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Investing Guides
November 18, 2024
Resonance Health Ltd (ASX: RHT) (Resonance or the Company) advises that it has been contracted by Sun Pharmaceutical Industries Limited, an international, publicly listed pharmaceutical company with global operations (Customer) to be the local Australian sponsor, and to provide clinical research organisation (CRO) services, trial site services, and imaging analysis services (collectively, Services), for their clinical trial in Australia of a new drug compound (Clinical Trial).
New Clinical Trial
The newly executed clinical trial agreement (Agreement) is worth an estimated AUD $13.775 million in revenue to the Resonance group over the next ~24 months, with the first payment of AUD $2.066 million due within 30 days of Agreement execution. Resonance, through its wholly owned subsidiary, CRO Services Pty Ltd (CRO Services), will serve as CRO and Local (Australian) Sponsor for the Customer and will engage and make payment to the institutions, trial sites, and the vendors needed to conduct the Clinical Trial.
Whilst the Company will receive the first payment within 30 days of Agreement execution, provision of the Services under the Agreement (and the remaining payments) are subject to (among other things) receipt of regulatory approvals to commence the Clinical Trial including human research ethics committee approval (Regulatory Approvals).
Resonance will provide its imaging analysis services at various timepoints throughout the Clinical Trial along with clinical trial site services through its recently acquired TrialsWest business. It is notable that trial sites are among the largest vendors for clinical trials of this nature, so a benefit of the TrialsWest acquisition is that a significant portion of the revenues payable to trial sites will now stay within the Resonance group.
The Company expects patient recruitment for the Clinical Trial could commence in early 2025, subject to receipt of Regulatory Approvals, with both TrialsWest sites expected to play a key role in the recruitment of subjects and the conduct of the Clinical Trial.
This contract win highlights Resonance’s strategy of providing its technology and services to the burgeoning and highly technical global pharma and clinical trials markets.
The material commercial terms of the Agreement are set out at Annex A.
Resonance Health CEO, Mr Andrew Harrison commented:
“The Agreement is a direct result of the incredible work the team have done in executing the existing clinical trial with the customer and more broadly the Company’s focus on winning more work in the global clinical trials ecosystem. This illustrates our ability to win repeat work from customers, and our capacity to scale the size of contract wins.”
This announcement has been authorised for release in accordance with the delegated authority of the Board of Directors of Resonance Health Ltd.
Click here for the full ASX Release
This article includes content from Resonance Health Ltd, 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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5h
Successful Completion of Placement to Accelerate Clinical Programs
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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26 February
Japan Patent Allowance for RECCE® Anti-Infectives
Recce Pharmaceuticals Limited (ASX:RCE, FSE:R9Q), (Recce or the Company) the Company developing a New Class of Synthetic Anti-Infectives, is pleased to announce the receipt of a notice of allowance from the Japan Patent Office for Patent Family 4 for Recce’s Anti-infectives, expiry 2041.
The Japan Patent claims relate to RECCE® 327 (R327) and RECCE® 529 (R529), most notably:
- Process for preparation of RECCE® anti-infectives
- Use of R327/R529 for the treatment of disease, particularly in treatment of bacterial infections, viral infections and more
- Specifically, further validating RECCE® anti-infectives from studies in Acute bacterial skin and skin structure infections (ABSSSI), Diabetic Foot Infections (DFI), Burn Wounds, Lung Infections (including Ventilator-associated pneumonia/Hospital-acquired pneumonia), Urinary Tract Infections, Gonorrhoea, Influenza, SARS-CoV2
- Administration by oral, inhalation, transdermal delivery or by injection
- (into the bloodstream, intramuscular and/or intravenous)
- Administration may also be applied as an aerosol, gel, topical foam or ointment (or impregnated into a dressing for application to skin or mucous membranes for transdermal or transmucosal delivery)
This is the fourth Family 4 patent, alongside Australia, Canada and Israel, with further Patent Cooperation Treaty Country (PCT) submissions in respective stages of review/allowed.
Japan is the third largest pharmaceutical market in the world1, with a share of approximately 5% of the global pharmaceutical market.2 The antibiotic resistance market in Japan is expected to reach a projected revenue of US$ 411.3 million by 2030. A compound annual growth rate of 6.1% is expected of the Japanese antibiotic resistance market from 2024 to 2030.3
Recce Pharmaceuticals’ Chief Executive Officer, James Graham said:“We are encouraged by the Japan Patent Office’s formal recognition of Recce’s New Class of Anti-Infectives. Global patent protection underscores our commitment to addressing critical unmet medical needs with innovative therapies. We are well-positioned to deliver meaningful solutions for patients worldwide.”
Click here for the full ASX Release
This article includes content from Recce Pharmaceuticals, 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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22 January
Completion of Indonesian Seaweed Joint Venture Transaction
09 December 2024
StickIt Technologies Inc. Announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults for 2025
StickIt Technologies Inc.(the" Company "or "StickIt") (CSE: STKT), an Israeli Canadian technology company, announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults and start the research in 2025 once fund raising will be completed.
Stickit Technologies has developed a straw plus cartridge for delivering vitamins and/or medications for children and/or adults who have difficulty swallowing pills or for children who regularly miss medications and/or vitamins. The company, which filed a patent for a straw plus cartridge for transporting cannabinoids and/or medications, decided to develop a model of a medical straw for transporting vitamins and medications for children and adults.
The company intends to raise 1.5 million Canadian dollars for the new medical straw project during Q1 and Q2 2025. StickIt Technologies will establish a new subsidiary named "Stickit Pharma Ltd". and will be owned by the public company and the new investors who will join.
The company intends to seek partnerships with generic pharmaceutical companies globally that are interested in being part of the research and submission for FDA approval.
"This is a significant breakthrough for our company and the investors." says Eli Ben Haroosh, CEO of StickIt Technologies Inc. "We are looking for every opportunity to develop our technology and lead the global market. I believe that if we will raise the necessary fund and also succeed in raising partnerships with generic pharmaceutical companies, making Stickit a pharma leader very soon." concluded Ben Haroosh.
About StickIt Technologies Inc
StickIt is a technology company that invented and manufactures innovative products ("devices") that can contain varying quantities of Catabolites or Vitamins for recreational and medical users. Its operating model is to establish joint ventures/licensees ("partners") in countries around the world that will establish a production facility in which they will add the cannabinoid content to the "sticks" and "straws" produced and supplied by StickIt. The Company's precise dosing options cater to a wide range of effects, including painkilling, energizing, focus, sleep improvement, etc., and can be tailored to meet local preferences and regulations. StickIt Technologies serves customers worldwide.
For more information, please contact:
StickIt Technologies Inc.
Eli Ben Haroosh, CEO
E: info@stickit-labs.com
Sophie Galper , CFO
E: sophie@stickit-labs.com
Website: www.stickit-labs.com
Facebook: @Stickit
Twitter "X": @STICKIT74776509
LinkedIn: @Stickit-labs
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward-Looking Statements
This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by StickIt Technologies Inc. Readers are cautioned not to place undue reliance on forward-looking statements.
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03 December 2024
Invion Doses First Patient in Phase I/II Non-Melanoma Skin Cancer Trial
Invion Limited (ASX: IVX) (“Invion” or the “Company”) is pleased to announce the dosing of the first patient in its Phase I/II non- melanoma skin cancer (NMSC) trial conducted at Veracity Clinical Research (Veracity) in Brisbane.
Highlights:
- First patient has been dosed in Invion’s open label Phase I/II non-melanoma skin cancer (NMSC) trial using topical INV043.
- The study is being conducted at Veracity Clinical Research’s facilities, based in Queensland Australia.
- Skin cancer is one of the world’s most common cancers and NMSC constitutes >98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322.
- Preclinical studies indicate INV043 may have distinct advantages over current NMSC treatments, such as efficacy without scarring and with minimal pain.
- The NMSC trial follows the release of promising Phase II prostate cancer trial results using INV043, and Invion plans to leverage the NMSC data into a planned Phase II anogenital cancer trial
The trial marks a significant milestone for Invion and is designed to evaluate the safety and efficacy of its lead drug candidate INV043, a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT) for the treatment of multiple cancers.
Trial Design and Objectives
This open-label, adaptive trial provides flexibility to go beyond the testing and collection of human safety data of the topical formulation of INV043.
The initial part of the study aims to assess the safety profile of the topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (cSCC). Subsequent parts aim to address dose optimisation (dose-light interval and light intensity) and the identification of efficacy signals. Part 3 will expand testing to include superficial Basal Cell Carcinoma (sBCC)
The adaptive design allows for modifications to the trial procedures based on interim results, enhancing the efficiency and effectiveness of the study. As such, the trial will enrol a minimum of 18 patients, which can be increased depending on the results.
Veracity will select male and female patients over the age of 18 with non-metastatic cSCC and sBCC, although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
Significance of NMSC
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322. The prevalence of the disease highlights the urgent need for effective and affordable treatments with minimal side effects.
Currently, the mainstream treatment for SCC and BCC is surgery, which can lead to permanent scarring. Preclinical studies undertaken at the Hudson Institute of Medical Research showed the potential for INV043 to regress cancers without scarring and with minimal pain.
Next Steps
The NMSC trial follows the release of promising results from a Phase II prostate cancer trial using the same active pharmaceutical ingredient, INV043. Once the trial results have been analysed, in addition to progressing the NMSC program, Invion plans to leverage this data into a planned Phase II anogenital cancer trial using topical INV043, and potentially including the use of immune checkpoint inhibitors (ICIs) on the back of solid in vivo data from the Peter MacCallum Cancer Centre.
This study showed 80% complete pathological control of anal squamous skin cancers versus a 12% response rate on ICI treatments on a standalone basis.
The Executive Chair and Chief Executive Officer of Invion, Thian Chew, said:
“Having the first patient dosed in our NMSC trial is a significant milestone for Invion in demonstrating the potential for the Photosoft technology to address limitations and undesirable side effects of current standard of care for NMSCs, including scarring and pain.”
“On the back of the recently announced prostate cancer results, this trial can also provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers. This can then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”
The NMSC trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
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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