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Scale AI’s Defense Deal: A New Frontier in Military AI Technology

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Scale AI secures multimillion-dollar contract with Department of Defense
– “Thunderforge” program aims to integrate AI into military planning and operations
– Tech industry continues shifting towards military AI partnerships

Scale AI has entered a pivotal moment in the evolving landscape of military artificial intelligence, securing a multimillion-dollar contract with the Department of Defense for the “Thunderforge” program. This landmark deal represents a significant step in the integration of AI technologies into military strategic planning and operational decision-making.

The Defense Innovation Unit’s flagship program will leverage AI agents to enhance military capabilities across multiple domains. Partnering with technology giants like Anduril and Microsoft, Scale AI will develop AI solutions designed to accelerate decision-making processes and provide advanced modeling and simulation capabilities.

CEO Alexandr Wang emphasized the transformative potential of the technology, stating that their AI solutions will “modernize American defense” and provide military leaders with a technological advantage. The program’s initial rollout will focus on U.S. Indo-Pacific and European Commands, with plans to expand to additional areas.

The contract highlights a broader trend in the tech industry’s approach to military partnerships. Companies that previously maintained strict policies against military applications are now actively engaging with defense initiatives. OpenAI, Google, and other major tech firms have quietly modified their stance on military technology use, reflecting a significant shift in the industry’s perspective.

This evolution hasn’t been without controversy. Tech employees have historically voiced concerns about their companies’ military contracts, most notably during Google’s Project Maven, which involved AI analysis of drone surveillance footage. Margaret Mitchell, an AI ethics researcher, points out the complex ethical considerations, noting that companies cannot fully control how their technologies might be ultimately utilized.

The Thunderforge program emphasizes “speed” as a critical advantage, with defense officials repeatedly highlighting the need for rapid decision-making in modern warfare. The AI agents will support various military functions, including modeling potential scenarios, suggesting courses of action, and creating automated workflows.

While Scale AI maintains that the program will operate under human oversight, the broader implications of AI in military applications remain a topic of intense debate. The potential for AI to transform military operations is significant, but so are the ethical concerns surrounding autonomous decision-making systems.

Other recent military AI partnerships underscore this trend. Anthropic has collaborated with Palantir and Amazon Web Services to provide AI models for intelligence agencies, while OpenAI has partnered with Anduril to develop advanced systems for national security missions.

The technology’s potential extends beyond traditional warfare, with applications in intelligence gathering, threat assessment, and strategic planning. However, experts like Mitchell caution that the line between defensive technology and potential harm can be increasingly blurry.

As military AI continues to evolve, the tech industry finds itself at a critical intersection of innovation, ethics, and national security. Scale AI’s Thunderforge program represents a significant milestone in this ongoing technological transformation.

Release – NN, Inc. Reports Fourth Quarter and Full Year 2024 Results

Posted on by aweinsoff@channelchek.com

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NN delivers performance as expected in first full year of transformation

NN is accelerating and further refining transformation plans in 2025

CHARLOTTE, N.C., March 05, 2025 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR) (“NN” or the “Company”), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today reported its financial results for the fourth quarter and full-year ended December 31, 2024. Key results for the quarter and full-year ended 2024 include (compared with the fourth quarter and full-year of 2023):

  • Net sales of $106.5 million and $464.3 million, decreased by 5.3% and 5.1%, respectively.
  • Pro forma net sales, adjusted for sale of Lubbock, rationalized business, and other pro forma adjustments, increased by 2.0% and declined by 0.2%, respectively.
  • GAAP earnings per share of $(0.51) and $(1.11), respectively.
  • Adjusted earnings per share of $(0.02) and $(0.17), respectively.
  • Adjusted EBITDA of $12.1 million and $48.3 million, an increase of $2.1 million and $5.2 million, respectively.
  • NN’s first full year of transformation plan was a success – upgraded its leadership team, rationalized money-losing legacy business, secured new program awards to offset rationalized business and create a path to year-over-year growth, increased gross profit margins, decreased borrowing rates, and decreased leverage.
  • $73 million of new business wins in 2024, topping the previous record of $63 million in 2023.
    • NN is tracking on pace with its 5-year sales growth and diversification goals and has delivered a 2-year new business wins total of $136 million. The Company has won $13 million in new wins in 2025 YTD and remains on pace with its business development efforts.
    • The Company is on pace to achieve its organic growth goal of reaching $600 million in sales.
    • New wins have begun launching and ramping into the Company’s sales run-rates with over 70 programs scheduled for start-of-production during 2025; approximately $21 million of new business is being launched in Q1 2025 across multiple plants and countries.
  • NN’s China operations sales growth continues at a measured pace, up by 15.6% and 20.6%, versus the prior year fourth quarter and full-year, respectively. NN’s China operations continue to fund their own growth through local cash flow generation.
  • NN’s Term Loan refinancing process continues, and the transaction will enable the Company to continue its 5-year transformation plans.

“We are pleased overall with the results of our first full year of our transformation plan, during which we made immediate and significant progress.” said Harold Bevis, President and Chief Executive Officer of NN, Inc. “We also gained the confidence to accelerate our pace. A few highlights are as follows:

  • Upgraded a significant number of leadership positions, including upgrades across our C-suite, and among our operational leaders, commercial leaders, and finance team. NN is adding to and creating the most competitive engineering and business development team in the history of the Company, adding to our Stamped Products, Electrical, and Medical teams.
  • In 2025, we are launching the highest number of new products in recent history. By being careful and selective, we have been able to keep our cash capex spending to normal levels by leveraging our $340 million installed base of machinery and equipment and $56 million of land and buildings.
  • We have significantly improved the underperforming performance at the ‘Group of 7’ plants that had previously generated $112.6 million of net sales and negative $11.5 million of adjusted EBITDA in 2023; we have fixed four plants and we are closing three. In 2025, we expect this same set of plants to generate $5 million of adjusted EBITDA.
  • Growth of the US electrical grid power business is expected to continue in 2025 as electrical demand increases due to data centers, electric, and hybrid vehicles.”

Mr. Bevis concluded, “Looking ahead to 2025, as we continue along our transformation path, we are focused on creating a refreshed and extended balance sheet, stronger free cash flow, a powerful new business acquisition program, and a further strengthening of our management team. I would like to thank the NN team and our partners who are working together to create sustainable value.”

Fourth Quarter Results

Net sales were $106.5 million, a decrease of 5.3% compared to the fourth quarter of 2023 net sales of $112.5 million, which was primarily due to the sale of our Lubbock operations, lower volumes, and unfavorable foreign exchange effects of $1.6 million. As a result, on a pro forma basis, sales increased 2% over the same period of prior year.

Loss from operations was $16.9 million compared to a loss from operations of $7.9 million in the fourth quarter of 2023. The increased loss from operations was primarily due to lower sales volume.

Income from operations for Power Solutions was $1.3 million compared to income from operations of $2.8 million for the same period in 2023. Loss from operations for Mobile Solutions was $12.9 million compared to loss from operations of $5.7 million for the same period in 2023.

Net loss was $21.0 million compared to net loss of $20.5 million for the same period in 2023.

Full-Year Results

Net sales decreased by $25.0 million, or 5.1%, during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the sale of our Lubbock operations, customer settlements received in 2023, rationalized volume at plants undergoing turnarounds and unfavorable foreign exchange effects of $3.5 million. These decreases were partially offset by the net impact of contractual pass-through material pricing provisions. As a result, on a pro forma basis, sales decreased 0.2%.

Loss from operations was $27.5 million in the year ended December 31, 2024 compared to a loss from operations of $21.8 million in the year ended December 31, 2023, primarily due to lower revenue, the impairment of machinery and equipment at a plant that will close in 2025, higher travel, stock compensation and severance expense, partially offset by lower salaries due to a reduction in headcount.

Net loss was $38.3 million compared to net loss of $50.2 million for the same period in 2023. The improvement is primarily due to the $7.2 million gain on sale of the Lubbock operations and a decrease in noncash derivative mark-to-market losses, as well as increased share of net income from joint venture.

Fourth Quarter Adjusted Results

Adjusted income from operations for the fourth quarter of 2024 was $2.4 million compared to adjusted loss from operations of $1.4 million for the same period in 2023. Adjusted EBITDA was $12.1 million, or 11.3% of sales, compared to $10.0 million, or 8.9% of sales, for the same period in 2023.

Adjusted net loss was $0.9 million, or $0.02 per diluted share, compared to adjusted net loss of $4.9 million, or $0.10 per diluted share, for the same period in 2023. Free cash flow was a generation of cash of $3.8 million compared to a generation of cash of $1.3 million for the same period in 2023.

Power Solutions 
Net sales for the fourth quarter of 2024 were $39.2 million compared to $43.3 million in the same period in 2023. The decrease is primarily due to lower volumes, including from the sale of the Lubbock operations, offset partially by pricing.

Net sales decreased by $5.4 million, or 2.9%, during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the sale of our Lubbock operations, premium pricing received on a certain customer project during the first quarter of 2023, and unfavorable foreign exchange effects of $0.2 million. These decreases were partially offset by higher precious metals pass-through pricing.

Adjusted income from operations was $4.6 million compared to adjusted income from operations of $5.8 million in the fourth quarter of 2023. The decrease in adjusted income from operations was primarily due to the lower revenue, including from the sale of the Lubbock operations, partially offset by cost reduction initiatives.

Income from operations increased by $2.0 million during the year ended December 31, 2024 compared to the same period in the prior year, primarily due to an increase in sublease income earned on closed facilities and lower depreciation and amortization expense due to sold or fully utilized assets.

Mobile Solutions

Net sales for the fourth quarter of 2024 were $67.4 million compared to $69.2 million in the fourth quarter of 2023, a decrease of 2.7%. The decrease in sales was primarily due to rationalized volume at plants undergoing turnarounds, contractual reduction in customer pass-through material pricing, and unfavorable foreign exchange effects of $1.6 million.

Net sales decreased by $19.4 million, or 6.4%, during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due rationalized volume at plants undergoing turnarounds, contractual reduction in customer pass-through material pricing, a customer settlement received in 2023 and unfavorable foreign exchange effects of $3.3 million.

Adjusted income from operations was $2.5 million compared to adjusted loss from operations of $2.3 million in the fourth quarter of 2023. The increase in adjustment income from operations was primarily due to the rationalization of underperforming business.

Loss from operations changed unfavorably by $6.3 million during the year ended December 31, 2024, compared to the prior year, primarily due to the impairment of machinery and equipment at a plant that will close in 2025. The change was also impacted by higher depreciation expense and selling, general and administrative costs.

2025 Outlook

Guidance assumes a similar FX, trade policy, and metal industry environment as in 2024.

Revenues should be between $450 to $480 million, depending on FX and tariff impacts

  • At midpoint, slight growth over 2024 on a proforma basis
  • Core performance metrics normalized for sale of Lubbock and rationalized business during 2024

Adjusted EBITDA should be between $53 and $63 million, depending on FX and tariff impacts

  • At midpoint, up ~15% over 2024 on a proforma basis
  • Core performance metrics normalized for sale of Lubbock and rationalized business during 2024

New business wins between $60 to $70 million

  • Targeting larger amounts from stamped products, electrical products and medical products
  • China will fund its own new wins program
  • Continue to leverage $340 million of machinery and equipment to minimize cash capex spend

Chris Bohnert, Senior Vice President and Chief Financial Officer, commented, “The key end markets NN serves remain solid on balance, subject to potential impacts of foreign exchange rate fluctuations, volume uncertainty and tariff impacts. These uncertainties are initially moving us to the low half of the Revenue and adjusted EBITDA ranges for the full-year. We expect our profitability results to be supported by stronger margins as a result of cost-out actions and operational efficiencies, as well as the launching of new business wins. Our adjusted EBITDA forecast calls for solid year-over-year improvement driven by a combination of a stronger gross margin profile, and the benefit of our consistent actions to improve our fixed and variable cost structure.”

Mr. Bohnert concluded, “The refinancing of our Term Loan is in process and our focus remains on improving our financial flexibility and supporting our profitable growth strategy. While this process is influenced by NN’s positively evolving growth capital and capacity expansion needs, as well as the Company’s changing cost structure, we expect this process to conclude in the first half of the year, which will provide us the runway needed to continue our multi-year transformation.”

Conference Call

NN will discuss its results during its quarterly investor conference call on March 6, 2024, at 9 a.m. ET. The call and supplemental presentation may be accessed via NN’s website, www.nninc.com. The conference call can also be accessed by dialing 1-877-255-4315 or 1-412-317-6579. For those who are unavailable to listen to the live broadcast, a replay will be available shortly after the call until March 6, 2026.

NN discloses in this press release the non-GAAP financial measures of adjusted income (loss) from operations, adjusted EBITDA, adjusted net income (loss), adjusted net income (loss) per diluted common share, and free cash flow. Each of these non-GAAP financial measures provides supplementary information about the impacts of restructuring and integration expense, acquisition and transition expenses, foreign exchange impacts on inter-company loans, amortization of intangibles and deferred financing costs, and other non-operating impacts on our business.

The financial tables found later in this press release include a reconciliation of adjusted income (loss) from operations, adjusted operating margin, adjusted EBITDA, adjusted EBITDA margin, adjusted net income (loss), adjusted net income (loss) per diluted share, free cash flow to the U.S. GAAP financial measures of income (loss) from operations, net income (loss), net income (loss) per diluted common share, and cash provided (used) by operating activities.

About NN, Inc.

NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.

Except for specific historical information, many of the matters discussed in this press release may express or imply projections of revenues or expenditures, statements of plans and objectives or future operations or statements of future economic performance. These statements may discuss goals, intentions and expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to NN, Inc. (the “Company”) based on current beliefs of management as well as assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “possible,” “potential,” “predict,” “project”, “achieve”, “growth”, “enable”, “improve”, or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such forward-looking statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; the impacts of pandemics, epidemics, disease outbreaks and other public health crises on our financial condition, business operations and liquidity; competitive influences; risks that current customers will commence or increase captive production; risks of capacity underutilization; quality issues; material changes in the costs and availability of raw materials; economic, social, political and geopolitical instability, military conflict, currency fluctuation, and other risks of doing business outside of the United States; inflationary pressures and changes in the cost or availability of materials, supply chain shortages and disruptions, the availability of labor and labor disruptions along the supply chain; our dependence on certain major customers, some of whom are not parties to long-term agreements (and/or are terminable on short notice); the impact of acquisitions and divestitures, as well as expansion of end markets and product offerings; our ability to hire or retain key personnel; the level of our indebtedness; the restrictions contained in our debt agreements; our ability to obtain financing at favorable rates, if at all, and to refinance existing debt as it matures; our ability to secure, maintain or enforce patents or other appropriate protections for our intellectual property; new laws and governmental regulations; the impact of climate change on our operations; uncertainty of government policies and actions after recent U.S. elections in respect to global trade, tariffs and international trade agreements; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

With respect to any non-GAAP financial measures included in the following document, the accompanying information required by SEC Regulation G can be found in the back of this document or in the “Investors” section of the Company’s web site, www.nninc.com, under the heading “News & Events” and subheading “Presentations.”

Investor & Media Contacts: 
Joe Caminiti or Stephen Poe 
NNBR@alpha-ir.com 
312-445-2870

View Full Release Here.

Release – CoreCivic Announces Resumption of Operations at South Texas Family Residential Center in Dilley, Texas

Posted on by aweinsoff@channelchek.com

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March 5, 2025

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BRENTWOOD, Tenn., March 05, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today that it has agreed under an amended intergovernmental services agreement (IGSA) between the City of Dilley, Texas, and U.S. Immigration and Customs Enforcement (ICE) to resume operations and care for up to 2,400 individuals at the South Texas Family Residential Center in Dilley, Texas (the Dilley Facility). Simultaneously, CoreCivic has entered into a new lease agreement with Target Hospitality Corporation (Target), the owner of the facility, over a period co-terminus with the ICE agreement.  

The Dilley Facility was purpose-built for ICE in 2014 to provide an appropriate setting for a family population. CoreCivic managed the Dilley Facility from its construction in 2014 through August 2024, when funding for the contract with ICE was terminated and the facility was idled. CoreCivic will again be responsible for providing residential services in an open and safe environment that offers residents indoor and outdoor recreational activities, life skills, counseling, group interaction, and access to religious and legal services. In addition, CoreCivic will assume the additional responsibility of onsite medical care. Food services will be provided by Target.

The amended IGSA expires in March 2030 and may be further extended through bilateral modification. The agreement provides for a fixed monthly payment in accordance with a graduated schedule to correlate with the activation of each neighborhood within the facility. Total annual revenue once fully activated is expected to be approximately $180 million, inclusive of medical services. We began pre-activation activities earlier this year and expect this award to be accretive to earnings beginning in the second quarter of 2025.

Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “With this award and the additional capacity provided to ICE through four contract modifications we announced last week, we are grateful for the trust our government partner has placed in us. We have an extensive supply of available beds, either owned directly or provided by third parties like Target, that provides our government partners the flexibility to satisfy their immediate and long-term needs in a cost-effective manner. We are entering a period when our government partners — particularly our federal government partners — are expected to have increased demand. We anticipate continued robust contracting activity throughout 2025 that will help meet their growing needs.”

Patrick Swindle, CoreCivic’s President and Chief Operating Officer stated, “We are offering our staff the opportunity to transfer to the Dilley Facility and expect many who accept transfer opportunities will be professionals who previously provided services at the facility prior to its closure last year, expediting the activation process. We are also pleased to again work with Target, which has been a fantastic partner since our relationship began in 2014.”  

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes statements as to our beliefs and expectations of the outcome of future events that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.

Contact:  Investors: Michael Grant – Managing Director, Investor Relations – (615) 263-6957
Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – Direct Digital Holdings and Green Tea Technology Introduce Teranexa: A Collaborative Joint Venture for AI-Enhanced City Solutions

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March 05, 2025 9:00 am EST Download as PDF

HOUSTON, March 5, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (DRCT) and Green Tea Technology have jointly established Teranexa. This new joint venture aims to assist cities in leveraging AI to enhance operations and improve constituent services. Teranexa offers these Al enablement platforms through its trusted partner network of certified industry leaders like IBM and HPE, as well as others.

Teranexa’s platform can unify a city’s infrastructure costs by combining hardware, software, and services to address city challenges. This approach allows cities to implement AI solutions while managing interconnected issues affecting growth and livability.

Direct Digital Holdings will contribute its expertise in data monetization and technology solutions, while Green Tea will bring its proficiency in rapid IT project deployment. Together, these contributions are expected to enable Teranexa to provide comprehensive city solutions supported by proven methodologies and experienced teams.

Mark Walker, CEO of Direct Digital Holdings, stated, “As we look to optimize our business in 2025, we see this venture as a potential to improve city operations, making them more efficient and data-driven. Teranexa aims to bring scalable, AI-driven solutions to municipalities.”

Mike Little, CEO at Green Tea Technology, added, “Teranexa will provide a Smart City as a Service AI platform for cities to enhance operations and facilitate data-driven decision-making. Our service offers municipalities a foundation for growth and long-term development.”

As part of a soft launch, Teranexa will be introduced at an event during SXSW on Friday, March 7th, in Austin, TX. This gathering will allow industry professionals to network and learn about Teranexa’s approach to city innovation.

You can request an invite here.

For more information about Teranexa and its Smart City as a Service AI solution, visit Teranexa.ai.

About Teranexa
Teranexa, a joint venture between Direct Digital Holdings (NASDAQ: DRCT) and Green Tea Technology, provides AI-driven Smart City as a Service solutions that help cities operate more efficiently, serve residents more effectively, and create new revenue streams. Its fully managed platform integrates infrastructure, data intelligence, AI applications, and monetization tools, enabling municipalities to streamline operations, improve services, and unlock new economic opportunities. Teranexa empowers city leaders to address pressing challenges, optimize resources, and build scalable, secure AI infrastructure for communities by transforming raw city data into actionable insights.

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.

At Direct Digital Holdings, we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”

About Green Tea Technology
Green Tea Technology is a leading IT solutions provider in Austin, Texas. As an accredited HPE Certified GreenLake integration partner, the company is at the forefront of delivering cutting-edge Hybrid cloud solutions tailored to meet the unique needs of businesses, both large and small. Green Tea Technology is committed to innovation and sustainability and is dedicated to architecting robust, scalable, and environmentally-friendly IT infrastructures.

Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

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SOURCE Direct Digital Holdings

Released March 5, 2025

Release – Ocugen Provides Business Update with Fourth Quarter and Full Year 2024 Financial Results

Posted on by aweinsoff@channelchek.com

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March 5, 2025

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Conference Call and Webcast Today at 8:30 a.m. ET

  • Reached an alignment with FDA on Phase 2/3 pivotal confirmatory clinical trial for OCU410ST for Stargardt disease potentially expediting clinical development by two to three years
  • Completed dosing in OCU410 Phase 2 ArMaDa clinical trial (N=51) for geographic atrophy (GA). Data and Safety Monitoring Board (DSMB) recently reviewed interim safety data from Phase 2. All subjects from multiple dose levels in Phase 2 to date demonstrated a very favorable safety and tolerability profile.
  • Positive 2-year long-term data across multiple mutations of retinitis pigmentosa (RP) from the Phase 1/2 clinical trial of OCU400 demonstrated a durable and statistically significant (p=0.005) improvement in visual function (LLVA) in all evaluable treated subjects at two years when compared to untreated eyes
  • OCU400 remains on track to meet 1H 2025 recruitment completion and potential BLA/MAA filings by mid-2026

MALVERN, Pa., March 05, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported fourth quarter and full year 2024 financial results along with a general business update.

“Ongoing data from all three clinical programs, along with patient testimonials, continue to support the benefit of one-time treatment from our revolutionary modifier gene therapy platform—as we are seeing consistent stabilization or improvement in treated eyes while maintaining a favorable safety and tolerability profile,” said Dr. Shankar Musunuri, Chairman, CEO and Co-founder of Ocugen. “Throughout 2024, the Company continually advanced its clinical programs in line with enrollment and dosing timelines, and we will continue to drive the product pipeline forward in 2025.”

Recently, the Company announced it will proceed with a Phase 2/3 pivotal confirmatory clinical trial of OCU410ST for Stargardt disease after alignment with the FDA. This accelerated regulatory pathway for OCU410ST is driven by the incredible unmet medical need that exists for 100,000 Stargardt patients in the U.S. and Europe who have no treatment option available. Accelerating the clinical timeline of OCU410ST is expected to save significant costs in addressing disease burden even sooner than anticipated.

The OCU410ST Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, 200-μL injection of OCU410ST at a concentration of 1.5 x 1011 vector genomes (vg)/mL in the eye with worse visual acuity, and 17 of whom will serve as untreated controls. One-year data will be utilized for the BLA filing planned for 2027. 6-month data from Phase 1 of the OCU410ST GARDian clinical trial demonstrated considerably slower lesion growth (52%) from baseline in treated eyes versus untreated fellow eyes and clinically meaningful 2-line (10-letter) improvement in visual function (BCVA), which is statistically significant (p=0.02) in treated eyes.

This week, the DSMB for the OCU410 ArMaDa clinical trial for GA convened and reviewed the safety and tolerability profile of an additional 15 subjects from the Phase 2 portion of the study. No serious adverse events related to OCU410 have been reported to date in all 60 subjects, including Phase 1. Unlike currently available treatments for GA, there were no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization, and no adverse events of special interest.

Preliminary 9-month efficacy data of OCU410 in GA patients showed considerably slower lesion growth (44%) from baseline and clinically meaningful 2-line (10-letter) improvement in visual function (LLVA) in treated eyes compared to untreated eyes in the Phase 1 portion of the trial. Furthermore, a single subretinal OCU410 treatment preserves more retinal tissue around GA lesions of treated eyes at 9 months compared to published data on currently available GA therapies. GA, an advanced form of dry age-related macular degeneration, affects 2-3 million people in the U.S. and Europe combined.

Two-year data from the Phase 1/2 OCU400 clinical trial for RP demonstrated a durable and statistically significant (p=0.005) improvement in visual function (LLVA) in all evaluable treated subjects when compared to untreated eyes. 100% (10/10) of treated evaluable subjects showed improvement or preservation in visual function compared to untreated eyes, and OCU400 was observed to have a favorable safety and tolerability profile in all subjects across multiple mutations.

In parallel with clinical milestones, considerable regulatory accomplishments were achieved, including orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD), and positive opinions from the EMA’s Committee for Advanced Therapies (CAT) for OCU400, OCU410, and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification.

Ocugen’s biologic candidate moved into the clinic and patients are currently being dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). OCU200 has the potential to change the treatment landscape for DME, diabetic retinopathy, and wet age-related macular degeneration with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors that play a crucial role in disease pathogenesis and holds the promise to benefit all DME patients, including the 30-40% of patients who do not respond to current anti-VEGF therapies.

“I am extremely proud of our team at Ocugen, who are working tirelessly to enroll patients across all four clinical programs in close collaboration with the study centers and investigators,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “It is very gratifying to think about the potential unmet medical need that can be addressed through modifier therapy for patients who currently have no options and are facing the prospect of losing their vision altogether.”

Finally, the Investigational New Drug (IND) application for OCU500—the Company’s inhaled mucosal vaccine for COVID-19 was cleared by the FDA. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is expected to sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray.

To extend the cash runway into the first quarter of 2026, and support Ocugen’s clinical trials, the Company secured $65 million in equity/debt financings in the second half of 2024. Further supporting Ocugen’s efforts to enable long-term shareholder value, garner significant visibility within the investment community, and broaden the shareholder base, the Company was included in the Russell Index in May 2024.

“Meaningful progress in 2024 and recent success with FDA brought us closer to our goal of three potential BLAs in the years—2026, 2027, 2028, encompassing RP, Stargardt and GA treatments, respectively,” said Dr. Musunuri. “While this is an ambitious goal, I am confident that we have the strategic and scientific expertise, and an unrelenting commitment to patients, to deliver on our commitment.”

Business Updates

Novel Modifier Gene Therapy Platform—Potentially Targeting Three BLA Filings in the Next Three Years

  • OCU400 –The European Commission (EC) provided a positive opinion from the EMA’s CAT for OCU400 ATMP classification. Actively enrolling patients in the U.S. and Canada in the Phase 3 liMeliGhT clinical trial for the treatment of RP and are on track to complete enrollment in the first half of 2025 and file BLA and MAA submissions in mid-2026.
  • OCU410ST –The EMA granted OMPD for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD3). The FDA approved a Phase 2/3 pivotal confirmatory clinical trial for BLA filing. Plan to initiate the Phase 2/3 study mid-2025 and targeting BLA submission by 2027. The EC provided a positive opinion from the EMA’s CAT for OCU410ST ATMP classification.
  • OCU410 – Completed dosing in Phase 2 of the OCU410 Phase 1/2 ArMaDa clinical trial ahead of schedule. Intend to complete 1-year follow up in the first quarter of 2026 and targeting a BLA filing in 2028. The EC provided a positive opinion from the EMA’s CAT for OCU410 ATMP classification.

Financial Results

  • Fourth quarter — Research and development expenses for the three months ended December 31, 2024, were $8.3 million compared to $7.8 million for the three months ended December 31, 2023. General and administrative expenses for the three months ended December 31, 2024, were $6.3 million compared to $5.2 million for the three months ended December 31, 2023. Ocugen reported a $0.05 net loss per common share for the three months ended December 31, 2024, compared to a $0.04 net loss per common share for the three months ended December 31, 2023.
  • Full year — Research and development expenses for the year ended December 31, 2024, were $32.1 million compared to $39.6 million for the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024, were $26.7 million compared to $32.0 million for the year ended December 31, 2023. Ocugen reported a $0.20 net loss per common share for the year ended December 31, 2024, compared to a $0.26 net loss per common share for the year ended December 31, 2023.
  • Ocugen’s cash and restricted cash, totaled $58.8 million as of December 31, 2024, compared to $39.5 million as of December 31, 2023. The Company estimates that its current cash, cash equivalents, and investments will enable it to fund its operations into the first quarter of 2026. The Company had 291.4 million shares of common stock outstanding as of December 31, 2024.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s leadership team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 5045393
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety and efficacy thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, expected cash runway into the first quarter of 2026, the ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing and future clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com 

View Full Release Here.

Jazz Pharmaceuticals Acquires Chimerix in $935 Million Deal to Expand Oncology Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Jazz Pharmaceuticals expands oncology pipeline with the $935 million acquisition of Chimerix, gaining dordaviprone, a potential treatment for rare brain tumors.
– Dordaviprone targets a critical unmet need for H3 K27M-mutant diffuse glioma, with an FDA Priority Review and a PDUFA decision expected by August 18, 2025.
– The deal strengthens Jazz’s rare disease focus and could provide durable revenue growth with patent protection extending to 2037.

Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced its acquisition of Chimerix (NASDAQ: CMRX) for approximately $935 million in an all-cash transaction. The deal, expected to close in the second quarter of 2025, will bolster Jazz’s oncology portfolio by adding Chimerix’s lead asset, dordaviprone, a promising treatment for rare brain tumors.

Dordaviprone is a novel small-molecule therapy in development for H3 K27M-mutant diffuse glioma, an aggressive brain tumor that primarily affects children and young adults. Currently, there are no FDA-approved treatments specifically for this patient group, with radiation being the standard approach. The drug has been granted Priority Review by the FDA, with a target decision date set for August 18, 2025. If approved, dordaviprone could become a breakthrough treatment and may qualify for a Rare Pediatric Disease Priority Review Voucher (PRV).

Jazz Pharmaceuticals’ Chairman and CEO, Bruce Cozadd, emphasized the strategic importance of the acquisition. “Dordaviprone has the potential to become a standard of care for a rare oncology disease with no current FDA-approved treatments,” said Cozadd. “This deal reinforces our commitment to patients with rare diseases and adds a near-term commercial opportunity to our pipeline.”

Chimerix CEO Mike Andriole echoed this sentiment, highlighting the benefits of Jazz’s global commercial scale in expanding access to dordaviprone. “This agreement enables us to reach more patients globally while delivering significant value to our shareholders,” he stated.

Dordaviprone is currently being studied in a Phase 3 ACTION trial, evaluating its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation. If successful, this could expand its use beyond recurrent cases.

The acquisition price of $8.55 per share represents a 72% premium over Chimerix’s closing stock price on March 4, 2025. Jazz will finance the transaction using its existing cash and investments.

The deal strengthens Jazz’s position in rare oncology and provides a potential long-term revenue stream, with patent protection for dordaviprone extending to 2037. If approved, the drug could see a rapid commercial launch in the U.S. in the second half of 2025.

Jazz expects to leverage its development and commercialization expertise to execute a strong launch strategy, positioning dordaviprone as a new standard of care for H3 K27M-mutant diffuse glioma. The acquisition is subject to customary closing conditions, including regulatory approvals and the tendering of a majority of Chimerix’s shares.

With this move, Jazz Pharmaceuticals reinforces its commitment to oncology innovation and its mission to address significant unmet medical needs. If the FDA grants approval, dordaviprone could be a game-changer for brain tumor treatment, offering hope to patients with limited options.

Take a moment to take a look at other emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Research Analyst Robert Leboyer’s coverage list.

The GEO Group (GEO) – Upgrading to Outperform with $32 PT

Posted on by cpereira@noblefcm.com


Wednesday, March 05, 2025

The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 103 facilities totaling approximately 83,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

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.

Upgrading to Outperform. We are upgrading GEO shares to Outperform with a $32 near-term price target. We believe there is substantial opportunity just in filling existing beds under current contracts, with the opening of currently idle facilities, new facilities, and expansion of the ISAP program providing additional upside.

Opportunity. GEO has an additional 17,000 beds to provide for ICE detention requirements, which would increase GEO’s overall bed capacity for ICE to about 32,000 beds. The incremental 17,000 beds includes approximately 9,400 beds in current idle facilities that will be reconfigured for detention use and approximately 7,700 incremental beds available at existing GEO serviced ICE and U.S. Marshal’s facilities under contract. Management estimates the utilization of these additional 17,000 beds could generate between $500 million and $600 million in incremental annualized revenues, with margins consistent with secure services owned facilities which average 25% to 30%.


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).

*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. 

Cadrenal Therapeutics (CVKD) – Development Agreement With Abbott Brings Another Tecarfarin Indication To Clinical Trials

Posted on by cpereira@noblefcm.com


Wednesday, March 05, 2025

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.

Cadrenal and Abbott Announce The LVAD Collaboration We’ve Been Waiting For. Cadrenal announced a development agreement with Abbott (ABT, Not Rated) to develop Tecarfarin in patients with Abbott’s HeartMate3 LVAD (left ventricle assist device). Under the agreement, Abbott will support Cadrenal’s pivotal TECH-VLAD (TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices) trial in its design, site selection, recruitment, and its HeartMate3 experience.

LVAD Patients Have An Unmet Need For A New Anticoagulant. While Direct Oral Anticoagulation Drug (DOAC) category has been highly successful, there are several populations where they are not effective or have safety risks. Patients with LVAD devices can only use warfarin, a drug that has variable efficacy with several drawbacks, including a requirement for frequent patient monitoring. LVAD patients have less effective anticoagulation and remain at high risk for coagulation events (bleeding, stroke, myocardial infarct). 


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).

*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. 

Ocugen (OCGN) – OCU410 and OCU410ST Receive ATMP Classification In Europe

Posted on by cpereira@noblefcm.com


Tuesday, March 04, 2025

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

Ocugen Now Has Three Products With ATMP Designation. Two Ocugen products, OCU410 and OCU410ST, received Advanced Therapy Medicinal Product (ATMP) designation from the European Medicines Agency Committee for Advanced Therapies (EMA-CAT). These join OCU400, which received this designation for retinitis pigmentosa (RP) in February 2025. The designation is similar to the Breakthrough Therapy designation from the FDA, allowing increased interactions with the regulators and accelerating regulatory review.

OCU410 Has Completed Phase 2 Dosing In GA. The Phase 2 portion of the ArMaDa (pronounced ‘Armada”) trial has completed enrollment for OCU410 in geographic atrophy (GA), a lesion that results from advancing dry Age-related Macular Degeneration (dry AMD). The study has enrolled 51 patients randomized into a high dose arm, medium dose arm, or control. The completion of the dosing phase was ahead of our expected time frame, keeping the company on schedule to conduct Phase 3 in 2026 and potentially file for regulatory approval in 2028.


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).

*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. 

Release – Cadrenal Therapeutics Announces Collaboration Agreement with Abbott in Support of Pivotal Study of Tecarfarin in Patients with HeartMate 3™ LVAD

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

  • Strengthens the Potential for Improved Patient Outcomes through Improvements in the Quality of Anticoagulation, Enhancing Hemocompatibility in HeartMate 3™ LVAD patients

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapeutics, with the late-stage asset tecarfarin, a new oral Vitamin K antagonist (VKA), today announced the signing of a Collaboration Agreement with Abbott (NYSE: ABT) to support Cadrenal’s pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial.

Under the terms of the Collaboration and Data Sharing Agreement, Abbott will support Cadrenal on the planning and execution of the TECH-LVAD trial to evaluate the efficacy and safety of tecarfarin in patients with LVADs. Under the Agreement, Abbott will share insights from recent HeartMate 3™ trials and will support Cadrenal with: trial design, site identification, trial awareness, and HeartMate 3™ expertise.

“We are pleased to have the support of Abbott, a global healthcare leader, which further validates the advancement into late-stage clinical development of tecarfarin. This partnership strengthens our access to key clinical trial sites and enhances patient enrollment efforts,” said Quang X. Pham, Chief Executive Officer, Cadrenal Therapeutics, Inc. “Together, we have a unique opportunity to evaluate tecarfarin in combination with the HeartMate 3™ LVAD, advancing our commitment to bringing forward the first innovation in vitamin K-targeted anticoagulation in over 70 years.”

Abbott’s HeartMate 3™ LVAD is a mechanical circulatory support device designed for patients with advanced heart failure. Abbott’s heart pumps have set the standard in LVAD therapy. The HeartMate 3™ LVAD is the most advanced LVAD yet and the only one currently available in the United States. According to Business Research Insights, the LVAD market was valued at $1.1 billion in 2023 and is projected to reach $2.4 billion by 2032.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing specialized therapeutics for rare cardiovascular conditions. The Company is developing its late-stage asset, tecarfarin, a new oral vitamin K antagonist (VKA) designed to be a better and safer anticoagulant than warfarin, for individuals with implanted cardiac devices. Although warfarin is widely used off-label for several rare cardiovascular conditions, extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges.

Cadrenal is pursuing a product-in-a-pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted left ventricular assist devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapeutics. For more information, visit www.cadrenal.com and connect with us on LinkedIn.

Safe Harbor

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the collaboration strengthening the potential for improved patient outcomes through improvements in the quality of anticoagulation enhancing hemocompatibility in HeartMate 3™ LVAD patients; Abbott supporting Cadrenal on the planning and execution of the TECH-LVAD trial to evaluate the efficacy and safety of tecarfarin in patients with LVADs; Abbott sharing insight from recent HeartMate 3™ trials and supporting Cadrenal with: trial design, site identification, trial awareness, and HeartMate 3™ expertise; the support of Abbott further validating the advancement into late-stage clinical development of tecarfarin; bringing forward the first innovation in vitamin K-targeted anticoagulation in over 70 years; meeting the unmet needs of LVAD patients by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges, Cadrenal building build a pipeline of specialized cardiovascular therapeutics and the LVAD market being projected to reach $2.4 billion by 2032. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to utilize Abbott’s expertise to advance tecarfarin, the ability to successfully collaborate with Abbott, the initiation of the pivotal clinical trial for tecarfarin in LVAD patients by Cadrenal and for Cadrenal to provide improved patients outcomes and efficacy and safety for LVAD patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Corporate and Investor Relations

Lisa DeScenza

LaVoieHealthScience

(978) 395-5970

ldescenza@lavoiehealthscience.com

Media

Andrew Korda

LaVoieHealthScience

(617) 865-0043

akorda@lavoiehealthscience.com

Release – Bitcoin Depot Schedules Fourth Quarter and Full Year 2024 Conference Call for Tuesday, March 18th at 10:00 am ET

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

March 04, 2025 8:00 AM EST Download as PDF

ATLANTA, March 04, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, will hold a conference call and live audio webcast on Tuesday, March 18th at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) to discuss its financial results for the fourth quarter and full year ended December 31, 2024. Bitcoin Depot plans to release results before the market open on the same day.

Call Date: Tuesday, March 18, 2025  
Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time)

Phone Instructions
U.S. and Canada (toll-free): 888-596-4144
U.S. (toll): 646-968-2525
Conference ID: 8224936

Webcast Instructions
Webcast link: https://edge.media-server.com/mmc/p/8kgtbeme

A replay of the call will be available beginning after 2:00 p.m. Eastern time through March 25, 2025.

U.S. & Canada (toll-free) replay number: 800-770-2030
U.S. toll number: 609-800-9909
Conference ID: 8224936

If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

About Bitcoin Depot
Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with over 8,400 kiosk locations as of February 25, 2025. Learn more at www.bitcoindepot.com.

Contacts:

Investors
Cody Slach
Gateway Group, Inc.
949-574-3860
BTM@gateway-grp.com

Media
Brenlyn Motlagh, Ryan Deloney
Gateway Group, Inc.
949-574-3860
BTM@gateway-grp.com

Primary Logo

Source: Bitcoin Depot Inc.

Released March 4, 2025

Release – Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at 7th International Congress on Controversies in Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 04, 2025 7:00am EST Download as PDF

TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia

TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized Phase 3 studies

FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia

If approved by FDA, it would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years

CHATHAM, N.J., March 04, 2025 (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, presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria. A copy of the Company’s presentation, titled “Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Treatment of Fibromyalgia at Bedtime to Target Non-Restorative Sleep Showed Durable Pain Reduction in Two Double-Blind Randomized Phase 3 Studies” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

“Since fibromyalgia is a chronic pain condition, medicines to treat fibromyalgia need to provide durable benefits,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “A randomized controlled study showed that oral, swallowed cyclobenzaprine fails to provide any durable (>1 month) benefit1. In contrast, TNX-102 SL has shown statistically significant, durable activity (3 months) in reducing fibromyalgia pain in two Phase 3 studies. The U.S. Food and Drugs Administration (FDA) has set a PDUFA goal date of August 15, 2025 for a decision on marketing authorization. TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”

Dr. Lederman continued, “TNX-102 SL is designed as a bedtime treatment to target non-restorative sleep, which in turn has shown to result in reduced pain. By providing transmucosal delivery of the tertiary amine tricyclic, TNX-102 SL results in reduced formation of the persistent active metabolite, norcyclobenzaprine (norCBP) relative to oral delivery. NorCBP accumulates after oral delivery and its potent inhibition of the norepinephrine transporter may relate to why oral cyclobenzaprine has transient (one month) activity in fibromyalgia, but not durable (three months) activity in reducing fibromyalgia pain1. Fibromyalgia, has historically been overlooked. Patients’ needs have been inadequately addressed by the three approved products, which results in many patients being prescribed chronic opioids, that are believed to be ineffective, and an actually deleterious, treatment strategy.”

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a potent antagonist at four post-synaptic receptors, each of which is involved in regulating sleep. TNX-102 SL is designed for rapid, transmucosal absorption and, as demonstrated in pharmacokinetic studies, bypasses first-pass hepatic metabolism resulting in greater bioavailability of cyclobenzaprine that aligns with the sleep cycle to target non-restorative sleep. The sublingual formulation also results in substantially reduced creation of the active metabolite norCyclobenzaprine (norCBP) due to the bypass of first-pass hepatic metabolism. In two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia, TNX-102 SL 5.6 mg met the pre-specified primary endpoints of significantly reducing daily pain compared to placebo after 14 weeks of treatment. In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed.

About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC) 2-4. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.

About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.

1Carette S, et al. Arthritis Rheum. 1994, 37(1):32-40. doi: 10.1002/art.1780370106
2Fitzcharles MA, et al. Lancet. 2021;397:2098-110
3Clauw DJ. Ann Rheum Dis. Published Online First: 2024
4Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363

Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia, now recognized as the prototypic nociplastic syndrome and as a chronic overlapping pain condition (COPC). TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years 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. 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; their efficacy and safety have not been established 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released March 4, 2025

The ODP Corporation (ODP) – Doubling Down on B2B

Posted on by cpereira@noblefcm.com


Tuesday, March 04, 2025

Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services. It offers merchandise, such as general office supplies, computer supplies, business machines and related supplies, and office furniture through its chain of office supply stores under the Office Depot, Foray, Ativa, Break Escapes, Worklife, and Christopher Lowell brand names. The company also provides graphic design, printing, reproduction, mailing, shipping, and other services through design, print, and ship centers. It has operations throughout North America, Europe, Asia, and Central America. The company also sells its products and services through direct mail catalogs, contract sales force, Internet sites, and retail stores, through a mix of company-owned operations, joint ventures, licensing and franchise agreements, alliances, and other arrangements. As of December 31, 2008, Office Depot operated 1,267 North American retail division office supply stores and 162 international division retail stores, as well as participated under licensing and merchandise arrangements in 98 stores. The company was founded in 1986 and is based in Boca Raton, Florida.

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.

Macro Headwinds. While macro headwinds remain in the B2B and B2C segments, green shoots are appearing, with new B2B contracts and an expanding pipeline of new business opportunities. Over at retail, the Company has seen improved traction with targeted profitable sales campaigns and value added promotions.

Playing to its Strengths. Project “Optimize for Growth” and the B2B focus plays into ODP’s core strengths, such as robust supply chain assets, distribution capabilities, and an expansive B2B customer base. We believe these moves position ODP to unlock sustainable growth and long-term success.


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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.