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FDA Has Granted Innocan Pharma a Meeting Date for LPT-CBD for Chronic Pain

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The regulatory approval process with the U.S. Food and Drug Administration has commenced for Innocan’s LPT-CBD release technology, marking a key step in the advancement of non-opioid pain management

HERZLIYA, Israel and CALGARY, AB, May 21, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”), is pleased to announce significant advancements in the regulatory process for its Liposome-Cannabidiol (LPT-CBD) technology, which provides an innovative solution in non-opioid pain management. The U.S. Food and Drug Administration (“FDA”) has granted Innocan an Investigational New Drug (“IND”) number and approved an initial meeting with the Company to discuss the strategic path forward.

 

 

The meeting with the FDA has been set for July 31, 2024, where Innocan will present its preclinical results and proposed clinical development plan. This meeting is key to launching human clinical trials for the LPT-CBD injectable drug, developed to provide a novel treatment option for chronic pain.

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“We are very pleased with this crucial step towards launching our IND program for LPT-CBD in the United States,” commented Iris Bincovich CEO of Innocan Pharma. “This upcoming FDA consultation is pivotal, poised to set the stage for our clinical trials and drive forward our mission to revolutionize pain management. We look forward to the FDA reviewing our development program and providing us with guidance on our advancement to human clinical trials.”

Continued Iris Bincovich, CEO, “I thank Prof. Chezy Barenholz and Dr. Ahuva Cern of the Hebrew University of Jerusalem, renowned experts in liposome research, for their continued efforts providing strong supportive data on LPT-CBD, enabling our upcoming engagement with FDA.”

LPT therapy, which requires only one single monthly subcutaneous injection, offers a groundbreaking alternative to opioid-based approaches. Addressing the critical opioid crisis, where, according to the U.S. Centers for Disease Control and Prevention, over three-quarters of drug overdose deaths in the U.S. involve opioids, Innocan’s LPT-CBD presents a compelling, life-saving alternative. In multiple pre-clinical trials, Innocan’s therapy has shown consistent efficacy of its LPT-CBD injectable treatment, through prolonged and controlled release of CBD in animals with chronic pain conditions.

About Innocan

Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies based on advanced cannabinoids science, to treat various conditions to improve patients’ quality of life. This segment involves two drug delivery technologies: (i) LPT CBD- loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for: Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment, Innocan has established a joint venture by the name of BI Sky Global Ltd. that focuses on advanced targeted online sales. https://innocanpharma.com/

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For further information, please contact:

For Innocan Pharma Corporation:
Iris Bincovich, CEO

+1-516-210-4025

+972-54-3012842

+442037699377
[email protected]

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NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Cautionary note regarding forward-looking information

Certain information set forth in this news release, including, without limitation, information regarding research and development, collaborations, the filing of potential applications with the FDA and other regulatory authorities, the potential achievement of future regulatory milestones, the potential for treatment of conditions and other therapeutic effects resulting from research activities and/or the Company’s products, requisite regulatory approvals and the timing for market entry, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan’s control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements.

Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan’s public reports and filings which are available under Innocan’s profile at www.sedar.com.

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

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Latest News

Regulators Issue Joint Warning on Bank-Fintech Risks

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Regulators have issued a joint warning highlighting the risks associated with partnerships between banks and fintech companies. This warning underscores the need for careful management of these relationships to ensure regulatory compliance and mitigate potential risks.

Overview of the Joint Warning

The joint warning, issued by a coalition of financial regulators, emphasizes the importance of robust risk management practices when banks partner with fintech companies. These partnerships, while beneficial in driving innovation and enhancing customer services, also introduce new risks that must be addressed.

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Key Points of the Warning:

  • Regulatory Compliance: Banks must ensure that fintech partners comply with all relevant regulations and standards.
  • Risk Management: Robust risk management frameworks must be in place to identify, assess, and mitigate risks associated with fintech partnerships.
  • Data Security: Ensuring the security and privacy of customer data is paramount, particularly given the increasing prevalence of cyber threats.
  • Operational Resilience: Banks must ensure that fintech partnerships do not compromise their operational resilience and ability to deliver critical services.

Benefits of Bank-Fintech Partnerships

Despite the risks, partnerships between banks and fintech companies offer significant benefits, driving innovation and enhancing the customer experience.

Key Benefits:

  • Innovation: Fintech companies bring innovative technologies and solutions that can enhance banking services and products.
  • Customer Experience: Partnerships with fintechs can improve the customer experience by offering faster, more efficient, and personalized services.
  • Cost Efficiency: Fintech solutions can help banks reduce costs and improve operational efficiency through automation and digitalization.

Risks Associated with Bank-Fintech Partnerships

The joint warning highlights several risks associated with bank-fintech partnerships that must be carefully managed.

Key Risks:

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  • Regulatory Risk: Ensuring compliance with complex and evolving regulatory requirements is a significant challenge.
  • Cybersecurity Risk: Fintech partnerships can introduce cybersecurity vulnerabilities, making it essential to implement robust security measures.
  • Operational Risk: The integration of fintech solutions into banking operations can pose operational risks, particularly if not managed effectively.
  • Reputational Risk: Any issues or failures in fintech partnerships can damage the bank’s reputation and customer trust.

Strategies for Managing Risks

To mitigate the risks associated with fintech partnerships, banks must adopt comprehensive risk management strategies and ensure rigorous oversight.

Key Strategies:

  • Due Diligence: Conducting thorough due diligence on fintech partners to assess their regulatory compliance, security practices, and financial stability.
  • Contractual Safeguards: Including robust contractual safeguards in partnership agreements to outline responsibilities, expectations, and compliance requirements.
  • Continuous Monitoring: Implementing continuous monitoring and assessment of fintech partnerships to identify and address emerging risks.
  • Collaboration with Regulators:: Engaging with regulators to ensure that partnerships comply with regulatory requirements and to stay informed of any changes in the regulatory landscape.

The Role of Technology

Technology plays a crucial role in managing the risks associated with bank-fintech partnerships, offering tools and solutions that enhance oversight and compliance.

Key Technologies:

  • RegTech Solutions: Regulatory technology (RegTech) solutions can automate compliance processes, ensuring that fintech partnerships adhere to regulatory requirements.
  • Cybersecurity Tools: Advanced cybersecurity tools and solutions can enhance the security of fintech partnerships, protecting against cyber threats.
  • Risk Management Platforms: Integrated risk management platforms can provide real-time visibility into partnership risks and support proactive risk mitigation.

Conclusion

The joint warning issued by regulators highlights the need for careful management of bank-fintech partnerships to ensure regulatory compliance and mitigate potential risks. While these partnerships offer significant benefits, including innovation and enhanced customer experience, they also introduce new risks that must be addressed through robust risk management strategies. By leveraging technology and engaging with regulators, banks can effectively manage these risks and capitalize on the opportunities presented by fintech partnerships.

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Source of the news: American Banker

The post Regulators Issue Joint Warning on Bank-Fintech Risks appeared first on HIPTHER Alerts.

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Nasdaq Profit Beats Estimates as Fintech Sales Soar

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Nasdaq Inc. has reported earnings that exceeded analysts’ expectations, driven by a surge in fintech sales. This strong performance underscores the growing importance of fintech solutions in driving financial market innovation and growth.

Overview of Nasdaq’s Financial Performance

Nasdaq’s latest earnings report reveals impressive financial performance, with profits surpassing estimates due to robust growth in its fintech segment.

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Key Financial Highlights:

  • Revenue Growth: Nasdaq reported a significant increase in revenue, primarily driven by its fintech sales.
  • Earnings Beat: The company’s earnings per share (EPS) exceeded analysts’ expectations, highlighting its strong financial performance.
  • Fintech Segment: The fintech segment emerged as a key growth driver, contributing significantly to the overall revenue increase.

The Role of Fintech in Nasdaq’s Growth

Nasdaq’s fintech solutions have played a pivotal role in its recent financial success, offering innovative technologies that enhance market operations and customer services.

Key Fintech Solutions:

  • Market Technology: Nasdaq’s market technology solutions provide advanced trading, clearing, and market surveillance capabilities to financial institutions and exchanges.
  • Data and Analytics: The company’s data and analytics solutions offer valuable insights and support informed decision-making for market participants.
  • Corporate Solutions: Nasdaq’s corporate solutions include governance, risk management, and compliance tools that help companies navigate complex regulatory environments.

Factors Driving Fintech Sales Growth

Several factors have contributed to the surge in Nasdaq’s fintech sales, reflecting broader trends in the financial technology sector.

Key Drivers:

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  • Digital Transformation: The ongoing digital transformation in the financial industry has increased demand for advanced fintech solutions.
  • Regulatory Compliance: Growing regulatory requirements have driven demand for compliance and risk management solutions.
  • Market Volatility: Increased market volatility has highlighted the need for robust trading and market surveillance technologies.

Strategic Initiatives

Nasdaq has undertaken several strategic initiatives to capitalize on the growing demand for fintech solutions and drive long-term growth.

Strategic Focus Areas:

  • Innovation: Continuously investing in innovation to develop cutting-edge fintech solutions that address the evolving needs of the financial industry.
  • Partnerships: Forming strategic partnerships with other technology providers and financial institutions to enhance its product offerings and expand market reach.
  • Global Expansion: Expanding its presence in key markets around the world to capture new growth opportunities and serve a broader client base.

Future Prospects

Nasdaq’s strong financial performance and strategic initiatives position the company for continued growth in the fintech sector. The company plans to leverage its technological capabilities and market expertise to drive further innovation and expand its fintech offerings.

Growth Opportunities:

  • Product Development: Developing new fintech products and features to meet emerging market needs and regulatory requirements.
  • Mergers and Acquisitions: Exploring potential mergers and acquisitions to enhance its technology portfolio and market position.
  • Customer Engagement: Enhancing customer engagement through personalized solutions and services that address specific client needs.

Conclusion

Nasdaq’s impressive financial performance, driven by a surge in fintech sales, underscores the growing importance of fintech solutions in the financial market. The company’s strategic focus on innovation, partnerships, and global expansion positions it for continued growth and success. As Nasdaq continues to leverage its fintech capabilities, it is well-positioned to drive financial market innovation and deliver value to its clients and shareholders.

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Source of the news: Reuters

The post Nasdaq Profit Beats Estimates as Fintech Sales Soar appeared first on HIPTHER Alerts.

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K1 Issues MariaDB Compulsory Acquisition Notices

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MANHATTAN BEACH, Calif., July 26, 2024 /PRNewswire/ — Meridian BidCo LLC (“Bidco“), an affiliate of K1 Investment Management, LLC (“K1“), announced earlier this week that its tender offer to acquire the entire issued and to be issued share capital of MariaDB plc (“MariaDB“) for $0.55 per share (the “Offer“) had expired. The Offer was settled in accordance with its terms on July 25, 2024. Bidco now owns 61,263,283 MariaDB ordinary shares, representing 88.70% of the issued share capital of MariaDB as of July 22, 2024.

As previously announced, Bidco now intends to apply the provisions of Sections 456 to 460 of the Companies Act of 2014 of Ireland to acquire compulsorily, on the same terms as the Offer, any outstanding ordinary shares of MariaDB not acquired or agreed to be acquired pursuant to the Offer. 

On July 26, 2024, Bidco sent compulsory acquisition notices (the “Notices“) to those MariaDB shareholders who did not accept the Offer (the “Non-Assenting Shareholders“). Following the expiration of 30 calendar days from the date of the Notices, which is expected to be August 25, 2024 (the “Expiration Time“), unless a Non-Assenting Shareholder has applied to the Irish High Court and the Irish High Court orders otherwise, the shares of MariaDB held by Non-Assenting Shareholders will be acquired compulsorily by Bidco (without any action on the part of such shareholders) on the same terms as the Offer, on or about August 26, 2024. The cash consideration payable will be settled no later than three business days after the Expiration Time. There will be no redemption rights or liquidating distributions with respect to the Company’s warrants, which will expire worthless.

Following the compulsory acquisition process, Bidco intends to cause the ordinary shares of MariaDB to be delisted from the New York Stock Exchange and terminate the registration of the MariaDB ordinary shares under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act“), and suspend MariaDB’s reporting obligations under the Exchange Act as promptly as possible.

Enquiries

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Lazard (Financial Advisor to K1 and Bidco)
Adrian Duchini, Keiran Wilson, Charles White

                              Tel: +44 20 7187 2000

Haven Tower Group (Public Relations Advisor to K1)

Donald Cutler, Brandon Blackwell

                                                 Tel: +1 424 317 4850

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Important Notices

The K1 Responsible Persons (being the investment committee of K1), the Bidco officers and the Meridian TopCo LLC Officers accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the K1 Responsible Persons, the Bidco Officers, the Topco Officers, (who have taken all reasonable care to ensure that such is the case) the information contained in this announcement for which they have accepted responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Lazard Frères & Co. LLC, together with its affiliate Lazard & Co., Limited (which is authorised and regulated in the United Kingdom by the Financial Conduct Authority) (“Lazard“), is acting exclusively as financial adviser to K1 and Bidco and no one else in connection with the matters referred to in this announcement and will not be responsible to anyone other than K1 and Bidco for providing the protections afforded to clients of Lazard nor for providing advice in relation to the matters referred to in this announcement or any other matters referred to in this announcement. Neither Lazard nor any of its affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Lazard in connection with this announcement, any statement contained herein or otherwise.

Forward Looking Statements

This announcement (including any information incorporated by reference in this announcement), oral statements made regarding the Offer, and other information published by MariaDB, Bidco, K1 or any member of the K1 Group (as defined below) contain statements which are, or may be deemed to be, “forward looking statements.” Such forward looking statements are prospective in nature and are not based on historical facts, but rather on current expectations and on numerous assumptions regarding the business strategies and the environment in which any member of the K1 Group (including, after closing of the Offer, any of MariaDB and its subsidiaries and subsidiary undertakings (the “MariaDB Group“)) shall operate in the future and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by those statements. The forward looking statements contained in this announcement relate to K1, any member of the K1 Group’s (including any member of the MariaDB Group) future prospects, developments and business strategies, the progress of the compulsory acquisition process, the outcome of legal proceedings that may be instituted against the K1 Group and/or others relating to the Offer, potential adverse reactions or changes to business relationships resulting from the completion of the Offer, significant or unexpected costs, charges or expenses resulting from the Offer, negative effects of this announcement or the consummation of the Offer on the market price of MariaDB’s Shares, and potential failure to realize the expected benefits of the Offer and other statements other than historical facts. In some cases, these forward looking statements can be identified by the use of forward looking terminology, including the terms “believes,” “estimates,” “will look to,” “would look to,” “plans,” “prepares,” “anticipates,” “expects,” “is expected to,” “is subject to,” “intends,” “may,” “will,” “shall” or “should” or their negatives or other variations or comparable terminology. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend on circumstances that shall occur in the future. These events and circumstances include changes in global, political, economic, business, competitive, and market conditions and regulatory forces, future exchange and interest rates, changes in tax rates and future business combinations or disposals. If any one or more of these risks or uncertainties materializes or if any one or more of the assumptions prove incorrect, actual results may differ materially from those expected, estimated or projected. Such forward looking statements should therefore be construed in the light of such factors. Neither K1, Bidco nor any member of the K1 Group, nor any of their respective associates or directors, officers or advisers, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward looking statements in this announcement shall actually occur. The forward looking statements speak only as of the date of this announcement. All subsequent oral or written forward looking statements attributable to any of K1 and all of its affiliates, including K5 Private Investors, L.P. (the “K1 Group“), or any of their respective associates, directors, officers, employees or advisers, are expressly qualified in their entirety by the cautionary statement above. K1 and the K1 Group expressly disclaim any obligation to update such statements other than as required by law or by the rules of any competent regulatory authority, whether as a result of new information, future events or otherwise.

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Further Information

This announcement is for information purposes only and is not intended to, and does not, constitute an offer to sell or invitation to purchase any securities, or the solicitation of any vote or approval in any jurisdiction pursuant to the Offer or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this announcement is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. The release, publication or distribution of this announcement in certain jurisdictions may be restricted by law and therefore persons in such jurisdictions into which this announcement is released, published or distributed should inform themselves about and observe such restrictions.

View original content:https://www.prnewswire.co.uk/news-releases/k1-issues-mariadb-compulsory-acquisition-notices-302207896.html

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