Principal Technologies Inc. (the " Company ") (TSXV: PTEC) (FSE: J07), is pleased to announce the closing of the first tranche (" Tranche 1 ") of its previously announced non-brokered private placement (the " Offering ") with one investor, MRPT Invest UG (" MRPT "), a company owned and controlled by Markus Mair . The Company issued a total of 4,000,000 units at $0.25 per unit for gross proceeds of $1,000,000 . Each unit (a " Unit ") will consist of one common share (a ' Share ") of the Company and one common share purchase warrant (a " Warrant "). Each Warrant entitles the holder to purchase one additional Share of the Company at $0.30 for a period of two (2) years from the date of closing. The Warrants are subject to a blocker term that prohibits exercise of the Warrants to the extent the holder would as a result of any exercise exceed 19.99% of then issued Shares.
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Principal Technologies Announces Extension of Private Placement Closing Date
Principal Technologies Inc. (the "Company") (TSXV: PTEC; FSE: J07), announces that it has received an extension from the TSX Venture Exchange with respect to the duration of its previously announced private placement (the "Private Placement") (see the Company's press releases dated April 3, 2024; June 7, 2024; and June 20, 2024), and intends to close a second and final tranche of the Private Placement on or before July 15, 2024.
ON BEHALF OF THE BOARD
Jerry Trent, Chief Executive Officer
Principal Technologies Inc.
For investor inquiries or further information, please contact:
Office@principal-technologies.com
Forward-looking statements:
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca. The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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Principal Technologies
Overview
The healthcare sector has experienced considerable disruption in recent years, from emerging telehealth innovations to new tools for treatment and diagnosis. Each new technology has the potential to change — or even save — countless lives. Yet distributing these technologies to the global market is often far easier said than done, thanks to regulatory challenges and a lack of investment capital.
Principal Technologies (TSXV:PTEC,FRA:J07) intends to tear those barriers down. Based in Vancouver, British Columbia, Principal Technologies focuses on investing in life-saving and life-improving healthcare technologies and innovations. Working through a wholly owned European subsidiary, the company intends to invest in private healthcare technology companies in Europe, and expose them to the North American marketplace where they can benefit from the region's higher valuation of med-tech companies.Principal increases shareholder value by steadily growing the company’s financial performance, and paying off debt with improved cash flows and new equity when capital markets are advantageous.
This process is repeated as new acquisition targets come into play.
Principal's risk management strategy revolves around its acquisition targets. It exclusively pursues companies with a proven competitive advantage; stable cash flow; disruptive technology portfolio with IP capable of significantly improving patient outcomes or quality of life; significant growth potential; and a qualified management team with a strong vested interest in success.
The company leverages exclusive access to key opinion leaders and medical advisory boards and has a highly experienced leadership team.
Notable individuals in its management roster include Jerry Trent, a highly accomplished international investment banker and portfolio manager; Prince Alfred of Liechtenstein, a senior member of the Liechtenstein family; Dr. Gerald Rainer, former CEO of Switzerland’s largest and most prestigious asset management company; and Dr. Ivo Ivanovski, former European IT Minister and currently CEO of Telekom Austria Group’s Tower Co.
Principal's directors, advisors and major shareholders all maintain significant connections throughout Europe's healthcare technology space, ensuring ongoing introductions to potential investments. The company also owns a clinical research organization which maintains a database of emerging technologies, allowing it to assess prospective acquisitions on an ongoing basis.
Company Highlights
- Principal Technologies invests in leading and proven European healthcare technologies.
- Principal drives value in its investments by purchasing them at a discount in the EU and exposing them to the North American market, which offers significantly higher valuations for healthcare technology companies.
- The company is managed, directed and advised by a group of incredibly experienced entrepreneurs and investors, all of whom maintain close industry connections in the EU.
- When acquiring a new target, Principal's first step is to ensure an equity control position. It will typically finance the acquisition through a combination of debt and equity, accessing major EU funds when financing leveraged buyouts.
- Principal has implemented multiple checks, balances and strategies to reduce and manage risk, including:
- Maintaining profit-oriented compensation plans to incentivize performance.
- Maintaining strict capital allocation at the corporate level.
- Ensuring a margin of safety compared to intrinsic value in negotiating its acquisition prices.
- Principal exclusively seeks managers and advisors who will allow it to broaden its competitive advantage, expand its operations and support international expansion.
Key Investments
Principal Technologies’ previous acquisitions demonstrate a successful track record of increasing shareholder value and providing growth capital, marketing expertise and access to an international network to expand its acquisitions’ global operations and revenue.
Vivostat
Vivostat is Principal Technologies’ most recent acquisition and the result of an extensive due diligence process and evaluation of numerous European healthcare technology companies. Vivostat’s technology is a unique and best-in-class system worldwide for on-site preparation and application of autologous (i.e. based on the patient’s own blood) concentrated fibrin and platelet enriched fibrin sealants for post-surgical use.
The technology has been used in more than 200,000 post-surgical procedures, with peer-reviewed evidence of zero rejection and infection rates, which is unparalleled.
Vivostat has been profitable for the last three years with a seven-figure net profit while serving less than 5 percent of its potential market.
Principal will roll out this best-in-class technology on a global scale.
E&E CRO
An 80-percent-owned clinical research organization, E&E facilitates the international distribution permits process for healthcare technology companies. This strategic investment will allow Principal Technologies to build a unique database which it will leverage to improve patient outcomes, serve the industry (hospitals, insurers and other stakeholders seeking medical information), as well as find new acquisition targets for its international rollout process. Based in the European Union, E&E is a cash-flow-positive company with stable revenue and a highly experienced in-house technical due diligence team.
Vision Surgery AI
A minor equity investment with the capacity for expanded ownership as operations increase, Vision Surgery AI uses advanced computer vision and artificial intelligence technology for real-time monitoring of surgical teams and operating room equipment.
Its technology detects and sends alerts about any anomaly or deviation from typical surgical procedures, significantly reducing complications and fatalities. Vision's technology also leverages collected observations to build a database of medical information for machine learning purposes. Given that roughly 80 percent of surgical fatalities stem from human error, Vision Surgery has the potential to considerably improve surgical outcomes.
Management Team
Jerry Trent - President and Group CEO / Member, Board of Directors
Jerry Trent is the founder of Trent Investments, a multi-family direct investment agency for European ultra-high-net-worth individuals and asset management funds. In Europe, he served as the head of global markets and investment banking at SberBank, as well as the head of M&A and member of the Global Deals Origination Group at PricewaterhouseCoopers. His experience also includes being a highly successful Wall Street investor and portfolio manager.
Prince Alfred von Liechtenstein - Chairman, Board of Directors
His Serene Highness Prince Alfred von Liechtenstein has served on numerous boards and in several supervisory positions, including at LGT Group (largest family-owned asset management group globally). He holds a master's degree in economics and informatics and has authored numerous books and articles on a wide range of topics. Prince Alfred von Liechtenstein is also the chairman of the advisory board of the International Peace Foundation - of which 19 advisors are Nobel Prize Laureates, including four in the medical field. His Serene Highness has also received multiple awards and prizes for his healthcare initiatives and humanitarian activity.
Dr. Leopold Specht - Member, Board of Directors
Dr. Leopold Specht is a veteran attorney with extensive investment experience. He is the owner of international corporate law firm Specht & Partner. In addition to serving on numerous boards, he is a member of the Economic Council at Harvard Institute for Global Law at Harvard Law School. Widely renowned for his expertise, Specht regularly serves as a guest lecturer at institutions such as Harvard University, Brown University, the University of Turin and the University of Sapienza Rome.
Peter McKeown - CFO
A seasoned finance and business professional, Peter McKeown has founded and served in executive positions at multiple successful listed companies. Armed with decades of experience, McKeown is a serial entrepreneur focused on the technology and resource sectors. He is also a chartered accountant with a Bachelor of Commerce in Accounting from Carleton University.
Dr. Gerald Rainer - Chairman, Board of Advisors
Dr. Gerald Rainer is the former CEO of Julius Baer, a US$400-billion asset management company in Switzerland. He has also served in multiple board and trustee positions at multi-billion dollar entities and trusts. His impressive business acumen and extensive international network have allowed him to also thrive as a serial entrepreneur.
Rick Geoffrion - Member, Board of Advisors
Rick Geoffrion has been president and CEO of multiple healthcare technology companies that have developed proprietary systems to significantly improve patient outcomes. Throughout his 35-year career, Geoffrion has also served in board positions at numerous healthcare technology companies. Currently, he is vice-chairman of the Mullings Group, a leading career development firm in the healthcare sector.
Dr. Ivo Ivanovski - Member, Board of Advisors
Dr. Ivo Ivanovski served as the IT Minister of the Republic of Macedonia from 2006 to 2015. He then entered the private sector as head of mergers and acquisitions, international affairs and regulations at A1 Telekom Austria Group, where he now serves as the CEO of the exchange-listed Tower Co. Ivanovski has received multiple awards in his career, including the International Telecommunication Union's Distinguished Silver Star Award and an Honorary Doctorate for Technology Leadership.
Joe Mullings - Member, Board of Advisors
Joe Mullings is the chairman and CEO of The Mullings Group Companies, including TMG Search and Dragonfly. The search firm, with over three decades in the industry, is responsible for more than 8,000 successful searches in medtech/healthtech/life sciences with clients ranging from multi-billion-dollar companies to emerging high-tech organizations worldwide. TMG's international presence and work with over 800 companies allow them to provide solutions to the clients they partner with across the globe. As the first search firm to integrate media and talent access, Dragonfly was launched as a media production company, complete with a state-of-the-art studio, for use by clients and partners for attention and awareness. Dragonfly is the media machine behind the eight-time award-winning video docuseries, "TrueFuture," hosted by Mullings.
PRINCIPAL TECHNOLOGIES ANNOUNCES CLOSING OF FIRST TRANCHE OF PRIVATE PLACEMENT
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PRINCIPAL TECHNOLOGIES ANNOUNCES UPSIZING OF PRIVATE PLACEMENT
/NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES /
Principal Technologies Inc. (the " Company ") (TSXV: PTEC) (FSE: J07), is pleased to announce an increase in the previously announced non-brokered financing of 4,000,000 units (see news release dated April 3, 2024 ), to 8,000,000 units at $0.25 (the " Offering Price ") for gross proceeds of up to $2,000,000 (the " Private Placement) . Each unit (a " Unit ") will consist of one common share (a " Share ") of the Company and one common share purchase warrant (a " Warrant "). Each Warrant entitles the holder to purchase one additional Share of the Company at $0.30 for a period of two (2) years from the date of closing. The Company has received $1,000,000 of subscriptions with funds being held in escrow. The closing of a first tranche is pending receipt of TSX Venture Exchange (" TSXV ") approval.
Proceeds of the Private Placement will be used for general working capital and corporate purposes of the Company, including those as may be required by Vivostat A/S (" Vivostat ") conditional on the closing of the acquisition of Vivostat.
The Private Placement is subject to approval of the TSXV and all securities of the Company issued pursuant to the Private Placement will be subject to a four-month hold period from the date of issuance. The Private Placement will not result in the creation of a new control person of the Company.
The securities offered have not been registered under the United States Securities Act of 1933, as amended (the " U.S. Securities Act "), or any state securities laws and may not be offered or sold absent registration or compliance with an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.
The Company also announces that principal amount of the secured loan from GreenIslands Opportunities Fund (the " Lender "), as announced in the April 3, 2024 , news release has increased from €8,000,000 to €9,000,000. The deemed price of the 2.5 million common shares (the " Consideration Shares ") issuable by the Company to the Lender as partial consideration for the acquisition of Vivostat (the " Acquisition ") shall have a deemed value of $0.25 per Consideration Share. All other terms of the loan will remain the same.
The person receiving the finder's fee in connection with the Acquisition (the " Finder's Fee "), subject to approval of the TSXV, is Reinhold Eder . The Finder's Fee will be calculated as 1% of the cash portion of the purchase price.
ON BEHALF OF THE BOARD
Jerry Trent, Chief Executive Officer
Principal Technologies Inc.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward- looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Forward-looking information and statements involve known and unknown risks and uncertainties that may cause the Company's actual results, performance, and achievements to differ materially from those expressed or implied by the forward-looking information and statements and accordingly, undue reliance should not be placed thereon. Forward-looking statements included in this press release include the closing of the Private Placement on the terms and timing set out herein; the receipt of all application Exchange and regulatory approvals and satisfaction of conditions pursuant to the Private Placement; receipt of TSXV approval for the Acquisition; realizing synergies between component companies and further acquisitions by Principal; and retention of Vivostat employees.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca. The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2024/07/c4738.html
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PRINCIPAL TECHNOLOGIES ANNOUNCES LOAN FINANCING AND PRIVATE PLACEMENT AND PROVIDES UPDATE ON VIVOSTAT A/S ACQUISITION
/NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES /
Principal Technologies Inc. (the " Company ") (TSXV: PTEC) (FSE: J07), is pleased to announce that on March 8, 2024 it entered into a binding commitment letter with the effect that the GreenIslands Opportunities Fund (the " Lender ") will provide a secured loan in the principal amount of €8,000,000 (the " Loan ") to provide acquisition financing with respect to the cash portion of the purchase price for Vivostat AS (" Vivostat "), as further outlined in its news release dated February 6, 2024 and for general working capital purposes.
The terms of the Loan include:
- the secured loan shall be provided to the Company by the Lender on a lump sum basis;
- interest rate of 12.00% per annum on the principal amount outstanding, payable up to and including the date which is six (6) years after the initial advance under the Loan (the " Loan Maturity Date ");
- interest will be payable quarterly and principal amount payable in twenty (20) quarterly installments;
- principal amount and interest in the first year shall not be paid until the Loan Maturity Date;
- the loan will be secured by, among other things, a pledge of all the shares acquired in Vivostat; and
- payment shall be permitted in full or in part with a 6% prepayment penalty on the prepaid amount.
The Loan provides full financing for the Company to close the Vivosat acquisition, and after final adjustments any remaining funds will be utilized by the Company for working capital purposes.
"This loan, by our major shareholder, effectively underwrites our previously-announced acquisition of Vivostat" commented Jerry Trent , Chief Executive Officer of Principal Technologies Inc. "Vivostat is the world's leading autologous sealant solution, developed by Bristol Myers Squibb at a cost of US$100 million . We are now on track to bring this solution to the thousands of hospitals and clinics in jurisdictions in which it has never been sold, including Japan , Brazil and Australia ."
Vivostat is a profitable company generating €3.8 million in revenue in 2023.
In addition, the Company is pleased to announce a non-brokered financing of up to 4,000,000 units at $0.25 (the " Offering Price ") for gross proceeds of up to $1,000,000 (the " Private Placement) . Each unit (a " Unit ") will consist of one common share (a ' Share ") of the Company and one common share purchase warrant (a " Warrant "). Each Warrant entitles the holder to purchase one additional Share of the Company at $0.30 for a period of two (2) years from the date of closing. Proceeds of the Private Placement will be used for general working capital and corporate purposes.
In connection with the Private Placement, pursuant to the policies of the TSX Venture Exchange (the " Exchange "), the deemed price of the 2.5 million common shares issuable by the Company as partial consideration for the acquisition of Vivostat shall be revised to the Offering Price.
The Private Placement is subject to approval of the Exchange and all securities of the Company issued pursuant to the Private Placement will be subject to a four month hold period from the date of issuance. The Private Placement will not result in the creation of a new control person of the Company.
The securities offered have not been registered under the United States Securities Act of 1933, as amended (the " U.S. Securities Act "), or any state securities laws and may not be offered or sold absent registration or compliance with an applicable exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws.
The Lender holds 38.03% of the Company's issued and outstanding shares and as such the Loan constitutes a related party transaction as defined under Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Loan is exempt from the formal valuation requirements pursuant to Subsection 5.5(b) of MI 61-101 (Issuer Not Listed on Specified Markets) and is exempt from the minority shareholder approval requirements pursuant to Subsection 5.7(f) of MI 61-101 (Loan to Issuer, No Equity or Voting Component). The material change report in relation to the related party transactions will be filed less than 21 days before the completion of the proposed Loan as the Company wishes to complete the corresponding acquisition of Vivostat as soon as commercially feasible.
ON BEHALF OF THE BOARD
Jerry Trent , Chief Executive Officer
Principal Technologies Inc.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca . The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/April2024/03/c3545.html
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PRINCIPAL TECHNOLOGIES ANNOUNCES FUNDAMENTAL ACQUISITION OF VIVOSTAT A/S
/Not for distribution to U.S. news wire services or for dissemination in the United States /
- Binding Share Purchase Agreement to purchase 100% of Denmark -based Vivostat A/S (" Vivostat ").
- Vivostat has a unique system for on-site preparation and application of autologous concentrated fibrin and platelet enriched fibrin sealants for use in post-surgical procedures.
- Used in over 200,000 surgical procedures, Vivostat's system has peer-reviewed evidence of zero rejection and infection rates.
- Vivostat has been profitable for the last 3 years and currently generates revenues of approximately €3,600,000 per year with a 60% gross profit margin.
- Vivostat is currently only actively marketed in six European countries representing less than 10% of its total addressable market.
- Transaction is expected to close on or before March 15, 2024 , subject to receipt of applicable approvals, including of the TSX Venture Exchange (" TSX-V ") and satisfaction of conditions.
Principal Technologies Inc. (the " Company " or " Principal ") (TSXV: PTEC) (FSE: J07), is pleased to announce that as at February 6, 2024 it entered into an arm's length binding Share Purchase Agreement (" SPA ") to acquire (the " Acquisition ") 100% of the equity interests of Vivostat, a 23-year-old Danish company which uses a unique autologous fibrin sealant solution for post-surgical use.
The Company will pay approximately €7,500,000 in cash plus 2,500,000 common shares in the capital of the Company at a price of $0.15 , based on last closing price of the common shares on the TSX-V prior to this announcement, to the owners of Vivostat, as adjusted under the SPA. The Company has received an expression of interest from a major European fund with respect to financing the Acquisition and also expects to close a concurrent non-brokered equity offering to be priced in the context of the market after the announcement of the Acquisition (the " Offering ").
Vivostat currently generates approximately €3,600,000 in revenues per year with a 60% gross profit margin. With Principal's backing and global expertise, Vivostat intends to accelerate the sales and marketing efforts in the six European Union (" EU ") countries, which currently account for the majority of sales, and to grow sales in the numerous other EU countries where it is licensed.
Jerry Trent , CEO of Principal, said, "We are delighted to announce our first major acquisition. This purchase is the culmination of an extensive due diligence process on dozens of potential healthcare targets in Europe . We were seeking a profitable target that offered truly industry-leading, licensed products with untapped global appeal. Such a target should also serve as a solid base upon which to build a profitable, scalable medtech and healthcare portfolio with strong synergies between its component companies. Vivostat checked all our boxes. We are excited to ramp up sales far beyond the current market. It is gratifying to note that all of Vivostat's key employees will remain with the Company and become critical parts of the growth we forecast for the Company."
Sven Lange , CEO of Vivostat, added, "The acquisition by Principal now sets the stage for the global sales expansion of our industry-leading and patented product, subject to securing applicable foreign licenses."
The Company expects to pay a 1% finder's fee in relation to the acquisition of Vivostat, subject to approval of the TSX-V. The transactions contemplated by the SPA and Offering are subject to receipt of all necessary regulatory approvals, and the satisfaction of various conditions to closing, including the approval of the TSX-V. The Offering remains subject to entering into definitive documentation.
The Shares issued pursuant to SPA will be subject to a hold period expiring four months and one day from the date of issuance in accordance with applicable Canadian securities laws.
Trading of the Company's common shares on the TSX-V will remain halted pending receipt and review of acceptable documentation pursuant to Section 5.6 (d) of TSXV Policy 5.3 regarding a Fundamental Acquisition.
Vivostat A/S manufactures and distributes a unique system for on-site preparation and application of autologous concentrated fibrin and platelet enriched fibrin sealants. The technology was originally developed by Bristol Myers Squibb in the 1990's at an approximate cost of over €80 million.
These fibrin sealants are beneficial in surgery to assist in the healing process and preventing infection. Vivostat's products are currently distributed primarily in the EU with over 12,500 surgical applications in the past year alone and over 200,000 since inception. The patented Vivostat system is backed by extensive positive research from peer-reviewed journals demonstrating evidence of zero rejection or infection rates.
Principal Technologies Inc. is a Canadian-based healthcare acquisition company. The Company is engaged in building a portfolio of profitable healthcare technology companies with a focus on those with global distribution potential which have intellectual property capable of enhancing medical treatment quality, cost efficiency, optimization of the patient pathway, and implementation of point of care technologies.
ON BEHALF OF THE BOARD
Jerry Trent , Chief Executive Officer
Principal Technologies Inc.
Neither the TSX-V nor its Regulation Services Provider (as that term is defined in policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant.
Forward-looking information and statements involve known and unknown risks and uncertainties that may cause the Company's actual results, performance and achievements to differ materially from those expressed or implied by the forward-looking information and statements and accordingly, undue reliance should not be placed thereon. Forward-looking statements included in this press release include the closing of the transactions contemplated by the SPA and the Offering on the terms and timing set out herein; receipt of additional licences; the funding for the cash portion of the purchase price of Vivostat; the receipt of all application regulatory approvals and satisfaction of conditions pursuant to the Offering and the SPA; realizing synergies between component companies and further acquisitions by Principal; and retention of Vivostat employees.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits and approvals; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedarplus.ca . The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/February2024/06/c6577.html
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PRINCIPAL TECHNOLOGIES CLOSES THIRD AND FINAL TRANCHE OF OVERSUBSCRIBED PRIVATE PLACEMENT
/Not for distribution to U.S. news wire services or for dissemination in the United States /
Principal Technologies Inc. (the " Company ") (TSXV: PTEC ), is pleased to announce the closing of the third and final tranche (" Tranche 3 ") of its previously announced non-brokered private placement (the " Offering "). The Company issued an additional 833,333 common shares (the " Shares ") at $0.15 per Share for gross proceeds of $124,999.95 bringing the total offering to 9,993,166 Shares for aggregate gross proceeds of $1,498,974.95 when combined with the two previous closings, subject to final approval from the TSX Venture Exchange (" TSXV "). For more information on the Offering, see the Company's news releases dated October 6, 2023 November 21, 2023 and December 21, 2023 .
In connection with the closing of Tranche 3, finder's fees totaling $4,000 cash were paid and non-transferable share purchase warrants issued to purchase up to 26,667 Shares of the Company for a period of twenty-four (24) months from the date of issuance, expiring on January 18, 2026 .
'We are very pleased to complete this $1.5 million private placement' said the Company's CEO, Jerry Trent. 'It provides ample funds for us to be able to seek out and validate a significant healthcare technologies opportunity for the Company, which is our main focus for 2024'.
The Company intends to use the net proceeds of the Offering for working capital in order to secure a major asset and for general corporate purposes. All currency in this news release is denominated in Canadian dollars.
All securities issued pursuant to the Offering, and any Shares that may be issuable on exercise of any such securities, will be subject to a statutory hold period expiring four months and one day from the date of issuance of such securities.
This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America . The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the " 1933 Act ") or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.
Jerry Trent, Chief Executive Officer
Principal Technologies Inc.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws. This information and statements address future activities, events, plans, developments and projections. All statements, other than statements of historical fact, constitute forward-looking statements or forward-looking information. Such forward-looking information and statements are frequently identified by words such as "may," "will," "should," "anticipate," "plan," "expect," "believe," "estimate," "intend" and similar terminology, and reflect assumptions, estimates, opinions and analysis made by management of the Company in light of its experience, current conditions, expectations of future developments and other factors which it believes to be reasonable and relevant. Forward-looking information and statements involve known and unknown risks and uncertainties that may cause the Company's actual results, performance and achievements to differ materially from those expressed or implied by the forward-looking information and statements and accordingly, undue reliance should not be placed thereon.
Risks and uncertainties that may cause actual results to vary include but are not limited to the availability of financing; fluctuations in commodity prices; changes to and compliance with applicable laws and regulations, including environmental laws and obtaining requisite permits; political, economic and other risks; as well as other risks and uncertainties which are more fully described in our annual and quarterly Management's Discussion and Analysis and in other filings made by us with Canadian securities regulatory authorities and available at www.sedar.com . The Company disclaims any obligation to update or revise any forward-looking information or statements except as may be required.
SOURCE Principal Technologies Inc.
View original content: http://www.newswire.ca/en/releases/archive/January2024/18/c2862.html
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Cardiol Therapeutics Reports Results of 2024 Annual General and Special Meeting of Shareholders
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), 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, announces the results from its annual general and special meeting of shareholders (the "Meeting") held virtually via live audio webcast, on June 26, 2024. Shareholders voted in favour of all management resolutions proposed in the Company's management information circular dated May 13, 2024.
Resolutions proposed and approved at the Meeting were:
The election of the following directors for the ensuing year: David Elsley, Peter Pekos, Dr. Guillermo Torre-Amione, Colin Stott, Michael Willner, Jennifer Chao, Chris Waddick, Teri Loxam.
The appointment of BDO Canada LLP as auditors of the Company until the next annual meeting and the authorization of the directors of the Company to fix the remuneration to be paid to the auditors.
The approval of the unallocated awards under the Company's Omnibus Equity Incentive Plan.
The results of the voting on the election of directors are as follows:
Nominees | Number of Shares For | Percentage of Votes Cast |
David Elsley | 17,994,588 | 99.66% |
Peter Pekos | 17,336,814 | 96.01% |
Dr. Guillermo Torre-Amione | 17,345,669 | 96.07% |
Colin Stott | 17,349,964 | 96.09% |
Michael Willner | 17,348,726 | 96.08% |
Jennifer Chao | 17,346,733 | 96.07% |
Chris Waddick | 17,352,587 | 96.10% |
Teri Loxam | 17,348,275 | 96.08% |
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: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including for primary efficacy endpoint and secondary endpoints, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/214672
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Cardiol Therapeutics to Webcast Virtual Annual General and Special Meeting of Shareholders on June 26th at 4:30 p.m. EDT
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), 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, announces that the Company's virtual Annual General and Special Meeting of Shareholders (the "AGM") will be webcast on June 26, 2024, at 4:30 p.m. EDT.
Cardiol Therapeutics 2024 AGM
When: June 26, 2024, at 4:30 p.m. EDT
Where: Virtual meeting only via live audio webcast online at: web.lumiagm.com/253136217
Additional information on the AGM, including details on how to participate and vote, is available on the Company's website at cardiolrx.com/investors/events-presentations/.
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: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including for primary efficacy endpoint and secondary endpoints, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/214271
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Cardiol Therapeutics Announces Positive Topline Data from its Phase II MAvERIC-Pilot Study Investigating CardiolRx for Recurrent Pericarditis
Administration of CardiolRx™ led to a marked reduction in the primary efficacy endpoint of pericarditis pain
CardiolRx™ also shown to reduce inflammation in patients with elevated CRP
89% of patients have continued into the extension phase of the study
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), 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, today reported 8-week clinical data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The data showed a substantial reduction in the primary efficacy endpoint of patient-reported pericarditis pain at the end of the 8-week treatment period ("TP"), as well as normalization of inflammation - as measured by C-reactive protein ("CRP" in 80% of patients with elevated CRP at baseline.
"We are delighted to share the primary endpoint data from the MAvERIC-Pilot study, demonstrating that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation, which were remarkably comparable in magnitude to the changes reported following immunosuppressive biologic therapy commonly used in third-line treatment of recurrent pericarditis," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer. "Based on the clinically meaningful impact of CardiolRx™ on the key symptom of this debilitating disease, we now anticipate that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™ designed to meet our objective of providing a more accessible and non-immunosuppressive therapy option for thousands of pericarditis patients."
MAvERIC-Pilot enrolled 27 patients diagnosed with symptomatic recurrent pericarditis. Each patient had a high disease burden as reflected in the mean baseline pericarditis pain score of 5.8 out of 10, and by the number of previous episodes of pericarditis: 9 patients (33%) with 2 previous episodes; 9 (33%) with 3; 4 (15%) with 4; and 5 (19%) with >4.
Summary of topline findings include:
- Primary endpoint of patient-reported pericardial pain on an 11-point numerical rating scale ("NRS") showed a mean reduction of 3.7, from 5.8 at baseline (range of 4 to 10) to 2.1 (range of 0 to 6) at 8 weeks. NRS is a validated instrument used to assess patient-reported pericarditis pain. Zero represents 'no pain at all', whereas the upper limit of 10 represents 'the worst pain ever possible'.
- Eight of the ten patients (80%) with a baseline CRP ≥1mg/dL had a normalization of CRP (≤0.5 mg/dL) at 8 weeks. The mean CRP decreased from 5.7 mg/dL at baseline to 0.3 mg/dL at 8 weeks. CRP is a commonly used clinical marker of inflammation, and in combination with the NRS score, is used by clinicians to assess clinical response and determine a recurrence.
- Eighty-nine percent of patients (24/27) have progressed from the TP into the extension period ("EP") of the study, defined as the additional 18-week period of CardiolRx™ treatment that follows the TP.
- CardiolRx™ was shown to be safe and generally well-tolerated.
MAvERIC-Pilot Study Design
The ongoing MAvERIC-Pilot study is evaluating CardiolRx™ in 27 adult participants (≥18 years) with symptomatic recurrent pericarditis (≥2 recurrences), with or without a raised CRP, at eight clinical sites across the United States. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The study design consists of an 8-week TP followed by an 18-week EP. Patients with pericarditis chest pain with an NRS pain score ≥4 together with either an elevated CRP (≥1mg/dL) or evidence of pericardial inflammation assessed by cardiac imaging have been enrolled. CardiolRx™ is added to stable doses of baseline therapy for recurrent pericarditis (non-steroidal anti-inflammatory drugs, colchicine, or corticosteroids, in any combination). In the first 10 days of the TP, CardiolRx™ is up-titrated to 10 mg/kg twice daily, or the maximum tolerated dose. Throughout the TP, patients continue receiving baseline therapy for recurrent pericarditis but are weaned off this during the EP to assess pericarditis recurrence. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using the NRS. Secondary endpoints include NRS pain score at 26 weeks, and freedom from pericarditis recurrence during the EP. Secondary CRP endpoints of interest include change from baseline to 26 weeks, and for patients with CRP ≥1 mg/dL at baseline, the time to CRP normalization, as well as the percentage of patients with normalized CRP at both 8 and 26 weeks.
Recurrent Pericarditis
Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
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: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including for primary efficacy endpoint and secondary endpoints, the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure, and the Company's anticipation that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. In addition, a decision to proceed with a Phase III trial is subject to full Phase II MAvERIC-Pilot study outcomes and regulatory authorization. Data from the Study is not necessarily indicative of results from future Phase III studies which may be conducted. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/212811
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Functional Mushrooms: A Market Overview
Functional mushrooms are experiencing a surge in popularity as their health and wellness benefits become increasingly well-known. Driven by multiple intersecting trends, this popularity is directly reflected in the market performance and outlook for functional mushroom products.
Gaining a deeper understanding of the market data and the progression of the functional mushroom industry can provide investors valuable insights into the opportunities in this emerging market.
Also known as adaptogenic or medicinal mushrooms, functional mushrooms are a subset of fungi valued for their potential health benefits. Whereas ordinary mushrooms provide good nutritional content, functional mushrooms contain a range of bioactive compounds, including beta-glucans, polysaccharides, triterpenoids and antioxidants. Owing to their therapeutic effects, functional mushrooms have a long history in herbal and traditional medicine.
Today, these fungi are used in a wide range of different scenarios.
Maitake mushrooms, for instance, are known to improve immune system strength while also supporting digestive health and acting as potent antioxidants. Cordyceps mushrooms, meanwhile, can potentially improve energy levels and promote better cognitive health through stress reduction. Other mushrooms, such as lion's mane, are excellent anti-inflammatories.
A booming market for mycelium
According to analyst Grand View Research, the global functional mushroom market reached US$31.71 billion in 2023 and is expected to grow at a CAGR of 11.2 percent to US$65.83 billion by 2030.
Prior to 2018, functional mushrooms were relatively unheard of, a niche product that few bothered to consider. That year, however, overall functional mushroom sales exploded, with sales of products containing maitake — the most popular functional mushroom that year — increasing by a staggering 811 percent. At the time, experts recognized their potential but also warned that marketing functional mushrooms would require a shift in how consumers viewed the fungi, something best achieved through creative marketing.
"Adaptogens are not good for everything," explained David Winston, a registered member of the American Herbalist's Guild and founder of manufacturing company Herbalist & Alchemist. "Adaptogens are not wonder drugs. They, like anything else, have benefits and limitations. There is some great research on adaptogens…but much of what is written online and in the popular press either misrepresents the research or is pure fantasy with greatly exaggerated claims."
Although functional mushrooms admittedly are still misrepresented in some circles, they have nevertheless experienced meteoric growth over the past several years — no doubt bolstered by the research Winston mentioned.
There are several other key trends that also contributed to this growth.
Consumers in 2018 were growing increasingly aware of their health and increasingly concerned about the detrimental effects of processed food. This awareness was due, in part, to emerging wellness trends that favored natural remedies. As functional mushrooms continued to grow in popularity, celebrity and influencer endorsements became increasingly commonplace.
This phenomenon inevitably drew new businesses to the functional mushroom space, resulting in significant investment and product innovation, further fueling market growth as functional mushrooms found their way into a variety of consumer goods.
Presently, the market outlook for functional mushrooms is highly positive — as evidenced by Grand View's forecasted CAGR. Already trending upward, consumer interest in health and wellness grew exponentially during the pandemic. Alongside the trends that nurtured the functional mushroom market's initial growth, investors can expect to see an uptick in both retail availability and product diversification as consumer demand continues to grow.
All indications point to substantial growth in the functional mushroom market, providing a lucrative opportunity for both investors and businesses operating within this space.
Companies to watch
Multiple companies have already emerged as leading innovators in the functional mushroom space. We've compiled a few of the most notable ones, including several that have expanded into mushroom cultivation.
Four Sigmatic
Four Sigmatic offers an alternative to bean-based coffee with several flavors designed to integrate functional mushrooms into daily routines. The brand is especially appealing to customers who may be new to mushroom-based supplements, as its core products require only that they swap out their morning coffee for something new. Four Sigmatic also offers a range of creamers and supplements, and several "starter kits" containing multiple product categories.
Fungtional Labs
Fungtional Labs sells organic, naturally-grown functional mushrooms in a wide array of supplements and beverages. The brand also takes things a step further. Billing itself as a "one-stop shop for everything mushroom," Fungtional Labs sells easy-to-use growing supplies, including spray kits, spawn bags, bins and fruiting bodies targeting the increasing number of mushroom cultivators in North America.
Om Mushrooms
Om Mushrooms emphasizes organic, sustainably sourced ingredients held to stringent quality standards. Om's key selling point, however, is that its high-quality mushroom products are also backed by rigorous scientific research. This, alongside the company's commitment to transparency and ESG principles, makes it a compelling investment for anyone interested in sustainability.
Real Mushrooms
Many mushroom companies rely on mushroom root, known as mycelium, to make their products. Real Mushrooms instead uses the mushrooms themselves, known as fruiting bodies. This is part of the company's push to prioritize potency and bioavailability. The brand claims its products contain high levels of beneficial compounds as well as authentic, potent mushroom extracts that offer maximum health benefits.
MUD/WTR
Made from a multitude of organic ingredients, including lion's mane and chaga, MUD/WTR's organic coffee claims to provide a natural energy boost without the jitters and crashes typically associated with caffeine. Though not strictly a functional mushroom company or product, MUD/WTR still has excellent investment potential. Health-conscious consumers are always on the lookout for coffee alternatives, after all — and given that 73 percent of Americans drink coffee every day, there's immense growth potential there.Investor takeaway
Functional mushrooms are now more popular than ever, and the market for products that contain them has never looked more promising. With strong performance, a positive market outlook and a large total addressable market, these fantastic fungi represent an excellent addition to any investment portfolio.
This INNSpired article is sponsored by Fungtional Labs. This INNSpired article provides information which was sourced by the Investing News Network (INN) and approved by Fungtional Labsin order to help investors learn more about the company. Fungtional Labsis a client of INN. The company’s campaign fees pay for INN to create and update this INNSpired article.
This INNSpired article was written according to INN editorial standards to educate investors.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Fungtional Labs and seek advice from a qualified investment advisor.
5 Biggest Pharmaceutical ETFs in 2024
The global pharmaceutical market reached a total value of US$1.6 trillion in 2023, according to Statista, up significantly from the US$888 billion seen just over a decade earlier in 2010.
Experienced and novice investors alike may want to consider pharmaceutical exchange-traded funds (ETFs) as a way to gain exposure to the top pharma companies. Like all ETFs, pharmaceutical ETFs are a good option for those who want to trade a set of assets in the pharmaceutical industry instead of focusing solely on individual pharmaceutical stocks.
The main advantage of a pharma ETF is the fact that it can provide exposure to an overarching sector, but still trades like a stock. Pharma ETFs also offer less market volatility and lower fees and expenses.
Big pharma ETFs
To help investors learn more about ETFs focused on the pharma sector, the Investing News Network presents the five top pharma ETFs by total assets under management, according to ETFdb.com.
Many of these funds have diverse holdings across some of the most important sectors in the pharmaceutical industry, including pain therapeutics, oncology, vaccines and biotechnology. Data was gathered on May 28, 2024.
1. iShares US Pharmaceuticals ETF (ARCA:IHE)
Total assets under management: US$677.53 million
Created on May 5, 2006, this iShares ETF tracks some of the top US pharma companies. In total, the iShares US Pharmaceuticals ETF has 36 holdings, with the vast majority being large-cap stocks.
Of its holdings, Eli Lilly (NYSE:LLY) and Johnson & Johnson (NYSE:JNJ) are by far the largest portions in its portfolio, coming in at weightings of 24.46 percent and 21.79 percent, respectively. The next highest are Pfizer (NYSE:PFE) at 5.02 percent, Merck (NYSE:MRK) at 4.49 percent and Zoetis (NYSE:ZTS) at 4.38 percent.
2. VanEck Vectors Pharmaceutical ETF (NASDAQ:PPH)
Total assets under management: US$571.28 million
Established in late 2011, the VanEck Vectors Pharmaceutical ETF tracks the MVIS US Listed Pharmaceutical 25 Index. It has the capacity to provide big returns, even though there are some risks attached to the ETF. An analyst report indicates that investors looking for "tactical exposure" to the pharma sector might consider this ETF as an investment option.
The ETF has 25 holdings, with the top five being Eli Lilly with a weight of 12.3 percent, Novo Nordisk (NYSE:NVO) at 10.02 percent, Johnson & Johnson at 6.35 percent, Merck at 6.23 percent and AstraZeneca (NASDAQ:AZN) at 5.97 percent.
3. Invesco Pharmaceuticals ETF (ARCA:PJP)
Total assets under management: US$268.35 million
The Invesco Pharmaceuticals ETF is primarily focused on providing exposure to US-based pharma companies. An analyst report states that this ETF chooses individual securities based on certain investment criteria, namely stock valuation and risk factors. Invesco changed the fund's name from the Invesco Dynamic Pharmaceuticals ETF in August 2023.
This ETF was started on June 23, 2005, and currently tracks 23 companies. Its top holdings are Geron (NASDAQ:GERN) with a weight of 6.44 percent, Amgen (NASDAQ:AMGN) at 6.28 percent, Eli Lilly at 6.22 percent, Pfizer at 6.09 percent and Regeneron Pharmaceuticals (NASDAQ:REGN) at 6.05 percent.
4. SPDR S&P Pharmaceuticals ETF (ARCA:XPH)
Total assets under management: US$193.9 million
The SPDR S&P Pharmaceuticals ETF came into the market on June 19, 2006, and represents the pharmaceutical sub-industry sector of the S&P Total Markets Index. An analyst report for the ETF suggests that due to its narrow focus — which includes pharma giants that post "big returns" during times of consolidation — it should not be considered for a long-term portfolio.
This pharma ETF tracks 42 holdings; its top five are Organon (NYSE:OGN) with a weight of 5.6 percent, Merck at 5.14 percent, Eli Lilly at 5.13 percent, Pfizer at 5.1 percent and Axsome Therapeutics (NASDAQ:AXSM) with a weight of 4.86 percent.
5. KraneShares MSCI All China Health Care Index ETF (ARCA:KURE)
Total assets under management: US$46.82 million
The KraneShares MSCI All China Health Care Index ETF was launched in February 2018 and tracks an index of large- and mid-cap Chinese stocks in the healthcare sector, all weighted by market capitalization.
According to an analyst report, the fund provides investors with "exposure to a relatively small slice of the Chinese economy that tends to be dominated by pharmaceuticals." The ETF tracks 72 holdings, and its top five are Shenzhen Mindray Bio-Medical Electronics (SZSE:300760) at 8.82 percent, Jiangsu Hengrui Medicine (SHA:600276) at 6.35 percent, BeiGene (OTC Pink:BEIGF,HKEX:6160) at 4.85 percent, CSPC Pharmaceutical Group (OTC Pink:CSPCY,HKEX:1093) at 4.18 percent and WuXi Biologics (OTC Pink:WXIBF,HKEX:2269) at 3.59 percent.
This is an updated version of an article originally published by the Investing News Network in 2016.
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Securities Disclosure: I, Melissa Pistilli, hold no investment interest in any of the companies mentioned in this article.
Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy portfolio
- In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36 weeks 1
- Endothelin A (ETA) receptor activation contributes to elevated proteinuria in IgAN 2-5 ; atrasentan is a potent, selective ETA receptor antagonist with potential to reduce persistent proteinuria and preserve kidney function for a broad patient population 1
- IgAN is a heterogeneous, progressive, rare kidney disease with a need for effective, targeted therapies 6,7 ; up to 30% of patients with persistent proteinuria (≥1 g/day) progress to kidney failure within 10 years 8
- Through its rare kidney disease portfolio, Novartis is committed to exploring a range of treatment options with different modes of action to slow IgAN progression
Novartis today presented results from a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN) 1 . Patients treated with atrasentan, in addition to supportive care (maximally tolerated and stable dose of a renin-angiotensin system [RAS] inhibitor), achieved a 36.1% (p
Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals 10 . US FDA submission for atrasentan in IgAN is on track for the first half of 2024.
"For those living with IgAN and their families, the disease can have a significant impact not only physically, but also mentally. When my son Eddie was diagnosed with IgAN 20 years ago, there were no FDA-approved medicines developed to treat IgAN. That was as devastating as the diagnosis itself because we felt completely in the dark about how to manage the condition," said Bonnie Schneider , Director and Co-Founder, IgAN Foundation . "It's a disease that affects people differently, and what works for one person may not work for another. We're pleased to see ongoing research into different treatments and are excited for a future where the community will have options to meet their individual needs."
The ALIGN study continues in a blinded manner, and therefore only limited interim analysis results can be presented 11,12 . The final analysis, including the key secondary endpoint of change from baseline in estimated glomerular filtration rate (eGFR) at 136 weeks, and the results in participants receiving a sodium-glucose co-transporter-2 (SGLT2) inhibitor as background care in an exploratory cohort, is expected in 2026 11,12 .
"ETA receptor activation causes proteinuria, which is usually one of the first clinical signs of IgAN. Patients with persistent proteinuria have a poorer prognosis and are more likely to progress to kidney failure," said Professor Hiddo Heerspink, Professor of Clinical Trials and Personalized Medicine at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen and ALIGN blinded Steering Committee Chair. "We need targeted treatment options that can support patients with IgAN across the care pathway. These data from the ALIGN study further demonstrate the ability of atrasentan to significantly reduce proteinuria and, if approved, its potential to become a new foundational treatment for people living with IgAN that can be seamlessly added to current supportive therapy."
"Atrasentan has the potential to help transform how IgAN is managed for many people living with this complex illness," said David Soergel , M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. "Our multi-product IgAN portfolio aims to address the needs of a broad, heterogenous patient population with different modes of action to target distinct drivers of the disease, with the ultimate goal of improving patient care in this therapeutic area."
At ERA, Novartis is also presenting new data across its rare disease portfolio, including 6-month data for Fabhalta ® (iptacopan) in C3 glomerulopathy (C3G) from the Phase III APPEAR-C3G study, long-term 33-month efficacy and safety data for Fabhalta in C3G from the Phase II extension study, additional data for Fabhalta in IgAN from the 9-month interim analysis of the Phase III APPLAUSE-IgAN study, 1-year Phase I/II data for investigational zigakibart in IgAN, and data from real-world studies in C3G and atypical hemolytic uremic syndrome (aHUS) 13-16 .
About ALIGN
The ALIGN study (NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of atrasentan versus placebo in patients with IgAN at risk of progressive loss of kidney function 11,12 . In total, 340 patients with biopsy-proven IgAN with baseline total proteinuria ≥1 g/day despite optimized RAS inhibitor treatment were randomized to receive once-daily oral doses of atrasentan (0.75 mg) or placebo for approximately 2.5 years (132 weeks) 11,12 . Patients continue receiving a maximally tolerated and stable dose of a RAS inhibitor as supportive care (unless they are unable to tolerate RAS inhibitor therapy) 11,12 . An additional group of 64 patients receiving a stable dose of SGLT2 inhibitor for at least 12 weeks have also been enrolled 11,12 .
The primary efficacy endpoint of the study is change in proteinuria as measured by 24-hour UPCR from baseline to 36 weeks 11,12 . Secondary and exploratory objectives include evaluating the change in kidney function from baseline to 136 weeks as measured by eGFR, as well as safety and tolerability 11,12 .
About atrasentan
Atrasentan is an investigational potent and selective oral ETA receptor antagonist, currently in Phase III development for IgAN and early-stage development for other rare kidney diseases 1,11,12,17 . Activation of the ETA receptor contributes to elevated proteinuria, which is associated with kidney damage, fibrosis and loss of kidney function in IgAN 2-5 . Atrasentan has potential to be added to current supportive therapy to reduce persistent proteinuria and preserve kidney function for a broad patient population 1 . Preclinical models have also suggested that atrasentan may reduce inflammation and fibrosis in IgAN 18-21 .
About IgA nephropathy (IgAN)
IgAN is a heterogeneous, progressive, rare kidney disease 6 . Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN 22 .
Up to 30% of people who have IgAN with persistent higher levels of proteinuria (≥1 g/day) may progress to kidney failure within 10 years 8 . There is a need for effective, targeted therapies for IgAN that can help slow or prevent progression to kidney failure 6,7,23 .
Novartis commitment in rare kidney diseases
At Novartis, our journey in nephrology began more than 40 years ago when the development and introduction of cyclosporine helped reimagine the field of transplantation and immunosuppression. We continue today with the same bold ambition to transform the lives of people living with kidney diseases.
Through our portfolio, we are exploring potential therapeutic options to address the current unmet needs of people living with rare diseases, including IgAN, C3G, aHUS, immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN). Innovative treatment options that target the underlying causes of these diseases may preserve kidney function and help people live longer without the need for dialysis or transplantation.
IgAN is a heterogeneous disease presenting with a variety of clinical manifestations, phenotypes, and variable speeds of progression 6 . In addition to atrasentan, Novartis is advancing the development of two other therapies in IgAN with highly differentiated mechanisms of action: Fabhalta, an investigational oral Factor B inhibitor of the alternative complement pathway, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody, which are both in Phase III development 24-26 . Through our IgAN pipeline, we are committed to creating a portfolio of innovative medicines that improve and extend the lives of people living with kidney disease.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
A bout Novartis
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Reimagine medicine with us: Visit us at https://www.novartis.com and https://www.novartis.us and connect with us on LinkedIn , LinkedIn US , Facebook , X/Twitter , X/Twitter US and Instagram .
References
- Heerspink HJL, Jardine M, Kohan D, et al. ALIGN Phase 3 Primary Endpoint Analysis: Atrasentan Shows Significant Reduction in Proteinuria in Patients with IgA Nephropathy. Presented at European Renal Association (ERA) Congress; May 25, 2024 ; Stockholm , Sweden.
- Tycová I, Hrubá P, Maixnerová D, et al. Molecular Profiling in IgA Nephropathy and Focal and Segmental Glomerulosclerosis. Physiol Res . 2018;67(1):93-105. doi:10.33549/physiolres.933670
- Lehrke I, Waldherr R, Ritz E, Wagner J. Renal Endothelin-1 and Endothelin Receptor Type B Expression in Glomerular Diseases with Proteinuria. J Am Soc Nephrol . 2001;12(11):2321-2329. doi:10.1681/ASN.V12112321
- Zanatta CM, Veronese FV, Loreto Mda S, et al. Endothelin-1 and Endothelin A Receptor Immunoreactivity is Increased in Patients with Diabetic Nephropathy. Ren Fail . 2012;34(3):308-315. doi:10.3109/0886022X.2011.647301
- Kohan DE, Barton M. Endothelin and Endothelin Antagonists in Chronic Kidney Disease. Kidney Int . 2014;86(5):896-904. doi:10.1038/ki.2014.143
- Kidney Disease: Improving Global Outcomes (KDIGO) 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int . 2021;100(4):S1-S276. doi:10.1016/j.kint.2021.05.021
- Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An Update on the Pathogenesis and Treatment of IgA Nephropathy. Kidney Int . 2012;81(9):833-843. doi:10.1038/ki.2011.501
- Reich HN, Troyanov SAA, Scholey JW, Cattran DC. Remission of Proteinuria Improves Prognosis in IgA Nephropathy. J Am Soc Nephrol . 2007;18(12):3177-3183. doi:10.1681/ASN.2007050526
- Kim SG, Inker LA, Packham DK, et al. WCN23-1126 Atrasentan for the Treatment of IgA Nephropathy: Interim Results of the AFFINITY Study. Kidney Int Rep . 2023;8(9):1902. doi:10.1016/j.ekir.2023.02.1088
- Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Point in Trials of IgA Nephropathy. Clin J Am Soc Nephrol . 2019;14(3):469-481. doi:10.2215/CJN.08600718
- ClinicalTrials.gov. NCT04573478. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (ALIGN). Available from: https://clinicaltrials.gov/study/NCT04573478 . Accessed May 2024.
- Lambers Heerspink H, Jardine M, Kohan DE, et al. WCN23-1085 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy – The ALIGN Study. Kidney Int Rep . 2023;8(3):S279-S280. doi:10.1016/j.ekir.2023.02.630.
- Kavanagh D, Bomback A, Vivarelli M, et al. Efficacy and Safety of Iptacopan in Patients with C3 Glomerulopathy: Results from the Phase 3 APPEAR-C3G Trial. Presented at European Renal Association (ERA) Congress; May 25, 2024 ; Stockholm , Sweden.
- Nester CM, Eisenberger U, Karras A, et al. Update to the Long-Term Safety and Efficacy of Iptacopan in C3G: 33-Month Extension Study Data from Patients Enrolled in a Phase 2 Study. Presented at European Renal Association (ERA) Congress; May 25, 2024 ; Stockholm , Sweden.
- Perkovic V, Kollins D, Papachristofi O, et al. Efficacy and Safety of Iptacopan in Patients with Primary IgA Nephropathy: Interim Analysis Results of the Phase 3 APPLAUSE-IgAN Study. Presented at European Renal Association (ERA) Congress; May 25, 2024 ; Stockholm , Sweden.
- Barratt J, Kooienga L, Agha I, et al. One Year of Zigakibart Treatment Shows Clinically Meaningful Proteinuria Reduction and Good Tolerability in a Phase 1/2 Study of IgA Nephropathy. Presented at European Renal Association (ERA) Congress; May 25, 2024 ; Stockholm , Sweden.
- ClinicalTrials.gov. NCT04573920. A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (AFFINITY). Available from: https://clinicaltrials.gov/study/NCT04573920 . Accessed May 2024.
- Sasser JM, Sullivan JC, Hobbs JL, et al. Endothelin A Receptor Blockade Reduces Diabetic Renal Injury via an Anti-Inflammatory Mechanism. J Am Soc Nephrol . 2007;18(1):143-154. doi:10.1681/ASN.2006030208
- Olson E, McConnell M, Ragan S, et al. MO264: Selective Endothelin A Receptor Antagonist Atrasentan Attenuates Mesangial Cell Injury, Proteinuria and Intra-Renal Proliferative, Inflammatory and Fibrotic Transcriptional Networks in a Rat Model of Mesangioproliferative Glomerulonephritis. Nephrol Dial Transplant . 2022;37:S3. doi:10.1093/ndt/gfac067.063
- Cox J, Gunawan M, Wu J, et al. A Central Role of Endothelin A Receptor Activation in Mesangial Cell – Podocyte Crosstalk in IgA Nephropathy and Other Mesangio-Proliferative Glomerulopathies. Glomerular Dis . 2022;2(Suppl 1):1-78. doi:10.1159/000525410
- King A, Oballa R, Gunawan M, et al. POS-378 Selective ETA Antagonist Atrasentan, Rapidly Reduces Albuminuria and Downregulates Intra-Renal Pro-Inflammatory and Pro-Fibrotic Transcriptional Networks in the gddY Mouse Model of Spontaneous IgA Nephropathy. Kidney Int Rep . 2021;6(4):S164. doi:10.1016/j.ekir.2021.03.396
- McGrogan A, Franssen CF, de Vries CS. The Incidence of Primary Glomerulonephritis Worldwide: A Systematic Review of the Literature. Nephrol Dial Transplant . 2011;26(2):414-430. doi:10.1093/ndt/gfq665
- Xie J, Kiryluk K, Wang W, et al. Predicting Progression of IgA Nephropathy: New Clinical Progression Risk Score. PLoS ONE. 2012;7(6):e38904. doi:10.1371/journal.pone.0038904
- Novartis. Novartis completes acquisition of Chinook Therapeutics. Available from: https://www.novartis.com/news/media-releases/novartis-completes-acquisition-chinook-therapeutics . Accessed May 2024.
- Novartis. New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN). Available from: https://www.novartis.com/news/media-releases/new-novartis-fabhalta-iptacopan-data-show-clinically-meaningful-and-statistically-significant-proteinuria-reduction-383-versus-placebo-patients-iga-nephropathy-igan . Accessed May 2024.
- Perkovic V, Kollins D, Renfurm R, et al. WCN24-1506 Efficacy and Safety of Iptacopan in Patients with IgA Nephropathy: Interim Results from the Phase 3 APPLAUSE-IgAN Study. Kidney Int Rep . 2024;9(4):S506. doi:10.1016/j.ekir.2024.02.1414
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