Release – Direct Digital Holdings’ AI Council Launches “Demystifying AI” Ebook to Bridge the Enterprise AI Divide

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February 13, 2025 10:00 am EST Download as PDF

New guide provides a practical framework for small and mid-market business leaders to navigate generative AI adoption

HOUSTON, Feb. 13, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the release of “Demystifying AI,” the first in a series of ebooks, published under its AI Council, which address the widening divide between organizations embracing generative AI and those hesitant to adopt it. The comprehensive guide aims to help business leaders understand and navigate the challenges of navigating the opportunities and risks of implementing AI technology.

“Every day, we see the impact of generative AI on workplace productivity and innovation, yet many business leaders still struggle to separate hype from reality,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings and AI Council member. “While large enterprises benefit from dedicated AI teams, the reality is that any company, regardless of size, can successfully adopt these technologies to stay competitive – if they have the right knowledge.”

Transforming Understanding into Action
“Demystifying AI” offers business leaders a clear, practical exploration of artificial intelligence, focusing on what AI is—and, importantly, what it isn’t. The guide helps leaders understand AI as a collaborative tool that enhances human capabilities rather than replaces them. It demonstrates how it can handle routine tasks while allowing teams to focus on higher-value work.

The guide addresses the key factors to successfully bridging the gap between AI’s potential and its practical implementation, including:

  • Risk management strategies that protect organizational interests
  • Security protocols that safeguard sensitive information
  • Implementation frameworks that ensure responsible AI adoption

“Organizations that understand how to leverage AI effectively today will have a significant competitive advantage tomorrow,” added Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings and AI Council member. “Our ebook provides the foundational knowledge leaders need to make informed decisions about AI adoption in their businesses.”

These resources offer a complete pathway for organizations to confidently move into AI adoption. To download the “Demystifying AI” ebook, please visit our AI Council Resource Center.

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.”

Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

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SOURCE Direct Digital Holdings

Released February 13, 2025

Release – Comtech Launches Industry-First Multipath Radio Platform

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By The Comtech Editorial Team – Feb 13, 2025 | 3 min read

MPR platform provides industry-first multipath mitigation capabilities in single integrated, antenna agnostic platform

CHANDLER, Ariz. – February 13, 2025– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global communications technology leader, today announced the launch of the Company’s new multipath radio (“MPR”) platform. As the first-ever terrestrial high data rate over-the-horizon integrated radio of its kind, MPR will empower first responders, warfighters, and commercial operators with new high data rate communications capabilities on a single antenna agnostic platform.

Built on the proven success of Comtech’s next-generation Troposcatter systems, the MPR platform’s multimode functionality, diverse antenna support, and advanced signal processing techniques empower users to establish secure, reliable and resilient communications links in challenging environments where traditional radios struggle. Today, MPR supports line-of-sight (“LOS”), obstructed-line-of-sight (“OLOS”), and beyond-line-of-sight (“BLOS”) scenarios.

“Comtech’s MPR is optimized for on-the-move, at-the-halt, and fixed applications in a flexible, low Size Weight and Power (“SWAP”) terrestrial over-the-horizon communications platform,” said Daniel Gizinski, President of Comtech’s Satellite and Space Communications Segment. “MPR’s functionality and ease of use is a true game-changer for end users, demonstrating the ability to be set up and deployed in less than 10 minutes as well as delivering industry-leading data rates continuously over long distances. The software-defined nature of Comtech’s MPR platform also enables the system to adapt and incorporate new capabilities over time.”

In the past, terrestrial BLOS communications systems were limited due to large size, high-power requirements, and complexity of operation. Leveraging over 40 years of multipath radio technology leadership, Comtech’s MPR is revolutionizing high data rate communications capabilities by providing a rapidly deployable, transportable, low SWAP solution for military and commercial operators.

Comtech’s Multipath Mitigation Technology Advantage:

Today, reliable communications in diverse environments are essential for military and critical infrastructure applications. However, multipath propagation, where radio signals travel along multiple paths before reaching the end user, disrupts signal integrity, causing a drop in communications or total loss of connectivity. Comtech’s MPR solves multipath disruption by a unique combination of diverse techniques, advanced forward error correction, and adaptive coding and modulation, that represent a first for the industry.

Operational Value for End Users:

  • BLOS without SATCOM: MPR provides real-time data connectivity over-the-horizon up to 150 miles; this capability can be critical in satellite contested environments or when limited space segment is available.
  • Reliable Communications: The MPR ensures clear and consistent communications across echelons, overcoming signal degradation caused by terrain or obstacles.
  • Enhanced Situational Awareness: Reliable data exchange facilitates a shared understanding of a variety of scenarios ranging from military operations to disaster response, which is crucial for informed decision-making.
  • Improved Interoperability: The MPR is over the air compatible with Comtech’s entire Family of Troposcatter Systems. To enhance network and information interoperability, MPR provides an easy-to-use Layer 2 interface integration package for all IP based MESH and MANET radio networks.
  • Common Digital Architecture: MPR is designed to leverage a common digital architecture across the Company’s other product lines, including Comtech’s Digital Common Ground modems.
  • Low SWAP: The MPR provides users maximum SWAP flexibility against varied environments. The small footprint and rapid set up provide users with a true expeditionary capability.
  • Enhancements: Comtech’s MPR has a series of planned enhancements, including point-to-multi-point, which will allow simultaneous communications to multiple on-the-move platforms and stationary sites, eliminating the need for multiple systems at the hub location.

Recent U.S. Department of Defense Demonstrations Validate MPR Capabilities:

During an initial Joint Service demonstration along Florida’s panhandle, Comtech’s MPR delivered 14 megabits of data continuously over a 101-mile BLOS link using no vertical lift.

During the U.S. Navy’s Silent Swarm 2024 exercise, Comtech’s new MPR platform completed a long-range ship-to-shore connection for an unmanned surface vessel-revolutionizing at-sea command, control, communications, computers, cyber, intelligence, surveillance, and reconnaissance mission support.

For more information Comtech’s new MPR platform, please visit our webpage: https://comtech.com/capability/mpr-platform/.

About Comtech

Comtech Telecommunications Corp. is a leading provider of satellite and space communications technologies; terrestrial and wireless network solutions; Next Generation 911 (NG911) and emergency services; and cloud native capabilities to commercial and government customers around the world. Through its culture of innovation and employee empowerment, Comtech leverages its global presence and decades of technology leadership and experience to create some of the world’s most innovative solutions for mission-critical communications. 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.

Investor Relations

Maria Ceriello

631-962-7115

Maria.Ceriello@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – V2X Holds Top Spot on GSA’s OASIS+ Contract Across All Eight Domains

V2X (PRNewsfoto/V2X, Inc.)

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February 13, 2025

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RESTON, Va., Feb. 13, 2025 /PRNewswire/ — V2X Inc. (NYSE: VVX) has been awarded a position on the General Services Administration’s (GSA) One Acquisition Solution for Integrated Services Plus (OASIS+) contract across all eight domains, solidifying its role as a leading provider of integrated mission solutions for the U.S. Government.

Through OASIS+, V2X will deliver a comprehensive suite of services, supporting mission-critical needs in:

  • Technical and Engineering
  • Research and Development
  • Intelligence Services
  • Environmental Services
  • Facilities Management
  • Logistics
  • Management and Advisory Services
  • Enterprise Solutions

OASIS+ is designed to streamline acquisitions, enhance procurement efficiency, and increase transparency, enabling federal agencies to access top-tier professional services with greater flexibility.

“We are one of only 10 companies that were awarded a position across all OASIS+ domains—a testament to the depth and breadth of our capabilities,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “This win demonstrates our ability to support the most complex government missions with full lifecycle solutions.”

As a multiple-award, indefinite delivery/indefinite quantity contract, OASIS+ represents a next-generation vehicle for procuring professional services. With a potential 10-year period of performance and no ceiling limit, it empowers agencies to plan and execute mission-essential procurements without disruption.

V2X’s presence across all eight domains underscores its unmatched expertise, commitment to innovation, and mission-first approach in supporting the evolving needs of federal customers.

About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

Investor Contact 
Mike Smith, CFA
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com
719-637-5773

Media Contact
Angelica Spanos Deoudes
Senior Director, Marketing and Communications 
Angelica.Deoudes@goV2X.com
571-338-5195

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SOURCE V2X, Inc.

Release – Kelly Reports Fourth-Quarter and Full-Year 2024 Earnings

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February 13, 2025

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TROY, Mich., Feb. 13, 2025 (GLOBE NEWSWIRE) —  Kelly (Nasdaq: KELYA, KELYB), a leading specialty talent solutions provider, today announced fourth-quarter and full-year 2024 earnings.

  • Q4 revenue of $1.2 billion, down 3.3% year-over-year reflecting the previously disclosed dispositions and acquisitions, and up 4.4% on an organic basis. Full-year revenue of $4.3 billion, down 10.4% as reported and up 0.5% on an organic basis.
  • Q4 operating loss of $56.7 million on $80.8 million non-cash impairment charges; $29.2 million of operating income on an adjusted basis, up 32% versus the prior year period
  • Q4 adjusted EBITDA of $43.5 million, up 34% versus the prior year; adjusted EBITDA margin increased 110 basis points versus the prior year period to 3.7%
  • Full-year operating loss of $15.1 million resulting from non-cash impairment charges; adjusted operating income of $92.1 million; adjusted EBITDA of $143.5 million, up 31% versus the prior year, and adjusted EBITDA margin of 3.3%, an increase of 100 basis points versus the prior year
  • Company expects to deliver incremental organic revenue growth and adjusted EBITDA margin expansion during fiscal 2025
  • Announces planned retirement of president and chief executive officer Peter Quigley by the end of 2025

“We are pleased with our results in the fourth quarter, during which we drove organic revenue growth that outpaced the market and increased adjusted EBITDA by 34 percent. Our positive performance bookended a year of significant strategic progress on our specialty growth journey as we continued to shift toward higher margin, higher growth markets and solutions,” said Peter Quigley, president and chief executive officer. “In 2024, we delivered 100 basis points of net margin expansion, unlocked more than $100 million in capital by further streamlining our operating model, and redeployed that capital toward our transformational acquisition of Motion Recruitment Partners. We enter 2025 a more efficient and focused company well positioned to capitalize as demand improves and deliver top- and bottom-line growth.”

Financial Results for the thirteen-week period ended December 29, 2024:

  • Revenue of $1.2 billion, a 3.3% decrease compared to the corresponding quarter of 2023 resulting primarily from the sale of the Company’s European staffing operations on January 2, 2024, partially offset by the May 2024 acquisition of Motions Recruitment Partners (“MRP”). Excluding the European staffing operations and MRP, revenue was up 4.4% on an organic basis as organic growth initiatives drove market share gains despite broader industry declines. MRP revenue added 9.8% to reported fourth-quarter year-over-year revenue growth.
  • Operating loss of $56.7 million, reflecting $80.8 million in non-cash impairment charges compared to earnings of $7.3 million reported in the fourth quarter of 2023. Adjusted earnings1 were $29.2 million in the fourth quarter of 2024 and $22.1 million in the fourth quarter of 2023. Adjusted EBITDA1 of $43.5 million, an increase of 34% versus the prior year period. Adjusted EBITDA margin of 3.7%, an increase of 110 basis points. Reflects organic improvement of 50 basis points and a 60 basis point impact from the European staffing operations sale.
  • Loss per share was $0.90 compared to earnings per share of $0.31 in the fourth quarter of 2023. On an adjusted basis1, earnings per share were $0.82 in the fourth quarter of 2024 compared to $0.93 per share in the corresponding quarter of 2023.

Financial results for the 52-week period ended December 29, 2024:

  • Revenue of $4.3 billion, a decrease of 10.4% compared to the prior year resulting primarily from the sale of the European staffing operations partially offset by the acquisition of MRP. Excluding the impact of the European staffing operations sale and MRP, revenue was up 0.5% on an organic basis. MRP added 5.9% to reported year-over-year revenue growth.
  • Operating loss of $15.1 million, reflecting $86.3 million of non-cash impairment charges compared to earnings of $24.3 million reported in 2023. Adjusted earnings1 were $92.1 million in 2024 and $69.1 million in 2023. Adjusted EBITDA of $143.5 million, an increase of 31% versus the prior year. Adjusted EBITDA1 margin of 3.3%, an increase of 100 basis points. Reflects organic improvement of 50 basis points, a 40 basis point impact from the European staffing sale and 10 basis point improvement from the acquisition of MRP.
  • Loss per share was $0.02 compared to earnings per share of $0.98 in 2023. On an adjusted basis1, earnings per share were $2.34 in 2024 compared to $2.20 per share in 2023.

Adjusted measures represent non-GAAP financial measures. Refer to our reconciliation of non-GAAP financial measures to the most closely related GAAP measure included in this document.

Financial Outlook*:

First Half 2025:

  • Revenue – total Company first half revenue up approximately 10% due to the benefit of the MRP acquisition, up modestly on an organic basis
    • Total Company revenue growth will be slightly higher in Q1 than in Q2 given the May 31, 2024 MRP transaction closing date
  • GP rate – total Company rate up approximately 80 basis points reflecting the benefit of the MRP acquisition; organic GP rate roughly flat
  • Adjusted SG&A – increase modestly on a quarterly run rate basis relative to Q4 2024, includes impact of payroll tax and performance-based incentive resets
    • Total D&A of approximately $13.5 million per quarter expected
  • Adjusted EBITDA margin – up 10 basis points to approximately 3.6%
  • Tax rate – effective rate in the high teens

*Assumes relatively consistent staffing market conditions in the first half of the year

Planned Retirement of President and Chief Executive Officer Peter Quigley:

Kelly also announced that Peter Quigley has informed Kelly’s board of directors of his intention to retire from his role as president and chief executive officer by the end of 2025. Quigley intends to serve in his current role until his successor is appointed and an orderly transition is completed. The compensation and talent management committee of the board, which is responsible for executive development and succession, has initiated a process to identify Quigley’s successor and engaged a nationally recognized search firm. The board will consider internal and external candidates with the skills and experience to continue accelerating the Company’s progress on its specialty growth journey.

The anticipated retirement of Quigley, who will turn 64 in April, follows a successful career that includes 22 years with Kelly. Prior to being named president and chief executive officer in 2019, he served as an officer in key roles including general counsel and chief administrative officer, and president of global staffing. Quigley’s leadership and passion for serving customers and talent have been instrumental to Kelly’s transformation into a leading global specialty talent solutions provider.

Quarterly Cash Dividend and Share Repurchase:

Kelly also reported that on February 11, its board of directors declared a dividend of $0.075 per share. The dividend is payable on March 12, 2025, to stockholders of record as of the close of business on February 26, 2025. In addition, Kelly executed share repurchases of $10.0 million during the fourth quarter of 2024 as part of the previously announced, board approved share repurchase program.

In conjunction with its earnings release, Kelly has published a financial presentation and will host a live webcast of a conference call with financial analysts at 9 a.m. ET on February 13 to review the results from the quarter and answer questions. The presentation and a link to the live webcast will be accessible through the Company’s public website on the Investor Relations page under Events & Presentations. The webcast will be recorded, and a replay will be available within one hour of completion of the event through the same link as the live webcast.

Forward-Looking Statements

This release contains statements that are forward looking in nature and, accordingly, are subject to risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about Kelly’s financial expectations, are forward-looking statements. Factors that could cause actual results to differ materially from those contained in this release include, but are not limited to, (i) changing market and economic conditions, (ii) disruption in the labor market and weakened demand for human capital resulting from technological advances, loss of large corporate customers and government contractor requirements, (iii) the impact of laws and regulations (including federal, state and international tax laws), (iv) unexpected changes in claim trends on workers’ compensation, unemployment, disability and medical benefit plans, (v) litigation and other legal liabilities (including tax liabilities) in excess of our estimates, (vi) our ability to achieve our business’s anticipated growth strategies, (vii) our future business development, results of operations and financial condition, (viii) damage to our brands, (ix) dependency on third parties for the execution of critical functions, (x) conducting business in foreign countries, including foreign currency fluctuations, (xi) availability of temporary workers with appropriate skills required by customers, (xii) cyberattacks or other breaches of network or information technology security, and (xiii) other risks, uncertainties and factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release and we undertake no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.

About Kelly®

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 400,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2024 was $4.3 billion. Learn more at kellyservices.com.

KLYA-FIN

ANALYST & MEDIA CONTACT:
Scott Thomas
(248) 251-7264
scott.thomas@kellyservices.com

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Release – Comstock Fuels and Gresham’s Eastern Execute Definitive Agreement

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Finalizes Commercial Licensing Agreement in Pakistan for SAF and Other Renewable Fuels

OKLAHOMA CITY, OKLAHOMA – FEBRUARY 13, 2025 – Comstock Inc. (NYSE: LODE) today announced the execution of a definitive master license agreement between Comstock Fuels Corporation (“Comstock Fuels”) and Gresham’s Eastern (Pvt) Ltd (“Gresham’s”), a leading sustainable energy engineering, equipment and construction company based in Pakistan, under which Comstock Fuels granted Gresham’s a license to develop and manage facilities based on Comstock Fuels’ advanced lignocellulosic biomass refining processes in Pakistan.

Gresham’s plans to initially develop a commercial demonstration facility in Lahore, Pakistan, capable of initially processing 75,000 metric tons of biomass annually, marking Comstock Fuels’ fifth licensed refinery project under contract. The Lahore facility will be designed to generate the prerequisite operational and economic data for scaling up to a 1,000,000 metric tons per year (“MTPY”) commercial facility, aligning with the rapidly growing global market demand for increased production of sustainable aviation fuel (“SAF”). Gresham’s ultimately plans to develop several similar facilities to use abundant, locally available agricultural and forestry residuals, as well as sustainably grown energy crops with the potential to unlock billions of dollars in exports while positioning Gresham’s as a leading contributor toward Pakistan’s commitment to producing 60% renewable energy by 2030.

Mian Suhail Husain, CEO of Gresham’s, commented, “We are focused on deploying truly scalable and sustainable energy solutions in Pakistan. We are on the doorstep of a globally significant opportunity where our combined competencies can generate significant economic growth for our nation and communities alike.” 

Pakistan’s abundant biomass resources provide an ideal foundation for developing a robust renewable fuel production ecosystem that prioritizes fulfilling regional demand while targeting export markets across the Middle East and North Africa (“MENA”). Pakistan produces about 100 million metric tons of agricultural residue biomass per year, or enough to produce about 14 billion gallons of renewable fuels per year at Comstock Fuels’ proven yields of up to 140 gallons per dry metric ton on a gasoline gallon equivalent basis (“GGE”), depending on the feedstock, site conditions, and other process parameters.

“Gresham’s is well positioned to make a transformative contribution to Pakistan’s economic development and sustainable energy objectives,” stated David Winsness, President of Comstock Fuels. “This partnership showcases the quality and speed of global adoption of our industry-leading solution, and we’re excited to get started in Lahore and well beyond.”

Under the agreement, Gresham’s will lead the development, financing, construction, and management of facilities based on Comstock Fuels’ proprietary Bioleum refining technologies. Each Bioleum Refinery will operate under a site-specific license agreement to ensure compliance with Comstock Fuels’ performance and quality standards. Comstock Fuels will contribute site specific technology rights in exchange for a 20% equity stake in each Bioleum Refinery, a 6% royalty fee on each refinery’s product revenues, and a 6% engineering fee equal to total capital and construction costs. The agreement additionally granted Gresham’s the exclusive right to market projects based on Comstock Fuels’ technologies in Pakistan, subject to satisfaction of a series of commercialization milestones, including financing, construction, and commissioning of Gresham’s planned Lahore facility and multiple subsequent commercial facilities.

About Gresham’s Eastern (Pvt) Ltd.

For the better part of six decades, Gresham’s name has been synonymous with Quality and Innovation. Today, Pakistan-based Gresham’s is a premier project developer, engineering, equipment fabricator and construction company focused on deploying technology-leading, sustainable energy solutions and initiatives across Pakistan. To learn more, visit www.gel1947.com.

About Comstock Fuels Corporation

Comstock Fuels Corporation (“Comstock Fuels”) delivers advanced lignocellulosic biomass refining solutions that set industry benchmarks for production of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel (“SAF”), and other renewable Bioleum™ fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 140 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”), depending on feedstock, site conditions, and other process parameters. Comstock Fuels additionally holds the exclusive rights to intellectual properties developed by Hexas Biomass Inc. (“Hexas”) for production of purpose grown energy crops in liquid fuels applications with proven yields exceeding 25 to 30 dry metric tons per acre per year. The combination of Comstock Fuels’ high yield Bioleum refining platform and Hexas’ high yield energy crops allows for the production of enough feedstock to produce upwards of 100 barrels of fuel per acre per year, effectively transforming marginal agricultural lands with regenerative practices into perpetual “drop-in sedimentary oilfields” with the potential to dramatically boost regional energy security and rural economies.

Comstock Fuels plans to contribute to domestic energy dominance by directly building, owning, and operating a network of Bioleum Refineries in the U.S. to produce about 200 million barrels of renewable fuel per year by 2035, starting with its planned first 400,000 barrel per year commercial demonstration facility in Oklahoma. Comstock Fuels also licenses its advanced feedstock and refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.comstockfuels.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its TwitterLinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com

For media inquiries or questions:
Colby Korsun
Comstock Fuels Corporation
fuels@comstockinc.com

Forward-Looking Statements

This press release and any related calls or discussions may include 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. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Release – The ODP Corporation to Announce Fourth Quarter & Full Year 2024 Results Wednesday, February 26, 2025

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BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 12, 2025– The ODP Corporation (NASDAQ:ODP) (“ODP,” or the “Company”), a leading provider of products, services, and technology solutions to businesses and consumers, will announce fourth quarter and full year 2024 financial results before the market open on Wednesday, February 26th, 2025. The ODP Corporation will webcast a call with financial analysts and investors that day at 9:00 am Eastern Time which will be accessible to the media and the general public.

To listen to the conference call via webcast, please visit The ODP Corporation’s Investor Relations website at investor.theodpcorp.com. A replay of the webcast will be available approximately two hours following the event. A copy of the earnings press release, supplemental financial disclosures and presentation will also be available on the website.

About The ODP Corporation
The ODP Corporation (NASDAQ:ODP) is a leading provider of products and services through an integrated business-to-business (B2B) distribution platform and omnichannel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; and Veyer, LLC, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.

ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Grand&Toy is a trademark of Grand & Toy, LLC in Canada. Any other product or company names mentioned herein are the trademarks of their respective owners.

Tim Perrott
Investor Relations
561-438-4629
Tim.Perrott@theodpcorp.com

Source: The ODP Corporation

Release – Conduent Reports Fourth Quarter and Full Year 2024 Financial Results

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February 12, 2025

Earnings/Financial

Key Q4 and Full Year 2024 Highlights

  • Revenue: Q4 $800M / FY $3,356M
  • Adj. Revenue (1) : Q4 $800M / FY $3,176M
  • Pre-tax Income (Loss): Q4 $(82)M / FY $504M
  • Adj. EBITDA Margin (1) : Q4 4.0% / FY 3.9%
  • New Business Signings ACV (2) : Q4 $137M / FY $485M
  • Net ARR Activity Metric (2) (TTM): $92M

FLORHAM PARK, N.J., Feb. 12, 2025 — Conduent Incorporated (Nasdaq: CNDT), a global technology-led business process solutions and services company, today announced its fourth quarter and full year 2024 financial results.

Cliff Skelton, Conduent President and Chief Executive Officer stated, “2024 proved to be broadly in line with what we planned for. It was a year we said would be characterized by a continued shift to growth, with a focus on new leadership, a rationalized portfolio, improved industry recognition, and improved client retention. It was all of that and more, enhanced by divestitures with solid multiples and a 50% reduction in debt compared to year-end 2023.”

“From a numbers perspective, while timing drove a slightly weaker top line finish to the year, it was offset by an EBITDA margin on the high end of expectations. Quarterly Adjusted Revenue improved sequentially for the past three quarters and Adjusted EBITDA also increased over the past three quarters.”

“We remain bullish on achieving expectations in 2025. We continue to see opportunities for a further rationalized portfolio and remain focused on delivering outstanding service to our valued client base.”

Key Financial Q4 & Full Year 2024 Results

Performance Commentary
During 2024, the Company completed three divestitures as part of its portfolio rationalization strategy. The transfer of the BenefitWallet portfolio was completed during the second quarter of 2024 for a total purchase price of $425 million. During the second quarter of 2024, the company also completed the sale of the Curbside Management and Public Safety businesses with a purchase price of $230 million, $50 million of which is deferred to the first half of 2025. During the third quarter of 2024, the company completed the sale of the Casualty Claims Solutions Business and received $224 million of cash consideration.

Also, during 2024, the Company used a portion of the proceeds from the divested businesses to voluntarily prepay all of the principal of the Term Loan B and $137 million of the Term Loan A.

Conduent’s liquidity position remains strong with long-dated debt maturities and a modest net leverage ratio.

Full year 2024 pre-tax income (loss) was $504 million versus $(332) million in the prior year. This increase is primarily driven by the gain on the sale of the three divested businesses noted above, as well as a goodwill impairment in the prior year.

During 2024 the Company completed its previously approved $75 million share repurchase program and bought back a total of 52 million shares of common stock, including approximately 38 million shares purchased from Carl Icahn and affiliates.

Additional Q4 & Full Year 2024 Performance Highlights

Conduent achieved several milestones in technology-led solutions, operational excellence and culture, including:

  • Announced several implementations and advanced solutions in Transportation including expanded 3D fare gates, open payment digital wallet fare collection and all-electronic express lane tolling for clients in the US and Europe;
  • Implemented several digital payment solutions for several states that combat fraud and disburse payments to those in need;
  • Integrated AI-driven solutions by TALON and Jellyvision’s ALEX with Conduent’s Life@Work Connect Experience Platform to enhance employee benefits decisions;
  • Collaborated with Microsoft on an initiative across the Conduent portfolio to drive innovation using Microsoft Azure OpenAI Services;
  • Earned Leader Recognition from:
    • Information Services Group (ISG) as a U.S. and Europe “Leader” in its 2024 Contact Center – Customer Experience Services Provider Lens™ report; and
    • NelsonHall’s NEAT Report for Healthcare Payer Operational Transformation; CX Services Transformation – Cost Optimization Focus; and Multi-Process HR Transformation Services for Large Enterprises.
  • Earned Recognition for Industry Leadership and Culture:
    • “GovTech Top 100 Company” for the third consecutive year;
    • Newsweek Top 100 Most Loved Workplaces for third consecutive year;
    • “Best Place to Work for Disability Inclusion” (Disability Equality Index); and
    • Forbes’ list of America’s Best Employers for Diversity for the fourth consecutive year.

FY 2025 Outlook 

Conference Call
Management will present the results during a conference call and webcast on February 12, 2025 at 9:00 a.m. ET.

The call will be available by live audio webcast along with the news release and online presentation slides at https://investor.conduent.com/.

The conference call will also be available by calling 877-407-4019 toll-free. If requested, the conference ID for this call is 13750544.

The international dial-in is 1-201-689-8337. The international conference ID is also 13750544.

A recording of the conference call will be available by calling 1-877-660-6853 three hours after the conference call concludes. The replay ID is 13750544.

The telephone recording will be available until February 26, 2025.

About Conduent
Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 56,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $85 billion in government payments annually, enabling approximately 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing over 13 million tolling transactions every day. Learn more at www.conduent.com.

Non-GAAP Financial Measures
We have reported our financial results in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). In addition, we have discussed our financial results using non-GAAP measures. We believe these non-GAAP measures allow investors to better understand the trends in our business and to better understand and compare our results. Accordingly, we believe it is necessary to adjust several reported amounts, determined in accordance with U.S. GAAP, to exclude the effects of certain items as well as their related tax effects. Management believes that these non-GAAP financial measures provide an additional means of analyzing the results of the current period against the corresponding prior period. However, these non-GAAP financial measures should be viewed in addition to, and not as a substitute for, our reported results prepared in accordance with U.S. GAAP. Our non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable U.S. GAAP measures and should be read only in conjunction with our Consolidated Financial Statements prepared in accordance with U.S. GAAP. Our management regularly uses our non-GAAP financial measures internally to understand, manage and evaluate our business and make operating decisions. Providing such non-GAAP financial measures to investors allows for a further level of transparency as to how management reviews and evaluates our business results and trends. These non-GAAP measures are among the primary factors management uses in planning for and forecasting future periods. Compensation of our executives is based in part on the performance of our business based on certain of these non-GAAP measures. Refer to the “Non-GAAP Financial Measures” section attached to this release for a discussion of these non-GAAP measures and their reconciliation to the reported U.S. GAAP measures.

Forward-Looking Statements

This press release, any exhibits or attachments to this release, and other public statements we make may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “expectations,” “in front of us,” “plan,” “intend,” “will,” “aim,” “should,” “could,” “forecast,” “target,” “may,” “continue to,” “looking to continue,” “endeavor,” “if,” “growing,” “projected,” “potential,” “likely,” “see,” “ahead,” “further,” “going forward,” “on the horizon,” “as we progress,” “going to,” “path from here forward,” “think,” “path to deliver,” “from here,” and similar expressions (including the negative and plural forms of such words and phrases), as they relate to us, are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact included in this press release or any attachment to this press release are forward-looking statements, including, but not limited to, statements regarding our financial results, condition and outlook; changes in our operating results; general market and economic conditions; and our projected financial performance, including all statements made under the section captioned “FY 2025 Outlook” within this release. These statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions, many of which are outside of our control, that could cause actual results to differ materially from those expected or implied by such forward-looking statements contained in this press release, any exhibits to this press release and other public statements we make.

Important factors and uncertainties that could cause our actual results to differ materially from those in our forward-looking statements include, but are not limited to: government appropriations and termination rights contained in our government contracts, the competitiveness of the markets in which we operate and our ability to renew commercial and government contracts, including contracts awarded through competitive bidding processes; our ability to recover capital and other investments in connection with our contracts; our reliance on third-party providers; risk and impact of geopolitical events and increasing geopolitical tensions (such as the war in the Ukraine and conflict in the Middle East), macroeconomic conditions, natural disasters and other factors in a particular country or region on our workforce, customers and vendors; our ability to deliver on our contractual obligations properly and on time; changes in interest in outsourced business process services; claims of infringement of third-party intellectual property rights; our ability to estimate the scope of work or the costs of performance in our contracts; the loss of key senior management and our ability to attract and retain necessary technical personnel and qualified subcontractors; our failure to develop new service offerings and protect our intellectual property rights; our ability to modernize our information technology infrastructure and consolidate data centers; expectations relating to environmental, social and governance considerations; utilization of our stock repurchase program; risks related to our use of artificial intelligence; the failure to comply with laws relating to individually identifiable information and personal health information; the failure to comply with laws relating to processing certain financial transactions, including payment card transactions and debit or credit card transactions; breaches of our information systems or security systems or any service interruptions; our ability to comply with data security standards; developments in various contingent liabilities that are not reflected on our balance sheet, including those arising as a result of being involved in a variety of claims, lawsuits, investigations and proceedings; risks related to recently completed divestitures including the (i) transfer of the Company’s BenefitWallet’s health savings account, medical savings account and flexible spending account portfolio, (ii) the sale of the Company’s Curbside Management and Public Safety Solutions businesses and (iii) the sale of the Company’s Casualty Claims Solutions business, including but not limited to the Company’s ability to realize the benefits anticipated from such transactions, unexpected costs, liabilities or delays in connection with such transactions, and the significant transaction costs associated with such transactions; risk and impact of potential goodwill and other asset impairments; our significant indebtedness and the terms of such indebtedness; our failure to obtain or maintain a satisfactory credit rating and financial performance; our ability to obtain adequate pricing for our services and to improve our cost structure; our ability to collect our receivables, including those for unbilled services; a decline in revenues from, or a loss of, or a reduction in business from or failure of significant clients; fluctuations in our non-recurring revenue; increases in the cost of voice and data services or significant interruptions in such services; our ability to receive dividends or other payments from our subsidiaries; and other factors that are set forth in the “Risk Factors” section, the “Legal Proceedings” section, the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and other sections in our 2024 Annual Report on Form 10-K, as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with or furnished to the Securities and Exchange Commission. Any forward-looking statements made by us in this release speak only as of the date on which they are made. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether because of new information, subsequent events or otherwise, except as required by law.

###

Appendix

Definitions

Net ARR Activity Metric (TTM)

Projected Annual Recurring Revenue (ARR) for contracts signed in the prior 12 months, less the annualized impact of any client losses, contractual volume and price changes, and other known impacts for which the company was notified in that same time period, which could positively or negatively impact results. The metric annualizes the net impact to revenue. Timing of revenue impact varies and may not be realized within the forward 12-month timeframe. The metric is for indicative purposes only. This metric excludes non-recurring revenue signings. This metric is not indicative of any specific 12 month timeframe.

New Business Annual Contract Value (ACV): (New Business TCV / contract term) multiplied by 12.

New Business Total Contract Value (TCV): Estimated total future revenues from contracts signed during the period related to new logo, new service line or expansion with existing customers.

TTM: Trailing twelve months.

PBT: Profit before tax.

Non-GAAP Financial Measures

We have reported our financial results in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). In addition, we have discussed our financial results using non-GAAP measures.

We believe these non-GAAP measures allow investors to better understand the trends in our business and to better understand and compare our results. Accordingly, we believe it is necessary to adjust several reported amounts, determined in accordance with U.S. GAAP, to exclude the effects of certain items as well as their related tax effects. Management believes that these non-GAAP financial measures provide an additional means of analyzing the results of the current period against the corresponding prior period. However, these non-GAAP financial measures should be viewed in addition to, and not as a substitute for, the Company’s reported results prepared in accordance with U.S. GAAP. Our non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable U.S. GAAP measures and should be read only in conjunction with our Consolidated Financial Statements prepared in accordance with U.S. GAAP. Our management regularly uses our non-GAAP financial measures internally to understand, manage and evaluate our business and make operating decisions, and providing such non-GAAP financial measures to investors allows for a further level of transparency as to how management reviews and evaluates our business results and trends. These non-GAAP measures are among the primary factors management uses in planning for and forecasting future periods. Compensation of our executives is based in part on the performance of our business based on certain of these non-GAAP measures.

Management cautions that amounts presented in accordance with Conduent’s definition of non-GAAP financial measures may not be comparable to similar measures disclosed by other companies because not all companies calculate non-GAAP measures in the same manner.

A reconciliation of the following non-GAAP financial measures to the most directly comparable financial measures calculated and presented in accordance with U.S. GAAP are provided below.

These reconciliations also include the income tax effects for our non-GAAP performance measures in total, to the extent applicable. The income tax effects are calculated under the same accounting principles as applied to our reported pre-tax performance measures under Accounting Standards Codification 740, which employs an annual effective tax rate method. The noted income tax effect for our non-GAAP performance measures is effectively the difference in income taxes for reported and adjusted pre-tax income calculated under the annual effective tax rate method. The tax effect of the non-GAAP adjustments was calculated based upon evaluation of the statutory tax treatment and the applicable statutory tax rate in the jurisdictions in which such charges were incurred.

Adjusted Revenue, Adjusted Profit Before Tax, Adjusted Net Income (Loss), Adjusted Diluted Earnings per Share, Adjusted Weighted Average Common Shares Outstanding, and Adjusted Effective Tax Rate

We make adjustments to Revenue, Net Income (Loss) before Income Taxes for the following items, as applicable, to the particular financial measure, for the purpose of calculating Adjusted Revenue, Adjusted Profit Before Tax, Adjusted Net Income (Loss), Adjusted Diluted Earnings per Share, Adjusted Weighted Average Common Shares Outstanding, and Adjusted Effective Tax Rate:

  • Amortization of acquired intangible assets. The amortization of acquired intangible assets is driven by acquisition activity, which can vary in size, nature and timing as compared to other companies within our industry and from period to period.
  • Restructuring and related costs. Restructuring and related costs include restructuring and asset impairment charges as well as costs associated with our strategic transformation program.
  • Goodwill impairment. This represents goodwill impairment charges arising from annual or interim goodwill testing.
  • (Gain) loss on divestitures and transaction costs, net. Represents (gain) loss on divested businesses and transaction costs.
  • Litigation settlements (recoveries), net represents settlements or recoveries for various matters subject to litigation.
  • Loss on extinguishment of debt. This represents write-off related debt issuance costs related to prepayments of debt.
  • Other charges (credits). This includes Other (income) expenses, net on the Consolidated Statements of Income (loss) and other adjustments.
  • Divestitures. Revenue and Adjusted EBITDA of divested businesses are excluded.

The Company provides adjusted net income and adjusted EPS financial measures to assist our investors in evaluating our ongoing operating performance for the current reporting period and, where provided, over different reporting periods, by adjusting for certain items which may be recurring or non-recurring and which in our view do not necessarily reflect ongoing performance. We also internally use these measures to assess our operating performance, both absolutely and in comparison to other companies, and in evaluating or making selected compensation decisions.

Management believes that the adjusted effective tax rate, provided as supplemental information, facilitates a comparison by investors of our actual effective tax rate with an adjusted effective tax rate which reflects the impact of the items which are excluded in providing adjusted net income and certain other identified items, and may provide added insight into our underlying business results and how effective tax rates impact our ongoing business.

Adjusted Revenue, Adjusted Operating Income and Adjusted Operating Margin

We make adjustments to Revenue, Costs and Expenses and Operating Margin for the following items, as applicable, for the purpose of calculating Adjusted Revenue, Adjusted Operating Income and Adjusted Operating Margin:

  • Amortization of acquired intangible assets.
  • Restructuring and related costs.
  • Interest expense. Interest expense includes interest on long-term debt and amortization of debt issuance costs.
  • Goodwill impairment.
  • Loss on extinguishment of debt.
  • (Gain) loss on divestitures and transaction costs, net.
  • Litigation settlements (recoveries), net.
  • Other charges (credits).
  • Divestitures.

We provide our investors with adjusted revenue, adjusted operating income and adjusted operating margin information, as supplemental information, because we believe it offers added insight, by itself and for comparability between periods, by adjusting for certain non-cash items as well as certain other identified items which we do not believe are indicative of our ongoing business, and may also provide added insight on trends in our ongoing business.

Adjusted EBITDA and EBITDA Margin

We use Adjusted EBITDA and Adjusted EBITDA Margin as an additional way of assessing certain aspects of our operations that, when viewed with the U.S. GAAP results and the accompanying reconciliations to corresponding U.S. GAAP financial measures, provide a more complete understanding of our on-going business. Adjusted EBITDA represents income (loss) before interest, income taxes, depreciation and amortization and contract inducement amortization adjusted for the following items. Adjusted EBITDA Margin is Adjusted EBITDA divided by revenue or adjusted revenue, as applicable.

  • Restructuring and related costs.
  • Goodwill impairment.
  • Loss on extinguishment of debt.
  • (Gain) loss on divestitures and transaction costs, net.
  • Litigation settlements (recoveries), net.
  • Other charges (credits).
  • Divestitures.

Adjusted EBITDA is not intended to represent cash flows from operations, operating income (loss) or net income (loss) as defined by U.S. GAAP as indicators of operating performance.

Free Cash Flow

Free Cash Flow is defined as cash flows from operating activities as reported on the consolidated statement of cash flows, less cost of additions to land, buildings and equipment, cost of additions to internal use software, and proceeds from sales of land, buildings and equipment, as applicable. We use the non-GAAP measure of Free Cash Flow as a criterion of liquidity. We use Free Cash Flow as a measure of liquidity to determine amounts we can reinvest in our core businesses, such as amounts available to make acquisitions and invest in land, buildings and equipment and internal use software, after required payments on debt. In order to provide a meaningful basis for comparison, we are providing information with respect to our Free Cash Flow reconciled to cash flow provided by operating activities, which we believe to be the most directly comparable measure under U.S. GAAP.

Adjusted Free Cash Flow

Adjusted Free Cash Flow is defined as Free Cash Flow from above plus adjustments for litigation insurance recoveries, transaction costs, taxes paid on gains from divestitures and litigation recoveries, proceeds from failed sale-leaseback transactions and certain other identified adjustments, as applicable. We use Adjusted Free Cash Flow, in addition to Free Cash Flow, to provide supplemental information to our investors concerning our ability to generate cash from our ongoing operating activities; by excluding these items, we believe we provide useful additional information to our investors to help them further understand our ability to generate cash period-over-period as well as added information on comparability to our competitors. Such as with Free Cash Flow information, as so adjusted, it is specifically not intended to provide amounts available for discretionary spending. We have added certain adjustments to account for items which we do not believe reflect our core business or operating performance, and we computed all periods with such adjusted costs.

Revenue at Constant Currency

To better understand trends in our business, we believe that it is helpful to adjust revenue to exclude the impact of changes in the translation of foreign currencies into U.S. Dollars. We refer to this adjusted revenue as “constant currency.” Currency impact is determined as the difference between actual growth rates and constant currency growth rates. This currency impact is calculated by translating the current period activity in local currency using the comparable prior-year period’s currency translation rate.

Non-GAAP Outlook

In providing the Full Year 2025 outlook for Adjusted EBITDA and Adjusted EBITDA Margin we exclude certain items which are otherwise included in determining the comparable U.S. GAAP financial measure. A description of the adjustments which historically have been applicable in determining Adjusted EBITDA and Adjusted EBITDA Margin is reflected in the table below. We are providing such outlook only on a non-GAAP basis because the company is unable without unreasonable efforts to predict with reasonable certainty the totality or ultimate outcome or occurrence of these adjustments for the forward-looking period, which can be dependent on future events that may not be reliably predicted. Based on past reported results, where one or more of these items have been applicable, such excluded items could be material, individually or in the aggregate, to reported results. We have provided an outlook for Adjusted Revenue only on a non-GAAP basis using foreign currency translation rates as of fiscal year end due to the inability to, without unreasonable efforts, accurately predict foreign currency impact on revenues. Full Year 2025 Outlook for Adjusted Free Cash Flow is provided as a factor of expected Adjusted EBITDA, and such outlook is only available on a non-GAAP basis for the reasons described above. For the same reason, we are unable to provide a GAAP expected adjusted tax rate, which adjusts for our non-GAAP adjustments.
Non-GAAP Reconciliations: Adjusted Revenue, Revenue at Constant Currency, Adjusted Net Income (Loss), Adjusted Effective Tax, Adjusted Operating Income (Loss) and Adjusted EBITDA were as follows (see footnotes on last page of Non-GAAP reconciliations):

Media Contacts

Sean Collins

Conduent

Sean.Collins2@conduent.com

+1-310-497-9205

Giles Goodburn

Conduent

ir@conduent.com

+1-203-216-3546

Release – Ocugen, Inc. Announces Dosing Completion in the Phase 2 ArMaDa Clinical Trial for OCU410—a Multifunctional Modifier Gene Therapy for the Treatment of Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Research News and Market Data on OCGN

February 12, 2025

PDF Version

  • Completed Phase 2 enrollment with randomization of 51 subjects into treatment and control arms
  • Phase 1/2 study (N=60) demonstrated favorable safety and tolerability profile with no serious adverse events related to OCU410, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization
  • Subjects showed considerably slower lesion growth (44%) from baseline in treated eyes versus untreated fellow eyes at 9 months in follow-up data from the Phase 1 study
  • Clinically meaningful 2-line (10-letter) improvement in visual function (LLVA) in treated eyes compared to untreated eyes was noted in the Phase 1 portion of the trial
  • Preservation of retinal tissue at 9 months around GA lesions of treated eyes with a single injection of OCU410 in Phase 1 compared favorably to published data on a leading FDA-approved complement inhibitor given monthly or every other month at the same time points

MALVERN, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that dosing is complete, ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410—a novel multifunctional modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). Age-related macular degeneration (AMD) affects 1 in 8 people 60 years and older. The global prevalence of dAMD is 266 million worldwide and by 2050 more than 5 million Americans may suffer from this incurable condition. Today, GA – the later stage of dAMD – affects approximately 2-3 million people in the United States (U.S.) and Europe.

There are limited options for patients with dAMD in the U.S. and current therapies involve frequent (monthly or every other month) injections and have unwanted side effects that can affect vision. These therapies are not approved in Europe, leaving approximately 2 million patients with no therapeutic option.

“Dosing completion is a major accomplishment for our OCU410 program,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Based on the multifunctional effect of our modifier gene therapy, the profound unmet medical need, limited treatment options, and the fact that it is designed as a one and done treatment, we believe OCU410 can be a potential blockbuster therapy and the gold standard for treating GA worldwide. The data from this trial will help us design a future pivotal Phase 3 study planned for 2026 and enable our commercial strategy for Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings as soon as 2028.”

“The preliminary efficacy and safety data from the Phase 1/2 study are highly encouraging, demonstrating the potential of OCU410 to improve both structural and functional outcomes,” said Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics and Biomedical Engineering with Tenure at Duke University Eye Center. “I look forward to the Phase 2 results and believe a one-time gene therapy could reshape the treatment landscape, offering a transformative option for patients.”

GA is a multifactorial disease with a complex etiology that involves genetic and environmental factors. The current treatment options for GA in the U.S. are limited to those targeting a single mechanism—the complement pathway—requiring frequent intravitreal injections, either monthly or every other month. By contrast, OCU410 is a multifunctional modifier gene therapy, which targets multiple pathways associated with GA.

“Given the safety concerns associated with currently approved GA treatments, the encouraging safety and tolerability profile of OCU410 offers a promising treatment option,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “With Phase 2 enrollment now complete, OCU410 has the potential to be a one-time treatment, reducing the burden of frequent injections, improving patient compliance, and ultimately enhancing quality of life.”

In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD will be assessed. Fifty-one (51) patients were randomized 1:1:1 into either of two treatment groups (medium or high dose) or a control group. In the treatment groups, subjects received a single subretinal 200-µL administration of 5 x 1010 vector genomes (vg)/mL (medium dose) or 1.5 x 1011 vg/mL (high dose), while the control group remained untreated.

The ArMaDa clinical trial for OCU410 is being performed at 14 leading retinal surgery centers across the U.S.

About the Phase 1/2 ArMaDa clinical trial
The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open label, dose-escalation study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome assessor-blinded, dose-expansion study in which subjects were randomized in a 1:1:1 ratio to either the medium dose or high dose OCU410 treatment groups or to an untreated control group.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 utilizes an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

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 patients’ 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, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing 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; the ability of OCU410 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study 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 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

Release – Perfect Corp. to Announce Financial Results for the Full Year of 2024 on February 26, 2025

Research News and Market Data on PERF

February 12, 2025

NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a global leader in providing augmented reality (“AR”) and artificial intelligence (“AI”) Software-as-a-Service (“SaaS”) solutions to beauty and fashion industries, today announced that it plans to release its financial results for the full year of 2024 before U.S. markets open on Wednesday, February 26, 2025 and to hold a conference call at 7:30 p.m. Eastern Time the same day on February 26, 2025 (or 8:30 a.m. Taipei Standard Time the following day on February 27, 2025).

The Company’s management will discuss the financial results and latest developments during the conference call. For participants who wish to join the call, please complete online registration using the link provided below in advance of the conference call. Upon registration, each participant will receive a participant dial-in number and a unique access PIN, which can be used to join the conference call.

Registration Link: https://registrations.events/direct/Q4I516303

A live and archived webcast of the conference call will also be available at the Company’s investor relations website at https://ir.perfectcorp.com.

About Perfect Corp.

Perfect Corp. (NYSE: PERF) leverages ‘Beautiful AI’ innovations to make our world more beautiful. As a pioneer and leader in the space, Perfect Corp. works with over 650 partners around the globe to empower brands to embrace the digital-first world by transforming shopping journeys through digital tech innovations. Perfect Corp.’s suite of enterprise solutions delivers synergistic, technology-driven experiences that facilitate sustainable, ultra-personalized, and engaging shopping journeys through hyper-realistic virtual try-ons, AI-powered skin analyses, personalized product recommendation tools and many more Beautiful AI innovations. For more information, visit https://ir.perfectcorp.com/.

Category: Investor Relations

Investor Relations Contact
Investor Relations, Perfect Corp.
Email: Investor_Relations@PerfectCorp.com

Source: Perfect Corp.

Release – Great Lakes Dredge & Dock Corporation Schedules Announcement of 2024 Fourth Quarter Results

Research News and Market Data on GLDD

Feb 11, 2025

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HOUSTON, Feb. 11, 2025 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (NASDAQ: GLDD) today announced that it will release the financial results for its three and twelve months ended December 31, 2024 on Tuesday, February 18, 2025 at 7:00 a.m. C.S.T. A conference call with the Company will be held the same day at 9:00 a.m. C.S.T.

Investors and analysts are encouraged to pre-register for the conference call by using the link below. Participants who pre-register will be given a unique PIN to gain immediate access to the call. Pre-registration may be completed at any time up to the call start time.

To pre-register, go to https://register.vevent.com/register/BI3ee71908023c466fb83abf345f36e0ca

The live call and replay can also be heard at https://edge.media-server.com/mmc/p/oqt4ireo or on the Company’s website, www.gldd.com, under Events on the Investor Relations page. A copy of the press release will be available on the Company’s website.

The Company
Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the developing offshore energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 135-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

For further information contact:
Tina Baginskis
Director, Investor Relations
630-574-3024

Release – ISG to Announce Fourth-Quarter Financial Results

Research News and Market Data on III

2/7/2025

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III ), a leading global technology research and advisory firm, said today it will release its fourth-quarter financial results on Thursday, March 6, 2025, at approximately 4:15 p.m., U.S. Eastern Time.

The firm will host a conference call with investors and industry analysts at 9 a.m., U.S. Eastern Time, the following day, Friday, March 7. Dial-in details are as follows:

  • The dial-in number for U.S. participants is+1 (800) 715-9871.
  • International participants should call+1 (646) 307-1963.
  • The security code to access the call is4083759.

Participants are requested to dial in at least five minutes before the scheduled start time.

A recording of the conference call will be accessible on ISG’s investor relations page for approximately four weeks following the call.

About ISG

ISG (Information Services Group) (Nasdaq: III ) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including AI, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

Release – Nutriband Receives Notice Of Allowance For New U.S. Patent Covering Its Transdermal Abuse Deterrent Technology Aversa™

Research News and Market Data on NTRB

The AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents already issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia

February 07, 2025 08:45 ET 

ORLANDO, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on February 3, 2025 for patent application 18/369,241, “Abuse and Misuse Deterrent Transdermal Systems” which covers its Aversa™ abuse deterrent technology. The receipt of a Notice of Allowance means that the USPTO is expected to issue a U.S. patent for this application after administrative processes have been completed.

The expected issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first and only abuse deterrent pain patch on the market.

Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1

____________________________________________

1 Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: Support@nutriband.com

SOURCE: Nutriband Inc.

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human

Research News and Market Data on ELDN

February 7, 2025

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Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital

Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens

IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig. The procedure was performed on January 25, 2025, by surgeons at Massachusetts General Hospital (MGH) in collaboration with our partner eGenesis. In December 2024, MGH received Food and Drug Administration (FDA) approval to proceed with this transplant and plans to perform two additional xenotransplants this year, further advancing the field of xenotransplantation. Following the successful transplant, the patient was discharged from the hospital and is now off dialysis for the first time in over two years.

“This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis. We are grateful to the patient, the team at MGH, and our partner eGenesis for supporting tegoprubart’s central role in these landmark procedures,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans. Our anti-CD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”

Similar to the first-ever kidney xenotransplant, also conducted at MGH in March 2024, tegoprubart is being administered to the current patient investigationally as part of a regimen designed to prevent the body from rejecting the transplanted pig organ. Tegoprubart is designed to block CD40L and has been shown to inhibit multiple costimulatory receptors including CD40 and CD11, key components of how immune cells communicate with one another. Based on extensive prior research, tegoprubart has been observed to be generally safe and well-tolerated in multiple potential indications, including for the prevention of rejection following kidney allotransplantation.

“I would like to thank Eledon for their work supporting this historic xenotransplant. Immunosuppression presents one of the greatest challenges for transplantation in both human and non-human organs. The need for advancements in immunosuppressive medications is critical for advancing our field and improving the quality of life for transplant patients everywhere,” said Dr. Leonardo Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital.

Tegoprubart was also used as a cornerstone component of the chronic immunosuppression regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human, performed at the University of Maryland Medical Center in September 2023. Currently, tegoprubart is being evaluated in three global clinical studies for the prevention of organ rejection in patients receiving kidney transplants and in a separate investigator sponsored trial for the prevention of islet transplant rejection in patients with type 1 diabetes (T1D). Eledon recently announced initial data from this investigator-initiated islet transplant trial, conducted by the research team at the University of Chicago Medicine Transplant Institute, that demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.

The Company plans to report updated interim clinical trial from its ongoing Phase 1b and long-term safety and efficacy extension studies in kidney transplant this summer, topline results from its Phase 2 BESTOW kidney transplant trial in the fourth quarter of 2025, and longer-term follow up results from the investigator-led islet transplant clinical trial at UChicago Medicine Transplant Institute later this year.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedInTwitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com 

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com 

Source: Eledon Pharmaceuticals