Release – GeoVax Announces Gedeptin® Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients

Research News and Market Data on GOVX

 

Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors

Expanded Development for Monotherapy and Combination Therapy Anticipated

Atlanta, GA, January 4, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin® in patients suffering from advanced head and neck cancer.

Kelly McKee, MD, MPH, GeoVax’s Chief Medical Officer stated, “Completion of this trial will be a significant milestone in our Gedeptin clinical development program. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of this year. In the interim, we are in active discussions with advisors on protocol development in support of a follow-on Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal.  Our intent is to discuss this follow-on protocol with the FDA, in conjunction with a complete review of the results of the current trial, to ensure alignment with the regulator’s expectations.  We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.”

Dr. McKee continued, “Demonstrating the safety, tolerability, and stabilization or shrinkage of injected tumors in patients receiving multiple cycles of Gedeptin opens the door to advancing this promising therapeutic in additional patients with advanced head and neck cancer as well as in patients with other solid tumor types and at multiple points in their therapeutic journey.”

David Dodd, GeoVax’s Chairman and CEO, commented, “We believe that the successful completion of the current trial, in conjunction with earlier findings from the completed Phase 1 first-in-human trial and preclinical investigations, provide a sound rationale for proceeding with further Gedeptin investigations.  These will include adjustments to the Gedeptin treatment regimen and combination with immune checkpoint inhibitors in advanced head and neck cancer as well as for additional cancerous and non-cancerous tumor indications. These advances represent a significant potential opportunity for GeoVax to improve the performance of immune checkpoint inhibitors and/or introduce Gedeptin as a treatment option in patients with earlier-stage disease.”

About Gedeptin®

Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a very toxic antitumor compound in situ.

The ongoing Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entails up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

A previously reported interim data review demonstrated:

  • No dose limiting toxicities or serious adverse events (SAEs) are definitively attributable to treatment. Additionally, no adverse events above grade 3 severity have been reported.
  • Up to 5 cycles of Gedeptin treatment have been administered without limiting sequelae. Intratumoral expression of the PNP transgene by RT-PCR has been established in treated tumors studied to date.
  • Impairment of tumor growth (i.e., “stable disease” using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study.

The current study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program.  The FDA has also granted Gedeptin orphan drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:                  Investor Relations Contact:                  Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – ISG Launches Suite of Applied AI Advisory Services

Research News and Market Data on III

1/4/2024

Firm plans to leverage its longstanding expertise in technology sourcing and governance to help enterprise clients adopt AI at scale

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, has launched a new suite of advisory services to help clients navigate the complexities and implications of adopting artificial intelligence at scale.

“Artificial Intelligence, specifically Generative AI, is the next big thing in technology,” said Michael P. Connors, chairman and CEO of ISG. “Gen AI has risen to the top of the agenda for the world’s largest corporations. Business leaders are already seeking our advice and guidance on the practical applications of this technology, as well as longer-term strategies for scaling AI as the technology grows and matures.”

ISG Research forecasts the global market for AI-related managed services should reach $175 billion by 2030, Connors said.

Organizations already working with ISG on AI engagements include a global hospitality and entertainment company, a major U.S. manufacturer, two major global insurance companies, and a U.S. state government, with many others in discussions with the firm about advancing their AI agenda.

“ISG has always been at the forefront of guiding our clients through the complexities of adopting technology at scale,” said Steve Hall, ISG president and newly appointed as the firm’s first chief AI officer. “Our expansion into applied AI strategy and advisory is our next great leap forward, ensuring businesses can harness AI to drive unprecedented value into every aspect of their operations.”

Hall noted clients trust ISG for its independent advice and long-held expertise in technology sourcing and governance. “Typical of the feedback we’re getting from our clients is this statement: ‘We wanted to get ISG in right at the start of our journey so we can cut through the hype and do this right the first time. This is moving so fast we need to avoid any missteps.’”

ISG’s Applied AI Advisory services help clients assess their AI readiness, identify practical use cases, experiment with proofs of concept, create an AI strategy, and establish a business case for investment. ISG also helps clients select the right business partners and build a cognitive infrastructure to support AI at scale. Finally, ISG provides training and organizational change management, a strategy realization office, and governance through a proprietary AI control plane to help clients mitigate risk and maximize ROI from their AI investments.

ISG was the first sourcing advisory firm to establish a reference architecture for applied Generative AI when it published a September 2023 global study of enterprise use cases. An analysis of the use cases shows AI can lower the cost of IT operations by 30 to 58 percent.

The use cases range from personalizing customer experiences at scale and optimizing supply chain operations to enhancing decision-making through predictive analytics and pioneering the development of new products and services.

The ISG study found that 85 percent of enterprises believe investment in generative AI over the next two years is important, but only a small percentage are achieving tangible results today.

Hall said ISG is looking to help clients move beyond the hype and identify practical applications of AI that can lead to enterprise-wide adoption.

“Our goal is to empower businesses to define their AI-driven future, find the perfect partners to make it a reality, lead change in their organizations, and realize tangible value at a scale,” he said.

Hall noted that successful adoption of AI at scale will require the use of an “AI control plane” to oversee and manage the deployment of artificial intelligence systems.

“An AI control plane encompasses robust security measures to safeguard against data breaches and unauthorized access, ensuring the integrity and confidentiality of sensitive information,” said Hall.

“It also ensures AI operations adhere to legal and ethical standards and avoid biases, protecting users’ rights and promoting fairness, while providing oversight of AI-related expenditures and resource allocation, enabling efficient budget management and cost optimization.”

For more information about ISG’s Applied AI Advisory services, visit this webpage.

About ISG

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

Source: Information Services Group, Inc.

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Release – Kratos and Rancher Government Solutions Announce Strategic Partnership to Enable Customers to Seamlessly Deploy and Scale Virtual Ground Systems Using Kratos’ OpenSpace® Software Platform

Research News and Market Data on KTOS

January 4, 2024 at 8:00 AM EST

First-to-Market OpenSpace Platform is a Software-Based Networking Solution that Connects Space to the Dynamic Ground, Supporting Multiple Satellites, Orbits, Payloads and Services

SAN DIEGO, Jan. 04, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets and Rancher Government Solutions (RGS), the leading provider of enterprise Kubernetes management solutions to the U.S. Government, announced today a strategic partnership to enable customers to seamlessly deploy and scale virtual ground systems using Kratos’ software-based OpenSpace® Platform.

With increasingly complex and dynamic satcom and Earth Observation missions, satellite operators and government agencies are transitioning from fixed and proprietary hardware to flexible and scalable generic compute-based cloud environments. This enables a virtualized and software-defined ground system like Kratos’ OpenSpace Platform to more cost effectively and securely support multiple missions simultaneously, deliver services faster and streamline operations.

Today, customers leverage a range of computing environments from bare metal, virtual machines to the cloud, making the deployment of software-based ground systems more complex and time consuming. Working together, Kratos and Rancher Government Solutions have enhanced the ability of the OpenSpace Platform, the first commercially available, fully virtualized and software-defined satellite ground system to be deployed more easily across customer environments.

“With Rancher, the OpenSpace Platform deploys its virtual functions including modems, channelizers, combiners, and more, as Kubernetes-based containerized software applications that act as independent and portable computing environments that can run and scale on any infrastructure,” said Brandon Gulla, Chief Technology Officer at RGS. “We are proud to be working with Kratos to support this truly transformational platform that will free satellite operators from proprietary hardware architectures and move to software-defined, flexible and extensible virtual platforms.”

By the nature of it being software-defined and containerized, the OpenSpace Platform is already much faster, and more flexible to deploy than traditional hardware-based satellite ground systems. As customer demands grow, the software-based OpenSpace Platform can reconfigure on the fly and deploy new services automatically and cost effectively in minutes. Software containers can be spun up and down and scaled on demand elastically using a single management interface from the Rancher Platform.

“Rancher serves as the Kubernetes management technology that supports the OpenSpace Platform’s ability to automate the deployment, scaling, and management of our containerized workloads,” said Anthony Semiao, Chief Solutions Architect of the OpenSpace Platform. “The combined technologies support hybrid and multi-cloud environments enabling OpenSpace customers to run in the data center and cloud environment of their choice such as Google, Amazon or Microsoft and to easily switch from one cloud provider to another.”

About Kratos OpenSpace
Kratos’ OpenSpace family of solutions enables the digital transformation of satellite ground systems to become a more dynamic and powerful part of the space network. OpenSpace® is the industry’s only commercially available digital transformation solution that enables operators of satellites, Ground Systems-as-a-Service (GSaaS) providers, teleports and others in the satellite services supply chain to capitalize on dynamic ground capabilities. The OpenSpace family consists of three product lines: OpenSpace SpectralNet for converting satellite RF signals to be used in digital environments; OpenSpace quantum products, which are virtual versions of traditional hardware components; and the OpenSpace Platform, the first commercially available, fully orchestrated, software-defined ground system. These three OpenSpace lines enable satellite operators and other service providers to implement digital operations at their own pace and in ways that meet their unique mission goals and business models. For more information about the OpenSpace family, visit www.KratosDefense.com/OpenSpace.

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 utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach reducing cost, schedule and risk, and enabling us to be first to market with cost effective solutions. Kratos is known as the 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 and as a competitive differentiator to our large traditional prime system integrator partners and also to our government and commercial customers. Kratos’ primary business areas include, virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

About Ranger
Rancher Government Solutions (RGS) is specifically designed to address the unique security and operational needs of the U.S. Government and military as it relates to application modernization, containers, and Kubernetes.

Rancher is a complete open source software stack for teams adopting containers. It addresses the operational and security challenges of managing multiple Kubernetes clusters at scale, while providing DevOps teams with integrated tools for running containerized workloads.

RGS supports all Rancher products with U.S. based American citizens who are currently supporting programs across the Department of Defense, Intelligence Community, and civilian agencies. From more information, visit www.ranchergovernment.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.

Kratos Press Contact:
Yolanda White
858-812-7302 Direct

Kratos Investor Information:
877-934-4687
investor@kratosdefense.com

Rancher Government Press Contact:
Don Poole
(844) 747-7779
don.poole@ranchergovernment.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Harte Hanks Extends Line of Credit with Texas Capital Bank

Research News and Market Data on HHS

Extends Existing Line of Credit by Six Months

CHELMSFORD, MA / ACCESSWIRE / January 4, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for 100 years, today announced that the company has extended its $25 million secured revolving line of credit with Texas Capital Bank for an additional six (6) month term, beyond its original maturity date in December, 2024. The revised loan agreement, which now matures at the end of June, 2025, will enhance the Company’s financial flexibility and provide the Company with operational stability over this extended term.

The Company intends to use the credit facility for working capital and to create growth opportunities by investing in and enhancing client offerings.

“Texas Capital continues to be an important partner for Harte Hanks, and we are gratified in their confidence to extend our line of credit,” commented Kirk Davis, Harte Hanks’ Chief Executive Officer. “Having launched our transformation plan, Elevate, in Q3 of 2023, this successful extension supports our growth and transformation initiatives for the future.”

About Harte Hanks:

Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including HBOMax, GlaxoSmithKline, Unilever, Pfizer, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks, Inc.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

SOURCE: Harte Hanks, Inc.



View the original press release on accesswire.com

Release – Cocrystal Pharma Provides an Update on the Clinical Development of its Novel, Broad-Spectrum Antiviral Investigational Candidates

Research News and Market Data on COCP

JANUARY 04, 2024

BOTHELL, Wash., Jan. 04, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) provides an update on the clinical development of its oral first-in-class pan-norovirus and pan-coronavirus dual protease inhibitor CDI-988 and its oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A. CDI-988 and CC-42344 were specifically designed and developed using Cocrystal’s unique structure-based drug discovery technology platform to be effective on a broad range of viruses causing these diseases.

“We are encouraged that the preliminary data of the ongoing Phase 2a and Phase 1 studies showed CC-42344 and CD-988 were well-tolerated with favorable safety profiles,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We see great promise with both of these drug candidates as potential effective oral treatments for highly contagious, pandemic viruses, while also providing significant market opportunities for Cocrystal.”

CDI-988 targets a highly conserved region in the active site of the main 3CL protease required for viral RNA replication for pandemic norovirus and coronaviruses, including SARS-CoV-2. CDI-988 is being evaluated for safety and pharmacokinetics in a randomized, double-blinded, placebo-controlled Phase 1 study in healthy subjects being conducted in Australia. The Company reports favorable preliminary data from the single-ascending dose cohorts of the clinical study. Cocrystal expects to report topline results from the Phase 1 study this year.

CC-42344 binds to a highly conserved PB2 site of the influenza A polymerase complex and exhibits a novel mechanism of action that inhibits viral replication. A randomized, double-blind, placebo-controlled Phase 2a clinical study with CC-42344 is underway in the United Kingdom. The Company reports favorable tolerability and safety in the first cohort of the Phase 2a influenza A challenge study and expects to report topline results from the Phase 2a clinical study this year. In 2022 Cocrystal reported favorable safety and tolerability results in the healthy volunteer Phase 1 study with CC-42344 conducted in Australia.

About Norovirus

Although norovirus is a worldwide public health problem, there are no effective treatments or vaccines. Norovirus afflicts an estimated 685 million people annually at an estimated societal cost of $60 billion. About 200 million cases are seen among children under 5 years old, leading to an estimated 50,000 child deaths every year, mostly in developing countries, according to the Centers for Disease Control and Prevention (CDC). CDI-988 in vitro studies showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases, which have caused the majority of norovirus outbreaks worldwide since 2002, and a favorable pharmacokinetic property targeting the gastrointestinal tract.

About COVID-19
COVID-19 hospitalizations have recently increased in the U.S. with the new JN.1 variant responsible for about 20% of these cases. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031. The ability of someone with no symptoms to transmit infection to another person has heightened the public health challenge of COVID-19. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern. By targeting the viral replication protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including COVID-19 and its variants, as well as for Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

About Seasonal Influenza
Each year there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the promise and potential of the two product candidates, the clinical development of CC-42344 as a product candidate for oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A and the Phase 2a study for such product candidate, CC-988 as a product candidate for dual oral antiviral inhibitor for the treatment of coronavirus and norovirus and the Phase 1 study for such product candidate, the potential efficacy and clinical benefits of, and market for, such product candidates, and the expected results and topline data from these clinical trials in 2024. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, and the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released January 4, 2024

Release – ZyVersa Therapeutics Announces Equity Research Coverage Initiated by Noble Capital Markets

Research News and Market Data on ZVSA

Jan 4, 2024

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  • ZyVersa is developing two proprietary product platforms targeting renal and inflammatory diseases.
  • Cholesterol Efflux MediatorTM VAR 200, designed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.
  • Inflammasome ASC Inhibitor IC 100, designed to inhibit multiple inflammasome pathways to attenuate initiation and perpetuation of damaging inflammation pathogenic in numerous inflammatory diseases.

WESTON, Fla., Jan. 04, 2024 (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 that Noble Capital Markets has initiated company-sponsored equity research coverage. To obtain a copy of the full report authored by Noble Capital Markets’ Senior Research Analyst Robert LeBoyer, as well as news and advanced market data on ZyVersa Therapeutics, please go to Channelchek.com.

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 clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the kidneys’ filtration system. 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.

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small/microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. For more information, please visit www.noblecapitalmarkets.com or email: contact@noblecapitalmarkets.com.

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. For more information, go to www.channelchek.com or email: contact@channelchek.com.

Cautionary Statement Regarding Forward-Looking Statements

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.

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
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
Dschemelia@tiberend.com
609-468-9325

Release – V2X wins $190M U.S. Army Contract to Enhance Warfighter Readiness in Middle East Operations

Research News and Market Data on VVX

January 4, 2024

MCLEAN, Va., Jan. 4, 2024 /PRNewswire/ — V2X, Inc. (NYSE: VVX) was awarded a $190 million contract from the U.S. Army as part of the United States Army Central Command (USARCENT) Training and Range Operations Maintenance Services Contract (ATROMS). The competitively bid firm-fixed-price contract will span five-years, continuing V2X’s support to USARCENT’s mission in Kuwait as well as other locations within the U.S. Central Command (USCENTCOM) Area of Responsibility (AOR). V2X will provide training support services as well as instruction, operation, and maintenance of Training Aids, Devices, Simulators and Simulations (TADSS). These services are crucial in expanding the USARCENT ability to not only maintain but enhance warfighter readiness.

“With this significant contract award, V2X reaffirms its commitment to bolstering the U.S. Army’s training and operational capabilities in dynamic environments,” said Chuck Prow, President and Chief Executive Officer at V2X. “Our proven expertise and dedication underscore our mission to empower the warfighter’s readiness for any challenge.”

Given the challenging dynamics of the Middle East and USCENTCOM AOR landscapes, the contract facilitates the rapid deployment of a multitude of Live, Virtual, and Constructive (LVC) resources, effectively enhancing the strategic positioning of USARCENT.

About V2X

V2X builds smart solutions designed to integrate physical and digital infrastructure – from base to battlefield – by aligning people, actions, and outputs. Formed by the merger of Vectrus and Vertex, we bring a combined 120 years of successful mission support. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.

The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian, and international clients. Our global team of approximately 15,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations, to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

Media Contact
Angelica Spanos Deoudes
Senior Media Strategist
Communications@goV2X.com
571-338-5195

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-wins-190m-us-army-contract-to-enhance-warfighter-readiness-in-middle-east-operations-302025734.html

SOURCE V2X, Inc.

Release – Snail Games’ ARKade Ambassador Program Reshapes Gaming Connections

Research News and Market Data on SNAL

January 3, 2024 at 4:06 PM EST

A Community Journey, 186M+ Minutes Strong

CULVER CITY, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail” or “the Company”), a leading, global independent developer and publisher of interactive digital entertainment, introduced the ARKade Ambassador Program, an influencer community initiative designed to express gratitude to and foster connections among creators within the ARK community, alongside the launch of ARK Survival Ascended on Steam. The distinctive perspectives and insightful contributions of these creators have played a pivotal role in uncovering community insights and generating genuine feedback. This involvement has led to an impressive viewership of 186,509,155+ minutes of ARKade content, establishing a robust and captivated audience.

The success of ARKade has been further enhanced by the support of notable sponsors such as MadCatz, Streamlabs, and Glytch, who have generously sponsored ARKade prizes for streamers. These strategic collaborations not only elevate the experience for content creators but also opens the door for future collaborative opportunities as the ARK franchise continues to grow.

“We are thrilled with the enthusiastic response ARKade has received from both content creators and sponsors,” Jim Tsai, Chief Executive Officer of Snail, Inc. “The numbers speak for themselves, and the success of the ARKade Ambassador Program is a testament to the engaging and immersive nature of ARK Survival Ascended.”

Looking ahead, Snail Games is excited to build on this momentum, fostering new connections, and expanding collaborations with creators and brands as they continue to evolve the ARK franchise.

Checkout our ARKade Sponsors:
http://www.madcatz.com/
https://glytchenergy.com/
https://streamlabs.com/

About Snail, Inc.- https://www.snailgamesusa.com/
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.

Contacts:

Investors:
investors@snail.com

Press:
Media@snailgamesusa.com

Release – GeoVax Announces Issuance of Malaria Vaccine Patent

Research News and Market Data on GOVX

 

Patent Covers Multiple Component Vaccine for Both Prevention and Treatment

Atlanta, GA, January 3, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,857,611 to GeoVax, pursuant to the Company’s patent application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”

The claims granted by the patent generally cover compositions comprising GeoVax’s modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.

David Dodd, GeoVax President and CEO, commented, “During 2023, there were the first cases of locally transmitted malaria reported in the United States in 20 years, with cases reported in Florida, Maryland and Texas. Worldwide, there are over 600,000 deaths annually attributed to malaria. This patent represents a potentially significant advance against a most critical deadly threat worldwide. While our focus and priority is to support our clinical-stage programs, we also remain strongly committed to improving public health worldwide and developing vaccines against global public health threats, such as malaria, as a part of our long-term vision for the company.”

According to data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite’s life cycle. GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:             Investor Relations Contact:             Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – ZyVersa Therapeutics CEO, Stephen C. Glover, Issues Letter to Shareholders Providing Outlook for 2024

Research News and Market Data on ZVSA

Jan 3, 2024

PDF Version

WESTON, Fla., Jan. 03, 2024 (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 that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Letter to Shareholders providing a corporate outlook with anticipated milestones for 2024. The full text of the letter follows.

A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUTIVE OFFICER

To my fellow shareholders,

Like so many in the biotech and pharmaceutical industry, we are looking forward to 2024 with great optimism for improved conditions in the financial markets and a milestone-rich year in the development of our lead renal and anti-inflammatory therapeutic candidates, which is expected to drive value for our shareholders. Our renal and inflammatory disease pipelines each have potential to address multiple indications. Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.

On the financial front, various market watchers are seeing signals that the biotech and pharma investment environment is set to trend positively in 2024. Capital is again starting to flow to companies that are seeking to innovate through differentiated technologies or novel mechanisms of action. Near the end of 2023, we began to witness an increase in financings and an uptick in M&A across multiple sectors from inflammatory diseases to oncology. These were driven by investors targeting high upside opportunities and large pharma seeking to re-energize their product pipelines. Our team at ZyVersa shares this optimism, anticipating improved conditions as we focus our efforts on developing innovative, disease-modifying treatments to help improve patients’ quality of life.

We are looking forward to an active first quarter of this new year, including initiation of our first clinical trial for our Cholesterol Efflux MediatorTM VAR 200. VAR 200 is designed to ameliorate renal lipid accumulation that damages the kidney’s filtration system. Currently there are no approved treatments that target lipid accumulation, which is known to contribute to structural damage, proteinuria, and progression of kidney disease. The current standard of care addresses glomerular hypertension and inflammation.

We are on schedule to initiate our Phase 2a clinical trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024. This will be an open label trial for real-time data reads. Initial data is anticipated to be available mid-year. DKD represents a significant area of unmet need, as it is the leading cause of end-stage kidney disease, requiring dialysis or kidney transplant for survival. 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. We are optimistic that the protection against kidney injury, fibrosis, and disease progression that was demonstrated with VAR 200 in animal models of three different kidney diseases will translate to humans. Data from our initial Phase 2a trial will not only provide proof-of-concept for VAR 200 in renal patients, it will also provide valuable insights for designing future trials with VAR 200 in other planned renal indications, including two rare kidney diseases, focal segmental glomerulosclerosis (FSGS) and Alport syndrome.

We are equally excited about our progress in the development of our proprietary Inflammasome ASC Inhibitor IC 100, which is designed to block initiation and perpetuation of damaging inflammation that contributes to a multitude of inflammatory diseases. A growing body of scientific literature reinforces the central role of multiple types of inflammasomes in the development and progression of inflammatory diseases, and we continue to report on these developments as they are published. By inhibiting Inflammasome ASC rather than a sensor molecule such as NLRP3, IC 100 targets multiple types of inflammasome pathways (including NLRP3, NLRP1, and AIM2), which is expected to provide better control of damaging inflammation and its perpetuation.

The IC 100 preclinical program is nearing completion and IND submission is planned for the fourth quarter of 2024, with Phase 1 trial initiation expected shortly thereafter.

Two Platforms, Singular Vision

We view 2024 as a potentially transformative year for ZyVersa based on the value-building milestones that we expect to achieve over the next 12 to 15 months. I look forward to working with my leadership team and fellow Board members to execute a business and clinical strategy that has potential to position ZyVersa as a leading and innovative company developing transformative drugs for underserved patients with renal and inflammasome-mediated inflammatory diseases.

Though our platforms are independent from each other, our mission is singular – to develop drug therapies that can restore health and improve quality of life for patients living with the often debilitating symptoms of renal and inflammatory diseases. We look forward to embarking on what we believe will be a productive 2024. We thank you for your continued support.

Sincerely,
Stephen C. Glover
Co-Founder, Chairman, Chief Executive Officer, and President
ZyVersa Therapeutics

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.

Cautionary Statement Regarding Forward-Looking Statements

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

Release – Greater Boston-Based Harte Hanks Continues Growth Phase with Addition of Global Advertising Executive Elizabeth Ross to Board of Directors

Research News and Market Data on HHS

After relocating its Headquarters to Massachusetts, the 100-year-old public company is optimizing its growth strategy with operational and leadership advancements

CHELMSFORD, MA / ACCESSWIRE / January 3, 2024 / Harte Hanks, Inc. (NASDAQ:HHS), a global sales, marketing, and customer experience company with 3,000 employees in 10 offices worldwide, announced this week the addition of corporate advertising leader Elizabeth Ross to the Board of Directors, effective January 2, 2024. Ross’s appointment to the Board is a well-planned part of Harte Hanks’ exciting growth-phase strategy, launched in 2023 with the company’s 100-year anniversary and appointment of industry-veteran Kirk Davis as the new CEO.

As the current CEO of Shift Paradigm, a leading growth and technology business partner, Elizabeth Ross brings decades of agency experience in B2B and B2C marketing. She is a growth-focused executive with expertise creating concepts and driving value for some of the world’s biggest brands, including Target, United Health, PepsiCo, Walmart, and Microsoft.

“In building our Board, we knew we wanted a strategic and creative thinker with a track record of driving growth and value. Elizabeth Ross is an excellent fit for us. Harte Hanks is a customer company-we help our clients better understand, attract, and engage their customers. Elizabeth brings a tremendous amount of real market knowledge and experience to this customer-facing domain. We are very pleased to welcome her to Harte Hanks,” said Jack Griffin, Chairman of the Board of Directors.

“I’ve spent a lot of my career at the intersection of technology, people, and insights, and Harte Hanks is a dynamic company innovating in this space on a global scale,” says Elizabeth Ross. “I’m honored and excited to join the Board. Harte Hanks is very well positioned to build on its impressive base of services. In my many conversations with Kirk [Davis] and the Board, it’s clear we share a growth and development mindset and a vision of capitalizing on advancements in technology to personalize and improve business services and transactions.”

“Elizabeth’s deep experience in formulating marketing strategy, applying technology to business, expanding client relationships and leading agencies adds immediate strategic value to our plans for 2024,” says Kirk Davis, CEO. “Technology-driven agency services are a segment of the Harte Hanks portfolio we plan to grow in 2024-2025, so her insight and background will be an important asset to us.”

Founded in 1923, Harte Hanks is a leading global customer experience company that partners with clients to provide CX strategy, data-driven analytics and actionable insights combined with seamless program execution for optimized customer engagement. Harte Hanks drives measurable results in both sales and customer loyalty for an ever-growing list of blue-chip companies and their brands including HBOMax, GlaxoSmithKline, Unilever, Pfizer, Volvo, Ford, FedEx, Blue Cross/Blue Shield, Sony, IBM, and more.

For More Information, please contact:
Robert Wyman
Robert.Wyman@HarteHanks.com
978-265-8919

SOURCE: Harte Hanks, Inc.



View the original press release on accesswire.com

Release – Kelly Completes Sale of European Staffing Business to Gi Group Holdings S.P.A.

Research News and Market Data on KELYA

January 3, 2024

  • Sharpens its focus on higher margin, higher growth global managed service provider (MSP) and recruitment process outsourcing (RPO), and North American specialty outcome-based and staffing services
  • Accelerates transformation to deliver significantly improved net margin
  • Cash proceeds to be redeployed in pursuit of growth through organic and inorganic investments

TROY, Mich., Jan. 03, 2024 (GLOBE NEWSWIRE) —  Kelly (Nasdaq: KELYA, KELYB), a leading global specialty talent solutions provider, today announced it has completed the sale of its European staffing business to Gi Group Holdings S.P.A. (“Gi”). Kelly previously announced on November 2, 2023, that it had entered into a definitive agreement to sell the business to Gi.

“Today is a significant milestone in Kelly’s journey to become a more focused enterprise positioned to accelerate profitable growth,” said Peter Quigley, president and chief executive officer. “By further streamlining the company’s operating model to focus on higher margin, higher growth business and unlocking significant capital, we have greater flexibility and capacity to invest where we can compete and win over the long term.”

Kelly received cash proceeds of €100 million upon closing the transaction. Additional proceeds from an earnout provision based on a multiple of an adjusted 2023 EBITDA measure would be payable in the second quarter of 2024 if achieved.

With the sale of Kelly’s European staffing business, the company’s operating model comprises four reportable segments focused on global MSP and RPO solutions, and North American specialty outcome-based and staffing services. The segments include Professional & Industrial; Science, Engineering & Technology; Education; and Outsourcing & Consulting Group. The company retains its MSP, RPO, and functional service provider business, maintaining a global capability in these businesses in the North America, Asia Pacific, and Europe, Middle East, and Africa regions.

The sale also accelerates the company’s efforts to significantly improve its EBITDA margin through its ongoing business transformation initiative, contributing approximately 30 basis points of favorable impact on a pro forma, full year 2023 basis. By combining this impact with the benefit of a full year of expected transformation-related savings and current top-line expectations, the company would expect to achieve a normalized, adjusted EBITDA margin in the range of 3.3% to 3.5%.

DLA Piper served as legal counsel to Kelly.

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 450,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2022 was $5.0 billion. Learn more at kellyservices.com.

Forward-Looking Statements

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

KLYA-FIN

ANALYST CONTACT:  MEDIA CONTACT:
Scott Thomas  Jane Stehney
(248) 251-7264  (248) 765-6864
scott.thomas@kellyservices.com   stehnja@kellyservices.com 

Release – The ODP Corporation Announces HG Vora Representative Steps Down from Board of Directors

Research News and Market Data on ODP

BOCA RATON, Fla.–(BUSINESS WIRE)–Jan. 2, 2024– The ODP Corporation (“ODP,” or the “Company”) (NASDAQ:ODP), a leading provider of business services, products and digital workplace technology solutions to businesses and consumers, today announced that, following the expiration of the January 2021 Cooperation Agreement between the Company and HG Vora, Marcus Dunlop, partner at HG Vora, has stepped down from the ODP Board of Directors, effective December 31, 2023.

“We greatly appreciate Marcus Dunlop’s service as a Board member over the past three years,” said Joseph S. Vassalluzzo, Chairman of ODP’s Board. “The Board thanks him for his insightful perspectives during his time as a Director and respects his decision to step down at this time. HG Vora continues to be an important independent shareholder of ODP.”

“I have seen firsthand ODP’s commitment to creating shareholder value through its focus on efficient operations,” said Marcus Dunlop, partner at HG Vora. “We remain supportive of the Board’s ongoing efforts to execute on its long-term strategy and shareholder-focused capital allocation plan.”

HG Vora owns 3.0 million shares, or approximately 8% of the Company’s outstanding common stock.

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 omni-channel presence, which includes 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 ODP Business Solutions, LLC; Office Depot, LLC; Veyer, LLC; and Varis, Inc, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.

ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. Varis is a trademark of Varis, Inc. Grand&Toy is a trademark of Grand & Toy, LLC in Canada. ©2023 Office Depot, LLC. All rights reserved. Any other product or company names mentioned herein are the trademarks of their respective owners.

FORWARD LOOKING STATEMENTS

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements or disclosures may discuss goals, intentions and expectations as to future trends, plans, events, results of operations, cash flow or financial condition, the potential impacts on our business due to the unknown severity and duration of the COVID-19 pandemic, or state other information relating to, among other things, the Company, based on current beliefs and assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “expectations”, “outlook,” “intend,” “may,” “possible,” “potential,” “predict,” “project,” “propose” or other similar words, phrases or expressions, or other variations of such words. These forward-looking statements are subject to various risks and uncertainties, many of which are outside of the Company’s control. There can be no assurances that the Company will realize these expectations or that these beliefs will prove correct, and therefore investors and stakeholders should not place undue reliance on such statements.

Factors that could cause actual results to differ materially from those in the forward-looking statements include, among other things, highly competitive office products market and failure to differentiate the Company from other office supply resellers or respond to decline in general office supplies sales or to shifting consumer demands; competitive pressures on the Company’s sales and pricing; the risk that the Company is unable to transform the business into a service-driven, B2B platform that such a strategy will not result in the benefits anticipated; the risk that the Company will not be able to achieve the expected benefits of its strategic plans, including its strategic shift to maintain all of its businesses under common ownership; the risk that the Company may not be able to realize the anticipated benefits of acquisitions due to unforeseen liabilities, future capital expenditures, expenses, indebtedness and the unanticipated loss of key customers or the inability to achieve expected revenues, synergies, cost savings or financial performance; the risk that the Company is unable to successfully maintain a relevant omni-channel experience for its customers; the risk that the Company is unable to execute the Maximize B2B Restructuring Plan successfully or that such plan will not result in the benefits anticipated; failure to effectively manage the Company’s real estate portfolio; loss of business with government entities, purchasing consortiums, and sole- or limited- source distribution arrangements; failure to attract and retain qualified personnel, including employees in stores, service centers, distribution centers, field and corporate offices and executive management, and the inability to keep supply of skills and resources in balance with customer demand; failure to execute effective advertising efforts and maintain the Company’s reputation and brand at a high level; disruptions in computer systems, including delivery of technology services; breach of information technology systems affecting reputation, business partner and customer relationships and operations and resulting in high costs and lost revenue; unanticipated downturns in business relationships with customers or terms with the suppliers, third-party vendors and business partners; disruption of global sourcing activities, evolving foreign trade policy (including tariffs imposed on certain foreign made goods); exclusive Office Depot branded products are subject to additional product, supply chain and legal risks; product safety and quality concerns of manufacturers’ branded products and services and Office Depot private branded products; covenants in the credit facility; general disruption in the credit markets; incurrence of significant impairment charges; retained responsibility for liabilities of acquired companies; fluctuation in quarterly operating results due to seasonality of the Company’s business; changes in tax laws in jurisdictions where the Company operates; increases in wage and benefit costs and changes in labor regulations; changes in the regulatory environment, legal compliance risks and violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws; volatility in the Company’s common stock price; changes in or the elimination of the payment of cash dividends on Company common stock; macroeconomic conditions such as higher interest rates and future declines in business or consumer spending; increases in fuel and other commodity prices and the cost of material, energy and other production costs, or unexpected costs that cannot be recouped in product pricing; unexpected claims, charges, litigation, dispute resolutions or settlement expenses; catastrophic events, including the impact of weather events on the Company’s business; the discouragement of lawsuits by shareholders against the Company and its directors and officers as a result of the exclusive forum selection of the Court of Chancery, the federal district court for the District of Delaware or other Delaware state courts by the Company as the sole and exclusive forum for such lawsuits; and the impact of the COVID-19 pandemic on the Company’s business. The foregoing list of factors is not exhaustive. Investors and shareholders should carefully consider the foregoing factors and the other risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. The Company does not assume any obligation to update or revise any forward-looking statements.

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

Source: The ODP Corporation