MALVERN, Pa., January 13, 2026 (GLOBE NEWSWIRE) – Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast with KOLs and Ocugen executive leadership to discuss data from the first half of patients completing one year since treatment in the OCU410 Phase 2 ArMaDa clinical trial at 8:30 a.m. ET on Thursday, January 15, 2026. OCU410 is the Company’s novel modifier gene therapy candidate for geography atrophy secondary to dry age-related macular degeneration.
Study investigators leading the webcast include:
Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno School of Medicine
Jay Chhablani, MD, Vitreo-Retina Specialist at the University of Pittsburgh Eye Center
Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology, Director of CME-Ophthalmology, Duke University School of Medicine
Attendees are invited to participate on the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 7783588 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. 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, 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. 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.
Holiday Period Total Net Sales Increased 5.3% vs. Last Year Led by 9.7% Growth in Direct-to-Consumer Segment
NEW YORK–(BUSINESS WIRE)– Vince Holding Corp., (Nasdaq: VNCE) (“VNCE” or the “Company”), a global retail platform, today announced sales for the nine-week holiday period ended January 3, 2026.
Holiday Sales Highlights (Unaudited Results for Nine-Week Period Ended January 3, 2026)
Total company net sales increased 5.3% compared to the prior year period
Direct-to-Consumer segment sales increased 9.7% compared to the prior year period
Wholesale segment sales decreased 2.7% compared to the prior year period
Brendan Hoffman, Chief Executive Officer of VNCE commented, “Our direct-to-consumer segment continues to deliver exceptional results, building on the strong momentum from our strategic investments in customer experience enhancements and e-commerce capabilities. Within wholesale, we have continued to see strong performance at the register with key partners helping to offset disruption in receipt flow with Saks Global given current dynamics. This overall performance, combined with our disciplined approach to balancing strategic pricing changes, promotional activity, and cost management, demonstrates the strength of our business model. As we look ahead, we will continue to execute and deliver on our strategic priorities that we believe will position us well for long-term profitable growth.”
Based on holiday sales performance, total company net sales have trended in line with prior guidance and Adjusted EBITDA as a % of Net Sales and Adjusted Operating Income as a % of Net Sales have trended in line with the higher end of prior guidance ranges for the fourth quarter and full year fiscal 2025.
The Company continues to monitor developments with its wholesale partner, Saks Global, and guidance does not reflect any outcome of its reported status. Saks Global represented less than 7% of total company net sales as of Fiscal 2024.
The holiday sales results reported in this press release are unaudited and preliminary. These amounts are based on currently available information and are subject to change following the completion of any customary financial closing procedures for the fiscal quarter ending January 31, 2026.
ICR Conference As previously announced, the Company will be presenting at the 28th Annual ICR Conference today, Monday, January 12, 2026, at 8:30 AM Eastern Time. The audio portion of the presentation will be webcast live on the investor relations section of the Company’s website, http://investors.vince.com/.
ABOUT VINCE HOLDING CORP.
Vince Holding Corp. is a global retail platform that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 46 full-price retail stores, 14 outlet stores, and its e-commerce site, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.
Forward-Looking Statements: This document, and any statements incorporated by reference herein contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding, among other things, our current expectations about possible or assumed future results of operations of the Company and are indicated by words or phrases such as “may,” “will,” “should,” “believe,” “expect,” “seek,” “anticipate,” “intend,” “estimate,” “plan,” “target,” “project,” “forecast,” “envision” and other similar phrases. Although we believe the assumptions and expectations reflected in these forward-looking statements are reasonable, these assumptions and expectations may not prove to be correct and we may not achieve the results or benefits anticipated. These forward-looking statements are not guarantees of actual results, and our actual results may differ materially from those suggested in the forward-looking statements. These forward-looking statements involve a number of risks and uncertainties, some of which are beyond our control, including, without limitation: changes to and unpredictability in the trade policies and tariffs imposed by the U.S. and the governments of other nations; our ability to maintain our larger wholesale partners; our ability to maintain adequate cash flow from operations or availability under our revolving credit facility to meet our liquidity needs; general economic conditions; restrictions on our operations under our credit facilities; our ability to improve our profitability; our ability to accurately forecast customer demand for our products; our ability to maintain the license agreement with ABG Vince, a subsidiary of Authentic Brands Group; ABG Vince’s expansion of the Vince brand into other categories and territories; ABG Vince’s approval rights and other actions; our ability to realize the benefits of our strategic initiatives; the execution of our customer strategy; our ability to make lease payments when due; our ability to open retail stores under favorable lease terms and operate and maintain new and existing retail stores successfully; our operating experience and brand recognition in international markets; our ability to remediate the identified material weakness in our internal control over financial reporting; our ability to comply with domestic and international laws, regulations and orders; increased scrutiny regarding our approach to sustainability matters and environmental, social and governance practices; competition in the apparel and fashion industry; the transition associated with the appointment of new chief executive officer and new chief financial officer; our ability to attract and retain key personnel; seasonal and quarterly variations in our revenue and income; the protection and enforcement of intellectual property rights relating to the Vince brand; our ability to successfully conclude remaining matters following the wind down of the Rebecca Taylor business; the extent of our foreign sourcing; our reliance on independent manufacturers; our ability to ensure the proper operation of the distribution facilities by third-party logistics providers; fluctuations in the price, availability and quality of raw materials; the ethical business and compliance practices of our independent manufacturers; our ability to mitigate system or data security issues, such as cyber or malware attacks, as well as other major system failures; our ability to adopt, optimize and improve our information technology systems, processes and functions; our ability to comply with privacy-related obligations; our status as a “controlled company”; our status as a “smaller reporting company”; and other factors as set forth from time to time in our Securities and Exchange Commission filings, including those described under “Item 1A—Risk Factors” in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We intend these forward-looking statements to speak only as of the time of this release and do not undertake to update or revise them as more information becomes available, except as required by law.
The Waterfront Smart Home Community Lake Shore Reserve is Located on the Hickory Lake in Granite Falls, North Carolina Nearby Microsoft’s Upcoming 1,385 Acres Mega Park and will include 140 Luxury Smart Single-Family Homes
SKYX is Expected to Supply its All-In-One Smart Home Platform Hub Comprising its NVIDIA AI Ecosystem with over 10,000 Units Including its Advanced Smart Plug & Play Technologies, Ceiling Lighting, Ceiling Fans, Recessed Lights, Down Lights, EXIT Signs, Emergency Lights, Indoor and Outdoor Wall Lights Among Other Advanced Smart Products
SKYX’s Technologies Expansion Provides Additional Opportunities for Future Recurring Revenues Through Interchangeability, Upgrades, AI Services, Monitoring, Subscriptions, Among Others
MIAMI, Jan. 12, 2026 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart home platform technology company with over 100 pending and issued patents globally and 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today announced that it will supply and enable its advanced smart plug and play technologies to a luxury smart home residential development project Lake Shore Reserve on Hickory Lake in Granite Falls, North Carolina. The first phase of the project will include 140 luxury smart single-family homes.
The project will comprise luxury amenities including swimming pools, a state-of-the-art gym, modern meeting conference facilities, pickleball courts, nature walking trails, landscaped green spaces, and more.
SKYX is expected to provide its all-in-one smart home platform hub, integrated with the NVIDIA AI ecosystem, including over 10,000 units of its advanced and smart plug & play technologies, ceiling lighting, recessed lights, downlights, wall lights, EXIT signs, and EMERGENCY lights, plug-in LED backlight mirrors among other SKYX products.
1Majestic Development Co. luxury home founders and developers have over 20 years of experience in building luxury homes and developments in North Carolina and Florida among other locations. 1Majestic Development Co. is a partnership comprised of Robert Anderson, founder of ABH Construction, and One dwell Developers Group led by Ron Dable and Dror Tohar.
Majestic Group Project in North Carolina
1Majestic Development Co. General Partner, Ron Dable, said; “We are excited to collaborate with SKYX and bring their innovative technologies into our waterfront Lake Shore Reserve Granite Falls project. Our focus has always been on creating modern, high-quality living spaces that enhance the daily lives of our homeowners. By integrating SKYX’s advanced smart home AI-driven plug-and-play solutions, we are raising the standard of safety, convenience, and design for our communities.”
Rani Kohen, Founder and Executive Chairman, of SKYX Platforms, said; “We are happy to work with luxury home developers 1Majestic Group on this exciting and unique smart home waterfront community. We look forward to collaborating with them to enhance home values while creating smarter, safer, and advanced homes of the future.”
For information about the Lake Shore Reserve development Click Here.
To view SKYX’s Technologies demo video Click Here.
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
Deal strengthens Alliance’s leadership in premium home entertainment distribution across major franchises and catalog titles
PLANTATION, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a premier distributor and omnichannel fulfillment partner to the entertainment and pop culture collectibles industry, supplying more than 340,000 unique SKUs across music, video, video games, licensed merchandise, and exclusive collectibles to over 35,000 retail and e-commerce storefronts, today announced a new exclusive home entertainment license agreement with Amazon MGM Studios Distribution covering physical media distribution in the United States and Canada.
“Partnering with Amazon MGM Studios Distribution is a milestone for Alliance Entertainment, making us the exclusive distributor of an iconic library and highly anticipated new titles,” said Jeff Walker, CEO of Alliance Entertainment. “We’re combining our scale and tech-driven solutions to meet consumers where they are and redefining the collectibles market with physical releases that truly stand out for fans and collectors.”
With decades of operational excellence and the industry’s largest in-stock assortments, Alliance delivers rapid replenishment, broad visibility, and optimized placement – fueling category growth and ensuring seamless access for consumers. As a powerhouse partner, Alliance combines best-in-class creative and marketing, authoring and manufacturing expertise, and unmatched reach across wholesale, e-commerce, and brick-and-mortar retail.
“Alliance Entertainment brings a proven track record in physical media distribution, retail execution, and collector-focused releases,” said John Migliacci, Director, Digital/Domestic Distribution, Amazon MGM Studios Distribution. “This agreement supports our ongoing commitment to making our films and series available in premium formats across North America, while ensuring strong service levels for both customers and retail partners.”
“Amazon MGM Studios represents an extraordinary combination of iconic franchises, enduring classics, and an exciting slate of upcoming releases,” said Robert Oram, EVP of Alliance Home Entertainment. “We are excited to thoughtfully curate this library and bring it to market through premium physical formats, including collector editions and expanded 4K offerings that honor the storytelling and craftsmanship behind these titles.”
Under the agreement, Alliance will bring new releases such as Fallout Season 2 and Mercy to market, alongside revitalized catalog programs and expanded UHD and Blu-ray assortments. The agreement spans globally recognized franchises such as James Bond and Rocky, as well as acclaimed classics including The Silence of the Lambs and Legally Blonde, ensuring continued availability across major retail and direct-to-consumer channels.
This collaboration reinforces Alliance Entertainment’s leadership in physical media distribution and Amazon MGM Studios’ commitment to meeting consumer and retailer demand.
About Alliance Entertainment
Alliance Entertainment (NASDAQ: AENT) is a premier distributor and fulfillment partner for the entertainment and pop culture collectibles industry. With more than 340,000 unique in-stock SKUs – including over 57,300 exclusive titles across compact discs, vinyl LPs, DVDs, Blu-rays, and video games – Alliance offers the largest selection of physical media in the market. Our vast catalog also includes licensed merchandise, toys, retro gaming products, and collectibles, serving over 35,000 retail locations and powering e-commerce fulfillment for leading retailers. The company’s growing collectibles portfolio includes Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises. Leveraging decades of operational expertise, exclusive licensing partnerships, and a capital-light, scalable infrastructure, Alliance is a trusted partner to the world’s top entertainment brands and retailers. Our omnichannel platform connects collectors and fans to the products, franchises, and experiences they love – across formats and generations. For more information, visit www.aent.com.
About Amazon MGM Studios
Amazon MGM Studios is a leading entertainment company focused on the production and global distribution of film and television content. Original series premiere on Prime Video, which is available to watch on hundreds of compatible devices in more than 240 countries and territories worldwide. Original films are produced and acquired by the studio for theatrical release and exclusively for Prime Video. Amazon MGM Studios also produces content for MGM+, the premium pay television network.
Forward Looking Statements
Certain statements included in this Press Release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity. These statements are based on various assumptions, whether identified in this Press Release, and on the current expectations of Alliance’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Alliance. These forward-looking statements are subject to a number of risks and uncertainties, including risks relating to the anticipated growth rates and market opportunities; changes in applicable laws or regulations; the ability of Alliance to execute its business model, including market acceptance of its systems and related services; Alliance’s reliance on a concentration of suppliers for its products and services; increases in Alliance’s costs, disruption of supply, or shortage of products and materials; Alliance’s dependence on a concentration of customers, and failure to add new customers or expand sales to Alliance’s existing customers; increased Alliance inventory and risk of obsolescence; Alliance’s significant amount of indebtedness; our ability to refinance our existing indebtedness; our ability to continue as a going concern absent access to sources of liquidity; risks that a breach of the revolving credit facility could result in the lender declaring a default and that the full outstanding amount under the revolving credit facility could be immediately due in full, which would have severe adverse consequences for the Company; known or future litigation and regulatory enforcement risks, including the diversion of time and attention and the additional costs and demands on Alliance’s resources; Alliance’s business being adversely affected by increased inflation, uncertainty regarding tariffs, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; as well as our financial condition and results of operations; substantial regulations, which are evolving, and unfavorable changes or failure by Alliance to comply with these regulations; product liability claims, which could harm Alliance’s financial condition and liquidity if Alliance is not able to successfully defend or insure against such claims; availability of additional capital to support business growth; and the inability of Alliance to develop and maintain effective internal controls.
PDF VersionThe New Facility Supports Continued Growth in Kratos’ Products Sector, including HORUS, a High-Altitude Intelligence Surveillance Reconnaissance Imaging System, CRADLE, a Mobile Bistatic Radar Communications Platform, and UltraSpec, a Non-Destructive Inspection Technology for Advanced Composite Materials
SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a leader in defense, national security and global markets, today announced its continued build out to support the United States Defense Industrial Base with the expansion of operations in Birmingham, Alabama, with the addition of a new 40,000-square-foot facility, housing office and electro-mechanical systems and integration space, bringing Kratos’ total footprint at its Oxmoor Valley campus to approximately 150,000 square feet.
The Birmingham expansion reflects continued growth in demand across Kratos’ defense and national security programs and reinforces the company’s long-term commitment to Alabama’s skilled workforce, advanced manufacturing base, and role in supporting U.S. defense readiness. Kratos is the industry leader in making internally funded investments to rapidly design, develop and field relevant military grade hardware, software and systems, and in investing in new and additional infrastructure, facilities and equipment, all in support of U.S. National Security and the warfighter.
Michael Johns, Senior Vice President of Kratos SRE, said, “We are excited to continue our rapid expansion in the Birmingham area since the acquisition by Kratos three years ago. We have doubled the workforce in that time and will continue to position ourselves for additional growth by adding state-of-the-art facilities to match the top talent we are hiring.”
The new facility will support continued growth in Kratos’ products sector including HORUS, a high-altitude intelligence surveillance reconnaissance imaging system, CRADLE, a mobile bistatic radar communications platform, and UltraSpec, a non-destructive inspection technology for advanced composite materials—activities aligned with Kratos’ core mission areas.
Formerly Southern Research Engineering, Kratos acquired the business in May 2022 and now owns 52 acres in the Oxmoor Valley area where the company operates state-of-the-art laboratory facilities for the development of strategic deterrence systems, missiles, space and satellite communications, exotic material test and analysis, intelligence, surveillance and reconnaissance, hypersonic platforms, trusted and assured microelectronics, anti–tamper technology and other platforms and systems.
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, advanced 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 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
Company to also participate in Fireside Chat at Lytham Partners 2026 Investor Healthcare Summit on Thursday, January 15, 2026
SAN FRANCISCO, Jan. 12, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today highlighted the significant and persistent unmet medical need in heparin-induced thrombocytopenia (HIT) and underscored the promise of its recently acquired investigational drug candidate, VLX-1005, the first and only potent, highly selective 12-LOX inhibitor in clinical testing as a potential new treatment option.
Cadrenal Therapeutics acquired VLX-1005 in December 2025, recognizing its potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders.
Emerging data from a recent Phase 2 clinical trial evaluating VLX-1005 in individuals with suspected HIT suggest that VLX-1005 may reduce thrombotic complications, supporting its further development as a novel, mechanism-based therapy. Early trial results suggest that selective 12-LOX inhibition may offer a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation.
HIT is a serious immune-mediated reaction to heparin that paradoxically increases the risk of thrombosis despite a drop in platelet count. It occurs when antibodies activate platelets, triggering widespread clot formation in veins and arteries. Thrombotic complications affect a large proportion of patients and are the primary cause of illness and death in HIT. Recent clinical and translational research continues to reinforce the urgent need for safer, more targeted therapies that address the immune-driven platelet activation underlying this disease.
Recent findings reported in a 2025 American Society of Hematology (ASH) abstract by Shatzel et al. and in a 2025 publication by Ramadan et al. highlight the high incidence and clinical burden of thrombotic complications in HIT, even with current standard-of-care anticoagulation. These data emphasize the limitations of existing therapies, which primarily inhibit coagulation pathways but do not directly modulate the platelet immune responses central to HIT pathophysiology.
Growing scientific evidence has identified 12-lipoxygenase (12-LOX) as a key mediator of platelet activation and immune thrombotic responses. Foundational work by McKenzie et al. (2022) significantly advanced the understanding of 12-LOX signaling in platelet-driven immune thrombosis, including in HIT, supporting the enzyme as a compelling therapeutic target.
Historically, however, drug development efforts targeting 12-LOX have been hindered by a lack of selectivity, raising concerns about off-target effects and safety. This challenge has limited the clinical translation of earlier 12-LOX inhibitors.
VLX-1005 represents a breakthrough in this area. Supported by preclinical and translational studies (Tourdot et al., 2017; Renna et al., 2023), VLX-1005 is the first and only highly selective 12-LOX inhibitor in clinical development. Its selectivity profile is designed to specifically modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways.
Cadrenal is moving forward rapidly to engage with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT.
“HIT remains a life-threatening condition with a strikingly high risk of thrombosis despite available therapies,” said Quang X. Pham, CEO of Cadrenal Therapeutics. “By selectively targeting 12-LOX, VLX-1005 has the potential to address a core disease mechanism in HIT. We believe this program represents a meaningful opportunity to improve outcomes for patients who currently have limited options.”
VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation oral therapeutics targeting 12-LOX are also under development for type 1 diabetes and other chronic immune-mediated and inflammatory diseases.
Lytham Partners 2026 Investor Healthcare Summit
Cadrenal will participate in a webcast fireside chat at the Lytham Partners 2026 Investor Healthcare Summit, which will be held virtually at 4:30 p.m. ET on Thursday, January 15, 2026.
About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is developing differentiated products designed to bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding VLX-1005 as a potential therapeutic solution, the promise of VLX-1005 as a potential new treatment option for HIT, VLX-1005’s potential to transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, VLX-1005 reducing thrombotic complications in patients with HIT, selective 12-LOX inhibition offering a differentiated approach by addressing the immune thrombotic drivers of disease rather than solely suppressing coagulation, 12-LOX inhibitor in clinical development advancing into human clinical development, 12-LOX being able to modulate immune-mediated platelet activation while minimizing off-target inhibition of related lipid signaling pathways, Cadrenal moving forward to engage with the FDA to discuss the design of a potential pivotal Phase 3 registration study for VLX-1005 in HIT, the program representing a meaningful opportunity to improve outcomes for patients who currently have limited options. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT, including designing a pivotal Phase 3 registration study acceptable to the FDA; Cadrenal’s ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected including support for VLX-1005’s potential to be a treatment option for HIT and transform the treatment landscape for HIT and other immune-mediated thrombotic disorders, Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
CERRITOS, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based oncology groups in the United States, today reaffirmed 2025 guidance and provided its preliminary 2026 outlook.
2026 Outlook
For 2026, TOI anticipates that total revenue will be in the range of $630 million to $650 million, reflecting 28% growth from the midpoint of 2025 and 2026 guidance ranges, and including approximately $150 million of Capitation revenue in 2026. This expected top-line increase reflects continued expansion of delegated contracts in Florida, the annualized impact of strong volumes in the Dispensary segment during the second half of 2025, and broader organic growth and new contract wins across the platform. While these drivers are expected to contribute meaningfully to revenue in 2026, the Company anticipates profitability from newly onboarded delegated contracts to build progressively over the course of the year, with more fully realized economics in 2027.
Based on these factors, and inclusive of targeted investments to support TOI’s ongoing growth, we expect Adjusted EBITDA for 2026 to be in the range of $0 million to $9 million. At the midpoint of this range, 2026 would represent TOI’s first full year of Adjusted EBITDA profitability as a public company.
TOI uses Adjusted EBITDA, a non-GAAP metric, as an additional tool to assess its operational and financial performance. See “Financial Information: Non-GAAP Financial Measures” below. In reliance on the unreasonable efforts exception provided under Regulation S-K, TOI is not reasonably able to provide a quantitative reconciliation for forward-looking information of Adjusted EBITDA to net (loss) income, the most directly comparable GAAP financial measure, without unreasonable efforts due to uncertainties regarding taxes, capital expenditures, operating activities, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized (gains) losses on investments, practice acquisition-related costs, consulting and legal fees, transaction costs and other non-cash items. The variability of these items could have an unpredictable, and potentially significant, impact on TOI’s future GAAP financial results.
Longer-Term Outlook
Looking beyond 2026, we believe the Company is well positioned for continued expansion.
We seek to grow total revenue at an annual rate of approximately 20% through 2028 and believe Capitation and Dispensary revenue could increase to approximately 30% and 50% of total revenue, respectively. This projection reflects the ongoing migration of the business model towards comprehensive oncology care in an increasingly value-based landscape.
As TOI continues to scale, we believe margins have the potential to expand through 2028 to the mid-single-digit range as a percentage of revenue, driven by the expansion of the asset-light delegated capitated model, and continued SG&A leverage.
About The Oncology Institute
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
Forward-Looking Statements
This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “preliminary,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “predict,” “potential,” “guidance,” “approximately,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding outlook, projections, anticipated financial results, estimates and forecasts of revenue and other financial and performance metrics and projections of market opportunity and expectations. These statements are based on various assumptions and on the current expectations of TOI and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by anyone as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of TOI. These forward-looking statements are subject to a number of risks and uncertainties, with such risks and uncertainties increasing with the passage of time for longer-term outlook, including the accuracy of the assumptions underlying the 2026 full fiscal year outlook and the longer-term outlook with respect to Adjusted EBITDA and margins discussed herein, the outcome of judicial and administrative proceedings to which TOI may become a party or investigations to which TOI may become or is subject that could interrupt or limit TOI’s operations, result in adverse judgments, settlements or fines and create negative publicity; changes in TOI’s patient or payors’ preferences, prospects and the competitive conditions prevailing in the healthcare sector; failure to continue to meet stock exchange listing standards; the impact of a cybersecurity incident affecting a software provider on TOI’s business; those factors discussed in the documents of TOI filed, or to be filed, with the SEC, including the Item 1A. “Risk Factors” section of TOI’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 26, 2025 and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that TOI currently is evaluating or does not presently know or that TOI currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect TOI’s plans or forecasts of future events and views as of the date of this press release. TOI anticipates that subsequent events and developments will cause TOI’s assessments to change. TOI does not undertake any obligation to update any of these forward-looking statements. These forward-looking statements should not be relied upon as representing TOI’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Some of the financial information and data contained in this press release, such as Adjusted EBITDA, have not been prepared in accordance with United States generally accepted accounting principles (“GAAP”). TOI’s non-GAAP financial measures may be different from non-GAAP financial measures used by other companies. The presentation of non-GAAP financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial measures determined in accordance with GAAP. Because of the limitations of non-GAAP financial measures, you should consider the non-GAAP financial measures presented in this press release in conjunction with TOI’s financial statements and the related notes thereto.
TOI believes that the use of Adjusted EBITDA provides an additional tool to assess our operations and results of our performance, to plan and forecast future periods, and factors and trends in, and in comparing our financial measures with, other similar companies, many of which present similar non-GAAP financial measures to investors. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recorded in TOI’s financial statements.
TOI defines Adjusted EBITDA as net (loss) income plus depreciation, amortization, interest, taxes, non-cash items, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized gains or losses on investments and other adjustments to add-back the following: consulting and legal fees related to acquisitions, one-time consulting and legal fees related to certain advisory projects, software implementations and debt or equity financings, severance expense and temporary labor and recruiting charges to build out our corporate infrastructure.
Participating in the 28th Annual ICR Conference and Hosting a Fireside Chat at 10:30 AM ET Tomorrow
DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today reported preliminary sales results for the fourth quarter and full year ended December 28, 2025, and announced its participation at the 28th Annual ICR Conference.
Preliminary Sales Results for the Fourth Quarter and Full Year 2025
Our expectations with respect to our sales results for the fourth quarter and full year 2025 discussed below are based upon management estimates for the respective periods. Our expectations are subject to the completion of our financial closing procedures and any adjustments that may result from the completion of the review of our consolidated financial statements for the fourth quarter and full year 2025. Following the completion of our financial closing process and the review of our consolidated financial statements, we may report sales results for the fourth quarter and full year 2025 that could differ from our expectations, and the differences could be material.
The expectations set forth below have been prepared by, and are the responsibility of, our management. Deloitte & Touche, LLP, our independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to the preliminary estimates. Accordingly, Deloitte & Touche, LLP, does not express an opinion or any other form of assurance with respect thereto.
Preliminary total GAAP revenues for the full year 2025 are expected to be approximately $805 million, a 20% increase from the prior year’s $673 million. This growth was primarily driven by the acquisition of Benihana in May 2024. Comparable sales* are expected to decrease by approximately 3.7%.
Preliminary total GAAP revenues for the fourth quarter of 2025 are expected to be approximately $207 million, a 6.8% decrease from $222 million in the same quarter of 2024. This decline was primarily driven by RA Sushi and Kona Grill closures as part of the portfolio optimization and the change in the Company’s fiscal year. The Grill closures are expected to reduce total GAAP revenues by approximately 2.4%, representing 35% of the expected total GAAP revenue decline.
Effective January 1, 2025, the Company adopted a new fiscal calendar structure using four 13-week quarters, with a 53rd week added when necessary. The 2025 fiscal year ran from January 1, 2025, to December 28, 2025.
This fiscal calendar change created timing differences that impacted quarterly comparisons: the fourth quarter of 2025 had 91 days versus 92 days in the fourth quarter of 2024. Additionally, the New Year’s Eve holiday shifted from fiscal 2025 to fiscal 2026. The exclusion of New Year’s Eve in the current year impacted total GAAP revenues by approximately 2.5%, representing 37% of the expected total GAAP revenue decline. Fourth quarter comparable sales are expected to decrease by approximately 1.8%.
Preliminary sales highlights for the fourth quarter of 2025 compared to the same quarter in 2024 are as follows:
STK is expected to report positive comparable sales for the quarter of approximately 0.3%, representing the first quarter of positive comparable sales for the brand since 2023;
Benihana is expected to report flat comparable sales for the quarter;
Sequential improvement in consolidated comparable sales* of approximately 4 points from the third quarter driven by all brands during the quarter; and
First conversion of a RA Sushi to an STK in Scottsdale, Arizona is off to a strong start. In addition, in January 2026, the Company temporarily closed five Grills as part of the process to convert to future Benihana and STK restaurants.
“We were pleased to see sequential improvement in our comparable sales at all brands, with STK expected to end the quarter positive and Benihana essentially flat. We are seeing this momentum continue into the new year. We attribute this success to a robust holiday season and the strength of our operations initiatives. Headwinds continue to be strong, which we expect to result in lower-than-anticipated sales during the fourth quarter,” said Emanuel “Manny” Hilario, President and Chief Executive Officer of The ONE Group. “With challenges still impacting the industry, we attribute our traction to execution-driven initiatives within our direct control, including our targeted investments in reservation technology, streamlined operational flow, and comprehensive training initiatives. These efforts enabled us to capture even greater demand during our busiest periods by optimizing Benihana table efficiency while delivering exceptional and unforgettable experiences to our guests.”
“Looking to the new year, our number one priority is to conserve cash with the intent of optimizing our balance sheet. From a development perspective, we are focused on the RA Sushi and Kona Grill conversions to STK and Benihana restaurants and pursuing other asset-light opportunities to drive shareholder value. The recent signing of our Benihana development agreement is a game-changer, demonstrating the strong demand for our iconic brand. Additionally, our successful STK and Benihana openings and conversions, renewal of existing franchise agreements, and expanding presence in professional sports and entertainment stadiums further validate our disciplined approach to capital-efficient growth. We believe our future is bright, and we are well-equipped to capture the significant opportunities ahead of us.”
*Comparable sales, a non-GAAP financial measure, represent total U.S. food and beverage sales at owned and managed units opened for at least a full 24-months. This measure includes total revenue from our owned and managed locations. The Company monitors sales growth at its established restaurant base in addition to growth that results from restaurant acquisitions and new restaurant openings.
2025 Restaurant Development
The following restaurants were opened in 2025:
Franchised Benihana Express restaurant in Miami, Florida (June)
Licensed Benihana concession at UBS Arena in Elmont, New York (December)
Owned Benihana restaurant in San Mateo, California (March)
Owned STK restaurant in Topanga, California (April)
Owned STK restaurant in Los Angeles, California (May – relocation of our existing STK Westwood restaurant)
Owned STK restaurant in Scottsdale, Arizona (October – conversion of a former RA Sushi restaurant)
Owned STK restaurant in Oak Brook, Illinois (December)
Significant Asset-Light Expansion Planned for the Greater San Francisco Bay Area and Professional Sports and Entertainment Stadiums
In December 2025, The ONE Group announced that it entered into its largest asset-light development agreement in the Company’s history, securing development rights for a total of ten restaurants, either Benihana or Benihana Express locations, throughout the Greater San Francisco Bay Area with an experienced operator. This significantly accelerates its West Coast expansion while maintaining the Company’s focus on capital-efficient growth.
The ONE Group also strengthened its presence in high-traffic, professional sports and entertainment stadiums, demonstrating its ability to adapt its premium dining concepts to diverse formats. These partnerships are expected to generate high-margin royalty streams and create millions of fan impressions annually.
The Company renewed a three-year concession agreement at the Mortgage Matchup Center in Phoenix, Arizona, home of the Phoenix Suns (NBA) and Phoenix Mercury (WNBA). The venue currently has a Benihana concession, and the new agreement also provides for STK-branded products to be offered.
The Company also secured a new three-year Benihana concession at UBS Arena in Elmont, New York, home of the New York Islanders (NHL), expanding its reach in the New York metropolitan area. The UBS Arena concession complements the existing Benihana concession at Yankee Stadium.
Capital-Efficient Growth Strategy Planned for 2026
The ONE Group will prioritize capital-efficient growth in 2026, with a goal to significantly reduce discretionary capital expenditures.
New restaurant Company-owned development will be focused on locations requiring $1.5 million or less to open. The Company will also work through its existing pipeline of approximately twelve leases rather than sign new lease agreements, which we believe will strengthen its balance sheet while enhancing financial flexibility.
The ONE Group has identified up to nine additional Kona Grill and RA Sushi locations for conversion to either Benihana or STK formats through the end of 2026. These conversions are expected to require approximately $1 million in capital investment per restaurant and are anticipated to be accretive to EBITDA.
Conference Participation
Emanuel “Manny” Hilario, President and Chief Executive Officer, and Nicole Thaung, Chief Financial Officer, will host a fireside chat at the 28th Annual ICR Conference at 10:30 am Eastern Time on January 13, 2026, and meet with institutional investors in-person on January 12-13, 2026.
The webcast of the fireside chat can be accessed from the Investor Relations tab of the Company’s website at www.togrp.com under “News / Events.”
About The ONE Group
The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:
STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe, and the Middle East, featuring premium steaks, seafood, and specialty cocktails in an energetic upscale atmosphere.
Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
Benihana Express, a small footprint casual concept showcasing the best of Benihana but without teppanyaki tables or bar.
Kona Grill, a polished casual, bar-centric grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
Samurai, an interactive dining experience located in sunny Miami, FL, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki right before your eyes.
ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages, and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.
Additional information about The ONE Group can be found at www.togrp.com.
Cautionary Statement on Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including with respect to 2025 results, restaurant openings, and performance trends. Forward-looking statements may be identified by the use of words such as “target,” “intend,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements, including but not limited to: (1) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and/or licensing authorities; (2) changes in applicable laws or regulations; (3) the possibility that The ONE Group may be adversely affected by other economic, business, and/or competitive factors, including economic downturns; (4) the impact of actual and potential changes in immigration policies, including potential labor shortages; (5) the potential impact of the imposition of tariffs, including increases in food prices and inflation and any resulting negative impacts on the macro-economic environment; and (6) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q.
Investors are referred to the most recent reports filed with the Securities and Exchange Commission by The ONE Group. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
Non-GAAP Measures
The following table presents the elements of the quarterly and annual Comparable Sales measure for 2025:
2025 vs. 2024
Q1Actual
Q2Actual
Q3Actual
Q4Preliminary
Full YearPreliminary
US STK Total Restaurants
(3.6)%
(6.0)%
(5.8)%
0.3%
(3.7)%
Benihana Owned Restaurants
0.7%
0.4%
(4.0)%
(0.4)%
(0.8)%
Grill Concepts Owned Restaurants
(13.7)%
(14.6)%
(11.8)%
(9.4)%
(12.5)%
Combined Comparable Sales
(3.2)%
(4.1)%
(5.9)%
(1.8)%
(3.7)%
Benihana comprises approximately 58% of revenue, STK comprises 25% of revenue and Grill Concepts comprise approximately 17% of revenue.
TROY, MI, Jan. 12, 2026 (GLOBE NEWSWIRE) — Kelly Services, Inc. (Nasdaq: KELYA, KELYB) (the “Company”), a leading specialty talent solutions provider, announced today that its Board of Directors (the “Board”) has unanimously adopted a stockholder rights plan (the “Rights Plan”).
On Friday, January 9, 2026, the Terence E. Adderley Revocable Trust K (the “Trust”) notified the Board that it has entered into a definitive agreement to sell its entire holding, which constitutes 92.2%, of the voting Class B common stock to a private party. The Board and its advisors met several times over the course of the following days, and at a meeting held on January 11, 2026, the Board unanimously approved the adoption of the Rights Plan, which is intended to afford the Board sufficient time to become informed about and evaluate the terms of the transaction and any plans or proposals of the purchaser, and to consider the best interests of all stockholders of the Company.
After the Board meeting held on January 11, 2026, the Board notified a representative of the Trust that the Board had approved the Rights Plan. Throughout the evening of January 11, 2026, representatives of the Board, the Trust and the purchaser engaged in additional discussions about the Rights Plan and expect the dialogue to continue.
Pursuant to the Rights Plan, the Company will issue, by means of a dividend, to each outstanding share of Class A common stock and Class B common stock (collectively, the “Company common stock”) a right to purchase (a) 0.9833 shares of Class A common stock, subject to adjustment (a “Class A Common Stock Fraction”) and (b) 0.0167 shares of Class B common stock, subject to adjustment (a “Class B Common Stock Fraction”) to stockholders of record as of 5:15 p.m., Eastern Time, on January 11, 2026. Initially, these rights will not be exercisable and will trade with, and be represented by, the shares of the Company common stock.
The rights will expire on the earliest of (i) the close of business on January 10, 2027, (ii) the time at which the rights are redeemed, (iii) the time at which the rights are exchanged and (iv) the closing of a merger or acquisition transaction involving the Company pursuant to a merger or other acquisition agreement approved by the Board, in each case, pursuant to the Rights Plan.
Under the Rights Plan, the rights generally become exercisable if a person or a group of persons (each, an “acquiring person”) acquires beneficial ownership of 75% or more of the outstanding shares of the Class B common stock. In that situation, each holder of a right (other than the acquiring person, whose rights will become void and will not be exercisable) will be entitled to receive, upon exercise, shares (or fractions of shares) of Class A common stock and/or Class B common stock having a value equal to two times the exercise price of the right. In addition, if the Company is acquired in a merger or other business combination after an unapproved party acquires 75% or more of the outstanding shares of the Class B common stock, each holder of a right would then be entitled to receive, upon exercise, common stock of the acquiring company having a value equal to two times the exercise price of the right. The Board, at its option, may exchange each right (other than rights owned by the acquiring person that have become void) in whole or in part, at an exchange ratio of one Class A Common Stock Fraction and one Class B Common Stock Fraction (or, in some instances, as provided in the Rights Plan, for cash, additional shares or Class A common stock, other securities, or other assets) per right, subject to adjustment. Except as provided in the Rights Plan, the Board is entitled to redeem the rights at $0.001 per right.
If a person or group beneficially owns 75% or more of the outstanding shares of Class B common stock prior to the adoption of the Rights Plan, then that person’s or group’s, together with such person’s or group’s affiliates’ and associates’, existing ownership percentage will be grandfathered (except that, with certain exceptions, (i) if such person or group, along with such person’s or group’s affiliates and associates, increases its ownership of Class B common stock, or (ii) in the case of a person or group, together with such person’s or group’s affiliates and associates, who by reason of a right to acquire shares pursuant to an agreement, arrangement or understanding beneficially owns 75% or more of the outstanding shares of Class B common stock, if such person or group or one or more of such person’s or group’s affiliates or associates exercises such right to acquire or otherwise acquires some or all of such shares, pursuant to the terms and conditions of such agreement, arrangement or understanding and upon such exercise, acquisition or consummation, such person or group, together with all such person’s or group’s affiliates and associates, beneficially owns 75% or more of the outstanding shares of Class B Common Stock, in each such case, such person’s or group’s ownership percentage will no longer be considered grandfathered).
Additional information regarding the Rights Plan will be contained in a current report on Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.
Potter Anderson & Corroon LLP and Nelson Mullins Riley & Scarborough LLP are acting as legal advisors to the Company.
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 and solutions 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.
Analyst & Media Contact
Scott Thomas (248) 251-7264 scott.thomas@kellyservices.com
RESTON, Va., Jan. 12, 2026 /PRNewswire/ — V2X, Inc. (NYSE: VVX) is pleased to announce it has been awarded a contract under the Missile Defense Agency’s (MDA) Scalable Homeland Innovative Enterprise Layered Defense (SHIELD) indefinite-delivery/indefinite-quantity (IDIQ) contract vehicle.
Under this contract, valued with a ceiling of $151 billion, V2X will partner with the MDA and industry to accelerate the delivery of innovative defense capabilities across a range of mission areas. The SHIELD IDIQ is designed to support rapid innovative, scalable solutions, and advance technologies that strengthen national security and enhance defense readiness.
“The SHIELD IDIQ aligns directly with the work V2X is already performing to protect the nation. From supporting cornerstone sensor and missile defense programs like COBRA DANE and COBRA KING to enabling integrated defense operations worldwide, our teams deliver proven results every day,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “This award allows us to scale that impact in support of the Golden Dome initiative, strengthening national defense through our solutions.”
Over decades of service, V2X has advanced critical capabilities through programs that ensure readiness and defense modernization. Initiatives such as COBRA DANE and COBRA KING highlight the company’s expertise in early warning radar systems, sustainment, scalable integrations, and systems engineering, all of which directly support the goals of SHIELD and the Golden Dome American program.
The SHIELD award reinforces V2X’s alignment with the Golden Dome American program, a key priority of the current Presidential Administration focused on modernizing U.S. defense posture, enabling layered deterrence, and addressing emerging threats. Offering technical expertise in areas like advanced analytics, rapid prototyping, and cybersecurity, V2X will contribute meaningful innovations to strengthen the nation’s strategic defense.
For more information about how V2X supports the Golden Dome initiative and advances layered defense operations, visit gov2x.com/capabilities/golden-dome.
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.
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
New Agreement Significantly Extends Debt Maturity and Enhances Operational Flexibility
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) (the “Company”), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, today announced the successful completion of a new $415 million credit facility comprised of a $325 million term loan facility with Pathlight Capital LP (“Pathlight”) and an enhanced $90 million revolving credit facility with UMB Bank (“UMB”).
The new credit facility immediately strengthens the company’s financial position by extending its term debt maturity to 2031 and providing greater access to liquidity for future operations. This successful transaction is a testament to the confidence placed by Pathlight and UMB Bank in the stability and long-term cash flow potential of the SelectQuote business model, including the Company’s approximately $1 billion in commissions receivable and increasingly cash generative SelectRx pharmacy and healthcare services division.
The new agreement benefits the Company in several ways, including:
Extended Maturity: The proceeds from the new term loan facility were used to fully repay all existing term debt, including the outstanding balances previously due in June 2026 and September 2027. The transaction significantly extends the debt maturity by providing a new five-year maturity period to January 2031.
Enhanced Liquidity and Flexibility: The UMB revolving credit facility increases the Company’s access to liquidity with up to $90 million available during the peak season compared to the prior facility limit of $72 million. The new term loan provided by Pathlight offers a lower principal amortization and greater investment flexibility compared to the prior facility.
Improved Cost of Capital: The new credit facility provides a slightly improved cost of capital, provides for future interest rate step downs totaling up to 100 basis points, and significantly improves the Company’s operating flexibility.
“We are extremely pleased to announce this new financing agreement, which marks a significant milestone in the continued optimization of our capital structure,” said Tim Danker, SelectQuote’s Chief Executive Officer. “As we emerge from another successful Medicare Annual Enrollment Period, this new financing agreement positions us well to continue to invest and grow our industry-leading senior health insurance and healthcare services businesses.”
Tyler Harrington, Managing Director at Pathlight Capital said, “What gave us conviction was the strength and candor of the management team. They’ve built a diversified business and successfully navigated through periods of rapid growth and industry change. Our financing provides flexible capital to support the next phase of the Company’s growth.”
SelectQuote’s Chief Financial Officer, Ryan Clement added, “The Pathlight term loan provides a substantial extension of our debt maturity and a strong foundation for future growth. This successful financing is a clear validation of our business model and the confidence our lending partners have in SelectQuote’s cash flow generation capabilities. Coupled with the enhanced UMB revolver, we have significantly strengthened our liquidity position and overall financial flexibility to execute on our strategic priorities. We are excited to partner with Pathlight and to build upon our long-standing relationship with UMB Bank on this transaction.”
Jefferies served as Exclusive Financial Advisor to SelectQuote in the transaction. Wachtell, Lipton, Rosen & Katz served as legal advisor to SelectQuote.
Forward Looking Statements
This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, changes in reimbursement rates under our contracts with pharmacy benefit managers, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.
With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
About Pathlight Capital:
Pathlight Capital is a private credit investment manager dedicated to meeting the needs of companies that operate across a broad range of industries by providing asset-based loans secured on a first or second lien basis against tangible and intangible assets. Pathlight aims to provide creative financing solutions to allow management teams to access incremental liquidity for the purposes of funding working capital, debt refinancings, growth, acquisitions, dividends and turnaround strategies. For more information, please visit www.pathlightcapital.com.
About UMB:
UMB Financial Corporation (Nasdaq: UMBF) is a financial services company headquartered in Kansas City, Mo. UMB offers commercial banking, which includes comprehensive deposit, lending, investment and retirement plan services; personal banking, which includes comprehensive deposit, lending, wealth management and financial planning services; and institutional banking, which includes asset servicing, corporate trust solutions, investment banking and healthcare services. UMB operates branches throughout Missouri, Arizona, California, Colorado, Iowa, Kansas, Illinois, Minnesota, Nebraska, New Mexico, Oklahoma, Texas, Utah, and Wisconsin. As the company’s reach continues to grow, it also serves business clients nationwide and institutional clients in several countries. For more information, visit UMB.com, UMB Blog, UMB Facebook and UMB LinkedIn.
VIRGINIA CITY, NEVADA, January 12, 2026 — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) and Comstock Metals LLC (“Comstock Metals”), a leader in the responsible recycling of end-of-life solar panels with the only certified, North American, zero-landfill solution, announced today that it has secured its California-based facility dedicated to serving its California customer base, the largest single U.S. market. This first satellite storage and prepping facility is strategically located in the heart of the Central Valley of California. The facility represents a critical hub for the responsible collection, preparation and aggregation of decommissioned photovoltaic (PV) panels for ultimate closed-loop recycling in its fully permitted recycling facility in Nevada.
As solar energy adoption continues to grow across the western United States, the need for compliant and environmentally responsible end-of-life solutions is critical. Comstock Metals’ California facility is designed to directly support solar developers, utilities, installers, and asset owners by providing a centralized location for the safe handling, consolidation, and logistics coordination of retired solar panels.
Comstock Metals’ California facility can now optimize network logistics and costs for the western U.S. and:
Enable direct support for solar asset owners, developers, EPCs, and installers;
Enhance our ability to rapidly and fully respond to customer needs;
Facilitate decommissioning efforts by providing a “local” base from which to operate;
Centralize collection points for end-of-life solar panels in California; and
Coordinate all handling, storage, and logistics coordination compliantly.
By enabling reliable, efficient, and compliant interstate transport and recycling, Comstock Metals helps reduce landfill disposal, conserve natural resources, and support the long-term sustainability of the solar industry.
“Our goal is to help close the loop on solar energy by ensuring that panels at the end of their useful life are managed responsibly and the critical minerals and materials are repurposed for productive use,” said Dr. Fortunato Villamagna, President of Comstock Metals. “This facility allows us to directly support California’s clean energy leadership while ensuring materials are transported efficiently to our specialized recycling operations in Nevada.”
The new facility in California accepts end-of-life and decommissioned solar panels from commercial, utility-scale, and other approved sources. Panels received at the site are prepared and optimized for transportation and shipped in accordance with all applicable state and federal regulations to Comstock Metals’ certified recycling facilities in Nevada, where critical materials such as aluminum, silver, copper, gallium, and other metals can be repurposed.
“Comstock Metals is setting the global standard in solar panel recycling by creating a scalable, reliable, efficient, and optimized network of decommissioning, collecting, aggregating, storing and full-recovery processing (and ultimately refining) nodes designed and built for speed and scale,” said Corrado De Gasperis, Executive Chairman and CEO of Comstock. “Most of the industry is still getting their heads around the magnitude of inevitable end of life panels, measured in the tens of millions and then hundreds of millions, and growing, and our demonstrated ability to scale and meet those volumes delivers true sustainability and peace of mind to our customers.”
About Comstock Inc.
Comstock Inc. (NYSE: LODE) innovates and commercializes technologies, systems and supply chains that enable, support and sustain clean energy systems by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable metals, like silver, aluminum, gold, and other critical minerals, primarily from end-of-life photovoltaics. 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 X.com, LinkedIn 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: Judd B. Merrill, Chief Financial Officer Tel (775) 413-6222 ir@comstockinc.com
For media inquiries: Zach Spencer, Director of External Relations Tel (775) 847-7573 media@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; divestitures, spin-offs or similar distribution transactions, 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, divestitures, spin-offs or similar distribution transactions, 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, spin-offs or similar distribution transactions, 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.
Study supports favorable safety and tolerability profile and clinically meaningful functional and structural benefits in Stargardt disease patients
MALVERN, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the publication of positive Phase 1 GARDian1 trial results for OCU410ST, its novel modifier gene therapy for Stargardt disease, in the peer-reviewed journal Nature Eye—published by the Royal College of Ophthalmologists.
The publication, A novel modifier gene therapy to treat Stargardt disease: Phase 1 GARDian1 Trial Insights, was authored by Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno School of Medicine; Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology, Director of CME-Ophthalmology, Duke University School of Medicine; Benjamin A. Bakall, MD, PhD. Associated Retina Consultants, President and Founder, Retina Research Foundation of America, Clinical Assistant Professor, University of Arizona College of Medicine; and Ocugen researchers Dr. Murthy Chavali and Dr. Huma Qamar. The publication reports comprehensive 12-month safety, tolerability, and exploratory efficacy data from the first-in-human Phase 1 trial evaluating OCU410ST in patients with early to advanced Stargardt disease.
The Phase 1 GARDian1 trial demonstrated robust efficacy and safety outcomes supporting the clinical development of OCU410ST:
Key Findings include:
Among six patients with gradable Fundus Auto Fluorescence images, atrophic lesion growth was reduced by 54% (0.55 ± 0.27 mm²) in treated eyes, compared to untreated fellow eyes (1.19 ± 0.31 mm²) over 12 months
Lesion expansion was 50% slower (0.10 ± 0.039 mm/year) in treated eyes versus untreated eyes (0.19 ± 0.026 mm/year), below published natural history rates (0.14–0.18 mm/year)
Among six BCVA-evaluable patients without confounders, treated eyes gained +6 letters in BCVA (+4.5 letters) compared to a −1.5 letter decline in untreated fellow eyes at 12 months
100% of treated eyes either stabilized (±4 letters) or improved (≥5 letters) in visual acuity
No drug-related serious adverse events or adverse events of special interest were observed
Stargardt disease is the most common form of inherited macular degeneration, affecting more than 100,000 people in the United States and Europe combined. The disease is characterized by progressive central vision loss due to photoreceptor degeneration caused by toxic lipofuscin accumulation in the retinal pigment epithelium. Currently, no approved treatment exists for this devastating condition, representing a critical unmet medical need.
“This publication in Eye validates the scientific approach and clinical promise of OCU410ST as a modifier gene therapy for Stargardt disease,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “The Phase 1 GARDian1 trial demonstrated convergent functional and structural benefits. This represents a paradigm shift from any other approaches, including oral or mutation-constrained replacement approaches, to an agnostic modification strategy that can potentially benefit patients regardless of their underlying ABCA4 mutation with a potential single gene therapy for life. These results provide important support for our ongoing Phase 2/3 GARDian3 trial.”
“The consistent benefits observed across both structural and functional endpoints including slowing atrophic lesion progression and stabilization or improvement in visual acuity highlight the potential of this modifier gene therapy platform approach to transform treatment outcomes for patients with Stargardt disease, who currently have no disease-modifying options available,” said Dr. Arshad M. Khanani, lead author of the publication, Director of Clinical Research at Sierra Eye Associates, and Ocugen Scientific Advisory Board member. “I am looking forward to the data read out from the ongoing Phase 2/3 GARDian3 trial.”
The Phase 2/3 GARDian3 trial is progressing ahead of schedule with anticipated enrollment completion in the first quarter of 2026. The Company remains positioned for Biologics License Application (BLA) filing in the first half of 2027, aligned with its strategy to advance three regulatory submissions in three years.
About OCU410ST OCU410ST utilizes an AAV5 delivery platform to deliver the RORA (RAR-Related Orphan Receptor A) gene to the retina. By restoring nuclear hormone receptor signaling, OCU410ST addresses pathophysiological pathways linked to Stargardt disease, including lipofuscin formation, oxidative stress, complement activation, inflammation, and photoreceptor survival networks independent of the underlying ABCA4 genotype.
About Stargardt Disease Stargardt disease type 1 is a genetic eye disorder caused by biallelic mutations in the ABCA4 gene. The condition leads to progressive macular degeneration, with onset typically occurring during childhood or adolescence. Affected patients experience progressive central vision loss while peripheral vision is usually preserved. There are currently no FDA-approved treatments for this orphan indication.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. 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 OCU410ST 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.
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