
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
Cardiex is trailblazing the health technology industry through its innovative solutions that are transforming cardiovascular health care.
Cardiex Limited (ASX:CDX) is an ASX-listed medical technology company leveraging its proprietary SphygmoCor® technology to develop and market vascular biomarker technologies and digital solutions focused on the world’s largest health disorders. The company’s groundbreaking technology – SphygmoCor® – set the benchmark for noninvasive measurement of central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
While measuring arterial health parameters has always been considered clinically beneficial, it was not considered for routine out-patient clinical use as it previously required an invasive catheterization procedure with a pressure sensor inserted into the aorta. Founded on 40 years of hemodynamics studies and backed by 20+ years of research, Cardiex’s SphygmoCor technology employs non-invasive techniques to assess "central aortic waveforms," offering valuable insights into various clinically significant arterial health parameters including arterial stiffness, central blood pressure (the pressure at the heart), pulse pressure, and crucial indicators of vascular health for major organs such as the heart, brain and kidneys.
Assessing central blood pressure directly at the heart is deemed superior to conventional blood pressure measurements taken at the arm, primarily owing to the heart's proximity to vital organs. Cardiex’s FDA-cleared devices replace traditional blood pressure technology for first-line screening and monitoring of arterial health status. The unique physiologic insights from the company’s devices provide clinically relevant information that helps guide treatment decisions and offers profound benefits for all members of the healthcare community:
For Healthcare Providers: Enable physicians to make more informed treatment decisions based on clinically relevant vascular health data.
For Patients: Give patients the tools to make better decisions about their own health.
For Pharmaceutical Companies: Generate reliable, real-world, clinically relevant data to accelerate drug development and commercialization.
For more than two decades, the company’s SphygmoCor technology has set the benchmark for vascular biomarker assessments, adopted by premier hospitals and pharmaceutical giants worldwide. SphygmoCor is the chosen technology for measuring central blood pressure in all of the "top 20 hospitals" in the US and has played a crucial role in the clinical trials of leading firms including Bayer, AstraZeneca, Roche, Novartis and GlaxoSmithKline.
Between 2002 and 2023, CDX received five FDA clearances, the latest for the CONNEQT Pulse, a first-of-its-kind connected vascular biometrics monitor.
Cardiex devices have previously been sold and used exclusively in clinical settings – principally by specialist clinicians, for research, and by pharmaceutical companies for drug assessment.
The introduction of CONNEQT Pulse represents a significant shift for Cardiex, allowing the company to enter the connected care market and transition from niche segments to the mass healthcare market. Priced comparably to a home health monitor, the CONNEQT Pulse is positioned for widespread adoption and can be deployed at scale in general healthcare practices, homes, or any location where patients are present.
The CONNEQT Pulse will also bolster Cardiex's portfolio in clinical trial solutions with the introduction of a decentralized clinical trial (DCT) platform. The Cardiex DCT platform empowers clinical trial managers to remotely monitor thousands of patients in their homes, enabling pharmaceutical companies to more effectively evaluate potential vascular outcomes across various trial phases. This leads to increased efficiency and cost-effectiveness in trial outcomes.
Furthermore, in response to the growing demand for proactive health monitoring, Cardiex will be launching an innovative wrist-worn device that leverages the SphygmoCor technology to deliver a medical grade wearable with capabilities far beyond conventional health trackers. The CONNEQT Band will be a wearable “cuffless” device designed to monitor vascular health in patients as well as to provide general health insights to consumers.
Cardiex’s goal is to establish a holistic ecosystem that promotes cardiovascular well-being and empowers users to proactively manage their health as an integral part of individuals' health routines, contributing to a paradigm shift in preventive cardiovascular care.
The company’s first-mover advantage and exclusive technology FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics grant it a distinctive market position. CDX recently secured AU$14 million in funding, which is enough to steer the company towards profitability.
With the entry into the connected care home market with the CONNEQT Pulse, CDX is transitioning towards a recurring revenue model based on monthly subscription fees. This should excite investors, given that the recurring revenue model will receive a higher multiple by the market, thereby boosting the company's valuation.
CONNEQT is focused on devices and solutions for home health, remote patient monitoring, and decentralized clinical trials. Cardiex offers two devices under the CONNEQT brand – the recently FDA-cleared CONNEQT Pulse and the upcoming CONNEQT Band wearable. The company estimates CONNEQT’s total addressable market opportunity to be nearly $283 billion across three markets – remote patient monitoring ($175 billion), health wearables ($104 billion), and decentralized clinical trials ($14 billion).
CONNEQT Pulse: The CONNEQT Pulse provides measurements of both central and brachial blood pressures, alongside vascular biomarkers reflecting arterial stiffness and overall vascular health—metrics once exclusively only available to specialist clinics, research, and pharmaceutical companies. As a Bluetooth-enabled device, it empowers patients and health enthusiasts to track their arterial health from home, employing the same advanced tools used by top cardiologists in research centers and clinics.
Physicians can prescribe the CONNEQT Pulse to patients requiring heart health monitoring. Patient data seamlessly integrates with the CONNEQT Patient Management Portal (CPMP), a HIPAA-compliant cloud-based tool that enables healthcare providers to remotely track patients' arterial health by way of a tablet. Furthermore, consumers and patients can access comprehensive arterial health insights, coaching, lifestyle programs, and additional health resources via the CONNEQT app.
CONNEQT Band: CONNEQT Band is a world's-first dual sensor arterial health wearable device featuring an innovative design with dual (wrist-and finger-based) photoplethysmography (PPG) optical sensors. The wrist-based sensor continuously captures physiological data such as heart rate, respiration, stress, activity, sleep, and pulse oximetry, while our patented on-demand finger-based side sensor uniquely derives clinically meaningful vascular biomarkers representing arterial stiffness and cardiovascular health.
By combining data from both sensors, the CONNEQT Band offers users a comprehensive view of their overall cardiovascular health which has never been available outside of a physician’s office. The CONNEQT Band is also supported by the CONNEQT app, available for both iOS and Android devices, which serves as a hub where users can easily access detailed reports, track their progress over time, explore content, and receive personalized health insights and recommendations.
The CONNEQT Band is currently in the process of FDA submission preparation. This innovative device is poised to extend the company's portfolio in connected health technology, offering users a new, user-friendly tool for monitoring their health metrics. With its cutting-edge features, the CONNEQT Band is expected to make a significant impact in the way individuals manage their wellness, bridging the gap between advanced health monitoring and everyday convenience.
A significant global market opportunity in wearable health devices is driven by nearly 1.3 billion hypertensive and other vascular disease patients. Some of the other wearable device firms have attracted significant funding at high valuations in recent times. For instance, Oura Health, a Finnish company that makes smart rings for tracking sleep and physical activity, was valued at $2.55 billion in April 2022.
Craig Cooper has established numerous prosperous health, digital media, technology and wellness ventures. Notably, he co-founded Boost Mobile, a prominent telecommunications company recognized as one of the leading mobile phone businesses in the USA. He is acknowledged as a distinguished authority and influential figure on a global scale in mobile and wireless technology, as well as businesses related to digital health and medical technology. His venture capital endeavors have secured over AU$3 billion, financing some of the most impactful global digital media technology companies. Cooper is also a principal of C2 Ventures, Cardiex’s largest shareholder.
Niall Cairns boasts a successful 25-year record of investing in both private and public companies. He has played a pivotal role in advancing the global expansion of more than 50 enterprises spanning various sectors, including digital media, agtech, medtech, consumer internet, and SaaS-based businesses. Cairns is also a principal of C2 Ventures, Cardiex’s largest shareholder.
King Nelson brings over 30 years of extensive experience in medical devices. He was previously the president and CEO at Uptake Medical Corporation, concentrating on treatments for emphysema and lung cancer. Before Uptake, he served as president and CEO of Kerberos Proximal Solutions, a company later acquired by FoxHollow Technologies. He was also president and CEO of VenPro, a heart valve business acquired by Medtronic. King also accumulated 19 years of experience with Baxter International and American Hospital Supply Corporation, progressing through various roles with increasing responsibilities. These roles included serving as division president for Dade Diagnostics, Bentley Labs, and Baxter’s Perfusion Services. Nelson is currently the CEO at Q’Apel Medical, a medical device company specializing in neurovascular disease.
Charlie Taylor has over three decades of international advisory experience and recently concluded his tenure as senior partner at McKinsey, where he oversaw the health and public sector practice. Taylor has counseled numerous private and public sector healthcare organizations in Australia and globally, covering areas such as strategy, digitalization, operational enhancements, growth transformations, international expansion, supply chain management, mergers and acquisitions, and board governance. He is a non-executive director of Healius, a leading Australian health diagnostics company, and a part-time senior board advisor at McKinsey for the health and public sector practice.
Dr. Sanjeev Bhavnani has served as a senior medical officer at the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health (CDRH), overseeing clinical and scientific initiatives concerning digital health and medical devices incorporating artificial intelligence.
Bhavnani is also currently a senior cardiologist and principal investigator of digital health and machine learning at Scripps Clinic in San Diego, California, where he leads programs to develop and validate new technologies and to evaluate the safety and effectiveness of DHTs, nanosensors, cloud-based analytical platforms, handheld imaging technologies, AI/ML algorithms and software as a medical device. For over a decade, Bhavnani was the principal investigator of 90 clinical trials and patient care programs. These programs have enrolled over 30,000 patients in the US and in resource-limited areas. His team developed the SMART-FHIR integration interface for DHT data into EMRs for remote patient monitoring, remote therapeutic monitoring, and chronic care management, creating a real-world data platform to monitor the healthcare quality of DHT and ML devices in traditional and new consumer models of care delivery.
Catherine Liao has served as our chief strategy officer since September 2022. Previously, Liao served as chief executive officer of Blumio, a pioneering medical device startup, from February 2016 to September 2022, where she led efforts in raising capital, formed a leadership and advisory board rich in knowledge spanning healthcare innovations, enterprise technology, and sensor technology. Her notable achievements include leading the commercialization of a groundbreaking medical radar sensor development platform, which garnered significant industry attention and was eventually acquired by Cardiex. Liao holds an MBA from Imperial College London and a Master of Science in Health Economics from the London School of Economics. These credentials underscore her deep and comprehensive insight into the intricacies of both the business world and the healthcare sector, demonstrating a balanced expertise critical for navigating and innovating within today’s complex healthcare economies.
Dr. Mark Gorelick has served as Cardiex’s chief product officer since December 2020, bringing a wealth of experience from various leadership roles in the health and wellness technology sector. With an impressive tenure beginning in 2007, he has been at the helm as managing director of XPhys Technologies, a company at the forefront of developing innovative fitness, health, and wellness products. His strategic vision was further demonstrated through his role as vice-president of Digital Health, from 2018 to 2019, at Performance Lab Technologies, acclaimed for its software development prowess in the health sector. Further cementing his reputation in health technology, Gorelick served as the chief science officer at PAI Health (originally Mio Global) from 2015 to 2018, where he was instrumental in advancing health technology software solutions. Holding a BSc and MSc in kinesiology from Dalhousie University and a Ph.D. in biomedical science from University of Wollongong, Gorelick’s educational background underscores his deep-rooted understanding and innovative approach to biomedical science and kinesiology, reinforcing his invaluable contribution to our company and the broader health technology landscape.
Biomarker technologies and digital solutions to address the world’s largest health disorders.
Thanks to exchange-traded funds (ETFs), investors don’t have to be tied to one specific stock. When it comes to biotech ETFs, they give sector participants exposure to many biotech companies via one vehicle.
ETFs are a popular choice as they allow investors to enter the market more safely compared to investing in standalone stocks. A key advantage is that even if one company in the ETF takes a hit, the impact will be less direct.
Below the Investing News Network takes a look at five small-cap biotech ETFs. The funds were selected using ETFdb.com, and only ETFs with total assets under management (AUM) under US$100 million as of June 30, 2025, were considered.
All other figures were also current as of that date. Read on to learn more about these investment vehicles.
AUM: US$81.2 million
Launched in December 2014, the ALPS Medical Breakthroughs ETF tracks small- and mid-cap biotech stocks that have one or more drugs in either Phase II or Phase III US FDA clinical trials. Its holdings must have a market cap between US$200 million and US$5 billion.
There are 104 holdings in this biotechnology fund, with about 50 percent being small- and micro-cap stocks. Its top holdings include Nuvalent (NASDAQ:NUVL) at a weight of 3.55 percent, Axsome Therapeutics (NASDAQ:AXSM) at 3.42 percent and Alkermes (NASDAQ:ALKS) at 3.18 percent.
AUM: US$72.18 million
The Tema Oncology ETF provides exposure to biotech companies operating in the oncology industry. It includes companies developing a range of cancer treatments, including CAR-T cell therapies and bispecific antibodies.
Launched in August 2023, there are 51 holdings in this biotechnology fund, of which about half are small- to mid-cap stocks. Among its top holdings are Roche Holding (OTCQX:RHHBF,SWX:RO) at a weight of 5.32 percent, Eli Lilly and Company (NYSE:LLY) at 5.19 percent and BridgeBio Pharma (NASDAQ:BBIO) at 4.88 percent.
AUM: US$52.8 million
The Direxion Daily S&P Biotech Bear 3x Shares ETF is designed to provide three times the daily return of the inverse of the S&P Biotechnology Select Industry Index, meaning that the ETF rises in value when the index falls and falls in value when the index rises. Leveraged inverse ETFs are designed for short-term trading and are not suitable for holding long-term. They also carry a high degree of risk as they can be significantly affected by market volatility.
Unlike the other ETFs on this list, LABD achieves its investment objective through holding financial contracts such as futures rather than holding individual stocks.
AUM: US$50.83 million
Launched in November 2023, the Tema GLP-1 Obesity and Cardiometabolic ETF tracks biotech stocks with a focus on diabetes, obesity and cardiovascular diseases. The fund was renamed on March 25 from Tema Cardiovascular and Metabolic ETF, and again on June 27 from the GLP-1 Obesity and Cardiometabolic ETF.
There are 47 holdings in this biotechnology fund, with about 75 percent being large-cap stocks and 18 percent mid-cap. About three-quarters of its holdings are based in the US. Its top holdings are Eli Lilly and Company at a 9.78 percent weight, Abbott Laboratories (NYSE:ABT) at 4.58 percent and Novo Nordisk (NYSE:NVO) at 4.42 percent.
AUM: US$47 million
The ProShares Ultra NASDAQ Biotechnology ETF was launched in April 2010 and is leveraged to offer twice daily long exposure to the broad-based NASDAQ Biotechnology Index, making it an ideal choice “for investors with a bullish short-term outlook for biotechnology or pharmaceutical companies.” However, analysts also advise investors with a low risk tolerance or a buy-and-hold strategy against investing in this fund due to its unique nature.
Of the 262 holdings in this ETF, the top biotech stocks are Gilead Sciences (NASDAQ:GILD) at a 5.57 percent weight, Vertex Pharmaceuticals (NASDAQ:VRTX) at 5.53 percent and Amgen (NASDAQ:AMGN) at 5.33 percent.
This is an updated version of an article originally published by the Investing News Network in 2015.
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.
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
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 Limited in 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 Limited and 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.
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Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.