Release – Kratos Receives Approximate $30 Million Sole Source Air Defense System Hardware Production Award

Research News and Market Data on KTOS

April 17, 2025 at 8:00 AM EDT

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SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a technology company in the defense, national security and global markets, announced today that it has received an approximate $30 million Sole Source Air Defense System Hardware Production award.  Kratos is an industry leading designer, engineer and manufacturer of military grade hardware, at quantity, in support of United States air defense, hypersonic, propulsion, high-performance jet drones and other mission critical National Security related systems.  Work under this production award will be performed at a secure Kratos manufacturing facility.   Due to competitive, security related and other considerations, no additional information will be provided related to this award.

Eric DeMarco, President and CEO of Kratos, said, “Kratos is a recognized industry leader in designing, engineering and manufacturing military grade hardware for weapon systems—systems that have to work every time for our warfighters, partners and customers.  Kratos’ C5ISR business unit is currently under contract and in large scale production on multiple hypersonic, missile, radar, and air defense related systems, including this program award we announced today. Our entire Company is proud to have been selected to produce and provide this critical air defense system hardware for this United States National Security customer.”

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Burghoff
claire.burghoff@kratosdefense.com

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

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Source: Kratos Defense & Security Solutions, Inc.

Release – V2X to Announce First Quarter 2025 Financial Results

Research News and Market Data on VVX

April 17, 2025

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RESTON, Va., April 17, 2025 /PRNewswire/ — V2X, Inc., (NYSE: VVX), a leading provider of global mission solutions, will report first quarter 2025 financial results on Monday, May 5, 2025, after market close. Senior management will conduct a conference call at 4:30 p.m. ET that same day.

V2X (PRNewsfoto/V2X, Inc.)

U.S.-based participants may dial in to the conference call at 877-300-8521, while international participants may dial 412-317-6026. A live webcast of the conference call as well as an accompanying slide presentation will be available at https://app.webinar.net/0pq4wxEAbDQ and on the Investors section of the V2X website at https://gov2x.com/.

A replay of the conference call will be posted on the V2X website shortly after completion of the call and will be available for one year. A telephonic replay will also be available through May 19, 2025, at 844-512-2921 (domestic) or 412-317-6671 (international) with passcode 10198194.  

About V2X
V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.

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

Media Contact
Angelica Spanos Deoudes
Director, Corporate Communications
Angelica.Deoudes@goV2X.com
571-338-5195

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-to-announce-first-quarter-2025-financial-results-302431149.html

SOURCE V2X, Inc.

Release – GeoVax Provides Update on BARDA Project NextGen and Outlines 2025 Business Momentum

Research News and Market Data on GOVX

Company Reaffirms Commitment to Innovation in COVID-19, Oncology, and Biosecurity Amid Strategic Program Developments

ATLANTA, GA, April 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today addressed the termination of its Project NextGen (PNG) award by the Biomedical Advanced Research and Development Authority (BARDA), effective April 11, 2025. The Company also provided a comprehensive business update across its core programs, including the next-generation COVID-19 vaccine (GEO-CM04S1), cancer immunotherapy (Gedeptin®), Mpox/smallpox vaccine (GEO-MVA), and advanced MVA manufacturing process.

GeoVax expressed disappointment in the HHS/BARDA action but remains committed to the critical medical need addressed by GEO-CM04S1, particularly among the more than 40 million immunocompromised Americans—and over 400 million people globally—who remain inadequately protected by the current authorized COVID-19 vaccines.  Thus far, clinical data in support of GEO-CM04S1 demonstrate encouraging support of the potential of GEO-CM04S1 for providing (a) more robust immune response, (b) increased durability and (c) protective immunity for those patients with depleted immune systems inadequately responding to the current authorized COVID-19 vaccines.

The Company also noted recent public statements by HHS leadership acknowledging the potential enhanced value of multi-antigen vaccines addressing respiratory viruses.  Of special note is that GEO-CM04S1 was the only multi-antigen/polyvalent COVID-19 vaccine candidate selected under the PNG initiative.

“While the recent HHS/BARDA Stop Work Order action was disappointing and surprising, our commitment to protecting vulnerable populations remains unchanged, and our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs,” said David Dodd, Chairman and CEO of GeoVax.

Continued Progress Across a Catalyst-Rich Pipeline

GEO-CM04S1: Advancing to Meet Unmet COVID-19 Needs

GEO-CM04S1 continues to demonstrate potential as both a primary and booster vaccine, especially in immunocompromised patients. Key milestones anticipated during 2025 include:

  • Healthy Adult Booster Trial – Enrollment is complete; data readout expected in H1 2025.
  • CLL Patient Study (Immunocompromised patient study) – Ongoing enrollment; interim results resulted in continuation of the GEO-CM04S1 arm, whereas the Data Safety Review Board recommended early termination of the mRNA arm, which was subsequently implemented.
  • Stem Cell Transplant/CAR-T Trial (Immunocompromised patient study) – Enrollment and evaluation continue among hematological patients receiving stem cell transplantation or CAR-T therapy, comparing GEO-CM04S1 to mRNA COVID-19 vaccines.

GEO-CM04S1 is a multi-antigen COVID-19 vaccine, utilizing a synthetic-MVA platform, expressing both S and N antigens, offering the potential for broader, more durable protection than current mRNA vaccines.

Gedeptin®: Advancing into Phase 2 in Solid Tumors

GeoVax’s oncology program, utilizing the Gedeptin® technology, is planned to progress to a Phase 2 trial in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. Gedeptin has received Orphan Drug designation for use among advanced head & neck cancer patients.  The Gedeptin technology provides potential for expansion into other solid tumors including triple-negative breast cancer, melanoma, and soft tissue sarcoma.

GEO-MVA: Addressing Biosecurity and Global Vaccine Equity

GeoVax anticipates initiating clinical trials in 2025 for GEO-MVA, its Mpox/smallpox vaccine candidate. The Company has successfully produced cGMP clinical product and is focused on completing the vaccine vialing in support of initiating clinical evaluation during H2 2025.  GEO-MVA positions GeoVax to offer a U.S.-developed alternative to foreign-sourced vaccines amid rising global biosecurity threats and constrained supply.

Advanced Manufacturing: Scaling MVA for Global Reach

GeoVax is advancing continuous cell line manufacturing for MVA-based vaccines, offering a path to scalable, cost-effective production—including localized manufacturing for low- and middle-income countries. This innovation addresses critical gaps in vaccine self-sufficiency and supply resilience.

Outlook for 2025

Despite the PNG award termination, GeoVax anticipates a milestone-rich 2025 across its portfolio. The Company will continue to engage with government and industry partners, pursue clinical trial completions, and drive innovation through expanded AI integration to optimize development, trial operations, and manufacturing efficiency.

“Our scientific foundation is strong and our strategy is clear,” added Dodd. “GeoVax remains committed to delivering transformative solutions for unmet medical needs in infectious disease and cancer. We’re advancing with purpose and fully prepared to deliver on the promise of our development program.”

For further details on GeoVax’s programs and progress, visit www.geovax.com.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. 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

Release – 1-800-FLOWERS.COM, Inc. to Release its Fiscal 2025 Third Quarter Results on Thursday, May 8, 2025

Research News and Market Data on FLWS

Apr 16, 2025

JERICHO, N.Y.–(BUSINESS WIRE)– 1-800-FLOWERS.COM, Inc. (NASDAQ: FLWS) (the “Company”),a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships, today announced that the Company will release financial results for its fiscal 2025 third quarter on Thursday, May 8,2025. The press release will be issued after the market close and will be followed by a conference call with members of senior management at 4:30 p.m. (ET).

The conference call will be available via live webcast from the Investors section of the Company’s website at www.1800flowersinc.com/investors. A recording of the call will be posted on the website within two hours of the call’s completion. A telephonic replay of the call can be accessed beginning at 7:00 p.m. (ET) on May 8, 2025, through May 15, 2025, at: (US) 1-877-344-7529; (Canada) 855-669-9658; (International) 1-412-317-0088; enter conference ID: #4626916.

Special Note Regarding Forward-Looking Statements:

Some of the statements contained in the Company’s scheduled Thursday, May 8, 2025, press release and conference call regarding its results for its fiscal 2025 third quarter, other than statements of historical fact, may be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the applicable statements. For a more detailed description of these and other risk factors, please refer to the Company’s SEC filings including its Annual Reports and Forms 10K and 10Q available at the Investor Relations section of the Company’s website at 1800flowersinc.com. The Company expressly disclaims any intent or obligation to update any of the forward-looking statements made in the scheduled conference call and any recordings thereof, or in any of its SEC filings, except as may be otherwise stated by the Company.

About 1-800-FLOWERS.COM, Inc.

1-800-FLOWERS.COM, Inc. is a leading provider of gifts designed to help inspire customers to give more, connect more, and build more and better relationships. The Company’s e-commerce business platform features an all-star family of brands, including: 1-800-Flowers.com®, 1-800-Baskets.com®, Cheryl’s Cookies®, Harry & David®, PersonalizationMall.com®, Shari’s Berries®, FruitBouquets.com®, Things Remembered®Moose Munch®, The Popcorn Factory®, Wolferman’s Bakery®, Vital Choice®, Simply Chocolate® and Scharffen Berger®. Through the Celebrations Passport® loyalty program, which provides members with free standard shipping and no service charge on eligible products across our portfolio of brands, 1-800-FLOWERS.COM, Inc. strives to deepen relationships with customers. The Company also operates BloomNet®, an international floral and gift industry service provider offering a broad-range of products and services designed to help members grow their businesses profitably; Napco℠, a resource for floral gifts and seasonal décor; DesignPac Gifts, LLC, a manufacturer of gift baskets and towers; Alice’s Table®, a lifestyle business offering fully digital livestreaming and on demand floral, culinary and other experiences to guests across the country; and Card Isle®, an e-commerce greeting card service. 1-800-FLOWERS.COM, Inc. was recognized among America’s Most Trustworthy Companies by Newsweek. 1-800-FLOWERS.COM, Inc. was also recognized as one of America’s Most Admired Workplaces for 2025 by Newsweek and was named to the Fortune 1000 list in 2022. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS. For more information, visit 1800flowersinc.com.

FLWS-COMP
FLWS-FN

Investor Contact:

Andy Milevoj

amilevoj@1800flowers.com

Media Contact:

Cherie Gallarello

cgallarello@1800flowers.com

Source: 1-800-FLOWERS.COM, Inc.

Release – Comstock Metals and RWE Enter Strategic Solar Recycling Partnership

Research News and Market Data on LODE

Virginia City, Nevada, April 16, 2025 – Comstock Inc. (NYSE American: LODE) announced today that its subsidiary, Comstock Metals LLC (“Comstock Metals”), a pioneer in sustainable, zero-landfill solar panel recycling has entered into a Master Services Agreement (MSA) with RWE Clean Energy, the U.S. subsidiary of leading global energy company, RWE.

Comstock Metals will provide RWE with recycling, decommissioning, and logistics services for their expansive U.S. solar installations ensuring a zero-landfill solution for 100% of the recovered solar panel materials.

Under the terms of this new agreement, Comstock Metals will serve as a preferred, strategic partner for the recycling, disposal, and decommissioning services for RWE’s solar installations. These projects will include the recycling of solar panels and related equipment, logistics management, eco-friendly disposal practices, and the safe transportation of materials. “This partnership underscores our shared commitment to sustainability and innovation,” stated Dr. Fortunato Villamagna, President of Comstock Metals. “RWE has consistently showcased exceptional commitment to their mission of providing renewable energy solutions by leading the adoption of solar energy and reducing carbon emissions. Comstock Metals complements RWE’s efforts as a trusted provider in the renewable energy market, ensuring environmentally conscious recycling of the solar panels and their components.”

This agreement represents a continuation and expansion of the successful collaboration between the dedicated teams of Comstock Metals and RWE on multiple projects throughout Nevada and California. Comstock Metals has already successfully coordinated the decommissioning, transportation, and recycling of more than 4 million pounds of end-of-life solar materials for RWE, with much more anticipated as demand for responsible recycling grows.

“Comstock Metals continues to systemically identify and close critical gaps in the nascent solar panel recycling sector, creating new capabilities and long-term service opportunities for both the company and the entire supply chain,” said Comstock Inc.’s Executive Chairman and CEO, Corrado De Gasperis. “With these rapidly expanding industry partnerships, we are creating unique, sustainable, and full-service solutions for the world’s most renowned renewable energy companies.”

About RWE in the U.S.

Through its subsidiary RWE Clean Energy, RWE is the third largest renewable energy company in the United States, with a presence in most U.S. states from coast to coast. RWE’s team of about 2,000 employees in the U.S. stands ready to help meet the nation’s growing energy needs. With its homegrown and fastest-to-market product, RWE supports the goal of American Energy dominance and independence. To that end, RWE Clean Energy is committed to increasing its already strong asset base of over 10 gigawatts of operating wind, solar and battery projects, focusing on providing high-quality jobs. RWE invests in local and rural communities while strengthening domestic manufacturing supporting the renaissance of American industry. This is complemented by RWE’s energy trading business. RWE is also a major offtaker of American liquified natural gas (LNG). To learn more, please visit RWE Clean Energy website.

As an energy company with a successful history spanning more than 125 years, RWE has an extensive knowledge of the energy markets and an excellent expertise in all major power generation and storage technologies, from nuclear, coal and gas to hydro, batteries, wind and solar.

About Comstock Metals

Comstock Metals is a leading, Nevada-based, zero-landfill recycling solution that specializes in the environmentally responsible recycling of solar panels and related renewable energy infrastructure and equipment. Comstock’s unique thermal delaminating processes, ongoing material innovations, and sustainable practices differentiates its recycling leadership and strengthens the supply chain of domestically manufactured electrification products. www.comstockmetals.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 Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its X.comLinkedIn 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:
William McCarthy, Chief Operating Officer
Tel (775) 413-6222
ir@comstockinc.com

For media inquiries:
Tracy Saville, Director of Marketing
Tel (775) 847-7573
media@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.

Release – Saga Communications, Inc. Announces Date and Time of 1st Quarter Earnings Release and Conference Call

Research News and Market Data on SGA

April 14, 2025 16:05 ET 

GROSSE POINTE FARMS, Mich., April 14, 2025 (GLOBE NEWSWIRE) — Saga Communications, Inc. (Nasdaq: SGA) announced today that it will release its 1st Quarter 2025 results at 9:00 a.m. EDT on Thursday, May 8, 2025. The company will be holding a conference call on the same date at 11:00 a.m. EDT. The dial-in numbers are as follows:

Domestic and International Dial-in Number: (973) 528-0008
Conference Entry Code: 530273

The Company requests that all parties that have a question that they would like to submit to the Company to please email the inquiry by 10:00 a.m. EDT on May 8, 2025, to SagaIR@sagacom.com. The Company will discuss, during the limited period of the conference call, those inquiries it deems of general relevance and interest. Only inquiries made in compliance with the foregoing will be discussed during the call.

Saga’s earnings release will contain certain non-GAAP financial measures including station operating income, trailing 12-month consolidated EBITDA, and same station financial information. A reconciliation of all non-GAAP financial measures to the most directly comparable GAAP measures will be provided in the earnings release.

Saga is a media company whose business is devoted to acquiring, developing, and operating broadcast properties with a focus on providing opportunities complimentary to our core radio business including digital, e-commerce, local on-line news services and non-traditional revenue initiatives.  Saga owns or operates broadcast properties in 28 markets, including 82 FM and 32 AM radio stations and 79 metro signals. For additional information, contact us at (313) 886-7070 or visit our website at www.sagacom.com.

Contact:
Samuel D. Bush
(313) 886-7070

Release – Alliance Resource Partners, L.P. Announces Jesse M. Parrish Will Serve as Senior Vice President of Alliance Coal, LLC

Research News and Market Data on ARLP

Apr 14, 2025 3:36 PM Eastern Daylight Time

TULSA, Okla.–(BUSINESS WIRE)–Alliance Resource Partners, L.P. (NASDAQ: ARLP) today announces that Jesse M. Parrish will join Alliance Coal, LLC (“Alliance Coal”) as its Senior Vice President – Operations where he will be responsible for assisting with the management of our coal operations. Mr. Parrish previously served as Chief Executive Officer of Blackhawk Mining, LLC (“Blackhawk”), which produces metallurgical coal at eight mining complexes across southern West Virginia and eastern Kentucky and employs approximately 2,000 people.

“I am pleased to welcome Jesse to ARLP,” said Joseph W. Craft III, Chairman, President and Chief Executive Officer. “Jesse’s strong leadership skills, experience and expertise in the coal industry will be a valuable addition to the Alliance Coal management team as we continue to provide our customers with reliable baseload fuel to meet the significant growth in U.S. electricity demand from data centers and on-shoring of manufacturing. I look forward to working closely with him to deliver attractive returns to our unitholders.”

Prior to serving as Chief Executive Officer, Mr. Parrish held various other positions over his long career at Blackhawk, including President, Chief Financial Officer, Vice President and Director of Strategic Planning and Corporate Communications at Blackhawk. Prior to joining Blackhawk, Jesse practiced law at Bingham Greenebaum Doll LLP, where he focused on coal-related financings, mergers and acquisitions, and environmental matters. Mr. Parrish is a graduate of the University of Kentucky with a Bachelor of Business Administration in Finance and a Juris Doctor. Parrish has previously served as the chairman for the West Virginia Coal Association and the Kentucky Coal Association and is a trustee for the Energy and Mineral Law Foundation.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the second largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is positioning itself as a reliable energy partner for the future by pursuing opportunities that support the growth and development of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Contacts

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Release – Townsquare Announces Conference Call to Discuss First Quarter 2025 Results

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PURCHASE, N.Y., April 14, 2025 (GLOBE NEWSWIRE) — Townsquare Media, Inc. (NYSE: TSQ) (“Townsquare” or the “Company”) announced today that it will release first quarter 2025 financial results before the market opens on Thursday, May 8, 2025. The Company will host a conference call to discuss certain first quarter 2025 financial results on Thursday, May 8, 2025 at 8:00 a.m. Eastern Time.

The conference call dial-in number is 1-800-717-1738 (U.S. & Canada) or 1-646-307-1865 (International) and the conference ID is “Townsquare.” A live webcast of the conference call as well as the press release disclosing the Company’s results will be available on the investor relations page of the Company’s website at www.townsquaremedia.com.

A telephone replay of the conference call will be available through May 15, 2025. To access the replay, please dial 1-844-512-2921 (U.S. & Canada) or 1-412-317-6671 (International) and enter confirmation code 1134601. A web-based archive of the conference call will also be available on the investor relations page of the Company’s website.

About Townsquare Media, Inc.
Townsquare is a community-focused digital and broadcast media and digital marketing solutions company principally focused outside the top 50 markets in the U.S. Townsquare Ignite, our robust digital advertising division, specializes in helping businesses of all sizes connect with their target audience through data-driven, results based strategies, by utilizing a) our proprietary digital programmatic advertising technology stack with an in-house demand and data management platform and b) our 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. Townsquare Interactive, our subscription digital marketing services business, partners with SMBs to help manage their digital presence by providing a SAAS business management platform, website design, creation and hosting, search engine optimization and other digital services. And through our portfolio of local radio stations strategically situated outside the Top 50 markets in the United States, we provide effective advertising solutions for our clients and relevant local content for our audiences. For more information, please visit www.townsquaremedia.comwww.townsquareinteractive.com, and www.townsquareignite.com.

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

Release – Perfect Corp. to Announce Financial Results for First Quarter of 2025 on April 28, 2025

Research News and Market Data on PERF

April 14, 2025

NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a global leader in providing augmented reality (“AR”) and artificial intelligence (“AI”) Software-as-a-Service (“SaaS”) solutions to beauty and fashion industries, today announced that it plans to release its financial results for the first quarter of 2025 before U.S. markets open on Monday, April 28, 2025 and to hold a conference call at 8:00 p.m. Eastern Time the same day on April 28, 2025 (or 8:00 a.m. Taipei Standard Time the following day on April 29, 2024).

The Company’s management will discuss the financial results and latest developments during the conference call. For participants who wish to join the call, please complete online registration using the link provided below in advance of the conference call. Upon registration, each participant will receive a participant dial-in number and a unique access PIN, which can be used to join the conference call.

Registration Link: https://registrations.events/direct/Q4I51630494

A live and archived webcast of the conference call will also be available at the Company’s investor relations website at https://ir.perfectcorp.com.

About Perfect Corp.
Perfect Corp. (NYSE: PERF) leverages ‘Beautiful AI’ innovations to make our world more beautiful. As a pioneer and leader in the space, Perfect Corp. works with over 650 partners around the globe to empower brands to embrace the digital-first world by transforming shopping journeys through digital tech innovations. Perfect Corp.’s suite of enterprise solutions delivers synergistic, technology-driven experiences that facilitate sustainable, ultra-personalized, and engaging shopping journeys through hyper-realistic virtual try-ons, AI-powered skin analyses, personalized product recommendation tools and many more Beautiful AI innovations. For more information, visit https://ir.perfectcorp.com/.

Category: Investor Relations

Investor Relations Contact
Investor Relations, Perfect Corp.
Email: Investor_Relations@PerfectCorp.com

Source: Perfect Corp.

Release – Alliance Resource Partners, L.P. Announces First Quarter 2025 Earnings Conference Call

Research News and Market Data on ARLP

April 14, 2025

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TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) will report its first quarter 2025 financial results before the market opens on Monday, April 28, 2025. Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.

To participate in the conference call, dial U.S. Toll Free (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13753170.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the second largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is positioning itself as a reliable energy partner for the future by pursuing opportunities that support the growth and development of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – Nutriband Granted Patent in Macao for its AVERSA Abuse Deterrent Transdermal Technology

Research News and Market Data on NTRB

Nutriband granted patent protecting its AVERSA abuse deterrent platform technology in Macao, a Special Administrative Region of the People’s Republic of China

April 11, 2025 07:00 ET 

ORLANDO, Fla., April 11, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received notification that its patent has been granted in Macao for its patent entitled, “Abuse and Misuse Deterrent Transdermal Systems,” which protects its AVERSA™ abuse deterrent transdermal technology.

The Macao Intellectual Property Office granted patent J/9010 on February 11, 2025 as recorded in Macao Official Bulletin No. 10 on March 5, 2025. Macao is a Special Administrative Region (SAR) of the People’s Republic of China that has its own patent system and patent laws which are separate and distinct from those of mainland China.

The AVERSA™ abuse deterrent technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia as well as two regions of China: Hong Kong and Macao.

Nutriband’s AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse while making sure that these drugs remain accessible to those patients who really need them.

Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop its lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system.

AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1

____________________________________________________
1 Health Advances AVERSA Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: Support@nutriband.com

SOURCE: Nutriband Inc.

Release – Bit Digital, Inc. Secures Site for New Tier 3 Data Center to Support Cerebras Colocation Contract

Research News and Market Data on BTBT

NEW YORK, April 11, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”) announced today that it has secured the rights to a new data center site in Saint-Jérôme, Québec (“MTL-3”), which is under development and will support the previously announced 5MW colocation agreement with Cerebras Systems (“Cerebras”), a leader in generative AI infrastructure.

The facility spans approximately 202,000 square feet on 7.7 acres and is being developed to support current contracted capacity, with future expansion potential subject to utility approvals. The transaction was executed under a lease-to-own structure, which includes a fixed-price purchase option exercisable within 12 months. The lease term is 20 years, with two 5-year extension options.

The project is being delivered through WhiteFiber, Bit Digital’s high-performance computing platform. The facility is being retrofitted to Tier 3 standards, with development costs expected to total approximately CAD $55 million (approximately $40MM USD), and a targeted go-live date of July 2025.

“This milestone represents continued momentum in our strategy to deliver purpose-built AI infrastructure at scale,” said Sam Tabar, CEO of Bit Digital. “Speed to market is a key differentiator in the AI infrastructure space, and this site reflects our ability to mobilize and deliver capacity on accelerated timelines. We’re proud to advance our partnership with Cerebras while expanding our data center footprint in the greater Montréal region, a growing hub for AI innovation.”

Cerebras has contracted for 5MW (IT load) of built-to-suit infrastructure under a five-year colocation agreement announced in February 2025. Under the terms of the agreement, Cerebras holds a right of first refusal (ROFR) for any additional megawatt capacity that becomes available at the site.

About Bit Digital

Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. The Company’s HPC business operates under the WhiteFiber Inc. (“WhiteFiber”) brand. Our operations are located in the US, Canada, and Iceland. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com, or follow us on LinkedIn or X.

Investor Notice

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (Annual Report). Notwithstanding the fact that Bit Digital Inc. has not conducted operations in the PRC since September 30, 2021 we have previously disclosed under Risk Factors in our Annual Report: “We may be subject to fines and penalties for any noncompliance with or any liabilities in our former business in China in a certain period from now on.” Although the statute of limitations for non-compliance by our former business in the PRC is generally two years and the Company has been out of the PRC, for more than two years, the Authority may still find its prior bitcoin mining operations involved a threat to financial security. In such event, the two-year period would be extended to five years. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors. See “Safe Harbor Statement” below.

Safe Harbor Statement

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

Release – Unicycive Presents New Patient-Level Data Underscoring Challenges Faced with Current Phosphate Binders and Highlighting the Potential of Oxylanthanum Carbonate to Address Barriers to Adherence for Patients with Hyperphosphatemia on Dialysis

Research News and Market Data on UNCY

April 10, 2025 8:00am EDT Download as PDF

– Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy –

– Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use –

– Results to be presented in poster sessions at the NKF Spring Clinical Meetings –

LOS ALTOS, Calif., April 10, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced new patient-reported outcomes data from its pivotal Phase 2 study of OLC as well as from a new survey conducted by the National Kidney Foundation (NKF) with sponsorship from Unicycive. OLC is an investigational treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The findings will be presented today in poster sessions at the NKF Spring Clinical Meetings taking place in Boston.

OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis and set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.

“As many as two out of three of patients with end-stage kidney disease undergoing dialysis don’t consistently adhere to their phosphate binder treatment; common barriers are side effects, pill burden, and unpalatable formulations,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial. “These new patient-reported outcomes underscore the potential of OLC to enhance adherence, reduce treatment burden and improve patient satisfaction. OLC could be a welcome new phosphate binder choice for patients with hyperphosphatemia due to its favorable tolerability, small, easy-to-swallow size and low pill burden.”

Patient-Reported Outcomes Data
Patient-reported outcomes from the open-label Phase 2 UNI-OLC-201 clinical trial compared patients’ satisfaction with their pre-trial phosphate binders versus OLC at the end of the study based on responses to a questionnaire completed by 80 patients. This research will be presented by Guru Reddy, PhD., in the poster titled “Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence” (Poster # G-018) on Thursday, April 10, from 5:15–7:30 p.m. ET.

Results:

  • OLC reduced pill burden by 50% – patients took a median of three tablets of OLC per day versus six tablets of phosphate binders prior to the trial.
  • OLC improved adherence – 70% of patients reported consistent adherence with OLC compared to 58% who reported adherence to their pre-trial phosphate binders.
  • OLC was preferred – 79% of patients indicated a preference for OLC versus 4% who preferred their pre-trial phosphate binder medications.
  • OLC improved patient satisfaction – 98% of patients agreed that OLC was easy to take versus 38% who said that about their pre-trial phosphate binder medication, and 89% reported they were satisfied with OLC treatment versus 49% who were satisfied with pre-trial phosphate binders.

Patient Survey Results
In partnership with Unicycive, NKF conducted an online survey of patients undergoing dialysis to assess the top barriers to phosphate binder adherence and to better understand what treatment characteristics could improve adherence. A total of 200 patients aged 40 and older completed the online survey from February 15 to May 16, 2024. This research will be presented by Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities, in a poster titled “Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients” (Poster # G-297) on Thursday, April 10, from 5:15-7:30 p.m. ET.

Results showed:

  • Forgetfulness (63%) was the primary barrier to consistent medication use followed by excessive pill number (47%) and large pill size (47%).
  • Additional barriers to adherence included difficulties carrying pills (45%), gastrointestinal side effects (29%), unpleasant taste (20%), social embarrassment when taking medication (13%), and cost (10%).
  • Patients were more likely to prefer medication regimens with fewer and smaller pills, underscoring the impact of pill burden on adherence.

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 LinkedInX, 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, 2024, 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

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Source: Unicycive Therapeutics, Inc.

Released April 10, 2025