Tesla Stock Jumps as Robotaxi Testing Without Safety Driver Signals Autonomous Breakthrough

Tesla shares moved sharply higher Monday after confirmation that the company has begun testing its Robotaxi service without a safety driver, a milestone that investors and analysts see as a major step toward fully autonomous transportation.

The rally followed social media footage showing a Tesla Robotaxi operating in Austin, Texas with no human driver inside the vehicle. The video quickly gained traction after Ashok Elluswamy, who leads Tesla’s AI and autonomous driving efforts, acknowledged the clip with a brief but telling comment: “And so it begins.” Tesla CEO Elon Musk later confirmed the development, stating that testing is underway with no occupants in the car.

Shares of Tesla rose roughly 4% following the confirmation, pushing the stock closer to its prior all-time highs and reinforcing renewed optimism around the company’s long-promised autonomy strategy. The move lends credibility to Musk’s recent claim that Tesla is only weeks away from unsupervised robotaxi operations.

Austin has emerged as the proving ground for Tesla’s Robotaxi ambitions, with limited deployments already underway using safety drivers. The latest test suggests the company is moving closer to removing that final safeguard, a critical hurdle before broader commercial expansion. Musk has previously said Tesla plans to expand Robotaxi testing beyond Austin and the San Francisco Bay Area into markets such as Phoenix and Nevada.

Wall Street bulls were quick to seize on the news. Wedbush analyst Dan Ives reiterated his long-standing optimism on Tesla, describing the development as the beginning of the company’s “autonomous chapter.” In a note to clients, Ives said 2026 could be a defining year for Tesla as autonomous driving and robotics move from concept to scale.

According to Ives, Tesla is on track for an accelerated Robotaxi rollout across the U.S., with volume production of the company’s purpose-built Cybercab expected to begin in the spring. The futuristic two-seat vehicle, unveiled last year without a steering wheel or pedals, has become central to Tesla’s long-term autonomous strategy.

Early feedback on Tesla’s latest Full Self-Driving software has also added fuel to the rally. Automotive reviewers and journalists who have tested the newest version report smoother driving behavior and fewer required interventions compared with prior iterations. While competitors like Alphabet-backed Waymo still lead in publicly reported safety metrics, the gap appears to be narrowing.

The market reaction highlights a broader shift in how investors are valuing Tesla. Rather than focusing solely on vehicle deliveries and margins, attention is increasingly turning to software, AI, and recurring revenue opportunities tied to autonomy. Wedbush maintains an Outperform rating on the stock and a $600 price target, arguing that autonomous driving could unlock a path toward a multi-trillion-dollar valuation.

Still, challenges remain. Regulatory approval, public trust, and demonstrable safety performance will be essential before Tesla can scale Robotaxi services nationwide. But for the first time in years, tangible evidence appears to support Tesla’s autonomy narrative.

For investors, the confirmation of driverless Robotaxi testing marks more than just a technical achievement — it signals that Tesla’s long-awaited autonomous future may finally be arriving.

Alliance Entertainment’s Handmade by Robots™ Welcomes Seasoned Sales Executive Brian Maggio to Drive Next Phase of Growth

Research News and Market Data on AENT

PLANTATION, Fla., Dec. 12, 2025 (GLOBE NEWSWIRE) — Alliance Entertainment Holding Corporation (Nasdaq: AENT), a premier distributor and omnichannel fulfillment partner to the entertainment and pop culture collectibles industry, supplying more than 340,000 unique SKUs across music, video, video games, licensed merchandise, and exclusive collectibles to over 35,000 retail and e-commerce storefronts, today announced that Handmade by Robots™, its rapidly expanding vinyl-collectibles brand, has appointed industry veteran Brian Maggio as Vice President of Sales. The appointment marks a key step in accelerating the brand’s next phase of commercial growth following its strong performance since joining the Alliance portfolio last year.

“We are thrilled to welcome this exceptional sales leader to our growing team,” said Tony Moyers, SVP Collectibles at Alliance Entertainment. “With extensive history working with Handmade by Robots in previous roles and a track record of driving sales through every major North American retailer and key licensors in toys, gaming, and electronics, Brian steps into the Vice President of Sales role ready to accelerate our momentum.”

Handmade by Robots, known for its signature vinyl figures sculpted to resemble knitted and crocheted characters, has continued to gain momentum across major retailers and fan communities. With licensing partnerships spanning iconic entertainment franchises and a loyal global collector base, the brand is primed for expanded retail penetration, elevated product innovation, and scaled fan engagement.

Maggio brings decades of experience in building and executing sales strategies for licensed products across mass, specialty, and ecommerce channels. His appointment is designed to deepen retail partnerships; strengthen engagement with licensors; and support the brand’s expanding roadmap of character franchises, limited chase variants, and new product formats.

“As a collectibles geek, I’ve been watching the evolution of Handmade by Robots since its inception seven years ago,” said Maggio, incoming Vice President of Sales. “With an origin story that sets it apart, the lore of the Handmade by Robots brand really resonates with fans. The whimsical form factor was-and continues to be-unique and compelling in a sea of licensed vinyl figures. Handmade by Robots has tremendous potential through creative licensing, format variants, and expanding on the handmade aesthetic in innovative ways. I’m excited to play a role in the growth story of Handmade by Robots and equally thrilled to be a part of the passionate team at Alliance Entertainment.”

About Alliance Entertainment

Alliance Entertainment (NASDAQ: AENT) is a premier distributor and fulfillment partner for the entertainment and pop culture collectibles industry. With more than 340,000 unique in-stock SKUs – including over 57,300 exclusive titles across compact discs, vinyl LPs, DVDs, Blu-rays, and video games – Alliance offers the largest selection of physical media in the market. Our vast catalog also includes licensed merchandise, toys, retro gaming products, and collectibles, serving over 35,000 retail locations and powering e-commerce fulfillment for leading retailers. The company’s growing collectibles portfolio includes Handmade by Robots™, a stylized vinyl figure line featuring licensed characters from leading entertainment franchises. Leveraging decades of operational expertise, exclusive licensing partnerships, and a capital-light, scalable infrastructure, Alliance is a trusted partner to the world’s top entertainment brands and retailers. Our omnichannel platform connects collectors and fans to the products, franchises, and experiences they love – across formats and generations. For more information, visit www.aent.com.

Forward Looking Statements

Certain statements included in this Press Release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics and projections of market opportunity. These statements are based on various assumptions, whether identified in this Press Release, and on the current expectations of Alliance’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by an investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Alliance. These forward-looking statements are subject to a number of risks and uncertainties, including risks relating to the anticipated growth rates and market opportunities; changes in applicable laws or regulations; the ability of Alliance to execute its business model, including market acceptance of its systems and related services; Alliance’s reliance on a concentration of suppliers for its products and services; increases in Alliance’s costs, disruption of supply, or shortage of products and materials; Alliance’s dependence on a concentration of customers, and failure to add new customers or expand sales to Alliance’s existing customers; increased Alliance inventory and risk of obsolescence; Alliance’s significant amount of indebtedness; our ability to refinance our existing indebtedness; our ability to continue as a going concern absent access to sources of liquidity; risks that a breach of the revolving credit facility could result in the lender declaring a default and that the full outstanding amount under the revolving credit facility could be immediately due in full, which would have severe adverse consequences for the Company; known or future litigation and regulatory enforcement risks, including the diversion of time and attention and the additional costs and demands on Alliance’s resources; Alliance’s business being adversely affected by increased inflation, uncertainty regarding tariffs, higher interest rates and other adverse economic, business, and/or competitive factors; geopolitical risk and changes in applicable laws or regulations; as well as our financial condition and results of operations; substantial regulations, which are evolving, and unfavorable changes or failure by Alliance to comply with these regulations; product liability claims, which could harm Alliance’s financial condition and liquidity if Alliance is not able to successfully defend or insure against such claims; availability of additional capital to support business growth; and the inability of Alliance to develop and maintain effective internal controls.

For investor inquiries, please contact:

Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
AENT@redchip.com

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Release – Cadrenal’s Anticoagulation Platform Is Expanding in a $40 Billion Market

Research News and Market Data on CVKD

PONTE VEDRA, FL / ACCESS Newswire / December 12, 2025 / Cadrenal Therapeutics (NASDAQ:CVKD) believes it continues to be misread by the market. Yes, the Company is intentionally narrowly focused. However, the lane it occupies is among the most undertreated areas in medicine. Anticoagulation for difficult-to-treat patients has not seen meaningful reinvention in decades. Warfarin persists due to a lack of innovation. DOACs dominate because alternatives have not evolved. Cadrenal is stepping into that void with therapeutics being designed for the specific patient groups who struggle most with a 70-year-old drug (warfarin).

Tecarfarin, the Company’s late-stage asset, is the kind of drug candidate you notice only after you understand how fragile the current standard really is. Patients with end-stage kidney disease plus atrial fibrillation and advanced comorbidities do not get predictable outcomes from existing anticoagulants. Tecarfarin was engineered to solve that problem. Stable. Controlled. Reversible. The design reflects clinical demands that have gone unanswered for years. This is where Cadrenal begins to differ. It is not trying to win a popularity contest. It is trying to find a better solution to the shortcomings of current therapies.

That shift has been visible since August. Cadrenal advanced manufacturing readiness. It added clinical depth inside the leadership ranks. And it expanded the pipeline in a way that instantly upgraded the company’s strategic position. The acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for Heparin-Induced Thrombocytopenia (“HIT”), is expected to be a game changer. It is a signal that Cadrenal intends to play on a larger scale.

Expansion That Changes the Stakes

With that, Cadrenal no longer behaves like a one-asset microcap. It behaves like a company constructing a multi-shot clinical platform inside the $40 billion anticoagulation market. The acquisition of a Factor XIa portfolio opened the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed. When you combine that with tecarfarin’s chronic-care positioning, you get a company with meaningful reach across multiple high-value treatment environments.

The addition of VLX-1005 further expands the pipeline. HIT is one of the most dangerous complications in hospital care, and treatment options remain limited. A Phase 2 asset with existing regulatory advantages gives Cadrenal an immediate foothold in a space where clinicians are hungry for better solutions. This kind of diversification is not common among companies of this size. It changes the conversation about Cadrenal’s potential.

The valuation does not appear to have kept pace with the expansion. The stock still appears to trade as if the Company is a single-asset story with a narrow path ahead. Meanwhile, Cadrenal sits on a portfolio with three mechanistic approaches and multiple clinical catalysts. That gap between perception and reality is where opportunity usually forms. It does not stay open forever.

Underdog Periods Have an Expiration Date

Investors are beginning to rediscover the story. Still, it appears the market continues to price Cadrenal for what it was, not for what it is building. Companies that solve real problems in anticoagulation do not stay in microcap territory. Not when they have differentiated assets, expanding clinical programs, and designations that potentially derisk the regulatory pathway. Cadrenal has put all those elements in motion.

This could be the last period during which anyone can underestimate the Company. Tecarfarin is approaching Phase 3 trial readiness. VLX-1005 is entering a phase where clinical data becomes increasingly important. The Factor XIa platform gives the company hospital relevance that most microcaps never achieve. These are not theoretical advantages. They exist today. And bigger companies are hungry to add late-stage assets to their portfolios, and many of their drugs are coming off patent in this decade.

The underdog label still fits, but potentially not for long. Cadrenal is preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival. The market has been slow to adjust, but pipelines like this eventually speak loudly. When Cadrenal’s data hits, the story could flip from overlooked to obvious, and the window for catching the mispricing could close fast.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the Company being misread by the market; Warfarin persisting due to a lack of innovation; designing therapeutics for patient groups who struggle most with a 70-year-old drug; finding a better solution to the shortcomings of current therapies; the acquisition of VLX-1005, a Phase 2 program with Orphan Drug and Fast Track designations for HIT being a game changer; signaling Cadrenal intends to play on a larger scale; the acquisition of a Factor XIa portfolio opening the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the conversation about Cadrenal’s potential; the gap between perception and reality being where opportunity usually forms; investors beginning to rediscover the story; this being the last period during which anyone can underestimate the Company; Tecarfarin approaching Phase 3 trial readiness; the underdog label still fitting, but potentially not for long; preparing for a set of milestones that are expected to lead to a reevaluation upon their arrival, and the story flipping from overlooked to obvious; and the window for catching the mispricing closing fast when Cadrenal’s data hits. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to use the acquisition of a Factor XIa portfolio to open the door to acute hospital settings where safer, more controlled anticoagulation is urgently needed; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Accuracy & Disclosure Statement: Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.

At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM may hold shares of Cadrenal Therapeutics and may sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.

Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.

Contact for this content:

info@hawkpointmedia.com

SOURCE: Cadrenal Therapeutics

Release – CoreCivic Announces Promotion of Daren Swenson to Executive Vice President And Chief Corrections and Reentry Officer

Research News and Market Data on CXW

December 12, 2025

PDF Version

BRENTWOOD, Tenn., Dec. 12, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic” or the “Company”) announced today that CoreCivic’s Board of Directors (the “Board”) has appointed Daren Swenson, who currently serves as CoreCivic’s Senior Vice President and Chief Corrections Officer, to Executive Vice President and Chief Corrections and Reentry Officer (CCRO), effective January 1, 2026, overseeing the operations for our corrections, detention, and reentry facilities.

Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “Daren is an exceptional leader whose decades of service within the organization has allowed him to develop an in-depth knowledge of our business. I am confident that Daren’s demonstrated abilities will serve us well in the midst of a period of rapid growth.”

Patrick D. Swindle, CoreCivic’s President and Chief Operating Officer, added, “I look forward to Daren’s continued contributions to operational excellence, drawing on his extensive experience with the Company, as we tend to the growing needs of our government partners.”

Mr. Swenson said, “I am deeply honored by the trust CoreCivic’s Board and executive leadership have placed in me with this new role. Having spent my career with CoreCivic since 1992, I have witnessed firsthand the dedication and professionalism of our team as we work to serve our government partners and the public good. I am grateful for the opportunity to continue helping individuals on their path to reentry and addressing the complex needs of our government partners. As we move forward during this exciting period of growth, I look forward to working alongside my colleagues to deliver innovative solutions and uphold the high standards that define CoreCivic.”

Mr. Swenson began his career with CoreCivic in 1992 at our Prairie Correctional Facility in Appleton, Minnesota as a Correctional Sergeant. Before becoming Senior Vice President and Chief Corrections Officer of the Company, Mr. Swenson progressed through multiple leadership positions including Warden, Managing Director, and Vice President. Mr. Swenson holds bachelor’s degrees in psychology and sociology from North Dakota State University and a master’s degree in management with a concentration in Organizational Leadership from Middle Tennessee State University.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest operators of such facilities in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements concerning executive leadership positions at CoreCivic and prospects of growth in CoreCivic’s business. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.

Contact:Investors: Jeb Bachmann – Managing Director, Investor Relations – (615) 263-3024
Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – NN, Inc. Announces Formation of a Strategic Committee of the Board of Directors

Research News and Market Data on NNBR

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Committee to Evaluate a Broad Range of Strategic, Financing and Other Alternatives to Enhance Shareholder Value

CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) — NN, Inc. (“NN” or the “Company”) (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, today announced that the Board of Directors (the “Board”) has formed a Strategic Committee to oversee a review of strategic and financial alternatives to further enhance shareholder value.

The Strategic Committee is comprised of three independent directors, Raynard Benvenuti, Jeri Harman and Thomas Wilson, and has been tasked with evaluating a broad spectrum of strategic, financial and business configuration options for the Company. The Board has engaged Houlihan Lokey, a leading independent investment bank, as the Company’s financial advisor.

“The Board’s decision to form a Strategic Committee reflects our commitment to maximizing value for NN’s shareholders and evaluating potential avenues to achieve this objective,” said Ms. Harman, independent Chair of NN. Ms. Harman continued, “Over the past several years, we have strengthened our executive team, sharpened our strategic focus, expanded operating income and EBITDA, built a new sales pipeline of more than $800 million, secured approximately $200 million in new business, entered the medical and data center markets, developed a healthy M&A pipeline, and positioned the Company to scale up to its next stage of growth. These accomplishments have improved our earnings quality and enhanced our free cash flow generation profile. With this stronger foundation in place, we believe now is the right time to take a fresh, comprehensive look at additional ways to unlock value for our shareholders.”

Harold Bevis, President and Chief Executive Officer of NN, added, “As the Committee conducts its review, the Company remains focused on advancing its transformation plan and delivering the high-quality products, engineering support and service that our customers expect from NN.”

There can be no assurance that the process will result in any particular outcome. NN has not set a timetable for the completion of the review, and the Company does not intend to provide further updates unless and until the Board has approved a specific course of action or determines additional disclosure is appropriate or necessary.

ABOUT NN

NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and China. For more information about the company and its products, please visit www.nninc.com.

Forward-Looking Statements

This press release contains express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the strategic review, including the timing and outcome of such review, our long-term financial profile and other statements that are not historical fact. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “growth,” “guidance,” “intend,” “may,” “will,” “possible,” “potential,” “predict,” “project”, “trajectory” or other similar words, phrases or expressions. Forward-looking statements involve a number of risks and uncertainties that are outside of management’s control and that may cause actual results to be materially different from such statements. Such factors include, among others, general economic conditions and economic conditions in the industrial sector; material changes in the costs and availability of raw materials; the level of our indebtedness; our ability to secure, maintain or enforce patents or other appropriate protections for our intellectual property; and cyber liability or potential liability for breaches of our or our service providers’ information technology systems or business operations disruptions. The foregoing factors should not be construed as exhaustive and should be read in conjunction with the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Company’s filings made with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. New risks and uncertainties may emerge from time to time, and it is not possible for the Company to predict their occurrence or how they will affect the Company. The Company qualifies all forward-looking statements by these cautionary statements.

Investor Relations: 
Joseph Caminiti or Stephen Poe, Investors 
NNBR@alpha-ir.com  
312-445-2870 

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Source: NN, Inc.

Superior Group of Companies (SGC) – Highlights From NobleCon21


Friday, December 12, 2025

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

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

NobleCon21. On December 3rd, management presented at NobleCon20 at Florida Atlantic University (FAU) in Boca Raton, Florida. The presentation was conducted by Michael Benstock, Chairman & CEO, and Mike Koempel, CFO. The executives highlighted the company’s century-old operating history, its three diversified and profitable segments, branded products, healthcare apparel, nearshore contact centers, and a capital allocation strategy focused on shareholder returns. A replay of the presentation can be viewed here.

Healthcare. The healthcare apparel segment boasts multi-channel reach across retailers, e-commerce platforms, uniform stores, hospital systems, and specialty distributors. More than two million professionals wear the company’s brands, which includes Wink, Carhartt-branded scrubs, and Fashion Seal Healthcare. Notably, the company is well positioned for expansion supported by demographic aging and persistent healthcare labor shortages.


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

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

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

Cadrenal Therapeutics (CVKD) – New Anticoagulant Acquired For Heparin-Induced Thrombocytopenia.


Friday, December 12, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Cadrenal Continues Build Its Anticoagulation Pipeline. Cadrenal has acquired VLX-1005, a platelet inhibitor from Veralox Therapeutics, adding another novel small-molecule anti-coagulant to its pipeline. VLX-1005 is a selective inhibitor of 12-LOX, an enzyme that initiates a signaling pathway for platelet-mediated inflammation and leads to heparin induced thrombocytopenia (HIT). VLX-1005 has Orphan Drug Designation from the FDA and EMA.

VLX-1005 Has Completed A Phase 2 Clinical Trial. Two Phase 1 studies showed safety and tolerability, followed by a Phase 2 trial in patients with suspected heparin induced thrombocytopenia (HIT). Interim results to date showed reductions in thromboembolic events.


Get the Full Report

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

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

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

Housing Market Softens After Two-Year Run — A Shift Worth Watching

For the first time in more than two years, U.S. home prices have dipped into negative territory, slipping 1.4% in just the last three months. High-frequency data from Parcl Labs shows a modest decline nationally, but the shift carries more weight than the numbers suggest. After a long stretch of rising prices fueled by pandemic demand, extremely low inventory, and a surge in relocation activity, the market is now feeling the effects of high mortgage rates, slower buyer activity, and a consumer who is becoming increasingly cautious. For small-cap investors, this change in the housing landscape serves as a valuable indicator of broader economic sentiment.

The housing market has been wrestling with affordability pressures since mortgage rates spiked in 2022 and 2023, with the 30-year fixed rate jumping from under 4% to more than 7%. That rapid climb priced out large segments of buyers and forced sellers to adjust their expectations. While inventory is still historically low, active listings have risen 13% year over year, and many sellers are pulling their homes off the market entirely due to low demand. That type of hesitation reflects real-time consumer behavior—people are slowing down major purchases, reevaluating budgets, and becoming more selective. Housing tends to reveal economic shifts early, and the current softness mirrors the same cautious tone we’ve been seeing in certain pockets of the small-cap market.

Regionally, the data is even more telling. Markets like Austin are down 10% year over year, with Denver, Tampa, Houston, Atlanta, and Phoenix also showing notable declines. Meanwhile, cities like Cleveland, Chicago, New York, Philadelphia, and Boston are still posting price gains. This split environment is a reminder that the national average rarely tells the full story—both in real estate and in equities. Small-cap stocks behave the same way: some regions and sectors weaken sharply while others show surprising strength. Investors who learn to spot these patterns early often outperform.

Another challenge is the lack of updated government housing reports due to the recent federal shutdown. Without fresh data on housing starts, permits, or new home sales, analysts are relying heavily on private data, builder sentiment, and earnings commentary. Homebuilders themselves describe a market with weak demand and ongoing incentives, and their sentiment remains deep in negative territory. That combination—soft demand, cautious consumers, and uneven regional performance—is exactly the kind of environment where small caps tend to lag temporarily before outperforming when conditions improve.

Mortgage rates have barely moved in the last three months, even after the Fed’s recent rate cut, suggesting that home prices may hover around zero growth for some time. But for small-cap investors, this stability isn’t a bad thing. When markets pause, opportunities emerge. Historically, when housing cools without collapsing, it often sets the stage for strong small-cap recoveries once rates drift lower and consumer confidence finds its footing.

Home prices turning slightly negative isn’t a crisis—it’s a signal. It tells us the economy is recalibrating after years of aggressive tightening, and that consumers are adapting. For disciplined small-cap investors, this environment is a chance to study balance sheets, identify undervalued companies, and prepare for the next move higher. Economic resets don’t punish prepared investors—they reward them.

Federal Move on Marijuana Rescheduling Could Reshape the Sector

The U.S. cannabis sector is heading into a potentially transformative moment as reports surface that President Donald Trump is preparing to push for a reclassification of marijuana from a Schedule I drug to Schedule III. While no final decision has been made, the conversations happening between top administration officials and industry leaders signal a serious shift in federal posture—one that could reshape the economics, legal landscape, and competitive structure of the cannabis industry. For small-cap companies operating in or around this space, the impact could be particularly significant.

Cannabis has long been stuck at the federal level in a category reserved for substances with no accepted medical use, a classification that has held back the industry for decades. Reclassifying it to Schedule III would not legalize cannabis federally, but it would meaningfully reduce the restrictions companies face. The most immediate change would be relief from Section 280E of the tax code, which currently prevents cannabis operators from deducting ordinary business expenses. Larger players with substantial revenues would feel this impact first—but small-cap companies stand to benefit disproportionately because the tax burden has historically crushed their margins and limited their ability to reinvest.

A shift to Schedule III could also open the door to greater access to banking services, institutional capital, insurance products, and credit facilities. These are areas where small-cap operators—cultivators, distributors, multi-state operators, ancillary service providers, and biotech firms researching cannabinoids—have been at a disadvantage compared with more capitalized competitors. If traditional lenders and investors begin viewing cannabis as a legitimate medical or commercial sector rather than a high-risk legal minefield, the funding gap could narrow. That alone could reshape the competitive landscape, giving innovative but undercapitalized players a fighting chance to scale.

Public small-cap cannabis stocks are already reacting. Shares across the sector surged following the news, reflecting expectations that regulatory reform would unlock new revenue opportunities and ease long-standing financial pressures. But beyond the rally, the structural implications matter more. With reclassification, companies may finally be able to reduce compliance costs, expand into new states, and invest more aggressively in product development. Small-cap players focused on medical cannabis, CBD therapeutics, agricultural technology, and retail operations could all find themselves in a stronger position.

Of course, the path forward is not guaranteed. The reclassification process requires regulatory rulemaking and could face legal challenges, political resistance, and bureaucratic delays. The mixed landscape of state laws adds another layer of complexity that will not immediately disappear. And federal rescheduling alone does not address interstate commerce restrictions or full legalization—two changes that would unlock the broadest economic benefits.

Still, even a modest shift at the federal level can materially change market dynamics. The cannabis industry has operated for years under a patchwork of conflicting rules that increase costs and protect incumbents. Any move that reduces uncertainty—even if incremental—creates an environment where smaller, nimble companies can innovate, expand, and compete more effectively.

For small-cap investors, this moment is worth watching closely. Policy changes of this scale tend to create inefficiencies and valuation gaps, especially in sectors where regulation has held back growth. While volatility is likely as the political process unfolds, the prospect of lower taxes, reduced compliance friction, and increased access to capital could mark the beginning of a new cycle for cannabis-related equities.

Not Everyone Agreed: The Argument for Holding Rates Steady

The Federal Reserve’s December policy meeting delivered a third consecutive quarter-point rate cut, bringing the federal funds rate down to a 3.5%–3.75% range. But the decision was far from unanimous. In fact, the meeting produced the highest number of dissents in more than six years, with Chicago Fed President Austan Goolsbee, Kansas City Fed President Jeff Schmid, and Fed Governor Stephen Miran all breaking from the majority. Their reasons shed light on why the central bank remains cautious—and why some policymakers believe the Fed should have waited before easing further.

At the core of the dissent is a simple theme: uncertainty. Goolsbee and Schmid both argued that the Fed lacks enough recent data to justify another cut. With government reporting disrupted and key inflation releases delayed, the policymakers said they were uncomfortable lowering rates again without a clearer picture of how prices and demand are evolving. Goolsbee stressed that waiting until early 2026 for updated data would not have introduced meaningful economic risk, but it would have allowed the Fed to make a more informed call. In his view, patience was the more prudent option.

Both Goolsbee and Schmid pointed to inflation as the most compelling reason to pause. After moving sharply lower in 2023, progress on inflation has stalled for several months. Businesses across multiple sectors continue to cite rising input costs, and consumer surveys show persistent unease about prices. Schmid went further, warning that inflation is still “too hot” and that the economy’s ongoing momentum suggests current policy may not be restrictive enough. He raised the concern that households and firms could begin incorporating inflation into their everyday decision-making—a trend that historically makes inflation harder to bring down.

Goolsbee acknowledged that some price pressures appear tied to tariffs and may prove temporary, but he also highlighted risks that inflation in services could remain sticky. With the labor market cooling gradually rather than sharply, he argued there is no urgent economic threat that requires cutting rates before more evidence arrives. Hiring and firing activity has slowed into what he described as a “low hiring/low firing” environment—typical of businesses navigating uncertainty rather than signaling any dramatic downturn.

Fed Governor Stephen Miran dissented for a different reason, preferring a larger 0.50% cut. His stance reflects the broader tension within the central bank: some officials fear easing too slowly risks stalling momentum, while others worry easing too quickly risks reigniting inflation. The result is a policy landscape where the Fed is attempting to balance growth risks against inflation risks in real time, with incomplete information.

Still, the majority of the committee moved forward with the cut, signaling confidence that inflation will eventually resume its downward trend. But the dissents highlight that key voices inside the central bank are urging caution. For investors, the takeaway is straightforward: the Fed is not unanimously convinced that the inflation battle is over, and future rate moves may be more contested than markets expect.

Release – MAIA’s Ateganosine Surges Ahead with Breakthrough Momentum as Pivotal Phase 3 Trial Initiates

Research News and Market Data on MAIA

December 11, 2025 1:00pm EST Download as PDF

CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) — Ateganosine (THIO, 6-thio-2′-deoxyguanosine), a first-in-class telomere-targeting therapy under development by MAIA Biotechnology (NYSE American: MAIA), appears to be gaining increasing attention in the oncology community as emerging clinical results continue to surpass expectations in advanced non-small cell lung cancer (NSCLC). With the therapy’s Phase 2 trial ongoing and a pivotal Phase 3 program initiated this week, ateganosine is being closely watched as one of the most distinctive investigational approaches in solid-tumor treatment today.

We believe that MAIA has positioned itself at the forefront of a new scientific category in oncology. To our knowledge, Ateganosine remains the only direct telomere-targeting anticancer agent currently in clinical development anywhere—a key distinction in a treatment landscape where most therapeutic advances build upon established mechanisms rather than introduce entirely new ones.

According to management, statistical assessments of the Phase 3 trial points to a very high probability of technical success for regulatory approval of ateganosine.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.

A Dual Mechanism Unlike Existing Therapies

Ateganosine works through a dual mechanism of action that we believe differentiates it from existing chemotherapies, targeted agents, and immunotherapies.

First, the molecule is selectively incorporated into cancer-cell telomeres by telomerase, an enzyme active in more than 80% of human cancers. This incorporation disrupts telomeric structure and function, driving selective cancer-cell death.

Simultaneously, this disruption generates micronuclei carrying ateganosine-modified telomeric DNA fragments. These fragments interact with immune cells and trigger a potent immunogenic response involving both the cGAS/STING innate pathway and adaptive T-cell activation, further promoting tumor regression.

This integrated telomere-targeting–plus–immune-activation model represents a mechanism that to our knowledge is not seen in current NSCLC treatments and may hold implications for broader solid-tumor indications.

Phase 3 Outcomes are the Next Step

The launch of a Phase 3 trial reflects growing confidence in the maturing clinical profile. With NSCLC remaining one of the largest and most challenging oncology markets globally, in our opinion, the commercial opportunity for a first-in-class therapy with this level of early performance is substantial.

As the only telomere-targeting agent in clinical development that we are aware of, ateganosine could mark the start of a new therapeutic category. Should its results to date translate into later-stage confirmation, we believe the therapy could emerge as a major entrant in next-generation cancer treatment.

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
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released December 11, 2025

Release – GeoVax Addresses Identification of New Mpox Variant

Research News and Market Data on GOVX

Continued Mpox Evolution Underscores Dependence on a Single Global Supplier, Reinforcing the Critical Importance of GeoVax’s Accelerated GEO-MVA Program

Atlanta, GA – December 11, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today addressed reports from UK health authorities confirming the emergence of a newly evolved “recombinant” Mpox strain. Early analysis indicates the variant contains genetic elements from both Clade I and Clade II Mpox viruses, highlighting the ongoing evolution of the pathogen and the potential implications for disease severity, transmissibility, and vaccine readiness.

The discovery of this recombinant strain comes at a time when global Mpox vaccine supply remains concentrated in a single manufacturer – creating risks around preparedness, surge capacity, and geopolitical access. GEO-MVA is uniquely positioned in developing an expanded supply of MVA vaccine, bolstering domestic and global resilience.

GeoVax Highlights Strategic and Public Health Implications

  • The virus continues to evolve. Simultaneous circulation of multiple Mpox clades creates ongoing risk for recombination and changing outbreak behavior.
  • Global supply remains dangerously concentrated. A single-vendor global supply model heightens vulnerability for stockpile readiness and equitable vaccine distribution.
  • GEO-MVA is progressing as the first U.S.-based Mpox/smallpox vaccine. GeoVax aims to deliver a scalable, domestically manufactured solution that supports national biodefense and global supply diversification.
  • Clinical and manufacturing progress advancing: Final fill-finish activities of GEO-MVA are scheduled to be completed by year-end, with first-in-human studies planned upon regulatory clearance.

“The emergence of a recombinant Mpox strain is a timely reminder that viral evolution does not pause,” said David Dodd, Chairman & CEO of GeoVax. “With global vaccine supply dependent on a single provider, the risks to preparedness, national security, and market stability are clear. We are developing GEO-MVA to meet this strategic need – a U.S.-manufactured Mpox vaccine capable of supporting both domestic requirements and global demand.”

Favorable EMA Development Pathway Accelerates GEO-MVA

GeoVax recently received positive Scientific Advice from the European Medicines Agency (EMA) confirming that the Company may proceed directly to a single Phase 3 immuno-bridging trial with no Phase 1 or Phase 2 trials required to support a Marketing Authorization Application (MAA) for GEO-MVA. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also affirmed the adequacy of GeoVax’s proposed nonclinical package and agreed with the Company’s immunogenicity endpoints for demonstrating non-inferiority to the licensed comparator vaccine.

This guidance provides a significant acceleration of the regulatory timeline, a de-risked development path, and a potentially earlier commercialization opportunity across all 27 EU member states. As reinforced in a subsequent regulatory communication, the EMA’s pathway positions GeoVax for expedited approval, reduced development cost, and earlier revenue generation as the Company advances GEO-MVA toward Phase 3.

About GEO-MVA

GEO-MVA is GeoVax’s next-generation Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine, engineered to provide a durable, broad immune response with both civilian and biodefense (“dual-use”) applicability. Key attributes include:

  • U.S.-Based Manufacturing Pathway: GEO-MVA is being developed as the first U.S.-manufactured Mpox/Smallpox vaccine, reducing reliance on foreign suppliers and supporting national security priorities.
  • Dual-Use Capability: Designed to meet both public health needs and Strategic National Stockpile requirements.
  • Robust Multi-Antigen Immunity: MVA enables broad antigen presentation to support strong humoral and T-cell responses.
  • Scalable Modern Production: GeoVax’s planned transition to AGE1 continuous cell-line manufacturing is expected to expand output, reduce cost, and support global self-sufficiency.
  • Regulatory Momentum: EMA’s streamlined approach provides a clear, accelerated pathway for clinical advancement and commercialization.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

info@geovax.com

678-384-7220

Media Contact:

Jessica Starman

media@geovax.com 

Release – MAIA Biotechnology Announces First Patient Dosed in THIO-104 Phase 3 Pivotal Trial Evaluating Ateganosine as Third-Line Treatment for Advanced Non-Small Cell Lung Cancer

Research News and Market Data on MAIA

December 11, 2025 9:00am EST Download as PDF

Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy

CHICAGO, Dec. 11, 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 that the first patient has been dosed in the Company’s THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC).

The multicenter, open-label trial of patients who are resistant to CPI and chemotherapy treatments, is designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia. Screening and enrollment are now underway.

“Our strategy to bring our telomere-targeting treatment to market is proceeding according to plan as we advance our ateganosine program to a Phase 3 trial. This larger trial will provide us a robust dataset to support our case for commercial approval by the U.S. FDA,” said Vlad Vitoc, M.D., CEO of MAIA. “We have many sites in several countries already screening patients, and with our first patient dosed, we have achieved a key milestone along our path to potential FDA commercial approval. We expect to see Phase 3 results consistent with Phase 2 trial data showing median survival of 17.8 months compared to approximately six months of survival from chemotherapy. We are confident that ateganosine could become the new treatment standard for patients suffering from this devastating disease.”

Ateganosine sequenced with a CPI has shown exceptional efficacy in third-line NSCLC patients. As of September 17, 2025, the observed progression free survival (PFS) in THIO-101 was 5.6 months, more than double the standard of care PFS of 2.5 months. One patient that began therapy in March 2023 has shown survival of 30 months, or 912 days. 

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.

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-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

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
ir@maiabiotech.com

Primary Logo

Source: MAIA Biotechnology, Inc.

Released December 11, 2025