With the debut of CWENCH Hydration™ in its first major Canadian grocer, Cizzle Brands anticipates that it will be able to further penetrate the mainstream consumer market alongside the specialty athletic and fitness-related markets. Starting this month, CWENCH Hydration™ mix packets will be offered in the pharmacy section of 47 Metro supermarkets across the province of Ontario.
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Completion of Divesture of Non-US Assets
Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte US” or “the Company”) refers to its announcement released pre-open on 2 October 2024 regarding entry into an Intellectual Property Sales Agreement (the ‘Agreement’) and related documents with Prestige Consumer Healthcare Inc. and associated subsidiaries.
Hydralyte US is pleased to announce that the Agreement has completed and the sale proceeds of approximately US$9.45m (A$13.7m) have been received.
Click here for the full ASX Release
This article includes content from The Hydration Pharmaceuticals Company 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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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.
Lantheus increases shareholding in RAD with A$8m placement
CWENCH Hydration Gains Distribution in Metro Supermarkets Across Ontario
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") is pleased to announce that its flagship product CWENCH Hydration™ is launching in supermarkets operated under the Metro banner in Ontario, operated by the Metro, Inc. parent company. Initially, the pharmacy sections of 47 Metro supermarkets will be carrying CWENCH Hydration™ mix packets, sold in a 10-count format, which will be available in-store by the end of January 2025.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250109944605/en/
10-count packs of CWENCH Hydration™ mix will be sold in the pharmacy section of 47 Metro supermarkets in Ontario by the end of January 2025. (Photo: Business Wire)
This launch complements CWENCH Hydration™'s existing retail footprint in major Canadian chain retailers which includes Sport Chek, Canadian Tire, and Source for Sports, as detailed in Cizzle Brands' January 7, 2025 press release. Following this launch, CWENCH Hydration™ will be sold in more than 1,300 points of sale across Canada, the United States, and Europe.
The launch of CWENCH Hydration™ in Metro's Ontario supermarkets will mark the brand's first entry into the Canadian large-chain grocery market segment, which Cizzle Brands expects to help bolster mainstream adoption of CWENCH Hydration™ products.
To drive visibility of CWENCH Hydration™, Cizzle Brands will be working with Metro to provide training resources and materials for employees to improve conversion rates. Cizzle Brands also plans to provide ancillary marketing support to promote awareness of CWENCH Hydration's availability in Metro supermarkets.
As of September 28, 2024, Metro operates 995 stores primarily in Ontario and Quebec under banners including Metro , Metro Plus , Food Basics , and Super C . More information about Metro can be found on its website: https://www.metro.ca/
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "Here in Ontario, Metro is one of the most recognized names in the grocery category, and so we are very pleased that Metro is beginning to stock CWENCH Hydration™ products in its Ontario stores so shortly after we first launched the brand. Our objective is to turn CWENCH Hydration™ into a household name that is recognized as a better hydration option for athletes of all ages, and we believe that availability at Metro supermarkets will be a key step towards that. We look forward to working together to make this new-found partnership a productive and fruitful long-term business relationship."
About Cizzle Brands Corporation
Cizzle Brands is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands launched CWENCH Hydration in May of 2024, a better-for-you sports nutrition beverage that is now carried in over 1,200 stores in Canada, the United States, and Europe. CWENCH Hydration is tailored to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH, please visit: https://cwenchhydration.com/
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: the listing of the Company's common shares on the Cboe Canada; the timing of the commencement of trading of the common shares; and new products of the Company. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
Readers using news aggregation services may be unable to view the media. Please access SEDAR+ or the Investors section of the Company's website for a version of this press release containing all published media.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250109944605/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
CWENCH Hydration Gains Distribution in Metro Supermarkets Across Ontario
With the debut of CWENCH Hydration™ in its first major Canadian grocer, Cizzle Brands anticipates that it will be able to further penetrate the mainstream consumer market alongside the specialty athletic and fitness-related markets. Starting this month, CWENCH Hydration™ mix packets will be offered in the pharmacy section of 47 Metro supermarkets across the province of Ontario.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") is pleased to announce that its flagship product CWENCH Hydration™ is launching in supermarkets operated under the Metro banner in Ontario, operated by the Metro, Inc. parent company. Initially, the pharmacy sections of 47 Metro supermarkets will be carrying CWENCH Hydration™ mix packets, sold in a 10-count format, which will be available in-store by the end of January 2025.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250109944605/en/
10-count packs of CWENCH Hydration™ mix will be sold in the pharmacy section of 47 Metro supermarkets in Ontario by the end of January 2025. (Photo: Business Wire)
This launch complements CWENCH Hydration™'s existing retail footprint in major Canadian chain retailers which includes Sport Chek, Canadian Tire, and Source for Sports, as detailed in Cizzle Brands' January 7, 2025 press release. Following this launch, CWENCH Hydration™ will be sold in more than 1,300 points of sale across Canada, the United States, and Europe.
The launch of CWENCH Hydration™ in Metro's Ontario supermarkets will mark the brand's first entry into the Canadian large-chain grocery market segment, which Cizzle Brands expects to help bolster mainstream adoption of CWENCH Hydration™ products.
To drive visibility of CWENCH Hydration™, Cizzle Brands will be working with Metro to provide training resources and materials for employees to improve conversion rates. Cizzle Brands also plans to provide ancillary marketing support to promote awareness of CWENCH Hydration's availability in Metro supermarkets.
As of September 28, 2024, Metro operates 995 stores primarily in Ontario and Quebec under banners including Metro , Metro Plus , Food Basics , and Super C . More information about Metro can be found on its website: https://www.metro.ca/
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "Here in Ontario, Metro is one of the most recognized names in the grocery category, and so we are very pleased that Metro is beginning to stock CWENCH Hydration™ products in its Ontario stores so shortly after we first launched the brand. Our objective is to turn CWENCH Hydration™ into a household name that is recognized as a better hydration option for athletes of all ages, and we believe that availability at Metro supermarkets will be a key step towards that. We look forward to working together to make this new-found partnership a productive and fruitful long-term business relationship."
About Cizzle Brands Corporation
Cizzle Brands is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands launched CWENCH Hydration in May of 2024, a better-for-you sports nutrition beverage that is now carried in over 1,200 stores in Canada, the United States, and Europe. CWENCH Hydration is tailored to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH, please visit: https://cwenchhydration.com/
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: the listing of the Company's common shares on the Cboe Canada; the timing of the commencement of trading of the common shares; and new products of the Company. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
Readers using news aggregation services may be unable to view the media. Please access SEDAR+ or the Investors section of the Company's website for a version of this press release containing all published media.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250109944605/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Top 5 Small-cap Biotech Stocks (Updated January 2025)
The NASDAQ Biotechnology Index (INDEXNASDAQ:NBI) is trading at three-year highs in response to breakthrough innovations and increased deals for biotech stocks on the NASDAQ.
After dropping to a low of 3,637.05 in October 2023, the index climbed to a high of 4,954.813 on September 19, 2024. While the NBI is trading down at 4,399.36 as of January 7, 2025, further growth could be in store in the future. However, the current economic environment means the biotech sector may have a complex road ahead.
According to a recent report from Precedence Research, the global biotech market is expected to grow at a compound annual growth rate of 11.5 percent from now to 2034, reaching a valuation of US$4.61 trillion.
Driving that growth will be favorable government policies, investment in the sector, increased demand for synthetic biology and a rise in chronic disorders such as cancer, heart disease and hypertension.
The top NASDAQ biotech stocks have seen sizeable share price increases over the past year. For those interested in investing in biotech companies, the best-performing small-cap biotech stocks are outlined below.
Data was gathered on January 7, 2025, using TradingView’s stock screener, and all top small-cap biotech stocks in the list had market caps between US$50 million and US$500 million at that time.
1. Bright Minds Biosciences (NASDAQ:DRUG)
Year-over-year gain: 2,232.41 percent
Market cap: US$281.1 million
Share price: US$40.22
Bright Minds Biosciences is developing novel treatments for pain and neuropsychiatric disorders such as epilepsy, post-traumatic stress disorder and difficult-to-treat depression.
The company's platform includes serotonin agonists designed to provide powerful therapeutic benefits while minimizing the side effects.
Bright Minds is currently in Phase 2 clinical trials for its BMB-101, a highly selective 5-HT2C receptor agonist, in adult patients with classic absence epilepsy and developmental epileptic encephalopathy.
Bright Minds Biosciences' stock rocketed upwards in the fourth quarter, shooting up from US$2.49 to US$38.49 in one day on October 15. The company issued a press release stating it was "unaware of any material changes in the company's operations" that would have contributed to such a rally. The outperformance instead appears to be related to the October 14 announcement of Danish pharma company Lundbeck acquiring Longboard Pharma, another biotech company developing a 5-HT2C receptor agonist, for US$60 per share.
A few days later, Bright Minds announced a non-brokered private placement of US$35 million, which sent shares up to US$47.21 on October 18.
That same month the company shared its collaboration with Firefly Neuroscience (NASDAQ:AIFF) to use the latter’s advanced artificial intelligence, FDA-cleared BNA technology platform to provide a full analysis of the electroencephalogram (EEG) data from Bright Minds' BMB-101 Phase 2 clinical trial. This follows the pair’s previous successful collaboration to analyze data from Bright Mind’s first-in-human Phase 1 study of BMB-101.
Bright Minds' share price reached their highest yearly peak of US$55.77 on November 6.
2. Candel Therapeutics (NASDAQ:CADL)
Year-over-year gain: 518.52 percent
Market cap: US$371.37 million
Share price: US$8.35
Candel Therapeutics is a 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, 2024, sent the company's share price spiking upwards. It ultimately climbed to a year-over-year high of US$14.30 on May 16.
More recently, in December 2024, the company released positive topline data for CAN-2409 viral immunotherapy, achieving the primary endpoint in its Phase 3 prostate cancer trial.
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 had a number wins with the US Food and Drug Administration (FDA) in 2024. 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.
3. Rezolute Bio (NASDAQ:RZLT)
Year-over-year gain: 467.04 percent
Market cap: US$314.63 million
Share price: US$5.43
Late-stage biopharma company Rezolute is developing novel therapies targeting rare and chronic metabolic diseases. At the top of the company’s drug pipeline is RZ358, called ersodetug, which is being studied for the treatment of congenital hyperinsulinism and tumor hyperinsulinism. The company also has RZ402, which is targeted for patients with diabetic macular edema.
Ersodetug is currently in global Phase 3 clinical studies for congenital hyperinsulinism, with topline data expected in mid-2025. It opened to US participation in September after the FDA removed partial clinical holds.
In March, Rezolute shared results from a preclinical study that validated ersodetug’s potential to treat patients with non-islet cell tumors that have uncontrolled hypoglycemia. Rezolute announced positive topline results for its Phase 2 study of RZ402 in May.
The biotech stock had a great run up in the second quarter this year, climbing to an H1 2024 high of US$6.799 on June 5. Since then, Rezolute shares have managed to retain much of that value with a series of positive news releases.
The company closed on a public offering with net proceeds of about US$56.4 million later in June, which will help to fund post-Phase 3 planning for its ersodetug program in congenital hyperinsulinism as well as a potential late-stage, registrational, clinical study of ersodetug in patients with tumor hyperinsulinism associated with islet cell and non-islet cell tumors.
In August, the FDA granted clearance for Rezolute’s investigational new drug application for a Phase 3 study of ersodetug in tumor hyperinsulinism. Patient enrollment is slated to begin in the first half of 2025. In December, the FDA granted ersodetug orphan drug status for the treatment of hypoglycemia due to tumor HI.
Rezolute kicked off the new year with another FDA approval, this time garnering the breakthrough therapy designation for ersodetug for the treatment of hypoglycemia due to congenital hyperinsulinism.
4. Entera Bio (NASDAQ:ENTX)
Year-over-year gain: 301.52 percent
Market cap: US$97.61 million
Share price: US$2.65
Entera Bio’s proprietary N-Tab technology oral delivery platform allows for the development of therapies based on peptides and therapeutic proteins. The company is targeting a variety of indications, including osteoporosis, hyperparathyroidism and short bowel syndrome.
The company released a series of significant updates in March and April. This included the announcement of positive pharmacokinetic data for GLP-2 peptide tablet treatment for patients with short bowel syndrome as part of a joint study combining OPKO Health’s (NASDAQ:OPK) proprietary long acting GLP-2 agonist with Entera’s N-Tab technology.
In April, Entera announced the publication of Phase 2 clinical trial data from its EB613 program for osteoporosis. Unlike available osteoanabolic treatments, which are injections, EB613 is a once daily treatment administered through oral PTH(1-34) peptide tablets. According to the release, "Significant gains in bone mineral density of the spine and hip were observed at the end of the 6-month study and there were no significant safety concerns."
Entera Bio's share price reached its yearly peak of US$2.98 on April 12, 2024.
5. Benitec Biopharma (NASDAQ:BNTC)
Year-to-date gain: 251.42 percent
Market cap: US$258.63 million
Share price: US$11.14
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 US$10.47 on May 10.
Benitec is well-funded to advance its BB-301 clinical development program through the end of 2025. The company reported additional positive interim safety and efficacy data in mid-November. The company's share price hit its highest yearly value on December 11 at US$13.08.
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.
AMGEN TO PRESENT AT 43RD ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE
Amgen (NASDAQ:AMGN) will present at the 2025 J.P. Morgan Healthcare Conference at 3:00 p.m. PT on Monday, January 13, 2025 . Robert A. Bradway chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-to-present-at-43rd-annual-jp-morgan-healthcare-conference-302346181.html
SOURCE Amgen
News Provided by PR Newswire via QuoteMedia
AMGEN TO PRESENT AT 43RD ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE
Amgen (NASDAQ:AMGN) will present at the 2025 J.P. Morgan Healthcare Conference at 3:00 p.m. PT on Monday, January 13, 2025 . Robert A. Bradway chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-to-present-at-43rd-annual-jp-morgan-healthcare-conference-302346181.html
SOURCE Amgen
News Provided by PR Newswire via QuoteMedia
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