
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
Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.
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:
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.
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:
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.
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 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 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 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 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
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
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/
News Provided by GlobeNewswire via QuoteMedia
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
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
News Provided by GlobeNewswire via QuoteMedia
Australia’s healthcare and biotechnology sector has matured into one of the most promising and strategically important segments of the ASX. Fortunes can shift on a single clinical trial result. A company with no revenue today could be a global contender tomorrow — if its science holds up.
As investors sift through early stage biotech companies, the challenge is less about spotting ambition and more about recognising the markers of real-world impact: a strong intellectual property (IP) moat, well-timed milestones, non-toxic innovation and enough capital to get through the next inflection point. In a market where data can drive value faster than sales, understanding the rhythm of biotech development has become not just useful, but essential.
According to Australian market analyst firm Morgans, healthcare stocks have consistently delivered strong performances on the ASX over the last 10 years. With more than $8 billion in annual revenue, the Australian life science ecosystem is expected to continue to grow at an annual rate of 3 percent up to 2026.
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.
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.
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.
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:
These innovations benefit from Australia’s strong R&D ecosystem, leading universities and a regulatory structure capable of early phase clinical trials.
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.
A report by Jeremiah Grant, economic damages and business valuation expert at Arrowfish Consulting, outlines the following attributes to help investors evaluate biotech companies:
Companies meeting these criteria are prime candidates for exponential gains with risk-managed entry points.
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.
The global biotechnology sector is on track to become a multi-trillion dollar industry.
Worldwide, the biotech space was worth an estimated US$1.68 trillion last year, according to Cervicorn Consulting. That value is expected to grow at a compound annual growth rate of 9.18 percent through 2033 to become a US$3.54 trillion market.
The major factors driving this growth are a strong clinical pipeline of precision medicine and regenerative technologies, as well as a rising demand for treatments for chronic diseases such as cancer, diabetes and neurological disorders.
Australia's biotech market is growing as well. According to IBISWorld, annual revenue in Australia's biotech sector has grown at a compound annual growth rate of 2.4 percent over the last five years.
The firm projects that the sector will see revenue of AU$12.3 billion in 2025.
According to a report from KPMG, Australia’s biotech industry ranks fifth in the world for research and translation. “Australia’s renowned research and clinical trials capabilities, growing biotech industry and increasing investments in manufacturing can help bolster biotech breakthroughs,” the report’s authors stated.
Below the Investing News Network profiles the four best-performing ASX small-cap biotech stocks so far this year. Data was compiled on June 12, 2025, using TradingView’s stock screener. Read on to learn more about their activities so far this year.
Year-to-date gain: 100 percent
Market cap: AU$9.69 million
Share price: AU$0.066
NeuroScientific Biopharmaceuticals researches and develops biomedical products for the treatment of neurodegenerative conditions related to immune-mediated inflammatory disorders.
These types of disorders involve the immune system mistakenly attacking the body's own tissues.
The company’s shares got large bump to the upside in April following news of its intent to acquire 100 percent of the issued capital of private firm Isopogen, which would bring Isopogen's patented StemSmart stem cell technology into NeuroScientific's portfolio.
StemSmart improves the clinical efficacy of mesenchymal stromal cells (MSC) derived from adult human donor bone marrow. The treatment then interacts with a patient’s immune system to modulate immune responses.
StemSmart MSC is currently targeting the treatment of the inflammatory bowel disease Crohn's disease. According to the release, results of the Phase 2 trial of StemSmart MSC for treating refractory Crohn’s disease were promising. The next step for the treatment is a special access program for treating fistulising Crohn’s disease.
Shares surged in value from AU$0.035 on April 15, before the news was released, to AU$0.52 the next trading day. The stock reached its year-to-date high of AU$0.067 on June 11.
Year-to-date gain: 27.14 percent
Market cap: AU$6.01 million
Share price: AU$0.089
Invex Therapeutics is a biopharmaceutical company repurposing the drug Exenatide, a drug currently approved for type 2 diabetes, for the treatment of neurological conditions relating to raised intracranial pressure.
Invex collaborated with Tessara Therapeutics in pre-clinical trials, testing Exenatide on Tessara's Alzheimer's disease model, ADBrain. The trials focused on its therapeutic efficacy and safety in the prevention of cell death in the ADBrain neural micro-tissues.
In its March quarterly report, Invex shared that it had expanded its research collaboration with Tessara to study whether Exenatide can reduce Alzheimer's disease biomarkers and enact any positive effects on neural networks. The two are also planning a comparative analysis of Exenatide in normal versus Alzheimer's brain tissue with a focus on differential protein and gene expression. According to the release, results for the analyses are expected in the second half of 2025.
Shares in Invex hit their highest year-to-date value of AU$0.10 on May 8.
Year-to-date gain: 10.32 percent
Market cap: AU$92.23 million
Share price: AU$0.695
Argenica Therapeutics is developing novel neuroprotective therapeutics.
The company’s lead product candidate is ARG-007, a neuroprotective peptide candidate intended to protect brain cells and reduce cell death during a stroke and other types of neural injuries.
Shares in Argenica have experienced a degree of volatility for the first half of the year, trading in a range of AU$0.64 to AU$0.87, the latter being the value it reached as its year-to-date high on February 21.
In late January, Argenica announced a progress update from its Phase 2 clinical trial of ARG-007 in acute ischaemic stroke (AIS) patients. A review by the Data Safety Monitoring Board of the data out of the first 76 patients dosed in Argenica’s Phase 2 clinical trial recommended the study continue with no modifications.
Early the following month, Argenica released results from a large preclinical rat study that demonstrated ARG-007 significantly reduced axonal injury and neuroinflammation caused by moderate traumatic brain injury.
The company shared in May the granting of a new US patent covers the use of Argenica’s neuroprotective peptides in treating surgery patients at risk of suffering cerebral ischaemia or stroke, expanding the scope of its parent patent. In the release, Argenica also stated results from its Phase 2 clinical trial are expected in Q3 of this year.
Year-to-date gain: 6 percent
Market cap: AU$42.68 million
Share price: AU$0.053
Prescient Therapeutics is a clinical-stage oncology company developing personalized medicines, including targeted and cellular therapies. The company has built an extensive pipeline of later-stage and emerging assets in next generation targeted and cellular therapies and spanning a range of different cancers.
Prescient has the exclusive rights to the cell therapy platform technologies OmniCAR and CellPryme. Additionally, its lead drug candidate is PTX-100, a compound that can block an important cancer growth enzyme. The company is developing PTX-100 to treat cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin lymphoma that primarily affects the skin.
In mid-April, the US Food and Drug Administration granted Prescient’s PTX-100 fast-track designation for the treatment of adults with relapsed or refractory mycosis fungoides, the most common subtype of CTCL.
The company reached another significant milestone in May when its first patient was dosed in its Phase 2a study for PTX-100 for refractory or relapsed CTCL. The study plans to recruit patients in Australia, the US and Europe.
Shares in Prescient Therapeutics reached a year-to-date high of AU$0.06 for the first time on January 23 and most recently on June 10.
Don't forget to follow us @INN_Australiafor real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
At Web Summit Vancouver, experts speaking on the panel "A History of the Future of Healthcare" delivered a striking message: medicine is moving faster than ever, but it's not fast enough.
This paradox set the stage for a discussion about the transformation of healthcare via artificial intelligence (AI).
While many industries have been completely revolutionized by technology, the healthcare sector has often lagged, clinging to outdated practices. However, the participants agreed that AI is beginning to change that narrative, offering promising solutions and a glimpse into a future of personalized, efficient and proactive care.
As mentioned, panelists noted that while technology has transformed nearly every sector of modern life, healthcare still largely operates on practices that have seen little change for decades.
“The moment of physician-to-patient interaction, the physical examination, literally has hardly changed in the past 200 years,” said moderator Ohad Arazi, setting the stage for a talk about what healthcare could look like in 2030.
“Of course, many things in healthcare have changed, but it's been a very slow slog. And yet we see that the pace of change, the pace of adoption of innovation on both therapeutics and diagnostics, is accelerating.”
Lu Zhang, founder of Fusion Fund, highlighted that healthcare is now entering its “prime time for innovation,” emphasizing that the core goal for the future is to "improve the quality of life, to really enable the future of healthcare to be personalized … and also be able to do super early diagnostics and reduce the healthcare burden in the long term."
Zhang pointed to advances in AI-powered digital diagnostics for conditions like cancer, heart disease and mental health, citing the recent launch of the Arc Institute's Evo 2 AI model, designed to understand and generate genetic code.
Arc researchers recently published a preprint showing that their gene-editing technology can implement broad alterations to the human genome, something not achievable with other gene-editing techniques.
She also mentioned the promise of new digital therapeutics and regenerative medicine, noting a recent exhibition where researchers showcased 3 centimeters of beating heart tissue created from iPS cells.
These kinds of innovations could transform how practitioners approach health and wellness. Eric Hoskins, partner at Maverix Private Equity, offered a more cautious but ultimately optimistic perspective, identifying AI-guided personalized medicine as one of the “fast movers” poised to bring an abrupt and immediate change to healthcare.
However, the consensus was that challenges remain, particularly when it comes to navigating the regulatory landscape and addressing persistent data isolation issues within healthcare.
Dr. Victoria Lee, a physician and prominent leader in Canadian healthcare who previously served as president and CEO of the Fraser Health Authority, called for a decisive shift from a reactive “sickness care” model to a more proactive, AI-augmented model focused on prevention, personalization and long-term wellbeing.
She asserted that healthcare's massive data output (30 percent of global data) is an underutilized resource.
Zhang agreed, adding that less than 5 percent of that data is currently being used. This is primarily due to privacy compliance concerns, which could also be mitigated by the use of AI.
Coupled with a global healthcare worker shortage, Lee presented AI as the crucial enabler for this transformation, arguing that it is indispensable for improving both the efficiency of healthcare operations and the effectiveness of medical professionals in an era of exploding medical knowledge. Her most compelling vision is the implementation of precision wellbeing through digital twins and AI agents.
AI is already being used to personalize cancer treatment and reduce travel barriers via distributed platforms. A separate panel featuring James Lumsdaine, CEO of healthtech company Avitia, showcased the company’s AI-powered molecular diagnostics platform, which supports distributed cancer testing through simple blood draws. The technology has already been deployed in seven countries and has processed over 40,000 tests.
The platform, validated in Canada, the Middle East and Southeast Asia, reduces treatment times from weeks to days, improving patient outcomes and quality of life. Avitia's initiative aims to make cancer a manageable chronic condition, advocating for better access to precision care and advanced diagnostics at or near the patient's point of care.
“The ability of a patient to get personalized care for their cancer is now no longer limited by their ability to travel and where they're based,” Lumsdaine explained, laying out his vision for the company’s role in therapeutic innovation.
As transformative as AI-driven healthcare could be, scaling breakthroughs requires investment and infrastructure alongside regulatory evolution. During opening remarks at Web Summit, AI researcher and author Gary Marcus said biology is a natural fit for AI, especially in protein interaction modeling and drug development.
At the "Smart Money in 2025" panel, Wesley Chan of FPV Ventures also pointed to the life science space as a sector where AI has the clearest potential to deliver real-world productivity gains.
He argued that the convergence of biology and AI represents a generational opportunity for investors, citing companies like Strand Therapeutics, which used AI to develop a new mRNA cancer therapy.
Tom Beigala, founding partner at Bison Ventures, told journalist Anne Gaviola, moderator at the “The Healthtech Investment Checkup” panel, that he believes AI and next-generation computational technologies are driving innovation across the entire healthcare system, from making drug discovery easier and more cost effective, to optimizing data utilization and significantly increasing labor and clinical productivity.
Bison invests in early stage frontier tech companies, and its portfolio spans AI-enhanced drug discovery, advanced life science tools for pre-clinical testing and synthetic biology applications addressing broader public health challenges.
Outside AI, Beigala revealed his interest in the field of non-invasive cancer surgery using focused ultrasound technology. This burgeoning field uses technology that is often enhanced by AI for precision targeting. He pointed to an unnamed company rumored to be in acquisition discussions for a multibillion-dollar valuation.
For her part, Zhang highlighted Fusion Fund’s focus on AI-powered healthcare solutions that enhance workflow efficiency. She also pointed to physical AI, particularly surgical robots, as a promising area within healthcare, noting its potential to enable more non-invasive and micro-invasive surgical approaches.
But while the opportunity landscape is expanding, panelists emphasized that deploying these innovations successfully requires a clear-eyed understanding of the healthcare system’s structural complexity.
Beigala underscored that successful AI applications in healthtech require a deep understanding of the healthcare system's existing incentives and workflows, including how doctors bill and how insurance companies operate.
He also cautioned that AI, as merely a tool, must be strategically integrated to avoid unintended consequences and to ensure that it genuinely fits within established practices.
Beyond those challenges, Zhang touched upon external regulatory hurdles, citing the US Food and Drug Administration's current processes as a significant hurdle for innovation and market entry. However, she expressed optimism that the agency's exploration of AI could eventually accelerate and streamline the approval process.
The promise of AI to revolutionize healthcare is undeniable, but it’s solely a matter of technological development.
The conversations at Web Summit were a reminder that the future of healthcare also requires collaboration, trust and data governance. Together, these elements can pave the way for a healthcare landscape profoundly reshaped by AI.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.