Month: March 2025

Will Tesla Gain from Trump’s Auto Tariffs and EV Policy Shifts?

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– U.S.-based production shields Tesla from Trump’s auto tariffs, unlike GM and Ford.
– Musk says ending tax credits would hurt rivals more than Tesla.
– Musk sees self-driving tech as Tesla’s key long-term value.

President Donald Trump’s latest move to impose 25% tariffs on foreign automobiles and certain auto parts has shaken the auto industry, sending shares of major automakers tumbling. General Motors (GM) stock fell nearly 7%, while Ford (F) dropped 3%. But Tesla (TSLA) went in the opposite direction, climbing 5% in early trading, as analysts suggested the EV leader may be a “relative winner” in the tariff battle.

Unlike many of its competitors, Tesla is largely insulated from the impact of Trump’s tariffs thanks to its U.S.-based production. While the company operates gigafactories in China and Germany, none of the EVs built at those sites are sold in the U.S. Instead, Tesla’s American customers receive vehicles manufactured in Fremont, California, or Austin, Texas. This domestic production model allows Tesla to avoid the direct cost increases that automakers relying on foreign imports will now face.

By comparison, 77% of Ford’s vehicles are made in the U.S., followed by Stellantis (57%), Nissan (52%), and GM (52%). Many of these companies now find themselves in a difficult position, forced to absorb higher costs or pass them on to consumers. According to TD Cowen analyst Itay Michaeli, Tesla stands to benefit as its competitors struggle with price hikes. In particular, Tesla’s Model Y, a leading seller in the midsize crossover category, faces competition in a segment where nearly half of vehicles could now be subject to tariffs.

Despite Tesla’s apparent advantage, CEO Elon Musk has downplayed the impact of the tariffs on the company. In a post on X, Musk stated that Tesla is “NOT unscathed here” and that the impact on the company remains “significant.” However, he did not elaborate on how or why Tesla might be affected. While the new policy appears to hit Tesla’s competitors far harder, Musk’s comments suggest the company is still navigating challenges related to supply chains and international trade.

Trump, for his part, confirmed that he did not consult Musk before finalizing the tariffs, suggesting that the billionaire CEO “may have a conflict.” While Trump did not clarify the statement, it raises questions about whether Tesla’s relatively strong position under the new policy influenced the decision to exclude Musk from discussions.

Beyond tariffs, another potential battleground is the federal EV tax credit. Under the Inflation Reduction Act signed by President Biden in 2022, buyers can receive up to $7,500 in tax credits for purchasing an electric vehicle. Tesla has benefited from these incentives for years, particularly in its early days when it relied on federal subsidies to boost demand. However, Musk has previously indicated that Tesla no longer depends on these credits. He even suggested that if Trump and a Republican-controlled Congress were to eliminate them, it would hurt Tesla’s competitors far more than Tesla itself.

“I think it would be devastating for our competitors and for Tesla slightly. But long term, probably actually helps Tesla, would be my guess,” Musk said during Tesla’s Q2 earnings call last year.

The bigger bet for Tesla, however, isn’t just EVs—it’s autonomy. Musk has repeatedly stated that self-driving technology is Tesla’s true long-term value driver, not car sales. If Trump’s administration eases regulations around self-driving and robotaxi deployment, Tesla could benefit significantly.

For now, investors seem to agree with Musk. While traditional automakers scramble to reassess their supply chains and pricing strategies, Tesla’s stock continues to rise, reinforcing its position as one of the few beneficiaries of Trump’s aggressive trade policies.

Middle East Faces Trade War Uncertainty: Risks and Opportunities Ahead

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Oil prices remain vulnerable to the global trade war, impacting Gulf economies dependent on crude exports.
– Currency pegs to the U.S. dollar pose challenges, particularly for countries with high external debt.
– New trade corridors, particularly between the Gulf and Asia, offer potential opportunities amid shifting global supply chains.

The Middle East has largely avoided direct tariffs in the ongoing global trade war, but its economies remain vulnerable to broader economic shifts. With oil demand at risk, currency pressures mounting, and global trade flows changing, the region must navigate an increasingly uncertain landscape while also seizing new opportunities.

One of the most immediate concerns for the Middle East is oil. While a weaker U.S. dollar initially benefits oil-exporting nations by making crude cheaper for foreign buyers, tariffs and economic slowdowns could lead to lower global demand. Brent crude prices remain sensitive to global trade conditions, and a prolonged trade war could weigh on revenues for major producers like Saudi Arabia and the UAE. Despite efforts to diversify their economies, oil remains the backbone of many Gulf nations, making them particularly exposed to shifts in global demand.

Another challenge comes from currency pegs. Several Gulf states, including Saudi Arabia, the UAE, Qatar, Oman, and Bahrain, have their currencies tied to the U.S. dollar. As the dollar fluctuates in response to tariffs and economic policies, these countries face higher import costs. This could lead to inflationary pressures, especially in economies heavily reliant on imported goods. At the same time, countries with significant external debt, such as Lebanon, Jordan, and Egypt, could struggle with higher debt-servicing costs if the dollar strengthens further.

Trade tensions also pose risks to regional trade hubs like the UAE, which depend on global trade flows. As a logistics and financial center, Dubai has built its economy around international commerce, meaning a prolonged global slowdown could impact its growth. Economists warn that while Gulf economies have taken steps to diversify, the effects of reduced trade volumes could still be felt.

However, the situation is not entirely negative. The trade war has also encouraged the creation of new trade corridors, particularly between the Gulf and Asia. The GCC-Asia trade relationship has seen sustained growth, with increasing investment and business ties. China’s Belt and Road Initiative has already deepened economic connections, and as global supply chains shift, Middle Eastern economies could benefit from a larger role in these emerging trade networks.

Political factors could also play a role in shaping the region’s economic resilience. U.S. President Donald Trump has maintained strong ties with Gulf nations, particularly Saudi Arabia, and has shown an interest in keeping them aligned with U.S. economic and geopolitical priorities. This relationship may provide some buffer against trade war fallout, as evidenced by Jordan’s ability to secure exemptions from certain U.S. tariffs due to its strategic importance.

Looking ahead, Middle Eastern economies must continue to adapt to changing global conditions. Strengthening domestic demand, securing diversified trade partnerships, and managing currency risks will be key strategies for mitigating potential downturns. While challenges remain, opportunities exist for the region to carve out a more influential role in global trade as supply chains and economic alliances shift.

Release – AI Shakes Up Mainframe Strategies in U.S. Public Sector

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on III

3/27/2025

Breakthroughs breathe new life into legacy systems as agencies look for platforms to safely run AI models with sensitive data, ISG Provider Lens™ report says

STAMFORD, Conn.–(BUSINESS WIRE)– State and local governments in the U.S. are reevaluating mainframes as strategic assets and revisiting choices between reengineering and cloud migration, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III ), a global AI-centered technology research and advisory firm.

The 2025 ISG Provider Lens™ Mainframe — Services and Solutions report for the U.S. public sector finds that AI is beginning to make mainframes easier and less expensive to maintain. Agencies are also discovering that mainframes may be uniquely suited to running AI workloads while protecting mission-critical data. Advances in AI created a wave of public-sector interest in mainframes in 2024 that is expected to continue into 2025.

“AI offers a wealth of new options to help the public sector unleash the potential of mainframe systems,” said Nathan Frey, ISG partner and lead, U.S. Public Sector. “When agencies weigh those possibilities against the risks of moving data and applications that have run on mainframes for decades, they often reconsider their roadmaps.”

State, local and educational (SLED) agencies in the U.S. are now considering which applications to keep on mainframes, how to optimize those applications and how to efficiently access mainframe data for use with AI models, the report says. AI, including generative AI, can streamline software development, testing and documentation, making it easier to either refactor or maintain mainframe applications. AI code assistants and chatbots can reduce the impact of the mainframe skills shortage by helping newer developers get up to speed.

More agencies are exploring the potential of AI and gaining a new appreciation for mainframes’ formidable processing and data management capabilities. The Trump administration’s avowed goal of reducing the size and influence of the federal government is expected to increase interest in using AI for automation. State and local governments are considering the same as they face tight budgets and the possibility of taking over some federal functions.

Policies on offshoring state and local government data and computing are also changing, the report says. New hybrid cloud architectures make it easier to use resources outside the U.S. for cost savings while complying with regulations. DevOps methodologies offer new ways to segregate highly sensitive information, which needs to remain on premises or in the U.S., from less sensitive data that can safely be stored offshore.

Rising U.S. public-sector demand for mainframe services has attracted more providers to this market. However, as agencies increase their reliance on providers, they are gravitating toward those that have built up experience in the sector and that understand its unique mainframe requirements.

“State and local agencies in the U.S. are finally rising to the challenge of modernizing age-old mainframe IT environments,” said Jan Erik Aase, partner and global leader, ISG Provider Lens Research. “Leading service providers have the AI tools and specialized skills to help them make the leap.”

The report also explores other mainframe trends in the U.S. public sector, including rising IT collaboration among SLED agencies around the country and the impact of new training initiatives by providers.

For more insights into the mainframe challenges faced by the U.S. public sector, including software licensing issues and national political uncertainty, plus ISG’s advice for addressing them, see the ISG Provider Lens™ Focal Points briefing here.

The 2025 ISG Provider Lens™ Mainframe — Services and Solutions report for the U.S. public sector evaluates the capabilities of 29 providers across four quadrants: Mainframe Optimization Services, Application Modernization Services, Mainframe as a Service and Mainframe Operations.

The report names Wipro as a Leader in all four quadrants. It names DXC Technology, Ensono, Kyndryl and TCS as Leaders in three quadrants each. Accenture, FNTS and Infosys are named as Leaders in two quadrants each. Avanade, Capgemini, HCLTech, NTT DATA and Tech Mahindra are named as Leaders in one quadrant each.

In addition, DXC Technology is named as a Rising Star — a company with a “promising portfolio” and “high future potential” by ISG’s definition — in one quadrant.

In the area of customer experience, UST is named the global ISG CX Star Performer for 2024 among mainframe service providers. UST earned the highest customer satisfaction scores in ISG’s Voice of the Customer survey, part of the ISG Star of Excellence™ program, the premier quality recognition for the technology and business services industry.

Customized versions of the report are available from FNTS and RecoveryPoint.

The 2025 ISG Provider Lens™ Mainframe — Services and Solutions report for the U.S. public sector is available to subscribers or for one-time purchase on this webpage.

About ISG Provider Lens™ Research

The ISG Provider Lens™ Quadrant research series is the only service provider evaluation of its kind to combine empirical, data-driven research and market analysis with the real-world experience and observations of ISG’s global advisory team. Enterprises will find a wealth of detailed data and market analysis to help guide their selection of appropriate sourcing partners, while ISG advisors use the reports to validate their own market knowledge and make recommendations to ISG’s enterprise clients. The research currently covers providers offering their services globally, across Europe, as well as in the U.S., Canada, Mexico, Brazil, the U.K., France, Benelux, Germany, Switzerland, the Nordics, Australia and Singapore/Malaysia, with additional markets to be added in the future. For more information about ISG Provider Lens research, please visit this webpage.

About ISG

ISG (Nasdaq: III ) is a global AI-centered technology research and advisory firm. A trusted partner to more than 900 clients, including 75 of the world’s top 100 enterprises, ISG is a long-time leader in technology and business services that is now at the forefront of leveraging AI to help organizations achieve operational excellence and faster growth. The firm, founded in 2006, is known for its proprietary market data, in-depth knowledge of provider ecosystems, and the expertise of its 1,600 professionals worldwide working together to help clients maximize the value of their technology investments.

Source: Information Services Group, Inc.View all news

Release – Tonix Pharmaceuticals Announces Presentation at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on TNXP

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

CHATHAM, N.J., March 27, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025.

A copy of the Company’s poster will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the conference website.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also 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). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. 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 also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents 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 Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* 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.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released March 27, 2025

Release – Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis in Journal of Clinical and Translational Hepatology

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on Gyre Therapeutics

March 27, 2025

PDF Version

SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan.

The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People’s Republic of China (“PRC”) in October 2024. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline.

The PRC’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. Gyre expects to report topline results from this Phase 3 trial in the second quarter of 2025.

About Hydronidone (F351)

F351 is a next-generation anti-fibrotic compound and a structural analogue of Pirfenidone, the first approved treatment for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States and the PRC. F351’s dual mechanism has been shown to inhibit in vitro p38γ kinase activity and TGF-β1-driven collagen overproduction—both key drivers of liver fibrosis. F351 specifically targets hepatic stellate cells (“HSCs”), which are central to the progression of fibrosis. In preclinical studies, it has shown strong anti-proliferative and anti-fibrotic effects on HSCs. These effects have been validated across multiple in vivo models of liver fibrosis, including CCl4-induced liver fibrosis in mice, DMN- and HSA-induced liver fibrosis in rats, and a mouse model of MASH fibrosis (a form of MASH with fibrosis) induced by CCl4 plus a Western high-fat diet. Together, these results highlight F351’s potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For Investors:
Stephen Jasper
stephen@gilmartinir.com

Waraba Gold to Acquire Stake in Somaco Global Resources in Ivory Coast

Posted on by slightbourne@noblecapitalmarkets.com
Key Points Summary:
– Waraba Gold is acquiring up to an 80% stake in Somaco Global Resources, gaining access to prospective gold and manganese licences in northern Ivory Coast.
– The deal involves a $500,000 initial payment, $1.5 million over two years, and $5 million in exploration commitments, alongside issuing six million common shares.
– Waraba has suspended operations in Mali due to security concerns but remains committed to resuming activities when conditions improve.

Canadian mineral exploration company Waraba Gold has entered into an earn-in agreement to acquire up to an 80% stake in Somaco Global Resources, a move that strengthens its footprint in the West African mining sector. Somaco Global holds two highly prospective gold licence applications in northern Ivory Coast, a region known for its rich mineral deposits. These include the Sirasso licence and the Tengrela & Tiegba licences, both located near existing gold mines and mineralized shear zones.

One of the most significant assets in this deal is the Sirasso licence, covering 369.34km² in the Senoufou greenstone belt, an area recognized for its high gold potential. This licence was previously held in a joint venture (JV) with Barrick Gold, one of the world’s leading gold producers. Historically, greenstone belts have yielded high-grade gold deposits, and the Senoufou belt is no exception. Waraba’s investment signals confidence in the region’s potential for large-scale gold discoveries.

In addition to Sirasso, Waraba Gold gains access to the Tengrela & Tiegba licences, which span a combined area of nearly 767km². These licences are not only prospective for gold but also manganese, a critical mineral in steel production and battery technologies. The proximity of these licences to existing gold mines further enhances their exploration potential.

Under the terms of the agreement, Waraba Gold will gradually acquire an 80% stake in Somaco Global Resources over four years. The investment involves an initial payment of $500,000 to Somaco’s shareholders within the next two months, an additional $1.5 million to be paid over a two-year period, exploration commitments totaling $5 million over the next four years, and the issuance of six million common shares to Somaco shareholders upon the signing of a definitive joint venture agreement.

To finance the initial commitments, Waraba Gold announced plans to raise up to $500,000 through non-convertible unsecured debentures. These funds will also provide general working capital for the company’s operations. In addition, Waraba Gold will appoint two Somaco nominees as directors, further integrating the companies and ensuring a strategic partnership moving forward.

Alongside the Ivory Coast expansion, Waraba Gold provided an update on its Mali operations, revealing that it has temporarily suspended activities at the Fokolore Gold Project due to security concerns. Despite setbacks, Waraba remains committed to the Malian mining sector, having submitted a letter of intent for a mining permit in June 2024. However, with ongoing political instability, the company is waiting for conditions to improve before resuming full-scale operations.

West Africa has emerged as one of the fastest-growing gold mining regions globally, attracting major industry players. However, political uncertainties in countries like Mali have raised concerns among investors. Recently, CEOs of leading gold mining companies stated that Mali’s new mining code requires adjustments to encourage further foreign investment. Regulatory changes will play a crucial role in shaping the future of the region’s mining industry.

Waraba Gold’s agreement with Somaco Global Resources marks a strategic expansion into the Ivory Coast, an increasingly important gold-producing nation. By securing access to high-potential licences, Waraba is positioning itself for long-term growth in the West African mining sector. With ongoing fundraising efforts and a commitment to exploration, Waraba Gold aims to unlock significant value from its new assets. However, challenges in Mali and broader market uncertainties may still impact the company’s overall trajectory in the coming years.

Snail, Inc. (SNAL) – A First Look At Q4 Results

Posted on by cpereira@noblefcm.com


Thursday, March 27, 2025

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

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.

Solid Q4 results. The company reported Q4 revenue and adj. EBITDA of $26.2 million and $1.6 million, respectively. While revenue was modestly better than our estimate of $25.0 million, adj. EBITDA was a tad softer, as illustrated in Figure #1 Q4 Results. Notably, the variance in adj. EBITDA was driven by an increased focus on in-house development, resulting in higher R&D costs. We view the company’s efforts to diversify its revenue stream as a favorable development.

Portfolio expansion. The company has been taking steps to offer more games and products that could drive revenue diversification. Notably, the company launched ARK: Ultimate Mobile Edition in December and gained over 2 million users during the month. Additionally, the company soft launched a new mobile app, SaltyTV, which offers original short film content. Furthermore, the company acquired eleven games in 2024, with several releases expected in 2025.


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Trump to Announce New Auto Tariffs as Trade War Escalates

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– President Trump is set to unveil new auto tariffs, adding to a series of trade measures aimed at reshaping U.S. trade policy.
– The White House has confirmed retaliatory tariffs will be applied to several key trading partners.
– Global markets are reacting to uncertainty over the scope of these tariffs and their economic impact.

President Donald Trump is set to announce a fresh round of tariffs on auto imports later today, marking another escalation in his administration’s aggressive trade policy. These tariffs come as part of a broader effort to impose retaliatory duties on U.S. trading partners, a move that could significantly impact global trade dynamics.

The announcement follows weeks of speculation regarding which countries will be affected and to what extent. Trump has hinted at providing “a lot of countries breaks,” while also signaling that he does not want “too many” exemptions. The market is closely watching which nations will fall into the “dirty 15” category—those with trade imbalances deemed unfavorable to the United States.

The latest tariffs on automobiles add to an already sweeping list of trade measures enacted by the Trump administration. Earlier this month, a 25% tariff on steel and aluminum imports went into effect, impacting businesses across multiple industries.

The European Union responded swiftly, announcing counter-tariffs on $28 billion worth of U.S. goods. However, implementation has been staggered, with some key measures, like a 50% tariff on American whiskey, delayed until mid-April. This delay has sparked further uncertainty, with Trump threatening a 200% tariff on European spirits in retaliation.

Trump’s trade policies have already significantly impacted Canada and Mexico. As of March 4, the U.S. imposed a 25% tariff on all imports from its neighbors. However, a temporary pause was granted for goods and services that comply with the United States-Mexico-Canada Agreement (USMCA). This exemption is set to expire on April 2, leaving room for renegotiation.

In response, Canada introduced new tariffs on $20 billion worth of U.S. goods, further complicating trade relations. With both countries agreeing to reopen trade discussions, businesses on both sides of the border are bracing for potential disruptions.

Tensions between the U.S. and China remain high as Trump enforces new blanket tariffs of around 20% on top of the existing 10% duties from his first term. China has retaliated with up to 15% duties on U.S. agricultural products, including chicken and pork, which took effect on March 10.

Meanwhile, Venezuela has been targeted with a “secondary tariff” set to take effect on April 2. Under this measure, any country that buys oil or gas from Venezuela will face a 25% tariff when trading with the U.S. This move is expected to isolate Venezuela further while also impacting global energy markets.

The uncertainty surrounding these tariffs is already causing volatility in global markets. Investors are concerned about potential supply chain disruptions, rising costs for consumers, and retaliatory actions from key U.S. trade partners. The auto industry, in particular, could see increased costs, which may trickle down to car buyers in the form of higher prices.

As Trump’s trade war escalates, businesses and investors alike are preparing for a potentially turbulent economic landscape. With April 2—dubbed “Liberation Day” by Trump—fast approaching, all eyes are on the White House for further developments.

GameStop Stock Surges After Announcing Bitcoin Investment Plan

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– GameStop’s board has approved Bitcoin as a treasury reserve asset, following speculation about the company’s interest in cryptocurrency.
– The stock jumped nearly 13% in premarket trading after the announcement.
– Analysts remain skeptical, comparing the move to MicroStrategy’s Bitcoin strategy, but questioning its long-term impact on GameStop’s stock.

GameStop (NYSE: GME), the video game retailer-turned-meme stock, saw its shares surge nearly 13% in premarket trading on Wednesday after confirming plans to allocate a portion of its cash reserves to Bitcoin. The move signals yet another pivot for the company as it looks to redefine its business strategy and capture investor interest amid ongoing challenges in the retail gaming sector.

In a statement released Tuesday, GameStop announced that its board of directors unanimously approved an update to its investment policy, officially allowing the company to purchase and hold Bitcoin as a treasury reserve asset. This decision follows weeks of speculation, fueled in part by a cryptic social media post from GameStop Chairman Ryan Cohen in early February, featuring a meeting with MicroStrategy CEO Michael Saylor, a well-known Bitcoin advocate.

GameStop’s announcement aligns it with MicroStrategy (NASDAQ: MSTR), a company that has aggressively invested in Bitcoin as part of its corporate treasury strategy. MicroStrategy currently holds over 447,000 Bitcoin, a move that has significantly boosted its stock price during Bitcoin bull runs.

The decision to invest in Bitcoin represents a major strategic shift for GameStop, which has struggled to define a clear business model in recent years. Following its infamous Reddit-fueled short squeeze in 2021, GameStop has experimented with NFT marketplaces, digital asset wallets, and e-commerce expansions, but none have significantly altered its financial trajectory.

While Bitcoin has seen strong gains in 2024 and 2025, GameStop’s move raises questions about its long-term financial strategy. Unlike MicroStrategy, which transformed itself into a Bitcoin-centric company, GameStop remains primarily a retail business with declining revenue. The company’s fourth-quarter earnings report, also released Tuesday, revealed a 28% decline in net sales year-over-year, further emphasizing the financial struggles it faces.

Despite the stock’s rally, analysts remain divided on whether GameStop’s Bitcoin investment will provide meaningful value. Wedbush analyst Michael Pachter voiced concerns about the decision, noting that MicroStrategy trades at approximately twice the value of its Bitcoin holdings, meaning that even a full allocation of GameStop’s $4.6 billion cash reserves into Bitcoin may not provide the same level of stock appreciation.

Additionally, Bitcoin’s volatility presents a risk for GameStop, which is already navigating declining brick-and-mortar sales, shifting consumer preferences, and increased digital gaming competition. A sudden drop in Bitcoin’s price could negatively impact GameStop’s financial position, leaving it with fewer options to reinvest in its core business.

GameStop’s Bitcoin strategy will likely fuel speculation and volatility in its stock price, much like previous meme stock cycles. However, whether this move translates into long-term value remains uncertain. Investors will be watching closely to see how GameStop executes its Bitcoin investment plan and whether it adopts a broader digital asset strategy beyond cryptocurrency holdings.

For now, the announcement has given GameStop bulls a new reason to rally, but the company’s future remains uncertain as it bets on Bitcoin to help redefine its financial outlook.

Release – V2X Expands Army Training Support with $921 Million BEST MAC Contract

Posted on by aweinsoff@channelchek.com

Research News and Market Data on VVX

March 26, 2025

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RESTON, Va., March 26, 2025 /PRNewswire/ — V2X (NYSE: VVX) Inc., announced its selection as a winner on the Bridge to Enduring Synthetic Training Environment Tactical Engagement Simulation Systems (TESS) Multiple-Award Contract (BEST MAC) Lot 1. This contract supports the U.S. Army’s TESS devices, a vital component of its live training capabilities, by extending their product life and ensuring they meet the Army’s evolving requirements.

The indefinite-delivery, indefinite-quantity contract includes a ten-year period of performance consisting of a five-year base period and two options (three-year option and a two-year option), with a ceiling value of $921 million.

Under this award, V2X will support the U.S. Army’s TESS products that are designed to enable simulated engagements, either as weapons or targets, during live collective military training exercises. These devices include weapons, vehicles, and aviation systems. Existing TESS must be modified to stay relevant as changes to weapon systems evolve.

“The BEST MAC contract perfectly complements the work we perform under our $3.7 billion Warfighter-Training Readiness Solutions task order,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “Both programs demonstrate our commitment to the warfighter and our expertise in delivering readiness capabilities that enhance Army training and strengthen national security.”

“As the prime contractor for the Army’s largest training services program, V2X is uniquely positioned to deliver superior services that align with BEST MAC future requirements,” said Ken Shreves, Senior Vice President of Mission Support at V2X. “Our dedication to the Army goes beyond operational excellence—we are committed to reinforcing national security through mission-critical initiatives and ensuring troops are prepared worldwide.”

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

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

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

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SOURCE V2X, Inc.

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Americans’ Economic Expectations Plunge to 12-Year Low Amid Uncertainty

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– The consumer expectations index fell to 65.2, its lowest level in 12 years, signaling rising concerns about financial stability and economic conditions.
– Inflation expectations jumped to 6.2% in March, with fewer consumers optimistic about the stock market.
– Despite declining sentiment, economists and the Federal Reserve remain cautious about whether pessimism will translate into lower spending.

Americans’ confidence in the economy has fallen to its lowest level in over a decade, reflecting heightened concerns over inflation, financial uncertainty, and the impact of President Donald Trump’s economic policies. The latest consumer confidence index from the Conference Board dropped to 92.9 in March, down from 100.1 in February, marking the lowest reading in more than four years.

More concerning is the expectations index—a measure of consumers’ outlook on income, business conditions, and employment—which plunged to 65.2, its weakest level since 2013. This marks the second consecutive month the index has remained below 80, a level historically associated with an impending recession.

The biggest driver of the decline appears to be worsening personal financial expectations. Consumers are increasingly pessimistic about their future earnings and job security, with financial situation expectations hitting their lowest level in over two years.

Inflation remains a primary concern, with consumer expectations for price increases rising to 6.2% in March from 5.8% in February. This shift suggests that Americans anticipate higher costs for everyday goods and services in the months ahead.

At the same time, consumer optimism about the stock market has deteriorated. For the first time since 2023, more Americans expect stocks to decline rather than rise, with only 37.4% of respondents predicting market gains over the next year. This shift in sentiment could indicate broader concerns about economic volatility and the impact of recent policies on financial markets.

While these fears weigh on economic confidence, the labor market remains a bright spot. Among the five components of consumer confidence measured in the survey, only current job market conditions showed improvement in March. This suggests that while Americans are worried about inflation and market stability, they are not yet seeing widespread job losses.

While consumer sentiment is declining, the critical question remains: Will this pessimism lead to reduced spending and a slowdown in economic growth? So far, Federal Reserve officials and economists are unsure.

Fed Chair Jerome Powell acknowledged the disconnect between consumer surveys and actual economic behavior, noting that while people express concern about the economy, they often continue spending on major purchases like cars and homes. “The relationship between survey data and actual economic activity hasn’t been very tight,” Powell said in a recent press conference.

Economists at Morgan Stanley have also downplayed fears of an imminent recession, arguing that consumer spending remains resilient. While retail sales dipped in January, they rebounded in February, casting doubt on the notion that a major downturn is underway.

If consumer confidence continues to decline, it could eventually translate into lower spending, which would have significant implications for businesses and economic growth. However, for now, the broader economic data suggests that while uncertainty is high, the economy remains relatively stable. The coming months will be crucial in determining whether Americans’ pessimism is justified or if the economy can weather the storm.

Release – Comstock Settles Strategic Commitments and Strengthens Balance Sheet

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

VIRGINIA CITY, NEVADA, March 25, 2025 – Comstock Inc. (NYSE: LODE) (“Comstock,” “our” and the “Company”), today announced the timely completion of two successful settlements of prior outstanding strategic commitments. These commitments originated from prior acquisitions of foundational assets and intellectual property that have been instrumental in advancing Comstock’s renewable fuels and metals businesses. Comstock has eliminated regular cash payments and reinforced its financial position to support the Company’s long-term commercialization strategy.

“Both of these equity-based settlements were with the original founders and resulted in material, restructured savings, enhanced liquidity and increased financial flexibility,” said Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “We are grateful to the founders, their innovations, partnering, flexibility, and confidence in our equity and its value.”

The settlements align with Comstock’s ongoing efforts to simplify and strengthen its balance sheet, enhance liquidity, and position its differentiated technology and businesses for rapid, scalable, and long-term growth. With the metals segment achieving full operational status and remarkable, real-time revenue growth and the fuels segment securing multiple commercial, operational and jurisdictional support agreements, and direct strategic investments, both businesses remain focused on driving continued revenue generation and expanding their globally relevant network of supply chain partners.

About Comstock Inc.

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

Comstock Social Media Policy

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

Contacts

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

For media inquiries or questions:
Comstock Inc., Tracy Saville
Tel (775) 847-7573
media@comstockinc.com

Forward-Looking Statements 

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

Release – MAIA Biotechnology Announces Poster Presentation at ESMO’s European Lung Cancer Congress 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

March 25, 2025 8:46am EDT Download as PDF

  • Poster highlights potential predictive biomarker for therapeutic response in advanced non-small cell lung cancer (NSCLC)

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that an abstract detailing a potential predictive biomarker for THIO treatment was selected for poster presentation at the European Lung Cancer Congress 2025 (ELCC 2025) taking place, March 26-29, in Paris, France. ELCC is a program of the European Society for Medical Oncology (ESMO).

“We are proud to join ELCC 2025, a premier conference focused directly on the science of thoracic oncology,” said Vlad Vitoc, M.D., CEO of MAIA. “Our poster features our latest findings on cytokine Interleukin-6 (IL-6) as a potential predictive immune response biomarker for THIO sequenced with a checkpoint inhibitor. Predictive biomarkers can further illuminate THIO’s unique mechanisms of action which have shown exceptional efficacy in our Phase 2 clinical trial.”

Presentation details: 
Title:Phase 2 Study of Telomere-Targeting Agent THIO Sequenced by Cemiplimab in Immune Checkpoint Inhibitor-Resistant Advanced NSCLC: Interleukin-6 as a Potential Predictive Biomarker
Abstract number:997
Date:March 28, 2025
Time:12:00 p.m. CET
Presenter:Tomasz Jankowski, M.D., Ph.D. – Lead investigator for THIO-101 Phase 2 clinical trial
Poster access:MAIA’s poster will be available at maiabiotech.com/publications on March 28, 2025

The European Lung Cancer Congress is a collaborative effort of the most important multidisciplinary societies representing thoracic oncology specialists, working together to advance science, disseminate education and improve the practice of lung cancer specialists worldwide.

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 with 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 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, 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

Source: MAIA Biotechnology, Inc.

Released March 25, 2025