BOCA RATON, Fla.–(BUSINESS WIRE)–Dec. 14, 2023– The ODP Corporation (NASDAQ:ODP), a leading provider of products, services and technology solutions to businesses and consumers, today announced that it received a score of 100 on the Human Rights Campaign Foundation’s 2023-2024 Corporate Equality Index (CEI), the nation’s foremost benchmarking survey and report measuring corporate policies and practices related to LGBTQ+ workplace equality. The ODP Corporation joins the ranks of 545 major U.S. businesses that also earned top marks this year.
“The ODP Corporation is proud to be recognized as a top-scoring company 12 years in a row,” said Zoë Maloney, executive vice president and chief human resources officer for The ODP Corporation. “We are committed to fostering an inclusive workplace where our associates feel safe, respected, and valued for who they are. Embracing diverse perspectives allows us to connect more deeply with our customers and communities and unlocks the full potential of our team to innovate for continued progress.”
“For well over two decades, businesses have played an important role in furthering LGBTQ+ equality by centering employee needs and voices when it comes to workplace inclusion. While there is much more work to be done, year-over-year growth in CEI participation is evidence of a business community that recognizes the responsibility and value in upholding equity and inclusion,” said RaShawn “Shawnie” Hawkins, Human Rights Campaign senior director of workplace equality. “Our goal at the Human Rights Campaign Foundation is to work in a spirit of partnership with companies, providing educational resources and leading benchmarking, and collaborating on ways for businesses to support the LGBTQ+ community at a time when we face unprecedented legislative attacks, heightened anti-LGBTQ+ rhetoric and physical violence. The CEI is an ever-evolving tool – a blueprint that companies can use to show up more effectively in supporting their LGBTQ+ employees and their families.”
The results of the 2023-2024 CEI showcase how U.S.-based companies are promoting LGBTQ+ friendly workplace policies in the U.S. and abroad. The first year of the CEI included 319 participants, and the 2023-2024 CEI now includes 1,384 participants; further demonstrating the tremendous trajectory of the CEI, a record-breaking 1,340 businesses have non-discrimination protections specific to gender identity, up from just 17 in 2002. These critical non-discrimination protections cover 21 million employees in the U.S. and around the globe. The ODP Corporation’s efforts in satisfying all the CEI’s criteria earned a score of 100 and the designation as recipient of the Equality 100 Award: Leader in LGBTQ+ Workplace Inclusion.
The CEI rates employers providing these crucial protections to over 20 million U.S. workers and an additional 18 million outside of the U.S. Companies rated in the CEI include Fortune magazine’s 500 largest publicly traded businesses, American Lawyer magazine’s top 200 revenue-grossing law firms (AmLaw 200), and hundreds of publicly and privately held mid- to large-sized businesses.
The CEI rates companies on detailed criteria falling under four central pillars:
Non-discrimination policies across business entities;
Equitable benefits for LGBTQ+ workers and their families;
About the Human Rights Campaign Foundation The Human Rights Campaign Foundation is the educational arm of the Human Rights Campaign (HRC), America’s largest civil rights organization working to achieve equality for lesbian, gay, bisexual, transgender and queer (LGBTQ+) people. Through its programs, the HRC Foundation seeks to make transformational change in the everyday lives of LGBTQ+ people, shedding light on inequity and deepening the public’s understanding of LGBTQ+ issues, with a clear focus on advancing transgender and racial justice. Its work has transformed the landscape for more than 15 million workers, 11 million students, 1 million clients in the adoption and foster care system and so much more. The HRC Foundation provides direct consultation and technical assistance to institutions and communities, driving the advancement of inclusive policies and practices; it builds the capacity of future leaders and allies through fellowship and training programs; and, with the firm belief that we are stronger working together, it forges partnerships with advocates in the U.S. and around the globe to increase our impact and shape the future of our work.
About The ODP Corporation The ODP Corporation (NASDAQ:ODP) is a leading provider of products, services, and technology solutions through an integrated business-to-business (B2B) distribution platform and omnichannel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; Veyer, LLC; and Varis, Inc., The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.
ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis, Inc. Any other product or company names mentioned herein are the trademarks of their respective owners.
NEW ALBANY, Ohio, Dec. 14, 2023 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI), a global leader in the design and manufacturing of electrical systems, vehicle components and accessories, plastic products and robotic assemblies, today announced that its Board of Directors (the “Board”) has elected William C. Johnson as an independent director to the Board, effective December 8, 2023. Mr. Johnson will serve on the Compensation Committee and the Nominating, Governance and Sustainability Committee of the Board. He will stand for re-election at the Company’s 2024 Annual Meeting of Stockholders.
Mr. Johnson, 60, brings tremendous leadership experience to the CVG Board. Since October 2022, Mr. Johnson has served as CEO and a member of the Board of Directors of Avail Infrastructure Solutions. From October 2018 to July 2022, Mr. Johnson served as the President and CEO of Welbilt, Inc. (WBT), and from July 2016 to June 2018, he served President and CEO and COO of Chart Industries, Inc. Prior to that he held multiple roles of increasing responsibility at Dover Refrigeration and Food Equipment, Hillphoenix, ABB and ESAB. Mr. Johnson holds a Bachelor of Science degree in Ceramic engineering from Alfred University and a Master of Business Administration from Rollins College. He started his professional career as a Nuclear engineer in the US Navy aboard the submarine USS Stonewall Jackson.
“We welcome Bill to the CVG Board as the company executes its strategy to grow shareholder value,” said Robert Griffin, Chairman of the Board. “CVG will greatly benefit from his proven leadership experience. His record of success across various executive roles speaks to his exceptional capabilities that will serve us well in the Board room.”
“Being elected to the CVG Board of Directors is a tremendous honor,” said Mr. Johnson. “I am excited to work alongside the Board’s distinguished leaders to help guide the Company’s strategy into 2024 and beyond.”
About CVG
At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.
Investor Relations Contact: Ross Collins or Stephen Poe Alpha IR Group CVGI@alpha-ir.com
Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.
WESTON, Fla., Dec. 14, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces selection of contract research organization (“CRO”) George Clinical to manage its Phase 2a clinical trial with Cholesterol Efflux MediatorTM VAR 200 in patients with diabetic kidney disease (DKD). The clinical trial is expected to begin in the first quarter of 2024.
George Clinical is a leading global CRO, headquartered in Sydney, Australia, with more than 500 experienced people in 39 locations providing the full range of clinical trial services to pharmaceutical, medical device, and diagnostic customers for all trial phases, registration, and post-marketing trials. George Clinical, who combines scientific and clinical leadership with expert trial delivery to create distinctive world-class solutions, was the recipient of Citeline’s 2023 Clinical Research Team of the Year. They were recognized for their success in achieving their goals, effective work practices, creative solutions, and meeting major milestones within expected timelines.
“Initiation of the Phase 2a trial in patients with DKD marks a major milestone in the development of Cholesterol Efflux MediatorTM VAR 200 and for ZyVersa. It is the first clinical trial for VAR 200 and will help establish its effectiveness and safety in renal patients, and it will provide valuable insights to guide development for other planned renal indications (focal segmental glomerulosclerosis and Alport syndrome),” said Stephen C. Glover, ZyVersa’s Co-founder, Chief Executive Officer, and Chairman. “We are pleased to partner with George Clinical to manage this important study. With their unparalleled renal research experience in more than 50 chronic renal disease trials and their reputation as a high performing renal CRO, we are confident that our trial will be conducted in an efficient and timely manner to achieve our milestones and advance VAR 200’s development program to the next level.”
“Collaborating with ZyVersa Therapeutics on this trial shows not only our passion for kidney research but also the commitment to provide the necessary clinical research around innovative treatments that could help patients with unmet medical needs,” said George Clinical Chief Medical Officer Maria Ali.
About VAR 200
Cholesterol Efflux MediatorTM VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to kidney disease and its progression. VAR 200 passively and actively removes excess lipids from the kidney.
Preclinical studies in animal models of diabetic kidney disease, FSGS, and Alport syndrome, demonstrate that removal of excess cholesterol and lipids from the kidney’s filtration system with VAR 200 protects against structural damage and reduces excretion of protein in the urine (proteinuria). VAR 200 has potential to treat multiple kidney diseases, including diabetic kidney disease, and rare kidney diseases, FSGS (focal segmental glomerulosclerosis) and Alport syndrome. For more information about VAR 200, Click Here.
About ZyVersa Therapeutics, Inc.
ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes phase clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the filtering system of the kidneys. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. ZyVersa’s pipeline also includes proprietary inflammasome ASC inhibitor IC 100 that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing. A discussion of these and other factors, including risks and uncertainties with respect to ZyVersa, is set forth in ZyVersa’s filings with the Securities and Exchange Commission, including ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
Corporate and IR Contact Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
Media Contacts Casey McDonald cmcdonald@tiberend.com 646-577-8520
Dave Schemelia Dschemelia@tiberend.com 609-468-9325
MALVERN, Pa., Dec. 13, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the ArMaDa Phase 1/2 clinical trial of OCU410 (AAV-RORA), a modifier gene therapy product candidate being developed for dry AMD (dAMD).
“OCU410, our first-in-class modifier gene therapy for dAMD, addresses gaps among other therapies available and in development for dAMD as a potential one-time treatment for life,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “We are very pleased to continue advancing our ophthalmic gene therapy pipeline, which remains the Company’s primary focus.”
This Phase 1/2 trial will assess the safety and efficacy of OCU410 for geographic atrophy (GA) secondary to dAMD and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study. Phase 2 is a randomized expansion phase in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 dose groups or to an untreated control group.
OCU410 is a potential curative therapy with a single sub-retinal injection that targets multiple pathways causing dAMD, including lipid metabolism, inflammation, oxidative stress, and complement activation. Currently, the other therapeutic options available target only complement activation and require approximately 6-12 intravitreal injections annually.
“Breaking new ground in the pursuit of vision restoration, our pioneering modifier gene therapy candidate, OCU410, achieves another major milestone by dosing a GA patient in a Phase 1/2 clinical trial,” said Arun Upadhyay, PhD, Chief Scientific Officer, Head of R&D at Ocugen. “OCU410 offers hope for those battling GA that are faced with limited treatment options and the real prospect of ultimately losing their vision.”
“There remains a great unmet need for novel durable and effective treatments for GA, which remains one of the most common causes of vision loss globally,” said Benjamin Bakall, MD, PhD, director of clinical research at Associated Retina Consultants (ARC) and clinical assistant professor at University of Arizona, College of Medicine – Phoenix. “I am excited that we performed the first surgery with this novel therapeutic approach—designed to restore homeostasis and slow disease progression following a single treatment—at ARC in Phoenix, AZ, with the surgical team led by Dr. Mark Kwong, medical director of ARC.”
The first surgery was successful in delivering the new gene underneath the retina; the light sensitive nerve tissue lining the inside of the eye.
About dAMD and GA dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight.
dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.
GA, an advanced form of dry age-related macular degeneration, affects approximately 1 million people in the United States alone. About OCU410 OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA. Currently, the other therapeutic options available target only complement activation and require approximately 6-12 intravitreal injections annually.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
About Associated Retina Consultants Associated Retina Consultants is the largest independent retina practice in the state of Arizona, taking part in groundbreaking clinical trials to bring new treatments for the benefit of patients with diseases affecting the retina. In addition to collaborating with Ocugen on the OCU410 clinical trial, in October 2023, Associated Retina Consultants—with a surgical team led by Dr. Mark Kwong—performed gene therapy with OCU400 on a pediatric CEP290 patient. This was the first retinal gene therapy of its kind performed on a child in Arizona.
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.
Contact: Tiffany Hamilton Head of Communications IR@ocugen.com
Preclinical data show that narazaciclib treatment led to significant tumor growth inhibition, demonstrating synergy with standard-of-care ibrutinib, in ibrutinib-sensitive and -resistant settings
Early Phase 1/2 studies suggest potential for an improved profile and daily dosing
Dose escalation is underway in lead indication of Low Grade Endometrioid Endometrial Carcinoma (LGEEC), with plans to define the Recommended Phase 2 Dose (RP2D) and prepare for registrational studies, with a planned update in H1 2024
NEWTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preclinical data, highlighting narazaciclib’s preclinical activity in Bruton’s kinase inhibitor (BTKi)-resistant mantle cell lymphoma (MCL), in a poster presented on December 11, 2023 at the 65th Annual Meeting of the American Society for Hematology (ASH 2023) in San Diego.
“We are pleased to have shared data at ASH 2023 from preclinical studies with narazaciclib in MCL models. These results, which are consistent with data presented this year at the international MCL conferences, demonstrate that treatment with narazaciclib led to significant tumor growth inhibition when used as a single agent and that combination with ibrutinib demonstrated synergy, in both ibrutinib-sensitive and -resistant in vitro and in vivo settings,” said Steve Fruchtman, M.D., President and Chief Executive Officer. “These data are important because they provide further evidence for the potential use of narazaciclib in cancers with cyclin over-expression and elaborate our understanding of narazaciclib’s mechanism of action, including its ability to promote G1 cell cycle blockade.”
Dr. Fruchtman continued, “We believe that these data, along with the preclinical data presented on Friday, December 8th at the San Antonio Breast Cancer Symposium (SABCS), further underscore the impressive and differentiated profile of narazaciclib. The data presented at SABCS highlight narazaciclib’s multi-kinase activity, its ability to target resistance pathways missed by other CDK4/6 inhibitors, and its differentiated anti-tumor and immunomodulatory activity. The data presented at ASH 2023 show that narazaciclib, in combination with BTKi’s such as ibrutinib, also trigger metabolic reprogramming alongside DNA damage.”
“The totality of these data is helping us to shape the clinical program for narazaciclib, including the lead indication of LGEEC, with further potential to expand into additional investigator-sponsored studies in breast, ovarian, and other cancers. We are pleased with the early Phase 1/2 data for narazaciclib monotherapy and in combination with letrozole, showing lower levels of neutropenia and diarrhea, and the potential for once daily dosing. Both of these attributes could position narazaciclib as a differentiated and improved CDK4/6i. Looking ahead, we are enthusiastic to advance the clinical program for narazaciclib in 2024 and to update our stakeholders regarding our progress, including the planned completion of dose escalation studies, definition of an RP2D, and development of our registrational trial plans for LGEEC. The data presented at ASH suggest narazaciclib is a drug with the potential to target a variety of cancer indications with an unmet medical need, including MCL,” concluded Dr. Fruchtman.
Poster Highlights
Title: Narazaciclib, a differentiated CDK4/6 antagonist, prolongs cell cycle arrest and metabolomic reprogramming, enabling restoration of ibrutinib sensitivity in BTKi-resistant mantle cell lymphoma
Objectives: To evaluate the activity and mechanism of action of narazaciclib as a single agent and in combination with ibrutinib, in comparison to the standard-of-care ibrutinib, in preclinical models of MCL that are sensitive and resistant to ibrutinib treatment.
Snapshot of the Results and Conclusions:
Tumor Growth Inhibition: Narazaciclib showed safety and efficacy as a single agent in preclinical MCL models, including ibrutinib-resistant settings, with significant reductions in cell viability.
Combination Synergy: The narazaciclib plus ibrutinib combination showed synergy in vitro and in vivo, especially in ibrutinib-resistant models, with overall greater synergy, measured by lower “Combination Index” values, versus ibrutinib-sensitive cells.
Cell Cycle Blockade: The combination of narazaciclib plus ibrutinib induces a superior G1 cell cycle blockade in both ibrutinib-sensitive and ibrutinib-resistant MCL cells.
Metabolic programming: In ibrutinib-resistant cases, the synergy between narazaciclib and ibrutinib triggers metabolic reprogramming alongside DNA damage, mediated by the USP24 and P53 axis, as evidenced by several assays to assess mitochondrial metabolism.
Together, these preclinical data suggest that narazaciclib has important single agent activity and the potential to restore ibrutinib sensitivity in BTKi-resistant models, successfully meeting the primary objective of the study.
A copy of the poster is available on the “Scientific Presentations” section of the Onconova website.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer, ovarian cancer, multiple myeloma, and mantle cell lymphoma.
Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
With over 300,000 wishlist additions on Steam, Bellwright is poised to be a game-changer in the survival town building RPG genre
LOS ANGELES, Dec. 08, 2023 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, in collaboration with Donkey Crew, proudly presented a new trailer for its upcoming title, Bellwright, at The Game Awards. Renowned for its dedication to showcasing cutting-edge gaming experiences, this showcase comes a week after the exciting announcement of Bellwright’s debut in Steam Early Access in early 2024 and its successful feature on the PC Gaming Show: Most Wanted.
Key Highlights:
Trailer Debut: Snail captivated the audience with the mesmerizing story elements, “You Are The Bellwright” with visually appealing graphics, intricate crafting, and dynamic action and exploration elements. This open-world survival game introduces a medieval setting with a rich and compelling lore, distinguishing itself as a groundbreaking addition to Snail’s portfolio.
Wishlist Milestone: First introduced at the Steam’s Next Fest this summer, now with over 300,000 wishlists on Steam, Bellwright emerges as one of Snail’s most anticipated titles.
Snail’s expertise in the open-world survival gaming niche is exemplified by the strong install base and hours played of the ARK franchise. The unveiling of Bellwright, further underscores Snail’s commitment to pushing the boundaries of open-world survival gaming and solidifies the company’s reputation as a leader in creating immersive and engaging open-world experiences. Bellwright’s medieval backdrop and intricate lore demonstrates the versatility and depth of Snail’s prowess within this gaming genre.
Bellwright Key Features:
Survive and Explore: Engage in a challenging world where gathering, hunting, building, and crafting are essential for survival. Embark on a journey through the land to uncover its secrets and adventures, transcending the oppressive rule of the Crown and its Royal Army.
Conquer and Expand: Rise from a humble camp to become the leader of a rebellion. Strengthen your cause by improving relations with settlements, growing armies, and liberating regions from the Crown’s influence. Gain followers with unique knowledge, unlocking new resources to advance your town’s technologies.
Resource and Town Management: As you free villages from the Crown’s oppression, build, manage, and upgrade your outposts and towns. Organize your workers and train formidable soldiers, fostering the rebellion against the Crown.
Skill-Based Directional Combat: Choose from a diverse array of medieval weapons and armor, honing your unique style in directional combat. From swords and axes to heavy mauls and bows, showcase your skill in battle.
Army Command: Lead your armies strategically, employing cunning tactics to gain an advantage. Customize and train your troops to assert your dominance on the battlefield.
Deep Progression: Enhance your combat and survival skills, train your soldiers, and witness your workers evolve into master craftsmen. Each recruit brings unique knowledge, offering endless growth opportunities.
Story and Roleplay: Unravel family secrets, discover the truth behind the accused murder of the Prince, and navigate the mysteries of the kingdom as you expand your influence.
Early Access on Steam: The game’s Early Access phase on Steam will allow players to shape its development through valuable feedback.
“Bellwright is a testament to our unwavering dedication to crafting exceptional open-world survival experiences. Our success with the ARK franchise serves as a foundation for Bellwright, and we are eager to continue to bring innovation to the genre and share this new and captivating journey with our players.” – Jim Tsai, Chief Executive Officer of Snail, Inc.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Forward-Looking Statements This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding Snail’s intent, belief or current expectations. These forward-looking statements include information about possible or assumed future results of Snail’s business, financial condition, results of operations, liquidity, plans and objectives. The statements Snail makes regarding the following matters are forward-looking by their nature: growth prospects and strategies; launching new games and additional functionality to games that are commercially successful; expectations regarding significant drivers of future growth; its ability to retain and increase its player base and develop new video games and enhance existing games; competition from companies in a number of industries, including other game developers and publishers and both large and small, public and private Internet companies; its relationships with third-party platforms; expectations for future growth and performance; and assumptions underlying any of the foregoing.
BY THE COMTECH EDITORIAL TEAM – DEC 7, 2023 | 2 MIN READ
Q1 Consolidated Net Sales Up 2.1% Sequentially to $151.9 Million
Q1 Consolidated Operating Income Up 86.2% Sequentially to $2.1 Million
Q1 Consolidated Adjusted EBITDA of $18.4 Million, or 12.1% of Consolidated Net Sales
MELVILLE, N.Y. – December 7, 2023– Comtech (NASDAQ: CMTL) today announced its first quarter fiscal 2024 financial results and provided its second quarter fiscal 2024 financial targets in a letter to shareholders which is now posted to the Investor Relations section of Comtech’s website.
Investors are invited to access the first quarter fiscal 2024 shareholder letter at its web site at comtech.com/investors/. A copy of the letter will also be filed with the Securities and Exchange Commission in a Form 8-K.
Comtech also intends to host a previously scheduled earnings conference call at 5:00PM ET today. Individuals can access the conference call by dialing (800) 579-2543 (domestic) or (785) 424-1789 (international) and using the conference I.D. of “Comtech.” A replay of the conference call will be available for two weeks by dialing (888) 219-1269 or (402) 220-4945. A live webcast of the call is also available at comtech.com/investors/.
About Comtech
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.
Forward-Looking Statements
Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward- looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.
Diabetic kidney disease (DKD), which affects around 240 million people with Type 2 diabetes worldwide, is the leading cause of end-stage renal disease, which requires dialysis or kidney transplant for survival.
The article published in Alternative Therapies demonstrates that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as kidney function worsens, with highly significant elevations (p<0.01) at each stage of disease.
Data suggest that early DKD intervention with inflammasome inhibitors has potential to attenuate disease progression.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits multiple inflammasome pathways (including the inflammasome NLRP3 pathway) to attenuate initiation and perpetuation of damaging inflammation that is pathogenic in DKD and other inflammatory diseases.
WESTON, Fla., Dec. 07, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases, announces publication of an article in the peer-reviewed journal, Alternative Therapies, demonstrating that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as kidney function worsens.
In the paper titled, “Correlation Between Plasma NLRP3, IL-1β, and IL-18 and Diabetic Nephropathy in Patients With Type 2 Diabetes,” the authors evaluated the plasma of 152 patients with type 2 diabetes and DKD stratified by stage of disease (stages 1-5) and 30 patients with type 2 diabetes without kidney disease who serve as controls. Following are key findings reported in the paper:
Plasma levels of NLRP3 and proinflammatory cytokines, IL-1β, and IL-18, were significantly higher than controls in patients in each of the 5 stages of DKD, with progressively higher levels as kidney disease progressed (p<0.01).
NLRP3, IL-1β, and IL-18 levels positively correlated with DKD stage (p= 0.01), based on the Spearman correlation analysis.
These data are consistent with other studies demonstrating that inflammation has an important role in the development and progression of DKD.
“The research published in Alternative Therapies reinforces the role of inflammasome-driven inflammation in development and progression of DKD, the leading cause of end-stage kidney disease, which requires dialysis or kidney transplant for survival,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Although substantial progress has been made in slowing progression of DKD with introduction of ACE inhibitors, ARBs, and most recently SGLT2 inhibitors, patients are still progressing to end-stage renal disease. The data published in Alternative Therapies suggest that early DKD intervention with inflammasome inhibitors has potential to help attenuate disease progression.”
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
Corporate and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
SAN DIEGO, Dec. 07, 2023 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in defense, national security and global markets, announced today that it demonstrated 100% interoperability success at the first ever DIFI Plugfest where satellite solutions providers converged to test the interoperability of their Digital IF products.
Founded under the auspices of the IEEE, the Digital IF Interoperability (DIFI) Consortium is an independent, international group of companies, organizations, and government agencies that have an interest in the interoperability of satellite ground system equipment. Its Digital IF/RF standard is intended to accelerate industry transformation beyond stove-piped, hardware-based systems to digital software-defined networks.
“Plugfests” are events held to test electronic equipment and software product interoperability between vendors against a technical standard. Seven equipment makers participated in this inaugural DIFI Plugfest, led by Kratos providing the most products tested, including:
OpenSpace® quantumRadio – virtualized modem that provides RF signal processing for TT&C and narrowband payload missions
OpenSpace® quantumRX – virtualized modem that provides RF signal processing for wideband missions
OpenSpace® Channelizer and OpenSpace® Combiner – software used to split and combine digitized RF signals for more effective downlink and uplink processing
SpectralNet® Wideband Digitizer – converts RF signals into digital IP packets for RF over IP transport
“Kratos is leading the movement to build interoperable, standards-based products that bring satellite networks into the mainstream of the global communications infrastructure,” said Kevin Tobias, Director of Product Management at Kratos. “That leadership was evident in the success across the broad range of Kratos products at DIFI’s Plugfest event. With our OpenSpace, SpectralNet and quantum products, Kratos is working to build a digital future that delivers more flexible, streamlined and affordable satellite services worldwide.”
The implementation of the DIFI standard across a wide variety of ground system products is foundational in Kratos’ ongoing effort to support the mainstreaming of satellite services so that satellite ground systems operate seamlessly with today’s wireless and terrestrial networks. As a founding member of the DIFI Consortium, Kratos recognizes the importance of the adoption of standards like DIFI in advancing that transformation and the satellite industry’s ability to scale and meet future demand.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology company that develops and fields transformative, affordable systems, products and solutions for United States National Security, allies and global commercial enterprises. At Kratos, affordability is a technology, and Kratos is changing the way breakthrough technology is rapidly brought to market – at a low cost – with products, systems and technologies rather than slide decks or renderings. Through proven commercial and venture capital backed approaches, including proactive, internally funded research and streamlined development processes, Kratos is focused on being first to market with our solutions, well in advance of competition. Kratos is the recognized technology disruptor in our core market areas, including Space and Satellite Communications, Cyber Security and Warfare, Unmanned Systems, Rocket and Hypersonic Systems, Next-Generation Jet Engines and Propulsion Systems, Microwave Electronics, C5ISR and Virtual and Augmented Reality Training Systems. 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 25, 2022, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that Beth Simermeyer has been elected to the Board of Directors, effective December 5, 2023.
“We are excited to welcome Beth, a dynamic business leader with a proven track record of success to ACCO Brands’ Board of Directors. Beth’s extensive marketing expertise, P&L ownership and global leadership mindset, will further enhance our Board and help us execute on our strategic transformation. We look forward to leveraging Beth’s insights to continue to further strengthen the company going forward,” said Boris Elisman, Executive Chairman of ACCO Brands Corporation.
Ms. Simermeyer brings substantial business leadership experience in marketing, transformation, innovation, growth acceleration, acquisitions and top and bottom-line delivery in the consumer goods, industrial and healthcare sectors. In her most recent role as Global Group President, Executive Vice President, Healthcare and Life Sciences at Ecolab (NYSE: ECL) she launched and led the global Life Sciences business that has become a top investment priority for the company. During her more than thirty-year career, Ms. Simermeyer held several senior brand and general management roles, including Ecolab’s Chief Marketing Officer, where her responsibilities spanned sustainability, customer insights, branding and communications. Prior to joining Ecolab, Ms. Simermeyer was Senior Vice President, North America at S.C. Johnson. She started her career at The Procter & Gamble Company (NYSE: PG). Since 2019, she has served as an Independent Director at the Securian Financial Group.
About ACCO Brands
ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.
Christopher McGinnis Investor Relations (847) 796-4320
Kori Reed Media Relations (224) 501-0406
Source:
December 7, 2023
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that Beth Simermeyer has been elected to the Board of Directors, effective December 5, 2023.
“We are excited to welcome Beth, a dynamic business leader with a proven track record of success to ACCO Brands’ Board of Directors. Beth’s extensive marketing expertise, P&L ownership and global leadership mindset, will further enhance our Board and help us execute on our strategic transformation. We look forward to leveraging Beth’s insights to continue to further strengthen the company going forward,” said Boris Elisman, Executive Chairman of ACCO Brands Corporation.
Ms. Simermeyer brings substantial business leadership experience in marketing, transformation, innovation, growth acceleration, acquisitions and top and bottom-line delivery in the consumer goods, industrial and healthcare sectors. In her most recent role as Global Group President, Executive Vice President, Healthcare and Life Sciences at Ecolab (NYSE: ECL) she launched and led the global Life Sciences business that has become a top investment priority for the company. During her more than thirty-year career, Ms. Simermeyer held several senior brand and general management roles, including Ecolab’s Chief Marketing Officer, where her responsibilities spanned sustainability, customer insights, branding and communications. Prior to joining Ecolab, Ms. Simermeyer was Senior Vice President, North America at S.C. Johnson. She started her career at The Procter & Gamble Company (NYSE: PG). Since 2019, she has served as an Independent Director at the Securian Financial Group.
About ACCO Brands
ACCO Brands, the Home of Great Brands Built by Great People, designs, manufactures and markets consumer and end-user products that help people work, learn, play and thrive. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found at www.accobrands.com.
Christopher McGinnis Investor Relations (847) 796-4320
Total Digital Revenue(1) was $73M in the quarter, representing 44% of revenue Digital-only subscribers total 721,000, exceeding guidance and up 36% YOY Adjusted EBITDA(2) in line with full year guidance
DAVENPORT, Iowa, Dec. 07, 2023 (GLOBE NEWSWIRE) — Lee Enterprises, Incorporated (NASDAQ: LEE), a digital-first subscription platform providing high quality, trusted, local news, information and a major platform for advertising in 75 markets, today reported preliminary fourth quarter fiscal 2023 financial results(3) for the period ended September 24, 2023.
“Our fourth quarter digital subscription results lead the industry by a significant margin, continuing the streak for 16 consecutive quarters. Subscribers to our digital products totaled 721,000, up 36% compared to last year and digital-only subscription revenue accelerated–growing 68% on a Same-store basis(4),” said Kevin Mowbray, Lee’s President and Chief Executive Officer. “Amplified Digital® revenue totaled $24 million in the quarter, leading to an 11% increase over the prior year(4). Total Digital Revenue increased 14% in the quarter(4), and represented 44% of our total operating revenue. The rapid pace of digital growth is driven by our strong execution of our Three Pillar Digital Growth Strategy,” Mowbray added.
“Adjusted EBITDA in the quarter was up 29% sequentially, due to our rapid digital growth and strong cost management execution,” said Mowbray. “Our aggressive cost actions in FY23, as well as the strong performance of our digital revenue streams, will have a favorable impact on FY24 operating results. We anticipate full year FY24 Adjusted EBITDA to be in the range of $83 million to $90 million,” added Mowbray.
“The long-standing industry-leading digital execution gives us even more confidence in our transformation. In fact, the best-in-class performance increases our long-term outlook on digital-only subscribers by one-third to 1.2 million and digital subscription revenue by approximately 50% to more than $150 million. These significant improvements to our long-term outlook demonstrate our confidence in Lee’s digital transformation. We are on a clear path to becoming sustainable solely from the revenue and cash flow from our digital products,” said Mowbray.
Key Fourth Quarter Highlights:
Total operating revenue was $164 million.
Total Digital Revenue was $73 million, a 14% increase over the prior year(4), and represented 44% of our total operating revenue.
Digital-only subscription revenue increased 68% in the fourth quarter compared to the same quarter last year(4) due to a 36% increase in digital-only subscribers and marketing efforts driving price yields. Digital-only subscribers totaled 721,000 at the end of the September quarter.
Digital advertising and marketing services revenue represented 68% of our total advertising revenue and totaled $49 million. Digital marketing services revenue at Amplified Digital® fueled the growth, with quarterly revenue of $24 million.
Digital services revenue, which is predominantly BLOX Digital, totaled $5 million in the quarter.
Operating expenses totaled $156 million and Cash Costs(2) totaled $138 million.
Net loss totaled $1 million and Adjusted EBITDA totaled $30 million.
2024 Fiscal Year Outlook:
Total Digital Revenue
$310 million (+13% YOY) – $330 million (+21% YOY)
Digital-only subscribers
771,000 (+7% YOY)
Adjusted EBITDA
$83 million (-3% YOY) – $90 million (+6% YOY)
Long-Term Outlook (2024 – 2028):
Total Digital Revenue
$450 – $500 million
Digital-only subscribers
1.2 million
Debt and Free Cash Flow:
The Company has $456 million of debt outstanding under our Credit Agreement(5) with BH Finance. The financing has favorable terms including a 25-year maturity, a fixed annual interest rate of 9.0%, no fixed principal payments, and no financial performance covenants.
As of and for the period ended September 24, 2023:
The principal amount of debt totaled $456 million, a reduction of $7 million for the fiscal year.
Cash on the balance sheet totaled $15 million. Debt, net of cash on the balance sheet, totaled $441 million.
Capital expenditures totaled $5 million for the full year. We expect $10 million of capital expenditures in FY24.
For fiscal year 2023, cash paid for income taxes totaled $4 million. We expect cash paid for income taxes to total between $10 million and $15 million in 2024.
We made no pension contributions in the fiscal year.
Conference Call Information:
As previously announced, we will hold an earnings conference call and audio webcast today at 9 a.m. Central Time. The live webcast will be accessible at www.lee.net and will be available for replay 24 hours later. Analysts have been invited to ask questions on the call. Questions from other participants may be submitted by participating in the webcast. To participate in the live conference call via telephone, please register here. Upon registering, a dial-in number and unique PIN will be provided to join the conference call.
About Lee:
Lee Enterprises is a major subscription and advertising platform and a leading provider of local news and information, with daily newspapers, rapidly growing digital products and nearly 350 weekly and specialty publications serving 75 markets in 26 states. Year to date, Lee’s newspapers have an average daily circulation of 1.0 million, and our legacy websites, including acquisitions, reach more than 31 million digital unique visitors. Lee’s markets include St. Louis, MO; Buffalo, NY; Omaha, NE; Richmond, VA; Lincoln, NE; Madison, WI; Davenport, IA; and Tucson, AZ. Lee Common Stock is traded on NASDAQ under the symbol LEE. For more information about Lee, please visit www.lee.net.
FORWARD-LOOKING STATEMENTS — The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. This release contains information that may be deemed forward-looking that is based largely on our current expectations, and is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those anticipated. Among such risks, trends and other uncertainties, which in some instances are beyond our control, are:
The overall impact the COVID-19 pandemic has on the Company’s revenues and costs;
The long-term or permanent changes the COVID-19 pandemic may have on the publishing industry, which may result in permanent revenue reductions and other risks and uncertainties;
We may be required to indemnify the previous owners of BH Media or The Buffalo News for unknown legal and other matters that may arise;
Our ability to manage declining print revenue and circulation subscribers;
The impact and duration of adverse conditions in certain aspects of the economy affecting our business;
Changes in advertising and subscription demand;
Changes in technology that impact our ability to deliver digital advertising;
Potential changes in newsprint, other commodities and energy costs;
Interest rates;
Labor costs;
Significant cyber security breaches or failure of our information technology systems;
Our ability to achieve planned expense reductions and realize the expected benefit of our acquisitions;
Our ability to maintain employee and customer relationships;
Our ability to manage increased capital costs;
Our ability to maintain our listing status on NASDAQ;
Competition; and
Other risks detailed from time to time in our publicly filed documents.
Any statements that are not statements of historical fact (including statements containing the words “aim”, “may”, “will”, “would”, “could”, “believes”, “expects”, “anticipates”, “intends”, “plans”, “projects”, “considers” and similar expressions) generally should be considered forward-looking statements. Statements regarding our plans, strategies, prospects and expectations regarding our business and industry, including statements regarding the impacts that the COVID-19 pandemic and our responses thereto may have on our future operations, are forward-looking statements. They reflect our expectations, are not guarantees of performance and speak only as of the date the statement is made. Readers are cautioned not to place undue reliance on such forward-looking statements, which are made as of the date of this release. We do not undertake to publicly update or revise our forward-looking statements, except as required by law.
Assets loss (gain) on sales, impairments and other, net
6,137
21,055
(70.9
)
1,882
9,716
(80.6
)
Restructuring costs and other
4,552
2,858
59.3
12,673
22,720
(44.2
)
Operating expenses
156,077
198,555
(21.4
)
660,496
761,775
(13.3
)
Equity in earnings of associated companies
2,993
1,446
107.0
6,527
5,657
15.4
Operating income
10,927
(3,472
)
(414.7
)
37,169
24,851
49.6
Non-operating (expense) income:
Interest expense
(10,326
)
(10,292
)
0.3
(41,471
)
(41,770
)
(0.7
)
Curtailment gain
—
—
—
—
1,027
(100.0
)
Pension withdrawal cost
(1,200
)
—
—
(1,200
)
(2,335
)
(48.6
)
Pension and OPEB related benefit (cost) and other, net
162
5,488
(29.9
)
2,420
19,022
(87.3
)
Non-operating expenses, net
(11,364
)
(4,804
)
136.6
(40,251
)
(24,056
)
67.3
Income (loss) before income taxes
(437
)
(8,276
)
NM
(3,082
)
795
(487.7
)
Income tax (benefit) expense
888
(1,666
)
NM
(349
)
698
(150.0
)
Net (loss) income
(1,325
)
(6,610
)
NM
(2,733
)
97
NM
Net income attributable to non-controlling interests
(659
)
(526
)
25.3
(2,534
)
(2,114
)
19.9
Loss attributable to Lee Enterprises, Incorporated
(1,984
)
(7,136
)
NM
(5,267
)
(2,017
)
161.1
Earnings (loss) per common share:
Basic
(0.32
)
(1.23
)
NM
(0.90
)
(0.35
)
NM
Diluted
(0.32
)
(1.23
)
NM
(0.90
)
(0.35
)
NM
DIGITAL / PRINT REVENUE COMPOSITION (UNAUDITED)
Three months ended
Twelve months ended
(Thousands of Dollars)
September 24, 2023
September 25, 2022
September 24, 2023
September 25, 2022
Digital Advertising and Marketing Services Revenue
49,270
49,110
193,173
181,465
Digital Only Subscription Revenue
18,661
11,168
60,700
40,120
Digital Services Revenue
5,020
4,355
19,362
17,955
Total Digital Revenue
72,951
64,633
273,235
239,540
Print Advertising Revenue
23,302
39,931
125,804
184,963
Print Subscription Revenue
58,792
78,541
252,591
313,504
Other Print Revenue
8,966
10,532
39,508
42,962
Total Print Revenue
91,060
129,004
417,903
541,429
Total Operating Revenue
164,011
193,637
691,138
780,969
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES (UNAUDITED)
The table below reconciles the non-GAAP financial performance measure of Adjusted EBITDA to net income, its most directly comparable GAAP measure:
Three months ended
Twelve months ended
(Thousands of Dollars)
September 24, 2023
September 25, 2022
September 24, 2023
September 25, 2022
Net (loss) income
(1,325
)
(6,610
)
(2,733
)
97
Adjusted to exclude
Income tax (benefit) expense
888
(1,666
)
(349
)
698
Non-operating expenses, net
11,364
4,804
40,251
24,056
Equity in earnings of TNI and MNI(6)
(2,993
)
(1,446
)
(6,527
)
(5,657
)
Assets loss (gain) on sales, impairments and other, net
6,137
21,055
1,882
9,716
Depreciation and amortization
7,524
9,099
30,621
36,544
Restructuring costs and other
4,552
2,858
12,673
22,720
Stock compensation
421
311
1,806
1,337
Add:
Ownership share of TNI and MNI EBITDA (50%)
3,476
1,676
7,604
6,541
Adjusted EBITDA
30,044
30,081
85,228
96,052
The table below reconciles the non-GAAP financial performance measure of Cash Costs to Operating expenses, the most directly comparable GAAP measure:
Three months ended
Twelve months ended
(Thousands of Dollars)
September 24, 2023
September 25, 2022
September 24, 2023
September 25, 2022
Operating expenses
156,077
198,555
660,496
761,775
Adjustments
Depreciation and amortization
7,524
9,099
30,621
36,544
Assets loss (gain) on sales, impairments and other, net
6,137
21,055
1,882
9,716
Restructuring costs and other
4,552
2,858
12,673
22,720
Cash Costs
137,864
165,543
615,320
692,795
The table below reconciles the non-GAAP financial performance measure of Same-Store Revenues to Operating Revenues, its most directly comparable GAAP measure:
Three months ended
Twelve months ended
(Thousands of Dollars)
September 24, 2023
September 25, 2022
Percent Change
September 24, 2023
September 25, 2022
Percent Change
Print Advertising Revenue
23,302
39,931
(41.6
)
125,804
184,963
(32.0
)
Exited operations
(29
)
(6,609
)
NM
(14,595
)
(34,760
)
NM
Same-store, Print Advertising Revenue
23,273
33,322
(30.2
)
111,209
150,203
(26.0
)
Digital Advertising Revenue
49,270
49,110
0.3
193,173
181,465
6.5
Exited operations
(5
)
(370
)
NM
(1,083
)
(964
)
NM
Same-store, Digital Advertising Revenue
49,265
48,740
1.1
192,090
180,501
6.4
Total Advertising Revenue
72,572
89,041
(18.5
)
318,977
366,428
(12.9
)
Exited operations
(34
)
(6,979
)
NM
(15,679
)
(35,724
)
NM
Same-store, Total Advertising Revenue
72,538
82,062
(11.6
)
303,298
330,704
(8.3
)
Print Subscription Revenue
58,792
78,541
(25.1
)
252,591
313,504
(19.4
)
Exited operations
(4
)
(182
)
NM
(382
)
(834
)
NM
Same-store, Print Subscription Revenue
58,788
78,359
(25.0
)
252,209
312,670
(19.3
)
Digital Subscription Revenue
18,661
11,168
67.1
60,700
40,120
51.3
Exited operations
—
—
NM
—
—
NM
Same-store, Digital Subscription Revenue
18,658
11,139
67.5
60,535
39,977
51.4
Total Subscription Revenue
77,453
89,709
(13.7
)
313,291
353,624
(11.4
)
Exited operations
(7
)
(211
)
NM
(547
)
(977
)
NM
Same-store, Total Subscription Revenue
77,446
89,498
(13.5
)
312,744
352,647
(11.3
)
Print Other Revenue
8,966
10,532
(14.9
)
39,508
42,962
(8.0
)
Exited operations
—
(7
)
NM
(10
)
(82
)
NM
Same-store, Print Other Revenue
8,966
10,525
(14.8
)
39,498
42,880
(7.9
)
Digital Other Revenue
5,020
4,355
15.3
19,362
17,955
7.8
Exited operations
—
—
NM
—
—
NM
Same-store, Digital Other Revenue
5,020
4,355
15.3
19,362
17,955
7.8
Total Other Revenue
13,986
14,887
(6.1
)
58,870
60,917
(3.4
)
Exited operations
—
(7
)
NM
(10
)
(82
)
NM
Same-store, Total Other Revenue
13,986
14,880
(6.0
)
58,860
60,835
(3.2
)
Total Operating Revenue
164,011
193,637
(15.3
)
691,138
780,969
(11.5
)
Exited operations
(41
)
(7,197
)
NM
(16,236
)
(36,783
)
NM
Same-store, Total Operating Revenue
163,970
186,440
(12.1
)
674,902
744,186
(9.3
)
NOTES
(1) Total Digital Revenue is defined as digital advertising and marketing services revenue (including Amplified Digital®), digital-only subscription revenue and digital services revenue.
(2) The following are non-GAAP (Generally Accepted Accounting Principles) financial measures for which reconciliations to relevant GAAP measures are included in tables accompanying this release:
Adjusted EBITDA is a non-GAAP financial performance measure that enhances financial statement users overall understanding of the operating performance of the Company. The measure isolates unusual, infrequent or non-cash transactions from the operating performance of the business. This allows users to easily compare operating performance among various fiscal periods and how management measures the performance of the business. This measure also provides users with a benchmark that can be used when forecasting future operating performance of the Company that excludes unusual, nonrecurring or one-time transactions. Adjusted EBITDA is a component of the calculation used by stockholders and analysts to determine the value of our business when using the market approach, which applies a market multiple to financial metrics. It is also a measure used to calculate the leverage ratio of the Company, which is a key financial ratio monitored and used by the Company and its investors. Adjusted EBITDA is defined as net income (loss), plus non-operating expenses, income tax expense, depreciation and amortization, assets loss (gain) on sales, impairments and other, restructuring costs and other, stock compensation and our 50% share of EBITDA from TNI and MNI, minus equity in earnings of TNI and MNI.
Cash Costs represent a non-GAAP financial performance measure of operating expenses which are measured on an accrual basis and settled in cash. This measure is useful to investors in understanding the components of the Company’s cash-settled operating costs. Periodically, the Company provides forward-looking guidance of Cash Costs, which can be used by financial statement users to assess the Company’s ability to manage and control its operating cost structure. Cash Costs are defined as compensation, newsprint and ink and other operating expenses. Depreciation and amortization, assets loss (gain) on sales, impairments and other, other non-cash operating expenses and other expenses are excluded. Cash Costs also exclude restructuring costs and other, which are typically paid in cash.
(3) This earnings release is a preliminary report of results for the periods included. The reader should refer to the Company’s most recent reports on Form 10-Q and on Form 10-K for definitive information.
(4) Same-store revenues is a non-GAAP performance measure based on GAAP revenues for Lee for the current period, excluding exited operations. In 2023, exited operations include (1) businesses divested and (2) the elimination of stand-alone print products discontinued within our markets.
(5) The Company’s debt is the $576 million term loan under a credit agreement with BH Finance LLC dated January 29, 2020 (the “Credit Agreement”). Excess Cash Flow is defined under the Credit Agreement as any cash greater than $20,000,000 on the balance sheet in accordance with GAAP at the end of each fiscal quarter, beginning with the quarter ending June 28, 2020.
(6) TNI refers to TNI Partners publishing operations in Tucson, AZ. MNI refers to Madison Newspapers, Inc. publishing operations in Madison, WI.
WESTON, Fla., Dec. 06, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa” or “the Company”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases with high unmet needs, announced today the pricing of a “reasonable best efforts” public offering of 4,000,000 shares of common stock (or pre-funded warrants in lieu thereof) and accompanying Series A and Series B warrants to purchase up to an aggregate of 8,000,000 shares of common stock at a combined public offering price of $1.25, resulting in gross proceeds of approximately $5.0 million. The Series A Warrants to purchase up to an aggregate of 4,000,000 shares of common stock and Series B Warrants to purchase up to an aggregate of 4,000,000 shares of common stock will have an exercise price of $1.25 per share, will be exercisable immediately following the date of issuance and will expire five years and eighteen months from the original issuance date, respectively.
The closing of the offering is expected to occur on or about December 11, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds of this offering for working capital and other general corporate purposes.
A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.
The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-275320) previously filed with the Securities and Exchange Commission (SEC) which became effective on December 6, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. An electronic copy of the final prospectus will be filed with the SEC and may be obtained, when available, on the SEC’s website located at http://www.sec.gov and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About ZyVersa Therapeutics
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including market and other conditions, ZyVersa’s ability to satisfy all conditions precedent to the closing of the offering; ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate and IR Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
Media Contacts Tiberend Strategic Advisors, Inc. Casey McDonald cmcdonald@tiberend.com 646-577-8520
Dave Schemelia dschemelia@tiberend.com 609-468-9325
NEW YORK, Dec. 6, 2023 /PRNewswire/ — AdTheorent Health, a division of AdTheorent Holding Company, Inc. (Nasdaq: ADTH), a programmatic digital advertising leader using advanced machine learning and privacy-forward solutions to drive advertiser outcomes, today announced that it has earned Neutronian’s NQI Data Quality certification, awarded to companies that maintain the highest standards of data quality, privacy, and transparency. AdTheorent Health received Neutronian’s NQI Data Quality certification for its groundbreaking algorithm-based, ID-independent Health Audiences, powered by HABi™.
Using the most comprehensive, primary-sourced health dataset in market, HABi enables health advertisers to research, create and activate ID-independent health audiences in one platform.
Advertisers can explore de-identified health records in real time based on diagnosis, procedures, prescribed medication, healthcare specialty and many other attributes. Based on the attributes selected, users can see a variety of health Insights, such as top diagnosis, top prescribed medication, top procedures performed, age, gender, and geographical breakdown, and then correlate such insights with available targetable digital media. This allows advertisers to create and activate custom health audiences on the platform that are tailored to their unique objectives. These AdTheorent Health Audiences are ID-independent, privacy-forward and fully customizable with the highest performance in market.
To become Neutronian Certified, AdTheorent Health underwent a comprehensive audit of the processes, procedures and data used to build AdTheorent Health Audiences. The “Certified by Neutronian” badge, supported by proprietary and innovative data-evaluation procedures, helps brand and agency marketers identify top-quality, privacy compliant datasets to use for their marketing efforts. For buyers of marketing data, Neutronian certification provides transparency and clarity with an independent verification of data quality. This eases the data vetting burden on buyers and helps high-quality data providers stand out from the rest.
AdTheorent Health went through a Neutronian’s rigorous audit process covering five main categories of data quality, privacy and transparency including:
CONSENT & COMPLIANCE
Consent standards and opt-in/out process
Privacy and compliance disclosures (ex. GDPR, CCPA, etc.)
SOURCING TRANSPARENCY
Data sources and data capture mechanisms
Transparency of data sources and data use details externally
DATASET CHARACTERISTICS
Type(s) of dataset – deterministic and/or modeled
Data cleansing practices – de-duplication, removal of fraudulent data, etc.
METHODOLOGY &PROCESSING
Data processing and retention controls
Statistical methodology utilization – modeling, weighting, etc.
PERFORMANCE
Methods used to evaluate data accuracy
Frequency of evaluating data performance
AdTheorent Health exceeded all Neutronian Certification criteria, providing marketers the confidence that AdTheorent Health Audiences, built by HABi, have been qualified through an extremely comprehensive and in-depth audit of data sources, processes and privacy compliance.
“Having the highest standard of data quality, privacy and transparency is particularly important in the healthcare industry and we are honored that AdTheorent Health Audiences, built by HABi, received the Neutronian NQI certification,” said Jim Lawson, CEO of AdTheorent. “AdTheorent Health Audiences represent a groundbreaking approach to audience creation, and this certification validates AdTheorent’s position as a leader in privacy-forward and industry compliant healthcare solutions.”
“We are pleased that AdTheorent Health has earned Neutronian Certification for its prioritization of data quality, privacy, and transparency,” said Lisa Abousaleh, CEO and co-founder of Neutronian. “AdTheorent Health’s transparent approach to audience creation, utilizing de-identified health data that is then correlated to real time programmatic signals, allows health marketers to achieve their desired advertising outcomes in the most privacy-forward way possible – this is a tangible differentiator in the health advertising ecosystem.”
About AdTheorent AdTheorent (Nasdaq: ADTH) uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Leveraging only non-sensitive data and focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals.
AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for five consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada. For more information, visit adtheorent.com.
About Neutronian: Neutronian is a SaaS company providing the industry’s most comprehensive approach to data privacy and quality verification. Using a standard evaluation framework, Neutronian produces independent data privacy “credit scores” and in-depth data quality certification. These solutions provide marketers with the transparency they need to confirm that their data and inventory partners are privacy compliant and ensure that their campaigns are running in privacy safe environments. High quality, privacy compliant data providers that work with Neutronian to improve their data privacy scores or achieve certification can be rewarded via faster sales cycles and increased customer trust. For more information, please visit neutronian.com.
