof-of concept data 2 for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans
Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its Phase 1 ‘HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors.
The open-label Phase 1 "HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia.
"Dosing patients in the HEAT clinical trial marks an important milestone in our transition to a clinical-stage company," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the ‘HEAT' trial represents a significant step toward achieving RAD202's potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life."
HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers 2 . Preclinical findings 3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies.
"It is a privilege to be the first centre to administer 177Lu-RAD202, targeting HER2-positive tumors in this Phase 1 clinical trial (HEAT)." said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at St John of God Murdoch Hospital. "This opens the possibility of novel therapeutic avenues for patients with aggressive tumor types, including breast, ovarian, gastric, pancreatic, bladder, and several other cancers. With the trust put in us by Radiopharm, we look forward to a successful trial with beneficial outcomes for our patients."
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 metastases. Learn more at radiopharmtheranostics.com .
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
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
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
________________________________
1 clinicaltrials.gov/study/NCT06824155
2 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-3622
3 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-z
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Radiopharm Theranostics Reports Preclinical Lu177-B7H3-mAb Data Demonstrating Favourable Biodistribution and High Tumour Uptake
Supports plans to advance the RV01 program to first-in-human therapeutic basket study in solid tumour cancers
Data completes preclinical package for Investigational New Drug submission in mid-2025 with Phase 1 therapeutic study initiation expected in 4Q25
Radiopharm Theranostics (ASX: RAD, 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 preclinical data from studies with the Lu177-B7H3-monoclonal antibody RV01 demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake. In addition, the Fc region modifications of the monoclonal antibody (mAb) confirm a shorter half-life, compared to traditional mAbs. The shorter half-life and other Fc modifications have the potential to limit off-target exposure to the isotope and mitigate toxicities associated with traditional monoclonal antibody therapies.
RV01 is the Company's B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumours and not in healthy tissues, which is being developed in partnership with MD Anderson Cancer Center. The B7-H3 targeting monoclonal antibody (mAb) is designed to target various solid tumours that express the B7-H3 protein. High expression of this target is associated with a poor prognosis in many cancer types.
"We are especially pleased with these new preclinical data as they further validate earlier preclinical work that showed strong affinity to the target without the extensive circulation time of other monoclonal antibodies. Our mAb has been purposefully modified in the Fc-region with the objective of maintaining the same targeting capabilities together with a reduced half-life. Most mAbs have a typical half-life of over one week, whereas RV01 peaks within one to two days," stated Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.
"The antibody shows faster liver excretion in the preclinical experiments, allowing the isotope enough time to effectively target the tumor potentially without the associated toxicities. Unlike peptides or small molecules, mAbs are excreted by the liver, the most radio-resistant organ. This, combined with the faster excretion due to the shortened half-life, potentially offers important advantages compared to excretion via the kidneys, where the elimination of radiopharmaceuticals can result in significant potential toxicities," added Dr. Voliotis.
The new preclinical data corroborate conclusions from earlier preclinical mouse studies that identified a high-affinity antibody highly selective to the cancer-specific 4Ig isoform of the B7-H3 receptor, demonstrated complete regression of established solid tumours with treatment and showed promising evidence of immune system stimulation and the ability to confer immune memory.
"This biodistribution study is the last preclinical work needed to complete the preclinical package for our Investigational New Drug Application (IND) with the U.S. Food and Drug Administration. These data allow us to confirm our guidance to file the IND-submission in mid-2025 and to initiate our first-in-human Phase 1 basket study by the end of this year," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
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/
An image accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7ff2e681-52ea-43e1-9cf4-250f2bb12480
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Inside the ASX Biotech Boom: What’s Fuelling the Next Wave
On a global scale, the biotechnology market size was pegged at US$1.55 trillion in 2023, with growth projections reaching US$3.88 trillion by 2030, according to a report from Grand View Research.
While much global biotech attention is focused on the NASDAQ, the ASX has carved out a niche as a launchpad for early stage innovation, offering investment exposure before major clinical or regulatory milestones are reached.
Investors’ approach to biotech stocks
Evaluating a biotech investment requires a unique set of variables that may be different from traditional valuation metrics, like earnings and revenue.
“Biotech doesn’t fit neatly into traditional valuation frameworks. Revenue might not exist yet. Profits could be years away. And the outcome of a single clinical trial can send valuations soaring or crashing overnight,” wrote Lior Ronen, founder and CEO of Finro Financial Consulting.
In this sector, every stage — from preclinical to Phase III — serves as a potential value inflection point. Investors also prioritise pipeline diversity. A single therapy focus can be riskier than a platform addressing multiple indications or mechanisms, which inherently balances failure risk.
Robust IP is essential. Comprehensive IP protection enhances both commercial potential and the opportunity for strategic partnerships. Capital discipline is another key consideration. With no immediate revenue stream, biotech firms need to manage cash efficiently. Companies that combine non-dilutive funding, such as grants, with lean operations can extend their runway and reduce dilution for existing shareholders.
External validation through partnerships with research institutions or global pharmaceutical companies further strengthens investor confidence.
Together, these factors compose a robust framework for evaluating biotech investments. Investors who monitor upcoming catalysts like clinical data releases or regulatory meetings stand a strong chance of making timely and informed decisions.
Clinical milestones as catalysts
Timing is often the most critical variable in biotech investing. With less than 10 percent of drug candidates making it from clinical trials to approval, securing positions before significant catalysts is crucial.
Each phase of clinical trials — Phase I (safety), Phase II (efficacy) and Phase III (confirmatory efficacy and large-scale safety) — represents a de-risking stage. Success at any point can trigger partnerships, licensing discussions or stock run ups. For example, Neuren Pharmaceuticals (ASX:NEU) surged after receiving US Food and Drug Administration approval for a Phase III trial of its NNZ-2591 to treat a rare condition called Phelan-McDermid syndrome.
Understanding both where a company sits in this sequence, and whether it’s sufficiently funded to reach its next milestone, are essential for well-timed entry and exit strategies.
Over the years, Australia has produced several beacon biotech stories:
CSL (ASX:CSL) grew from a government vaccine lab to a global biotech powerhouse worth over AU$140 billion. Its journey blends scientific innovation, strategic acquisitions and sustained global expansion.
Mesoblast (ASX:MSB) has navigated multiple clinical programs and regulatory reviews, demonstrating how IP-protected assets and global licensing deals can foster long-term growth despite inevitable setbacks.
These cases demonstrate that scalable platforms, a global mindset, clinical progress and IP robustness are the legs on which biotech success stands.
Emerging biotech platforms
Australia’s next wave of biotech leaders is emerging in areas such as immunotherapy, RNA platforms, regenerative medicine and non-invasive cancer therapies. Investor-favoured trends include:
- Non-toxic cancer treatments
- Theragnostics (integrated diagnostics and therapy)
- RNA-based therapeutics
- Platform technologies with cross-disease applications
These innovations benefit from Australia’s strong R&D ecosystem, leading universities and a regulatory structure capable of early phase clinical trials.
Case in focus: Invion Limited
Invion Limited (ASX:IVX) is emerging as a standout in the ASX biotech landscape, advancing a novel, IP-protected photodynamic therapy (PDT) platform with strong early clinical momentum.
Invion has a portfolio of over 300 unique compounds protected by over 10 patent families. Its lead cancer compound, INV043, is designed to selectively destroy cancer cells using light-activated photosensitisers, while leaving healthy tissue unharmed — a promising non-toxic, non-invasive alternative to chemotherapy, radiation or surgery.
The therapy’s dual mechanism of targeted cell death and immune activation positions it within the growing field of theragnostics, combining diagnostic and therapeutic utility. INV043 has demonstrated tumour fluorescence under violet light and therapeutic efficacy under red light, offering potential value not only as a treatment but also as a tool for visualising and monitoring cancer in real time.
The theragnostic potential of Invion's INV043.
Image via Invion Limited.
Invion recently reported positive Phase II results in prostate cancer, showing a 44 percent tumour response rate (PSMA-PET scans) and no serious adverse events across six treatment cycles.
A separate Phase I/II trial in non-melanoma skin cancer also reported no treatment-related pain or adverse events and early indications of lesion reduction. This trial will support the company’s upcoming anogenital cancer study in partnership with Peter MacCallum Cancer Centre.
The potential for a drug to be effective against more than one cancer target is unusual, to say the least. What makes the technology even more unique is its potential ability to stimulate the body’s immune system to continue to fight cancers. This was demonstrated in preclinical animal studies carried out by Invion’s research partners, the Peter MacCallum Cancer Centre and Hudson Institute of Medical Research on various cancers, including ovarian, colorectal, kidney, lung, triple negative breast and T-cell lymphoma.
Additionally, Invion has partnered with two South Korean pharmaceutical groups, Hanlim Pharm Co., Ltd. and Dr. I&B Co., Ltd. These parties are providing non-dilutive funding for studies using Invion’s Photosoft™ technology platform on glioblastoma (a deadly brain cancer), esophageal cancer and the human papillomavirus (HPV).
Beyond oncology, Invion is applying its Photosoft platform to infectious diseases, where resistance to antibiotics is escalating globally. Preclinical data show broad-spectrum antimicrobial activity, including against antibiotic-resistant pathogens and even SARS-CoV-2, without promoting resistance. This expands the company’s addressable market while reinforcing the flexibility of its core platform technology.
In a market where combination therapies are becoming standard, INV043’s ability to enhance immunotherapy responses may significantly increase its licensing or partnering potential.
With a capital-efficient structure, validated early data, world-renowned partners and a growing portfolio of trials across multiple cancers and infectious diseases, Invion is positioned as a platform biotech that is scalable, defensible and aligned with global healthcare trends favouring safety, precision and accessibility.
Strategic criteria for identifying the next breakout
A report by Jeremiah Grant, economic damages and business valuation expert at Arrowfish Consulting, outlines the following attributes to help investors evaluate biotech companies:
- A platform technology with multiple therapeutic or diagnostic uses
- Strong IP protection, preferably with international reach
- Active clinical relevance and small-scale data or early trial feedback
- Clear, upcoming regulatory or clinical milestones
- A capital-efficient model, supported by non-dilutive finance
- Strategic validation through partnerships or collaborations
- A confident commercial or licensing roadmap
Companies meeting these criteria are prime candidates for exponential gains with risk-managed entry points.
Investor takeaway
The ASX healthcare and biotech sector offers a distinctive opportunity for investors who understand its unique valuation drivers. While inherently high risk, the sector can deliver high-reward outcomes when approached with informed timing, strategic insight and rigorous scientific evaluation.
Innovators like Invion, which combine strong IP, scalable platforms, disciplined funding and impending clinical inflection, represent the kind of high-upside opportunities that savvy investors seek. By marrying financial discipline with scientific foresight, investors can access what may be one of the most transformative sectors of the next decade.
This INNSpired article is sponsored by Invion Limited (ASX:IVX). This INNSpired article provides information which was sourced by the Investing News Network (INN) and approved by Invion Limitedin order to help investors learn more about the company. Invion Limited is a client of INN. The company’s campaign fees pay for INN to create and update this INNSpired article.
This INNSpired article was written according to INN editorial standards to educate investors.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Invion Limitedand seek advice from a qualified investment advisor.
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