Category:

Release – Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

January 28, 2025 7:00am EST 

Large pill size, high pill burden and palatability were identified as key barriers for phosphate binder adherence

LOS ALTOS, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of a review on patient perspectives regarding phosphate management in the peer-reviewed journal, Journal of Nephrological Science.

The publication, entitled “Patient Perspectives: The Effects of Contemporary Phosphorus Management on Quality of Life,” examines the challenges of phosphate management therapies from patients’ viewpoints, focusing on the limitations of current phosphate binders and their effect on patients’ quality of life. The publication underscores key findings from patient surveys and medical literature, identifying critical barriers to effective phosphorus management and emphasizing the need for patient-centered approaches to improve clinical outcomes and patient satisfaction.

“In therapeutic categories with significant patient non-adherence to standard of care like chronic kidney disease (CKD), it is essential to understand the factors disrupting medical intervention in order to offer physicians and patients innovative solutions,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe products like Oxylanthanum Carbonate (OLC), which is characterized by small pill size, lower pill burden, and easy-to-swallow tablets, have the potential to address many of the inherent challenges in phosphorus management that often lead to nonadherence and poor serum phosphate control. If approved, we look forward to offering OLC to CKD patients on dialysis with hyperphosphatemia.”

Key Findings:

  • Hyperphosphatemia is linked to increased mortality risk.
  • Dialysis patients often face a high daily pill burden, with phosphate binders making up about 50% of the total.
  • Nonadherence to phosphate binders is a significant challenge contributing to elevated phosphate levels. Studies show non-adherence rates range from 22% to 74%, with a mean non-adherence rate of 51%.
  • Factors contributing to non-adherence include large pill size, high pill burden, and unpleasant gastrointestinal side effects. Social factors and timing complexities also impact adherence.
  • Engaging patients in discussions about different phosphate binders and their unique characteristics is key to improving adherence and satisfaction. New therapies that reduce pill size or burden while maintaining efficacy could enhance clinical outcomes, quality of life, and the patient-clinician relationship.

The full publication can be accessed here.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source:

Released January 28, 2025

The ODP Corporation (ODP) – Expanding the Addressable Market

Posted on by cpereira@noblefcm.com


Tuesday, January 28, 2025

Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services. It offers merchandise, such as general office supplies, computer supplies, business machines and related supplies, and office furniture through its chain of office supply stores under the Office Depot, Foray, Ativa, Break Escapes, Worklife, and Christopher Lowell brand names. The company also provides graphic design, printing, reproduction, mailing, shipping, and other services through design, print, and ship centers. It has operations throughout North America, Europe, Asia, and Central America. The company also sells its products and services through direct mail catalogs, contract sales force, Internet sites, and retail stores, through a mix of company-owned operations, joint ventures, licensing and franchise agreements, alliances, and other arrangements. As of December 31, 2008, Office Depot operated 1,267 North American retail division office supply stores and 162 international division retail stores, as well as participated under licensing and merchandise arrangements in 98 stores. The company was founded in 1986 and is based in Boca Raton, Florida.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

A Hospitality Agreement. The ODP Corporation’s Business Solutions segment entered into a key new partnership with one of the world’s largest hotel management organizations, becoming a preferred provider for operating supplies and equipment. We believe expansion into the hospitality market is a strategic step forward for ODP which leverages the Company’s expertise and represents a major inflection point for the Company. In our view, ODP is well positioned to pursue growth in new and growing industry segments.

Details. Under the new agreement, ODP will provide high-quality textiles for bed and bath products. It will also distribute liquid beauty products and lodging kits, all uniquely packaged to accommodate the needs of every client and guest. The expansion of their product portfolio also includes hotel room technology and in-room amenities.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Kratos Defense & Security (KTOS) – Raising Price Target

Posted on by cpereira@noblefcm.com


Tuesday, January 28, 2025

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Raising Price Target. We are maintaining our Outperform rating but raising our price target on KTOS shares to $38 from a prior $30. KTOS shares have performed well since we raised our price target to $30 in mid-November and have spent the last two weeks above our old target. We remain positive on the growth potential for Kratos, both on the defense and commercial sides.

Drivers. We continue to believe KTOS shares benefit from investor belief in the Trump Administration’s determination to increase defense spending and allocate more dollars to areas in Kratos’ wheelhouse, such as unmanned systems, hypersonics, and space. We also expect less friction from a drawn-out continuing resolution.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

DeepSeek Shakes Wall Street: How a Chinese AI Upstart Threatens U.S. Tech Dominance

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– DeepSeek’s cost-effective AI model challenges U.S. tech giants, raising doubts about massive AI spending.
– The R1 model, developed for under $6 million, rivals OpenAI’s ChatGPT, sparking investor concerns.
– Wall Street reacts sharply, with major tech stocks like Nvidia and Microsoft experiencing significant drops.

The AI revolution, which has captivated Wall Street and reshaped the tech landscape, is facing a new challenge. DeepSeek, a Chinese AI startup, has emerged as a formidable competitor to U.S. tech giants, sparking concerns about the future of American AI leadership. With its cost-effective and high-performing AI model, DeepSeek is not only disrupting the market but also forcing investors to rethink the exorbitant spending habits of Silicon Valley.

DeepSeek’s R1 model, released in late January 2025, has quickly gained traction, topping iPhone download charts in the U.S. and rivaling OpenAI’s ChatGPT in performance benchmarks. What sets DeepSeek apart is its ability to achieve these results at a fraction of the cost. While OpenAI’s GPT models reportedly cost over 100 million to train, DeepSeek claims its breakthrough was developed for less than 6 million. This stark contrast has raised questions about the necessity of the massive investments being made by U.S. tech companies.

The implications of DeepSeek’s success are far-reaching. If cheaper alternatives can deliver comparable results, the current AI development process—built on expensive chips and vast amounts of data—could be upended. This has already sent shockwaves through Wall Street. Nvidia, a key player in the AI chip market, saw its stock drop by more than 12%, while other tech giants like Microsoft, Alphabet, and Amazon also experienced declines. The broader market felt the impact, with the Nasdaq Composite sinking 2.2% as investors grappled with the potential risks to tech’s growth trajectory.

The financial significance of prominent tech players weighed down the entire market. All three major indexes were in the red, with the tech-heavy Nasdaq Composite sinking 2.2%. A slowdown in tech also highlighted how reliant the broader market is on Silicon Valley to continue to deliver growth. Any risk to tech’s upward trajectory can have an outsize impact on Wall Street.

DeepSeek’s rise also underscores the complexities of the global tech race. Despite U.S. export controls on advanced chips designed to curb China’s AI progress, DeepSeek’s engineers managed to innovate using less advanced technology. This not only challenges the effectiveness of such restrictions but also highlights China’s growing ability to compete in the AI arena.

The global battle over tech supremacy has escalated in recent years, evolving into a key theme in foreign policy. Logistic shocks brought on by the Covid pandemic also underscored the importance of domestic supply chains and protecting access to key technology. The US has attempted to maintain its edge in advanced tech by banning the export of certain goods in the interest of national security. Cutting edge GPU semiconductors, the kind used in building out advanced AI tools, are among the the technologies that American firms are restricted from selling to China.

But the early success of DeepSeek, which was purportedly developed for mere millions, indicates its engineers were able to essentially circumvent those restrictions by working with less advanced technology. The export controls were designed to prevent or slow China’s AI progress. But in forcing Chinese technologists to work without the most cutting-edge tools, a foreign competitor managed to develop a far cheaper and perhaps more innovative model.

As Wall Street reevaluates the AI spending boom, DeepSeek’s emergence serves as a reminder that innovation doesn’t always come with a hefty price tag. The question now is whether U.S. tech giants can adapt to this new reality or if they risk being outpaced by more cost-efficient competitors.

Diversified Expands Portfolio with Strategic Maverick Natural Resources Acquisition

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– $1.275B deal creates $3.8B energy giant with doubled production
– Shifts from gas-heavy to balanced oil/gas portfolio
– 3.3x EBITDA price with $345M cash flow; EIG takes 20% stake

Diversified Energy (NYSE:DEC) made waves in the energy sector Monday with its $1.275 billion acquisition of Maverick Natural Resources, a move that signals a major shift in domestic energy production strategy and could spark further consolidation in the industry.

The deal, which combines two major players in the U.S. energy market, is set to nearly double Diversified’s revenue and significantly boost its free cash flow, according to company statements. Market observers note this could mark the beginning of a new wave of consolidation in the domestic energy sector, as companies seek to build scale and efficiency in an increasingly competitive market.

“This acquisition expands our unique and highly focused energy production company with a complementary portfolio of attractive, high-quality assets,” said Rusty Hutson, Jr., CEO of Diversified. The combined company will boast an enterprise value of approximately $3.8 billion and operate across five distinct regions, with production reaching approximately 1,200 MMcfe/d.

What’s catching investors’ attention is the deal’s attractive valuation at roughly 3.3 times LTM EBITDA, suggesting Diversified may have found value in a market where quality assets often command premium multiples. The transaction structure, including the assumption of $700 million in Maverick debt and the issuance of 21.2 million new shares, appears designed to maintain financial flexibility while expanding the company’s operational footprint.

Perhaps most significantly, the merger dramatically shifts Diversified’s production mix. While the company has historically been heavily weighted toward natural gas with about 85% of production, Maverick brings a more balanced portfolio with 55% liquids production. This diversification could prove crucial in navigating volatile energy markets.

The deal also marks a strategic entry into the coveted Permian Basin, while strengthening Diversified’s position in the Western Anadarko Basin. Industry analysts suggest this multi-basin exposure could provide valuable operational flexibility and help mitigate regional production risks.

EIG, a major energy-focused investor, will emerge as a significant stakeholder, owning approximately 20% of the outstanding shares post-merger. This backing from a sophisticated institutional investor may provide additional validation for Diversified’s growth strategy.

Looking ahead, the combined company is positioned to benefit from substantial operational synergies and improved market presence. With a projected free cash flow of $345 million, the merged entity should have ample resources to fund both growth initiatives and shareholder returns.

The transaction, expected to close in the first half of 2025, still requires shareholder approval and regulatory clearance. However, with unanimous board approval and strong strategic rationale, the deal appears well-positioned to move forward.

For investors watching the energy sector, this merger could signal a broader trend toward consolidation as companies seek to build scale and improve operational efficiency in an evolving market landscape. The success of this integration could set a template for future deals in the domestic energy sector.

Take a moment to take a look at Senior Research Analyst Mark Reichman’s Industrials and Basic Industries coverage list.

Release – GeoVax Advanced MVA Manufacturing Process: Aimed to Enhance Vaccine Supply Worldwide

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 27 January 2025
  • Created: 27 January 2025
  • Hits: 60

Process Expected to Increase Production Yield, Flexibility at Lower Cost

Atlanta, GA – January 27, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today’s pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing.

The Power and Versatility of the MVA Platform

The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including:

  • Protection against diseases such as Mpox and smallpox.
  • Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2.
  • Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings.

Advancing MVA Manufacturing

Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines.  GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include:

  • A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs.
  • Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs.

This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines.

Addressing Global Health Needs

“Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative,” said David Dodd, Chairman and CEO of GeoVax. “By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises.”

GeoVax’s MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale.

Recent Conference Presentations

GeoVax CEO David Dodd recently presented the company’s strategic initiatives and the potential of GEO-MVA at:

  • Biotech Showcase: January 14, 2025
  • Emerging Growth Conference: January 16, 2025

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned to initiate in mid-2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, 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 austin.murtagh@precisionaq.com sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Release – Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to Initiate Phase 1 Clinical Trial Evaluating First-in-Class OCU500 Inhaled Vaccine Candidate for COVID-19

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

January 27, 2025

PDF Version

  • OCU500 will be administered via inhalation and as a nasal spray
  • COVID-19 remains a substantial public health threat in the U.S. and around the world
  • Phase 1 clinical trial is anticipated to start in 2Q 2025

MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray.

“We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen,” said Mike Shine, Senior Vice President, Commercial at Ocugen. “COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”

Even though the pandemic has ended, COVID-19 still presents a significant burden in the U.S. The Centers for Disease Control (CDC) estimates that from October 1, 2024 to January 11, 2025, there were 4.4 to 7.9 million COVID infections, resulting in 120,000 to 210,000 hospitalizations and 14,000 to 25,000 deaths.

The Phase 1 trial would enroll 80 adult subjects aged 18 to 64 years. Forty (40) subjects would be assigned to the low-dose group, and 40 subjects would be assigned to the high-dose group. Within each group, 20 subjects would receive the inhalation form of the vaccine, and the other 20 subjects would receive the intranasal form. The primary aim of the study would be to determine safety, while secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.

OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered via inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered intramuscularly. Ocugen intends to expand this mucosal platform to address other serious respiratory threats including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).

The original ChAd36 vector that makes the Ocugen vaccine unique was licensed from Washington University in St. Louis.

“We are delighted to see the progress of the ChAd36 vector encoding a SARS-CoV-2 spike antigen that was originally designed and tested at Washington University in St. Louis,” said Dr. Michael Diamond, Professor of Medicine and Co-Director of the Center for Vaccines and Immunity to Microbial Pathogens at Washington University School of Medicine. “We believe this vector is ideal for mucosal administration and can be designed to carry COVID-19 strains as well as influenza and antigens from other respiratory viruses,” added Dr. David Curiel, Professor of Radiation Oncology, Washington University School of Medicine, co-collaborator on the vector design. 

Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.

“Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern,” said Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. “This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu.”

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.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU500 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

Release – Townsquare Forms Strategic Alliance With Steel City Media

Posted on by aweinsoff@channelchek.com

Research News and Market Data On TSQ

Jan 27, 2025 

Purchase, NY – January 27, 2025 – Townsquare Media, Inc. (NYSE: TSQ), a leader in digital advertising and marketing solutions focused on markets outside of the Top 50 in the United States, announced today a strategic digital advertising partnership with Steel City Media, a multi-media company with market-leading media outlets in Pittsburgh and Kansas City. Townsquare teased this partnership in the pre-release of their estimated 2024 financial results last week.

“We could not be more excited to have the talented team at Steel City Media join our partnership program. They will now be able to leverage Townsquare Ignite’s cutting-edge digital advertising and marketing solutions to their expansive customer base, which importantly exists in markets that do not compete with ours,” said Todd Lawley, President of Townsquare Ignite, the Company’s Digital Advertising division. “Our expertise is coaching and training high performing broadcast sales teams to leverage our proprietary programmatic advertising platform and data-driven insights to deliver exceptional results for their clients. By sharing our proven strategies and dynamic approach, we look forward to helping Steel City strengthen their digital capabilities, driving growth and measurable success for their clients.”

Click here to view the complete press release

About Townsquare Media, Inc.

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 345 local terrestrial radio stations in 74 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com and NJ101.5.com, and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com, and Loudwire.com. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com, and www.townsquareignite.com.

Investor Relations:
Claire Yenicay
(203) 900-5555
investors@townsquaremedia.com

Bit Digital (BTBT) – Secures New HPC Contract with Anchor Customer

Posted on by cpereira@noblefcm.com


Monday, January 27, 2025

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Contract. Last Friday, Bit Digital announced a new agreement with its anchor customer in the GPU Cloud portion of its HPC business. The new 464 Nvidia B200 GPUs contract replaces a prior agreement to provide 2,048 H100 GPUs. The contract represents approximately $15 million of annualized revenue and features a two-month prepayment from the customer. While the new agreement reduces annualized revenue from what the Company anticipated last year (roughly $50 million), management is exploring additional contracts with the customer, which we are hopeful, when combined, will at least rise to the originally expected contract level.

Additional Terms. Under the new agreement, Bit Digital will provide the customer with 58 B200 servers (464 GPUs) for 18 months. Furthermore, the customer may deduct 100% of the service fees from the previously paid $30 million non-refundable deposit. 


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Graham Corporation Announces Third Quarter Fiscal Year 2025 Financial Results Conference Call and Webcast

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GHM

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM), a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy and process industries, announced that it will release its third quarter fiscal year 2025 financial results before financial markets open on Friday, February 7, 2025.

The Company will host a conference call and webcast to review its financial and operating results, strategy, and outlook. A question-and-answer session will follow.

Third Quarter Fiscal Year 2025 Financial Results Conference Call

Friday, February 7, 2025
11:00 a.m. Eastern Time
Phone: (201) 689-8560
Internet webcast link and accompanying slide presentation: ir.grahamcorp.com

A telephonic replay will be available from 3:00 p.m. ET on the day of the teleconference through Friday, February 14, 2025. To listen to the archived call, dial (412) 317-6671 and enter conference ID number 13750971 or access the webcast replay via the Company’s website at ir.grahamcorp.com, where a transcript will also be posted once available.

ABOUT GRAHAM CORPORATION

Graham is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy and process industries. Graham Corporation and its family of global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems.

Graham routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

For more information, contact:
Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Tom Cook
Investor Relations
Phone: (203) 682-8250
Tom.Cook@icrinc.com

Source: Graham Corporation

Release – Bit Digital, Inc. Secures New B200 GPU Contract with Key Customer

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on BTBT

NEW YORK, January 24, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”), a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York, today announced a new agreement with a key customer for 464 Nvidia B200 GPUs, expanding its GPU Cloud business. This new agreement replaces a prior agreement whereby the Company was to provide the customer with an incremental 2,048 H100 GPUs and the Company continues to explore additional GPU contracts with this customer for 2025.

Under the terms of the agreement, Bit Digital will provide the customer with 58 Nvidia B200 servers (464 GPUs) for a period of eighteen months. The contract represents approximately $15 million of annualized revenue for Bit Digital and features a two-month prepayment from the customer. However, the customer may deduct 100% of the service fees from the $30 million non-refundable deposit previously paid to the Company. The contract is scheduled to commence on June 30th, 2025, and the GPUs will be deployed in Iceland. To fulfill the contract, Bit Digital has placed an order for 58 Nvidia B200 servers for approximately $21MM which are expected to be delivered well in advance of the service commencement date. Bit Digital intends to finance the purchase with cash and customer deposits and intends to retain complete ownership of the servers.

Sam Tabar, CEO of Bit Digital, commented: “We are pleased to have reached this agreement with a key customer. This contract delivers significantly improved margins compared to the original plan, which included a sale-leaseback agreement for a portion of the deployment. We look forward to exploring additional new business with this customer for 2025 while remaining focused on execution.”

About Bit Digital

Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. Our operations are located in the US, Canada, and Iceland. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com.

Investor Notice 

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 3.D of our Annual Report on Form 20-F for the fiscal year ended December 31, 2023 (“Annual Report”). Notwithstanding the fact that Bit Digital Inc. has not conducted operations in the PRC since September 30, 2021 we have previously disclosed under Risk Factors in our Annual Report: “We may be subject to fines and penalties for any noncompliance with or any liabilities in our former business in China in a certain period from now on.” Although the statute of limitations for non-compliance by our former business in the PRC is generally two years and the Company has been out of the PRC, for more than two years, the Authority may still find its prior bitcoin mining operations involved a threat to financial security. In such event, the two-year period would be extended to five years. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors. See “Safe Harbor Statement” below.

Safe Harbor Statement 

This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Release – The GEO Group Announces Date for Fourth Quarter 2024 Earnings Release and Conference Call

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GEO

  • Earnings Release Scheduled for Thursday, February 27, 2025 Before the Market Opens
  • Conference Call Scheduled for Thursday, February 27, 2025 at 11:00 AM (Eastern Time)

BOCA RATON, Fla.–(BUSINESS WIRE)–Jan. 23, 2025– The GEO Group, Inc. (NYSE:GEO) (“GEO”) will release its fourth quarter 2024 financial results on Thursday, February 27, 2025 before the market opens. GEO has scheduled a conference call and simultaneous webcast for 11:00 AM (Eastern Time) on Thursday, February 27, 2025.

Hosting the call for GEO will be George Zoley, Executive Chairman of the Board, J. David Donahue, Chief Executive Officer, Wayne Calabrese, President and Chief Operating Officer, and Mark Suchinski, Chief Financial Officer.

To participate in the teleconference, please contact one of the following numbers 5 minutes prior to the scheduled start time:

1-877-250-1553 (U.S.)
1-412-542-4145 (International)

In addition, a live audio webcast of the conference call may be accessed on the Webcasts section of GEO’s investor relations home page at investors.geogroup.com. A webcast replay will remain available on the website for one year.

A telephonic replay will also be available through March 6, 2025. The replay numbers are 1-877-344-7529 (U.S.) and 1-412-317-0088 (International). The passcode for the telephonic replay is 3882673. If you have any questions, please contact GEO at 1-866-301-4436.

Pablo E. Paez 1-866-301-4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.

Novo Nordisk Stock Soars After Groundbreaking Results for New Obesity Drug

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Novo Nordisk’s amycretin led to 22% average weight loss in a 36-week trial.
– Shares rose 7.13%, marking the best single-day gain since March 2024.
– Amycretin targets dual hormones to tackle hunger and appetite, showcasing groundbreaking innovation.

Novo Nordisk shares surged Friday after the pharmaceutical giant announced promising early-stage trial results for amycretin, a groundbreaking weight-loss drug administered through a once-weekly injection. The Danish company revealed that the treatment led to an average weight reduction of 22% in overweight and obese patients over a 36-week trial, marking a significant advancement in the fight against obesity. This compares to a 2% weight gain observed in patients receiving a placebo, showcasing the drug’s potential to reshape the treatment landscape for weight management.

The trial involved 125 participants and highlighted amycretin’s innovative mechanism of action. The drug targets GLP-1, a gut hormone that regulates appetite, and amylin, a hormone produced by the pancreas that influences hunger. This dual-action approach is a step forward from Novo Nordisk’s flagship products, Wegovy, which mimics GLP-1, and Ozempic, its well-known diabetes treatment. Amycretin’s ability to address weight loss through multiple pathways underscores its potential to provide life-changing results for patients struggling with obesity.

Novo Nordisk’s stock rose by 7.13% on Friday, reaching its best single-day performance since March 2024. The initial gains peaked at nearly 14% before settling, reflecting strong investor confidence in the company’s ability to expand its market dominance in obesity therapeutics. Fellow Danish drugmaker Zealand Pharma also benefited from the announcement, with shares climbing 4.7%, while rival Eli Lilly, the maker of obesity drug Zepbound, saw a slight dip in premarket trading.

The pharmaceutical industry has been increasingly focused on developing more effective weight-loss solutions, with obesity affecting millions worldwide and posing significant health risks. Novo Nordisk’s continued innovation in this space has made it a frontrunner, and the results from the amycretin trial further solidify its position. The company is already exploring oral formulations of the drug, which, in a separate early-stage trial announced last September, demonstrated a 13.1% weight reduction over 12 weeks.

Safety and tolerability are key considerations for any obesity treatment, and amycretin appears to meet these benchmarks. The most common side effects observed during the trial were gastrointestinal issues, but most were mild to moderate in severity. These findings align with patient tolerability seen in previous trials for similar drugs, making amycretin a promising addition to Novo Nordisk’s portfolio.

Martin Lange, executive vice president for development at Novo Nordisk, expressed optimism about the trial results. “We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,” Lange said in a statement. “The results seen in the trial support the weight-lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist.”

As Novo Nordisk invests further in amycretin, the drug has the potential to transform the obesity treatment market, which is projected to grow substantially in the coming years. The company’s strategic focus on innovative, science-driven solutions positions it to maintain a competitive edge while addressing a critical global health challenge.