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05 December 2024
Cardiex Limited
Investor Insight
Cardiex is trailblazing the health technology industry through its innovative solutions that are transforming cardiovascular health care.
Overview
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.
Company Highlights
- Cardiex Limited is an ASX-listed medical technology company that develops and markets vascular biomarker technologies and digital solutions for the world’s largest health disorders.
- The company’s offerings encompass FDA-cleared medical and home health devices alongside digital solutions tailored for managing health and wellness, delivering unique physiologic insights that inform clinical treatment decisions.
- The company’s groundbreaking technology – named SphygmoCor® – set the benchmark for measuring central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
- These biomarkers, extensively researched and detailed in numerous peer-reviewed journals, assess cardiovascular risk and guide disease management by predicting organ damage (such as the heart, brain, and kidneys) and outcomes (including heart failure, ischemic heart disease, and stroke), significantly influencing disease prognosis and clinical treatment.
- CDX received five FDA clearances from 2002 to 2023, the most recent for the CONNEQT Pulse, a world-first connected vascular biometric monitor. The CONNEQT Pulse targets new and significant healthcare channels and transitions the company towards a recurring revenue model based on monthly subscription fees.
- CDX's technology is uniquely FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics – thereby granting it a distinctive competitive market position. With a significant funding round recently secured, CDX is poised for profitability ahead.
- CDX more than doubled its annual company revenue and other income to $12.4 million in 2024, compared to $6 million in 2023.
Products and Solutions
CONNEQT
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.
Board of Directors and Management
Craig Cooper – Chief Executive Officer and Executive Director
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 - Executive Chairman
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 – Non-executive Director
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 – Non-executive Director
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.
Sanjeev Bhavnani – Chief Clinical Officer
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 – Chief Strategy Officer
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.
Mark Gorelick – Chief Product Officer
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.
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Biomarker technologies and digital solutions to address the world’s largest health disorders.
05 June
Offer Booklet - Non-Renounceable Entitlement Offer
02 June
Cardiex Receives TGA Approval for CONNEQT Pulse Device
30 May
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Orphan Drug Designation Granted by U.S. FDA for Anal Cancer
12 August
Top 5 Small-cap Biotech Stocks of 2025
The NASDAQ Biotechnology Index (INDEXNASDAQ:NBI) is trading at three year highs despite market volatility, responding to breakthrough innovations and increased deals involving NASDAQ biotech stocks.
After dropping to a low of 3,637.05 in October 2023, the index climbed to a nearly three year peak of 4,954.813 on September 19, 2024. While the index had pulled back to 4,530.69 as of August 5, 2025, further growth could be in store.
According to a Towards Healthcare analyst report, the global biotech market is expected to grow at a compound annual growth rate of 12.5 percent from now to 2034, reaching a valuation of US$5.04 trillion.
Driving that growth will be favorable government policies, investment in the sector, increased demand for synthetic biology and a rise in chronic disorders such as cancer, heart disease and hypertension.
The top NASDAQ biotech stocks have seen sizeable share price increases over the past year. For those interested in investing in biotech companies, the best-performing small-cap biotech stocks are outlined below.
Data was gathered on August 5, 2025, using TradingView’s stock screener. Small-cap biotech stocks with market caps between US$50 million and US$500 million at that time were considered for this list.
1. Tiziana Life Sciences (NASDAQ:TLSA)
Year-to-date gain: 227.8 percent
Market cap: US$256.36 million
Share price: US$2.26
Tiziana Life Sciences is a clinical-stage biopharma which is developing therapies for autoimmune and inflammatory diseases, degenerative diseases, and cancer-related to the liver. Its pipeline of candidates is built on its patent drug delivery technology that provides a possible alternative to intravenous delivery.
Tiziana’s lead candidate is intranasal foralumab, a fully human anti-CD3 monoclonal antibody.
Tiziana Life Sciences shares hit US$1.69 on March 7 after the company filed an investigational new drug application with the US Food and Drug Administration (FDA) for a Phase 2 clinical trial in amyotrophic lateral sclerosis (ALS), which is supported by the ALS Association. However, by early April it had fallen back to US$0.78 per share.
Positive news flow later in the spring gave Tiziana shares another boost. In April, John Hopkins University and the University of Massachusetts commenced dosing of the biotech company's intranasal foralumab in Phase 2 trials for patients with non-active secondary progressive multiple sclerosis. On May 7, the company shared positive results from the use of its lead candidate in improving the quality of life for patients with that form of multiple sclerosis.
Tiziana is also studying the use of intranasal foralumab for treating moderate Alzheimer’s disease. On May 9, it announced that PET scans of a patient with moderate Alzheimer's showed a significant reduction in microglia activation associated with neuroinflammation after three months of treatment.
Shares of Tiziana reached US$1.62 on May 13. On July 21, the company announced an "unexpected discovery" following immunologic analysis of the patient with Alzheimer's disease:
"In an unexpected discovery, the analysis revealed an increase in phagocytosis markers in classical monocytes, suggesting that nasal foralumab may enhance their ability to clear amyloid plaques. This unexpected effect may open new avenues for treating Alzheimer’s Disease by targeting both inflammation and amyloid accumulation."
Tiziana shares climbed through the remainder of the month, hitting a year-to-date high of US$2.50 on July 31.
2. Palvella Therapeutics (NASDAQ:PVLA)
Year-to-date gain: 224.98 percent
Market cap: US$416.08 million
Share price: US$37.64
Palvella Therapeutics is a clinical-stage biopharma developing treatments targeting rare genetic skin diseases for which there are no FDA-approved therapies. Its pipeline centers on its patented QTORIN platform, which has an initial focus on rare genetic skin diseases. Its lead product candidate, QTORIN rapamycin, is currently in a Phase 2 clinical trial in cutaneous venous malformations, and a Phase 3 clinical trial in microcystic lymphatic malformations (LM).
QTORIN rapamycin has been granted breakthrough therapy designation, orphan drug designation and fast-track designation from the FDA for the treatment of microcystic LMs.
After starting the year at US$12, shares of Palvella had surged to US$20.99 by February 18. About a week earlier, the company had shared plans to expand the Phase 3 trial to include pediatric patients from three to five years of age. That momentum in Palvella's share price continued to rally to US$29 per share on March 13.
June produced a number of significant milestones for Palvella. On June 9, the company received initial proceeds from a grant issued by the FDA Office of Orphan Products Development for its Phase 3 trial, and on June 23, it completed enrollment for the trial with 51 subjects, 25 percent over its target.
The company closed out the month with news that it had been added to the broad-market Russell 3000 Index (INDEXRUSSELL:RUA) and the Russell 2000 Index (INDEXRUSSELL:RUT).
The company said it remains on track to deliver top-line Phase 3 data in Q1 2026 to support its planned new drug application submission later that year. While the company didn't release news in July, its share price climbed significantly through the month to hit a year-to-date high of US$39.87 on July 28.
3. OKYO Pharma (NASDAQ:OKYO)
Year-to-date gain: 163.03 percent
Market cap: US$117.35 million
Share price: US$3.13
OKYO Pharma is a clinical-stage biopharma developing therapies for the treatment of neuropathic corneal pain and dry eye disease. Its lead candidate is urcosimod, a non-steroidal anti-inflammatory and non-opioid analgesic.
So far in 2025, the company has achieved multiple milestones related to its Phase 2 trial of urcosimod for treatment of neuropathic corneal pain. On April 30, OKYO announced plans to end the trial early to analyze the data from the patients who had completed the trial, with the goal of accelerating its clinical development and expanding the program.
Supporting the decision was the fact that urcosimod had previously demonstrated safety in OKYO's completed Phase 2 trial of the candidate to treat patients with dry eye disease.
The next day, news broke that the FDA granted urcosimod fast-track designation for the treatment of neuropathic corneal pain. OKYO's stock price reached US$1.57 on May 1.
On July 17, OKYO posted strong top-line data from its Phase 2 clinical trial, and stated it is planning a meeting with the FDA to discuss next steps for its lead drug candidate. The following day, OKYO received US$1.9 million in non-dilutive funding to support its clinical development of urcosimod.
Shares of OKYO hit a year-to-date high of US$3.17 on August 5.
4. IO Biotech (NASDAQ:IOBT)
Year-to-date gain: 129.47 percent
Market cap: US$144.28 million
Share price: US$2.16
IO Biotech is developing immune-modulating therapeutic cancer vaccines based on its T-win technology platform, designed to activate T cells to target both tumor cells and the immune-suppressive cells.
The clinical-stage biopharmaceutical company's lead cancer vaccine candidate, IO102-IO103, which has the brand name Cylembio, is currently in clinical trials. IO102-IO103 has breakthrough therapy designation from the FDA when used in combination with Merck's (NYSE:MRK) anti-PD-1 therapy KEYTRUDA for the treatment of advanced melanoma based on positive Phase 1/2 first line metastatic melanoma data.
At the start of the year, IO Biotech completed enrollment in its Phase 2 trial of IO102-IO103 with KEYTRUDA as a treatment given before and after surgery for resectable melanoma or head and neck cancer.
On February 4, the company published results from a preclinical study of its second immune-modulatory therapeutic cancer vaccine candidate, IO112, targeting arginase 1, which plays a key role in immune suppression.
In mid-March, IO Biotech was named to Fast Company’s list of the world’s most innovative companies of 2025.
The following month, the company presented new preclinical data for its lead candidate IO102-IO103, as well as IO170, which targets transforming growth factor beta. In its Q1 financial results and business highlights, released on May 14, IO Biotech shared that a readout of primary endpoint data from its pivotal Phase 3 trial of its lead investigational therapeutic cancer vaccine in patients with advanced melanoma is expected in the third quarter of 2025.
Shares of IO Biotech reached a year-to-date high of US$2.40 on July 28.
5. Spero Therapeutics (NASDAQ:SPRO)
Year-to-date gain: 110.95 percent
Market cap: US$124.12 million
Share price: US$2.22
Spero Therapeutics is developing novel treatments for rare diseases and multi-drug resistant bacterial infections with high unmet need. The company’s lead drug candidate is tebipenem pivoxil hydrobromide (HBr), a late-stage development asset developed in collaboration with pharma giant GSK (NYSE:GSK).
HBr is used to treat complicated urinary tract infections (cUTIs), including pyelonephritis. Spero has an exclusive license agreement with GSK for the development and commercialization of the drug candidate in all ex-Asia markets. The FDA has granted tebipenem HBr qualified infectious disease product and fast-track designations.
Shares of Spero traded below US$1 for much of the first half of 2025. However, the stock surged 245 percent on May 28 to reach US$2.35 after Spero reported that its Phase 3 trial evaluating tebipenem HBr for treating cUTIs met its primary endpoint and stopped early for efficacy. GSK plans to include the findings in a filing to the FDA during H2.
Spero shares reached a year-to-date high of US$3.04 on July 9.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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12 August
SVN-SDN-14 PTSD Programme - Positive pre-clinical results with three high-performing candidates advancing to in vivo studies
Solvonis Therapeutics plc (LSE: SVNS), a clinical-stage biopharmaceutical company developing novel medicines for addiction and mental health disorders, today announces positive results from pre-clinical screening in its SVN-SDN-14 programme, identifying three high-performing candidates to advance into in vivo studies.
The SVN-SDN-14 series is a novel class of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET") modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with Post-Traumatic Stress Disorder ("PTSD"), which the Company estimates affects over 20 million people across UK, US, and main EU markets. By modulating neurochemical pathways associated with trust, empathy, and social bonding, these compounds aim to help patients rebuild interpersonal relationships, reduce social isolation, and engage more effectively in therapy.
In-vitro screening for SERT, DAT, and NET modulation activity identified three of six synthesised candidates with robust, balanced modulation profiles across all three neurotransmitter systems. These are precisely the mechanistic attributes the programme is targeting to deliver a new class of medicine for trauma-related mental health conditions such as PTSD.
While the Company had previously anticipated selecting a single lead candidate at this stage, the positive performance of three candidates has delivered an optimal outcome - a strong, competitive shortlist with multiple best-in-class contenders. This outcome increases optionality, strengthens the dataset and enhances the probability of selecting a best-in-class candidate with strong commercial potential.
The three shortlisted candidates will now advance to the final stage of the current work package - in vivo preclinical studies.
Professor David Nutt, Chief Scientific Officer of Solvonis, commented: "It is encouraging to see three candidates with equally strong, balanced SERT, DAT, and NET modulation profiles. This gives us a solid basis from which to make an informed choice. The in vivo data will enable us to select the candidate with the best potential to advance as a new treatment option for PTSD."
Anthony Tennyson, Chief Executive Officer of Solvonis, added: "These results represent an important step forward for the programme. Having three high-performing candidates at this stage, rather than a single clear lead, provides us with greater flexibility and a stronger position from which to select the most promising option for PTSD."
Enquiries:
Solvonis Therapeutics plc (LEI: 2138005PH7OJRCRPUD88)
Anthony Tennyson, CEO & Executive Director
anthony@solvonis.com
Allenby Capital Limited (Financial Adviser and Joint Broker)
Nick Naylor / Nick Athanas / Ashur Joseph (Corporate Finance)
Guy McDougall (Sales & Corporate Broking)
+44 (0) 20 3328 5656
Singer Capital Markets (Joint Broker)
Phil Davies
+44 (0) 20 7496 3000
About Solvonis Therapeutics plc
Solvonis Therapeutics plc (LSE: SVNS) is a clinical-stage biopharmaceutical company developing novel medicines for addiction and mental health disorders. Headquartered in London and listed on the main market of the London Stock Exchange, Solvonis is advancing a differentiated pipeline of repurposed and novel compounds targeting high-burden neuropsychiatric conditions with significant unmet need.
The Company's lead programmes address Alcohol Use Disorder ("AUD") and Post-Traumatic Stress Disorder ("PTSD")-conditions affecting over 80 million people across the UK, US, and EU4. Its lead asset, SVN-001, is currently in Phase 3 for severe AUD in Europe and the UK. SVN-002 is preparing for a Phase 2b trial in the US targeting moderate to severe AUD. Solvonis also has a preclinical PTSD programme leveraging novel serotonin-dopamine modulators designed to enhance pro-social behaviour and long-term outcomes.
In addition, Solvonis is advancing an AI-supported discovery platform built on a proprietary CNS compound library, with initial focus on depression and stimulant use disorders. This initiative expands the Company's R&D pipeline into earlier-stage innovation while maintaining strategic focus on comorbid and underserved neuropsychiatric conditions.
With a capital-efficient model, dual development strategy, and near-term partnering opportunities, Solvonis is positioned to generate value through innovation in neuropsychiatry.
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11 August
New Harvard Study Links Lithium Deficiency to Alzheimer’s
Lithium, a naturally occurring trace element in the brain, may be able to unlock a key medical mystery: why some people develop Alzheimer’s disease and others don’t, despite similar brain changes.
In a recently published study, scientists at Harvard Medical School state that lithium not only exists in the human brain at biologically meaningful levels, but also appears to protect against neurodegeneration.
Additionally, their work shows that lithium supports the function of all major brain cell types.
The decade-long study drew on mouse experiments and analyses of human brain and blood samples across the spectrum of cognitive health. The Harvard team discovered that as amyloid beta, the sticky protein associated with Alzheimer’s, begins to accumulate, it binds to lithium and depletes its availability in the brain. This drop in lithium impairs neurons, glial cells and other brain structures, accelerating memory loss and disease progression.
“The idea that lithium deficiency could be a cause of Alzheimer’s disease is new and suggests a different therapeutic approach,” said Bruce Yankner, who is the senior author of the study.
Yankner, a professor of genetics and neurology at Harvard Medical School who in the 1990s was the first to show that amyloid beta is toxic to nerve cells, said the new findings open the door to treatments that address the disease in its entirety, rather than targeting single features like amyloid plaques or tau tangles.
To explore this possibility, researchers screened for lithium compounds that could evade capture by amyloid beta.
They identified lithium orotate as the most promising candidate. In mice, the compound reversed Alzheimer’s-like brain changes, prevented cell damage and restored memory, even in animals with advanced disease.
Crucially, the effective dose was about one-thousandth of that used in psychiatric treatments, avoiding the toxicity risk that has hampered lithium’s clinical use in older patients.
“You have to be careful about extrapolating from mouse models, and you never know until you try it in a controlled human clinical trial,” Yankner cautioned. “But so far the results are very encouraging.”
The path to these findings began with access to an unusually rich source of brain tissue.
Working with the Rush Memory and Aging Project in Chicago, the team examined postmortem samples from thousands of donors, from cognitively healthy individuals to those with mild cognitive impairment and full-blown Alzheimer’s.
Using advanced mass spectrometry, they measured trace levels of about 30 metals. Lithium stood out as the only one whose levels dropped sharply at the earliest stages of memory loss.
The pattern matched earlier population studies linking higher environmental lithium levels, including in drinking water, to lower dementia rates. But unlike those correlations, the Harvard team directly measured brain lithium and established a normal range for healthy individuals who had never taken lithium as medication.
“Lithium turns out to be like other nutrients we get from the environment, such as iron and vitamin C,” Yankner said. “It’s the first time anyone’s shown that lithium exists at a natural level that’s biologically meaningful without giving it as a drug.”
To test whether this deficiency was more than an association, the researchers fed healthy mice a lithium-restricted diet, lowering brain lithium to levels seen in Alzheimer’s patients.
The animals developed brain inflammation, lost connections between neurons and showed cognitive decline; however, replenishing them with lithium orotate reversed these changes. What's more, mice given the compound from early adulthood were protected from developing Alzheimer’s-like symptoms altogether.
The findings raise several possibilities. Measuring lithium levels in blood could become a tool for early screening, identifying people at risk before symptoms emerge. Furthermore, amyloid-evading lithium compounds could be tested as preventive or therapeutic agents, potentially altering the disease course more fundamentally than existing drugs.
For now, researchers stress that no one should self-medicate with lithium supplements.
The team emphasized that the safety and efficacy of lithium orotate in humans remain unproven, and clinical trials will be needed to determine whether the dramatic benefits seen in mice translate to people.
Don’t forget to follow us @INN_Resource for real-time news updates!
Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.
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