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![Hydralyte International (ASX:HPC)](https://investingnews.com/media-library/hydralyte-international-asx-hpc.png?id=50438348&width=1200&height=800)
Hydralyte International: Leveraging a Rapidly Expanding Hydration Market in North America
Hydralyte International (ASX:HPC) is a rapid hydration solutions business with a solid manufacturing base and supply chain focused on the large North American and European markets. The company recently surpassed US$10.4 million in 12-month trailing revenue with a gross margin of a staggering 58 percent during Q3 FY23 delivering strong revenue of US$2.6 million in Q3 2023.
Hydralyte rapid rehydration product was also the number one SKU in the hydration category on Amazon Prime Day in Canada. Hydralyte delivered ~US$140,000 in gross sales over 48 hours – which has underpinned a strong ecommerce sales pipeline in the recent months.
Hydralyte is available in three forms: ready-to-drink, tablet and dissolvable powder stick. All three are widely accepted in the medical community. Hydralyte is also frequently used by professional athletes as an alternative to sports drinks.
Made from all-natural ingredients, it contains the precise ratio of glucose and electrolytes necessary to rehydrate. Its innovative formula contains up to 75 percent less sugar and four times more electrolytes than the majority of sports drinks.
Company Highlights
- Hydralyte International is a rapid hydration drink business with a focus on North America and established supply chains in both the United States and Canada.
- The company's 2023 financials are incredibly promising:
- Trailing 12 months revenue of US$10.4 million in Q3 FY23
- 58 percent gross margin in Q3 2023
- Cash burn reduction of 47 percent on PCP to US$1.46 million in Q3 FY22, with initiatives in place expected to reduce this further
- US$140,000 in gross sales from Amazon Prime Day in July.
- Although Hydralyte recently reduced its marketing expenditure, it still experienced strong revenue growth throughout the first three quarters of 2023, driven by ongoing eCommerce sales, an established brick-and-mortar footprint, new SKU additions and a partnership with leading entrepreneur and actress, Shay Mitchell.
- The United Kingdom represents an international expansion opportunity for Hydralyte, with products being sold on Amazon UK and appearing on store shelves in Whole Foods and Chemist Warehouse.
- Agreement with specialist e-commerce company RooLife Group Limited (ASX: RLG) to exclusively market, sell and distribute Hydralyte products in China
- Appointed leading health and wellness products broker LeBeau Excel as its new sales broker, giving Hydralyte the ability to significantly expand its footprint in the Canadian market.
- In addition to a solid manufacturing base and supply chain, Hydralyte is supported by leaders with decades of experience in health and wellness.
- Hydralyte products are widely accepted in both the medical and athletic communities. As a result, the company is extremely well-positioned to leverage the fast-growing electrolyte hydration drinks market.
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Hydralyte International
Overview
Hydralyte International (ASX:HPC) is an ASX-listed rapid hydration solutions business focused on the lucrative North American market. With an established supply chain in Canada and the United States, the company consolidated its market position in FY23 with a 10 percent increase in net sales to $10 million. The impressive increase in group sales was achieved with a disciplined cost focus which flowed through to a significant US$5.7 million in cash savings. And there was ongoing momentum in the first quarter of FY24, with consistent growth in net sales to US$2.17 million on strong gross margins of 56 percent.
Hydralyte’s multi-channel distribution strategy includes a targeted growth through ecommerce. Its rapid rehydration product has been the number one SKU in the hydration category on Amazon Prime Day in Canada, where it's the number two hydration brand overall with a 21 percent market share. Starting on Prime Day, Hydralyte delivered ~US$140,000 in gross sales over 48 hours.
It's also worth noting that all this revenue growth – alongside a partnership with Shay Mitchell – occurred with an ongoing reduction in marketing expenditure. In 2024, marketing costs as a percentage of net revenue decreased to 37 percent from 48 percent in Q1 2023. This is due in part to the company's solid leadership team, featuring professionals with decades of expertise in health and wellness, as well as heavy brand investments which have been made throughout 2022.
In Australia, New Zealand and parts of Southeast Asia, Prestige Consumer Healthcare (NYSE:PBH) holds the exclusive sales and distribution rights to Hydralyte products. PBH is an American over-the-counter healthcare marketing and distribution company, dating back more than 100 years.
Hydralyte International's robust supply chain, sales trajectory, manufacturing approach and product strategy are far from the only reasons it shows such promise as an investment. Current market trends also significantly favor the company's core value proposition. Valued at US$1.68 billion in 2023, the global electrolyte hydration drinks market is expected to reach US$2.78 billion by 2033 as consumers turn away from high-sugar, low-electrolyte drinks and towards more clinical hydration products.
Roughly 75 percent of Americans are dehydrated at any given time. The reasons are many and varied, ranging from travel and exercise to alcohol and illness. Its symptoms are something many of us have simply learned to live with – irritability, brain fog, dizziness, increased thirst, dry mouth and fatigue, to name just a few.
Hydralyte fits the bill perfectly for these consumers. Founded with the goal of making a difference through better hydration, Hydralyte is able to treat dehydration more effectively than the majority of sports drinks on the market. Thanks to its proprietary formula – which uses a precise ratio of water, electrolytes and glucose based on the World Health Organization's recommended formula for rapid rehydration.
Hydralyte is available in three forms: ready-to-drink, tablet and dissolvable powder stick. All three are widely accepted in the medical community. Hydralyte is also frequently used by professional athletes as an alternative to sports drinks.
In short, thanks to its market position, strong leadership and science-based formula, Hydralyte represents the perfect opportunity for investors to enter the lifestyle sports market.
Company Highlights
- Hydralyte International is a rapid hydration drink business with a focus on North America and established supply chains in both the United States and Canada.
- The company’s latest financials show a consistent upward trajectory with respect to its key growth targets:
- 10 percent increase in FY2023 net sales to US$10 million
- 2ppt increase in gross margin to 54 percent resulting in a 15 percent increase in gross profit from US$4.7 million to $5.4 million
- Net sales of US$2.17 million in Q1 2024, up 2 percent on in Q4 2023 with an uplift in gross margins to 56% (adjusted for one-off items)
- Strong momentum in FY24 with underlying sales growth for Q1 2024 of US$2.62 million, an increase of 23 percent from the previous quarter.
- Appointment of leading health and wellness products broker LeBeau Excel as new national sales broker for Canada, giving Hydralyte the ability to significantly expand its footprint in the Canadian market.
- Ongoing product development with a focus on high-margin growth channels, including Hydralyte Rapid Rehydration, a unique formula to take advantage of the lucrative ready-to-drink category for hydration products
- In addition to a solid manufacturing base and supply chain, Hydralyte is supported by leaders with decades of experience in health and wellness.
- Hydralyte products are widely accepted in both the medical and athletic communities. As a result, the company is well-positioned to leverage the fast-growing electrolyte hydration drinks market.
Core Product Offering
Hydralyte Rapid Rehydration
Hydralyte is based on the World Health Organization's recommended formula for rapid rehydration. Made from all-natural ingredients, it contains the precise ratio of glucose and electrolytes necessary to rehydrate. Its innovative formula contains up to 75 percent less sugar and four times more electrolytes than the majority of sports drinks.
Highlights:
- Multiple SKUs: Available as a tablet, powder and premade drink, Hydralyte comes in a range of different flavors and formulations, including:
- Liver Support: 7 key electrolytes, six antioxidants, ginger, turmeric, milk thistle and prickly pear.
- Apple Cider Vinegar: 4 key electrolytes, apple cider vinegar, vitamins B12, B6 and C.
- Collagen: 5 key electrolytes, Verisol collagen, vitamin C and zinc.
- Immunity with Elderberry: 7 key electrolytes, vitamin C, magnesium and zinc.
- SPORT: Launched in 2022, these tablets are designed with the needs of athletes in mind.
- Under development: Hydralyte Rapid Rehydration, a unique formula with inherent advantages in comparison to competitor products in the lucrative ready-to-drink product category
- Promising Partnerships: In December 2022, Hydralyte launched a brand partnership with Shay Mitchell, a Canadian actress and entrepreneur with over 36 million Instagram followers. The two parties launched a co-branded product through HPC eCommerce channels and Amazon USA to leverage Ms Mitchell’s high profile in the North American wellness market.
- Strategic Agreements: Recently appointed LeBeau Excel as its new sales broker to significantly expand Hydralyte’s footprint in the Canadian market. Along with a strong sales team and in-store support, the Lebeau Excel appointment is expected to generate additional margin growth through more streamlined distribution.
Management Team
Oliver Baker – CEO
Oliver Baker is the former general manager of Swisse Wellness USA, a vitamin, supplement and skincare brand that in 2015 sold for US$1.7 billion. During his tenure at Swisse, Baker employed a dedicated eCommerce strategy that enabled a successful US launch. He also led the integration team in Guangzhou, migrating ~US$73 million in sales and building a local team in the Chinese market.
Prior to his position at Swisse, Baker worked in multiple global and national sales and marketing roles with a focus on sports sponsorships.
Adem Karafili – Independent, Non-executive Chairman
A registered CPA and business professional with more than 15 years of experience, Adem Karafili has operated in leadership positions across a range of different sectors and industries. Most recently, he spent several years at Swisse Wellness, beginning as chief financial officer before becoming chief operating officer and managing director. While there, he helped to establish Swisse as a leading global health and wellness brand. Karafili holds a Bachelor of Business Administration in accounting and is chairman of multiple health and wellness corporations.
Chris Kavanaugh – CFO
Chris Kavanaugh has over 20 years of experience running finance and operations for growing startups from inception to US$30M+ in revenue. He has worked with Hydralyte for over five years, starting as a controller before being promoted to chief financial officer in 2021. Prior to his position at Hydralyte, he served as a director of finance for companies including Fullbridge, Education Incorporated and OneVision Resources. Kavanaugh has a bachelor's degree in accounting and management with a double major in information systems from Indiana University of Pennsylvania.
Nick Berry – Non-executive Director
Nick Berry brings over 19 years of experience in the Australian finance industry, specialising in equity and debt capital markets, mergers and acquisitions and strategic planning. With a proven track record in raising capital and structuring and negotiating complex financial transactions, Nick has demonstrated extensive expertise and leadership in the field. He previously served as an Executive Director at Nomura Australia and is currently a Director of PURE Asset Management Pty Ltd.
Margaret Hardin – Independent, Non-executive Director
Margaret Hardin has served as CEO and CFO for numerous major product companies in the United States including Baby Super Brands, ERGObaby Carrier Incorporated and Munchkin. With over two decades of experience, Hardin has a well-established reputation for driving growth through innovation, strategic acquisitions and geographic expansion. She holds a BBA from New Mexico State and an MBA from the Booth Graduate School of Business at the University of Chicago.
Brandon Fishman – US Advisor
Brandon Fishman is the Founder and CEO of VitaCup, a vitamin-infused functional coffee and tea brand that surpassed US$20 million in sales in five years. Fishman has worked with multiple Fortune 500 brands in a range of different capacities, in the process building up considerable entrepreneurial wisdom. Other companies founded by Fishman include NewCondosOnline and Internet Marketing Incorporated. Fishman holds a Bachelor of Business Administration and Finance from Emory University and a Master's in Real Estate & Business from the University of San Diego.
Radiopharm Theranostics Targets Nasdaq Listing by End of 2024
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, today announced it expects to obtain a secondary listing on the Nasdaq Capital Market by the end of 2024.
As announced on 14 February 2023, the Company initiated the process to obtain a secondary listing on the Nasdaq Capital Market. Due to market conditions, the Company subsequently delayed the process.
As announced on 25 June 2024, as part of a A$70 million capital raising, the Company agreed with certain US institutional investors to seek a listing of its ordinary shares in the form of American Depositary Shares on Nasdaq by the end of 2024.
Yesterday the Company filed an amendment to its registration statement on Form 20-F with the US Securities and Exchange Commission (SEC) and is continuing to progress a listing application with Nasdaq. The Company expects the SEC and Nasdaq to complete their respective review processes by late August and, when their processes are successfully completed, then the listing on Nasdaq would occur.
The Nasdaq listing will take the form of a Level 2 American Depositary Receipt program, with each American Depositary Share representing 200 ordinary shares, and will not involve the raising of any capital. The American Depositary Shares (ADS) are expected to trade on Nasdaq under the ticker RADX. Deutsche Bank Trust Company Americas will be appointed by the Company as depositary, custodian and registrar of the ADS.
The Nasdaq listing will complement the existing primary listing of RAD shares on the Australian Securities Exchange (ASX) with minimal additional administration. Ordinary shares are currently listed on the ASX under the RAD symbol where they will continue to trade following the Nasdaq listing.
"We are confident that obtaining a listing on Nasdaq will complement our loyal existing Australian shareholder base by expanding Radiopharm’s access to investors globally, and thereby drive increased shareholder value with enhanced liquidity for all shareholders," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
This program is part of an ongoing strategy to expand the Company’s reach to US institutional and retail investors by enabling them to purchase the Company’s shares via a US stock market, in the American time zone and in US dollars.
The review process by the SEC in relation to the registration statement and by Nasdaq in relation to the listing application continues to be in progress. There can be no assurance as to the completion or timing of this process or such a listing.
Authorised on behalf of the Radiopharm Theranostics board of directors by Executive Chairman Paul Hopper.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, 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.
Top 5 NASDAQ Biotech Stocks of 2024
The NASDAQ Biotechnology Index (INDEXNASDAQ:NBI) has traded at three-year highs in the first half of 2024 in response to looming interest rate cuts, breakthrough innovations and increased deals in the space.
After dropping to a low of 3,637.05 in October 2023, the index climbed to start 2024 at 4,457.02. It did hit a bump in the road early in Q2 when it plunged to 4,056.3 in April, but it quickly recovered and has since tracked even higher, reaching 4,634.21 on June 24. But while the current economic environment means the biotech sector may have a complex road ahead, robust growth could be in store in the future.
According to a recent report from Precedence Research, the global biotech market is expected to grow at a compound annual growth rate of 11.8 percent from now to 2033, reaching a valuation of US$4.25 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 companies have seen sizeable share price increases this past year. For those interested in investing in biotech companies, here are the top gainers outlined below.
Data was gathered on July 8, 2024, using TradingView’s stock screener, and all NASDAQ biotech stocks had market caps between US$50 million and US$500 million at that time.
1. Elevation Oncology (NASDAQ:ELEV)
Year-to-date gain: 416.67 percent; market cap: US$152.17 million; share price: US$2.79
Elevation Oncology’s focus is on developing cancer therapies targeting a range of solid tumors. The company’s oncology pipeline is based on its expertise in antibody-drug conjugates (ADC) and includes lead candidate EO-3021, which is designed to target solid tumors associated with gastric, gastroesophageal junction, pancreatic or esophageal cancers.
In April, Elevation presented preclinical data demonstrating proof-of-concept for its HER3-ADC program targeting solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer.
In late June, Elevation announced the expansion of its ongoing Phase 1 clinical trial for EO-3021 to include two combination cohorts evaluating the drug for the treatment of advanced gastric or gastroesophageal junction cancer. This expansion will see the company evaluating EO-3021 in combination with Eli Lily's (NYSE:LLY) ramucirumab, a VEGFR2 inhibitor, in second-line patients, and in combination with GSK's (LSE:GSK) dostarlimab, a PD-1 inhibitor, in the front-line setting.
Elevation Oncology's share price reached the highest point in 2024 on March 1, hitting US$5.01. While it's no longer at that peak, the company's stock is still up considerably from the start of the year.
2. Candel Therapeutics (NASDAQ:CADL)
Year-to-date gain: 287.92 percent; market cap: US$171.69 million; share price: US$5.77
Candel Therapeutics is another NASDAQ biotech company focused on developing oncology treatments. The company’s pipeline includes two clinical stage multimodal biological immunotherapy platforms.
Candel’s lead product candidate CAN-2409 is in a Phase 2 clinical trial in non-small cell lung cancer and borderline resectable pancreatic cancer, as well as Phase 2 and 3 trials for localized, non-metastatic prostate cancer. Positive interim data for the trial on pancreatic cancer, released on April 4, sent the company's share price spiking upwards.
Its second lead product candidate is CAN-3110, which is in an ongoing Phase 1 clinical trial in recurrent high-grade glioma (HGG).
The company has had a number wins with the US Food and Drug Administration (FDA) so far this year. In February, Candel’s CAN-3110 received regulatory approval for a fast track designation for the treatment of recurrent HGG. The agency also granted Candel orphan drug designation for CAN-2409 for the treatment of pancreatic cancer in April and CAN-3110 for HGG in May.
This NASDAQ biotech stock has had an excellent second quarter this year. After spiking on positive interim trial data for CAN-2409 in April, it continued climbing to hit a year-to-date high of US$14.00 on May 15.
3. Benitec Biopharma (NASDAQ:BNTC)
Year-to-date gain: 201.25 percent; market cap: US$90.58 million; share price: US$9.67
California-based Benitec Biopharma is advancing novel genetic medicines via its proprietary “Silence and Replace” DNA-directed RNA interference platform. The company is currently focused on developing therapeutics for chronic and life-threatening conditions including oculopharyngeal muscular dystrophy (OPMD). Its drug candidate BB-301 was granted orphan drug designation by the FDA and the European Medicines Agency.
In April, Benitec reported positive interim clinical trial data for its first OPMD subject treated with BB-301 in its Phase 1b/2a study. Following the report, Benitec's share price began trending upward, and reached its highest point in 2024 on May 20 when it hit US$10.47. The company expects to report additional interim safety and efficacy data in the second half of the year.
4. Eliem Therapeutics (NASDAQ:ELYM)
Year-to-date gain: 151.11 percent; market cap: US$452.81 million; share price: US$6.78
Eliem Therapeutics is undergoing a transformation this year following the acquisition of private biotech firm Tenet Medicines in June. Going forward, Eliem’s focus will be on developing therapeutics for autoimmune-driven inflammatory diseases. Its lead product candidate is now TNT119, an anti-CD19 antibody targeting a range of autoimmune diseases, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy.
Eliem has also completed a US$120 million private placement bringing its total cash and cash equivalents of approximately US$220 million. The company says its planned operations are now sufficiently funded into 2027, and expects to initiate Phase 2 clinical trials of TNT119 this year.
Eliem is another NASDAQ biotech stock that had a great second quarter this year, posting a year-to-date high of US$10.20 on May 7.
5. Cardiol Therapeutics (TSX:CRDL)
Year-to-date gain: 128.77 percent; market cap: US$129.03 million; share price: US$1.87
Biopharma company Cardiol Therapeutics is developing novel treatments for inflammation and fibrosis in cardiovascular conditions, including pericarditis, myocarditis, and heart failure.
The company has two drug candidates in its pipeline: CardiolRX, an orally administered cannabidiol under clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis; and CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
The FDA granted CardiolRx orphan drug designation in February. Cardiol released positive top-line results in mid-June for its Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. The company believes the results will support moving the drug to Phase 3 clinical trials.
The positive news flow contributed to the strong momentum the stock has enjoyed this year, leading to a year-to-date share price high of US$2.91 on June 12.
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.
First Patient Dosed with PD-L1 Nanobody in Phase 1 Therapeutic Non-Small Cell Lung Cancer Trial
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer.
- First patient dosed with RAD 204 (PD-L1 nanobody) in a Phase 1 therapeutic trial at Wollongong Hospital, New South Wales.
- Phase 11 First-In-Human study designed to assess safety and tolerability of 177Lu-RAD204 in PD-L1-positive individuals with metastatic Non-Small Cell Lung Cancer (NSCLC).
- 16 patients previously dosed in Phase 1 diagnostic study demonstrated safety and effective biodistribution, and validate the strong potential for 177Lu-RAD204 for the treatment of advanced NSCLC.
- First patient dosed with RAD 204 marks a significant milestone in Radiopharm’s commitment to developing transformative oncology radiotherapeutics.
The open-label Phase 1 study, entitled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is a First-In-Human dose escalation trial of 177Lu-RAD 2041, and is designed to evaluate the safety and preliminary efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC. Previously published2 Phase I data of 16 NSCLC patients imaged with RAD 204 have demonstrated that the diagnostic is safe and associated with acceptable dosimetry.
The study is currently being conducted in Australia at Wollongong Hospital (NSW), Princess Alexandra Hospital (QLD), and Hollywood Private Hospital (WA), with the support of GenesisCare CRO.
“Radiopharm is delighted to announce this important milestone in our evolution to a clinical-stage company,” said Riccardo Canevari, CEO and Managing Director of Radiopharm. “Despite progressive improvements in the first-line setting for metastatic NSCLC, the majority of patients will progress and require further therapeutic options in the second-line setting. Current options following progression offer modest activity, making this setting an area of unmet need. With RAD 204, we hope to provide an alternative strategy that can improve clinical outcomes for NSCLC patients, while preserving quality of life.”
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, 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.
Can AI Help Detect Cancer? Data Analysis Could Open Up Possibilities for Healthcare Industry
Artificial intelligence (AI) has emerged as a valuable tool for solving complex societal issues, and although it's a new industry, its impact is already being felt in key areas of the life science sector.
AI models in healthcare are quickly advancing beyond basic tasks like medical transcription and administrative streamlining; many systems can now effectively analyze extensive genetic data.
By harnessing AI models' ability to identify patterns and make predictions, medical professionals can institute more effective, personalized treatments and develop precision tests to catch diseases earlier.
At this year’s Collision event, held in Toronto from June 18 to 20, Wesley Chan, co-founder and managing partner at venture capital firm FPV Ventures, shared insights on AI's role in healthcare with Fox Business correspondent Susan Li.
Chan said that while the life science market has been somewhat overlooked in the AI boom so far, his company predicts that it will benefit greatly from AI technology over the next five to 10 years.
“We’re in a lot of life science companies,” he said about FPV Ventures. “A lot of them use AI to help accelerate drug discovery, or to validate their thesis or to test out some of their assumptions without having to go in depth.”
Guardant using liquid biopsy tests to look for signs of cancer
Liquid biopsies, a non-invasive blood test, have shown strong promise in cancer detection, especially when it comes to monitoring ongoing treatment and detecting cancer recurrence.
Speaking at Collision, Dr. Craig Eagle, chief medical officer at large-cap biotechnology company Guardant Health (NASDAQ:GH), outlined SHIELD, a blood test his company has developed to screen for colorectal cancer.
“One of the things that’s challenging in oncology is that the cause of the disease is a molecular abnormality, often centered around the DNA. That abnormality can either be purely inherited or environmental, but for most people it’s in between," he explained to the audience at the conference.
Standard cancer diagnosis procedures typically involve retrieving a tissue sample, which Dr. Eagle said represents a challenge when the suspected cancer is deep within the body.
“So what we’re developing is blood-based testing. A simple tube of blood, no different to what you can do with a cholesterol or diabetes sugar test," he said on stage at the event, noting that during cell growth and turnover, some cancer cells are shed into the bloodstream. Liquid biopsy is a method of cancer detection that analyzes these shed cells to look for cancer signals in the bloodstream. Blood tests can also help physicians monitor cancer as it progresses and changes, which can help them develop the best treatment plan for each individual patient.
“You can't really treat or manage a cancer or disease unless you understand it. So by understanding the deeper molecular causes of cancer, we're actually able to get those insights even further and enable informed decision making," Dr. Eagle commented. "A simple liquid biopsy test gets the information you need at the molecular level."
How were liquid biopsy tests first developed?
One of the earliest liquid biopsy tests was the prostate-specific antigen test, which was approved by the US Food and Drug Administration (FDA) in 1986. It was initially only used to monitor cancer that had already been diagnosed, but in 1994 physicians began using it alongside digital rectal exams to screen for cancer signals in men over 50.
Later, researchers developed liquid biopsy tests that searched for two types of biomarkers in blood samples: circulating tumor cells (CTCs), which have detached from the primary tumor and entered the bloodstream, and circulating tumor DNA (ctDNA), smaller fragments that enter the blood when cancer cells die and break apart.
Ongoing efforts have been devoted to developing more comprehensive liquid biopsy tests. A 1999 study that detected aberrant p16 methylation in the blood of liver cancer patients provided the concept that biomarkers more specific to certain types of cancer can be detected in the blood. The completion of the Human Genome Project in 2003 helped further develop comprehensive cancer detection methods, including liquid biopsy tests.
The Cancer Genome Atlas was launched in 2006. It maps out the genomic changes in cancer and provides insights into its molecular basis, creating a clearer picture of cancer-specific biomarkers. Technologies like next-generation sequencing and microfluidic technologies were developed concurrently, enhancing the sensitivity of liquid biopsy tests by enabling the detection of rare cancer biomarkers. These new technologies also reduced costs and improved throughput.
Additionally, since the early 2000s the FDA has granted approval to multiple technologies specifically designed to capture and enumerate CTCs. Prior to the FDA's approval of CellSearch tumor detection technology for metastatic breast cancer in 2004, finding CTCs was challenging due to the rarity of these cells in the bloodstream. The development of the CellSearch technology revolutionized CTC detection by offering a non-invasive and highly sensitive approach.
Furthermore, the CellSearch technology helped researchers gain insights into the genomic alterations and signaling pathways that drive tumor growth, which can be used to tailor treatments to target specific molecular vulnerabilities.
Harnessing AI for better cancer detection
Guardant is one of the few companies with FDA-approved liquid biopsy companion diagnostic tests in the US market, and Dr. Eagle presented a compelling case for the widespread adoption of liquid biopsies in oncology.
He stressed that liquid biopsy tests offer a more effective and accessible way to test for cancer when compared to traditional screening methods. They are non-invasive and can easily be administered during other standard blood tests, eliminating the need for additional appointments or specialized equipment.
Dr. Eagle also noted that the convenience and simplicity of regular screenings would likely encourage more patients to participate, as they can be seamlessly integrated into their ongoing healthcare routines.
Aside from that, he pointed out that traditional cancer screenings can pose accessibility challenges for patients due to various barriers, such as geographical constraints, financial limitations or other factors. These obstacles can lead to prolonged waiting periods or limited access to procedures like colonoscopies, stool or tissue sample collection and imaging scans. Additionally, liquid biopsy tests provide results sooner than other methods. Meanwhile, the simplicity of the tests, combined with their ability to detect multiple cancer types, reduces their overall cost.
Liquid biopsies also have the potential to help researchers recognize signals of other diseases. Dr. Eagle explained that DNA damage is used as a metric to assess an individual's risk of developing a disease.
Rather than focusing only on the DNA sequence itself, epigenetics — the study of how genes are expressed and regulated — can help researchers understand the role of gene expression in cancer development and progression, as well as provide additional information about a person’s health.
“So that programming now becomes a massive database that we get to see in liquid biopsy,” said Dr. Eagle.
This is where AI becomes the most crucial. He emphasized that AI analytics will accelerate over the next five to 10 years, and that this technology will be essential for the successful analysis of enormous data sequences. He believes that there will be a rapid evolution in the field of oncology from its current state.
“We've got trials going on in smokers looking for lung cancer from a blood test, and we're seeing if we can break the back of that challenge. We're also looking at multiple cancers beyond that, whether it be lung cancer in nonsmokers, whether it be liver cancer, kidney cancer, breast cancer, etc. They're all going to be from a blood test.”
Investor takeaway
The integration of AI with innovative technologies like liquid biopsies holds immense potential to revolutionize disease detection, treatment and monitoring. These developments could pave the way for a future where personalized, preventative medicine becomes the norm.
Don’t forget to follow us @INN_Technology for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Top 3 Canadian Biotech Stocks of 2024
Biotech is a dynamic industry that is driving scientific advancements and innovation in healthcare.
According to Grandview Research, the global biotech market was worth US$1.55 trillion in 2023, and the firm expects it to grow at a CAGR of 13.96 percent between 2024 and 2030 to reach a value of US$3.08 trillion.
In Canada, the biotech industry is home to companies pursuing cutting-edge therapies and medical technologies, and the Investing News Network has identified the top three biotech stocks based on their year-on-year gains.
Data on Canadian biotech stocks was collected on July 2, 2024, using TradingView's stock screener and companies listed had market capitalizations of over C$50 million at that time. Companies on the TSX, TSXV and CSE were considered, but no TSXV-listed stocks made the list this time. Read on to learn what's been driving these biotech firms.
1. ME Therapeutics Holdings (CSE:METX)
Year-on-year gain: 7,900 percent; market cap: C$93.45 million; share price: C$4.00
ME Therapeutics Holdings is a biotechnology company focused on developing cancer-fighting drug candidates that can increase the efficacy of current immuno-oncology drugs by targeting suppressive myeloid cells, which have been found to hinder the effectiveness of existing immuno-oncology treatments. Immuno-oncology is a relatively new area of cancer drug research, and has shown promising results when used to treat cancer with low survival rates.
In December 2023, ME Therapeutics announced that its most advanced preclinical asset, h1B11-12, an antibody targeting G-CSF, had been found to bind to and neutralize G-CSF in lab tests and animal studies. Studies conducted with Dr. Kenneth Harder’s laboratory at the University of British Columbia revealed that G-CSF is involved in many different processes influencing how breast and colon cancers grow and spread.
In a January update, ME Therapeutics shared that preliminary results for clinical trials of h1B11-12 on non-human primates were tolerated well up to a dose of 10 milligrams per kilogram. The next step is to study how the drug behaves inside the body, which will help the company plan future research and decide how to continue developing h1B11-12.
ME Therapeutics saw a major share price boost on February 27, when it announced a non-brokered private placement to raise gross proceeds of up to C$1.55 million. It said it was unaware of any other change that would account for the rise.
2. Medicenna (TSX:MDNA)
Year-on-year gain: 172.86 percent; market cap: C$153.89 million; share price: C$1.91
Medicenna is a clinical-stage immuno-oncology company specializing in the development of innovative therapies for patients with challenging unmet needs. Its focus is on creating novel, highly selective versions of cytokines, such as IL-2, IL-4, and IL-13, which it refers to as "Superkines" and "empowered superkines."
Cytokines are small proteins that play a crucial role in regulating immune responses and helping cells communicate. Interleukins, which Medicenna says are at the core of its therapies, are groups of cytokines. The company's interleukins are engineered to fuse with specific molecules to optimize their function.
Medicenna's mission is to leverage its expertise in cytokine biology to design life-changing therapies that can potentially transform people's lives. Its therapies treat solid tumors, which have a low response rate to conventional cancer treatments, and autoimmune and neuroinflammatory diseases.
In April, the company shared the news that its lead candidate, MDNA11 has demonstrated therapeutic activity and an acceptable safety profile during clinical trials of monotherapy dose escalation in treating patients with advanced solid tumors. Late in the month, the company also closed on a C$20 million investment from RA Capital Management. The positive news flow provided enough momentum to push shares of Medicenna to a year-to-date high of C$2.85 on May 31.
More recently, Medicenna received regulatory approval for the European Medicines Agency to expand its phase 1/2 clinical trial of MDNA11 as a monotherapy and in combination with Keytruda to Europe.
3. Cardiol Therapeutics (TSX:CRDL)
Year-on-year gain: 116 percent; market cap: C$188.37 million; share price: C$2.70
Cardiol Therapeutics is a biopharma company developing innovative treatments for inflammation and fibrosis in cardiovascular conditions. Its research is concentrated on pericarditis, which is inflammation of the membrane surrounding the heart; myocarditis, or inflammation of the heart muscle; and heart failure.
Cardiol currently has two drug candidates in its pipeline. CardiolRX, the company's lead candidate, is an orally administered cannabidiol that is being clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis. Cardiol is also developing CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
The company's share price began a significant rise in mid-February, when the US Food and Drug Administration granted it orphan drug designation for CardiolRx. Less than a week later, Cardiol completed patient enrollment in a Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis.
The company went on to release positive top-line results in mid-June, which Cardiol President and CEO David Elsley said demonstrated "that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation." The company believes the results will help move the drug to Phase 3 clinical trials.
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.
Editorial Disclosure: Cardiol Therapeutics is a client of the Investing News Network. This article is not paid-for content.
Investor Webinar – 3pm AEST Tuesday 2 July
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that CEO and Managing Director Riccardo Canevari and Executive Chairman Paul Hopper will conduct an investor webinar to provide an update following announcement of the Company’s $70 million capital raising.
When: 3pm AEST, Tuesday 2 July 2024
Register at: https://us02web.zoom.us/webinar/register/WN_wcKESuixTf2e5TRIwVAW_Q
Upon registering attendees will receive an email containing information about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Radiopharm’s website and social media channels.
Questions can be sent in advance of the webinar to matt@nwrcommunications.com.au.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, 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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