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Fed Holds Rates Steady, Signals Caution on Inflation and Economic Policies

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– The Federal Reserve kept its benchmark interest rate unchanged at 4.25%-4.50%.
– Policymakers removed previous language suggesting inflation had “made progress” toward the 2% target.
– Uncertainty looms over the impact of President Trump’s proposed tariffs and economic policies.

The Federal Reserve opted to hold interest rates steady on Wednesday, pausing after three consecutive cuts in 2024, as officials await further data on inflation and economic trends. The unanimous decision keeps the federal funds rate within the 4.25%-4.50% range, with policymakers expressing a cautious stance on future rate moves.

Notably, the Fed adjusted its policy statement, omitting previous language that inflation had “made progress” toward its 2% target. Instead, it acknowledged that inflation remains “somewhat elevated.” This signals that officials see a higher bar for additional rate cuts, even after reducing borrowing costs by a full percentage point last year.

“Economic activity has continued to expand at a solid pace. The unemployment rate has stabilized at a low level in recent months, and labor market conditions remain solid,” the Federal Open Market Committee (FOMC) stated. Policymakers reiterated that future rate adjustments would be data-dependent, assessing incoming economic indicators and evolving risks.

The Fed’s cautious stance follows months of inflation readings that have hovered above its 2% target. While some indicators, such as the Consumer Price Index (CPI), have shown slight improvement, core inflation remains persistent. The next reading of the Fed’s preferred inflation gauge, the Personal Consumption Expenditures (PCE) index, is due on Friday and could influence future policy decisions.

Adding complexity to the Fed’s outlook, President Donald Trump has signaled intentions to impose tariffs on key trading partners, including Mexico, Canada, and China. Some economists warn that such actions could drive inflation higher, making the Fed’s task of achieving price stability more challenging. Furthermore, Trump has openly pushed for deeper rate cuts, hinting at potential friction with Fed Chair Jerome Powell.

With today’s decision, investors will closely monitor upcoming inflation reports and any shifts in the Fed’s stance. Policymakers have indicated expectations for just two rate cuts in 2025, down from previous forecasts of four. Any sustained inflationary pressures or shifts in fiscal policy could further delay monetary easing.

Fed Chair Powell is set to hold a press conference later today, where he is expected to provide additional insights into the central bank’s outlook and response to evolving economic conditions.

Release – Seanergy Maritime Expands Fleet with Two Japanese Ships: One Newcastlemax Vessel and One Capesize Vessel

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on SHIP

GLYFADA, Greece, Jan. 28, 2025 (GLOBE NEWSWIRE) — Seanergy Maritime Holdings Corp. (the “Company” or “Seanergy”) (NASDAQ: SHIP) announced today that it has entered into two definitive agreements with unaffiliated third parties in Japan for (i) the purchase of a Japanese-built Newcastlemax vessel and (ii) a bareboat charter with a purchase obligation for one Japanese-built Capesize vessel. The total acquisition cost is approximately $69.0 million.

Acquisition of a Japanese Newcastlemax Vessel

The Newcastlemax was built in 2013 at Imabari Shipbuilding Co., Ltd., Saijo Shipyard, a reputable Japanese shipyard, and has a cargo-carrying capacity of approximately 207,851 deadweight tons (“dwt”). The vessel will be renamed “Meiship” and is expected to be delivered within the first quarter of 2025, subject to customary closing conditions.

Acquisition of a Japanese Capesize Vessel through Bareboat Charter Agreement

The Capesize was built in 2011 at Mitsui SB and has a capacity of 178,459 dwt. Pursuant to the terms of the 6-month bareboat charter with an unaffiliated third party in Japan, Seanergy has advanced a down payment of $4.0 million and will pay an additional $4.0 million upon delivery of the vessel to the Company, as well as a daily bareboat rate of $9,750 over the charter period. The vessel will be renamed “Blueship” and is expected to be delivered within the first quarter of 2025. At the end of the 6-month bareboat period, Seanergy has an obligation to purchase the vessel for $22.5 million.

The purchase price for the two vessels is expected to be funded with a combination of cash on hand and proceeds from credit facilities the Company will seek to enter into.

Stamatis Tsantanis, the Company’s Chairman & Chief Executive Officer, stated:

“We are pleased to announce the addition of two high-quality Japanese vessels to Seanergy’s fleet, which will integrate perfectly with our existing pure-play Capesize fleet. These transactions mark a significant milestone in the Company’s strategic fleet expansion strategy, which is designed to strengthen our position within the industry. With a fully delivered fleet of 21 vessels and 3.8 million dwt, we are advancing our competitive edge through disciplined growth, in alignment with our focused capital allocation strategy.

“We expect these acquisitions to further enhance our operational capabilities while reinforcing our commitment to delivering consistent shareholder returns. We believe that the deliveries of the two new vessels are well-timed, based on the higher level of the freight futures for the second half of 2025.

“Despite the seasonal weakness, we remain confident in the long-term outlook of the Capesize sector, driven by favorable market fundamentals, a limited newbuilding orderbook, and what seems to be a sustained global demand for major raw materials.”

About Seanergy Maritime Holdings Corp.

Seanergy Maritime Holdings Corp. is an international shipping company that provides marine dry bulk transportation services through the ownership and operation of dry bulk vessels. The Company’s operating fleet consists of 19 Capesize vessels (1 Newcastlemax and 18 Capesize) with an average age of 13.8 years and aggregate cargo carrying capacity of approximately 3,417,608 dwt. Upon completion of the aforementioned transactions, the Company’s operating fleet will consist of 21 vessels (2 Newcastlemax and 19 Capesize), with an aggregate cargo carrying capacity of 3,803,918 dwt.

The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP”.

Please visit our company website at: www.seanergymaritime.com.

Forward-Looking Statements

This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, including with respect to fleet growth, market trends and shareholder returns. Words such as “may”, “should”, “expects”, “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company’s operating or financial results; the Company’s liquidity, including its ability to service its indebtedness; competitive factors in the market in which the Company operates; shipping industry trends, including charter rates, vessel values and factors affecting vessel supply and demand; future, pending or recent acquisitions and dispositions, business strategy, impacts of litigation, areas of possible expansion or contraction, and expected capital spending or operating expenses; risks associated with operations outside the United States; broader market impacts arising from trade disputes or war (or threatened war) or international hostilities, such as between Israel and Hamas or Iran and between Russia and Ukraine; risks associated with the length and severity of pandemics (including COVID-19), including their effects on demand for dry bulk products and the transportation thereof; and other factors listed from time to time in the Company’s filings with the SEC, including its most recent annual report on Form 20-F. The Company’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information please contact:

Seanergy Investor Relations
Tel: +30 213 0181 522
E-mail: ir@seanergy.gr

Capital Link, Inc.
Paul Lampoutis
230 Park Avenue Suite 1536
New York, NY 10169
Tel: (212) 661-7566
E-mail: seanergy@capitallink.com

Release – LODE: Comstock Fuels and the BDO Zone Initiative Align to Accelerate Sustainable Fuel Development

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LODE

OKLAHOMA CITY, OKLAHOMA – JANUARY 28, 2025 – Comstock Inc. (NYSE American: LODE) today announced that its subsidiary, Comstock Fuels Corporation (“Comstock Fuels”), has joined the BDO Zone Strategic Partners Network, a group of leading companies in the bioenergy sector that help accelerate and de-risk biobased project development in BDO Zones. The BDO Zone Initiative is an internationally recognized standards-based assessment which certifies “regional readiness for bio-manufacturing,” creates global connections, and ignites an influx of clean energy opportunities.

This groundbreaking collaboration combines the BDO Zone Initiative’s proven expertise and dedication in certifying “regional readiness for biomanufacturing” in biomass-rich regions with Comstock Fuels’ innovative renewable fuel solutions. This partnership will accelerate the identification, pre-certification and deployment of qualified feedstocks and investment-grade sustainable fuel production sites, with proven conversion technology. 

“Ecostrat’s BDO Zone Initiative has frankly revolutionized how we identify, validate and enable prime locations for sustainable biomass production,” said David Winsness, president of Comstock Fuels. “By integrating Comstock Fuels as a strategic partner for these pre-vetted regions, we’re accelerating commercialization by adding high competencies while eliminating critical barriers and redundancies to site selection and project deployment.”

The BDO Zone Initiative’s rigorous standards-based regional readiness assessments provide project developers and investors with sophisticated technical and financial analysis of biomass feedstock availability, infrastructure readiness, and operational feasibility. This systematic approach aligns perfectly with Comstock Fuels’ technology deployment prerequisites, positioning a standardized, turnkey solution for site and sustainable fuel project development. 

“Comstock Fuels’ expertise and innovative technologies are positioned to unlock a substantial amount of carbon-neutral, lignocellulosic feedstock production, representing a natural and strong addition to the BDO Zone Strategic Partners Network,” stated Jordan Solomon, chairman of the BDO Zone Initiative. “This partnership will materially increase the speed and development of advanced biofuel projects and aligns with our mission to accelerate sustainable, low-carbon initiatives within BDO Zones.”

This partnership is expected to significantly reduce project development timelines and risks, while increasing the success rate of new sustainable fuel facilities. The combined strengths of both companies in one, repeatable, effective, systemic process will help meet the growing North America demand for renewable fuel solutions.

About The BDO Zone Initiative

The BDO Zone Initiative certifies regional readiness for bio-based manufacturing, creates global connections with project developers, and ignites an influx of clean energy opportunities. A BDO Zone rating is an internationally recognized standards-based technical risk assessment of biomass feedstock, supply chain, and infrastructure risk with respect to the development potential of new biofuel, renewable chemical, biogas, and bioproduct plants. Investment grade ratings attract new bio-based manufacturing plants to the areas where they are most likely to succeed and create jobs. For more information on the BDO Zone Initiative, contact info@bdozone.org. To view all BDO Zone ratings, visit www.bdozone.org.

About Ecostrat Inc.

Ecostrat is the North American leader in biomass due diligence for biofuels, renewable chemicals, biogas, and bio-product project development and finance. Ecostrat led the USDOE/BETO funded project to develop the new investment Standards and Ratings for Biomass Supply Chain Risk. To learn more, please visit www.ecostrat.com.

About Comstock Fuels Corporation

Comstock Fuels Corporation (“Comstock Fuels”) delivers advanced lignocellulosic biomass refining solutions that set industry benchmarks for production of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel (“SAF”), and other renewable Bioleum™ fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 140 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”), depending on feedstock, site conditions, and other process parameters. Comstock Fuels additionally holds the exclusive rights to intellectual properties developed by Hexas Biomass Inc. (“Hexas”) for production of purpose grown energy crops in liquid fuels applications with proven yields exceeding 25 to 30 dry metric tons per acre per year. The combination of Comstock Fuels’ high yield Bioleum refining platform and Hexas’ high yield energy crops allows for the production of enough feedstock to produce upwards of 100 barrels of fuel per acre per year, effectively transforming marginal agricultural lands with regenerative practices into perpetual “drop-in sedimentary oilfields” with the potential to dramatically boost regional energy security and rural economies.

Comstock Fuels plans to contribute to domestic energy dominance by directly building, owning, and operating a network of Bioleum Refineries in the U.S. to produce about 200 million barrels of renewable fuel per year by 2035, starting with its planned first 400,000 barrel per year commercial demonstration facility in Oklahoma. Comstock Fuels also licenses its advanced feedstock and refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.comstockfuels.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its Twitter, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com

Forward-Looking Statements

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Trump Administration’s Federal Funding Freeze Sparks Widespread Concern

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Federal spending review pauses grants and loans temporarily
– Essential programs like Social Security remain operational
– Agencies have until February 10 to submit program details

In a sweeping move that could impact millions of Americans, the Trump administration has ordered an immediate pause on all federal grants and loans, raising alarm about potential disruptions to critical services from education to disaster relief. The directive, set to take effect Tuesday at 5 p.m. ET, follows last week’s suspension of foreign aid and marks a dramatic escalation in the administration’s efforts to reshape federal spending.

The Office of Management and Budget’s memo mandates that federal agencies halt funding while ensuring alignment with the president’s priorities, including recent executive orders ending diversity, equity, and inclusion initiatives. While Social Security and Medicare payments are explicitly protected, the freeze could affect trillions in federal spending across numerous sectors.

The impact of this directive is already generating significant controversy. Four nonprofit groups filed an immediate legal challenge, arguing the freeze “will have a devastating impact on hundreds of thousands of grant recipients.” Diane Yentel, president and CEO of the National Council of Nonprofits, warned that even a brief pause could have life-threatening consequences, affecting everything from cancer research to domestic violence shelters and suicide hotlines.

Democratic leadership has strongly opposed the move, with Senate Democratic Leader Chuck Schumer calling it “lawless, destructive, and cruel.” Senator Patty Murray, the top Democrat on the Senate Appropriations Committee, expressed concern about potential disruptions to essential services including childcare, housing, and infrastructure projects.

The administration’s authority to withhold congressionally approved funding is being questioned. While Trump has maintained that presidents have the power to withhold money for programs they oppose, the Constitution explicitly grants Congress control over spending matters. This constitutional tension is likely to be a central focus of legal challenges.

Republicans are divided on the measure. House Republican Tom Emmer defended the president’s actions as fulfilling campaign promises to “shake up the status quo,” while Representative Don Bacon expressed concerns after hearing from constituents who rely on federal grant money, noting, “We don’t live in an autocracy. It’s divided government.”

The freeze’s timing is particularly concerning for disaster-stricken areas in Los Angeles and western North Carolina, where Trump recently pledged government support. State and local governments heavily dependent on federal aid for essential services face uncertainty, particularly in low-income states that strongly supported Trump in the November election.

The directive gives agencies until February 10 to submit detailed information on affected programs, leaving many organizations in limbo. Jenny Young, spokesperson for Meals on Wheels America, highlighted the immediate anxiety this creates for vulnerable populations, noting that seniors are already worried about where their next meals will come from.

This funding pause represents the latest in a series of dramatic changes implemented by the Trump administration since taking office on January 20, including the termination of diversity programs, implementation of a hiring freeze, and efforts to modify civil service protections.

Atlas Energy’s Strategic Power Play: $220M Moser Energy Acquisition

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Atlas’s $220M Moser deal adds 212MW power fleet, expanding beyond proppant
– Deal valued at 4.3x 2025 EBITDA with Moser’s 50%+ margins
– Q4 revenue up 92% YOY despite profit pressure, Moser adds stability

Atlas Energy Solutions (NYSE: AESI) is making a bold move into the distributed power market with its $220 million acquisition of Moser Energy Systems, marking a significant expansion beyond its core proppant and logistics business. The deal, announced Monday, represents a strategic pivot that could reshape Atlas’s market position in the energy sector.

The transaction, structured with $180 million in cash and approximately 1.7 million shares of Atlas common stock, values Moser’s operations at roughly 4.3x projected 2025 Adjusted EBITDA. This relatively attractive multiple reflects the strategic value Atlas sees in Moser’s distributed power solutions business, which brings with it a substantial fleet of natural gas-powered assets totaling approximately 212 megawatts.

“This acquisition diversifies the Company into attractive high-growth end markets in both production and distributed power while strengthening Atlas’s current market position,” said John Turner, President and CEO of Atlas. The deal appears well-timed, as the energy sector increasingly focuses on efficient power solutions and environmental considerations.

Mark Reichman, Senior research analyst at Noble Capital Markets, sees broader implications for Atlas’s market position. “In our view, the accretive acquisition of Moser is a strategic play on the theme of electrification and growing demand for electricity,” he notes. “It provides a platform for growth in the distributed power market and provides entry into adjacent end markets, including midstream infrastructure, RNG plants, data centers, and industrial backup power. It enhances and extends Atlas’s competitive position as an integrated solutions provider with exposure to both oilfield services and the distributed power market.”

The strategic rationale becomes clearer when examining Atlas’s preliminary fourth-quarter results for 2024. While the company reported strong revenue growth of approximately 92% year-over-year for Q4, reaching between $270-272 million, its gross profit and Adjusted EBITDA showed some pressure. This acquisition could help stabilize earnings through market cycles by adding Moser’s impressive 50%+ EBITDA margins and robust cash flow generation to Atlas’s portfolio.

Moser’s integration into Atlas creates an innovative energy solutions provider that combines Atlas’s existing completion platform with Moser’s distributed power expertise. The merger brings critical manufacturing capabilities in-house, potentially reducing maintenance and equipment replacement costs while improving quality control. This vertical integration could prove particularly valuable in the current market environment where supply chain reliability is paramount.

The geographic fit appears strong, with Moser’s operations complementing Atlas’s core presence in the Permian Basin while adding diversity through operations across other key oil and gas basins in the central United States. This expansion could help Atlas better serve existing customers while opening new market opportunities.

Looking ahead, Atlas expects the transaction to close by the end of the first quarter of 2025, subject to customary conditions. The company has secured financing through an upsizing amendment to its existing delayed draw term loan facility, demonstrating confidence in the deal’s financial structure.

For investors, this acquisition signals Atlas’s evolution from a pure-play proppant and logistics provider to a more diversified energy solutions company. The move could reduce the company’s exposure to completion operation volatility while positioning it to capitalize on the growing demand for distributed power solutions in the oil and gas sector.

The market will be watching closely to see how quickly Atlas can integrate Moser’s operations and whether the projected $40-45 million in Adjusted EBITDA contribution for 2025 materializes as expected. With energy markets continuing to evolve, this strategic expansion could position Atlas for more stable growth in the years ahead.

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.

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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