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 New Stock Option Plan
Principal Technologies Inc. (the "Company") (TSXV: PTEC), is pleased to announce that the Board of Directors of the Company (the "Board") has approved the adoption of a new 20% fixed stock option plan (the "New Option Plan").
On July 11, 2023, the Board adopted a 10% fixed stock option plan (the "Considered Plan") (see press release date July 11, 2023). The Considered Plan was subject to approval by the TSX Venture Exchange (the "Exchange") and would be in addition to the Company's 10% rolling stock option plan (the "Option Plan") that was last approved by shareholders at their annual general and special meeting held on November 30, 2022. Upon review and consultation with the Exchange, the Board has subsequently adopted the New Option Plan.
The New Option Plan will reserve for issuance 4,575,092 common shares of the Company under similar terms and conditions as the existing Option Plan. The maximum term of each stock option (each an "Option") shall not be greater than ten years. The exercise price of each Option shall not be less than the market price of the Company's shares at the date of grant. Options granted to consultants performing investor relations activities shall vest over a minimum of 12 months with no more than 1/4 of such Options vesting in any three month period. All other Options vest at the discretion of the Board. If approved by shareholders, all issued and outstanding stock options granted under the Option Plan will be ratified, continued, and governed by the New Option Plan.
The Company has granted 2,125,000 conditional stock options ("Conditional Options") under the New Option Plan to the CEO of the Company at an exercise price of $0.12 per share. The Conditional Options will vest immediately and be exercisable for a 10-year term expiring July 10, 2033. The Conditional Options granted under the New Option Plan may not be exercised until disinterested shareholder approval has been received.
If approved by shareholders, the 2,125,000 Conditional Options will replace the existing performance bonus of the CEO that was approved by shareholders on June 30, 2021. This annual performance bonus is payable to a company controlled by the CEO and is calculated as 20% of the increase in the market value of the Company, if any, and is payable in treasury common stock. Moving the CEO to an approved stock option based compensation plan is better understood and accepted in the Canadian capital markets.
Shareholders will be asked to approve of the New Option Plan at the Annual General and Special Meeting of Shareholders to be held on December 12, 2023. A copy of the Management Information Circular for this meeting is available at www.SEDARplus.ca.
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 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.
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. 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.
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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PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program
- PTC to receive $1.0B in cash at closing -
- PTC is eligible to receive up to $1.9B in development, regulatory and sales milestones -
- PTC to share profits in the U.S. and tiered double-digit royalties on ex-U.S. net sales -
- Novartis will assume global development, manufacturing and commercial responsibilities following completion of placebo-controlled portion of ongoing PIVOT-HD study -
- PTC will host a conference call on Dec. 2, 2024 , at 8:30 am EST -
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the signing of an exclusive global license and collaboration agreement with Novartis Pharmaceuticals Corporation, a subsidiary of Novartis AG (NYSE: NVS), for its PTC518 Huntington's disease program, which includes related molecules. Under the agreement, PTC will receive an upfront payment of $1.0 billion up to $1.9 billion in development, regulatory and sales milestones, a profit share in the U.S., and double-digit tiered royalties on ex-U.S. sales.
"PTC518 is the leading oral disease-modifying therapy in development for Huntington's disease and the economics of this agreement are consistent with the promise of this treatment," said Matthew B. Klein , M.D., Chief Executive Officer, PTC Therapeutics. "This collaboration combines PTC's expertise in developing small molecule splicing therapies with Novartis's expertise in global development and commercialization of neuroscience therapies. We are excited to collaborate with Novartis to accelerate the potential of PTC518 for the hundreds of thousands of HD patients worldwide in need of a therapy designed to be well-tolerated and an effective disease-modifying therapy. PTC will use the proceeds of this transaction to expand our splicing platform as well as to support commercial and development portfolio activities."
"Huntington's Disease is a devastating, fatal, familial disease. This agreement with PTC is intended to bolster our neuroscience pipeline and reflects our strategic focus and commitment to explore new and potentially transformative approaches for neurodegenerative diseases with high unmet needs," said Vas Narasimhan, CEO of Novartis. "We look forward to building on our expertise in neurodegenerative diseases and experience in HD with the intention to advance this potential first in class oral therapy for the HD community."
PTC518 was discovered from PTC's validated splicing platform and is currently being studied in the ongoing Phase 2 PIVOT-HD trial. Interim results reported in June 2024 demonstrated that PTC518 treatment resulted in durable, dose-dependent reduction in blood and cerebrospinal fluid (CSF) mutant Huntingtin protein (HTT) levels as well as early signals of dose-dependent benefit on key clinical measurements at 12 months. 1 Importantly, PTC518 continues to demonstrate a favorable safety and tolerability profile. 1
Novartis will assume responsibility for PTC518's development, manufacturing and commercialization, following the completion of the on-going placebo-controlled portion of PIVOT-HD, which is expected to occur in H1 2025.
The companies will share U.S. profits and losses, on a 40/60 basis (40% PTC and 60% Novartis).
The closing of the transaction is subject to customary closing conditions, including regulatory clearance. The parties anticipate that the agreement will close in the first quarter of 2025.
Conference Call and Webcast Details:
PTC will hold a conference call at 8:30 am EST today to discuss this news. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations . A replay of the call will be available approximately two hours after completion of the call and will be archived on the company's website for 30 days following the call.
About Huntington's Disease
Huntington's disease (HD) is a fatal, hereditary, genetic disorder of the central nervous system. 2 It is caused by a defective gene. This gene produces a protein, called Huntingtin, which is involved in the functioning of the nerve cells in the brain (neurons). When the gene is defective, it produces an abnormal (or mutated) Huntingtin protein that is toxic and causes neuron damage and neuron death. 3 HD usually presents in people who are in their 30s or 40s. Symptoms can present earlier in life, and this is called the Juvenile HD. 3,4 There are also cases of infantile HD, when symptoms develop in children who are younger than 10 years old. 3 While symptoms vary from person to person, the disease primarily affects the brain and results in abnormal movements, difficulties with speech, swallowing and walking, as well as a number of other symptoms including behavioral, cognitive and motor symptoms. 5,6 While there are therapies approved for specific disease symptoms, currently, there is no cure for HD and there are no approved drugs that delay the onset or slow disease progression.
About PTC's Splicing Platform
PTC has pioneered the use of advanced alternative splicing technology to identify small molecules that affect mRNA splicing for the treatment of disease of high unmet need. PTC's validated splicing platform identified the first-ever approved small molecule splicing modifier - Evrysdi ® ( risdiplam ), and PTC has leveraged the extensive learnings from the SMA program to broaden the platform to support discovery programs across numerous therapeutic areas including neurodegenerative disease, oncology and metabolism. PTC has also developed a powerful high-throughput drug discovery platform ( PTSeek ™) that identifies small molecules that modulate pre-mRNA splicing to upregulate or down regulate targeted protein production, accelerating the discovery and early preclinical development process for candidate small molecule splicing agents.
About PTC Therapeutics, Inc.
PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to children and adults living with rare disorders. PTC's ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC's mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC's strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, Instagram, LinkedIn and X.
For More Information:
Investors:
Ellen Cavaleri
+1 (615) 618-6228
ecavaleri@ptcbio.com
Media:
Jeanine Clemente
+1 (908) 912-9406
jclemente@ptcbio.com
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historic fact, are forward-looking statements, including statements with respect to the future expectations, plans and prospects for PTC , including with respect to PTC's right to receive any upfront payment from Novartis ; PTC's right to receive development, regulatory and sales milestones, profit sharing and royalty payments from Novartis ; the continued development of PTC518; future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words, "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward -looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future; the expected benefits and opportunities related to the licensing agreement may not be realized or may take longer to realize than expected due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in development; success in early clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; data for PTC518 may not be sufficient for obtaining regulatory approval; significant business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of PTC's products and product candidates; PTC's scientific approach and general development progress; and the factors discussed in the "Risk Factors" section of PTC's most recent Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.
As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful.
The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.
References:
- PTC Therapeutics, "Interim PIVOT-HD Results Demonstrate Evidence of Favorable CNS Biomarker and Clinical Effects at Month 12 in Huntington's Disease Patients," news release, June 20, 2024 , https://ir.ptcbio.com/news-releases/news-release-details/interim-pivot-hd-results-demonstrate-evidence-favorable-cns
- World Health Organization, 2020. 8A01.10 Huntington disease. Available at: https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/2132180242 Accessed October 2021.
- Gatto EM, González Rojas N, Persi G, et al. Clin Parkinsonism Rel Disord 2020;3:100056.
- Tabrizi SJ, Flower MD, Ross CA, et al. Nat Rev Neurol 2020;16(10):529–546.
- Roos RAC. Orphanet J Rare Dis 2010;5:40.
- Kirkwood SC, Su JL, Conneally P, et al. Arch Neurol 2001;58(2):273–278.
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Ratio Enters License and Collaboration Agreement with Novartis for SSTR2-targeting Radiotherapeutic Candidate
Ratio to receive upfront, and potential milestones and tiered royalty payments
Ratio Therapeutics Inc. ( Ratio ), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, entered today into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration leverages Ratio's radioligand therapy discovery and development expertise as well as its technology platforms for the development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.
"The team at Ratio is honored and excited to partner with Novartis on the development of a next-generation SSTR2-targeting therapeutic," said Jack Hoppin , Ph.D., Chief Executive Officer of Ratio . "Together, we aim to develop a best-in-class therapy in the fight against SSTR2-expressing tumors."
"Radioligand therapies hold transformative potential for certain forms of cancer, and Novartis is committed to maximizing their impact by continually improving the benefit for patients," said Fiona Marshall , President of Biomedical Research at Novartis. "We are delighted to collaborate with Ratio to advance this RLT candidate and work together to bring forward additional therapeutic options for patients with difficult-to-treat cancer."
Under the terms of the agreement, Ratio will receive combined upfront and potential milestone payments up to $745m , and is eligible to receive tiered royalty payments. Ratio will collaborate with Novartis to drive preclinical activities to research and select an SSTR2-targeting development candidate. Novartis will assume responsibility for all remaining development, manufacturing, and commercialization activities.
The collaboration combines the expertise and strengths of Ratio and Novartis to further elevate the safety and efficacy of radiopharmaceuticals for patient benefit.
Chestnut Partners served as exclusive financial advisor to Ratio for this transaction.
About Ratio Therapeutics
Ratio Therapeutics Inc. is a clinical-stage pharmaceutical company with the mission to accelerate the development of next-generation precision radiopharmaceuticals for solid tumors and transform oncology treatment paradigms. With headquarters and laboratories in Boston, the company currently employs a growing team of multidisciplinary experts with backgrounds in radiopharmaceutical discovery and development. Ratio's proprietary R&D platforms, Trillium™ and Macropa™, enable the development of fit-for-purpose radiopharmaceuticals for therapy and imaging that possess pharmacokinetic modulation, thereby improving drug availability, tumor delivery, and tumor loading. The company is also currently advancing the development of its first FAP-targeted radiotherapeutic with plans to enter clinical trials next year.
Please visit www.ratiotx.com for more information and follow us on Twitter (X) and LinkedIn .
Media Contacts:
Rachelle Babb , Ph.D.
Russo Partners, LLC
rachelle.babb@russopartnersllc.com
+1 (929) 325-7559
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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 pharmaceutical 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 November 5, 2024.
1. VanEck Pharmaceutical ETF (NASDAQ:PPH)
Total assets under management: US$684.73 million
Established in late 2011, the VanEck 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 26 holdings, with the top five being Eli Lilly with a weight of 12.32 percent, Novo Nordisk (NYSE:NVO) at 8.15 percent, Johnson & Johnson at 6.71 percent, AbbVie (NYSE:ABBV) at 6.67 percent and Bristol-Myers Squibb (NYSE:BMY) at 5.33 percent.
2. iShares US Pharmaceuticals ETF (ARCA:IHE)
Total assets under management: US$624.31 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 40 holdings, with the vast majority being large-cap stocks.
Of its holdings, Johnson & Johnson (NYSE:JNJ) and Eli Lilly (NYSE:LLY) are by far the largest portions in its portfolio, coming in at weightings of 22.27 percent and 20.3 percent, respectively. The next highest are Bristol-Myers Squibb at 5.29 percent, Viatris (NASDAQ:VTRS) at 4.68 percent and Pfizer (NYSE:PFE) at 4.34 percent.
3. Invesco Pharmaceuticals ETF (ARCA:PJP)
Total assets under management: US$281.23 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 27 companies. Its top holdings are Abbott Laboratories (NYSE:ABT) with a weight of 5.86 percent, AbbVie at 6.67 percent, Johnson & Johnson at 5.47 percent, Amgen (NASDAQ:AMGN) at 5.46 percent and Pfizer at 5.43 percent.
4. SPDR S&P Pharmaceuticals ETF (ARCA:XPH)
Total assets under management: US$154.77 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 46 holdings, with relatively close weighting among its holdings. XPH's top five holdings are Corcept Therapeutics (NASDAQ:CORT) with a weight of 4.32 percent, Longboard Pharmaceuticals (NASDAQ:LBHP) at 4.13 percent, Intra-Cellular Therapies (NASDAQ:ITCI) at 3.97 percent, Bristol-Meyers Squibb at 3.82 percent and Edgewise Therapeutics (NASDAQ:EWTX) at 3.55 percent.
5. KraneShares MSCI All China Health Care Index ETF (ARCA:KURE)
Total assets under management: US$43.48 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."
The ETF tracks 55 holdings, and its top five are Shenzhen Mindray Bio-Medical Electronics (SZSE:300760) at 8.18 percent, Jiangsu Hengrui Medicine (SHA:600276) at 7.71 percent, BeiGene (OTC Pink:BEIGF,HKEX:6160) at 6.62 percent, Wuxi Biologics (OTC Pink:WXIBF,HKEX:2269) at 4.47 percent and Zhangzhou Pientzehuang Pharmaceutical (SHA:600436) at 3.63 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.
Big Pharma Stocks Eli Lilly, AbbVie and Pfizer Share Q3 Results
Major pharmaceutical players Eli Lilly (NYSE:LLY), AbbVie (NYSE:ABBV) and Pfizer (NYSE:PFE) reported mixed Q3 results, with each company facing distinct market forces, ranging from supply issues to financial constraints.
In its latest quarterly report, released on Wednesday (October 30), Eli Lilly missed on sales expectations for Zepbound, its popular weight-loss drug, and Mounjaro, its diabetes medication. Despite growing US demand for these products, supply chain management issues impacted the company’s ability to meet Wall Street's expectations.
According to Reuters, Eli Lilly dropped 8 percent on the news, reducing its market valuation by nearly US$70 billion.
CEO David Ricks said stock management issues with wholesalers were a major factor in the shortfall, noting that distributors were navigating storage and financial constraints that affected order volumes.
Eli Lilly's Q3 report indicates that Zepbound and Mounjaro collectively contributed US$4.37 billion to the company's revenues, falling short of analysts' projections of US$4.89 billion. The company has revised its 2024 profit forecast.
For its part, AbbVie reported a year-on-year decrease in net income, driven primarily by increased operating costs.
The company recorded a 12 percent drop in net income for the third quarter, amounting to US$1.56 billion, while net revenues grew to US$14.46 billion, reflecting a 3.8 percent increase from the previous year.
AbbVie’s CEO, Robert Michael, underscored that the company has seen strong commercial execution and pipeline growth, leading it to increase its guidance for the remainder of the year. He also confirmed a quarterly dividend increase.
In Q3, the company incurred a rise in operating expenses, which totaled US$10.63 billion, up 9 percent from the previous year. The increase was attributed to research and development costs and strategic acquisitions.
AbbVie’s earnings also reflected an increase in pre-tax income, which rose by 5 percent year-on-year to US$2.08 billion for the quarter. The firm's total revenues for the first nine months of 2024 climbed to US$41.23 billion, marking a 3 percent increase from the previous year, despite some challenges associated with operating costs.
On Monday (October 28), AbbVie announced plans to acquire privately held Aliada Therapeutics, a biotech company specializing in treatments for neurological disorders, for an estimated US$1.4 billion. The purchase will support AbbVie’s commitment to expanding its research and treatment capabilities in neurological and other specialty areas.
Meanwhile, Pfizer reported higher revenues, supported by strong sales of its COVID-19 therapies Paxlovid and Comirnaty.
The company’s quarterly revenues for Q3 totaled US$17.7 billion, up 31 percent year-on-year. This increase contributed to Pfizer’s revised guidance for the year, with projected revenues now estimated at US$61 billion to US$64 billion.
CEO Albert Bourla attributed the company’s performance to steady demand for COVID-19 medications, in addition to cost-control measures implemented during the quarter. A spike in COVID-19 cases contributed to heightened demand for Paxlovid, while Pfizer’s acquisition of Seagen bolstered revenues through additional sales of cancer treatments.
Pfizer’s adjusted financial outlook for 2024 reflects projected sales of up to US$64 billion, with estimated contributions of US$5 billion from Comirnaty and US$5.5 billion from Paxlovid for the year.
The company also reported growth across several key product lines, including Eliquis and Xtandi, though some products, like Xeljanz and Ibrance, saw declines due to regulatory changes and price pressures.
It's worth noting that activist investor Starboard Value has reportedly acquired a US$1 billion stake in Pfizer, equivalent to 0.6 percent of the company’s total shares. Its aim is to ignite a turnaround at the company.
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Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.
4 Best-performing Canadian Pharma Stocks of 2024
From established players to up-and-coming firms, Canada's pharmaceutical company is diverse and dynamic.
Canadian pharma companies are working to discover and develop major innovations amidst an increasingly competitive global landscape. Rising technologies such as artificial intelligence are playing a role in the landscape as well.
Here the Investing News Network lists the top Canadian pharma stocks on the TSX, TSXV and CSE by year-to-date gains. All data was compiled on October 28, 2024, using TradingView’s stock screener, and the companies considered had market caps above C$10 million at that time. Read on to learn about what's been driving their share prices.
1. Cipher Pharmaceuticals (TSX:CPH)
Year-to-date gain: 187.86 percent
Market cap: C$462.9 million
Share price: C$15.89
Cipher Pharmaceuticals is a specialty pharma company with a diverse portfolio of treatments, including a range of dermatology and acute hospital care products. The company has out-licensed some of its offerings as well. Cipher began trading on the OTCQX Best Market under the symbol CPHRF on January 29.
In addition to its current portfolio, Cipher has acquired Canadian rights multiple dermatology treatments currently undergoing Phase III clinical trials: MOB-015 for the treatment of nail fungus, and CF-101 for the management of moderate to severe plaque psoriasis. MOB-015 Phase III trial results are expected in January 2025, and a pivotal Phase III study for CF-101 is expected to start in 2024. The company is also conducting proof-of-concept studies on DTR-001, a topical treatment for removing tattoos.
On July 29, Cipher signed a definitive asset purchase agreement with ParaPRO for its US-based Natroba operations and global product rights. Natroba is a topical treatment for scabies and head lice, and it has FDA exclusivity for the scabies indication through 2033.
Cipher’s share price climbed significantly over the following month, which included the release of its Q2 results. Sales of Epuris, Cipher’s bioequivalent to Accutane, were up by 13 percent compared to Q2 2023, marking their fourth consecutive quarterly increase. However, its price took a hit in September on early blind results from the MOB-015 trials.
2. NurExone Biologic (TSXV:NRX)
Year-to-date gain: 123.73 percent
Market cap: C$35.85 million
Share price: C$0.66
NurExone Biologic is the biopharmaceutical company behind ExoTherapy, a drug delivery platform that uses exosomes, which are nano-sized extracellular vesicles, to create treatments for central nervous system disorders, spinal cord injuries and traumatic brain injuries. It is a less invasive alternative to cell transplantation, which requires surgery and carries the risk of rejection.
NurExone’s first nano-drug, ExoPTEN, uses a proprietary sIRNA sequence delivered with the ExoTherapy platform to treat spinal cord injuries. ExoPTEN received an Orphan Drug Designation from the US Food and Drug Administration (FDA) in October 2023, meaning it has been recognized as a potential treatment for rare medical conditions. The designation makes it eligible for incentives such as market exclusivity and regulatory assistance aimed at accelerating its development and approval.
During the release of NurExone’s Q1 results, the company shared it would be commencing human trials of ExoTPEN in 2025. On September 26, NurExone announced a non-brokered private placement of up to US$2 million, and reported it had closed the first tranche of US$1.61 million.
3. Satellos Bioscience (TSXV:MSCL)
Year-to-date gain: 86.67 percent
Market cap: C$91.84 million
Share price: C$0.84
Satellos is a Canadian pharmaceutical company expanding treatment options for muscle disorders. The company has focused specifically on Duchenne muscular dystrophy, developing therapies to regenerate and repair muscle tissue by targeting the specific biological pathways involved. Its lead candidate SAT-3247, targets a protein called AAK1, which regulates the activity of stem cells that activate and differentiate new muscle fibers.
An acceptance to commence Phase 1 clinical trials of the drug was announced on August 19 and the first patient was dosed on September 18. Analysis of tests conducted on canines, shared on October 1, showed improved muscle morphology and increased muscle regeneration with no adverse side effects.
4. Telescope Innovations (CSE:TELI)
Year-to-date gain: 79.17 percent
Market cap: C$23.36 million
Share price: C$0.43
Telescope Innovations is a chemical technology company that develops scalable manufacturing processes and tools that combine robotic automation, online analysis and machine learning for the pharmaceutical and chemical industries.
The company has commercialized its Direct Inject-LC system. Short for Direct Inject Liquid Chromatography, the system combines hardware and software to analyze chemical reactions and can potentially reduce the time and cost of new drug development.
On July 31, Telescope Innovations entered into a collaborative research agreement with pharma giant Pfizer (NYSE:PFE) to accelerate pharmaceutical research and development using automation, robotics and artificial intelligence.
According to a press release, some efforts will focus on deploying Self-Driving Laboratories, a concept pioneered by Telescope Innovations in which robotic systems carry out experiments while AI algorithms analyze the data in real-time to inform researchers about what the next steps should be. The release states that Self-Driving Laboratories are “capable of optimizing material properties and chemical synthesis methods up to 100x faster than traditional research methods.”
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Harris vs. Trump: The 2024 US Election, Drug Prices and Healthcare
The exorbitant cost of pharmaceutical drugs in the US has been a contentious issue for years, with the Republican and Democrat parties overtly at odds on the best way to lower drug prices.
Despite the best efforts of lawmakers on both sides of the aisle, prescription drug prices are still on the rise. Figures from the US Department of Health and Human Services show a 15.2 percent increase in the cost of prescription drugs from 2022 to 2023, with an average of US$590 per drug.
In the lead up to the 2024 US general election, the pharmaceutical industry is buttering its bread on both sides with nearly equal contributions to both parties. Citing data from OpenSecrets, KFF Health News reported in late August that drug companies had donated US$4.89 million to Democrats’ coffers and US$4.35 million to Republicans.
About one-third of the total pharma company campaign contributions are attributable to the three top donors: Pfizer (NYSE:PFE), Merck (NYSE:MRK) and Eli Lilly & Co. (NYSE:LLY).
Narrowing down on the presidential candidates, data retrieved from OpenSecrets on October 28 shows that Vice President Kamala Harris has been the bigger beneficiary of donations, receiving US$1.67 million compared to US$306,584 for former President Donald Trump. Both candidates have promised to tackle the high price of prescription drugs.
Surprisingly, the issue only came up once during the September 10 presidential debate between Harris and Trump, when Harris discussed it in response to a question from moderators about her proposed healthcare plan.
How would a potential Harris administration tackle the challenge of lowering prescription drug prices? Would pharmaceutical companies fare better under a second Trump administration?
First, let’s take a look at the healthcare policies and initiatives enacted under Trump’s prior presidency and during the current Biden-Harris administration, and then we'll examine the current platforms of the two candidates in this election and where they stand on drug prices.
The Trump administration's actions on healthcare and drug prices
Trump’s stance on lowering drug prices has been mostly at odds with the core of his fellow Republicans, which hamstrung his ability to implement his proposed policies.
Did Trump lower drug prices? Trump did have some success in lowering monthly insulin prices to US$35 for Medicare Part D plans, but only under a voluntary model. However, many of his other attempts failed to get off the ground for a variety of reasons.
“His efforts were largely fragmented and faced resistance from both the industry and lawmakers,” political strategist Sergio Jose Gutierrez, told KFF Health News. “The lack of a cohesive strategy and the limited ability to implement significant changes made his approach less effective compared to what a Harris-Walz administration could offer.”
Axios reports that while Trump’s staff did try to work with House Democrats on federal negotiated prescription drug prices under Medicare, he would later reject the proposal, “embracing GOP arguments it would lead to fewer cures.”
One of Trump’s attempts at lowering drug prices was the Most Favored Nation model, which would have tied the cost of certain drugs under Medicare to their costs in other, comparable countries. However, it encountered roadblocks in the courts due to challenges from pharmaceutical companies and concerns about its impact on hospitals and practices. It was ultimately never implemented, and was rescinded by the Centers for Medicare & Medicaid Services in December 2021 following multiple comment periods.
Another healthcare move under Trump that faced opposition was a plan to import drugs from abroad, which was announced during his term but required Food and Drug Administration approval. Although in 2024 Florida ultimately became the first state to win federal approval to import prescription drugs from Canada, Health Canada has put up resistance, citing the need to safeguard the country’s own limited drug supply.
In another federal court challenge to the Trump administration, several Big Pharma companies — including Merck, Eli Lily and Amgen (NASDAQ:AMGN) — took issue with a US Health and Human Services decree that televised drug ads must include the wholesale prices of the drugs advertised. As Reuters reported, the courts sided with the pharmaceutical companies' argument that Health and Human Services lacked the authority to force them to publicly disclose list prices and that the list prices could discourage people from seeking treatment.
With regards to the Obama-era Affordable Care Act (ACA), Trump has been a vocal critic of it in the ongoing healthcare debate. During his time in office, his administration made several attempts to weaken the ACA. For example, according to KFF Health News, “In 2017, (Trump) unsuccessfully attempted to repeal and replace the ACA with various plans that would have increased the number of uninsured Americans to 51 million.”
The Biden-Harris administration's actions on healthcare and drug prices
Even before Harris stepped into her role as vice president, she has been actively taking part in improving access to affordable healthcare and lower prescription drug prices. As a Senator, she guarded against Republican efforts to dismantle the ACA and co-sponsored the Medicare For All Act, which sought to establish a true single-payer healthcare model.
The Biden-Harris administration reversed the holes Trump tried to poke in the ACA; for example, restoring outreach and enrolment assistance as well as funding. On the flip side, Harris supported and the Biden administration approved Florida’s bid to access lower cost drugs from Canada.
In 2022, Harris helped to pass the administration’s Inflation Reduction Act (IRA), which capped drug prices at US$2,000 in total drug spending annually for Medicare beneficiaries, and extended the limited US$35 cap on monthly insulin supplies put forward under Trump to Medicare Part B and all Medicare Part D recipients.
On top of that, Harris cast the tie-breaking vote in the Senate in favor of legislation allowing Medicare to negotiate drug prices on the behalf of beneficiaries.
In August 2024, the government announced it had selected the first 10 drugs set to receive lower prices in 2026 — with discounts up to 79 percent — based on those negotiations. Many are indicated for diabetes and heart conditions, and are made by pharma giants such as Bristol-Myers Squibb (NYSE:BMY), Merck, AstraZeneca (NASDAQ:AZN), Novartis (NYSE:NVS,SWX:NOVN), Amgen and Johnson & Johnson (NYSE:JNJ). More drugs, specifically biologics, will face price cuts in 2028.
In terms of pharma regulations concerning drug prices in the broader market, President Joe Biden warned drug companies back in December 2023 that if prices on certain drugs developed with federal funds become too high, the government may find it necessary to seize the patents and allow competitors to make them as well. “Drugmakers are almost certain to challenge the plan in court if it is enacted,” reported the Associated Press.
Harris' 2024 healthcare and drug price platform
Now that Harris is out on the campaign trail, her healthcare and drug price platform is taking shape.
One of the policy goals of a Harris Administration is expanding the US$2,000 annual cap on prescription drug spending now enjoyed by Medicare recipients to all Americans with insurance. She said as much during her September 10 presidential debate with Trump.
“Since I’ve been vice president, we have capped the cost of prescription medications for seniors at $2,000 a year,” Harris said. “And when I am president, we will do that for all people.”
Harris has also vowed to protect the Affordable Care Act. “When I am president, we will do that for all people, understanding that the value I bring to this is that access to health care should be a right and not just a privilege of those who can afford it, and the plan has to be to strengthen the Affordable Care Act, not get rid of it,” she declared during the televised presidential debate.
Under Harris, the Democrats’ healthcare platform also includes ensuring prices for “brand-name and outlier generic drugs” don’t outpace the rate of inflation. The party is also keen on preventing Big Pharma from colluding on prices or manipulating the patent system.
As part of her campaign promises, Harris has also proposed to quicken the pace of lowering prescription drug prices for Medicare recipients. If elected, her administration will focus on speeding up negotiations on cutting costs on “some of the most expensive and most commonly used drugs by nearly 40 (percent) to 80 (percent),” so these discounts would come into play in 2026.
Republicans have warned the policy could slow the development of new drugs. Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center, says its "unclear" if that would truly be the case; however, she does thing caution is warranted. "I want to see, what does that mean for drug development? What does that mean for access for patients?", she said.
During the October 1 vice presidential debate, Harris' running mate Minnesota Governor Tim Walz reiterated her support for the ACA and held up the Medicare drug price negotiations under the Inflation Reduction Act as one of her great achievements during office.
"Kamala Harris negotiated drug prices for the first time with Medicare. We have 10 drugs that will come online, the most common ones that'll be there," he said.
Trump's running mate, Ohio Senator JD Vance, made some spurious claims about prescription drug prices only being up by 1.5 percent during the whole of Trump's first term compared to 7 percent during the Biden Administration.
CBS was quick to fact check his statements, showing that the average annual cost of prescription drugs per person was up by 9 percent from 2017 to 2019 under Trump and up by 11 percent between 2020 and 2022 under Biden. Looking at median cost instead of average, the data shows that costs were down under both administrations.
Trump's 2024 healthcare and drug price platform
During the presidential debate with Harris, Trump once again voiced his strong opposition to the Affordable Care Act: “Obamacare was lousy health care — always was. It's not very good today."
While he admits his administration was unable to repeal the ACA despite dozens of attempts that were blocked by Democrats, he would rather “just let it rot.”
When asked if he had any concrete healthcare plan for the country, he replied his team only has “concepts of a plan,” are considering “different plans” and would reveal more "in the not-too-distant future."
Senator JD Vance didn't provide much detail about his potential administration's healthcare plan during his debate performance either, although he did promise "we're going to cover Americans with pre-existing conditions" when pressed by Walz about his opposition to ACA.
Some on the other side of the aisle have said all the public needs to know about Trump’s healthcare plan can be found in Project 2025, a policy initiative by the Heritage Foundation published in 2022. Since Ronald Reagan’s presidency, every four years the conservative think tank has published a new batch of policy recommendations for the next Republican president.
Healthcare doesn’t get much space in the 900 plus page document, but what is addressed is the need to make dramatic changes to Medicaid, which serves low-income individuals and families, including repealing the law banning surprise medical billing. Also present are several directives aimed at curbing access to – and repealing FDA approval for – the abortion pill mifepristone, used in about half of US abortions, and the “week-after” contraceptive pill Ella. It also calls for the end of subsidies for stem cell or fetal cell research.
While Trump has disavowed Project 2025 and tried to distance himself from its authors, a large majority of its creators served in the first term of his administration. This includes prominent players such as Housing and Urban Development Secretary Ben Carson, acting Defense Secretary Chris Miller, deputy White House chief of staff Rick Dearborn, former Office of Management and Budget director Russ Vought and acting deputy secretary of the Department of Homeland Security Ken Cuccinelli.
Additionally, both Trump and the Heritage Foundation previously boasted that he enacted 64 percent of their recommendations within the first year of his presidency.
The 2024 GOP Platform document hosted on Trump’s campaign website states, “Healthcare and prescription drug costs are out of control. Republicans will increase Transparency, promote Choice and Competition, and expand access to new Affordable Healthcare and prescription drug options. We will protect Medicare, and ensure Seniors receive the care they need without being burdened by excessive costs.”
While Harris and Trump may be on opposite sides of the debate when it comes to the Affordable Care Act, both candidates are supportive of bringing down prescription drug costs.
While KFF Health News notes that prescription drug prices have not been a topic at the forefront of Trump's campaign, they did report that those close to him say he “would likely retain Medicare price negotiations unless the pharmaceutical industry can come up with something more compelling that they’d put on the table.”
However, Axios reports that a number of high-ranking Republicans are dead set on repealing the Medicare drug price negotiations set out under the IRA.
“Trump has pledged to ‘take on Big Pharma’ through administrative actions like tying what Medicare pays to prices in other developed nations,” said the news agency. “But he could still be open to repealing the IRA drug price measures, and his campaign isn't elaborating.”
Other efforts a second term Trump administration might take to reign in healthcare costs include placing caps on out-of-pocket insulin costs, importing US-made drugs that have been sold out of country and increasing competition among generic and biosimilar drugs.
According to KFF Health News, his administration may also seek to lower drug prices “in the Medicare 340B program, which requires drugmakers to provide outpatient drugs at reduced prices to eligible health organizations that serve lower-income and uninsured patients.”
It should be noted that in May 2024 US Court of Appeals for the District of Columbia ruled in favor of pharmaceutical companies, finding that they can limit their discounts under Medicare 340B.
As for the stalled Most Favored Nation model, one that is also supported by candidate Harris, Axios states that Trump has proposed taking executive action to make it a reality.
Investor takeaway
US federal election periods are often fraught with uncertainty for the life science sector. In the past, Republican administrations have been more favorable periods for pharmaceutical companies.
However, as with most aspects of American politics and industry, Trump has changed the game. The election of either candidate poses risks for pharma stocks.
But in terms of threats to drugmaker revenues and innovation, the Democrats’ push to more restrictive drug pricing regulations under Harris’ plans to expand the IRA present the bigger danger. The fact that nine out of the top 10 pharma companies with the highest 2024 campaign contributions have donated more to the Democrats and Harris shows that the pharmaceutical industry is well aware of the risk and are hedging their bets.
Since Harris is leading in the polls — even if only slightly — with a week left until the election, currying favor with a future Harris-Walz administration may be in their best interest.
Don’t forget to follow @INN_LifeScience for real-time updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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