During a fireside chat with analysts from Brookline Capital Markets, Radiopharm Theranostics’ (ASX:RAD) CEO Riccardo Canevari provided clinical and corporate updates highlighting the company’s achievements while waiting for the completion of its listing on the NASDAQ expected at the end of 2024.
Canevari provided some updates about the joint venture with MD Anderson Cancer Center and the progress with the B7-H3 targeting radio-antibody (BetaBart). BetaBart is the first targeted radiopharmaceutical against the 4Ig subtype of B7-H3, the most common subtype expressed in human tumors.
“Management is initially targeting small cell lung cancer but sees additional opportunities in colon, renal, lung, cervical, prostate and glioma cancers,” Canevari said. The joint venture is expecting to undertake its first-in-human Phase 1/2 therapeutic trial by mid-2025.
Canevari also outlined the progress of RAD’s focus programs including RAD101 for imaging brain metastases; RAD204 in NSCLC; RAD301 imaging in pancreatic cancer; and RAD202 in breast/gastric:
RAD initiated the process to obtain asecondary listing on the Nasdaq Capital Market in 2023, which the company expects to be completed by the end of 2024.
For the full analyst report, click here.
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Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.
Radiopharm Theranostics (ASX:RAD) is an innovative biopharmaceutical company specializing in the development of radiopharmaceutical products for both diagnostic and therapeutic applications. Founded with a mission to address significant unmet medical needs, particularly in oncology, the company has positioned itself at the forefront of the rapidly evolving field of precision medicine.
Radiopharm Theranostics presents a compelling value proposition for investors, characterized by several key factors:
Lantheus’ investment in Radiopharm marks a pivotal moment for both companies and holds substantial implications for the field of theranostics. The funding will facilitate Radiopharm's research and development efforts, accelerating its product pipeline and market presence. Under the agreement, Radiopharm will transfer two early preclinical assets to Lantheus for a further AU$3 million, fostering a collaborative relationship focused on radiopharmaceutical development. The collaboration positions Radiopharm to capitalize on the increasing demand for theranostic solutions, aligning with trends in personalized medicine. Moreover, this financial backing will support clinical trials and operational needs, while also aiming for the commercialization of their products.
Radiopharm has four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb) – with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development.
Radiopharm’s clinical stage development in the pipeline include:
The company recently received FDA approval for its investigational new drug application for 18-Pivalate (RAD 101). Labelled with the radioisotope F18, Pivalate is a small molecule that targets fatty acids synthase, which is overexpressed in brain tumours but not in normal cells.
Positive data from the company’s Phase 2 imaging trial of 17 patients with brain metastases has shown significant tumour uptake. Radiopharm holds an exclusive global license for the Pivalate platform.
Radiopharm highlights that Pivalate is potentially a new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients a better option in relation to current imaging technology, which has many limitations.
Paul Hopper is the founder of Radiopharm Theranostics. He has over 25 years of experience in the biotech, healthcare and life sciences. Focused on start-up and rapid-growth companies, he has served as the founder, chairman, non-executive director or CEO of more than 15 companies in the US, Australia and Asia. Previous and current boards include Imugene, Chimeric Therapeutics, Viralytics, Prescient Therapeutics and Polynoma. His experience covers extensive fund raising in US, Australia, Asia and Europe, and he has deep experience in corporate governance, risk management, and strategy.
Riccardo Canevari has broad and deep experience across specialty pharma, oncology and radiopharmaceuticals. He was most recently chief commercial officer of Novartis Advanced Accelerator Applications, one of the leading radiopharmaceutical and nuclear medicine companies, globally. He was responsible for global commercial strategy and country organizations in ~20 countries across North America, Europe and Asia. He was responsible for Lutathera’s in-market growth strategy and execution to build a blockbuster asset and for the pre-launch plan for Lu-PSMA 617 in metastatic prostate cancer. Prior to this, Canevari was senior vice-president and global head, breast cancer franchise for Novartis Oncology since 2017, overseeing the launch of major breast cancer products, including KISQALI and PIQRAY. He also held various management roles with Novartis Pharma and Ethicon/Johnson & Johnson.
Dr. Sherin Al-Safadi is an accomplished industry leader with many years of experience in pharmaceuticals and biotech. Most recently she was vice-president – medical affairs at POINT Biopharma, where she led the strategic and tactical planning for Phase III support and launch preparation of radiopharmaceuticals. She also provided strategic input and leadership for business development and licensing opportunities. She currently serves as co-founder and president at Foundation Amal (Canada-USA), overseeing an executive leadership team of 12 directors and members, who led the successful 2021 cross-border expansion into the USA and spearheaded the development of a successful branding and communication strategy. Al-Safadi holds a PhD in neurobiology from Concordia University, an MBA in entrepreneurship & management from the John Molson School of Business, and a MSc in pharmacology (oncology drug development) from McGill University.
Vimal Patel joins RAD from Orum Therapeutics where he was vice-president, head of CMC and supply chain. He was responsible for all CMC functions including process and analytical development, manufacturing, quality control, quality assurance, regulatory and supply chain. He led the successful manufacture of two ADCs and contributed to filing an IND leading to a Phase-I trial. Prior to Orum, Patel held roles of increasing responsibility in process development and manufacturing sciences at several companies, including Actinium Pharmaceuticals. Patel also held a position at Pfizer where he contributed to the refiling of Mylotarg and the filing of Besponsa BLAs. He also developed manufacturing processes for various ADCs. He also held roles at Daiichi Sankyo, Progenics Pharmaceuticals and SibTech in various capacities. Patel has MS in biotechnology from University of Connecticut and B.S. in chemical engineering from Sardar Patel University.
Noel Donnelly brings more than 25 years of leadership experience in finance, strategy and operations within the biopharmaceutical and biotechnology industries. He has a distinguished track record of building and leading cross-functional teams, driving corporate governance and executing complex financial strategies that support rapid company. growth. Donnelly is current the chief financial officer of PepGen, where he oversaw the company's financial strategy through its successful IPO, raising U$120 million and leading subsequent financial efforts that secured an additional US$90 million. Donnelly was previously the CFO of EIP Pharma (now, CervoMed), where he led the company's IPO plannig phase. He had a 15-year tenure at Takeda/Shire PLC, in various senior roles, where he led critical R&D integrations and oversaw more than US$160 billion in integration planning and execution. He was instrumental in shaping the company's portfolio management strategy.
Hollywood actors, professional athletes, and award-winning musicians alike have all relied on Don Saladino, coach and trainer of over 20 years, to reach their full potential in physical fitness. As an advisor to Cizzle Brands, Mr. Saladino will provide his insights, expertise, and access to his vast professional network for the commercialization and promotion of Cizzle Brands' product lines at a global scale.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that Don Saladino, a renowned coach and fitness expert to many A-List celebrities, professional athletes, and award-winning musicians has been engaged as an advisor to Cizzle Brands to help guide the Company's commercialization journey in the health and wellness space. Under his agreement with Cizzle Brands, Mr. Saladino will provide sales, marketing, and promotional support for Cizzle Brands' offerings, including through his TikTok (165k followers) and Instagram (432k followers) social media channels.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250121943080/en/
Don Saladino's one-minute Intro Reel video can be viewed on YouTube: https://www.youtube.com/watch?v=5L57AYEjZF4 (Photo: Business Wire)
Mr. Saladino has developed a reputation for training several A-List Hollywood stars, including Ryan Reynolds, Blake Lively, Anne Hathaway, John Krasinski, Emily Blunt, Liev Schreiber, Hugh Jackman and Joanna Gaines. In 2020, Mr. Saladino pivoted from running a brick-and-mortar gym in New York City to operating a global online fitness business which includes workout programs and challenges, an e-commerce portal for supplements, the Don Saladino App (available on the Apple App Store and Google Play), and yearly fitness retreats. Mr. Saladino has an extensive network of celebrity personalities to whom he will be supplying Cizzle Brands' products throughout the course of their training programs.
Additionally, Mr. Saladino has received extensive media coverage. Magazines such as Men's Health , Women's Health , and Muscle & Fitness have cited Mr. Saladino as a fitness expert. Muscle & Fitness has also featured Mr. Saladino on its print magazine cover in March 2018, October 2021, and November 2023. Other publications have featured Mr. Saladino including People , US Weekly , Cosmo , and Shape . Additionally, Mr. Saladino has done live fitness demonstrations on The Golf Channel , The Today Show , Good Morning America , Page Six TV , People NOW , E News , Fox News , and WebMD .
More information about Don Saladino can be found on his website at the following link: https://donsaladino.com/
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "We are keen to be working with Don, as he is one of the most recognized names in the fitness world with a highly engaged following, a well-earned reputation for generating results, and a broad network of highly influential executives. Cizzle Brands is only getting started with building out its presence in the world of health and wellness. With Don's knowledge of what the world's most elite athletes, entrepreneurs, and actors are demanding, we expect he will prove to be extraordinarily valuable to us as an advisor."
Regarding his appointment as an advisor to Cizzle Brands, Don Saladino commented, "In today's marketplace, very few companies truly have what it takes to formulate and produce athlete-grade products for training, nutrition, hydration, and overall wellness while also being appropriate for active people of all ages. The proven team behind Cizzle Brands has already demonstrated their ability to meet this standard with the recent successful launch of CWENCH Hydration™ which has already sold more than one million ready-to-drink units in less than a year on the market, with even more exciting offerings set to hit the market soon. As someone who personally incorporates Cizzle Brands' products into nutrition regimes for myself, my wife, and our two children, I am honoured to be part of the Cizzle Brands team, and there are exciting times to be had for all of us in 2025!"
Cizzle Brands also announced the issuance of 455,645 common shares (the "Settlement Shares") of the Company at a deemed price of $0.31 in settlement of $141,250 in debt. The Settlement Shares were issued to a provider who elected to receive part of their service fee in shares as opposed to cash. The Settlement Shares will be subject to a statutory hold period expiring four months and one day after the date of issuance pursuant to National Instrument 45-102 – Resale of Securities .
Celenza added: "I've always sought to have our key partners invested in our success, so I was pleased when one of our key professional advisers opted to receive part of their fee in equity. To me, it is one of the highest endorsements we've received to date."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed 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/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and 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: new products of the Company and potential sales and distribution opportunities; the role of Mr. Saladino with Cizzle Brands; the supply of Cizzle Brands' products through Mr. Saladino's training programs; the building of Cizzle Brands' presence in the world of health and wellness; and the value of Mr. Saladino as an advisor to Cizzle Brands. 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.
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For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). 1*
"Colorectal cancer is the third leading cause of cancer-related deaths in the United States , and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. 2 "LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."
The CodeBreaK 300 clinical trial compared LUMAKRAS at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC. Study results demonstrated that LUMAKRAS 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a p -value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant. Safety profiles were consistent with those historically observed for LUMAKRAS and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of LUMAKRAS 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant.
The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test. 3-5 This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.
"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih , M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. 3-6 "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with KRAS G12C-mutated metastatic colorectal cancer."
"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza , Chief Executive Officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."
* Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled 160 participants and compared LUMAKRAS ® (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix ® (panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.
About mCRC and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses. 7 It is also the third most commonly diagnosed cancer globally. 8
Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%. 9
KRAS mutations are among the most common genetic alterations in CRC, with the KRAS G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test. 3-5
About LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab)
In the U.S., LUMAKRAS is now approved in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines LUMAKRAS, a KRAS G12C inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of LUMAKRAS is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
LUMAKRAS received accelerated approval from the FDA on May 28, 2021 . The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023 , which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.
About Vectibix ® (panitumumab)
Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab) U.S. Indication
Vectibix ® in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C -mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
LIMITATIONS OF USE
Vectibix ® is not indicated for the treatment of patients with RAS- mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix ® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION FOR LUMAKRAS ® (SOTORASIB)
Hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Most Common Adverse Reactions
Drug Interactions
Please see accompanying LUMAKRAS ® full Prescribing Information .
IMPORTANT SAFETY INFORMATION FOR VECTIBIX ® (PANITUMUMAB)
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix ® monotherapy
Please see full Prescribing Information , including Boxed WARNING.
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. 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, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.
Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
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. 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. 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)
References
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Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). 1*
"Colorectal cancer is the third leading cause of cancer-related deaths in the United States , and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. 2 "LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."
The CodeBreaK 300 clinical trial compared LUMAKRAS at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC. Study results demonstrated that LUMAKRAS 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a p -value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant. Safety profiles were consistent with those historically observed for LUMAKRAS and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of LUMAKRAS 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant.
The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test. 3-5 This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.
"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih , M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. 3-6 "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with KRAS G12C-mutated metastatic colorectal cancer."
"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza , Chief Executive Officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."
* Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled 160 participants and compared LUMAKRAS ® (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix ® (panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.
About mCRC and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses. 7 It is also the third most commonly diagnosed cancer globally. 8
Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%. 9
KRAS mutations are among the most common genetic alterations in CRC, with the KRAS G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test. 3-5
About LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab)
In the U.S., LUMAKRAS is now approved in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines LUMAKRAS, a KRAS G12C inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of LUMAKRAS is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
LUMAKRAS received accelerated approval from the FDA on May 28, 2021 . The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023 , which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.
About Vectibix ® (panitumumab)
Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab) U.S. Indication
Vectibix ® in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C -mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
LIMITATIONS OF USE
Vectibix ® is not indicated for the treatment of patients with RAS- mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix ® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION FOR LUMAKRAS ® (SOTORASIB)
Hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Most Common Adverse Reactions
Drug Interactions
Please see accompanying LUMAKRAS ® full Prescribing Information .
IMPORTANT SAFETY INFORMATION FOR VECTIBIX ® (PANITUMUMAB)
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix ® monotherapy
Please see full Prescribing Information , including Boxed WARNING.
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. 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, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.
Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
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. 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. 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)
References
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SOURCE Amgen
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With a combined social media following of more than one million users, Coach Chippy is a leading influencer in youth hockey. Through his Tropical Flow flavour of CWENCH Hydration, which will be available for purchase at Pro Hockey Life, Source for Sports, Sports Excellence and other leading retailers, Coach Chippy will be creating greater visibility for CWENCH Hydration in a key demographic for the brand.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that it has teamed up with famed Canadian hockey influencer Coach Chippy to launch Tropical Flow , a special edition Coach Chippy-inspired flavour of CWENCH Hydration. Tropical Flow , which will be available in ready-to-drink and hydration mix formats, is CWENCH Hydration's fifth flavour option, along with Rainbow Swirl, Blue Raspberry, Cherry Lime and Berry Crush.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250116330910/en/
Canadian hockey influencer Coach Chippy has teamed up with Cizzle Brands to launch Tropical Flow, a new flavour of CWENCH Hydration™. Through his social media channels and major presence within the Canadian hockey sphere, the Company expects to cultivate valuable awareness for the CWENCH brand. (Photo: Business Wire)
The launch of Tropical Flow further strengthens the market position of CWENCH Hydration™ in the sports nutrition market. In Cizzle Brands' most recent quarterly financial results, the Company reported CAD $2.8 million in revenue from sales of CWENCH Hydration™ beverages and mixes, with CAD $1.75 million in gross profit for a 62.5% gross margin. Since its launch in late May of 2024, more than one million ready-to-drink ("RTD") units of CWENCH Hydration™ have been sold.
Under the agreement with Coach Chippy, Cizzle Brands will release a special-edition tropical fruit flavour of CWENCH Hydration™ featuring images of Coach Chippy, as well as his Style & Flow tagline (pictured below). At launch, Tropical Flow will be available for purchase at Pro Hockey Life, Source for Sports, Sports Excellence, Canlan Ice Sports and Buckingham Sports Group with additional retailers expected to offer it soon.
Coach Chippy will be a key driver in creating awareness for CWENCH Hydration and Tropical Flow through his social media profiles, which include:
TikTok: @coachchippyy (736,000 followers)
Instagram: @coach.chippy (450,000 followers)
YouTube: @coachchippy (111,000 followers)
More information about Coach Chippy can be found on his website at the following link: https://coachchippy.ca/en-cad/
Following its launch at the end of May 2024, CWENCH Hydration™ has established a robust brand profile among professional athletes and fans of all ages. As detailed in Cizzle Brands' Market Introduction press release , NHL players including Nathan MacKinnon and Cole Caufield have endorsed CWENCH Hydration™ as well as NBA All-Star Andrew Wiggins, Canadian Olympian Adriana Leon and up-and-coming hockey stars Gavin McKenna, Chloe Primerano and Jade Iginla. Additionally, CWENCH Hydration™ is the named sponsor of a four-rink hockey arena in Toronto known as CWENCH Centre - a Canlan Sports Community as well as a sponsor of over 500 youth hockey teams, which has the CWENCH brand displayed on the hockey gear of more than 12,000 youth hockey players across North America.
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "In many ways, Coach Chippy represents so much of what is great about youth hockey - passion, commitment and a great sense of joy. His message resonates with so many kids. As a dad myself, I hear about Coach Chippy all the time and know how much clout he has with one of our key demographics for CWENCH Hydration™. Chippy has been a part of the Cizzle Brands story since the early days of the Company, and we are thrilled to be deepening our partnership with him to further strengthen the profile of CWENCH Hydration™ in hockey communities across North America."
Coach Chippy added, "I've had a bunch of companies hit me up about product partnerships, but teaming up with the crew at Cizzle Brands was a no-brainer. When you're dialed in on being your best, CWENCH Hydration™ is the real deal. It's all-natural, sugar-free, and loaded with 6+ electrolytes. The product being healthy was a big deal for me—it's one of the main reasons I decided to put my name (and face) behind it. Staying hydrated the smart way is a huge part of the whole Style and Flow vibe. I'm really excited to bring Tropical Flow to the market."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed 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/
For more information about Spoken Nutrition, please visit: https://spokennutrition.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: new products of the Company and potential sales and distribution opportunities. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250116330910/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
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Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) is excited to announce that its cutting-edge anti-aging compound, TFC-1326, has been highlighted in Stonegate Healthcare Partners' latest research report. The publication, titled "Sirona Biochem's TFC-1326 Clinical Data Versus Retinoid Clinical Data," provides an extensive evaluation of TFC-1326's clinical trial performance, setting it apart from traditional retinoid treatments.
The report outlines the remarkable benefits of TFC-1326, including:
Stonegate Healthcare's analysis underscores TFC-1326's ability to deliver rapid, consistent results while also providing potent antioxidant and anti-inflammatory benefits. Unlike traditional retinoids, which can cause irritation, TFC-1326 is ideal for all skin types, including sensitive skin, redefining what's possible in the $12.5 billion global anti-aging market.
"This recognition by Stonegate Healthcare Partners highlights the transformative potential of TFC-1326," said Dr. Verrico, CEO of Sirona Biochem. "Our mission has always been to push the boundaries of skincare science, and we are proud to see our innovation recognized in this detailed analysis."
The publication positions TFC-1326 as a disruptive force in cosmetic dermatology, offering a highly effective, user-friendly alternative to conventional treatments. This achievement reflects Sirona Biochem's ongoing commitment to pioneering advanced solutions in the skincare industry.
Access the Full Report Here: https://shp.reportablenews.com/pr/stonegate-healthcare-research-update-on-sirona
https://stonegateinc.com/download/stonegate-healthcare-partners-announces-publication-of-a-literature-review-on-anti-aging-dermatology/?wpdmdl=1269&refresh=677efef279b251736376050
About Sirona Biochem Sirona is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees, and ongoing royalty payments. Sirona's laboratory, TFChem, is in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
Forward Looking Statements This news release includes certain statements that may be deemed "forward-looking statements." All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," "projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include market prices, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance, and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates, or opinions, or other factors, should change.
Contact Information: Christopher Hopton
Chief Financial Officer
Sirona Biochem Corp.
Phone: (604) 641-4466
Email: info@sironabiochem.com
Website: www.sironabiochem.com
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Cizzle Brands (CBOE:CZZL) is a sports nutrition company driving transformative change within the health and wellness industry. The company commenced trading on CBOE Canada on December 30, 2024, marking a significant milestone in its growth trajectory.
Cizzle Brands leverages deep-rooted connections in the professional sports sector by collaborating with elite athletes to trial and refine health and wellness products to ensure optimal performance, while still being appropriate for athletes of all ages. The CWENCH Hydration products underscore its commitment to premium-quality offerings.
Through Cizzle's broad-based grassroots programs, more than 12,000 youth athletes across North America are sponsored by Cizzle, featuring CWENCH logos on their helmets, jerseys and water bottles.
This Cizzle Brand Corporation profile is part of a paid investor education campaign.*
Click here to connect with Cizzle Brand (CBOE:CZZL) to receive an Investor Presentation
