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Release – Unicycive to Highlight Patient Reported Outcomes Data at Upcoming Medical Meetings Showing Oxylanthanum Carbonate Reduced Pill Burden and Improved Adherence in Treatment of Hyperphosphatemia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

March 13, 2025 7:00am EDT Download as PDF

LOS ALTOS, Calif., March 13, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. These data will be presented at three medical meetings, including the 2025 Annual Dialysis Conference (ADC), March 13-16, 2025, National Kidney Foundation (NKF) Spring Clinical Meetings, April 10-13, 2025, and the 2025 American Nephrology Nurses Association (ANNA) National Symposium, being held on May 1-4, 2025.

Unicycive’s investigational drug OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. If approved, OLC may provide patients and their physicians with a welcome new option to control hyperphosphatemia. The New Drug Application (NDA) for OLC was accepted by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.

“Despite the availability of several approved phosphate binders, hyperphosphatemia remains uncontrolled in 75% of people in the U.S. on dialysis due to challenges of insufficient potency, pill burden and unpalatable formulations. There is a critical need for more effective solutions,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Innovative solutions such as OLC that improve phosphate control and minimize pill size and count have the potential to significantly improve adherence, empowering those on dialysis to manage their treatment more effectively.”

Unicycive abstracts to be presented at the upcoming medical meetings include:

ADC

  • Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: A-6870
  • Presentation Details: Friday, March 14, 5:30-7:30 p.m. PT
  • Presenting Author: Doug Jermasek

NKF Spring Clinical Meetings

  • Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: G-018
  • Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
  • Presenting Author: Guru Reddy, PhD
  • Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients – Poster #: G-297
  • Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
  • Presenting Author: Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities

ANNA

  • Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients
  • Presentation Details: Friday, May 2, starting at 8:45 a.m. PT

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

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released March 13, 2025

FreightCar America (RAIL) – FreightCar Provides Outlook for 2025; Investor Webinar at 11:00 AM ET

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, March 13, 2025

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Full year 2024 financial results. FreightCar America generated 2024 adjusted net income to common stockholders of $4.5 million or $0.15 per share compared to a loss of $11.0 million or $(0.39) per share in 2023 and our estimate of $5.5 million or $0.17 per share. Gross margin as a percentage of revenue increased to 12.0% compared to 11.7% in FY 2023. Revenue and rail car deliveries increased to $559.4 million and 4,362 compared to $358.1 million and 3,022 in 2023. We had forecast revenue of $577.4 million and deliveries of 4,550. Adjusted EBITDA increased to $43.0 million compared to $20.1 million in 2023 and our estimate of $38.3 million. Full year adjusted free cash flow amounted to $21.7 million versus $(17.6) million in 2023.

Full Year 2025 corporate guidance. Management issued full year 2025 guidance. Railcar deliveries are expected to be in the range of 4,500 to 4,900, revenue is expected to be in the range of $530 million to $595 million, and adjusted EBITDA is expected to be in the range of $43 to $49 million. Compared to 2024, railcar deliveries, revenue, and adjusted EBITDA are expected to increase 7.7%, 0.6%, and 7.0%, respectively, at the midpoints of guidance. Our current 2025 estimates include railcar deliveries of 4,675 units, revenue of $580.6 million and EBITDA of $44.9 million.


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Mallinckrodt and Endo Announce $6.7B Merger to Create Specialty Pharma Giant

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Mallinckrodt and Endo will combine to form a diversified pharmaceutical powerhouse.
– The merger will create a company with $3.6 billion in projected 2025 revenue and $1.2 billion in adjusted EBITDA.
– The new entity will focus on branded specialty pharmaceuticals while planning to separate its generics and sterile injectables business.

Pharmaceutical companies Mallinckrodt and Endo have agreed to merge in a $6.7 billion deal that will create a new powerhouse in the specialty medication market, the companies announced Thursday.

The stock-and-cash transaction, expected to close in the second half of 2025, combines Mallinckrodt’s rare disease portfolio with Endo’s sterile injectables business, positioning the merged entity to compete more effectively in high-margin specialty pharmaceutical segments.

Shares of both companies jumped on the news, with Mallinckrodt stock up 7.2% and Endo shares surging 12.3% in morning trading.

Under the terms of the agreement, Endo shareholders will receive $80 million in cash while maintaining a 49.9% stake in the combined company. Mallinckrodt shareholders will hold the remaining 50.1% interest, with Mallinckrodt serving as the parent company.

The merged firm projects $3.6 billion in revenue for 2025 with $1.2 billion in adjusted EBITDA. Management expects to achieve $150 million in annual cost synergies by the third year post-merger, with $75 million realized in the first year.

Goldman Sachs is providing $900 million in committed financing to support the transaction. The combined company will operate with a net leverage ratio of approximately 2.3x, giving it significant financial flexibility for future growth initiatives.

Siggi Olafsson, CEO of Mallinckrodt, will lead the combined entity. The companies emphasized that the complementary nature of their businesses would maximize operational efficiencies while maintaining focus on innovation.

A key component of the merger strategy involves the eventual separation of the combined sterile injectables and generics businesses. While these operations will initially be integrated, management plans to spin off this unit as a standalone company, pending board approval and market conditions.

The core branded specialty pharmaceuticals business will focus on rare diseases and hospital-based therapies, areas where both companies have established market positions. With 17 manufacturing facilities and 30 distribution centers predominantly in the United States, the company will employ approximately 5,700 people worldwide.

According to Endo’s interim CEO Scott Hirsch, the merger will leverage complementary strengths and create immediate scale advantages in key therapeutic areas. The planned separation of the generics business aims to further sharpen focus on high-growth specialty markets.

The Mallinckrodt-Endo merger comes amid increasing consolidation in the pharmaceutical sector as companies look to gain scale and portfolio diversification.

Analysts at Morgan Stanley noted that the deal makes strategic sense for both companies, particularly given the challenges they’ve faced individually in recent years. The combined entity will have greater resources to invest in R&D and a stronger position in negotiations with payers and hospital systems.

However, some analysts expressed caution about integration risks and the ambitious timeline for the planned business separation. Healthcare analysts at JP Morgan pointed out that executing a merger of this scale while simultaneously preparing for a business spinoff creates significant operational complexity. The management team will need to carefully balance these priorities to deliver the promised synergies.

The combined company will be listed on the New York Stock Exchange following the transaction’s completion.

Take a moment to take a look at Noble Capital Markets’ Biotechnology Research Analyst Robert Leboyer’s coverage list.

Gold Hits Record Highs: What It Signals for Investors and the Economy

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Gold futures have surpassed $2,990 per ounce, with Wall Street forecasts predicting prices could reach $3,500 later this year.
– Geopolitical uncertainty, inflation concerns, and central bank purchases are fueling demand for the precious metal.
– Rising gold prices may signal investor caution, monetary policy shifts, and potential market volatility.

Gold has once again proven its status as a safe-haven asset, reaching new record highs as economic and geopolitical uncertainties continue to mount. The latest surge has pushed gold futures above $2,990 per ounce, with some analysts now predicting that prices could hit $3,500 by the third quarter of 2025.

A primary driver of gold’s rally has been increased geopolitical tensions and uncertainty surrounding global trade policies. The Trump administration’s latest tariff measures and ongoing shifts in international relations have created an environment of heightened risk, prompting investors to flock toward assets perceived as stable. Macquarie Group recently raised its gold price forecast, citing trade instability and inflationary pressures as key factors supporting higher prices. Similarly, BNP Paribas and Goldman Sachs have also adjusted their targets, expecting gold to trade above $3,100 an ounce in the near term.

Inflation expectations have played a significant role in gold’s rapid ascent. With the Federal Reserve facing ongoing pressure regarding interest rate policy, the release of softer inflation data has fueled speculation that the central bank may eventually cut rates to support economic growth. Historically, lower interest rates tend to weaken the U.S. dollar and make gold a more attractive investment, further fueling its rally. However, if inflation remains persistent, the Fed may be forced to maintain a more restrictive stance, potentially slowing gold’s upward momentum.

Another major factor driving gold’s price surge is continued central bank buying. Institutional investors and sovereign wealth funds have been stockpiling physical gold as a hedge against currency volatility and economic downturns. Reports indicate that significant amounts of gold have been shipped to vaults in New York in anticipation of potential trade restrictions and price disparities between London and U.S. markets. This surge in demand has tightened supply and contributed to rising prices.

Mark Reichman, research analyst for industrials and basic industries at Noble Capital Markets, highlighted the growing appeal of gold as a safe-haven investment. “Gold’s appeal as a safe-have asset has only grown stronger as investors fear an escalating trade war could trigger both inflation and an economic slowdown. Growing market volatility, along with anxiety associated with geopolitical tensions and the perception of chaotic policy execution in Washington and its attendant consequences, have all contributed to growing demand for gold as a hedge against uncertainty. While some of these catalysts could unwind over time, we think there are several underlying factors, including central bank buying, that could offer support for the gold price..”

The broader economic implications of gold’s record-breaking rally are worth considering. Historically, sharp increases in gold prices have often coincided with periods of financial instability or economic slowdowns. Investors tend to turn to gold during times of uncertainty, viewing it as a hedge against inflation, currency depreciation, and stock market volatility. If gold continues its upward trajectory, it could signal growing concerns over the stability of the global economy and financial markets.

For investors, the question now becomes whether gold’s rally is sustainable. While some analysts believe the precious metal still has room to run, others caution that the current surge could lead to increased volatility. If economic conditions stabilize, or if the Federal Reserve takes a more aggressive stance against inflation, gold prices could face downward pressure. On the other hand, if geopolitical risks escalate further, gold could remain a preferred asset for investors seeking protection against uncertainty.

As gold flirts with record highs, all eyes will be on central banks, inflation data, and geopolitical developments. Whether prices continue climbing or experience a pullback, gold’s performance will serve as an important barometer for global economic sentiment in the months ahead.

Canada Strikes Back: $21 Billion in Retaliatory Tariffs on U.S. Goods

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Canada imposes 25% tariffs on $21 billion of U.S. goods in response to Trump’s steel and aluminum duties.
– The tariffs target steel, aluminum, computers, sports equipment, and cast iron products.
– The European Union has also announced its own tariffs on U.S. goods, signaling broader economic consequences.

The ongoing trade tensions between the United States and Canada reached a new peak as Canada announced a fresh wave of retaliatory tariffs on more than $21 billion worth of American goods. The move comes in response to the Trump administration’s 25% duties on Canadian steel and aluminum, which took effect overnight. Canadian Finance Minister Dominic LeBlanc confirmed that these new tariffs, which will take effect immediately, add to the 25% counter-tariffs Ottawa imposed on $30 billion of U.S. goods earlier this month.

This latest round of tariffs escalates a trade conflict that has rattled markets and raised concerns among economists about supply chain disruptions. The affected goods include a broad range of industries, from steel and aluminum to computers, sports equipment, and cast iron products. As one of America’s largest trading partners, Canada’s decision underscores its commitment to defending its economy while further complicating trade relations with the U.S.

“This is much more than about our economy. It is about the future of our country,” said Melanie Joly, Canada’s foreign affairs minister. “Canadians have had enough, and we are a strong country.” The Canadian government’s firm stance reflects growing frustration with what it sees as aggressive economic tactics by the Trump administration.

The fallout from these tariffs is expected to ripple through multiple sectors. For businesses relying on U.S.-Canadian trade, the increased costs may lead to higher prices for consumers and disruptions in supply chains. Manufacturers, particularly in the auto and technology industries, will feel the strain as component costs rise. Meanwhile, small businesses on both sides of the border could struggle with the added burden of tariffs, limiting their competitiveness in an already volatile economic environment.

The trade dispute has also extended beyond North America. Following the U.S. steel and aluminum tariffs, the European Union announced it would impose tariffs on over $28 billion worth of U.S. goods starting in April. The global economic implications of these trade policies are becoming increasingly difficult to ignore, as countries respond with their own countermeasures, creating an environment of heightened uncertainty for businesses and investors alike.

Meanwhile, political tensions are also heating up. President Trump, a vocal advocate for tariffs, initially threatened to double the levies on Canadian steel and aluminum to 50% but later backed down after Ontario Premier Doug Ford threatened a retaliatory surcharge on electricity exports to the U.S. The back-and-forth illustrates the unpredictability of the current trade landscape and the challenges businesses face in navigating these policy shifts.

While the Trump administration argues that tariffs protect domestic industries and jobs, many economists warn that these measures can have the opposite effect. Higher costs for imported goods, potential job losses in export-dependent industries, and increased uncertainty on Wall Street are just some of the potential repercussions. As the situation continues to unfold, investors and businesses will be watching closely for signs of de-escalation or further trade confrontations.

Release -GeoVax Establishing Strategic Presence in Europe with Initial Footprint in the UK

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Hub to Advance Global Vaccine and Immuno-Oncology Development

ATLANTA, GA, March 12, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in the development of immunotherapies and vaccines, today announced its initial steps toward establishing a strategic presence in Europe, with the UK as its initial footprint. This move aligns with the Company’s commitment to advancing its vaccine and immunotherapy pipeline through global collaborations.

Efforts are underway to identify a UK location best suited to align with GeoVax’s development and corporate strategy. The Company already has several established connections in the UK and broader European region, including:

  • Scientific Expertise: Professor Teresa Lambe, a principal investigator at the Oxford Vaccine Group, recently joined GeoVax’s Scientific Advisory Board. Professor Lambe played a pivotal role in the development of the Oxford/AstraZeneca COVID-19 vaccine and has extensive experience in vaccine design and evaluation.
  • Manufacturing Partnerships: GeoVax maintains an existing contract development and manufacturing organization (CDMO) relationship with Oxford Biomedica PLC (Oxford, UK), as well as additional collaborations with Oxford Biomedica (France), with facilities in Strasbourg and Lyon.
  • Technology Licensing: The Company has a broad licensing agreement with ProBioGen AG (Berlin, Germany) to utilize their AGE1 continuous avian cell line for the manufacture of MVA vaccines.
  • European Collaborations: GeoVax currently collaborates with multiple European-based service providers and UK academic partners, reinforcing the strategic rationale for establishing a presence within the region.

To support this initiative, GeoVax is working closely with Professor Teresa Lambe and clinical investigators and scientists in Oxford and other academic centers across the UK to develop preclinical, translational, and clinical projects supporting its pipeline. Additionally, Dr. Deborah Spencer, a highly regarded expert in industry-academic partnerships and public health development, has recently been retained to facilitate and coordinate initiatives in the UK and Europe.

Establishing a strategic presence in Europe will support GeoVax’s infectious disease vaccine development efforts and play a key role in advancing Gedeptin®, the Company’s lead immuno-oncology candidate. Currently in clinical development for the treatment of advanced head and neck cancers, Gedeptin is anticipated to be further developed for use with immune checkpoint inhibitors as a potential treatment for various other solid tumors. GeoVax holds worldwide rights to Gedeptin for all indications.

“Expanding our presence into Europe represents a critical milestone for GeoVax as we continue to develop innovative solutions for infectious diseases and oncology, especially in building upon our initial UK footprint,” said David Dodd, President and CEO of GeoVax. “The globally recognized expertise of our key European collaborators and partners will significantly enhance our research and development capabilities. This expansion underscores our commitment to global collaboration and innovation in both vaccine and immuno-oncology development. As we accelerate the development of our infectious disease vaccine candidates and Gedeptin, we look forward to providing continued updates.”

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. 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:                               

info@geovax.com                                         

678-384-7220                                                            

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Inflation Cools, but Persists: Rising Costs of Food, Healthcare, and Transportation

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– The Consumer Price Index (CPI) rose 2.8% year-over-year in February, with food, medical care, and auto costs still climbing.
– A dozen large Grade A eggs now average $5.90, up 59% from a year ago.
– Inflation remains above the Fed’s 2% target, likely delaying any interest rate cuts.

American consumers continue to feel the sting of stubborn inflation as essential goods and services remain costly despite an overall slowdown in price growth. The latest Consumer Price Index (CPI) report showed a 2.8% year-over-year increase in February, a slight cooling from previous months but still well above the Federal Reserve’s 2% target.

One of the most notable price hikes continues to be in food costs, particularly for eggs. A dozen large Grade A eggs averaged $5.90 in February, a staggering 59% increase from a year ago. Other breakfast staples like coffee and bacon have also risen, adding to household grocery bills. While some categories, such as fruits and vegetables, saw modest declines, overall grocery prices remain elevated. Eating out is also becoming more expensive, with restaurant prices climbing 3.7% over the past year.

Medical expenses are another growing burden for consumers, with hospital costs up 3.6% year-over-year and nursing home care rising by 4.1%. Home healthcare costs surged 5.6%, reflecting the increasing demand for in-home medical services. Meanwhile, health insurance premiums climbed 3.9%, further squeezing household budgets already stretched thin by higher living costs.

The rising costs extend beyond healthcare and food, impacting transportation as well. Used car prices, which had been easing in previous months, surged again by 2.2% in January and another 0.9% in February. Auto insurance, a major expense for many households, has increased nearly 11% over the past year. Insurers continue to raise premiums as they struggle with underwriting losses, which have persisted for three consecutive years. However, there was some relief at the gas pump, with gasoline prices dipping slightly to a national average of $3.08 per gallon as of mid-March, down from $3.39 a year ago.

With inflation still running above target, the Federal Reserve faces a difficult decision in the coming months. The central bank has signaled that it will likely keep interest rates steady at its next policy meeting, as economic uncertainty surrounding tariffs and supply chain disruptions remains a concern. The Fed’s cautious stance reflects the balancing act it must perform—ensuring inflation continues to cool while avoiding any moves that could trigger a broader economic slowdown.

For consumers, the persistence of high prices across essential categories underscores the challenges of managing household budgets in this inflationary environment. While some areas, such as gasoline and certain food items, have seen modest relief, overall costs remain elevated. Policymakers will continue monitoring inflation trends closely, but for now, Americans should brace for continued financial strain as they navigate these price increases.

Saga Communications (SGA) – Digital Growth Strategy Appears To Be Gaining Traction

Posted on by cpereira@noblefcm.com


Wednesday, March 12, 2025

Saga Communications, Inc. is a broadcast company whose business is primarily devoted to acquiring, developing and operating radio stations. Saga currently owns or operates broadcast properties in 27 markets, including 79 FM and 33 AM radio stations. Saga’s strategy is to operate top billing radio stations in mid sized markets, defined as markets ranked (by market revenues) from 20 to 200. Saga’s radio stations employ a myriad of programming formats, including Active Rock, Adult Album Alternative, Adult Contemporary, Country, Classic Country, Classic Hits, Classic Rock, Contemporary Hits Radio, News/Talk, Oldies and Urban Contemporary. In operating its stations, Saga concentrates on the development of strong decentralized local management, which is responsible for the day-to-day operations of the stations in their market area and is compensated based on their financial performance as well as other performance factors that are deemed to effect the long-term ability of the stations to achieve financial objectives. Saga began operations in 1986 and became a publicly traded company in December 1992. The stock trades on NASDAQ under the ticker symbol “SGA”.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

An in-line quarter. The company reported Q4 revenue of $28.8 million and adj. EBITDA of $3.1 million, both of which declined over the prior year period, but were modestly better than our estimates of $27.7 million and $2.3 million, respectively. Notably, the company is focused on its blended digital growth strategy and reducing costs and improving profitability. We believe the company’s strategic actions are a step in the right direction for returning toward revenue and adj. EBITDA growth.

Cost-effective digital growth strategy. A key focus of the company is reducing costs that have no impact on revenue and continuing to emphasize the roll out of its blended digital advertising strategy. Notably, the blended strategy combines radio and digital advertising to provide a consistent message to customers on both mediums and to drive radio listeners to digital platforms. We view the company’s emphasis on the unique strategy favorably.


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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. 

E.W. Scripps (SSP) – Takes Steps To Assuage Debt Concerns

Posted on by cpereira@noblefcm.com


Wednesday, March 12, 2025

The E.W. Scripps Company (NASDAQ: SSP) is a diversified media company focused on creating a better-informed world. As one of the nation’s largest local TV broadcasters, Scripps serves communities with quality, objective local journalism and operates a portfolio of 61 stations in 41 markets. The Scripps Networks reach nearly every American through the national news outlets Court TV and Newsy and popular entertainment brands ION, Bounce, Defy TV, Grit, ION Mystery, Laff and TrueReal. Scripps is the nation’s largest holder of broadcast spectrum. Scripps runs an award-winning investigative reporting newsroom in Washington, D.C., and is the longtime steward of the Scripps National Spelling Bee. Founded in 1878, Scripps has held for decades to the motto, “Give light and the people will find their own way.”

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Q4 results exceed expectations. Revenues increased a strong 18.3% to $728.4 million, beating our $716.1 million estimate. The results benefited from better core advertising ($147.4 million vs our $143.0 million est.) and higher Political revenue ($174.4 million vs our $172.0 million est.). Adj. EBITDA was $229.6 million, better than our $226.1 million estimate. Figure #1 Q4 Results highlight our estimates versus reported results. 

Sluggish start. Management provided lackluster Q1 revenue guidance, expecting Local Media revenue to be down high single- digits with Scripps Networks revenue to be down mid single-digits. The sluggish Q1 reflects the absence of Political revenue, but likely weak core spot and National spot advertising. Notably, management guided interest expense to be $175 million to $185 million, less than our estimate of roughly $200 million. 


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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. 

Commercial Vehicle Group (CVGI) – Tough End to a Challenging Year

Posted on by cpereira@noblefcm.com


Wednesday, March 12, 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.

4Q Results. CVG reported 4Q24 revenue of $163.3 million, down 15.7% y-o-y due to ongoing weakness in the Construction and Ag markets, as well as a drop in Class 8 truck builds. Adjusted EBITDA was $0.9 million, down from $8.3 million. CVG reported an adjusted loss from continuing operations of $5.1 million, or a loss of $0.15/sh, compared to adjusted net income of $2.1 million, or EPS of $0.06, in 4Q23.

Strategic Initiatives. The Company implemented a number of strategic initiatives during 2024, including portfolio rationalization and the elimination of some 1,300 positions. These should result in some $15 million of gross savings in 2025, which should help improve margins.


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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. 

Bristol Myers Squibb to Acquire 2seventy Bio in $286 Million All-Cash Deal

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– BMS is acquiring 2seventy bio for $5.00 per share, an 88% premium to its last closing price.
– The deal strengthens BMS’s cell and gene therapy portfolio, particularly in multiple myeloma treatment.
– The acquisition comes amid increased M&A activity in biotech, signaling confidence in the sector’s long-term potential.

Bristol Myers Squibb (BMY) has announced a definitive agreement to acquire 2seventy bio (TSVT) in an all-cash deal valued at approximately $286 million. This acquisition further strengthens BMS’s foothold in the oncology space, particularly through its access to Abecma, an FDA-approved CAR T-cell therapy for multiple myeloma. The deal is expected to close in the second quarter of 2025, pending regulatory approvals and shareholder consent.

BMS’s acquisition of 2seventy bio aligns with its broader strategy to expand its presence in the high-growth cell and gene therapy market. 2seventy bio has focused exclusively on Abecma, a treatment developed in collaboration with BMS, to extend and improve the lives of patients with relapsed or refractory multiple myeloma. With this acquisition, BMS will take full control of Abecma’s commercialization and development, streamlining operations and potentially accelerating future advancements.

Chip Baird, CEO of 2seventy bio, emphasized the significance of the transaction, stating: “This acquisition ensures Abecma continues to reach patients in need while maximizing value for our stakeholders.” BMS, with its expansive resources and global reach, is well-positioned to drive further innovation in the cell therapy space.

The biotech sector has seen a resurgence in M&A activity, with pharmaceutical giants seeking to bolster their pipelines amid ongoing scientific advancements and a challenging regulatory landscape. The acquisition of 2seventy bio comes at a time when investors are looking for signs of stability in biotech, and deals like this reinforce confidence in the sector’s long-term growth potential.

The broader biotechnology sector, as measured by the iShares Biotechnology ETF (IBB), has posted gains year-to-date, reflecting renewed investor interest in the space. As larger pharmaceutical companies look to capitalize on cutting-edge therapies, small and mid-cap biotech firms with promising assets are becoming increasingly attractive acquisition targets. The deal values 2seventy bio at a significant premium, rewarding shareholders with an 88% increase from its prior trading price. However, it also raises questions about the long-term independence of innovative biotech firms. While consolidation can lead to greater efficiency and resource allocation, it may also reduce competition and limit the number of standalone biotech companies driving early-stage innovation.

For BMS, the acquisition is a strategic move to reinforce its oncology pipeline amid growing competition in the CAR T-cell therapy space. With this deal, BMS is betting on continued demand for personalized cell-based therapies and positioning itself to lead in this evolving field. Biotech acquisitions are often driven by the need for pharmaceutical companies to secure new revenue streams as patents on existing drugs expire. By acquiring 2seventy bio, BMS gains a competitive advantage in the high-value oncology segment, ensuring its ability to remain a dominant force in the industry.

Bristol Myers Squibb’s acquisition of 2seventy bio represents a significant development in the biotech sector. As M&A activity accelerates, the deal underscores the importance of targeted therapies in oncology and highlights the ongoing push by pharmaceutical giants to secure cutting-edge treatments. For investors, this acquisition may serve as a signal that biotech remains a strong sector, with potential for both innovation and consolidation in the years ahead.

Market Volatility and the Rise of Small-Cap Value Stocks

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– The Russell 2000 is down 2.8% for the day but remains up 9.55% year-to-date, while the NASDAQ-100 is down 4.3% for the day and 10% for the year.
– The Volatility Index (VIX) is at elevated levels, signaling increased investor uncertainty.
– While growth stocks face sell-offs, value stocks have shown relative resilience

The current market environment is one defined by stark contrasts. On one hand, major indices are faltering, led by a steep sell-off in technology stocks. The NASDAQ-100, once the pillar of market growth, is now in free fall, weighed down by declining FAANG stocks. Investors who previously viewed these stocks as untouchable are now reassessing their portfolios amid shifting economic conditions and concerns over stretched valuations.

At the same time, small-cap value stocks—often overlooked in favor of high-flying growth names—are quietly proving their resilience. While the iShares Morningstar Small-Cap Value ETF (ISCV) is down 3.7% year-to-date, this decline is minor compared to the broader indices. Historically, small-cap value stocks have shown their ability to outperform in recovery phases following market downturns, and many investors are beginning to recognize their potential.

What’s Driving the Shift Toward Value?

For years, growth stocks dominated, fueled by ultra-low interest rates and a market environment that rewarded future earnings potential over present fundamentals. That equation is shifting. With inflation concerns persisting and central banks maintaining a cautious approach to monetary policy, investors are prioritizing stability, profitability, and tangible value over speculative bets.

Warren Buffett’s move to trim his exposure to large-cap tech stocks speaks volumes about the changing investment landscape. Buffett, long known for his disciplined approach to investing, has historically favored companies with strong balance sheets, consistent earnings, and reasonable valuations. The fact that he is reducing positions in FAANG stocks suggests that even legendary investors see potential trouble ahead for high-growth names.

The Case for Small-Cap Value Stocks

Why should investors pay attention to small-cap value stocks right now? One key reason is valuation. While growth stocks have commanded high price-to-earnings (P/E) multiples, small-cap value stocks remain attractively priced, often trading at a discount relative to their historical averages. Additionally, many of these companies are less dependent on global economic conditions and trade policies, making them more insulated from external shocks.

Another factor is performance in post-recession recoveries. Historically, small-cap stocks tend to outperform large-cap stocks after periods of economic turmoil. When investor sentiment shifts and risk appetite returns, small-cap value stocks often experience significant upside, benefiting from their relatively lower valuations and higher growth potential.

Conclusion

The current market turbulence is forcing investors to rethink their strategies. While growth stocks, particularly in the tech sector, face continued headwinds, small-cap value stocks offer a compelling alternative for those seeking stability and potential upside. History suggests that in times of market uncertainty, companies with strong fundamentals and reasonable valuations often emerge as winners. While risks remain, the shift toward value is already underway—and small caps may be poised to shine in the months ahead.

Release – Comtech to Report Second Quarter Fiscal 2025 Results on March 12, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CMTL

By The Comtech Editorial Team – Mar 11, 2025 | 2 min read

CHANDLER, Ariz. – March, 11 2025– Comtech Telecommunications Corp. (NASDAQ: CMTL) (“Comtech” or the “Company”), a global communications technology leader, today announced that it plans to release its second quarter fiscal 2025 results after the market closes on Wednesday, March 12, 2025.

Following the release of the second quarter fiscal 2025 financial results, Comtech’s leadership team invites shareholders, potential shareholders, and other interested parties to join a conference call at 5:00 p.m. ET on Wednesday, March 12, to discuss the Company’s results, operations, and business trends.

A real-time webcast of the call will be available to the public at the investor relations section of the Comtech web site at www.comtech.com. Alternatively, investors can access the conference call by dialing (800) 274-8461 (primary) or (203) 518-9814 (alternate) and using the conference ID “Comtech.” A replay of the call will be available until Wednesday, March 19, by dialing (800) 938-2241 or (402) 220-1121.

About Comtech

Comtech Telecommunications Corp. is a leading provider of satellite and space communications technologies; terrestrial and wireless network solutions; Next Generation 911 (NG911) and emergency services; and cloud native capabilities to commercial and government customers around the world. Through its culture of innovation and employee empowerment, Comtech leverages its global presence and decades of technology leadership and experience to create some of the world’s most innovative solutions for mission-critical communications. For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

Investor Relations Contact

Maria Ceriello

631-962-7115

Maria.Ceriello@comtech.com

Media Contact

Jamie Clegg

480-532-2523

Jamie.Clegg@comtech.com

Rebecca Kral

Longacre Square Partners

Comtech@Longacresquare.com