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Release – Bit Digital, Inc. Announces Second Quarter of Fiscal Year 2024 Financial Results

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on BTBT

NEW YORK, August 19, 2024 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (the “Company”), a sustainable platform for digital assets and artificial intelligence (“AI”) infrastructure headquartered in New York City, today announced its unaudited financial results for the Second Quarter ended June 30, 2024.

Financial Highlights for the Second Quarter of 2024

  • Total revenue was $29.0 million for the Second Quarter of 2024, a 220% increase compared to the Second Quarter of 2023. The increase was primarily driven by the commencement of our high performance computing services (“HPC”) business and by a higher realized bitcoin price.
  • Revenue from bitcoin mining was $16.1 million for the Second Quarter of 2024, an 80% increase compared to the prior year’s quarter. The Company’s HPC recognized $12.5 million of revenue during the quarter compared to nil the prior year.
  • The Company had cash, cash equivalents and restricted cash of $61.4 million, and total liquidity (defined as cash, cash equivalents and restricted cash, USDC, and the fair market value of digital assets) of approximately $191.9 million1, as of June 30, 2024.
  • Total assets were $315.5 million and Shareholders’ Equity amounted to $295.3 million as of June 30, 2024.
  • Adjusted EBITDA2 was $(3.8) million for the Second Quarter of 2024 compared to $1.9 million for the Second Quarter of 2023. Adjusted EBITDA includes an $11.5 million unrealized loss on digital assets.
  • GAAP loss per share was $0.09 on a fully diluted basis for the Second Quarter of 2024 compared to a loss per share of $0.03 for the Second Quarter of 2023.

Operational Highlights for the Second Quarter 2024

  • The Company earned 244.2 bitcoins during the Second Quarter of 2024, a 23% decrease from the prior year. The decline was primarily driven by a reduction in block rewards following the halving event in April 2024 and by an increase in network difficulty.
  • The Company paid approximately $0.047 per kilowatt hour to its hosting partners for electricity consumed during the Second Quarter of 2024.
  • The average fleet efficiency for the active fleet was approximately 27.9 J/TH as of June 30, 2024.
  • The Company earned 109.4 ETH from native staking in the Second Quarter of 2024.
  • Treasury holdings of BTC and ETH were 585.6 and 27,226.23, respectively, with a fair market value of approximately $36.7 million and $93.5 million on June 30, 2024, respectively.
  • The BTC equivalent4 of our digital asset holdings as of June 30, 2024 (defined as if all ETH and USDC holdings were converted into BTC as of that date) was approximately 2,082.1 BTC5, or approximately $130.5 million.
  • As of June 30, 2024, we had 50,044 miners owned or operating (in Iceland) for bitcoin mining with a total maximum hash rate of 4.3 EH/s.
  • The Company’s active hash rate of its bitcoin mining fleet was approximately 2.6 EH/s as of June 30, 2024.
  • The Company purchased approximately 1,146 bitcoin mining units during the Second Quarter of 2024.
  • Approximately 86% of our fleet’s run-rate electricity consumption was generated from carbon-free energy sources as of June 30, 2024. These figures are based on data provided by our hosts, publicly available sources, and internal estimates, demonstrating our commitment to sustainable practices in the digital asset mining industry.
  • The Company had approximately 17,184 ETH actively staked in native staking protocols as of June 30, 2024.
  • In the second quarter of 2024, the Company finalized an agreement to supply its existing customer with an additional 2,048 GPUs over a three-year period. To help finance this operation, the Company entered into a sale-leaseback agreement with a third party, agreeing to sell 128 AI servers (equivalent to 1,024 GPUs) and lease them back for three years. In late July, at behest of the customer, the Company and the customer mutually agreed to temporarily delay the purchase order so that the customer could evaluate potentially upgrading the purchase order to include newer generation Nvidia GPUs. Accordingly, the Company and manufacturer mutually agreed to delay the Company’s purchase pending the contractual outcome with the Company’s customer. The Company expects to provide additional details about the revised deployment timeline in the coming weeks. The Company’s contract with the customer remains fully in effect, but may have to be amended to provide for newer generation GPUs. In early August, the Company received $30.0 million as a non-refundable prepayment from its customer, half of which will be distributed to the Company’s leasing partner.

Subsequent Events

On August 19, 2024, Bit Digital announced that it had signed a binding term sheet with Boosteroid Inc. (“Boosteroid”), the world’s third-largest cloud gaming provider. Upon signing a master service agreement (“MSA”), Boosteroid will place an initial purchase for a starting quantity of GPU servers with a five-year service duration. Bit Digital will provide Boosteroid with options to draw down additional servers in multiples of 100, up to a total of 50,000 GPU servers within five years after signing the MSA, depending on their deployment plans and subject to market conditions. The entire 50,000 GPU deployment represents an aggregate revenue opportunity to Bit Digital in excess of $700 million over the five-year term. The initial purchase includes GPU-servers based on AMD EPYC 4th Gen CPUs and RX7900XT GPUs, customized by ASUSTeK Computer Inc. (“ASUS”) and AMD for Boosteroid. Deployment is planned across a network of more than 10 data centers in the U.S. and Europe. The initial deployment is scheduled to begin over the next two to three months and is expected to generate approximately $13 million in revenue to Bit Digital over the five-year term, or approximately $2.6 million per year. Bit Digital’s entry into a MSA is conditioned upon further diligence of Boosteroid, customary legal and business reviews, internal approvals, and execution of an acceptable MSA.

Management Commentary

“The second quarter of 2024 was an important step in the evolution of Bit Digital. Despite the reduction in block rewards from the April ‘halving event’, our total revenue more than doubled from the prior year, principally aided by the first full quarter of revenue from our HPC services business. Our balance sheet remains a key strength that will enable us to withstand recent market volatility and deploy growth capital into high-return opportunities.

Mining economics remain challenging, and in the absence of a material improvement in expected payback periods for mining equipment, it is unlikely that we will reach our active hash rate target of 6.0 EH/s by year-end 2024. From the onset of the year, we have been cautious in terms of exahash growth, preferring to wait for the post-halving mining environment before enacting material growth. In the interim, we will focus on high grading our existing fleet while reserving the right to make opportunistic growth purchases should the returns profile justify the expenditure.

We continue to view the HPC business as the most attractive use of incremental growth capex in the current environment. Our pipeline remains strong and the main bottleneck to date has been a lack of personnel and man hours to bring contracts to the finish line. We have started to solve this issue, making our first key hire for this business earlier this month with a plan to further expand our personnel and improve our tech stack. Our growth pipeline remains strong, and we continue to believe we will be able to reach our $100 million annualized revenue target by year-end 2024 even if the 2,000 GPU expansion deployment with our existing customer is pushed into 2025.”

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. 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 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. See “Safe Harbor Statement” below.

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 – Bit Digital, Inc. Announces Binding Term Sheet with New HPC Customer Representing a More Than $700 Million Revenue Opportunity Over Five-Year Term

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on BTBT

NEW YORK, August 19, 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 signed a binding term sheet with Boosteroid Inc. (“Boosteroid”), a new customer for its high-performance computing (“HPC”) business.

Key Highlights

  • Initial Agreement: Upon signing a master service agreement (“MSA”), Boosteroid will place an initial purchase for a starting quantity of GPU servers with a five-year service duration. Bit Digital’s entry into a MSA is conditioned upon further diligence of Boosteroid, customary legal and business reviews, internal approvals, and execution of an acceptable MSA.
  • Revenue Impact: This initial order is expected to generate approximately $13 million in revenue to Bit Digital over the five-year term, or approximately $2.6 million per year.
  • Scalability: Bit Digital will provide Boosteroid with options to draw down additional servers in multiples of 100, up to a total of 50,000 GPU servers within five years after signing the MSA, depending on their deployment plans. The entire 50,000 GPU deployment represents an aggregate revenue opportunity to Bit Digital in excess of $700 million over the five-year term, depending on the deployment plan and subject to market conditions.
  • Technology and Deployment: The initial purchase includes GPU-servers based on AMD EPYC 4th Gen CPUs and RX7900XT GPUs, customized by ASUSTeK Computer Inc. (“ASUS”) and AMD for Boosteroid. Deployment is planned across a network of more than 10 data centers in the U.S. and Europe. The initial deployment is scheduled to begin over the next two to three months.

Sam Tabar, Bit Digital’s CEO, commented: “We are excited to expand our HPC business and provide mission-critical computing solutions to Boosteroid, a customer in a new end-market for our HPC offerings. We are impressed with Boosteroid’s business model and look forward to supporting their ambitious growth plans. We aim to deliver exceptional service quality and execution, laying the foundation for a long-term and growing partnership between our companies.”

Ivan Shvaichenko, Founder and President of Boosteroid, commented: “This collaboration between Boosteroid and Bit Digital enhances our existing partnerships with AMD and ASUS, creating a powerful synergy that will drive us toward our goal of becoming the leader in the global cloud gaming market. By leveraging the advanced computing power provided by Bit Digital and the cutting-edge technology from AMD and ASUS, we are poised to deliver an unparalleled gaming experience to millions of users worldwide. This partnership not only strengthens our GPU-based infrastructure, already one of the widest in the world, but also sets the foundation for long-term innovation and growth within the cloud gaming industry.”

About Boosteroid

Boosteroid is the world’s third-largest cloud gaming provider, following Microsoft and Nvidia. With a GPU-based infrastructure network spanning 22 data centers and 10 more expected to launch by the end of 2024, Boosteroid serves over 5.7 million users across Europe, North America, and South America. It partners with major brands like Google for cloud gaming on Chrome OS, and collaborates with Microsoft, Samsung, LG, Hisense, Philips, Sharp, etc. Boosteroid uses custom hardware solutions designed by ASUS, AMD, and other companies tailored specifically for their platform.

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.

Bit Digital (BTBT) – First Look at the Second Quarter

Posted on by cpereira@noblefcm.com


Tuesday, August 20, 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.

Results. Revenue for the quarter totaled $29.0 million, a 220% increase from last year of $9.0 million due to the inclusion of the HPC business. We estimated revenue of $24.9 million. Driven by an $11.5 million unrealized loss on digital assets, adjusted EBITDA was a negative $3.8 million from a positive $1.9 million last year. Net loss for the quarter was $12.0 million, or $0.09/sh, from a loss of $2.4 million, or $0.03/sh, the prior year.

A Temporary Setback. The Company’s anchor HPC client is temporarily delaying its purchase order to potentially upgrade the servers to have newer generation Nvidia GPUs. The contract may be amended to provide for the newer GPUs. We believe the delay to only be temporary as Nvidia’s new Blackwell architecture is expected to be released later in the year or in early 2025.


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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. 

Fed’s Balancing Act: Jackson Hole 2024

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Unemployment Rises: Fed officials consider rate cuts as jobless numbers climb.
– Inflation Eases: With inflation near target, focus shifts to avoiding job market fallout.
– Powell’s Key Address: Expectations build for guidance on balancing economic risks.

As the Federal Reserve officials convene for their annual central banking conference in Jackson Hole, Wyoming, the economic landscape is under intense scrutiny. With the U.S. unemployment rate currently at 4.3%, the Fed faces a delicate balancing act: managing inflation while avoiding a significant downturn in the job market. This year’s gathering, a key event for central bankers worldwide, is marked by growing unease about the potential weakening of the U.S. labor market and the implications for future monetary policy.

Historically, the U.S. has enjoyed periods of low unemployment, often below the long-term average of 5.7%. However, these periods have been punctuated by sharp spikes in joblessness during economic downturns, a pattern that Federal Reserve officials are keen to avoid. The current trend, with unemployment gradually increasing from 3.7% in January 2023 to 4.3% by July 2024, has raised concerns among policymakers. The rise in unemployment has been accompanied by an influx of 1.2 million people into the labor force, a typically positive sign that can paradoxically push the unemployment rate higher as more individuals actively seek work.

The Federal Reserve has maintained its benchmark policy rate in the 5.25%-5.50% range for over a year, the highest level in 25 years. However, with signs of a cooling job market, the conversation among Fed officials has shifted towards the possibility of cutting rates. Minneapolis Fed President Neel Kashkari, in a recent interview, noted that the balance of risks has shifted, making a debate about rate cuts at the upcoming September policy meeting appropriate. This sentiment has been echoed by other Fed officials, including San Francisco Fed President Mary Daly, who expressed growing confidence that inflation is returning to the Fed’s 2% target.

Indeed, the progress on inflation has been significant. The personal consumption expenditures (PCE) price index, a key measure tracked by the Fed, peaked at an annual rate of 7.1% in June 2022 but had dropped to 2.5% by July 2024. This progress suggests that the worst of the inflationary surge may be behind us, leading some policymakers to argue for a loosening of credit conditions to ensure a “soft landing” for the economy.

However, the labor market presents a more complicated picture. Recent data indicates that job growth is slowing, with only 114,000 positions added in July 2024, a figure that fell below expectations and pulled the three-month average below pre-pandemic levels. The unemployment rate’s rise, coupled with longer job search durations and a growing number of workers moving from employment to unemployment, signals potential weaknesses that the Fed must carefully navigate.

Despite these concerns, unemployment claims have not surged dramatically, and consumer spending remains robust. This mixed economic picture has led to a cautious stance among Fed officials, who are not yet ready to declare a crisis but are vigilant about the risks of keeping monetary policy too tight for too long. As Fed Chair Jerome Powell prepares to address the Jackson Hole conference, his remarks are expected to clarify the central bank’s approach to managing these risks, with an emphasis on avoiding a destabilizing spike in unemployment while ensuring that inflation remains under control.

The Jackson Hole conference, therefore, comes at a critical juncture. As the Fed weighs the potential for rate cuts against the backdrop of a slowing labor market and moderating inflation, the decisions made here could shape the trajectory of the U.S. economy in the months and years to come.

Mpox Resurgence: Biotech Sector Sees Renewed Interest Amid Global Health Concerns

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Mpox outbreaks boosts biotech stocks, especially those with related vaccines or treatments
– Small biotech firms see volatile, dramatic gains, prompting caution from analysts
– Renewed focus on infectious diseases may reshape biotech industry investments and partnerships

As the world grapples with a new outbreak of mpox, formerly known as monkeypox, the biotech sector is experiencing a surge of investor interest and market activity. The recent declaration of a global public health emergency by the World Health Organization (WHO) has thrust several biopharma companies into the spotlight, particularly those with potential treatments, vaccines, or diagnostic capabilities related to the virus.

The current outbreak, primarily driven by the more severe clade I variant, has already claimed over 1,100 lives in the Democratic Republic of Congo since January 2024. Unlike the 2022 outbreak, which was largely confined to specific communities, the new clade Ib variant appears to spread more easily through routine close contact, raising concerns about its potential for wider transmission.

This evolving situation has created a ripple effect across the biotech marketplace. Companies with mpox-related products or research pipelines have seen significant stock price movements. Danish biotech firm Bavarian Nordic, known for its mpox vaccine, has experienced a substantial surge in share value as it announces plans to ramp up production. Similarly, Emergent BioSolutions, with its approved smallpox treatment, has seen notable gains.

The diagnostic sector is also benefiting from the outbreak. Companies like Co-Diagnostics, which offers testing solutions, have seen increased investor interest. More dramatically, several smaller biotech firms focusing on infectious diseases have experienced explosive growth. Tonix Pharmaceuticals, Virax Biolabs, GeoVax, and Applied DNA Sciences have all seen their stock prices skyrocket, with some gaining over 100% in a single trading session.

However, industry analysts caution that such rapid gains may be unsustainable and could be subject to equally swift corrections. The volatile nature of biotech stocks, especially during disease outbreaks, is well-documented. Investors are advised to approach these opportunities with caution, considering both the potential for breakthrough developments and the risks associated with speculative investments.

The mpox outbreak is also rekindling interest in the broader infectious disease sector. Many investors and industry observers are drawing parallels to the early days of the COVID-19 pandemic, which saw unprecedented growth in vaccine and therapeutic development. This has led to increased funding and research initiatives across the biotech industry, not just for mpox-specific solutions, but for a wide range of potential emerging infectious diseases.

Large pharmaceutical companies are also taking notice. While they may not experience the same dramatic stock movements as smaller, more specialized firms, many are reassessing their infectious disease portfolios and considering new investments or partnerships in this area.

The outbreak is also highlighting the importance of preparedness and rapid response capabilities in the biotech sector. Companies with flexible platforms for developing vaccines or therapeutics are gaining attention from both investors and potential government partners.

As the situation continues to evolve, the biotech marketplace is likely to see ongoing volatility and opportunities. The mpox outbreak serves as a reminder of the critical role the sector plays in global health security and its potential for both scientific advancement and financial growth.

While the immediate focus remains on addressing the current health emergency, the long-term implications for the biotech industry could be significant. The outbreak may lead to increased investment in infectious disease research, new partnerships between academia and industry, and a renewed emphasis on global health preparedness – all factors that could shape the biotech landscape for years to come.

Take a moment to take a look at more emerging growth biotech companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.

AMD’s Acquisition of ZT Systems: A Strategic Play in the AI Arena

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Strategic Move: AMD acquires ZT Systems for $4.9 billion to bolster its AI and server capabilities.
– AI Focus: The acquisition targets the growing demand for AI-driven data centers, positioning AMD to challenge Nvidia.
– Future Plans: AMD aims to offload the server manufacturing business post-acquisition, streamlining its focus on AI hardware.

Advanced Micro Devices (AMD) has taken a significant step in its strategic push into the artificial intelligence (AI) market by announcing the acquisition of server builder ZT Systems for $4.9 billion. This bold move is designed to expand AMD’s portfolio of AI chips and hardware, positioning the company to compete more aggressively against industry leader Nvidia.

The acquisition deal, which AMD plans to fund 75% with cash and the remaining 25% in stock, reflects the company’s strong financial footing. As of the second quarter, AMD held $5.34 billion in cash and short-term investments, providing the liquidity necessary to pursue such a sizable transaction. The acquisition of ZT Systems comes at a time when the computing power required for AI applications is growing exponentially. Companies in the tech sector are increasingly focused on stringing together thousands of chips in large clusters to achieve the necessary data processing capabilities. This trend has elevated the importance of the server systems that house these chips, making the acquisition of ZT Systems a strategic move for AMD.

Lisa Su, AMD’s CEO, emphasized the importance of AI in the company’s long-term strategy. “AI systems are our number one strategic priority,” Su said in an interview with Reuters, highlighting the critical role AI plays in AMD’s growth plans. The integration of ZT Systems’ engineering talent will allow AMD to accelerate the development and deployment of its AI-focused graphics processing units (GPUs), particularly for large-scale cloud computing providers like Microsoft. The acquisition is expected to enable AMD to sell more GPUs, a key component in AI data centers, which are rapidly becoming the backbone of modern computing infrastructure.

While the acquisition is primarily about enhancing AMD’s AI capabilities, the company has no intention of entering the server manufacturing business on a permanent basis. Su made it clear that AMD plans to spin off ZT Systems’ server manufacturing operations once the deal is finalized. The company is currently focused on leveraging ZT Systems’ expertise to scale its AI hardware offerings and does not plan to compete with established server manufacturers like Super Micro Computer. As part of the acquisition, ZT Systems’ Chief Executive Frank Zhang will join AMD and report directly to Forrest Norrod, AMD’s head of data centers. This leadership transition is expected to ensure that the integration process is smooth and that AMD can quickly begin reaping the benefits of the acquisition. Out of ZT Systems’ approximately 2,500 employees, AMD plans to retain around 1,000 engineers, underscoring the value AMD places on the engineering talent that ZT Systems brings to the table.

ZT Systems, which generates about $10 billion in annual revenue, is a closely held company that has built a reputation for its expertise in server manufacturing and systems integration. The addition of ZT Systems to AMD’s portfolio is expected to strengthen the latter’s position in the competitive AI hardware market. The deal is anticipated to close in the first half of 2025, after which AMD plans to sell the server manufacturing business within the following 12 to 18 months. This approach aligns with AMD’s strategy of focusing on high-value, high-growth segments of the market, particularly AI hardware, rather than diversifying into lower-margin businesses.

The acquisition of ZT Systems also comes as AMD continues to face stiff competition from Nvidia, which has dominated the AI hardware market. Nvidia, once primarily known as a designer of gaming chips, has successfully pivoted to become a leading provider of AI hardware, including entire data center solutions. This year, Nvidia’s data center segment, which includes AI chips, is expected to generate $105.9 billion in revenue, far outpacing AMD’s AI chip revenue, which is projected to be around $4.5 billion. By acquiring ZT Systems, AMD is positioning itself to close this gap and capture a larger share of the AI market.

AMD’s customers, including tech giants like Microsoft and Meta Platforms, are increasingly reliant on advanced AI chips to power their data centers. The acquisition of ZT Systems is expected to enhance AMD’s ability to meet the growing demand for AI hardware and to compete more effectively with Nvidia in this critical area. Moreover, the deal is expected to contribute positively to AMD’s adjusted financial performance by the end of 2025, marking a significant milestone in the company’s ongoing transformation.

As the tech industry continues to evolve, the race to dominate the AI hardware market is heating up. AMD’s acquisition of ZT Systems is a clear signal that the company is serious about becoming a major player in this space. By strategically acquiring key assets and talent, AMD is positioning itself to capitalize on the rapid growth of AI and to challenge Nvidia’s dominance in the market. With the acquisition expected to close in 2025, all eyes will be on how AMD integrates ZT Systems and leverages this acquisition to drive its AI ambitions forward.

Release – SKYX to Collaborate with EGLO, European World Leading Design and Manufacturer of Decorative Lighting and Ceiling Fans

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on SKYX

The Collaboration Provides for the Joint Exploration and Product Development Potential for European and International markets for leveraging SKYX’s Technology, Product and Manufacturing Expertise of the Two Companies

MIAMI, Aug. 19, 2024 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart platform technology company with more than 97 issued and pending patents globally and over 60 lighting and home décor websites, announces a new collaboration with EGLO, an international market leading designer and manufacturer of decorative and functional lighting and ceiling fans.

The collaboration provides for the two companies to explore and evaluate the development of products that integrate SKYX’s technology for European and global markets, and the product driven needs of EGLO’s international customer base.

The collaboration is expected to further enhance SKYX’s U.S. and global market penetration through online, retail and builder segments.

SKYX’s advanced and smart technologies make homes and buildings smart and safe, while saving time, cost, and creating significant value for property developers and homeowners.

Rani Kohen, Founder and Executive Chairman of SKYX, said: “This collaboration opportunity is just another step in expanding the applicability and penetration of our technology to European and global markets and distribution channels. Aligning with industry leaders who support our vision for growth and innovation in smart home and lighting sectors is significant to our global expansion strategy.

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Release – Graham Corporation Announces Groundbreaking Ceremony for $17.6 Million Manufacturing Facility on Batavia, New York Campus

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GHM

New 29,000 square foot building will create 24 new full-time positions; expect to begin commercial operation summer of 2025

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“GHM” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries, announced that its operating company, Graham Manufacturing, will hold a groundbreaking ceremony today for its new 29,000-square-foot facility in Batavia, NY. This event marks a significant milestone in the Company’s ongoing growth and commitment to serving its customers and the community. The project represents a total investment of approximately $17.6 million, which includes a strategic investment of $13.5 million from one of the Company’s valued customers, with the remaining investment provided by Graham.

State and local officials will join Graham’s executive leadership and construction managers in turning the first ceremonial shovels of dirt, officially launching the building project.

The construction of the new facility is expected to be completed over the next twelve months with operations beginning shortly thereafter. The building will be equipped with state-of-the-art technology and designed with sustainability in mind, aligning with Graham’s broader environmental goals.

Dan Thoren, Graham Corporation President and Chief Executive Officer, commented, “Our new facility will play a key role in enhancing our operational capabilities, providing the expanded capacity to accelerate production to meet our customers’ growing requirements, particularly the U.S. Navy. Moreover, it will enable us to make a positive impact on the Batavia community. Once operational, the expanded operations are expected to create 24 new full-time skilled positions, reinforcing our commitment to job creation and community development.”

U.S. Senator Charles Schumer said, “Graham’s Batavia, NY workforce and the products they make are integral to supporting our nation’s national defense, and today’s $18 million expansion doubles down on their world-class work as a strategic supplier for the U.S. Navy. I’ve been proud to secure vital federal funding for the U.S. Navy’s Submarine and Aircraft Carriers Industrial Base supply chain that the Navy relies on to purchase technology and equipment made right here in Batavia by Graham’s existing 367-employee local workforce. This not only supports these local jobs, but enables the new 24-job $18 million expansion that we break ground on today. With today’s expansion, I commend Graham for setting sail to reach new horizons not only in this company’s growth but in support of our national defense.”

Claudia Tenney, U.S. Representative for New York’s 24th Congressional District, said, “Congratulations to Graham Corporation on breaking ground on this new manufacturing facility here in Batavia. Graham Corporation’s commitment to creating quality and innovative technologies for our military and providing 24 new job opportunities in our community is commendable. I am eager to witness the continued growth and positive impact Graham Corporation will have in our community and around the world.”

Graham is working with Ciurzynski Consulting, Montante Construction and Wolfe Architecture to design and build the advanced manufacturing facility.

About Graham Corporation

Graham is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries. Graham Corporation and its family of global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps, and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

Safe Harbor Regarding Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “will,” and other similar words. All statements addressing operating performance, events, or developments that Graham Corporation expects or anticipates will occur in the future, including but not limited to, timing on the completion of construction, potential expansion of operations, potential job creation, the timing on beginning new operations, and delivering timely or otherwise on schedule are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission, including under the heading entitled “Risk Factors,” its quarterly reports on Form 10-Q, and other filings it makes with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Deborah K. Pawlowski
Kei Advisors LLC
Phone: (716) 843-3908
dpawlowski@keiadvisors.com

Source: Graham Corporation

Released August 19, 2024

Release – Gray Media Announces Coverage Plans for 2024 Democratic National Convention

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GTN

ATLANTA, Aug. 19, 2024 (GLOBE NEWSWIRE) — Gray Media (NYSE: GTN) today announced comprehensive coverage plans for the 2024 Democratic National Convention.  

Starting Monday, August 19, through the conclusion of the convention on Thursday, August 22, Gray’s Washington DC Bureau and news teams from 13 Gray affiliates will report from Chicago on the local impact of the presidential and vice presidential nomination process and the Democratic party platform.   Coverage will be carried on Gray’s local affiliates and Local News Live, Gray’s national news network that provides live streaming coverage on more than 500 Gray station websites, connected TV apps, and mobile apps.

“The combined reporting power of Local News Live, the DC Bureau, and Gray newsrooms will provide substantial DNC coverage with a unique local perspective to our 113 markets across the country,” Gray’s Chief Operating Officer Sandy Breland said.  

All Gray-owned Wisconsin news operations will send reporting teams to the convention, including WMTV in Madison, WBAY in Green Bay, WEAU in Eau Claire, WSAW in Wausau, and KBJR in Superior (Duluth).  In addition, news crews from Gray affiliates WANF in Atlanta, Georgia, AZ Family in Phoenix, Arizona, WNDU in South Bend, Indiana, KHNL in Honolulu, Hawaii, WCAX in Burlington, Vermont, KTTC in Rochester, Minnesota, KEYC in Mankato, Minnesota, and KVLY in Fargo, North Dakota will be on site to provide daily coverage.

“We are dedicated to covering the biggest stories through a local lens,” explained Lisa Allen, General Manager of Gray’s Washington Operation. “With journalists in more than 100 markets, Gray’s teams can cover more ground than any other news source through Election Day.”

About Gray Media:

Gray Media, or Gray, is a multimedia company headquartered in Atlanta, Georgia, formally known as Gray Television, Inc.  The company is the nation’s largest owner of top-rated local television stations and digital assets serving 113 television markets that collectively reach approximately 36 percent of US television households. The portfolio includes 77 markets with the top-rated television station and 100 markets with the first and/or second highest rated television station, as well as the largest Telemundo Affiliate group with 43 markets totaling nearly 1.5 million Hispanic TV Households.  The company also owns Gray Digital Media, a full-service digital agency offering national and local clients digital marketing strategies with the most advanced digital products and services.  Gray’s additional media properties include video production companies Raycom Sports, Tupelo Media Group, and PowerNation Studios, and studio production facilities Assembly Atlanta and Third Rail Studios. Gray owns a majority interest in Swirl Films. For more information, please visit www.graymedia.com.

Gray Contact:

Sandy Breland, Executive Vice President, Chief Operating Officer, 404-266-8333

Release – Tonix Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operational Highlights

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on TNXP

On track to submit NDA in second half 2024 for TNX-102 SL for fibromyalgia; completed successful pre-NDA meetings with FDA in second quarter 2024

FDA granted Fast Track designation for TNX-102 SL for fibromyalgia

Commercial planning continues for U.S. launch of TNX-102 SL, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia

U.S. Department of Defense contract awarded for up to $34 million over 5 years to develop a broad-spectrum antiviral drug

World Health Organization (WHO) recently declared spread of mpox in multiple African countries a public health emergency of international concern – Tonix’s TNX-801 is an mpox vaccine in development which protects animals against lethal challenge of monkeypox virus

CHATHAM, N.J., Aug. 19, 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 financial results for the second quarter ended June 30, 2024, and provided an overview of recent operational highlights.

“In the second quarter of 2024, we made significant progress advancing our New Drug Application (NDA) and market access strategy for TNX-102 SL (cyclobenzaprine HCl sublingual tablets),” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are working diligently on the regulatory submission and are pleased to have been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and to be in alignment with the agency regarding the content of our proposed NDA package. Fast Track is designed to facilitate the development and expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. We are hopeful that TNX-102 SL can be the first new drug to treat fibromyalgia in more than 15 years.”

Dr. Lederman continued, “Additionally, we continue to advance other key pipeline candidates through a capital efficient strategy, including TNX-4200, our broad-spectrum antiviral program for which we were awarded up to $34 million over five years from the U.S. Department of Defense (DoD) to advance its development.”

Recent Highlights – Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, analgesic taken once-daily at bedtime for the management of fibromyalgia.

  • In July 2024, the FDA granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. The designation validates that fibromyalgia is a serious condition and that TNX-102 SL has the potential to address this unmet medical need. The Company continues to guide for submission of the NDA for TNX-102 SL in the second half of 2024 which would allow for a potential FDA approval in 2025.
  • In July 2024, Tonix announced that, based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM), fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID. The Company believes that diagnosing fibromyalgia in Long COVID patients will increase the potential market for TNX-102 SL following approval as compared to market estimates from before the COVID-19 pandemic.
  • During the second quarter, Tonix successfully completed two positive pre-NDA meetings with the FDA for TNX-102 SL for the management of fibromyalgia. The first, with minutes announced in June 2024, was a Type B Chemistry, Manufacturing, and Controls (CMC) meeting to seek alignment and agreement with the FDA on key CMC topics to support the planned NDA submission for TNX-102 SL. Based on formal meeting minutes, the Company believes it is aligned with the FDA on proposed drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging. At the second pre-NDA meeting announced in July 2024, the Company and the FDA aligned on nonclinical, clinical pharmacology and clinical matters and agreed that the proposed data package is sufficient to support the NDA submission.
  • In June 2024, at the American Society of Clinical Psychopharmacology (ASCP) meeting the Company presented new, additional data on TNX-102 SL, highlighting improvement in depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) as well as improvements in anxiety, memory and energy items on the Fibromyalgia Impact Questionnaire-Revised (FIQR). Depression was frequent among patients enrolled in the Phase 3 RESILIENT study, as ~47% reported experiencing depression within the past six months upon fibromyalgia diagnosis and ~25% of the intent-to-treat (ITT) population had experienced a lifetime major depressive episode (MDE). However, by Week 14 of the trial, the total BDI-II score in the TNX-102 SL group improved over placebo with a nominal p-value of 0.005 and an effect size of 0.27. On the FIQR, exploratory analyses uncorrected for multiplicity demonstrated improvement in the TNX-102 SL group over placebo in depression (p < 0.001), anxiety (p = 0.001), sensitivity (p = 0.020), memory problems (p = 0.001) and energy (p < 0.001). TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue. Together these findings provide further support that TNX-102 SL has broad-spectrum activity against fibromyalgia symptoms and may improve fibromyalgia at the syndromal level.
  • EVERSANA® Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TNX-102 SL. Tonix had previously announced that EVERSANA was selected to support the launch strategy and commercial planning of TNX-102 SL. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy. EVERSANA conducted primary research, analyzed potential market size, surveyed currently marketed treatment options and their market shares and interviewed physicians for feedback regarding the currently prescribed treatments and their interest in TNX-102 SL as a potential new treatment option. This physician feedback demonstrated high levels of dissatisfaction with currently prescribed drugs, a high unmet need for their fibromyalgia patients, and high levels of interest in TNX-102 SL’s favorable activity and tolerability profile. Further analysis showed that addictive opioids are prescribed more frequently than the currently approved drugs following fibromyalgia diagnosis. Physicians also indicated they would intend to use TNX-102 SL in 40% of their fibromyalgia patients.1

TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

  • In May 2024, Tonix announced a plan for a Phase 2, investigator-initiated OASIS trial, designed to examine the safety and efficacy of TNX-102 SL in treating Acute Stress Disorder (ASD) after motor vehicle collision. The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million contract from the DoD, which was awarded in September 2023.   TNX-102 SL will be evaluated for the reduction in severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in civilians after a motor vehicle collision. Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms within two weeks while evidencing similar favorable tolerability as in fibromyalgia patients.
  • Tonix expects to enroll the first patient in the Phase 2 OASIS trial in the third quarter of 2024.

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

  • Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in emergency rooms in the third quarter of 2024. In 2022, Tonix was awarded a Cooperative Agreement grant from the National Institutes of Health (NIH)’s National Institute of Drug Abuse (NIDA) to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.  

TNX-1900 (intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for adolescent obesity, binge eating disorder (BED), bone health in autism and social anxiety disorder (SAD).

  • TNX-1900 continues to be studied in four ongoing investigator-initiated Phase 2 studies. There are three studies at Massachusetts General Hospital: the POWER study for the treatment of adolescent obesity, the STROBE study for the treatment of BED, and the BOX study for the treatment of bone health in pediatric autism. In addition, Tonix is conducting an investigator-initiated study of TNX-1900 for the treatment of SAD at the University of Washington.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

  • In March 2024, Tonix announced that it received Rare Pediatric Disease designation from the FDA for TNX-2900 for the treatment of PWS. Tonix has an investigational new drug (IND) to support clinical development of TNX-2900 to treat PWS in children and adolescents, including a planned Phase 2, dose-finding study involving approximately 36 PWS patients. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022. PWS is a rare genetic disorder which causes cognitive and behavioral symptoms including pathological over-eating in childhood, which leads to severe metabolic sequelae in adolescence and adulthood.

Immunology Pipeline

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

  • The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including autoimmune diseases. Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications.2-4 Modeling studies from animal pharmacokinetic data2 predict a half-life of greater than three weeks for TNX-1500 in humans, which supports a monthly i.v. dosing regimen5,6. This analysis together with TNX-1500’s activity and tolerability in animals, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals.
  • In June 2024, at the American Transplant Congress 2024, Tonix announced data demonstrating the combined use of TNX-1500 and anti-CD28 monoclonal antibody, VEL-101 is associated with durable protection and graft survival and function in a nonhuman primate model. Further data demonstrated that TNX-1500 has promise to prevent rejection of 9-, or 10-gene-edited (GE) pig hearts.7,8 All research has been directed by the faculty of the Center for Transplantation Sciences at Massachusetts General Hospital.
  • Tonix completed the clinical stage of its Phase 1 single ascending dose study of TNX-1500 in healthy volunteers. The primary objectives of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous TNX-1500. This first-in-human study is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients.

Infectious Disease Pipeline

TNX-4200 (orally available CD45 antagonist), TNX-3900 (cathepsin inhibitor), TNX-4000 (glycan-targeted biologic)

  • Tonix is developing potential broad-spectrum antiviral drugs in three programs: CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors (TNX-3900) and viral glycan-targeted engineered biologics (TNX-4000).
  • In July 2024, the Company announced that the DoD’s Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA). The objective of the contract is to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The $34 million five-year contract will help fund and accelerate the development of Tonix’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. The Company’s program will focus on optimization and development of its TNX-4200 program, to develop an orally available CD45 antagonist, with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish physicochemical properties, pharmacokinetics, and safety attributes to support an IND submission and to fund a first-in-human Phase 1 clinical study.

TNX-801 (recombinant horsepox virus, live vaccine): potential vaccine to protect against mpox disease and smallpox.

  • In June 2024, Tonix announced data at an oral keynote presentation at the Vaccine Congress 2024, detailing the company vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox). TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than modern vaccinia viruses. In the data, Tonix highlighted positive preclinical efficacy, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus.9 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.  
  • The WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern, the second such declaration in the past two years called in response to transmission of the virus.
  • Mpox is epidemic in Central Africa and experts fear the new Clade 1 strain may spread to the U.S.
  • The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency.

TNX-1800 (modified recombinant horsepox virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein

  • In June 2024, the Company announced preclinical data, demonstrating immunity and tolerability, during an oral keynote talk at the Vaccine Congress 2024.10,11 Like TNX-801, TNX-1800 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than modern vaccinia viruses. 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.

Marketed Products – Recent Highlights

  • As of April 1, 2024, Tonix completed the transition to becoming a fully integrated biopharmaceutical company. Tonix Pharmaceuticals has implemented personnel, systems and contracts required to support a commercial organization and has assumed responsibility for distribution, selling and marketing of Zembrace SymTouch® and Tosymra®, as well as supply chain, regulatory and quality control of the two products.
  • In June 2024, the Company presented data at the 66th Annual Scientific Meeting of the American Headache Society (AHS) comparing real-world data with real-world usage of non-oral migraine products with the most recent AHS consensus statement. This data stressed the need for customizing treatment of migraine headaches to the needs of patients. Thus far, real world data show that conformity with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. The data show the use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the potential need for such drugs is anticipated to be a more substantial percentage of migraineurs based on epidemiological data.

TNX-102 SL has not been approved for any indication.

1EVERSANA primary physician research, May 2024; commissioned by Tonix

2Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022

3Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025

4Anand RP., et al. Nature. 2023:622, 393–401. https://doi.org/10.1038/s41586-023-06594-4

5Deng R., et al. Mabs. 2011. https://doi.org/10.4161/mabs.3.1.13799

6Tonix Pharmaceuticals – Data on File

7Revivicor 9-GE pigs: GalKO.β4GalNT2KO.GHRKO.hCD46.hCD55.hTBM.hEPCR.hCD47.hHO-1

8 Revivicor 10-GE pigs: GalKO.β4GalNT2KO.CMAHKO.GHRKO.hCD46.CD55.hTBM.hEPCR.hCD47.hHO-1.

9Noyce RS, et al. Viruses. 2023;15(2):356. doi:10.3390/v15020356.

10Awasthi M., et al. Viruses. 2023;15(10):2131. doi:10.3390/v15102131.

11Awasthi M., et al. Vaccines (Basel). 2023;11(11):1682. doi:10.3390/vaccines11111682.

      Recent Highlights – Financial

As of June 30, 2024, Tonix had $4.2 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used in operations was approximately $30.5 million for the six months ended June 30, 2024, compared to $56.3 million for the same period in 2023.

Subsequent to the quarter ending June 30, 2024, Tonix received net proceeds of approximately $3.5 million in a securities purchase agreement with certain institutional and retail investors, and sold 0.8 million shares of common stock under the ATM Sales Agreement, for net proceeds of approximately $0.4 million.

Second Quarter 2024 Financial Results

Net product revenue for the second quarter 2024 was approximately $2.2 million. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the second quarter 2024 was approximately $3.4 million, which included a write-down related to Tosymra and Zembrace finished goods inventory of approximately $1.7 million based on an assessment of inventory on hand and projected sales prior to the respective expiration dates.

Research and development expenses for the second quarter 2024 were $9.7 million, compared to $22.0 million for the same period in 2023. This decrease is predominantly due to decreased clinical, non-clinical and manufacturing expenses aligned with the Company’s capital efficient strategy.

Selling, general and administrative expenses for the second quarter 2024 were $7.5 million, compared to $7.0 million for the same period in 2023. The increase was primarily due to sales and marketing and the transition services expenses associated with the Company’s recently acquired marketed products offset by a decrease in financial reporting expenses.

Net loss available to common stockholders was $78.8 million, or $19.28 per share, basic and diluted, for the second quarter 2024, compared to net loss of $28.4 million, or $49.23 per share, basic and diluted, for the same period in 2023. Included in the net loss for the three months ended June 30, 2024, are non-cash asset impairment charges totaling $58.9 million. The basic and diluted weighted average common shares outstanding for the second quarter 2024 was 4,085,132 compared to 576,047 shares for the same period in 2023.

The impairment of the Tosymra and Zembrace inventory, intangibles and goodwill was driven by our delayed investment in the sales personnel required to drive growth in the business as we are focusing our cash resources to further our efforts to bring TNX-102 SL through the FDA approval process and to market. However, we believe that the benefits and long-term value proposition of the 2023 acquisition of Tosymra and Zembrace remain, in that we now have the infrastructure to be ready to manufacture and sell TNX-102 SL under an expedited timeline pending FDA approval for which we expect an FDA decision in 2025.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. 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 recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD, instrumental in progressing this development. 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.

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.

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GeoVax Labs (GOVX) – Raising Price Target To $10 Based On Program Progress

Posted on by cpereira@noblefcm.com


Monday, August 19, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

GeoVax Has Made Substantial Clinical and Manufacturing Process. We are raising our Price Target on GEOX to $10 based on the recent progress that has driven the stock through our previous $6 target. The company recently announced a DARPA grant for CM04S1 and its Phase 2 plans for Gedeptin in HNSCC. Last week, Mpox news highlighted recent advances in GeoVax’s manufacturing platform and its MVA-based vaccine for smallpox and Mpox.

Mpox News Draws Attention To GeoVax’s MVA Manufacturing Platform. On August 14, WHO declared Mpox to be a “public health emergency of international concern”, or PHEIC, due to a new type of Mpox (formerly monkeypox) spreading in West Africa. The new type is more infectious and more fatal than the type seen 2022. The previous virus spread through sexual contact (bodily fluids), while the current strain has also spread to health care workers through contact with patients’ clothing and bedding.


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*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. 

Wall Street Rallies: Stocks Poised for Best Week of 2024 as Recession Fears Fade

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– S&P 500 and Nasdaq on track for seventh consecutive day of gains
– Markets recovering from recent downturn, buoyed by positive economic data
– Investors eye Jackson Hole symposium for insights on Fed’s rate cut trajectory

Wall Street is gearing up to close its most impressive week of 2024, with major indices rebounding strongly as concerns about an economic slowdown dissipate. The S&P 500 and Nasdaq are set to mark their seventh straight day of gains, erasing losses from a recent market tumble and signaling renewed investor confidence.

This remarkable turnaround comes on the heels of encouraging economic data that has alleviated fears of an imminent recession. The week’s positive momentum has been fueled by reports indicating that inflation continues to trend downward towards the Federal Reserve’s target, while American consumer spending remains robust.

Oliver Pursche, senior vice president at Wealthspire Advisors, commented on the market’s resilience: “It has been a great week, and it has been a great year. There’s been some volatility, but major indices are all up nicely. What we saw a couple weeks ago was the market blowing off some steam.”

The rally has been broad-based, with the financial sector leading gains among S&P 500 components. However, not all sectors have participated equally, with real estate showing some weakness. This divergence highlights the nuanced nature of the current market environment, where investors are carefully weighing various economic indicators and sector-specific factors.

Looking ahead, market participants are eagerly anticipating the upcoming Jackson Hole Economic Symposium. This annual gathering of global central bank officials, scheduled for next week, could provide crucial insights into future monetary policy decisions. Federal Reserve Chair Jerome Powell’s keynote speech on Friday is expected to be a focal point, potentially setting expectations for the U.S. interest rate trajectory.

Austan Goolsbee, President of the Federal Reserve Bank of Chicago, has already set a dovish tone, cautioning against maintaining restrictive policy longer than necessary. This sentiment, coupled with recent economic data, has led to increased speculation about potential rate cuts. According to CME’s FedWatch tool, there’s a 74.5% probability that the Fed will implement a 25 basis point cut at its September meeting.

The market’s optimism is reflected in the performance of major indices. As of early afternoon trading, the Dow Jones Industrial Average was up 0.27%, the S&P 500 gained 0.21%, and the Nasdaq Composite added 0.25%. These gains put all three indices on track for their most substantial weekly percentage increases since October.

Despite the overall positive sentiment, some individual stocks faced headwinds. Applied Materials saw its shares decline by 1.7% despite forecasting stronger-than-expected fourth-quarter revenue. Similarly, packaging company Amcor’s U.S.-listed shares dropped 4.9% following a larger-than-anticipated decline in fourth-quarter sales.

As the trading week draws to a close, the market’s resilience in the face of recent volatility has been noteworthy. The shift from recession fears to recovery hopes underscores the fluid nature of investor sentiment and the importance of economic data in shaping market narratives.

With the Jackson Hole symposium on the horizon, investors will be keenly watching for any signals that might influence the Fed’s approach to monetary policy. The coming weeks could prove crucial in determining whether this rally has staying power or if new challenges lie ahead for Wall Street.

Release – Comtech Relocates Corporate Headquarters to Chandler, AZ

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CMTL

Arizona Governor, Chandler Mayor, and Local Leaders to Attend August 16 Ribbon Cutting to Celebrate the Relocation of Comtech’s Headquarters to Arizona

CHANDLER, Ariz. – Aug. 16, 2024– Comtech (NASDAQ: CMTL) (the “Company”), a global technology leader, today announced the relocation of its corporate headquarters from Melville, NY to Chandler, AZ. Comtech’s new corporate headquarters in Chandler boasts approximately 150,000 square feet of state-of-the-art office, engineering and manufacturing space that is designed to enhance operations, improve collaboration and accelerate the delivery of new technologies, systems and services to a variety of customers across global markets.

The decision to relocate Comtech’s headquarters to Chandler, first disclosed in March 2024, is rooted in the Company’s continued commitment to optimizing its corporate infrastructure and enhancing Comtech’s culture of innovation. The City of Chandler is already home to several of Comtech’s largest customers and provides easy access to a leading technology corridor that is renowned for yielding the talent needed to develop and execute the Company’s vision, which is centered on delivering trusted and resilient communications solutions to commercial and government customers across the globe.

“Chandler has established itself as a leading technology corridor in the United States,” said John Ratigan, Interim CEO of Comtech. “We are thrilled to expand our footprint in Arizona and excited to benefit from the City of Chandler’s continued commitment to innovation. This strategic move marks a significant milestone for the Company, and our new headquarters will play a central role in helping Comtech deliver new resilient, network agnostic, software-defined communications capabilities to some of the world’s most demanding customers, including the Department of Defense (“DoD”).”

To mark the milestone, the company will host a formal ribbon cutting ceremony today with Arizona Governor, Katie Hobbs, Chandler Mayor, Kevin Hartke, and other Arizona business and community leaders. While Comtech started welcoming employees to its new Chandler office in 2023, the Company has had a presence in Arizona and served local commercial, defense and government customers for over 25years.

“Today marks a momentous day for Arizona as we welcome Comtech, a leading global technology company, to its new home in Chandler,” said Arizona Governor Katie Hobbs. “Comtech’s Chandler headquarters will bring enhanced economic growth opportunities and highlights Arizona’s attractive business environment and reputation as a top hub for innovation and technology. We are proud to support Comtech in their new chapter and look forward to supporting Comtech’s success in Arizona.”

The technologies, solutions and services developed at Comtech’s Chandler headquarters currently serve a variety of commercial and government customers, including the U.S. government, the DoD, humanitarian agencies, satellite service providers, some of the nation’s largest cellular carriers, cruise lines, and emergency response agencies, among others. New offerings being developed at Comtech’s Chandler headquarters are designed to expand access to new connectivity services; connect the end users in some of the world’s most challenging geographic regions; and empower customers with new, integrated communications capabilities that can significantly enhance decision making capabilities when seconds matter most.

“I am thrilled that Comtech has chosen Chandler as the site for their new global headquarters,” said U.S. Representative Greg Stanton. “The investment Comtech is making in our community underscores the potential they see in our workforce, our infrastructure, and our economic climate. With over 50 years of technology leadership across global satellite, space, terrestrial, and wireless markets, Comtech is uniquely positioned to lead the way in connecting the unconnected and empowering the world with new technologies and services.”

Comtech is committed to continuing to enhance the Chandler community through local partnerships, strategic sponsorships and workforce development programs. Over the past two years, a variety of Arizona students participated in the Company’s summer internship program. In February, in partnership with the Society of Women Engineers at Arizona State University, Comtech sponsored and participated in the annual Chandler Innovation Fair. Last October, the Chandler Chamber of Commerce recognized Comtech as one of the Top 100 businesses in the city. And in March 2023, Comtech hosted its first-ever EXCHANGE event, an educational series inspiring woman of all ages to pursue STEAM career fields, in Chandler.

“We are excited to join Comtech in celebrating their new global headquarters in Chandler,” said Chandler Mayor Kevin Hartke. “Publicly traded headquarters do not relocate often, but we have found that Chandler’s robust talent pipeline and pro-business operating environment make a compelling case for corporate decision makers. Comtech adds to a growing list of headquarters that have landed in Chandler over the last few years. It has been a real pleasure working with the Comtech team during this process and we look forward to building a strong partnership in the years to come.”

As Comtech’s presence in Arizona continues to grow, the Company is currently hiring for a variety of Chandler-based positions. If you are interested in joining Comtech, please visit the careers page of the Company’s website for more information.

To learn more about the Company’s new Chandler, Arizona headquarters, please visit: https://comtech-ssd.hs-sites.com/az24

About Comtech

Comtech Telecommunications Corp. (Comtech) 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. 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

631-962-7102

investors@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com