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Release – Titan International inc. Closes on Strategic Partnership with Brazilian Wheel Manufacturer Rodaros

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Oct 28, 2025

WEST CHICAGO, Ill., Oct. 28, 2025 /PRNewswire/ — Titan International, Inc. (NYSE: TWI) (“Titan” or the “Company”), a leading global manufacturer of off-highway wheels, tires, assemblies, and undercarriage products, today announced the closing of a strategic partnership with Rodaros Industria de Rodas Ltda. (“Rodaros”), a Brazilian manufacturer of agricultural and construction wheels.  This deal was first announced during Titan’s second quarter 2025 earnings call on July 31st and has now completed formal regulatory review.

Rodaros is the second largest manufacturer of agricultural wheels in Brazil.  This partnership will be forged with an initial cash investment of $4 million by Titan for a 20% ownership stake and includes commitments to acquire the remaining 80% in 2029 based on financial performance criteria for final valuation of the enterprise.  Titan will obtain one Board seat within Rodaros (out of a three-member Board) and will begin providing financial leadership.

Paul Reitz, President and Chief Executive Officer of Titan stated, “This partnership reinforces Titan’s commitment to offering the best solutions for our customers’ equipment and to driving performance improvements in agriculture and construction operations. By combining Rodaros’ excellence in wheel manufacturing with Titan’s market leading tire production and distribution across the entire region, we are paving the way for the development of integrated solutions tailored to the Brazilian and South American markets.”

Mr. Reitz continued “Building on Titan’s One Stop Shop framework, this strategic partnership now gives us the opportunity to distribute wheel/tire assemblies to existing OEM customers, particularly in Brazil, the third largest agricultural market in the world.  Over the years, I’ve talked to key OEMs in Brazil, and they expressed enthusiasm about the opportunity to procure wheel/tire assemblies, which is something that none of our key competitors offer in that region. I expect this partnership to be a game changer for our customers and anticipate that wheel/tire assemblies will be a successful part of our Brazilian portfolio, much like they are in the US. Additionally, it gets us one step closer to our goal of being a supplier that OEMs can rely on for both wheels and tires, for all key geographies across the globe. We are excited about the growth opportunities that this partnership will provide for Titan, and about the ability to better serve our customers.”   

Ronaldo Linero, CEO of Rodaros added, “This partnership is founded on shared values and complementary technical expertise between the companies. Our goal is to generate real synergies and deliver added value to the end customer”.

About Titan

Titan International, Inc. (NYSE: TWI) is a leading global manufacturer of off-highway wheels, tires, assemblies, and undercarriage products. Headquartered in West Chicago, Illinois, the Company globally produces a broad range of products to meet the specifications of original equipment manufacturers (OEMs) and aftermarket customers in the agricultural, earthmoving/construction, and consumer markets. For more information, visit www.titan-intl.com.

Titan International, Inc. logo. (PRNewsFoto/Titan International)

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SOURCE Titan International, Inc.

Release – Codere Online to Release Financial Results for the Third Quarter 2025 on November 17th

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10/28/2025

Madrid, Spain and Tel Aviv, Israel, October 28, 2025 (GLOBE NEWSWIRE) – Codere Online Luxembourg, S.A. (Nasdaq: CDRO / CDROW) (the “Company” or “Codere Online”) a leading online gaming operator in Spain and Latin America, today announced that it will release its third quarter 2025 results prior to 8:30AM US Eastern Time on November 17, 2025.

At 8:30AM US Eastern Time on the same day, Codere Online’s management will host a conference call to discuss the results and provide a business update.

The Company’s earnings press release and related materials will be available on Codere Online’s website at www.codereonline.com. Dial-in details for the conference call as well as the audio webcast registration link are accessible in the Events & Presentations section of the same website. A recording of the webcast will be available following the conference call.

About Codere Online

Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina. Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.  

About Codere Group
Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

Contacts:

Investors and Media
Guillermo Lancha
Director, Investor Relations and Communications
[email protected]
(+34)-628-928-152

Release – Travelzoo Reports Third Quarter 2025 Results

Posted on by [email protected]
Travelzoo logo

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Oct 28, 2025, 09:46 ET

NEW YORK, Oct. 28, 2025 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):

  • Revenue of $22.2 million, up 10% year-over-year
  • Consolidated operating profit of $0.5 million
  • Non-GAAP consolidated operating profit of $1.1 million
  • Cash flow from operations of ($0.4) million
  • Earnings per share (EPS) of $0.01

Travelzoo, the club for travel enthusiasts, today announced financial results for the third quarter ended September 30, 2025. Consolidated revenue was $22.2 million, up 10% from $20.1 million year-over-year. In constant currencies, revenue was $21.9 million, up 9% year-over-year. Travelzoo’s reported revenue consists of advertising revenues and commissions, derived from and generated in connection with purchases made by Travelzoo members, and membership fees.

In Q3, Travelzoo continued to invest significantly in acquiring more Club Members when we saw that we can achieve a payback and positive return on investment (ROI) within a quarter. Marketing costs were expensed immediately. Membership fees revenue is recognized ratably over the subscription period of 12 months. The effect is a sizable reduction in EPS. We refer to our investor presentation.

Net income attributable to Travelzoo was $0.2 million for Q3 2025, or $0.01 per share, compared with $0.26 per share in the prior-year period.

Non-GAAP operating profit was $1.1 million. Non-GAAP operating profit excludes amortization of intangibles ($2,000), stock option expenses ($399,000), and severance-related expenses ($167,000). Please refer to “Non-GAAP Financial Measures” and the tabular reconciliation below.

“We will continue to leverage Travelzoo’s global reach, trusted brand, and strong relationships with top travel suppliers to negotiate more Club Offers for Club Members and add new benefits, such as our popular complementary airport lounge access worldwide in case of a delayed flight,” said Holger Bartel, Travelzoo’s Global CEO. “Travelzoo members are affluent, active, and open to new experiences. We inspire travel enthusiasts to travel to places they never imagined they could. Travelzoo is the must-have membership for those who love to travel as much as we do.”

Travelzoo North America
North America business segment revenue increased 11% year-over-year to $14.2 million. Operating profit for Q3 2025 was $1.1 million, or 8% of revenue, compared to operating profit of $3.2 million or 25% of revenue in the prior-year period.

Travelzoo Europe
Europe business segment revenue increased 9% year-over-year to $6.6 million. Operating loss for Q3 2025 was $640,000, or 10% of revenue, compared to operating profit of $1.0 million, or 17% of revenue in the prior-year period. The reported operating loss occurred because we acquired more Club Members.

Jack’s Flight Club
Jack’s Flight Club is a membership subscription service in which Travelzoo has a 60% ownership interest. Revenue increased 12% year-over-year to $1.4 million. The number of premium subscribers increased 8% year-over-year. Jack’s Flight Club’s revenue from subscriptions is recognized ratably over the subscription period (quarterly, semi-annually, annually). Operating profit for Q3 2025 was $20,000, compared to operating profit of $27,000 in the prior-year period.

New Initiatives
New Initiatives business segment revenue, which includes Licensing and Travelzoo META, was $27,000. Operating loss for Q3 2025 was $20,000.

In 2020, Travelzoo entered into royalty-bearing licensing agreements with local licensees for the exclusive use of Travelzoo’s brand, business model, and members in  Australia, Japan, New Zealand, and Singapore. Under these arrangements, Travelzoo’s existing members in Australia, Japan, New Zealand, and Singapore will continue to be owned by Travelzoo as the licensor. Licensing revenue from the licensee in Australia was $9,000 for Q3 2025. Licensing revenue from the licensee in Japan was $7,000 for in Q3 2025. Licensing revenue is expected to increase going forward.

Reach
Travelzoo reaches 30 million travelers. This includes Jack’s Flight Club. Comparisons to prior periods are no longer meaningful due to strategic developments of the Travelzoo membership.

Income Taxes
The reported income tax provision and reserves for Q3 2025 are $244,000. Travelzoo intends to utilize available net operating losses (NOLs) to largely offset its tax liability for Q3 2025.

Balance Sheet
As of September 30, 2025, cash, cash equivalents and restricted cash were $9.2 million. Cash flow from operations was ($0.4) million.

Deferred revenue increased because membership fees revenue is recognized ratably over the subscription period.

Share Repurchase Program
During Q3 2025, the Company repurchased 148,602 shares of its outstanding common stock.

L ooking Ahead
For Q4 2025, we expect year-over-year revenue growth to continue. We expect revenue growth to accelerate as a trend in subsequent quarters, as membership fees revenue is recognized ratably over the subscription period of 12 months, as we acquire new members, and as more Legacy Members become Club Members. Over time, we expect profitability to substantially increase as recurring membership fees revenue will be recognized. In the short-term, fluctuations in reported net income are possible. We might see attractive opportunities to increase marketing. We expense marketing costs immediately.

In 2024, we introduced a membership fee for Travelzoo. Legacy Members, who joined prior to 2024, continue to receive certain travel offers. However, Club Offers and new benefits are only available to Club Members, who pay the membership fee. Therefore, we are seeing many Legacy Members become Club Members over time—in addition to new members who join.

Non-GAAP Financial Measures
Management calculates non-GAAP operating income when evaluating the financial performance of the business. Calculation of non-GAAP operating income, also called “non-GAAP operating profit” in this press release and today’s earnings conference call, excludes the following items: amortization of intangibles, stock option expenses, and severance-related expenses. This press release includes a table which reconciles GAAP operating income to the calculation of non-GAAP operating income. Non-GAAP operating income is not required by, or presented in accordance with, generally accepted accounting principles in the United States of America (“GAAP”). This information should be considered as supplemental in nature and should not be considered in isolation or as a substitute for the financial information prepared in accordance with GAAP. In addition, these non-GAAP financial measures may not be the same as similarly titled measures reported by other companies.

Conference Call
Travelzoo will host a conference call to discuss third quarter 2025 results today at 11:00 a.m. ET. Please visit http://ir.travelzoo.com/events-presentations to

  • download the management presentation (PDF format) to be discussed in the conference call
  • access the webcast.

About Travelzoo
We, Travelzoo®, are the club for travel enthusiasts. We reach 30 million travelers. Club Members receive Club Offers personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with thousands of top travel suppliers—our long-standing relationships give us access to irresistible deals.

Certain statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. These forward-looking statements may include, but are not limited to, statements about our plans, objectives, expectations, prospects and intentions, markets in which we participate and other statements contained in this press release that are not historical facts. When used in this press release, the words “expect”, “predict”, “project”, “anticipate”, “believe”, “estimate”, “intend”, “plan”, “seek” and similar expressions are generally intended to identify forward-looking statements. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including changes in our plans, objectives, expectations, prospects and intentions and other factors discussed in our filings with the SEC. We cannot guarantee any future levels of activity, performance or achievements. Travelzoo undertakes no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this press release.

View full release here.

Investor Relations:
[email protected]

SOURCE Travelzoo

Release – SKYX Signs Agreement with Prominent U.S. and International Real Estate Developers Global Ventures Group to Deploy its Advanced Smart Home Technologies to Buildings and Hotels in Middle East Projects Including Saudi Arabia and Egypt

Posted on by [email protected]

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October 28, 2025 08:45 ET  | Source: SKYX Platforms Corp.

During the Course of the Agreement Global Ventures Group Plans to Deploy SKYX’s Smart Technologies into Tens of Thousands of Homes and Hotel Rooms 

SKYX Expects to Deploy Hundreds of Thousands of Products into Massive Growth of Middle East Projects

SKYX’s Technologies are Expected to Offer Long-Term Recurring Revenue Opportunities Through Monitoring, Subscriptions, and AI Services, in Addition to Product Upgrades, Interchangeability and Platform-Wide Integrations for Future Developments

MIAMI, Oct. 28, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 100 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become smart and safe as the new standard, today announced that it has entered into an agreement with Global Ventures Group, a leading U.S. and international real estate development firm based in Chicago, Illinois. Under the agreement, SKYX’s advanced smart home and smart building technologies will penetrate residential, commercial, and hotel projects across the Middle East, including developments in Saudi Arabia and Egypt. The collaboration marks a significant step in SKYX’s global expansion strategy as it continues to advance its mission to make homes and buildings smarter, safer, and more connected as the new standard.

The Global Ventures Group is led by Randall Langer, Founder and CEO, and a member of the U.S. Chamber of Commerce, participating in initiatives and councils in the Middle East and North Africa Region.

SKYX is expected to supply hundreds of thousands of units of its advanced and smart home technologies, including SKYX’s all-in-one smart home platform, its plug & play ceiling lighting, ceiling fans, recessed lights, down lights, EXIT signs, emergency lights, indoor and outdoor wall lights, plug-in LED mirrors, among other advanced smart products.

Randall Langer, Global Ventures Group Founder and CEO, said, “We are excited to collaborate with SKYX to bring their smart home and innovative technologies into our upcoming Middle East projects in Saudi Arabia and Egypt. As the founder of the Global Ventures Group and as a member of the U.S. Chamber of Commerce, our goal is to deploy leading and highly disruptive U.S. technologies into international projects. By integrating SKYX’s technologies in the Middle East, we are advancing the standards of safety, convenience, and design for communities throughout the region, and we look forward to expanding this collaboration and related initiatives with SKYX throughout future developments.”

For information about Global Ventures Group, visit https://www.gvgrp.com/

Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said; “We are excited to be working with a prominent U.S. and international developer such as the Global Ventures Group. We look forward to collaborating with them on international projects to enhance the value of buildings and hotel projects in the region while creating safer, advanced, and smart homes and buildings for the future.”

To view SKYX’s Technologies demo video CLICK HERE

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements
Certain statements made in this press release are not based on historical facts but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Investor Relations Contact:
Jeff Ramson
PCG Advisory
[email protected]

Release – Aurania Signs MOU with RSA S.R.L. and Firestone Ventures Inc. to Evaluate Potential Critical Metals Project in Europe

Posted on by [email protected]

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October 28, 2025 7:30 AM EDT | Source: Aurania Resources Ltd.

Toronto, Ontario–(Newsfile Corp. – October 28, 2025) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) has signed a Memorandum of Understanding (the “MOU”) with Società per il Risanamento e lo Sviluppo Ambientale dell’ex miniera di amianto di Balangero e Corio (Society for the Remediation and Environmental Development of the former asbestos mine of Balangero and Corio otherwise known as “RSA”), and Firestone Ventures Inc. (“Firestone”). The MOU aims to examine the extensive tailings for a potentially commercially viable recovery of valuable nickel and cobalt, two “Critical Metals” for electric battery production, as highlighted in the European Union Critical Raw Materials Act. The Company has been investigating this concept since March 2024 as complementary to the ongoing Corsica awaruite nickel programme. Firestone will be responsible for the carbon capture portion of the project.

The MOU allows for data collection and sampling of tailings at the former Balangero Asbestos Mine (1916-1990), approximately 25 km NNW of Turin, Italy, to:

  1. Examine the possibilities of extracting valuable nickel, cobalt, chromium, iron and copper from the waste piles, and
  2. Examine the feasibility of using the waste stream to capture carbon from industrial sources and permanently destroy all the asbestos minerals, thereby rendering the material completely benign.

This is a cleanup project with the added bonus of carbon capture and production of critical metals. The MOU has a term of 1 year, after which, if results prove favourable, the parties are expected to enter into a commercial agreement with respect to the extraction of metals from the waste piles and subsequent carbon capture from the waste product stream. Aurania and Firestone have exclusive access to the site for this evaluation.

RSA have determined that the main dry-stacked tailings pile contains approximately 60 million cubic metres of serpentinite waste rock (Oboni and others, 2011; doi:http://dx.doi.org/10.14288/1.0107741). This is material already excavated, milled, and heaped in a pile approximately 250 metres in height. It has been crushed to -10 cm, and the majority of the material is < 1 cm.

A rigorous determination of parameters has not yet been done, and as such, we stress caution; however, with a specific gravity of 2.55 as reported for average serpentinite by the United States Geological Survey (USGS) and a volume of 60 million cubic metres, circa 153 million tonnes of waste is considered to be in the waste pile. In a limited reconnaissance sampling program commissioned by Aurania in 2024, Maxime Dupéré (géo. Project Geologist, SGS Canada Inc. – Geological Services) reported an average of 0.15% nickel for the Balangero tailings. This agrees well with the published average of around 0.17- 0.18% (average of over fifty analyses, with minimum and maximum values ​​respectively around 0.1 and 0.3 %) as reported by Prof. Steffano Zucchetti in 1966. Assuming an average grade of 0.15% Ni, the waste pile could contain circa 229,500 tonnes of nickel. There is also a second, older tailings and waste rock pile on the property that is possibly of similar dimensions.

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Figure 1: Main tailings pile at the Balangero Mine. Approximate height is 250 metres.

To view an enhanced version of this graphic, please visit:
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Figure 2: Appearance of typical mine waste at Balangero.

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This represents a potentially valuable resource which has already been extracted, crushed and dry-stacked. No drilling, blasting or mining will be required in this project. The main target mineral is “awaruite”, a natural alloy of nickel and iron (Ni3Fe), with a composition of 77-83% Ni. There is no sulphide component, and this can be considered a “Green Nickel” recovery project. The awaruite nickel mineral was first described by Zucchetti in 1966, who discovered the mineral in magnetic sand, along with magnetite (Fe3O4). Zucchetti worked out an entire flow sheet for the beneficiation and recovery of the awaruite. Though the nickel-bearing awaruite mineral was not recognized at the time, the magnetic sand from the Balangero Mine tailings was used for some months in 1943 as furnace feed to make steel during World War II (Turin archives).

At present, some 450 kg of material taken from 36 sites across the property is being evaluated at STEVAL (Station expérimentale de valorisation des matières premières et des substances résiduaires) [Experimental station for the recovery of raw materials and residual substances] in Nancy, France. This will determine a complete mineralogical characterization of the material, the grain size of awaruite and other valuable minerals for potential recovery, the necessary grind size to liberate the metals, the bond index for crushing the material, and Davis Tube magnetic separation, which splits the sub-sample into magnetic and non-magnetic fractions. The magnetic fraction will then be fused with lithium metaborate/tetraborate flux and analyzed by X-ray fluorescence. These analyses are more representative of the recoverable grade of the waste since most recoverable nickel will be in the magnetic separate (e.g., awaruite), whereas the whole rock fusion/ICP analyses may include non-recoverable nickel hosted in silicate phases. This work is already ongoing.

International consultancy firm SRK has been retained to produce a Scoping Level Review on the Mineral Assets of the Balangero tailings retreatment project. We forecast this will take approximately 6 months to complete. Dr. Chiara Boschi, a Senior Researcher at the Institute of Geosciences and Earth Resources (IGG-CNR, Pisa, Italy), has been retained by Firestone to develop a process for using carbon dioxide from industrial sources to neutralize the contained asbestos in the tailings and fix the carbon permanently in a potentially useful form. Dr. Boschi is a recognized expert and published author on the carbonation of serpentinite and has over 15 years of experience in this regard.

RSA has some twenty years of experience in managing and reclaiming the Balangero Mine site and has been highly successful in reducing the threat of airborne asbestos, so today it is not considered a concern to local communities. It is not economically feasible at the known grades of nickel to consider the reopening of Balangero as a mining operation, and Aurania has no intention in this regard.

Dr. Keith Barron, a director and Chief Executive Officer of the Company, is also the President and a director of Firestone Ventures Inc.

Qualified Persons:
The geological information contained in this news release has been verified and approved by Aurania’s VP Exploration, Mr. Jean-Paul Pallier, MSc. Mr. Pallier is a designated EurGeol by the European Federation of Geologists and a Qualified Person as defined by National Instrument 43-101, Standards of Disclosure for Mineral Projects of the Canadian Securities Administrators.

About Aurania
Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

Information on Aurania and technical reports are available at www.aurania.com and www.sedar.com, as well as on Facebook at https://www.facebook.com/auranialtd/, Twitter at https://twitter.com/auranialtd, and LinkedIn at https://www.linkedin.com/company/aurania-resources-ltd-.

For further information, please contact:

Carolyn Muir
VP Corporate Development & Investor Relations
Aurania Resources Ltd.
(416) 367-3200
[email protected]		 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements
This news release contains forward-looking information as such term is defined in applicable securities laws, which relate to future events or future performance and reflect management’s current expectations and assumptions. The forward-looking information includes: that if results of the MOU prove favourable, a commercial agreement is expected to be entered into with respect to the extraction of minerals from the waste piles, the assumption that the waste pile may have the potential to contain circa 229,500 tonnes of nickel, that this represents a valuable resource which has already been extracted, crushed and dry-stacked, the expectation that the evaluation of 450 kg of material will provide mineralogical characterization and other expected information about such material, the timing to produce a Scoping Level Review on the Mineral Assets of the Balangero tailings retreatment project, Aurania’s objectives, goals or future plans, statements, exploration results, potential mineralization, the tonnage and grade of mineralization which has the potential for economic extraction and processing, the merits and effectiveness of known process and recovery methods, the corporation’s portfolio, treasury, management team and enhanced capital markets profile, the estimation of mineral resources, exploration, timing of the commencement of operations, the commencement of any drill program and estimates of market conditions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to Aurania, including the assumption that, there will be no material adverse change in metal prices, all necessary consents, licenses, permits and approvals will be obtained, including various local government licenses and the market. Investors are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected. Risk factors that could cause actual results to differ materially from the results expressed or implied by the forward-looking information include, among other things: failure to achieve the anticipated results, incorrect assumptions made in the initial evaluation of the project, failure to identify mineral resources; failure to convert estimated mineral resources to reserves; the inability to complete a feasibility study which recommends a production decision; the preliminary nature of metallurgical test results; the inability to recover and process mineralization using known mining methods; the presence of deleterious mineralization or the inability to process mineralization in an environmentally acceptable manner; commodity prices, supply chain disruptions, restrictions on labour and workplace attendance and local and international travel; a failure to obtain or delays in obtaining the required regulatory licenses, permits, approvals and consents; an inability to access financing as needed; a general economic downturn, a volatile stock price, labour strikes, political unrest, changes in the mining regulatory regime governing Aurania; a failure to comply with environmental regulations; a weakening of market and industry reliance on precious metals and base metals; and those risks set out in the Company’s public documents filed on SEDAR+. Aurania cautions the reader that the above list of risk factors is not exhaustive. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.

info

SOURCE: Aurania Resources Ltd.

Release – Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End

Posted on by [email protected]

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October 28, 2025 7:05am EDT Download as PDF

Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC

LOS ALTOS, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to the Company, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, the Company plans to resubmit the NDA for OLC by year-end.

“We are grateful for the highly constructive feedback and detailed meeting minutes we received from the FDA and look forward to resubmitting the NDA as we advance OLC toward potential approval,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Following our interactions with the FDA, we are very encouraged about the potential for a swift resolution of the issue raised in our CRL and we believe we are now on track to resubmit our NDA before the end of the year, which could lead to a PDUFA date in the first half of 2026. With over $42 million on our balance sheet as of September 30, we have a cash runway into 2027, enabling us to work through the regulatory approval process and continue to advance preparations for potential OLC commercialization while focusing on our mission to deliver improved treatment options for patients with hyperphosphatemia on dialysis.”

About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. 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). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. 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.

1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers.

Preliminary Financial Information
The preliminary financial information included in this press release is unaudited and is subject to completion of the Company’s quarter-end closing procedures and further financial review. Actual results may differ from these estimates as a result of the completion of quarter-end closing procedures, review adjustments and other developments that may arise between now and the time such financial information for the period is finalized. As a result, these estimates are preliminary, may change and constitute forward-looking information and, as a result, are subject to risks and uncertainties. These preliminary estimates should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles, and they should not be viewed as indicative of our results for any future period. The Company’s independent registered public accountants have not audited, reviewed, compiled, or performed any procedures with respect to these estimated financial results and, accordingly, do not express an opinion or any other form of assurance with respect to these preliminary estimates.

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; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to our ability to file an NDA before the end of 2025, risk that we do not get a PDUFA date in the first half of 2026; the accuracy of our cash on hand at September 30, 2025 and risk that our cash runway does not extend into 2027. 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.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
[email protected]

Media Contact:

Layne Litsinger
Real Chemistry
[email protected]

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released October 28, 2025

Release – Perfect Corp. Reports Unaudited Financial Results for the Three Months and the Nine Months Ended September 30, 2025

Posted on by [email protected]

Research News and Market Data on PERF

October 28, 2025

NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a leading artificial intelligence (“AI”) company offering AI and augmented reality (“AR”) powered solutions to beauty, fashion, photo and video creative industries, today announced its unaudited financial results for the three months ended September 30, 2025 and the nine months ended September 30, 2025.

Financial Results for the Three Months Ended September 30, 2025

Revenue

Total revenue was $18.7 million for the three months ended September 30, 2025, compared to $16.1 million in the same period of 2024, an increase of 15.7%. The increase was primarily due to strong growth momentum in the revenue of mobile app and web services subscriptions.

  • AI- and AR- cloud solutions and subscription revenue was $15.7 million for the three months ended September 30, 2025, compared to $13.4 million in the same period of 2024, an increase of 17.2%. The increase was driven by the continued revenue growth of YouCam mobile app and web services subscriptions, the growing popularity among consumers of Generative AI technologies and AI editing features for photos and videos, and the stable demand for the Company’s online virtual product try-on solutions from brand customers.
  • Licensing revenue was $2.2 million for the three months ended September 30, 2025, compared to $2.4 million in the same period of 2024, a decrease of 9.5%.

Gross Profit

Gross profit was $14.1 million for the three months ended September 30, 2025, compared with $13.0 million in the same period of 2024, an increase of 9.2%. Gross margin was 75.8% for the three months ended September 30, 2025, down from 80.3% in the same period of 2024. The decrease in gross margin was primarily due to the increase in AppStore and GooglePlay platform processing fees paid to digital distribution partners, such as Google and Apple, driven by the steady growth in our YouCam mobile app subscription revenue. In addition, the increases in AI server computing cost, resulting from the growing demand for premium features powered by generative AI photo and video services, also contributed to the decrease in gross margin.

Total Operating Expenses

Total operating expenses were $13.7 million for the three months ended September 30, 2025, compared with $13.0 million in the same period of 2024, an increase of 4.7%. The increase was primarily due to increases in sales and marketing expenses and research and development expenses, which were partially offset by a decrease in general and administrative expenses in the third quarter of 2025.

  • Sales and marketing expenses were $7.9 million for the three months ended September 30, 2025, compared to $7.1 million during the same period of 2024, an increase of 11.6%. This increase was primarily due to an increase in marketing events and advertising expenses related to our mobile apps and web services subscription.
  • Research and development expenses were $3.9 million for the three months ended September 30, 2025, compared to $3.2 million during the same period of 2024, an increase of 22.4%. The increase was caused by two main factors: (i) the continued foreign exchange impact caused by the depreciation of the U.S. dollar against New Taiwan dollar elevated personnel costs for our Taiwan-based development team, and (ii) the increase in research and development headcount and related compensation expenses following the acquisition of Wannaby Inc. (“Wannaby”) in the first quarter of 2025.
  • General and administrative expenses were $1.7 million for the three months ended September 30, 2025, compared to $2.1 million during the same period of 2024, a decrease of 18.2%. The decrease was primarily due to reduced corporate insurance premium and external professional service fees.

Operating Income/Loss

Total operating income were $0.5 million for the three months ended September 30, 2025, compared with an operating loss of $0.1 million in the same period of 2024, an increase of $0.6 million turning from a loss to an income position. The increase was primarily driven by higher revenue and gross profit, while operating expenses grew only modestly.

Net Income

Net income was $2.1 million for the three months ended September 30, 2025, compared to $2.5 million during the same period of 2024, a decrease of 17.9%. The decrease in net income was primarily due to (i) higher AppStore and GooglePlay platform processing fees, (ii) higher Taiwan personnel costs due to foreign exchange impact by a weaker U.S. dollar, (iii) increases in operating expenses after the acquisition of Wannaby, and (iv) lowered interest income due to decreases in interest rates on the Company’s cash reserve.

Beginning with the third quarter of 2025, we will no longer present adjusted net income (loss), as this metric is no longer utilized by our management to assess or evaluate our operating performance.

Operating Cash Flow

Operating cash flow was $2.8 million in the three months ended September 30, 2025, compared to $4.2 million in the same period of 2024, a decrease of 34.6%.

Financial Results for the Nine Months Ended September 30, 2025

Revenue

Total revenue was $51.0 million for the nine months ended September 30, 2025, compared to $44.3 million in the same period of 2024, an increase of 15.1%.

  • AI- and AR- cloud solutions and subscription revenue was $44.7 million for the nine months ended September 30, 2025, compared to $38.7 million in the same period of 2024, an increase of 15.4%. The increase was driven by the continued revenue growth of YouCam mobile apps and web services subscriptions.
  • Licensing revenue was $4.8 million for the nine months ended September 30, 2025, compared to $4.7 million in the same period of 2024, an increase of 1.0%.

Gross Profit

Gross profit was $38.9 million for the nine months ended September 30, 2025, compared with $35.2 million in the same period of 2024, an increase of 10.7%. Gross margin was 76.3% for the nine months ended September 30, 2025, slightly down from 79.4% in the same period of 2024.

Total Operating Expenses

Total operating expenses were $40.1 million for the nine months ended September 30, 2025, compared with $37.8 million in the same period of 2024, an increase of 5.9%. The increase was primarily due to increases in research and development and sales and marketing expenses, which were partially offset by a decrease in general and administrative expenses during the period.

  • Sales and marketing expenses were $23.1 million for the nine months ended September 30, 2025, compared to $21.3 million during the same period of 2024, an increase of 8.5%.
  • Research and development expenses were $11.5 million for the nine months ended September 30, 2025, compared to $9.2 million during the same period of 2024, an increase of 25.0%.
  • General and administrative expenses were $5.4 million for the nine months ended September 30, 2025, compared to $6.7 million during the same period of 2024, a decrease of 19.2%.

Operating Loss

Total operating loss were $1.1 million for the nine months ended September 30, 2025, compared with an operating loss of $2.7 million in the same period of 2024, a decrease of 57.7%. The decrease in operating loss was primarily driven by higher revenue and gross profit, while operating expenses grew only modestly.

Net Income

Net income was $4.6 million for the nine months ended September 30, 2025, compared to $3.9 million during the same period of 2024, an increase of 16.7%.

Operating Cash Flow

Operating cash flow was $10.8 million in the nine months ended September 30, 2025, compared to $9.8 million in the same period of 2024, an increase of 10.3%. The Company continues to invest in growth while maintaining a healthy cash flow to support business operations underscoring the Company’s operational health and sustainability.

Capital Resource

As of September 30, 2025, the Company’s cash and cash equivalents remained stable at $127.9 million (or $170.1 million when including 6-month time deposits of $36.3 million and money market funds of $5.9 million, which are classified as current financial assets at amortized cost and current financial assets at fair value through profit or loss under IFRS, respectively), compared to $127.1 million (or $165.9 million when including time deposits and money market funds) as of December 31, 2024.

Key Business Metrics

  • The number of active subscribers for the Company’s YouCam mobile apps and web services was 946,000 as of September 30, 2025, compared to over 960,000 as of June 30, 2025, a decrease of 1.5%. This slight decline was as a result of the mobile app subscription plan’s average selling price (“ASP”) increase initiative introduced in early 2025, which strategically prioritized higher revenue per user and long-term monetization efficiency over short-term volume growth.
  • As of September 30, 2025, the Company’s cumulative customer base included 842 brand clients, with over 953,000 digital stock keeping units (“SKUs”) for makeup, haircare, skincare, shoes, bags, eyewear, watches and jewelry products, compared to 818 brand clients and over 914,000 digital SKUs as of June 30, 2025. The number of Key Customers 1 of the Company as of September 30, 2025 was 142 compared to 139 as of June 30, 2025. The increase is mainly from acquisition of new customer in both makeup and skincare categories.

CEO Remarks and Business Outlook for 2025

Ms. Alice H. Chang, the Founder, Chairwoman, and Chief Executive Officer of Perfect commented, “Perfect Corp. continues to demonstrate steady revenue growth and resilience across its business segments. Our foundation remains strong, and our outlook for the future is bright, supported by ongoing AI innovation and expanding opportunities across both consumer and enterprise fronts. As we move through the remainder of 2025 and into 2026, our focus remains on driving sustainable growth through AI innovation and strategic diversification.

Since we founded Perfect Corp., we have always continued to reinvest in the growth of our products and new business. At the same time, we are striving to operate more efficiently and effectively with our work force. While we have consistently been net income positive, we achieved a milestone in the third quarter of 2025 by reaching operating profit for the first time, compared to operating losses in previous periods. As we align our budget for 2026, we remain focused on continuing to operate with profitability at the forefront.

Our B2C app and web service subscription business continues to show strong momentum, the revenue per user and user engagement continue to rise, validating the value of our premium AI-powered features and confirming the long-term health of our B2C business. We are witnessing a significant increase in user demand for AI-driven image and video generation, reflecting the accelerating shift toward creativity and personalization powered by AI. Building on this trend, we recently introduced new YouCam AI Agents designed to simplify and enhance the user experience.

YouCam AI Agent, a unified, conversational editor now available in YouCam PerfectandYouCam Makeup. By combining beauty styling, skin analysis, fashion try-ons, and pro-grade photo/video enhancement, the agent lets users describe the result they want and delivers fast, precise, studio-quality outputs in seconds. Powered by advanced vision-language AI and Perfect Corp.’s own leading beauty and fashion technologies, YouCam AI Agent sets a new benchmark for intuitive creativity—redefining everyday self-expression, beauty and style through a single, intelligent workflow.

At the core of our success lies the rapid adoption of generative AI in photo and video applications, which continues to be a key driver of both revenue growth and new subscriber acquisition. These technologies empower users to create photorealistic edits, immersive video effects, and personalized digital content that was once only achievable through professional tools—significantly broadening our appeal and deepening user engagement across the YouCam apps and web services ecosystem.

In parallel, our new application programming interface (API) business is gradually contributing to a new revenue stream. This offering allows third-party developers, agencies, and enterprise partners to integrate our proprietary AI, Generative AI, and AR technologies directly into their own ecosystems. We see tremendous potential in this channel to expand our product reach to a broader range of new clients and unlock new monetization opportunities through scalable, API-driven solutions.

Finally, our traditional B2B enterprise business in the beauty and fashion industries continues to navigate a challenging macroeconomic environment marked by cautious client spending and longer decision cycles. Nevertheless, Perfect Corp. remains the clear market leader in virtual try-on and AI beauty/fashion technology, maintaining deep partnerships with top global and luxury brands. As the luxury and beauty markets regain momentum, we believe Perfect Corp. is exceptionally well-positioned to capture the next wave of industry growth, supported by our proven technology leadership and trusted brand relationships.

Driven by steady revenue growth in both YouCam mobile apps and web service subscriptions, along with sustained demand for our enterprise SaaS solutions, the Company reaffirms its full-year 2025 revenue guidance of 13.0% to 14.5% year-over-year growth compared to 2024. This outlook reflects our most recent assessment of market conditions and internal performance trends and may be adjusted should conditions change.”

About Perfect Corp.

Founded in 2015, Perfect Corp. is a leading AI company offering self-developed AI- and AR- powered solutions dedicated to transforming the world with digital tech innovations that make your virtual world beautiful. On Perfect’s direct consumer business side, Perfect operates a family of YouCam consumer apps and web-editing services for photo, video and camera users, centered on unleashing creativity with AI-driven features for creation, beautification and enhancement. On Perfect’s enterprise business side, Perfect empowers major beauty, skincare, fashion, jewelry, and watch brands and retailers by supplying them with omnichannel shopping experiences through AR product try-ons and AI-powered skin diagnostics. With cutting-edge technologies such as Generative AI, real-time facial and hand 3D AR rendering and cloud solutions, Perfect enables personalized, enjoyable, and engaging shopping journey and helps brands elevate customer engagement, increase conversion rates, and propel sales growth. Throughout this journey, Perfect maintains its unwavering commitment to environmental sustainability and fulfilling social responsibilities. For more information, visit https://ir.perfectcorp.com/.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on beliefs and assumptions and on information currently available to Perfect. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including strategies or plans, are also forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. These statements are based on Perfect’s reasonable expectations and beliefs concerning future events and involve risks and uncertainties that may cause actual results to differ materially from current expectations. These factors are difficult to predict accurately and may be beyond Perfect’s control. Forward-looking statements in this communication or elsewhere speak only as of the date made. New uncertainties and risks arise from time to time, and it is impossible for Perfect to predict these events or how they may affect Perfect. In addition, risks and uncertainties are described in Perfect’s filings with the Securities and Exchange Commission. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Perfect cannot assure you that the forward-looking statements in this communication will prove to be accurate. There may be additional risks that Perfect presently does not know or that Perfect currently does not believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by Perfect, its directors, officers or employees or any other person that Perfect will achieve its objectives and plans in any specified time frame, or at all. Except as required by applicable law, Perfect does not have any duty to, and does not intend to, update or revise the forward-looking statements in this communication or elsewhere after the date of this communication. You should, therefore, not rely on these forward-looking statements as representing the views of Perfect as of any date subsequent to the date of this communication.

View full release here.

Investor Relations Contact
Investor Relations, Perfect Corp.
Email: [email protected]
Category: Investor RelationsSource: Perfect Corp.

Release – Newsmax Signs Deal to Make Channel Available in 900+ Hotels, 300,000 Rooms Nationwide

Posted on by [email protected]

Research News and Market Data on NMAX

October 27, 2025

BOCA RATON, FL / ACCESS Newswire / October 27, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced a new agreement with the leading provider of in-room entertainment for the hospitality industry that delivers the Newsmax channel to more than 900 hotels and 300,0000 hotel rooms across the U.S.

The agreement creates a new touchpoint for Newsmax, one of the top cable news channels, bringing the network’s 24/7 news coverage, analysis and programming directly to millions of hotel guests across the country.

“By expanding access to Newsmax in over 900 hotels, we’re not only ensuring that our viewers can stay tuned to Newsmax on the road but also growing awareness of the channel to millions of travelers every year who are looking for trusted, real-time news wherever they are,” Andy Biggers, SVP of Distribution at Newsmax.

This deal continues Newsmax’s strategic expansion across multiple platforms, including cable, streaming, OTT, and now, hospitality. With this move, Newsmax reinforces its presence as one of the fastest-growing news networks in America.

The Newsmax channel is available today on all major cable, satellite, and pay TV systems reaching about 60 million U.S. homes – on par with CNN, Fox and other major networks.

About Newsmax
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 40 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches 20 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”

Investor Contacts
Newsmax Investor Relations
[email protected]

SOURCE: Newsmax Inc.

View the original press release on ACCESS Newswire

Release – MAIA Biotechnology Presents Trial in Progress Poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Posted on by [email protected]

Research News and Market Data on MAIA

October 27, 2025 10:45am EDT Download as PDF

First five patients in Part C (expansion) of THIO-101 Phase 2 clinical trial enrolled in Taiwan and Turkey

CHICAGO, Oct. 27, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its recent attendance at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The Conference, held October 22-26, 2025, in Boston, MA, was hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NIC), and the European Organisation for Research and Treatment of Cancer (EORTC).

MAIA’s Sr. Medical Director, Victor Zaporojan, M.D., presented a Trial in Progress poster titled “A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress.”

Dr. Zaporojan stated, “It was a pleasure to engage with many oncologists and scientists at the AACR-NCI-EORTC Conference and share updates from Part C of our expanded Phase 2 trial. As enrollment continues, we’re seeing a safety profile well aligned with Parts A and B, and momentum is building. Our expert investigators are eager to bring this opportunity to more patients in more countries as new sites come online in the weeks ahead.”

MAIA also announced that it has enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase 2 trial. Screening for the trial is ongoing in Europe and Asia. With multi-continental trial locations, MAIA investigators can draw from a significantly larger patient pool for its third-line studies of ateganosine.

Dr. Saadettin Kiliçkap, Scientific Advisor to MAIA and key investigator for THIO-101 Part C in Turkey, commented, “It’s exciting to see ateganosine develop into what could be a promising treatment option for the large and underserved NSCLC patient population in our region. Lung cancer remains a major public health challenge here—it is the most common cancer and the leading cause of cancer-related death, particularly among men. While public health efforts have helped reduce incidence in men, rates among women continue to rise. Our medical community would welcome a breakthrough therapy that could meaningfully extend and improve the quality of life for patients with late-stage NSCLC.”

Dr. Kiliçkap has served as principal or sub-investigator in more than 100 national and international multi-center phase 2 and phase 3 clinical studies, many of which were related to lung cancer. His research focuses on medical oncology and cancer epidemiology, including solid tumors such as lung cancer, breast cancer, melanoma, and gastrointestinal system cancers, as well as targeted therapies and immunotherapy.

The high prevalence of smoking, compounded by air pollution, is the key driver of NSCLC in Turkey. A 2018 study reported that tobacco smoking accounted for 89.6% of lung cancer cases in Turkey.1 Subsequent research in 2019 suggested that prolonged exposure to ambient air pollution—particularly PM2.5 particulate matter—may have contributed to around 15% of lung cancer-related deaths, highlighting a significant additional risk when combined with smoking.2

MAIA’s Trial in Progress poster is available at maiabiotech.com/publications.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

1 Tobacco Induced Diseases, 14th Annual Conference of the International Society for the Prevention of Tobacco Induced Diseases (TID)
2 Department of Public Health, Trakya University, Faculty of Medicine, Türkiye

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Released October 27, 2025

Release – Kratos Forms Strategic Partnership with Korean Industry Leader to Advance Manned-Unmanned Teaming

Posted on by [email protected]

Research News and Market Data on KTOS

October 27, 2025

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SAN DIEGO, Oct. 27, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a leading technology company in the defense, national security, and global markets, today announced the formation of a strategic partnership with Korea Aerospace Industries (KAI), a major Korean defense organization to advance Manned-Unmanned Teaming (MUM-T) technologies and capabilities.

The collaboration builds on Kratos’ deep experience in affordable, high-performance tactical unmanned aerial systems—including the XQ-58A Valkyrie, Mako, and Tactical Firejet—and KAI’s aerospace technologies. Together, the organizations will work to integrate complementary systems and expertise to accelerate the development of interoperable, next-generation MUM-T solutions that enhance joint force readiness and operational flexibility.

“This partnership represents the next step in evolving how crewed and uncrewed aircraft operate together in contested environments,” said Steve Fendley, President of Kratos’ Unmanned Systems Division. “By combining Kratos’ proven autonomous jet systems with KAI’s advanced technologies, we are expanding the boundaries of affordable mass and collaborative combat capability for U.S. and allied forces.”

“Kratos has long believed that strategic international partnerships are key to ensuring readiness and deterrence through innovation,” said Eric DeMarco, President and CEO of Kratos. “Our collaboration with KAI, a world-class Korean organization, underscores our shared commitment to developing advanced, interoperable defense technologies that strengthen allied capability, resilience, and industrial cooperation.”

The strategic partnership will focus on joint research, system integration, and evolution of scalable MUM-T applications, including autonomous loyal wingmen, distributed sensing, and collaborative strike missions, all focused on affordable mass. Kratos and KAI will also evaluate opportunities for technology co-development, production, and export in alignment with U.S. and allied defense requirements.

About Kratos Defense & Security Solutions, Inc. 
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 Cantrell
[email protected]

Investor Information:
877-934-4687
[email protected]

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Release – Century Lithium Relocating Demonstration Plant to Tonopah, Nevada

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Research News and Market Data on CYDVF

October 27, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce that the Company has begun moving its Lithium Extraction Facility (“Demonstration Plant”) to the Company’s facility at the Tonopah Airport, Nevada. This relocation will consolidate the Company’s operations, improve logistical efficiency, reduce costs and strengthen support for ongoing and future activities.

“The relocation of the Demonstration Plant will allow the Company to consolidate support for the development of Angel Island,” said Bill Willoughby, President and CEO of Century Lithium. “Thanks to the knowledge and efforts of our team, led by Senior Vice President Todd Fayram, Century’s process has undergone various configurations while performing a multitude of tests towards the development of Century Lithium’s patent-pending process for chloride leaching and Direct Lithium Extraction (DLE).”

Century Lithium’s end-to-end process begins by treating Angel Island claystone under optimized conditions using hydrochloric acid, followed by neutralization using sodium hydroxide, with both the acid and base components sustainably produced on-site through the electrolysis of salt water. Following filtration, the resulting lithium chloride solution is treated by DLE to selectively recover lithium and refined to produce high-purity, battery-grade lithium carbonate suitable for electric vehicle and energy storage applications.

By relocating the Demonstration Plant, Century Lithium will gain more space to conduct research and development on battery materials, including lithium metal and lithium iron phosphate. The new location will also allow the construction of a larger assay and metallurgical laboratory at Tonopah to support Angel Island’s current and future laboratory needs.

Century Lithium’s 20-acre site at the Tonopah Airport is home to Century Lithium’s field office for Angel Island. It was integral for the preparation and handling of the bulk sample material treated in the 3-year-long pilot plant program at Amargosa Valley. Going forward, Century Lithium’s Tonopah Airport facility will be used for research and development for Angel Island, project support and administration.

ABOUT CENTURY LITHIUM CORP.

Century Lithium Corp. is an advanced-stage lithium company, focused on developing its 100%-owned lithium project Angel Island in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with direct lithium extraction to make battery-grade lithium carbonate product samples from Angel Island’s lithium-bearing claystone at its Demonstration Plant in Amargosa Valley, Nevada.

Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery-grade lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan, expected to yield an estimated life-of-mine average of 34,000 tonnes per year of lithium carbonate over a 40-year mine-life.

Century Lithium trades on both the TSX Venture Exchange under the symbol “LCE” and the OTCQX under the symbol “CYDVF”, and on the Frankfurt Stock Exchange under the symbol “C1Z”.

To learn more, please visit centurylithium.com.

ON BEHALF OF CENTURY LITHIUM CORP.

WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
[email protected]
centurylithium.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.

Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.

These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed, and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.

Release – Cocrystal Pharma Receives NIH SBIR Award to Advance its Influenza Inhibitor Program

Posted on by [email protected]

Research News and Market Data on COCP

October 27, 2025

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BOTHELL, Wash., Oct. 27, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received a Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). This approximately $500,000 award will support the Company’s development of a novel, oral, broad-spectrum antiviral candidate for the treatment of influenza A and B infections. Cocrystal plans to utilize these funds to characterize lead candidate molecules that inhibit the target of the essential function of the influenza polymerase complex.

“This award provides non-dilutive funding to advance our influenza A/B program targeting potent, broad-spectrum drugs toward the path of clinical development,” said Sam Lee, PhD, Cocrystal President and co-CEO. “We appreciate the funding and confidence from NIH, which further validates our structure-based drug discovery platform technology in developing new antiviral treatments.”

The NIH/NIAID Phase I award is designed to assess the scientific, technical and commercial potential of early-stage programs. Successful completion of Phase I may qualify the recipient eligible to apply for a larger Phase II award, which provides additional substantial funding to continue development.

“We have prioritized the pursuit of government and military funding to advance our antiviral pipeline while building shareholder value,” said James Martin, Cocrystal CFO and co-CEO. “This is an important milestone as we continue our work to secure additional non-dilutive capital.”

The research is supported by the National Institute of Allergy and Infectious Diseases of the NIH under award number 75N93025C00038. The content of this news release is solely the responsibility of Cocrystal and does not necessarily represent the official views of the NIH.

About Influenza

Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year, there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually.

Cocrystal Pharma’s Structure-Based Drug Discovery Platform Technology

Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancement of Cocrystal’s influenza A/B development program. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, the risks and uncertainties arising from the U.S. government shutdown in October 2025 which may delay or prevent us from receiving funds described in this press release, potential manufacturing and research delays arising from raw materials and labor shortages and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future contract research organizations (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of the studies we undertake including any adverse findings or delays, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by governmental authorities and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop and our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
[email protected]

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Released October 27, 2025

Release – Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence

Posted on by [email protected]

Research News and Market Data on TNXP

October 27, 2025 7:00am EDT Download as PDF

Tonmya demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study

Treatment was well tolerated with minimal effects on weight or blood pressure and discontinuation rate of 19% vs. placebo of 20.8%

Data support the potential of Tonmya as a well-tolerated, centrally acting, non-opioid analgesic and therapeutic option for adults with fibromyalgia

CHATHAM, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial biotechnology company presented data on Tonmya™, which was investigated as TNX-102 SL, at the 2025 American College of Rheumatology (ACR) Convergence, held October 24–29, 2025, in Chicago, Illinois. A copy of the Company’s presentation, titled “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

“Fibromyalgia is a debilitating condition that impacts more than 10 million adults in the U.S., and existing treatments are limited by tolerability and side effects,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at ACR highlight Tonmya’s ability to provide clinically meaningful pain reduction while remaining well-tolerated, reinforcing its value as a differentiated, centrally-acting non-opioid treatment for fibromyalgia.”

The data presented at ACR come from RESILIENT, a 14-week randomized, double blind, placebo controlled trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Treatment with Tonmya resulted in a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) versus placebo, along with significant improvements in sleep quality and fatigue as well as the symptoms and function domains of the Fibromyalgia Impact Questionnaire. In an exploratory analysis, among female participants, Tonmya was associated with improvements in sexual function in total score and across multiple subscales of the Changes in Sexual Functioning Questionnaire (CSFQ-14) versus placebo. Tonmya was well tolerated, with minimal impact on weight and blood pressure, no adverse sexual side effects and a low rate of adverse event-related discontinuations (6.1% on Tonmya, 3.5% on placebo). The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.

“The results from RESILIENT further support Tonmya’s role as an innovative treatment option that addresses chronic and widespread pain, one of the most burdensome symptoms of fibromyalgia,” added Gregory M. Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Tonmya’s favorable tolerability profile and unique formulation designed for bedtime sublingual administration offer patients and clinicians an important advancement in care.”

Tonmya was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults.

Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris 
Tonix Pharmaceuticals 
[email protected] 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
[email protected] 

Media Contact 
Ray Jordan 
Putnam Insights 
[email protected] 
 

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Source: Tonix Pharmaceuticals Holding Corp.

Released October 27, 2025