Month: June 2024

AI Revolution in Healthcare: Simplify Healthcare Acquires Virtical.ai

Posted on by slightbourne@noblecapitalmarkets.com

In a groundbreaking move, Simplify Healthcare has announced its acquisition of Virtical.ai, setting the stage for a dramatic transformation in health insurance technology. This strategic merger, revealed on June 24, 2024, combines Simplify Healthcare’s established SaaS platform with Virtical.ai’s advanced artificial intelligence capabilities, promising to revolutionize how health insurance providers operate in an increasingly complex market.

The timing of this acquisition is particularly significant as the healthcare industry grapples with mounting pressures to personalize services, streamline operations, and navigate intricate regulatory landscapes. By integrating Virtical.ai’s AI prowess into its Simplify Health Cloud™ platform, Simplify Healthcare aims to empower health insurance companies (Payers) with sophisticated tools to address these challenges effectively.

At the core of this acquisition lies the transformative potential of AI-driven solutions. Virtical.ai’s technology, which has been trained on an extensive database of health plan-specific documents, excels in data extraction and comparison. This capability enables Payers to offer highly personalized plans and benefits to both employer and individual segments, potentially revolutionizing the way health insurance is customized to meet individual needs.

Simplify Healthcare’s leadership team has expressed enthusiasm about the merger’s potential to reshape the industry. They emphasize the ability of AI models to process complex documents such as Statements of Benefits and Coverage (SBCs) and Machine Readable Files (MRFs), highlighting the potential for significant advancements in plan comparison, selection, and price transparency.

The acquisition also addresses critical challenges in network management. Virtical.ai’s platform can identify gaps in Payer networks by analyzing provider and member locations. This feature allows Payers to strategically promote their network coverage strengths and address deficiencies, ensuring members have access to suitable providers within their area. Moreover, the ability to benchmark negotiated provider rates against competitors offers Payers valuable insights for rate-setting and targeted marketing initiatives.

Virtical.ai’s leadership shares the excitement about the merger’s potential impact. They highlight how their AI models, built on decades of industry experience, are positioned to drive membership growth and revenue when integrated with Simplify Healthcare’s enterprise SaaS platform.

The integration of Virtical.ai’s technology is expected to enhance several of Simplify Healthcare’s existing solutions, including Benefits1™, Provider1™, Service1™, Claims1™, and Experience1™. These enhancements promise to provide Payers with more precise solutions to complex challenges in delivering products, benefits, and provider data.

Simplify Healthcare’s strategic team underscores the acquisition’s importance in the face of market disruptions. They believe that combining their industry-leading platform with Virtical.ai’s innovative AI solutions in Health Plan Sales and Network Management will empower Payers to achieve growth despite facing disruptive market and regulatory forces.

This merger also reflects a broader industry trend towards leveraging AI and machine learning to improve efficiency and personalization. By utilizing both generative AI and machine learning algorithms on unstructured document content and structured data, the combined entity aims to deliver cutting-edge solutions to Payers navigating the complexities of AI integration.

As the healthcare landscape continues to evolve, this acquisition positions Simplify Healthcare at the forefront of the AI revolution in health insurance technology. The promise of more personalized health plans, optimized network coverage, and data-driven decision-making tools could significantly impact not only Payers but also brokers and, ultimately, healthcare consumers.

With this bold move, Simplify Healthcare and Virtical.ai are poised to play a pivotal role in shaping the future of health insurance in an increasingly digital and personalized world. Their combined expertise and technological capabilities have the potential to drive innovation, enhance efficiency, and improve the overall experience for all stakeholders in the health insurance ecosystem.

Take a moment to take a look at GoHealth Inc. (GOCO), a health insurance marketplace that leverages modern machine-learning algorithms and helps individuals find the best health insurance plan for their specific needs.

Release – Tonix Pharmaceuticals Announces Proposed Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market data on TNXP

June 26, 2024 4:40pm EDT

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at investmentbanking@dawsonjames.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact 
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact 
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 26, 2024

Release – Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 26, 2024 3:13pm EDT

CHATHAM, N.J., June 26, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company, today announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. On June 26, 2024, Tonix received a letter from The Nasdaq Stock Market LLC stating that because Tonix’s shares had a closing bid price at or above $1.00 per share for a minimum of 10 consecutive business days, Tonix’s stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

**Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released June 26, 2024

Amazon Hits $2 Trillion Market Cap for the First Time as Tech Sector Thrives

Posted on by slightbourne@noblecapitalmarkets.com

In a testament to the enduring strength and allure of the technology sector, e-commerce and cloud computing giant Amazon has reached a market capitalization of $2 trillion for the first time. This milestone, achieved on June 26, 2024, underscores the robust performance of tech stocks and reinforces the sector’s position as a cornerstone of modern investment strategies.

Amazon’s ascent to the $2 trillion club is not an isolated event but part of a broader trend in the tech industry. The company joins an elite group of tech behemoths, including Nvidia, Apple, Alphabet, and Microsoft, all of which have surpassed this remarkable valuation threshold. This collective success story highlights the tech sector’s resilience and its ability to generate substantial returns for investors.

The driving force behind this surge in tech valuations is multifaceted. Generative artificial intelligence has emerged as a particularly potent catalyst, igniting investor excitement and fueling unprecedented growth. Nvidia, a key player in AI hardware, exemplifies this trend, having seen its market value skyrocket from $2 trillion to $3 trillion in just over three months.

Amazon’s journey to $2 trillion has been propelled by several factors. The company’s cloud computing arm, Amazon Web Services (AWS), has shown strong recovery and growth potential, particularly in the realm of AI services. Additionally, CEO Andy Jassy’s cost-cutting initiatives have bolstered earnings, earning the approval of investors and analysts alike.

The tech sector’s impressive performance extends beyond these giants. The Nasdaq, a tech-heavy index, has risen by approximately 18% year-to-date, outpacing broader market indices. This outperformance underscores the sector’s ability to navigate economic uncertainties and capitalize on emerging trends.

For investors, the tech sector continues to present compelling opportunities. The industry’s track record of innovation, adaptability, and growth makes it an attractive option for those seeking long-term value appreciation. From established giants like Amazon to emerging players in fields such as AI, cybersecurity, and clean tech, the sector offers a diverse range of investment prospects.

However, it’s crucial for investors to approach tech investments with a balanced perspective. While the sector has demonstrated remarkable growth, it also comes with its own set of risks, including regulatory challenges, intense competition, and the rapid pace of technological change. Diversification and thorough research remain key strategies for those looking to capitalize on the tech sector’s potential.

As we look to the future, the tech sector’s influence on the global economy shows no signs of waning. With ongoing advancements in AI, cloud computing, IoT, and other transformative technologies, the industry is poised to continue shaping our world and presenting new investment opportunities.

Amazon’s entry into the $2 trillion club is more than just a milestone for the company; it’s a reflection of the tech sector’s enduring strength and its potential to generate substantial returns. As technology continues to evolve and permeate every aspect of our lives, the sector remains a beacon for growth-oriented investors, offering the promise of innovation, disruption, and long-term value creation.

Release – North Central Texas Awards Comtech Public Safety Contract Valued at Approximately $30.0 Million

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CMTL

CHANDLER, Ariz. – June 26, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, today announced the North Central Texas Emergency Communications District (“NCT9-1-1”) awarded the Company a contract to deliver Next Generation 9-1-1 (“NG9-1-1”) services that will further modernize NCT9-1-1’s infrastructure. The NCT9-1-1 contract includes a five-year base award, as well as three additional two-year option periods, with a not to exceed value of approximately $30.0 million.

Comtech has partnered with NCT9-1-1 for over 10 years and the Company currently provides a wide range of call routing and call handling technologies serving over two million people in Texas. NCT9-1-1 is responsible for 40-plus Emergency Communications Centers in 13 counties and five municipalities surrounding the Dallas/Fort Worth Metroplex.

Through this new contract, Comtech’s comprehensive suite of public safety solutions will enable NCT9-1-1 to fully migrate to a new NG9-1-1 system. Comtech will also continue to enhance the region’s call routing capabilities by providing major NG9-1-1 sub-components, including Next Generation Core Services, Emergency Services Internet Protocol Network and Call Aggregation, among other services.

“As a longstanding partner, Comtech is working with NCT9-1-1 to bring forward new emergency response capabilities that ensure residents and visitors get the help they need when lives are on the line and seconds matter most,” said John Whitehead, General Manager of Comtech’s Safety and Security Technologies (“SST”) Division. “This contract further demonstrates the trust of our public safety partners in the United States, and we are honored to continue working with the NCT9-1-1 to deliver a purpose-built public safety architecture that meets the needs of communities and individuals in crisis.”

“Comtech is continuing to support the NCT9-1-1 by delivering critical NG9-1-1 capabilities that enhance emergency response services and protect our public,” said Christy Williams, Director of 9-1-1 at NCT9-1-1. “NCT9-1-1’s 10-plus year partnership with Comtech in the early adoption of NG9-1-1 services has taught us a lot. We are looking forward to continuous improvement with Comtech as we forge the future of emergency communications together.”

As one of the most trusted providers of public safety technologies, Comtech is continuing to expand its NG9-1-1 call routing and call handling solutions for governments and emergency response providers across the globe. The Company’s NG9-1-1 offerings are designed to adapt and continuously evolve over time to meet the needs of emerging use cases as well as future applications.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

Investor Relations

Maria Ceriello

631-962-7115

Maria.Ceriello@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Unicycive Therapeutics (UNCY) – The Moment We’ve Been Waiting For: OLC Pivotal Trial Meets Endpoints For Phosphate Control

Posted on by cpereira@noblefcm.com


Wednesday, June 26, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Side Effect Rates Were Low. Unicycive announced top-line results from its pivotal study to determine OLC (oxylanthanum carbonate) tolerability, safety, and dosing. The trial met its tolerability and safety endpoints with data that compares favorably with Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. An NDA filing is expected in 3Q24.

Low Discontinuation Rate Met The Primary Endpoint. Tolerability, the rate of discontinuations due to treatment related adverse events (TRAEs), was the primary endpoint. The Evaluable Population of 71 patients had only 1 TRAE discontinuation, a rate of 1.4%.  In the Safety Population, a total of 3 patients out of 86 discontinued due to TRAEs, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Bit Digital (BTBT) – AI Contract Expansion Finalized

Posted on by cpereira@noblefcm.com


Wednesday, June 26, 2024

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Finalized Terms. Yesterday, Bit Digital announced the Company finalized an agreement to supply its anchor AI client with an additional 2,048 GPUs. With the expansion, the client will now be supplied 4,096 GPUs. The contract now has total revenue of approximately $275 million, or $92 million on an annualized basis.

Purchasing More Servers. Bit Digital is purchasing 256 servers from Dell Technologies with a total of 2,048 Nvidia HGX H100 GPUs. Expected to be delivered in July 2024, the servers will be deployed to the Company’s Iceland datacenter and are expected to start generating revenue in August 2024. Management intends to finance the purchase with a mixture of cash and digital assets, and has entered into a sale-leaseback agreement for 1,024 of the GPUs with a third party entity. Recall, management previously noted an additional $60 million of capital would be needed for the purchase.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Cruise Stocks Surge: A Positive Signal for the Travel Sector’s Recovery

Posted on by slightbourne@noblecapitalmarkets.com

Today, the cruise ship industry is seeing remarkable activity in its stocks, with Carnival, Royal Caribbean, and Norwegian Cruise Line experiencing notable surges. This spike follows Norwegian Cruise Line’s announcement of enhanced financial guidance for 2024 and ambitious targets for 2026. The company’s new “Charting The Course” strategy, which includes significant yield growth expectations and improved EBITDA forecasts, has bolstered investor confidence, driving up not only Norwegian’s shares but also those of Carnival and Royal Caribbean.

The surge in these stocks signals a robust recovery for the cruise industry, which was one of the hardest-hit sectors during the COVID-19 pandemic. The current upswing is largely attributed to strong demand and record bookings reported by these companies, reflecting renewed consumer interest in cruise vacations. Additionally, strategic initiatives focusing on long-term financial health and sustainability are positioning these companies for continued growth and stability.

This positive momentum in the cruise sector has broader implications for the travel industry. Companies like Travelzoo, which specializes in travel deals, stand to benefit from the increased promotional activities and consumer interest in cruises. As cruise companies offer more deals to attract customers, platforms like Travelzoo can capitalize by featuring a wider range of cruise packages, driving higher engagement and potentially boosting revenues.

Investors observing these trends should note the underlying factors contributing to the surge. The increased bookings and optimistic financial forecasts indicate a strong recovery trajectory for the cruise industry. Moreover, strategic partnerships and marketing initiatives by cruise lines can enhance consumer reach and operational efficiency, creating a favorable environment for growth.

While the surge in cruise ship stocks is promising, it’s crucial for investors to consider the broader context and potential risks. The recovery is partly dependent on continued consumer confidence and the ability of these companies to manage operational challenges post-pandemic. Additionally, the sustainability initiatives and financial health strategies of these companies will play a significant role in their long-term performance.

In conclusion, the recent activity in cruise ship stocks highlights a positive outlook for the travel sector. Norwegian Cruise Line’s enhanced financial guidance and strategic targets have instilled confidence in the market, benefiting not only the company but also its competitors, Carnival and Royal Caribbean. For investors, understanding the dynamics driving this surge and the potential implications for related companies like Travelzoo can provide valuable insights into the evolving travel industry landscape. As always, it is essential to approach investment decisions with a comprehensive understanding of market trends and potential risks.

Release – Codere Online Reports Favorable AGM Results and Changes to its Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CDRO

06/25/2024

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Luxembourg, Grand Duchy of Luxembourg, June 25, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, today announced the favorable resolution of all 21 agenda items at the Annual General Meeting (AGM) held yesterday at the registered office of the Company, including the appointment of three new members to its Board of Directors.

Mr. Gabriel Saenz de Buruaga, Mr. Taavi Davies and Mr. Claude Noesen have been appointed as directors for an initial term of one year, replacing Mr. Patrick Ramsey, Ms. Michal Elimelech, and Mr. Laurent Teitgen.

Mr. Gonzaga Higuero, CEO of Codere Group, was re-appointed as director and will also serve as Chairman of the Board going forward. In regards to these changes, Mr. Higuero stated “we welcome these new additions to the Board and look forward to working with them to build upon the significant progress achieved by the Company in recent years.”

Mr. Higuero further added “I would also like to extend my sincere appreciation to Pat for his valuable contribution and dedication as Chairman since Codere Online went public in 2021, and I am excited that he will be joining me in the Board of our parent company, Codere New Topco, following its recently announced recapitalization and as it looks ahead to a promising future.”

For detailed biographies of the members of our Board of Directors please visit our website.

Changes to Board Committees

In the Board of Directors meeting held last week ahead of the AGM, the following changes to the Company’s Committees were approved:

  • Audit Committee – Appointment of Mr. Claude Noesen as member. Mr. Borja Fernández and Mr. Daniel Valdez will continue to serve as Chairman and member, respectively.
  • Compliance Committee – Appointment of Mr. Mark Dunn as Chairman and Mr. Taavi Davies as member. Mr. Rafael Catalá and Ms. Yaiza Rodríguez will continue to serve as members.

About Codere Online
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina. Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.

About Codere Group
Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

Forward-Looking Statements
Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans.

These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, and (xii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.

Trademarks
This document may contain trademarks, service marks, trade names and copyrights of Codere Online or other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this document may be listed without the TM, SM, © or ® symbols, but Codere Online will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.

Contacts:

Investors and Media
Guillermo Lancha
Director, Investor Relations and Communications
Guillermo.Lancha@codere.com
(+34) 628 928 152

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Source: Codere Online Luxembourg, S.A.

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From Crypto to Computing: Bit Digital’s AI Pivot Pays Off Big

Posted on by slightbourne@noblecapitalmarkets.com

In a move that’s turning heads on Wall Street, Bit Digital (Nasdaq: BTBT) is doubling down on its artificial intelligence infrastructure play. The New York-based company, once primarily known for its cryptocurrency mining operations, has just inked a deal that could redefine its future – and potentially reshape the landscape of AI computing services.

On June 25, 2024, Bit Digital announced the expansion of a contract with a major high-performance computing customer. The numbers are eye-popping: an additional 2,048 GPUs, bringing the total to 4,096, with a contract value of approximately $275 million over three years. That’s $92 million annually, for those keeping score at home.

But what’s really intriguing here isn’t just the scale of the deal – it’s what it represents. Bit Digital is making a calculated pivot, leveraging its expertise in managing complex computing operations to carve out a niche in the booming AI infrastructure market. And they’re doing it with gusto.

The company isn’t just talking a big game; they’re putting their money where their mouth is. They’ve placed an order for 256 servers from Dell Technologies, packed with Nvidia’s coveted HGX H100 GPUs. These aren’t your run-of-the-mill graphics cards; they’re the cream of the crop for AI computations, and Bit Digital is betting big on their potential.

What’s particularly savvy about this move is how Bit Digital is financing it. They’re using a mix of cash, digital assets, and a sale-leaseback agreement for half of the new GPUs. This financial juggling act demonstrates a level of fiscal acumen that should pique the interest of potential investors. It’s a strategy that minimizes upfront capital requirements while maximizing potential returns – music to any investor’s ears.

But here’s where it gets really interesting: this deal puts Bit Digital tantalizingly close to its goal of a $100 million annualized revenue run-rate by the end of 2024. They’re now sitting at over 90% of that target. For a company that was once primarily focused on bitcoin mining, this represents a remarkable transformation.

CEO Sam Tabar’s comments suggest this is just the beginning. He’s talking about “robust growth trajectory” and “scaling even further as the year progresses.” It’s the kind of optimistic language that makes investors’ ears perk up, especially when it’s backed by concrete deals like this one.

Of course, it’s not all smooth sailing. The AI infrastructure market is heating up, with tech giants and startups alike vying for a piece of the pie. Bit Digital will need to leverage its first-mover advantage and continue to execute flawlessly to maintain its edge.

Investors keen on getting more details won’t have to wait long. Bit Digital is slated to present at the Noble Capital Markets Consumer/TMT Virtual Conference this week. It’s an opportunity to hear directly from the company’s leadership about their strategy and future prospects.

As the lines between cryptocurrency, blockchain, and AI continue to blur, companies like Bit Digital are positioning themselves at the intersection of these transformative technologies. Their ability to pivot from crypto mining to AI infrastructure demonstrates an agility that could serve them well in the fast-paced tech sector.

For investors, Bit Digital represents an intriguing proposition. It’s a company with roots in the volatile world of cryptocurrency that’s now making significant inroads into the AI boom. As the demand for AI computing resources continues to skyrocket, Bit Digital’s bold moves could position them as a key player in this burgeoning field.

While the risks inherent in such a rapidly evolving sector shouldn’t be overlooked, Bit Digital’s recent contract win and ambitious revenue targets suggest a company that’s not just adapting to change, but actively shaping it. As always, potential investors should do their due diligence, but for those looking to ride the AI wave, Bit Digital is certainly a company worth watching.

Release – Bit Digital, Inc. Announces Finalized Terms for Contract Expansion with Major HPC Customer; Total Contract Value Now Worth Approximately $275 Million

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on BTBT

NEW YORK, June 25, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York, announced today that it has finalized an agreement to supply an existing customer with an additional 2,048 GPUs over a three-year term commencing upon deployment. With this agreement, the Company will supply this customer with a total of 4,096 GPUs for the respective three-year periods, amounting to total revenue of approximately $275 million, or $92 million on an annualized basis.

To fulfill the contract, the Company has placed a purchase order for 256 servers manufactured by Dell Technologies, an authorized Nvidia OEM, that are equipped with 2,048 Nvidia HGX H100 GPUs along with related equipment, which are expected to be delivered to the Company during July 2024. The servers will be deployed in Iceland at the datacenter where the Company’s existing AI servers are located and are expected to begin generating revenue in August 2024.

The Company intends to finance the deal with a mixture of cash and digital assets on the balance sheet. Bit Digital has elected to enter into a sale-leaseback agreement with a third-party entity for 1,024 GPUs which will reduce the Company’s capital outlay commensurately. Additionally, the Company continues to evaluate debt financing options that would allow the Company to retroactively finance its hardware assets.

Sam Tabar, Bit Digital’s CEO, commented: “We are pleased to finalize terms with our customer to expand their deployment to over 4,000 GPUs. This agreement significantly contributes to our goal of reaching a $100 million annualized revenue run-rate by the end of 2024, bringing us to over 90% of this target. Our primary objective in the HPC business is to execute effectively for our customers and help them achieve their AI ambitions. We continue to see a robust growth trajectory for this segment and look forward to scaling even further as the year progresses.”

About Bit Digital

Bit Digital, Inc. is a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City. Our bitcoin mining operations are located in the US, Canada, and Iceland. The Company has established a business line, Bit Digital AI, that offers infrastructure services for artificial intelligence applications. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com.

Investor Notice

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 3.D of our most recent Annual Report on Form 20-F for the fiscal year ended December 31, 2023. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Release – Harte Hanks Finalizes Annuity Purchase to Effectively Terminate Qualified Pension Plan I

Posted on by aweinsoff@channelchek.com

Research News and Market Data on HHS

Nationwide to Provide Benefits to Plan I Pension Members as of August 2024

CHELMSFORD, MA / ACCESSWIRE / June 25, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for over 100 years, announced today the successful divestment and termination of its obligations related to Qualified Pension Plan I (“Plan I”), effective as of August 2024.

On June 18, 2024, Harte Hanks selected and signed formal commitment letters with Nationwide to provide pension benefits to its Plan I pension members, commencing as of August 2024. Nationwide’s Pension Risk Transfer business leverages more than 60 years of annuity, defined benefit and risk management experience, as well as the company’s outstanding financial strength, to serve a book with more than 450 contracts with a focus on personalized service and transition simplicity. Harte Hanks will continue to make payments to plan members through the end of July 2024.

“We pride ourselves on offering a seamless transition experience for plan participants, helping them feel confident that their pension benefit will continue under our management,” said Paula Cole, vice president of Nationwide’s Pension Risk Transfer business. “We’re excited to welcome these new plan members to Nationwide and look forward to providing extraordinary care to them beyond just this transition.”

In accordance with the commitment letters with Nationwide, Harte Hanks made a one-time $6.1 million contribution to Plan I on June 20, 2024 and transferred $71.9 million of Plan I assets to Nationwide on June 24, 2024, thereby absolving Harte Hanks of all payment obligations under Plan I as of August 1, 2024. This annuity purchase completes Harte Hanks prior decision to terminate this pension plan, effective as of June 30, 2023.

“This plan termination and annuity agreement is a positive step to increasing Harte Hanks cash flow, as our Plan I pension payments will end as of July 31st, 2024, and our related PBGC insurance premium payments will stop shortly thereafter. This termination will also further streamline our balance sheet, removing the ongoing obligation related to Plan I. More importantly, we’re ensuring participants will be well taken care of by Nationwide, a company dedicated to extraordinary customer service,” commented David Garrison, Chief Financial Officer of Harte Hanks.

About Harte Hanks:

Harte Hanks (NASDAQ: HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including GlaxoSmithKline, Unilever, Pfizer, Bank of America, Warner Brothers Discovery, Volvo, Ford, FedEx, Midea and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

About Nationwide

Nationwide, a Fortune 100 company based in Columbus, Ohio, is one of the largest and strongest diversified insurance and financial services organizations in the United States. Nationwide is rated A+ by Standard & Poor’s. An industry leader in driving customer-focused innovation, Nationwide provides a full range of insurance and financial services products including auto, business, homeowners, farm and life insurance; public and private sector retirement plans, annuities and mutual funds; excess & surplus, specialty and surety; and pet, motorcycle and boat insurance.

For more information, visit www.nationwide.com.

Subscribe today to receive the latest news from Nationwide and follow Nationwide PR on X.

Nationwide, Nationwide is on your side and the Nationwide N and Eagle are service marks of Nationwide Mutual Insurance Company. © 2024

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) market conditions that may adversely impact marketing expenditures, and (ii) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (iii) the demand for our products and services by clients and prospective clients, including (iv) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (vi) our ability to predict changes in client needs and preferences; (b) economic and other business factors that impact the industry verticals we serve, including competition, inflation and consolidation of current and prospective clients, vendors and partners in these verticals; (c) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (d) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (e) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (f) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (g) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (h) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (i) the number of shares, if any, that we may repurchase in connection with our repurchase program; (j) unanticipated developments regarding litigation or other contingent liabilities; (k) our ability to complete reorganizations, including cost-saving initiatives; and (l) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 which was filed on April 1, 2024. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Investor Relations Contact:
Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR, HHS@fnkir.com,

SOURCE: Harte Hanks, Inc.

View the original press release on accesswire.com

Release – Tonix Pharmaceuticals Presents Vaccine Platform Data in Keynote Talk at the Vaccine Congress 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

June 25, 2024 8:00am EDT

Tonix’s live virus vaccine TNX-801 is designed to provide long-term protection from mpox and smallpox with one dose

TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with intratracheal monkeypox

Clade II mpox is now endemic in the U.S. with >30,000 cases reported since May 20221 and Clade I mpox is endemic in the Democratic Republic of the Congo2

Tonix’s vaccine platform has been selected by NIH’s Project NextGen for clinical testing

CHATHAM, N.J., June 25, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced data presented at an oral Keynote Talk at the Vaccine Congress 2024 held June 24-25, 2024 in Prague, Czech Republic. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The presentation titled, “A New Live Virus, One Dose Vaccine Platform for Mpox, Smallpox and COVID-19”, detailed the Company’s vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox) and smallpox and TNX-1800 (horsepox expressing SARS-CoV-2 spike protein) for protecting against COVID-19. TNX-801 and TNX-1800 are live replicating attenuated vaccines based on horsepox that are believed to provide immune protection with better tolerability than modern vaccinia viruses. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus3. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population.

“We are excited for the prospects of our live virus vaccine platform and look forward to advancing development for our vaccine candidates to prevent mpox, smallpox, COVID and other infectious diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-801 combines immune protection with improved tolerability compared to other vaccines based on orthopoxviruses. TNX-801 is administered with a single dose which has advantages over two-dose regimens. We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain. TNX-801 also has the potential to be used as a viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases. Tonix developed TNX-1800 as a vaccine to protect against COVID-19. We are excited that TNX-1800 was selected for the U.S. National Institute of Health’s (NIH’s) Project NextGen and we look forward to providing updates on the program.”

The presentation noted that the global mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox remains restricted to several Central African countries, including the Democratic Republic of the Congo, where it is currently endemic. Clade I mpox is typically associated with higher case fatality rates than Clade IIb mpox. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S.1,4.

Further, the presentation noted that the Bipartisan Commission on Biodefense recently highlighted the renewed dual threats of both a more virulent mpox epidemic as well as smallpox re-introduction from lab accidents or bad actors, while the National Academies of Science, in its review of smallpox preparedness, highlighted the need for new single dose vaccines against smallpox5,6.

The keynote presentation also included preclinical data for TNX-1800, demonstrating immunity and tolerability7,8. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

**Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

1McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morb Mortal Wkly Rep: United States. p. 435-440
2CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html
3Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234
4World Health OrganizationSAGE meeting highlights on updated mpox vaccine recommendations. 2024, March
5Bipartisan Commission on Biofence. Box the Pox: Redicing the risk of Smallpox and Other Orthopoxviruses, Washington:2024
6U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024
7Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.
8Awashti AM et al Vaccines (Basel). 2023 Nov 2;11(11):1682. doi:10.3390/vaccines11111682.PMID: 38006014

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

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Source: Tonix Pharmaceuticals Holding Corp.

Released June 25, 2024