SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in Defense, National Security and Global Markets announced today that its Space & Missile Defense (SMDS) business unit has ordered a combined total of nine new Zeus 1 and Zeus 2 rocket motors in preparation for upcoming initial customer funded flights. The Kratos developed Zeus family of Solid Rocket Motors (SRMs) is in direct response to the urgent need for affordable commercial launch vehicle stages for hypersonic test, ballistic missile target, sounding rocket and “other” customer missions. SMDS applied its significant experience to establish the Zeus 1 and Zeus 2 motor requirements and specifications in close coordination with respective customer and user communities. Kratos, through internal investments, funded development of the Zeus SRMs which are designed and manufactured to Kratos’ specifications by key merchant supplier and partner, Aerojet Rocketdyne.
The Kratos Zeus 1 and Zeus 2 SRMs provide substantial performance improvements over similar legacy and heritage SRMs within the same relevant form factor, allowing existing vehicle designs and launch infrastructure to remain unchanged while also promoting rapid integration of leading technology systems and payloads, including those currently under development by Kratos. These and other key attributes will provide Kratos’ customers opportunities to fly more often, faster and farther, using fewer stages, at a substantially reduced cost.
The Zeus 1 and Zeus 2 are high-performance 32.5-inch diameter SRMs, designed with versatility and affordability in mind as a complement to Kratos’ internally funded investments in the Erinyes hypersonic test “flyer” that is expected to debut later this year. Kratos Zeus SRMs will also complement Kratos’ internally funded, follow-on Dark Fury hypersonic system, which nature and performance characteristics are highly classified. These Kratos investments in the hypersonic and other relevant areas create a versatile family of test, evaluation and “other” products that offer complete systems, SRMs, and flyers. With the Zeus SRMs, and the Erinyes, Dark Fury, and other Kratos front ends, Kratos is one of the only companies boasting both launcher and “Flyer” systems within one organization, providing unmatched innovation, disruptive capabilities, mission responsiveness and affordability to the customer.
Dave Carter, President of Kratos Defense & Rocket Support Services Division, said, “The Kratos Zeus family of SRMs is representative of our strategy to internally fund, rapidly develop, be first to market and field affordable, relevant systems to the United States Department of Defense and our Allies. At Kratos, affordability is a technology, and the low cost of these incredibly effective, high-performance systems, is driving significant interest from the relevant customer and user communities, as represented by this initial order of Zeus SRMs.”
Eric DeMarco, President and CEO of Kratos, said, “Kratos Zeus family of SRMs demonstrates our internally funded investment strategy of delivering relevant products and systems, not power points or renditions, to the National Security market. Kratos Zeus family of motors, similar to other Kratos systems, including tactical drones like Valkyrie, our Oriole rocket, and our hypersonic flyers Erinyes and Dark Fury, are not only rapidly developed and demonstrated, but are also engineered up front for affordable mass production at quantity, an additional Kratos differentiator and value enhancer for our government customers and also for our traditional prime system integrator partners.”
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
Kratos Press Contact: Yolanda White 858-812-7302 Direct
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that its board of directors has declared a quarterly cash dividend of $0.075 per share. The dividend will be paid on March 27, 2024, to stockholders of record as of the close of business on March 15, 2024.
“This is the Company’s 25th quarterly cash dividend since it began paying dividends in 2018. The Company’s dividend has become an important part of our capital allocation strategy and we remain committed to supporting our quarterly dividend with our robust free cash flow. At the current stock price, on an annualized basis, our shareholders are receiving a 5% yield on their investment,” said Tom Tedford, President, and Chief Executive Officer of ACCO Brands.
About ACCO Brands Corporation
ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.
CULVER CITY, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, announces significant strides with the launch of West Hunt on Nintendo Switch and the introduction of ASA Premium Mods for ARK Survival Ascended. These initiatives underscore Snail Games’ unwavering commitment to continuously improving and enhancing its current portfolio of game titles.
West Hunt on Nintendo Switch
Snail Games’ independent game branch, Wandering Wizard, in collaboration with developing studio New Gen, recently launched West Hunt on Nintendo Switch. This highly anticipated game transports players into the heart of the Wild West, enabling them to embark on manhunts wherever they go. The launch of West Hunt on Nintendo Switch marks a significant milestone in Snail Games’ journey, as it extends the game’s reach beyond Steam into the thriving console gaming community. As players immerse themselves in the role of law-abiding Sheriffs or cunning outlaws, they are invited to experience the Wild West like never before. Snail Games’ commitment to broadening West Hunt’s success on Steam to new platforms exemplifies its dedication to continually growing its current titles.
ASA Premium Mods
Snail Games is also set to introduce ARK Survival Ascended’s Premium Mods program. This innovative initiative revolutionizes the modding landscape by providing unprecedented opportunities for monetization. With one of the most competitive revenue-sharing models in the industry, ARK Survival Ascended’s Premium Mods program ensures that modders are duly recognized and rewarded for their creativity and dedication. Moreover, ASA Premium Mods’ cross-platform compatibility across PC, Xbox, and PlayStation amplifies modders’ reach, enabling them to maximize their earnings and connect with a broader audience. ARK Survival Ascended’s mod program is committed to fostering an environment that encourages innovation, collaboration, and fair compensation for modders. The program aims to be a catalyst for positive change within the modding community, empowering creators to thrive in their craft. The premium mod program has launched on the PC platform with other platforms to follow in time.
“We remain committed to improving and elevating our current portfolio of games, ensuring that every player finds adventure and excitement in our diverse offerings. We embark on these exciting new ventures with our community and partners at the forefront of our strategy,” said Jim Tsai, Chief Executive Officer of Snail Games.
With the launch of West Hunt on Nintendo Switch and the introduction of ASA Premium Mods for ARK Survival Ascended, Snail Games believes that it will continue to lead the way in the gaming industry, driving forward its vision of innovation and growth.
Snail, Inc. is a leading global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PC’s and mobile devices.
About Wandering Wizard
Wandering Wizard is passionately committed to championing indie game developers. We provide a platform for fresh voices, revolutionary ideas, and daring experiments within the indie gaming realm. Embracing the inherent risks of indie game development, we partner with creators worldwide to enrich the global gaming community with inclusive, inspiring, and innovative gaming experiences.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful, including the launch of ARK: Survival Ascended, ARK: The Animated Series and ARK 2; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms such as Xbox Live and Game Pass, PlayStation Network, Steam, Epic Games Store, the Apple App Store, the Google Play Store, My Nintendo Store and the Amazon Appstore; expectations for future growth and performance; and assumptions underlying any of the foregoing.
Colossus SSP’s Inclusive Marketplace Approach to Further Advance SHE Media’s Work in Fueling Growth of Women-Owned & Diverse-Owned Properties
HOUSTON and NEW YORK, Feb. 15, 2024 /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”), Huddled Masses, LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), announced today that SHE Media, the top 10 lifestyle media group that includes SheKnows, Flow Space, StyleCaster, Soaps and BlogHer, has selected Colossus SSP as a new supply-side platform partner. Colossus SSP has a strong track-record in connecting advertisers with a truly inclusive audience, at scale, tapping into a range of multicultural / diverse publishers, as well as top-tier general market media.
Colossus SSP will serve as a programmatic exchange sell-side partner for SHE Media’s flagship brands and other properties, all of which are focused on providing useful and inspiring high-quality content for women, reaching a total audience of 74+ million users per month[1]. Key to the partnership, Colossus SSP will provide access to inventory across SHE Media’s Meaningful Marketplaces – a robust community of independent, premium, women-owned and diverse-owned publishers that SHE Media assists with monetization, operations and educational services.
“The tens of millions of women that visit SHE Media properties and engage with its content are a tremendous asset to advertisers across category sectors,” said Mark D. Walker, CEO and Co-Founder, Direct Digital Holdings. “Not only do women represent more than half of the U.S. population, they are responsible for 85 percent of the day-to-day spending decisions and 80 percent of all healthcare choices for the family. Partnering with SHE Media will open Colossus SSP’s pipeline of advertisers to this valuable audience. In addition, it’s an honor to work with a company that also champions inclusivity across the media and marketing ecosystem.”
“SHE Media’s strategic partnership with Direct Digital Holding’s Colossus SSP will further solidify both companies’ deep-seated commitment to the economic growth of women-owned and diverse-owned media,” said Kate Calabrese, SVP, Media Solutions, SHE Media. “This integration will deliver an additional pathway to match advertisers with both the audiences they intend to reach and with the independent publishers whose businesses they are dedicated to support.”
“We are excited to be working with SHE Media because it is such a perfect fit for Colossus SSP. Their dynamic female-focused content and coveted female audience are very much aligned with the needs of the advertisers that we serve,” added Lashawnda Goffin, CEO, Colossus SSP.
Forward-Looking Statements This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.
As used below, “we,” “us,” and “our” refer to Direct Digital Holdings. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements.
All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics, such as the ongoing global COVID-19 pandemic; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, of receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the SEC that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
About SHE Media As a top 10 lifestyle media company reaching 74+ million monthly visitors, SHE Media focuses on the power of content and community to move our culture forward. SHE Media believes that media companies can and should be a force for good in the world. The company’s rich editorial ranges from health, food, and family to career and entertainment. SHE Media’s flagship brands, SheKnows, Flow Space, StyleCaster, Soaps and BlogHer, produce award-winning lifestyle content and events that reflect the passion and purpose of the company. In addition to the flagship brands, the SHE Media Collective supports thousands of independent publishers and content creators with technology, education, and monetization opportunities to grow their businesses.
SHE Media has a longstanding commitment to the advancement of equity and inclusion through media. In 2021, SHE Media launched Meaningful Marketplaces enabling advertisers to buy media at scale from a community of women and minority-owned publishers, ensuring that independent media receives the economic support to thrive. SHE Media is also dedicated to advancing women’s health. In 2023, SHE Media launched Flow Space, an all-new digital and live media platform providing content, community, and commerce in service of women’s whole life health. Part of Penske Media Corporation (PMC), SHE Media is based in New York, with offices in Los Angeles. Follow SHE Media on LinkedIn, Instagram, Facebook and Twitter.
About Direct Digital Holdings Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
Q4 operating earnings of $7.3 million, or up 59% to $22.1 million on an adjusted basis
Q4 revenue was flat; down 1.3% in constant currency
Q4 adjusted EBITDA margin increased 60 basis points to 2.6% driven by meaningful reduction in operating expenses resulting from business transformation initiatives
Company expects Q1 2024 sale of European staffing operations, sustained structural expense reductions and near-term outcome from growth initiatives to drive further expansion of EBITDA margin
TROY, Mich., Feb. 15, 2024 (GLOBE NEWSWIRE) — Kelly (Nasdaq: KELYA, KELYB), a leading specialty talent solutions provider, today announced results for the fourth quarter of 2023.
Peter Quigley, president and chief executive officer, announced revenue for the fourth quarter of 2023 totaled $1.2 billion, a 0.1% decrease, or a 1.3% decrease in constant currency, compared to the corresponding quarter of 2022. Year-over-year revenue trends were impacted by customers’ more guarded approach to hiring and initiating new projects or capital spending partially offset by favorable foreign currency impacts.
Kelly reported operating earnings in the fourth quarter of 2023 of $7.3 million, compared to earnings of $4.6 million reported in the fourth quarter of 2022. Earnings in the fourth quarter of 2023 include $14.8 million of charges related to transformation actions and the first-quarter 2024 sale of our European staffing operations. Excluding those charges, adjusted earnings were $22.1 million in the fourth quarter of 2023. Earnings in the fourth quarter of 2022 included a $10.3 million goodwill impairment charge related to RocketPower. Excluding the impairment charge and a $0.9 million gain related to the sale of real property, adjusted earnings from operations were $14.0 million. Adjusted earnings improved primarily as a result of lower selling, general and administrative expenses, partially offset by unfavorable business mix and lower permanent placement fees which resulted in lower gross profit.
Earnings per share in the fourth quarter of 2023 were $0.31 compared to a loss per share of $0.02 in the fourth quarter of 2022. Included in earnings per share in the fourth quarter of 2023 were restructuring charges, net of tax, of $0.16. In addition, there were $0.46 per share of tax adjustments, transaction costs, and an unrealized loss on a forward contract, all net of tax, related to the first-quarter 2024 sale of our European staffing operations. Included in the loss per share in the fourth quarter of 2022 is a $0.23 per share goodwill impairment charge, net of tax, related to RocketPower, partially offset by a $0.02 per share gain on sale of real property, net of tax. On an adjusted basis, earnings per share were $0.93 in the fourth quarter of 2023, an improvement from $0.18 per share in the corresponding quarter of 2022.
“In the fourth quarter, we captured steady demand in Education and most of our outcome-based specialties in P&I, which continue to demonstrate resilience amid a challenging operating environment. We remained focused on the future as well, driving significant progress on our transformation initiatives while completing the sale of Kelly’s European staffing operations which we closed in early January, unlocking more than $100 million of capital and additional net margin expansion,” said Quigley. “Taken together, these accomplishments have propelled Kelly’s EBITDA margin to 3% entering 2024 – a step change from the company’s historical average of approximately 2%. As we continue to build a more efficient, effective, and focused enterprise, I am confident we are well positioned to capture increased customer demand when the operating environment rebounds and accelerate profitable growth.”
Kelly also reported that on February 13, its board of directors declared a dividend of $0.075 per share. The dividend is payable on March 13, 2024, to stockholders of record as of the close of business on February 27, 2024.
In conjunction with its fourth-quarter earnings release, Kelly has published a financial presentation on the Investor Relations page of its public website and will host a conference call at 9 a.m. ET on February 15 to review the results and answer questions. The call may be accessed in one of the following ways:
Via the Telephone (877) 692-8955 (toll free) or (234) 720-6979 (caller paid) Enter access code 5728672 After the prompt, please enter “#”
A recording of the conference call will be available after 1:30 p.m. ET on February 15, 2024, at (866) 207-1041 (toll-free) and (402) 970-0847 (caller-paid). The access code is 5856971#. The recording will also be available at kellyservices.com during this period.
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 500,000 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 2023 was $4.8 billion. Learn more at kellyservices.com.
BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 15, 2024– The GEO Group, Inc. (NYSE: GEO) (“GEO”), a leading provider of support services for secure facilities, processing centers, and reentry centers, as well as enhanced in-custody rehabilitation, post-release support, and electronic monitoring programs, reported today its financial results for the fourth quarter and full year 2023.
Full Year 2023 Highlights
Total revenues of $2.41 billion
Net Income of $113.8 million
Adjusted EBITDA of $507.2 million
Reduced Total Net Debt by Approximately $197.0 million in FY23 to $1.78 billion
For the full year 2023, we reported total revenues of $2.41 billion compared to $2.38 billion for the full year 2022. We reported net income for the full year 2023 of $113.8 million, compared to $171.7 million for the full year 2022. Results for the full year 2023 reflect a year-over-year increase of $61.9 million in net interest expense as a result of the transactions we completed in August 2022 to address the substantial majority of our outstanding debt and the impact of higher interest rates. For the full year 2023, we reported Adjusted EBITDA of $507.2 million, compared to $540.0 million for the full year 2022. During 2023, we reduced our total net debt by approximately $197.0 million to approximately $1.78 billion.
Fourth Quarter 2023 Highlights
Total revenues of $608.3 million
Net Income of $31.8 million
Adjusted EBITDA of $129.0 million
For the fourth quarter 2023, we reported net income of $31.8 million, compared to $41.5 million for the fourth quarter 2022. We reported total revenues for the fourth quarter 2023 of $608.3 million compared to $620.7 million for the fourth quarter 2022. We reported fourth quarter 2023 Adjusted EBITDA of $129.0 million, compared to $145.5 million for the fourth quarter 2022.
George C. Zoley, Executive Chairman of GEO, said, “Our company delivered strong operational and financial performance in 2023, resulting in the second-best year in our company’s 40-year history. We believe that the unparalleled scope of our diversified services platform, which allows us to offer a full spectrum of innovative solutions to our government agency partners, gives GEO a unique competitive advantage to capture future quality growth opportunities. We are also pleased with the substantial progress we made in 2023 towards our objective of reducing our net debt, deleveraging our balance sheet, and positioning GEO to explore options to return capital to shareholders in the future. We believe that our disciplined allocation of capital to reduce debt, along with our demonstrated track record delivering strong and predictable annual cash flows, will meaningfully enhance value for our shareholders over time.”
Financial Guidance
Today, we issued our initial financial guidance for 2024. For the full year 2024, we expect Net Income to be in a range of $110 million to $125 million on annual revenues of approximately $2.4 billion and reflecting an effective tax rate of approximately 28 percent, exclusive of any discrete items. We expect full year 2024 Adjusted EBITDA to be between $485 million and $515 million.
We believe that U.S. Immigration and Customs Enforcement (“ICE”) continues to face budgetary pressures, and the outcome and timing of ongoing federal government appropriations discussions in the United States Congress remain uncertain. As a result of these factors, our initial financial guidance for 2024 incorporates a range of assumptions.
The midpoint of our guidance range assumes stable populations across our ICE Processing Centers and stable participant counts under the federal government’s Intensive Supervision and Appearance Program (“ISAP”) contract. On the low end of our range, our guidance assumes that federal government appropriations discussions continue to be delayed throughout the year and that ongoing budgetary pressures result in some moderate decreased utilization of both ICE Processing Centers and the ISAP contract. On the high end of our range, our guidance assumes only some moderate increases in the utilization of ICE Processing Centers and the ISAP contract should additional funding be appropriated for ICE during this federal fiscal year.
Additionally, our initial 2024 guidance does not include the potential reactivation of any of our remaining idle Secure Services facilities, which total approximately 9,000 beds, or any potential new contract wins by our diversified business segments.
For the first quarter of 2024, we expect Net Income to be in a range of $22 million to $24 million and quarterly revenues in a range of $600 million to $610 million. We expect first quarter 2024 Adjusted EBITDA to be in a range of $117 million to $122 million. Compared to fourth quarter 2023, our first quarter 2024 guidance reflects the impact of having one fewer day in the quarter. Additionally, our first quarter of the year is impacted by higher costs related to payroll taxes, which are frontloaded in the beginning of each year.
Conference Call Information
We have scheduled a conference call and webcast for today at 11:00 AM (Eastern Time) to discuss our fourth quarter and full year 2023 financial results as well as our outlook. The call-in number for the U.S. is 1-877-250-1553 and the international call-in number is 1-412-542-4145. In addition, a live audio webcast of the conference call may be accessed on the Webcasts section under the News, Events and Reports tab of GEO’s investor relations webpage at investors.geogroup.com. A replay of the webcast will be available on the website for one year. A telephonic replay of the conference call will be available through February 22, 2024, at 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The participant passcode for the telephonic replay is 5397718.
About The GEO Group
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 100 facilities totaling approximately 81,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.
Reconciliation Tables and Supplemental Information
GEO has made available Supplemental Information which contains reconciliation tables of Net Income Attributable to GEO to Adjusted Net Income, and Net Income to EBITDA and Adjusted EBITDA, along with supplemental financial and operational information on GEO’s business and other important operating metrics. The reconciliation tables are also presented herein. Please see the section below titled “Note to Reconciliation Tables and Supplemental Disclosure – Important Information on GEO’s Non-GAAP Financial Measures” for information on how GEO defines these supplemental Non-GAAP financial measures and reconciles them to the most directly comparable GAAP measures. GEO’s Reconciliation Tables can be found herein and in GEO’s Supplemental Information available on GEO’s investor webpage at investors.geogroup.com.
Note to Reconciliation Tables and Supplemental Disclosure – Important Information on GEO’s Non-GAAP Financial Measures
Adjusted Net Income, EBITDA, and Adjusted EBITDA are non-GAAP financial measures that are presented as supplemental disclosures. GEO has presented herein certain forward-looking statements about GEO’s future financial performance that include non-GAAP financial measures, including Net Debt, Net Leverage, and Adjusted EBITDA. The determination of the amounts that are included or excluded from these non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts recognized in a given period.
While we have provided a high level reconciliation for the guidance ranges for full year 2024, we are unable to present a more detailed quantitative reconciliation of the forward-looking non-GAAP financial measures to their most directly comparable forward-looking GAAP financial measures because management cannot reliably predict all of the necessary components of such GAAP measures. The quantitative reconciliation of the forward-looking non-GAAP financial measures will be provided for completed annual and quarterly periods, as applicable, calculated in a consistent manner with the quantitative reconciliation of non-GAAP financial measures previously reported for completed annual and quarterly periods.
Net Debt is defined as gross principal debt less cash from restricted subsidiaries. Net Leverage is defined as Net Debt divided by Adjusted EBITDA.
EBITDA is defined as net income adjusted by adding provisions for income tax, interest expense, net of interest income, and depreciation and amortization. Adjusted EBITDA is defined as EBITDA adjusted for (gain)/loss on asset divestitures, pre-tax, net loss attributable to non-controlling interests, stock-based compensation expenses, pre-tax, transaction related expenses, pre-tax, one-time employee restructuring expenses, pre-tax, other non-cash revenue and expenses, pre-tax, and certain other adjustments as defined from time to time.
Given the nature of our business as a real estate owner and operator, we believe that EBITDA and Adjusted EBITDA are helpful to investors as measures of our operational performance because they provide an indication of our ability to incur and service debt, to satisfy general operating expenses, to make capital expenditures, and to fund other cash needs or reinvest cash into our business.
We believe that by removing the impact of our asset base (primarily depreciation and amortization) and excluding certain non-cash charges, amounts spent on interest and taxes, and certain other charges that are highly variable from year to year, EBITDA and Adjusted EBITDA provide our investors with performance measures that reflect the impact to operations from trends in occupancy rates, per diem rates and operating costs, providing a perspective not immediately apparent from net income.
The adjustments we make to derive the non-GAAP measures of EBITDA and Adjusted EBITDA exclude items which may cause short-term fluctuations in income from continuing operations and which we do not consider to be the fundamental attributes or primary drivers of our business plan and they do not affect our overall long-term operating performance.
EBITDA and Adjusted EBITDA provide disclosure on the same basis as that used by our management and provide consistency in our financial reporting, facilitate internal and external comparisons of our historical operating performance and our business units and provide continuity to investors for comparability purposes.
Adjusted Net Income is defined as net income attributable to GEO adjusted for certain items which by their nature are not comparable from period to period or that tend to obscure GEO’s actual operating performance, including for the periods presented (gain)/loss on asset divestitures, pre-tax, (gain)/loss on the extinguishment of debt, pre-tax, transaction related expenses, pre-tax, one-time employee restructuring expense, pre-tax, and tax effect of adjustments to net income attributable to GEO.
Safe-Harbor Statement
This press release contains forward-looking statements regarding future events and future performance of GEO that involve risks and uncertainties that could materially and adversely affect actual results, including statements regarding GEO’s financial guidance for the full year and first quarter of 2024, statements regarding GEO’s efforts to market its current idle facilities, GEO’s focus on reducing net debt, deleveraging its balance sheet, and positioning itself to explore options to return capital to shareholders, and GEO’s assumptions regarding the utilization of ICE Processing Centers and the ISAP contract during 2024. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” or “continue” or the negative of such words and similar expressions. Risks and uncertainties that could cause actual results to vary from current expectations and forward-looking statements contained in this press release include, but are not limited to: (1) GEO’s ability to meet its financial guidance for 2024 given the various risks to which its business is exposed; (2) GEO’s ability to deleverage and repay, refinance or otherwise address its debt maturities in an amount and on terms commercially acceptable to GEO, and on the timeline it expects or at all; (3) GEO’s ability to identify and successfully complete any potential sales of company-owned assets and businesses on commercially advantageous terms on a timely basis, or at all; (4) changes in federal and state government policy, orders, directives, legislation and regulations that affect public-private partnerships with respect to secure, correctional and detention facilities, processing centers and reentry centers, including the timing and scope of implementation of President Biden’s Executive Order directing the U.S. Attorney General not to renew the U.S. Department of Justice contracts with privately operated criminal detention facilities; (5) changes in federal immigration policy; (6) public and political opposition to the use of public-private partnerships with respect to secure correctional and detention facilities, processing centers and reentry centers; (7) any continuing impact of the COVID-19 global pandemic on GEO, GEO’s ability to mitigate the risks associated with COVID-19, and the efficacy and distribution of COVID-19 vaccines; (8) GEO’s ability to sustain or improve company-wide occupancy rates at its facilities in light of any continuing impact of the COVID-19 global pandemic and policy and contract announcements impacting GEO’s federal facilities in the United States; (9) fluctuations in GEO’s operating results, including as a result of contract terminations, contract renegotiations, changes in occupancy levels and increases in GEO’s operating costs; (10) general economic and market conditions, including changes to governmental budgets and its impact on new contract terms, contract renewals, renegotiations, per diem rates, fixed payment provisions, and occupancy levels; (11) GEO’s ability to address inflationary pressures related to labor related expenses and other operating costs; (12) GEO’s ability to timely open facilities as planned, profitably manage such facilities and successfully integrate such facilities into GEO’s operations without substantial costs; (13) GEO’s ability to win management contracts for which it has submitted proposals and to retain existing management contracts; (14) risks associated with GEO’s ability to control operating costs associated with contract start-ups; (15) GEO’s ability to successfully pursue growth and continue to create shareholder value; (16) GEO’s ability to obtain financing or access the capital markets in the future on acceptable terms or at all; and (17) other factors contained in GEO’s Securities and Exchange Commission periodic filings, including its Form 10-K, 10-Q and 8-K reports, many of which are difficult to predict and outside of GEO’s control.
MCLEAN, Va., Feb. 14, 2024 /PRNewswire/ — V2X, Inc., (NYSE: VVX), a leading provider of global mission solutions, will report fourth quarter and full year 2023 financial results on Tuesday, March 5, 2024, before market open. Senior management will conduct a conference call at 8:00 a.m. ET that same day.
U.S.-based participants may dial in to the conference call at 877-407-3982, while international participants may dial 201-493-6780. A live webcast of the conference call as well as an accompanying slide presentation will be available at https://app.webinar.net/WrwGVYwl6dA and on the Investors section of the V2X website at https://gov2x.com/.
A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through March 19, 2024, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 13743860.
ABOUT V2X V2X builds smart solutions designed to integrate physical and digital infrastructure – by aligning people, actions, and outputs. Formed by the merger of Vectrus and Vertex, we bring a combined 120 years of successful mission support. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.
The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 15,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.
Contact Information
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 Media Strategist Communications@goV2X.com 571-338-5195
BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 14, 2024– The ODP Corporation (NASDAQ:ODP) (“ODP,” or the “Company”), a leading provider of business services, products and digital workplace technology solutions to businesses and consumers, will announce fourth quarter and full year 2023 financial results before the market open on Wednesday, February 28th, 2024. 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, a B2B digital procurement solution, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; Veyer, LLC; and Varis, Inc., 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. Varis is a trademark of Varis, Inc. 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.
Madrid, Spain and Tel Aviv, Israel, February 14, 2024 (GLOBE NEWSWIRE) – Codere Online Luxembourg, S.A. (Nasdaq: CDRO / CDROW) (the “Company” or “Codere Online”) a leading online gaming operator in Spain and Latin America, today announced that it will release its fourth quarter and full year 2023 results prior to 8:30AM US Eastern Time on February 29, 2024.
At 8:30AM US Eastern Time on the same day, Codere Online’s management will host a conference call to discuss the results and provide a business update.
The Company’s earnings press release and related materials will be available on Codere Online’s website at www.codereonline.com. Dial-in details for the conference call as well as the audio webcast registration link are accessible on the Events & Presentations section of the same website. A recording of the webcast will be available following the conference call.
About Codere Online
Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.
About Codere Group Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).
Contacts:
Investors and Media Guillermo Lancha Director, Investor Relations and Communications Guillermo.Lancha@codere.com (+34)-628-928-152
Clinical results show that Tonyma™ has broad-spectrum activity, addressing the three core fibromyalgia symptoms: pain, fatigue, and sleep disturbance
Tonmya™ has a favorable tolerability profile well-suited for chronic treatment
CHATHAM, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, held a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, and the path to file for FDA approval in the second half of 2024. The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.).
The webinar featured two thought leaders in the field of fibromyalgia: Daniel Clauw, M.D., Professor of Anesthesiology, Medicine and Psychiatry, Director Chronic Pain & Fatigue Research Center, University of Michigan, and Lesley Arnold, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine.
Tonmya™ is a centrally acting, non-opioid, non-addictive, bedtime medication. As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya™ for the management of fibromyalgia.
“These data offer new hope for patients with fibromyalgia,” said Dr. Arnold. “Many of my patients have required combination treatments to combat their multiple fibromyalgia-related symptoms. We haven’t seen a medication that can treat fatigue, sleep, and pain all together. Having a compound like Tonmya™ that may address all three is very exciting.”
“The fact that cyclobenzaprine was beneficial in many other key symptom domains, including sleep quality, is important to fibromyalgia patients,” said Dr. Clauw. “We’re really beginning to understand how crucial sleep is in alleviating and potentially preventing fibromyalgia symptoms.”
Dr. Arnold stated that most patients are open to new treatment options, citing lack of efficacy in some cases, tolerability issues and unwanted side effects associated with the currently approved fibromyalgia treatments. “Since patients typically need to be treated for prolonged periods of time, it is important to develop a therapeutic which is well-tolerated.”
“We believe that these positive results show that fibromyalgia can be successfully treated by Tonmya™ and may provide the opportunity for Tonix to have the first FDA-approved drug for fibromyalgia in more than a decade,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We are now an important step closer to bringing a new, first-line treatment to fibromyalgia patients that offers broad symptom relief and favorable tolerability for chronic use and adherence.”
About the Phase 3 RESILIENT Study The RESILIENT study was a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of Tonmya™ (TNX-102 SL: cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. The two-arm trial randomized 457 participants in the U.S. across 33 sites. The first two weeks of treatment consisted of a run-in period in which participants started on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The study met the pre-specified primary endpoint of daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation (p=0.00005).
For more information, see ClinicalTrials.gov Identifier: NCT05273749.
About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About Tonmya™ (also known as TNX-102 SL) Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of CBP-HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.
Tonix Pharmaceuticals Holding Corp.* Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to reduce the severity of acute stress reaction and the frequency of acute stress disorder and posttraumatic stress disorder. This trial is being sponsored by the University of North Carolina and received funding support from the U.S. Department of Defense. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA and received funding from the National Institute on Drug Abuse (NIDA). A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
PDF Version•Up to 16 million adults in the US are living with a neurological disease, the leading cause of physical and cognitive disability, and 1.2 million new cases are diagnosed annually.•The review article summarizes data demonstrating that inflammation resulting from activation of more than one type of inflammasome contributes to development of neurological diseases and that ASC specks lead to their progression.•ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC and ASC specks from multiple types of inflammasomes to block initiation and perpetuation of damaging inflammation.•IC 100 preclinical data demonstrate that it penetrates the brain, and that it has promising therapeutic potential for neurological diseases based on preclinical studies representative of multiple sclerosis, Alzheimer’s disease, traumatic brain injury, and spinal cord injury.WESTON, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, highlights data from a review article published in Nature Reviews Neurology. This article provides increasing evidence that activation of several types of inflammasomes and extracellular ASC specks contribute to the development and progression of multiple neurological diseases including Alzheimer’s disease (AD), Parkinson’s disease (PD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), epilepsy, traumatic brain injury (TBI), and stroke.In the paper titled, “Inflammasomes in neurological disorders — mechanisms and therapeutic potential,” the authors reviewed 297 published papers that included data from cell cultures, preclinical disease models, and human tissue analysis to summarize the current evidence for and understanding of inflammasome activation in various neurological diseases. Key learnings include:•Many neurological conditions involve an underlying chronic inflammasome-mediated inflammatory process that worsens the trajectory of these conditions.•Beyond NLRP3, evidence suggests that other inflammasomes, including but not restricted to NLRP1, NLRC4, and AIM2, and their downstream effectors contribute to neuropathology in AD, PD, ALS, MS, stroke, epilepsy, and TBI.•Inflammasome-induced release of ASC specks into the extracellular space seems to be important in the speed of neurodegeneration in conditions such as AD and PD.The authors concluded, “Use of inflammasome-targeted therapeutic approaches could improve existing therapeutic strategies for multiple neurological conditions.” To review the publication, Click Here.“We are thrilled to see the large number of studies summarized in the review article published in Nature Reviews Neurology that reinforce the role of multiple types of inflammasomes and extracellular ASC specks in the development and progression of numerous neurological diseases,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. These studies, in combination with our own preclinical program, substantiate the rationale for targeting inflammasome ASC to inhibit multiple inflammasome pathways and to disrupt the function of ASC specks to control inflammation in numerous neurological diseases.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.About Inflammasome ASC Inhibitor IC 100IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.About ZyVersa Therapeutics, Inc.ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.Cautionary Statement Regarding Forward-Looking StatementsCertain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.Corporate, Media, and IR Contact:Karen CashmereChief Commercial Officerkcashmere@zyversa.com786-251-9641
GAITHERSBURG, Md., Feb. 14, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”, and together with its subsidiaries, “YS Group”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced the appointment of six new members to its Board of Directors (the “Board”), effective February 13, 2024. The six new directors are: Dr. Yuntao Cui; Dr. Jin Wang; Mr. Henry Chen; Mr. Haitao Zhao; Mr. Pierson Yue Pan; and Ms. Brenda Chunyuan Wu.
In addition to the new appointments, the Board has elected Dr. Ajit Shetty, who had served as the Company’s Interim Chairperson of the Board since December 9, 2023, as Chairperson of the Board, effective February 13, 2024.
Dr. Yuntao Cui has over 15 years of law-related work experience, and has previously worked as a Senior Lawyer at Zhong Lun Law Firm, one of the top law firms in China, and as General Manager of Legal Affairs at Wanda Group, a top conglomerate in the real estate, finance, and hospitality industries. Dr. Cui is currently a Senior Vice President and General Counsel at Juventas Cell Therapy Ltd., a leading immune cell therapy company. Dr. Cui holds a JD from Renmin University of China.
Dr. Jin Wang is Founding Partner and CEO of Manhattan Capital Investment Consulting Group (“MCG”), and has managed the venture capital investment fund Nuokang Venture Fund since 2014. Dr. Wang has more than 27 years of experience finding, building, and strategizing for biotech companies, including his co-founding and angel investment in leading medical professional networking and service firm DXY. Dr. Wang previously worked as an analyst and Asia/Greater China Regional Director for Paramount Capital Investment, LLC, and co-founded the Sino-American Pharmaceutical Professionals Association (“SAPA”) in 1993. Dr. Wang holds a PhD in Biomedical Science from Worcester Polytechnic Institute.
Mr. Henry Chen is the CEO of Monument Pacific Development Corp., a California-based company dedicated to developing, managing, and operating residential and commercial properties in Northern and Southern California. Mr. Chen received his MBA from the University of California, Berkeley’s Hass School of Business in 2012, and a Bachelor of Laws in Business Administration and Management from the Beijing University of Chemical Technology in 2005.
Mr. Haitao Zhao has served as a Partner of the Shanxi Tie Niu law firm since 2016, where he is responsible for handling corporate law related to intellectual property protection, corporate internal governance, and financing-related legal services. Previously, Mr. Zhao worked as an Attorney for the Beijing Ding En law firm from 2012-2016. He holds an MA in International Law from Shanxi University.
Mr. Pierson Yue Pan has served as a Vice President of Monument Pacific Development Corp. since 2018. Previously, Mr. Pan worked as Vice President of Project Development at real estate developer Propriis from 2012-2018, and as General Manager of the Africa Market with the China Civil Engineering Construction Company Nigeria Limited from 2004-2011. Mr. Pan holds an MBA from the University of California, Berkeley’s Hass School of Business.
Ms. Chunyuan (Brenda) Wu currently serves as the CFO of YS Group, a position she has held since December 31, 2020. Previously, Ms. Wu served as CFO of YS Group Biopharma from 2018-2020, and as Financial Controller for the same company from 2013-2018. Ms. Wu has also previously worked as a Senior Auditor at Ernst & Young. Ms. Wu holds degrees in Accounting and Finance from Washington State University.
Dr. Ajit Shetty, Chairperson of the Board of Directors of the Company, commented, “We are pleased to welcome each of our new directors to the Board. Each of these talented individuals brings valuable expertise in various aspects of corporate governance, legal affairs, business management, and strategic decision-making. We expect that their diverse experience and commitment to success will serve our company well going forward.”
About YS Biopharma
YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit investor.ysbiopharm.com.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of the Company, the development progress of all product candidates, the progress and results of all clinical trials, the Company’s ability to source and retain talent, and the cash position of the Company following the closing of the Business Combination. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from those expressed or implied by these forward-looking statements. Although YS Biopharma believes that it has a reasonable basis for each forward-looking statement contained in this press release, YS Biopharma cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. In addition, there are risks and uncertainties described in the documents filed by YS Biopharma from time to time with the U.S. Securities and Exchange Commission (“SEC”). These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, the outcome of any potential litigation, government or regulatory proceedings, the sales performance of the marketed vaccine product and the clinical trial development results of the product candidates of YS Biopharma, and other risks and uncertainties, including those included under the heading “Risk Factors” in the post-effective amendment No. 2 to Form F-1 filed with the SEC on January 23, 2024 which became effective on January 25, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.
IRVINE, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the Company’s Compensation Committee granted 42,500 restricted stock units (RSUs) and stock options to purchase an aggregate of 90,000 common shares, at a per share exercise price of $1.77, the closing price of Eledon’s common stock on the grant date, to one employee. The RSUs and stock options were granted as inducements material to the new employee entering employment with Eledon in accordance with Nasdaq Listing Rule 5635(c)(4).
The RSUs vest fully on the one-year anniversary of the grant date. The stock options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and 6.25% of the stock options vesting quarterly thereafter until fully vested on the fourth anniversary of the grant date. In each case, vesting is subject to the relevant employee’s continued service with Eledon on the applicable vesting date.
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 CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. 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.
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