The Conversation (0)
Cardiol Therapeutics President and CEO, David Elsley
Description
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 101, an F18 radiolabeled Pivalate for brain metastases, received FDA IND approval for a Phase 2b trial aiming to enroll 30 patients, with the first dose expected in Q4 2024 and results anticipated mid-2025.
- RAD 204, a Lu-177-labeled nanobody targeting PD-L1 in NSCLC, recently dosed its first patient in a Phase 1 dose-escalating trial in Australia.
- RAD 301, a 68Ga-labeled αvβ6-integrin for imaging Pancreatic Ductal Adenocarcinoma, also recently dosed its first patient in a Phase 1 trial at Montefiore Medical Center, building on positive compassionate use data from 99 patients.
- RAD 402, targeting advanced prostate cancer with Tb-161, which has shown higher tumor uptake compared to Lu-177.
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.
Highlights of the report
- Clinical Updates -- RAD has advanced several clinical programs which include RAD 101 with the first dose expected in Q4 2024.
- Collaborations with Leading Industry Players -- RAD has increased its ownership in Radiopharm Ventures to 75 percent from 51 percent.
- NASDAQ Listing Expected YE 2024 -- RAD is progressing toward a secondary listing on the NASDAQ Capital Market by the end of 2024.
- Cash Runway Into June 2026 -- In June 2024, RAD announced a capital raise of AU$70 million (USD $47million)
For the full analyst report, click here.
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Radiopharm Theranostics
Investor Insight
Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.
Overview
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:
- Strategic Partnerships
- Lantheus’ strategic investment in Radiopharm Theranostics, committing up to AU$18 million, strengthens Radiopharm's financial position and supports the advancement of its projects.
- Radiopharm owns 75 percent interest in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center, to develop novel radiopharmaceutical products for cancer treatment.
- Market Positioning: Radiopharm is strategically positioned to capture a significant share of the expanding theranostics market.
- Diverse Product Pipeline: The company boasts a robust pipeline of radiopharmaceutical products targeting various oncological diseases, which diversifies risk and increases potential revenue streams.
- Innovative Technology: Radiopharm's focus on leveraging technological advancements in radiopharmaceuticals, particularly in treating oncological diseases, positions it at the cutting edge of medical innovation.
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.
Company Highlights
- Radiopharm Theranostics is focused on developing and commercializing radiopharmaceutical products and nuclear medicines for both therapeutic and diagnostic applications in precision oncology.
- 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.
- The company has received clearance from the US Food and Drug Administration for an investigational new drug application with two INDs (one for RAD 301 and one for RAD 101). Phase 1 for RAD 301 and for RAD 204 is in progress.
- The company aims to commercialize its pipeline for possible licensing and distribution agreements and has secured four platform technologies, which it is seeking to develop for the diagnosis and treatment of certain cancers.
- Radiopharm owns 75 percent interest in Radiopharm Ventures, a joint venture created with The University of Texas MD Anderson Cancer Center.
Technology and Clinical Pipeline
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:
- PD-L1 (non-small cell lung cancer indication) - currently in phase 1 in Australia;
- HER2 (breast/gastric cancer indication) - will begin phase 1 trials this year;
- Integrin VB6 (pancreatic cancer indication) - now in Phase I imaging in pancreatic cancer.
- Fatty Acid Synthase (brain METS indication) - preclinical has been completed and with IND approval for Phase IIb Imaging
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.
Management Team
Paul Hopper – Executive Chairman
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 – Managing Director and Chief Executive Officer
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 - Vice-president, Medical Affairs
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 - Vice-president, CMC
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 - Non-executive Director
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.
Radiopharm Theranostics ‘Extends Runway’ to Key Milestones with AU$70M Investments: Report
The anticipated acceleration in growth from the capital infusion and asset development synergy underscores the strategic significance of this partnership.
“This collaboration is pivotal, as Lantheus's expertise and established market presence in key regions, such as the US, Canada and Europe, significantly enhance the strategic value of their investment in Radiopharm,” the report said.
Under the agreement Lantheus will make an initial strategic equity investment of AU$7.5 million. Lantheus has an option to invest an additional AU$7.5 million within the next six months under the same terms. In addition, will transfer two early preclinical assets to Lantheus for AU$3 million. These assets include a TROP2 targeting nanobody and a LRRC15 targeting mAb.
“The anticipated acceleration in growth from the capital infusion and asset development synergy further underscores the strategic significance of this partnership.”
Highlights of the report:
- Strategic investment by and asset transfer agreement with Lantheus Holdings mark a significant enhancement in Radiopharm's growth strategy and capital strength
- Radiopharm has secured firm commitments from institutional and sophisticated investors for a significant capital increase through another placement totaling A$62.5 million.
- Radiopharm Theranostics is positioned in the growing radiopharmaceutical market, which is projected to reach $9.67 billion by 2026. The company's diversified portfolio targets various cancers, including prostate, breast, renal cell carcinoma, and lung cancer.
For the full analyst report, click here.
This content is intended only for persons who reside or access the website in jurisdictions with securities and other applicable laws which permit the distribution and consumption of this content and whose local law recognizes the scope and effect of this Disclaimer, its limitation of liability, and the legal effect of its exclusive jurisdiction and governing law provisions [link to Governing Law section of the Disclaimer page].
Any investment information contained on this website, including third party research reports, are provided strictly for informational purposes, are general in nature and not tailored for the specific needs of any person, and are not a solicitation or recommendation to purchase or sell a security or intended to provide investment advice. Readers are cautioned to seek the advice of a registered investment advisor regarding the appropriateness of investing in any securities or investment strategies mentioned on this website.
PRISM MarketView Features Q&A with President and CEO David Elsley: Cardiol Therapeutics Enters Phase 3 Clinical Trial for CardiolRx Addressing Patients with Recurrent Pericarditis
PRISM MarketView announces the release of an informative interview with Cardiol Therapeutics President and CEO, David Elsley, who discusses the company's lead oral drug, CardiolRx™, which is entering a late-stage Phase III clinical trial, MAVERIC, for patients with recurrent pericarditis who are at high risk for recurrence.
Cardiol Therapeutics is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. Elsley states, "CardiolRx™ is uniquely positioned to address critical gaps in the current treatment options for recurrent pericarditis."
During a discussion with PRISM MarketView, Elsley describes the market opportunity for its lead drug candidate, its key differentiators from other treatments, the recent Phase II MAvERIC-Pilot study results, the company's financial position and key upcoming milestones. "With its potential to be safer, more cost-effective, and disease-modifying, CardiolRx™ could significantly improve the standard of care for the thousands of patients living with recurrent pericarditis," Elsley commented regarding the potential positive impacts and market opportunity for its lead drug candidate.
The full interview can be found at: https://prismmarketview.com/cardiol-therapeutics-nasdaq-crdl-accelerates-late-stage-trial-targeting-1b-recurrent-pericarditis-market-aiming-to-transform-heart-disease-care/
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com .
About PRISM MarketView:
Established in 2020, PRISM MarketView is dedicated to the monitoring and analysis of small cap stocks in burgeoning sectors. We deliver up-to-the-minute financial market news, provide comprehensive investor tools and foster a dynamic investor community. Central to our offerings are proprietary indexes that observe emerging sectors, including biotech, clean energy, next-generation tech, medical devices and beyond. Visit us at prismmarketview.com and follow us on Twitter .
PRISM MarketView does not provide investment advice.
Disclaimer
This communication was produced by PRISM MarketView, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See www.pcgadvisory.com/disclosures .
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AMGEN ANNOUNCES 2025 FIRST QUARTER DIVIDEND
Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.38 per share dividend for the first quarter of 2025. The dividend will be paid on March 7, 2025 to all stockholders of record as of the close of business on February 14, 2025 .
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 .
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)
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