
March 03, 2025
Invion Limited (ASX: IVX) (“Invion” or the “Company”) is pleased to announce that it has successfully completed a new share placement (Placement) to raise $2.0 million to advance research and development in Photosoft™ as a potential treatment for a range of cancers.
Highlights:
- Invion raises $2M via a share placement with the new shares priced at $0.14, a 2.5% premium to the 30-day VWAP and nil discount to last closing price
- Investors in the placement will also receive one unquoted three-year option (exercise price of $0.28) for every new share
- Proceeds from the placement will be used to:
- Recruit from a second site for Invion’s Phase I/II skin cancer trial
- Initiate a Phase I/II anogenital trial with the Peter MacCallum Cancer Centre
- Fund general working capital
- A successful outcome in the anogenital trial may enable orphan drug designation in the US to fast-track trials in the rare disease indication(s)
- Multiple milestones on the horizon, including:
- Results from the skin cancer trial
- Initiation & progress on the anogenital trial
- Updates on the glioblastoma, oesophageal cancer and HPV studies that are fully funded by Invion’s partners
The offer price for the new shares of $0.14 per share represents a 2.5% premium to the 30-day volume-weighted average price (VWAP) and a zero discount to its last closing price before the Placement announcement on 27 February 2025.
The lead manager for the Placement, Blue Ocean Equities (Lead Manager), received strong demand for the Placement, which was originally seeking to raise $1.5 million from sophisticated investors.
The Placement will comprise of two tranches:
- Tranche 1: Placement of approximately 7.0 million new shares at A$0.14 per New Share to raise approximately $1 million utilising the Company’s existing placement capacity under ASX Listing Rule 7.1A, and
- Tranche 2: Placement of the balance of shares, conditional on the Company obtaining shareholder approval at the Extraordinary General Meeting (EGM) expected to be held in April 2025.
Investors in the placement will receive one unquoted attaching option for each new share with an exercise price of $0.28 and will expire three years from issue, subject to shareholder approval at the EGM.
The Lead Manager is to receive a capital raising fee of 6% on the proceeds of the Placement and will also receive a tranche of options to an equivalent value of approximately $80,000 using a Black Scholes options pricing formula with the following inputs:
- Exercise price – each option will have an exercise price which is a 50% premium to the 15-day VWAP calculation as at the date of the placement.
- Expiry – the options will expire 2 years from the date of issuance.
- Volatility rate – 100%.
- Risk Free Rate – 5%.
The Company will lodge an appendix 3B with the ASX with these details as soon as the number of options has been calculated. These issue of these options is subject to the approval of shareholders at the EGM.
Use of Proceeds from the Placement
Proceeds from the raise will be used to recruit from a second clinical site for Invion’s Phase I/II non-melanoma skin cancer (NMSC) trial, initiate a Phase I/II anogenital trial with the Peter MacCallum Cancer Centre (Peter Mac) and for general working capital.
Invion plans to leverage the safety data from the NMSC trial to accelerate a pathway to the anogenital trial as both trials are using the same topical formulation of INV043. Anogenital cancers include penile, vulva and anal cancers, which are rare diseases.
A successful outcome in the anogenital trial may enable orphan drug designation with the U.S. Food & Drug Administration (FDA). The granting of an orphan drug designation will give Invion a faster and more cost-effective path to commercialise Photosoft for the treatment of the rare disease(s) in question.
Thian Chew, Invion’s Executive Chair and CEO, commented:
“We are delighted to welcome new shareholders to Invion via the Placement, many of whom are sophisticated investors in the biotech space that are supporting the Company after reviewing our achievements and the multiple milestones in our horizon.
“In addition to the skin and anogenital cancer trials, these milestones also include updates on the glioblastoma, oesophageal cancer and human papilloma virus studies that are fully funded by our partners.”
This announcement was approved for release by Invion’s Board of Directors.
Click here for the full ASX Release
This article includes content from Invion Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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The Conversation (0)
10 April
Invion Limited
Investor Insight
With a strong IP portfolio, deep clinical-stage pipeline, global collaborations and an experienced leadership team, Invion is poised for transformative value creation as it enters the next phase of clinical and commercial growth.
Overview
Invion Limited (ASX:IVX) is a clinical-stage Australian life sciences company focused on transforming photodynamic therapy (PDT) into a next-generation solution for treating cancer and infectious diseases. The company’s core value lies not just in preclinical promise, but in real-world clinical validation.
At the heart of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively target diseased cells and, upon light activation, induce a precise oxidative stress response to destroy them. Unlike conventional PDTs that suffer from toxicity and off-target effects, Photosoft compounds are engineered for enhanced safety, specificity, immune activation, and theragnostic utility. INV043, Invion’s lead cancer drug candidate, has demonstrated up to 80 percent tumor control in combination with immune checkpoint inhibitors, and is now in human trials.The company is actively progressing a broad pipeline across multiple indications, including:
- A Phase I/II trial in non-melanoma skin cancer (NMSC), now dosing in Australia
- An anogenital cancer trial in collaboration with Peter MacCallum Cancer Centre, scheduled to begin in 2025
- A completed investigator-led Phase II prostate cancer trial, showing a 40 to 44 percent response rate with a strong safety profile
These trials signal a critical shift for Invion from preclinical research to meaningful clinical validation, spanning both systemic and topical formulations. The safety data from the NMSC trial is expected to support accelerated development of the anogenital cancer program, given both use the same topical compound.
The clinical results so far have been consistent with the findings from the preclinical studies – showing INV043 to be very safe with promising efficacy signals. The next set of trials aim to further solidify the potential for the technology, where the one drug can treat multiple cancers, improve patient outcomes when using checkpoint inhibitors in combination with INV043 and demonstrate its diagnostic and theragnostic potential.
Beyond internally funded trials, Invion is strategically expanding its clinical and commercial footprint through non-dilutive, global partnerships. In South Korea, Hanlim Pharm is funding the preclinical development of Photosoft for glioblastoma multiforme — a highly aggressive brain cancer — and oesophageal cancer, both of which present major unmet needs. These programs are fully financed by Hanlim, with Invion retaining all intellectual property
Similarly, Dr. I&B Co. (Dr.inB), another South Korean group, is backing the development of Photosoft for human papillomavirus (HPV) in a new proof-of-concept trial. This collaboration not only funds a novel therapeutic area outside of oncology but underscores the versatility of Photosoft as a multi-indication, platform technology. Invion bears none of the clinical trial costs and maintains all rights to future commercialization.
In parallel, Invion is expanding the Photosoft platform into infectious diseases, where preclinical studies have demonstrated broad-spectrum antimicrobial activity. The compound has proven effective in vitro against:
- Antibiotic-resistant “superbugs”
- Fungal and bacterial infections
- SARS-CoV-2 (Omicron)
- Oral and periodontal conditions such as peri-implant mucositis
These results reflect Invion’s long-term vision of developing a scalable, accessible and affordable therapy platform that addresses both high-burden cancers and the growing global threat of antimicrobial resistance. With Photosoft, the company is building a foundation not just for treating disease — but for reshaping therapeutic accessibility and patient outcomes worldwide.
Company Highlights
- Clinical-stage Pipeline in Multiple Indications: Successfully completed Phase II prostate cancer trial, ongoing Phase I/II skin cancer trial, and anogenital cancer trial initiating in 2025. Multiple cancer and infectious disease programs underway.
- Photosoft Platform Technology: Combines cancer selectivity, immune system activation, and minimal toxicity. Preclinical studies show INV043 can regress multiple cancers, deliver superior safety and efficacy and improve tumour control to 80 percent in combination therapy studies with blockbuster ICIs (vs 12 percent with ICIs alone).
- Renowned Partners & Global Pharma-funded Collaborations: Working with distinguished research institutions like Peter MacCallum Cancer Centre and Hudson Institute of Medical Research. Further, Hanlim Pharm (GBM, oesophageal cancer) and Dr.inB (HPV) are funding multiple programs without requiring Invion to contribute capital or give up IP.
- Theragnostic Capability: Photosoft compounds enable both treatment and imaging, allowing for highly precise cancer targeting and enhanced surgical decision-making.
- Strong Clinical and IP Foundation: GMP-grade INV043 manufactured and patented in Australia, with global IP protection extending to at least 2041.
- Compelling Upside: Following a share consolidation and reduced overhangs, IVX offers significant re-rating potential with multiple clinical readouts expected over the next six to 12 months.
Key Programs
Non-melanoma Skin Cancer
Invion’s leading active trial is a Phase I/II adaptive clinical study targeting non-melanoma skin cancer — a condition that represents 98 percent of all skin cancers and constitutes a substantial public health burden in Australia. Using a topical formulation of INV043, the trial is designed with a 3+3 structure allowing real-time protocol optimization for safety and efficacy. The formulation offers significant cosmetic and pain-reduction benefits over existing approved PDT treatments like Metvix (by Galderma S.A.) and excisional surgery, both of which have limitations related to scarring and pain. Dosing of the first patient commenced in December 2024, with ongoing recruitment and interim data expected in the second half 2025 or early 2026. The skin cancer program not only represents a potentially fast path to market but also supports downstream programs, such as the anogenital cancer study, through shared formulation and safety data.
Anogenital Cancers (Peter Mac Collaboration)
The anogenital cancer program is a major upcoming milestone for Invion, developed in collaboration with the prestigious Peter MacCallum Cancer Centre in Melbourne, Australia, one of the leading oncology research centres in the world. Utilizing the same topical INV043 formulation as the non-melanoma skin cancer trial, this Phase I/II study will leverage safety data from the trial to accelerate approval timelines. The anogenital trial targets high-risk lesions and cancers with limited therapeutic options, and benefits from the scientific and operational expertise of Peter Mac. Preclinical data showed exceptional synergy when INV043 was used in combination with immune checkpoint inhibitors (anti-PD-1), achieving up to 80 percent tumor-free responses in models of anal squamous cell carcinoma, compared with a circa 12 percent response rate with aniti-PD-1 alone. This program exemplifies Invion’s theragnostic strength, where the compound also enables fluorescent visualization of tumor margins to aid surgical decision-making.
Prostate Cancer (Phase II Completed)
INV043 has completed a Phase II investigator-led clinical trial in prostate cancer, funded by the RMW Cho Group. The trial involved sublingual systemic administration of the compound followed by targeted light therapy. Following COVID-related disruptions, a second cohort of 16 patients was successfully treated and evaluated using PSMA-PET scans and RECIST criteria. Results were compelling: 44 percent of patients showed no detectable cancer via PSMA-PET scan three months post-treatment, while 40 percent demonstrated partial or stable response by MRI. The therapy was extremely well-tolerated, with no serious adverse events and only mild treatment-emergent side effects. These findings serve as clinical proof-of-concept for systemic delivery of INV043, highlighting its potential for deeper-seated cancers and reinforcing its safety and scalability.
Glioblastoma and Oesophageal Cancer (Hanlim Pharma Collaboration)
Through a strategic partnership with South Korean pharmaceutical company Hanlim Pharma, Invion is advancing preclinical programs for two highly aggressive and deadly cancers: glioblastoma multiforme and oesophageal cancer. Hanlim is funding both programs entirely, allowing Invion to retain all IP and avoid capital outlay. These programs are exploring INV043’s efficacy in some of the most treatment-resistant solid tumors, with early-stage studies underway and updates expected in 2025. If successful, this collaboration could lead to regional licensing or joint ventures in Asia, significantly expanding Invion’s global footprint.
HPV and Infectious Diseases (Dr.inB Collaboration)
Dr.inB, a leading PDT innovator in South Korea, is partnering with Invion to develop Photosoft-based treatments for HPV-related conditions, including genital warts and potentially HPV-linked cancers. The program, which includes proof-of-concept human trials, is entirely funded by Dr.inB, and Invion retains all IP and commercialization rights. Beyond HPV, Photosoft has demonstrated broad-spectrum antimicrobial potential against antibiotic-resistant bacteria, fungi and viruses, including SARS-CoV-2. This opens the door to applications in periodontal disease, peri-implant mucositis, and other infectious conditions. PDT’s unique mechanism of action — using light to generate oxidative stress — renders it immune to resistance development, making it an ideal candidate for combatting antimicrobial resistance, one of the top 10 threats to humanity identified by the World Health Organization.
Management Team
Thian Chew – Executive Chairman & CEO
Thian Chew brings over two decades of executive and advisory experience in healthcare and finance. He is the co-founder of Chronic Airway Therapeutics and a board advisor at Stanford Medicine’s Center for Asian Health Research and Education (CARE). Formerly an executive director at Goldman Sachs and director at KPMG Consulting, Chew combines strategic vision with operational rigor. He is an adjunct professor at the University College London and associate professor at HKUST, holding dual an MBA from Wharton School (Palmer Scholar) and an MA from the Lauder Institute, University of Pennsylvania.
Robert Ramsay – Scientific Advisor
A world-renowned expert in immunotherapy and translational cancer biology, Robert Ramsay is a senior scientist at Peter MacCallum Cancer Centre and has over 30 years of oncology research experience. He was instrumental in demonstrating the synergy between INV043 and checkpoint inhibitors, leading to his appointment as a key advisor. Ramsay also served as president of the Australian Society for Medical Research.
Scott Carpenter – Program Director
Scott Carpenter brings cross-functional expertise in regulatory affairs, business development and stakeholder engagement. He previously held leadership roles at Starpharma, AusBiotech and Bayer CropScience and holds an MBA from Melbourne Business School.
Sebastian Marcuccio – Medicinal Chemistry Lead
The co-inventor of Invion’s PDT patents, Sebastian Marcuccio is the founder of Advanced Molecular Technologies and has a deep background in pharmaceutical R&D, including with CSIRO. He is currently adjunct professor at La Trobe University and holds a PhD in organic chemistry.
Kim Steel – Clinical Trial Director
With more than 18 years of experience managing global Phase I-IV drug and device trials across 14 countries, Kim Steel has worked with Novotech and Pacific Clinical Research. She is managing director of SAPRO Consulting, leading operational delivery for Invion’s ongoing trials.
Alexander Bennett – Technical Advisor, Light Devices
A veteran of scientific instrumentation development, Alexander Bennett brings 35+ years of experience designing medical and forensic light systems. He led PDT light source trials at Peter MacCallum Cancer Centre and ensures the clinical precision of INV043’s light activation protocol.
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18 June
Medibank to Fund Emyria’s PTSD Program at Perth Clinic
Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) a leader in developing and delivering innovative mental health treatments, is pleased to announce that Medibank Private Limited (“Medibank”), Australia’s largest private health insurer, has commenced funding for eligible customers to access Emyria’s Empax PTSD care program delivered in association with Perth Clinic.
Key Highlights:
- Medibank (ASX: MPL) to fund eligible customer participation in Emyria’s Post-Traumatic Stress Disorder (PTSD) care program through Perth Clinic, with no out-of-pocket costs 1.
- Medibank is Australia’s largest health insurer supporting over 4.2 million customers.
- Agreement is multi-year and marks the first major private health insurance funding of a psychotherapy-led PTSD program in Australia.
- Strong validation of Emyria’s Empax Model, which integrates psychiatrist-supervised therapy, care coordination, and real-world data capture.
- Emyria’s ambition is to scale a sustainable, data-generating mental health platform nationally, building on initial program at Perth Clinic.
- Firm bids received from new and existing sophisticated and professional investors for a Placement of $4M (before costs) at $0.024 per share, including Director Participation of $197,000 (subject to shareholder approval).
This multi-year agreement enables eligible and screened Medibank customers to receive Empax’s comprehensive psychological trauma care program once admitted to Perth Clinic 2, reducing a major barrier to access for those with complex mental health conditions.
The psychotherapy program is now live and accessible by eligible customers. There are no minimum or maximum patient quotas. Due to the individualised nature of the treatment the associated cost per customer will vary according to clinical requirements.
A Clinically Rigorous and Integrated Care Model
Emyria’s Empax Model combines psychiatrist-supervised psychotherapy, specialist care coordination, and real-world data monitoring. Each patient undergoes a personalised course of treatment tailored to their needs.
Key components include:
- Psychiatrist-led, and ethics-endorsed care protocols delivered by trained clinicians;
- Rigorous patient selection and screening planning;
- Fit-for-purpose treatment environments;
- Strong clinical governance frameworks;
- Integrated data capture and analysis to support continuous improvement, and;
- Durable real-world outcomes. 3
While individual treatment plans differ, similar programs delivered by Emyria typically involve a course of care valued between $20,000 and $30,000.
Delivering Advanced Mental Health Care Nationally Under the Empax Model
The partnership with Medibank reflects growing recognition of the urgent need for better mental health treatments and positions Emyria as a national leader in advanced psychological trauma care. It also demonstrates how Emyria’s integrated care model can align with hospital infrastructure and insurer funding to deliver scalable, measurable care.
Emyria Executive Chairman Greg Hutchinson said that Medibank’s commitment to funding new mental health initiatives, including innovative psychotherapy programs, underscores the huge need for funding in this previously under-represented area of healthcare.
“Whilst we’ve seen great advances in many areas of medicine over the past 20 years, mental health incidence and prevalence have increased to unacceptable levels. It’s clear that mental health requires not just more resources, but a multi-faceted, multi-stakeholder and more innovative approach.
We commend Medibank for their leadership in funding new mental health initiatives, support that will expand access to promising therapies for more Australians suffering with complex and persistent mental health challenges”.
Click here for the full ASX Release
This article includes content from Emyria Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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12 June
HITIQ Announces Exclusive Global Agreement with Shock Doctor for PROTEQT Instrumented Mouthguard
Common Shareholder Questions – Entitlement Offer
HITIQ Limited (ASX: HIQ) (HITIQ or the Company), a pioneer in concussion management, proudly announces an exclusive global agreement with Shock Doctor, the world’s leading mouthguard innovator. This landmark agreement marks Shock Doctor’s two-year effort to design a mouthguard that will integrate HITIQ’s PROTEQT technology. The result is a fully developed, market-ready solution that merges HITIQ’s smart sensor technology with Shock Doctor’s unmatched global production partner capabilities.
- Global Breakthrough: In a world-first exclusive, HITIQ secures an exclusive global agreement with Shock Doctor, the #1 global mouthguard brand, to provide a self-fit “boil and bite” mouthguard design incorporating PROTEQT instrumented technology revolutionizing the ease of use of cutting edge PROTEQT concussion management technology.
- Unmatched Partnership: Shock Doctor’s world-class mouthguard design expertise unites with HITIQ’s advanced sensor technology to deliver a game-changing safety solution. This agreement enables HITIQ to scale PROTEQT’s commercialisation globally, with plans to manufacture 20,000 units in 2025 and 100,000 units in 2026.
- Ready for Athletes: The co-branded mouthguard with the PROTEQT system, now in production, rolls out to community sports through partnerships with VAFA, AFL Barwon, and Westfield Sports High, with more to come.
Shock Doctor: The Ultimate Mouthguard Partner
Shock Doctor is the only company with the expertise, infrastructure and scale to provide a self-fit mouthguard that can integrate HITIQ technology thus enabling reliable worldwide distribution. The co- branded PROTEQT mouthguard, featuring HITIQ’s PROTEQT logo and Shock Doctor’s “SHOCK” branding, integrates advanced impact sensors into a high-performance design, setting a new global standard for athlete safety.
Left image: The PROTEQT HITIQ/SHOCK co branded instrumented mouthguard. Right image: Market ready PROTEQT concussion management system
PROTEQT: Redefining Safety, PROTEQT’s concussion management system detects head impacts, assesses risks, and guides recovery with precision, backed by a 7-day telehealth service using the Sports Concussion Assessment Tool (SCAT). Built on HITIQ’s proven Nexus iMG technology, validated by elite partners like the AFL and NRL, PROTEQT is ready to protect community athletes worldwide. Strategic partnerships with VAFA (HITIQ’s Official Concussion Technology Partner), AFL Barwon, and Westfield Sports High ensure rapid adoption, with more collaborations in development.
Global Impact, Unmatched Scale Shock Doctor’s design and production partner prowess enable PROTEQT’s rapid production at affordable price points, with production trials confirming a robust supply chain. This exclusive global agreement, built on World Rugby’s approval and a U.S. patent for HITIQ’s Nexus technology, positions PROTEQT as a global leader in athlete safety.
Leadership Vision
Earl Eddings, Executive Chair, HITIQ: “This world-first global agreement with Shock Doctor, the global mouthguard leader, is a defining moment. PROTEQT, now market-ready, combines our cutting-edge technology with their mouthguard excellence to transform concussion management worldwide.”
Jay Turkbas, SVP Product Development: Shock Doctor, Inc. It was a welcome challenge developing and producing the physical structure to house HITIQ’s sensor technology. Paired with Shock Doctor’s world-class design and development expertise we are proud of this groundbreaking mouthguard solution allowing HITIQ to provide PROTEQT technology that can redefine athlete safety globally.”
Click here for the full ASX Release
This article includes content from HITIQ Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here
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05 June
HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems
HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Device designation for its Aortic Stenosis (“AS”) ECG algorithm.
Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. Early symptoms are frequently vague or absent, resulting in delayed diagnosis and treatment. If unrecognized, AS can cause irreversible myocardial damage and significant deterioration in cardiac function.
The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences' MyoVista Insights™ cloud-based platform which would directly integrate with hospital electronic health record (“EHR") systems, requiring no additional hardware or testing. This technology provides several key clinical advantages:
- Detection in asymptomatic or under-evaluated patients who may not yet show signs of AS.
- Real-time or retrospective analysis using existing ECG data already captured during routine care.
- Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers.
The algorithm was developed using advanced convolutional neural network (CNN) deep learning techniques and trained on more than 120,000 ECG records. In performance evaluations, it demonstrated the ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy (AUROC) increasing as the disease progressed.
This breakthrough gives clinicians the ability to identify aortic valve disease earlier in its course, allowing for timely interventions and improved patient outcomes. The AI-ECG algorithm was developed at the Icahn School of Medicine at Mount Sinai by Dr. Akhil Vaid.
"Receiving FDA Breakthrough Device Designation marks another significant milestone for HeartSciences," said Andrew Simpson, CEO of HeartSciences. "By combining the widespread accessibility of ECGs with the power of deep learning, our aortic stenosis algorithm has the potential to transform how this serious and often silent disease is detected—leading to earlier referrals, better treatment pathways, and ultimately, improved lives."
About HeartSciences
HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve ECG’s clinical utility. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and intends to provide these AI-ECG algorithms on a device agnostic cloud-based solution as well as a low-cost ECG hardware platform. Working with clinical experts, HeartSciences ensures that all solutions are designed to work within existing clinical care pathways, making it easier for clinicians to use AI-ECG technology to improve their patient's care and lead to better outcomes. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test.
For more information, please visit: https://www.heartsciences.com. X: @HeartSciences
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2024, filed with the SEC on September 12, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2024, filed with the SEC on December 16, 2024, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2025, filed with the SEC on March 13, 2024 and in HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Investor Relations:
Integrous Communications
Mark Komonoski
Partner
Phone: 877-255-8483
Email: mkomonoski@integcom.us
Media Contact:
HeartSciences
Gene Gephart
Phone: +1-682-244-2578 Ext. 2024
Email: info@heartsciences.com
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20 May
Exclusive UK Packaging Agreement signed between Sharpak Aylesham Limited, Zoono, and OSY
Zoono Group Limited (Company) (ASX: ZNO) is pleased to update the market on an exclusive contract signed with Sharpak Aylesham Limited (Sharpak) and the Company’s partner in the food supply chain sector, OSY Group Limited (OSY).
Background
When, around three years ago, the Company's traditional markets for anti-microbial products were decimated by over-supply problems and dwindling public sentiment, the Board made a decision, of necessity, to focus on the pursuit of niche sectors which it believed suited the characteristics of its products and where significant sales opportunities existed. One such sector, introduced to Zoono by OSY, was the food supply chain sector and, in particular, the application of the Company's products to food packaging for the purpose of extending food shelf-life and reducing food waste, a challenge for supermarkets and food producers across the globe.
In conjunction with OSY (Zoono's partner in this project) and following nearly three years of testing and promotion of its shelf-life extension products and technologies, Zoono is pleased to announce that it and OSY have signed an exclusive agreement with Sharpak (the UK division of a leading European manufacturer of packaging solutions for the food industry - see below for further details on Sharpak).
The agreement builds on the Company's platform in the UK & EU food shelf-life extension market, via advanced trials with multiple leading supermarkets and international food producers. One leading UK premium supermarket has endorsed the technology’s status as a “game changer” in the industry due to its unique ability to be applied to a wide range of products and packaging types.
Sharpak's operations in the UK supply a large market share of the packaging of soft fruits sold by UK supermarkets, with its packaging also used for a broad cross-section of fresh produce and other food categories including meat and poultry.
Material Contract Terms
Sharpak has signed an exclusive contract with Zoono and OSY to use the Company's shelf-life extension products and OSY's application technologies on its food packaging ranges for soft fruits sold to major UK supermarkets.
Click here for the full ASX Release
This article includes content from Zoono Group, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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15 May
Accent Trial Data Demonstrates that Narmafotinib + Chemotherapy Combination Superior to Chemotherapy Alone
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce important new data from our ongoing ACCENT clinical trial in pancreatic cancer. The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane. Fifteen (15) confirmed partial responses (PRs) have now been recorded in the trial, a level of response sufficient to demonstrate that the combination of narmafotinib and chemotherapy is superior to chemotherapy alone.
HIGHLIGHTS
- Key milestone achieved, with 15 confirmed responses recorded in the ongoing Phase 1b/2a ACCENT trial
- Sufficient confirmed responses have now been recorded to demonstrate that narmafotinib combined with chemotherapy is superior to chemotherapy alone.
- The ACCENT trial is evaluating narmafotinib in combination with the chemotherapies gemcitabine and Abraxane® in patients with advanced pancreatic cancer
- Narmafotinib is a highly potent and selective FAK inhibitor discovered at the Melbourne-based Cooperative Research Centre for Cancer Therapeutics.
- Phase 2a ACCENT trial is fully recruited with top-line data expected in mid Q3 2025
A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected. As pancreatic cancer is highly aggressive it is extremely rare for patients to achieve a complete response (CR).
The ACCENT trial is an open-label study meaning that all patients on the study receive narmafotinib in combination with the standard-of-care therapy. The data obtained in this trial is compared to historical data for the combination of gemcitabine and Abraxane in pancreatic cancer, and specifically data from the MPACT study, upon which we have closely modelled our trial1.
At the outset of the study a statistical analysis was performed which identified that a patient cohort of 50 patients would be sufficient to allow the efficacy of our combination to be ascertained with reasonable confidence if 15 or more responders (confirmed PR or CR) were recorded. A total of 55 advanced pancreatic patients have enrolled in the study since January 2024, with 21 patients still on study at this time.
As noted in our recent press release2, the drug continues to be well tolerated by patients with the rate and type of adverse events for the narmafotinib combination being similar to that reported for chemotherapy alone.
Amplia CEO and MD Dr Chris Burns commented: “We are extremely excited to have now recorded 15 confirmed partial responses in the ACCENT trial, demonstrating the benefit of adding narmafotinib to standard-of-care chemotherapy. With over 20 patients still on study we are hopeful that further PR’s will be observed”
Click here for the full ASX Release
This article includes content from Amplia Therapeutics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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28 April
Binding Commitments Received for A$1.0 Million under Convertible Note Placement
Nutritional Growth Solutions Limited (ASX:NGS) ("NGS" or "the Company"), is pleased to announce that it has received binding commitments for the issue of 1,000,000 convertible notes (Placement CNs), to be issued at $1.00 each (CN Placement).
HIGHLIGHTS
- NGS has secured commitments of A$1.0 million under a placement of convertible notes.
- Under the placement, 1,000,000 convertible notes will be issued at A$1.00 each, with the conversion of the convertible notes into ordinary shares in NGS at a price of between A$0.03 and A$0.025 per ordinary share to occur within 10 business days of NGS shareholders approving their conversion including for the purposes of ASX Listing Rule 7.1.
- Each investor who is issued with ordinary shares on conversion of the convertible notes will be issued with one option for each fully paid ordinary share that is issued on conversion of the convertible notes, with that issuance of options to take place on the same date as the ordinary share issuance date. This is expected to be within 10 business days of NGS shareholders approving that issuance of options including for the purposes of ASX Listing Rule 7.1. These options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per option, and will expire 3 years following their issue date if they have not been exercised during that 3 year period.
- The placement of convertible notes was supported by Australian sophisticated and professional investors.
- Funds raised from the placement of convertible notes will be used to purchase inventory for retail expansion in CVS and Wakefern, as well as working capital and corporate expenses.
The offer of the Placement CNs was made to sophisticated and professional investors in Australia and successfully closed, achieving binding commitments of A$1.0 million.
Stephen Turner, NGS CEO and Managing Director, commented on the CN Placement:
“We are very pleased with the strong support shown by investors in this placement, which provides important growth capital to support our retail expansion into leading U.S. retailers, including CVS and Wakefern. We would like to thank our shareholders for their ongoing support as we execute our growth strategy and build on the momentum from our recent distribution achievements.”
The conversion of the convertible notes into fully paid ordinary shares in NGS will take place at a price of between A$0.03 and A$0.025 per ordinary share within 10 business days of NGS shareholders approving their conversion including for the purposes of ASX Listing Rule 7.1. NGS expects to convene a general meeting of its shareholders to consider whether to approve the conversion of the convertible notes into fully paid ordinary shares in NGS and whether to approve the issuance of options within the next few weeks.
Until the convertible notes are converted into ordinary shares or redeemed, they bear interest which is payable quarterly in arrear at either 10% per annum (if the holder of the convertible notes elects not to receive ordinary shares in NGS in lieu of cash interest), or 15% per annum (if the holder of the convertible notes elects to receive ordinary shares in NGS in lieu of cash interest). Issuance of ordinary shares in NGS in lieu of cash interest is subject to NGS being in compliance with the ASX Listing Rules. If the convertible notes have not been converted by the date that is 2 years after their issue date, they will be redeemed by NGS at their issue price.
Each investor who is issued with ordinary shares on conversion of the convertible notes will be issued with one option for each fully paid ordinary share that is issued on conversion of the convertible notes, with that issuance of options to take place on the same date as the ordinary share issuance date. This is expected to be within 10 business days of NGS shareholders approving that issuance of options including for the purposes of ASX Listing Rule 7.1. These options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per option, and will expire 3 years following their issue date if they have not been exercised during that 3 year period (the CN Holder Options). Quotation of the CN Holder Options on the ASX will be sought.
USE OF PROCEEDS
The net proceeds from the issue of the convertible notes are planned to be used in the following areas:
LEAD MANAGER OPTIONS
The Company engaged GBA Capital Pty Ltd (AFSL 544680) to act as lead manager for the CN Placement (Lead Manager).
Under the terms of the mandate with the Lead Manager, the Lead Manager will be issued with 30% of the number of CN Holder Options (the Lead Manager Options). The Lead Manager Options will be exercisable on a 1:1 basis into fully paid ordinary shares in NGS at an exercise price of $0.04 per Lead Manager Option. The Lead Manager Options will expire 3 years following their issue date if they have not been exercised during that 3 year period.
The Lead Manager Options will be issued within 10 business days of NGS shareholders approving that issuance including for the purposes of ASX Listing Rule 7.1. NGS expects the Lead Manager Options to be issued at the same time as the issuance of the CN Holder Options. Quotation of the Lead Manager Options on the ASX will be sought.
Click here for the full ASX Release
This article includes content from Nutritional Growth Solutions Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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