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Early Detection Breakthrough: Biotech Companies Lead the Way in Pancreatic Cancer Treatment

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USA News Group Commentary

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, May 17, 2024 /PRNewswire/ — USA News Group – A new study is bringing hope in the fight against one of the deadliest cancers, revealing a blood test that can detect early-stage pancreatic cancer with 97% accuracy. This breakthrough is crucial, as Johns Hopkins Medicine reports that up to 10% of patients diagnosed early can become disease-free after treatment. The American Cancer Society estimates that around 66,440 people (34,530 men and 31,910 women) in the USA will be diagnosed with pancreatic cancer this year, with approximately 51,750 expected to succumb to the disease. Behind the scenes, biotech drug developers are working diligently to advance new treatments and improve patient outcomes, including recent updates from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Roche Holding AG (OTCQX: RHHBY), Merus N.V. (NASDAQ: MRUS), MacroGenics, Inc. (NASDAQ: MGNX), and Immuneering Corporation (NASDAQ: IMRX).

One innovative immunotherapeutic agent, pelareorep, developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is advancing as a potential treatment for multiple cancers, particularly breast and pancreatic cancer. After receiving Fast Track Designation from the FDA for pancreatic cancer in late 2022 due to encouraging clinical results, Oncolytics has embarked on a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR). This partnership is set to begin planning the evaluation of pelareorep for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) within GCAR’s anticipated master protocol, which is expected to generate registration-enabling data.

“We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR’s planned adaptive trial in pancreatic cancer patients,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients. GCAR’s anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner.”

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Oncolytics is progressing with its lead asset, having recently secured regulatory clearance to evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) +/- Tecentriq® from Roche Holding AG (OTCQX: RHHBY) in newly diagnosed pancreatic cancer patients in a new cohort of its ongoing GOBLET study. This approval follows clearance from German regulatory and ethics bodies. The new cohort is supported by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to expedite the development of new treatments for pancreatic cancer.

Positive outcomes from the pelareorep/mFOLFIRINOX combination could significantly boost Oncolytics’ efforts in combating pancreatic cancer. Previously, Oncolytics has shared encouraging data results from the combination of pelareorep with Tecentriq, gemcitabine and nab-paclitaxel. The team at Oncolytics is optimistic that if the mFOLFIRINOX combination shows improved response rates compared to historical control trials, it could advance to a registration-enabling study. This would provide two potential pelareorep-based treatment options for pancreatic cancer patients. Additionally, planned translational research for this cohort will delve deeper into understanding pelareorep’s mechanism of action, particularly its effects on the tumor microenvironment (TME).

In this evaluation, Oncolytics will also explore how tumor responses correlate with the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect seen in prior pancreatic cancer studies. The company intends to commence patient enrollment for the mFOLFIRINOX/pelareorep study cohort in Q2 2024.

Roche recently had an investigator-led trial of Tecentriq terminated back in March, while another clinical supply agreement was reached in May to evaluate another Tecentriq combination. Roche is also moving forward with partners BioNTech for a jointly-developed pancreatic cancer vaccine that demonstrated lasting responses in an early trial. In Phase II trials, the mRNA vaccine is administered along with Roche’s Tecentriq and chemo against pancreatic cancer.

Now Roche is also working through an agreement with PathAI, a global leader in artificial intelligence AI-powered technology for pathology. Under the terms of the deal, PathAI will work exclusively with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space.

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“This collaboration with Roche is a testament to our shared commitment to advancing the field of digital pathology and AI-enabled diagnostics for both drug development and clinical care,” said Dr. Andy Beck, CEO and Co-Founder of PathAI. “High medical value diagnostic products with seamless integration into the laboratory workflow will accelerate the transition to digital pathology as the standard to aid clinicians in diagnosis and biomarker characterisation.”

Recently the FDA granted priority review to a biologics license application (BLA) from Merus N.V. (NASDAQ: MRUS), seeking the approval of zenocutuzumab (MCLA-128) (“Zeno”) for use in the treatment of patients with pancreatic cancer (and NSCLC). The FDA has already granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.

FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1-positive cancer, a disease with poor prognosis and high unmet need,” said Andrew Joe, MD, Chief Medical Officer at Merus NV. “Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1-positive lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies.”

MacroGenics, Inc. (NASDAQ: MGNX) recently delivered an update on its corporate progress, which included preclinical data for its MGC028 at the recent AACR Annual Meeting, after the antibody-drug conjugate (ADC) demonstrated specific antitumor activity in in vivo models representing pancreatic cancer (among other cancers).

“In preclinical studies, MGC028 demonstrated specific antitumor activity in in-vivo models representing gastric, lung, pancreatic, colorectal, small cell carcinoma, the head and neck, and cholangiocarcinoma,” said Scott Koenig, President and CEO of MacroGenics during a recent earnings call. “In addition, in a nonhuman primate study, MGC028 was well tolerated at high dose levels with mild reversible side effects and no ocular toxicity, which is offered a concern with tubulin-inhibitor-based ADCs. These promising preclinical results support the continued investigation of MGC028 as a therapeutic option for treating ADAM9 solid tumors.”

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Back in February, Immuneering Corporation (NASDAQ: IMRX) was granted Fast Track Status for its IMM-1-104 for pancreatic cancer. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.

“We welcome FDA’s decision to grant Fast Track designation for IMM-1-104,” said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering in a statement. “Our Phase 1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer, as well as a number of other tumor types associated with the RAS pathway. We look forward to a data-rich 2024 as we plan to provide multiple readouts from our study this year.”

Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ 

USA NEWS GROUP
[email protected]
(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.

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While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

View original content:https://www.prnewswire.co.uk/news-releases/early-detection-breakthrough-biotech-companies-lead-the-way-in-pancreatic-cancer-treatment-302149143.html

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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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