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Release – MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

September 11, 2025 9:27am EDT

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CHICAGO, Sept. 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 highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regimens.

As of June 30, 2025,

  • Estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months. The comparable PFS threshold in standard of care treatments is 2.5 months1.
  • Estimated median overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025).
  • Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival.

“THIO-101 continues to reveal impressive efficacy with observed progression free survival of 5.6 months, which is more than double the standard of care PFS of just 2.5 months. The data also demonstrates the durability of ateganosine treatment through extended treatment cycles, which is in line with consistent tolerability and low toxicity,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are seeking further validation of ateganosine’s strong efficacy in our THIO-101 Phase 2 expansion trial, which began enrolling patients in July 2025.”

Details of THIO-101, including efficacy data and safety findings, are included in MAIA’s poster for the 2025 IASLC World Conference on Lung Cancer (WCLC), available at maiabiotech.com/publications.

About Ateganosine

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

About THIO-101 Phase 2 Clinical Trial

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

1 Shepherd F, et al. N Engl J Med 2005;353:123-132, Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

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Source: MAIA Biotechnology, Inc.

Released September 11, 2025

Vince Holding Corp. (VNCE) – Delivered A Strong Quarter

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, September 11, 2025

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

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

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

Solid Q2 Results. The company reported Q2 revenue of $73.2 million, modestly beating our estimate of $72.0 million, and adj. EBITDA of $6.7 million, which strongly outperformed our estimate of $0.85 million by 685%, as illustrated in Figure #1 Q2 Results. The strong adj. EBITDA was largely driven by management’s ability to execute on its tariff mitigation strategies, resulting in an improved gross profit margin.

Mitigating tariff impacts. Importantly, the company’s gross profit margin increased 300 basis points over the prior year period. The improvement was driven by lower product costing and higher pricing, contributing a 340 basis point improvement, as well as less discounting, which resulted in a 210 basis point improvement. However, the positive margin contributions were softened by tariff and freight impacts of 170 basis points and 100 basis points, respectively.


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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. 

Lucky Strike Entertainment (LUCK) – Initiated Debt Refinancing

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, September 11, 2025

Lucky Strike Entertainment is one of the world’s premier location-based entertainment platforms. With over 360 locations across North America, Lucky Strike Entertainment provides experiential offerings in bowling, amusements, water parks, and family entertainment centers. The company also owns the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Lucky Strike Entertainment, please visit ir.luckystrikeent.com.

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

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

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

Strategic update. On September 10, the company announced that its wholly-owned subsidiary Kingpin Intermediate Holdings LLC initiated a private offering of  $700 million in new senior secured notes, due in 2032. Concurrently, the company launched a refinancing of its corporate term loan and revolving credit facility. The company expects the initial amount of the refinanced term loan and revolving credit facility to be $1 billion and $400 million, respectively. 

Use of capital. Importantly, the net proceeds from the new debt offering and the refinanced credit facilities are earmarked for retiring the company’s existing term loan, revolving credit facility, and bridge loan, which was used to acquire 58 real estate assets in July. Furthermore, the remaining proceeds will be used to fund the company’s strategic initiatives.


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. 

Vimeo to Go Private in $1.38 Billion Deal with Bending Spoons

Posted on by slightbourne@noblecapitalmarkets.com

Vimeo (NASDAQ: VMEO) has entered into a definitive agreement to be acquired by Bending Spoons in an all-cash transaction valued at approximately $1.38 billion. Under the terms of the deal, Vimeo shareholders will receive $7.85 per share, a price that reflects a 91% premium over the company’s 60-day volume-weighted average stock price as of September 9, 2025.

The decision to sell follows a comprehensive review of strategic options by Vimeo’s board. The agreement positions Vimeo to accelerate its long-term goals while providing shareholders with immediate and certain value. Once the deal is finalized, Vimeo will become a privately held company, and its stock will no longer be traded on public exchanges.

For Vimeo, the acquisition represents both a fresh chapter and a return to its roots. As a public company, it faced increasing pressure to balance growth initiatives with short-term financial expectations. Transitioning to private ownership under Bending Spoons is expected to provide greater flexibility to invest in innovation across self-serve tools, enterprise services, and streaming solutions. The company is also expected to expand its portfolio of AI-enabled features, reflecting the growing role of artificial intelligence in video production, editing, and distribution.

Bending Spoons, headquartered in Milan, has built a reputation for acquiring and scaling digital platforms with global reach. Its portfolio already includes well-known names such as Evernote, WeTransfer, Brightcove, Meetup, and Remini. By adding Vimeo, the company is signaling a strong commitment to video as a cornerstone of digital business. The firm has stated its intention to make significant investments in Vimeo’s operations, particularly in the U.S. and other priority markets, to enhance performance, reliability, and user experience.

The timing of the deal also reflects the rising strategic importance of video platforms. Businesses, creators, and enterprises increasingly rely on video for communication, marketing, and engagement. With demand for professional-grade video tools surging, Vimeo’s integration into the Bending Spoons ecosystem could help it compete more effectively with rivals while scaling globally.

From an investor standpoint, the acquisition delivers a substantial return at a time when Vimeo’s share price had struggled to reflect its long-term potential. The 91% premium on the stock’s recent trading average underscores the confidence Bending Spoons has in Vimeo’s future growth and the value of its established brand and customer base.

The transaction, unanimously approved by Vimeo’s board, is expected to close in the fourth quarter of 2025, pending shareholder approval and regulatory clearance. In the meantime, Vimeo will continue to meet its reporting obligations but will not host a third-quarter earnings call as it transitions toward private ownership.

By aligning with Bending Spoons, Vimeo is expected to gain the resources and strategic support needed to expand its role in the rapidly evolving video market. As global demand for high-quality, AI-driven video solutions continues to rise, this acquisition positions Vimeo for renewed growth and relevance in a highly competitive digital landscape.

Is Gold Becoming Investors’ First Choice as the New Safe Haven?

Posted on by slightbourne@noblecapitalmarkets.com

Gold is having a remarkable year, climbing 39% year-to-date and setting records as investors increasingly seek safety outside of traditional markets. While the surge has sparked comparisons to past market dislocations, this rally is shaped by a unique combination of monetary policy shifts, debt concerns, and political uncertainty.

At the center of the story is the Federal Reserve. After holding rates at restrictive levels for longer than many expected, the Fed has pivoted toward easing. Markets are now pricing in further rate cuts as inflation cools but economic momentum slows. Lower borrowing costs typically reduce the opportunity cost of holding non-yielding assets like gold, fueling demand. But interest rates alone don’t explain the intensity of this rally.

A bigger factor is the growing anxiety around government debt. The United States, along with Germany, France, and the UK, is facing ballooning debt-to-GDP ratios. Once considered the safest of all havens, government bonds are losing their luster. Investors are increasingly asking: if sovereign debt is no longer risk-free, where should capital be parked? For many, the answer is gold. Unlike paper assets, gold cannot be debased by policy or politics. That reallocation of assets—away from Treasuries and into bullion—is one of the key drivers of today’s market.

Politics has only added fuel. Former President Trump’s legal battle over tariffs, which is now under review by the Supreme Court, could have major consequences. If the Court rejects the tariffs, the U.S. may be forced to refund billions of dollars to trading partners. Such a ruling would undermine the tariff regime entirely, creating both a short-term hit to government finances and long-term uncertainty over trade policy. International companies benefiting from freer trade might welcome the decision, but for the U.S. it could add to fiscal pressures and accelerate debt growth. That prospect strengthens the case for gold as a hedge against political and fiscal instability.

Investors also see echoes of history. In October 1987, during the dot-com bust, and again in the 2008 financial crisis, gold proved resilient when other assets collapsed. Those moments are often described as “black swan” events—rare and unpredictable shocks that reshape markets. Today’s surge suggests investors are bracing for another unforeseen disruption. What’s different this time is that the flight to gold isn’t just a reaction to crisis—it’s happening preemptively, driven by structural concerns over debt, politics, and the durability of fiat money.

The result is an unprecedented rush. For the first time, gold is not just a defensive asset but a proactive store of value that investors are chasing in anticipation of turbulence ahead. With rates heading lower, fiscal balances worsening, and political battles creating new risks, gold has emerged as the one constant—an asset that transcends borders, politics, and policy.

Whether this marks the beginning of a new golden era or simply another speculative peak remains to be seen. But one thing is clear: gold’s role in global markets is being redefined, not as a hedge of last resort, but as a safe haven of first choice.

Release – Nutriband Inc. Quarterly Report Highlights Record Revenue for Q2, 2025 up 50.87% YOY and Strategic Progress Toward NDA Filing for AVERSA Fentanyl

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NTRB

September 10, 2025 09:15 ET | Source: Nutriband Inc.

    ORLANDO, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) reported its financial results for the six months ended July 31, 2025. The company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl which has been granted a Type C meeting on September 18th.

    Nutriband is continuing to expand its kinesiology tape contract manufacturing services through its Pocono Pharma subsidiary. The company produced a record six months, reporting revenue of $1,289,884, up 50.87% YOY.

    Progress continues on the development of AVERSA Fentanyl, Nutriband is reminding exiting shareholders and updating new shareholders on its development pathway, emphasizing that the NDA will primarily rely on data from a single phase 1 Human Abuse Potential study. Importantly, no Phase 2 or Phase 3 clinical trials will be required before submission.

    If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally. AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million, according to a market analysis report from Health Advances.

    AVERSA Buprenorphine, which is the company’s second application for AVERSA, is projected to reach peak annual sales of up to $130 million.

    As of July 31, 2025, Nutriband’s cash reserves stand at $6.9 million, supporting the company’s ongoing development and commercialization efforts for AVERSA Fentanyl. The company’s total assets are valued at $10.17 million, with stockholders’ equity amounting to $8.5 million.

    About Nutriband Inc.

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

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

    Forward-Looking Statements

    Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January, 2025, filed April 28, 2025, the Forms 10-Q’s filed subsequent to the Form 10-K in 2025, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

    For more information, contact:

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

    Release – Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GLSI

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    September 10, 2025 6:00am EDT

    STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population.

    The designation specifically states that “GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation.”

    The Fast Track designation for GLSI-100 may lead to earlier drug approval as the Company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from FLAMINGO-01. The Company may be able to utilize a rolling review process, where completed parts of the BLA can be submitted for review, even though other parts of the application are still being completed.

    Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit.”

    CEO Snehal Patel commented, “We are excited to have received Fast Track designation. The FDA review of our Fast Track application included a review of the potential of GLSI-100 as a new drug to treat serious conditions and to fill unmet medical need. By showing the potential of GLSI-100 to prevent metastatic breast cancer recurrence in the patient population that we are studying, we were able to estimate the potential lives that could be saved. The Company plans to continue discussions with the FDA, and potentially the European regulatory authorities, to explore additional ways to make GP2 and GLSI-100 available to larger populations.”

    A description of the Fast Track criteria and process is available on the FDA website:
    https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

    As described by the FDA website:

    “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions…Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy…Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.”

    The FDA website further states:

    “Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

    • Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
    • Avoiding serious side effects of an available therapy
    • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
    • Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
    • Ability to address emerging or anticipated public health need

    A drug that receives Fast Track designation is eligible for some or all of the following:

    • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
    • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
    • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
    • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”

    Previously Published Phase IIb Data

    In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

    • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products
    • Peak immune response at 6 months
    • No reported serious adverse events attributable to treatment
    • Well-tolerated safety profile

    Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection. In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100.

    About FLAMINGO-01 and GLSI-100

    FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

    For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

    Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

    Forward-Looking Statement Disclaimer

    Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

    Company Contact
    Snehal Patel
    Investor Relations
    Office: (832) 819-3232
    Email: info@greenwichlifesciences.com

    Investor & Public Relations Contact for Greenwich LifeSciences
    Dave Gentry
    RedChip Companies Inc.
    Office: 1-800-RED CHIP (733 2447)
    Email: dave@redchip.com

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    Source: Greenwich LifeSciences, Inc.

    Released September 10, 2025

    Release – MustGrow Secures $2 Million Line of Credit with CIBC; Guaranteed by EDC

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MGRO

    SASKATOON, Saskatchewan, Canada, September 10, 2025 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce it has secured a $2.0 million line of credit with Canadian Imperial Bank of Commerce, guaranteed by Canada’s Export Development Canada (“EDC”) (the “LOC”).

    Access to funds will allow MustGrow to produce its organic mustard-derived biofertility product TerraSanteTM to meet growing demand from U.S. commercial farming operations.  In addition, the LOC will help support working capital requirements for its Canadian sales and distribution division, NexusBioAg.

    The LOC carries a interest rate linked to Canada’s prime rate plus 1.00%, per annum. The current Canadian prime rate is 4.95%.  EDC has guaranteed the LOC on MustGrow’s behalf.  MustGrow will endeavour to increase the LOC size to support accelerating TerraSanteTM product demand in the U.S.

    “We are seeing significant uptake from large U.S. commercial farming operations which further validates the effectivess, efficiency, and economics of our organic biofertility product TerraSanteTM,” asserted Corey Giasson, President and CEO of MustGrow.  “Utilizing our LOC on such favourable terms will enable us to build inventory to meet increasing U.S. demand for TerraSanteTM and support NexusBioAg’s growing operations here in Canada.” 

    About MustGrow

    MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 109 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 58.9 million common shares issued and outstanding and 67.5 million shares fully diluted. For further details, please visit www.mustgrow.ca.

    Contact Information

    Corey Giasson Director & CEO
    Phone: +1-306-668-2652
    info@mustgrow.ca

    MustGrow Forward-Looking Statements

    Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

    Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: the receipt of final approval by the TSXV and those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

    Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

    © 2025 MustGrow Biologics Corp. All rights reserved.

    Release – V2X, General Motors, and U.S. Army Celebrate 11 Years of the Shifting Gears Automotive Technician Training Program

    Posted on by aweinsoff@channelchek.com
    V2X (PRNewsfoto/V2X, Inc.)

    Research News and Market Data on VVX

    September 09, 2025

    FORT HOOD, Texas, Sept. 9, 2025 /PRNewswire/ — This month marks the 11th anniversary of the Shifting Gears Automotive Technician Training Program, a collaborative initiative between V2X Inc. (NYSE: VVX), General Motors (GM), and the U.S. Army at Fort Hood. For more than a decade, this innovative program has provided transitioning service members with valuable hands-on training and career pathways as certified GM service technicians.

    Since its inception, more than 50 graduating cohorts have completed the eight-week program, that’s about 1,000 students, equipping veterans with in-demand technical skills and preparing them for careers at GM dealerships nationwide. Every graduate has been successfully placed at a GM dealership, with many advancing to achieve World Class Technician status, the highest certification level available to GM technicians.

    “Celebrating 11 years of Shifting Gears is more than just recognizing a program, it’s honoring the service members whose dedication continues beyond the uniform,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X.  “Through this partnership, we’re ensuring that our nation’s veterans have the skills, stability, and opportunity they deserve as they transition into civilian careers.”

    The program represents a cornerstone of V2X’s commitment to supporting warfighters throughout their journey, from delivering world-class training under the Army’s largest training contract (W-TRS), to preparing them for civilian success.

    “This program not only builds financial stability for veterans but also ensures dealerships across the country benefit from the discipline, technical expertise, and problem-solving skills of those who have served,” said Wensinger.

    The Shifting Gears Automotive Technician Training Program stands as a model of public-private collaboration, providing enduring value for veterans, industry, and communities nationwide.

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

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

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

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-general-motors-and-us-army-celebrate-11-years-of-the-shifting-gears-automotive-technician-training-program-302550185.html

    SOURCE V2X, Inc.

    Release – Nicola Mining Commences Shipping Of Gold Concentrate Under Partnership With Talisker Resources

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on HUSIF

    September 8, 2025

    News Releases

    VANCOUVER, BC, September 8, 2025 – Nicola Mining Inc. (the “Company” or “Nicola”) (TSX: NIM) (OTCQB: HUSIF) (FSE: HLIA) announces that it has commenced shipping of gold concentrate via a partnership with Talisker Resources Ltd. (TSX: TSK) (OTCQX: TSKFF) (“Talisker”). Under a Mining, Milling and Smelting Agreement, the parties sold 707 ounces of gold in August, generating gross proceeds of approximately US$2.3 million. 

    Production benefited from extensive upgrades that included automation of several aspects of concentrate production, for the purpose of flotation recovery.  In addition, the Company’s installation of a large concentrator optimized free gold recovery, which is important for ore from Talisker and the Company’s Dominion Gold Project.  The Company confluence of numerous upgrades clearly impacted recovery and highlights Nicola’s ability to ramp up future production.

    Pre-Processed Ore and Bagged Flotation Concentrate

    Mr. Peter Espig, CEO of the Company, commented: “The culmination of our continuous multiple mill facility upgrades is the solidification of Nicola becoming a producer that is poised to benefit from gold and silver prices.  The Company continues to conduct work at its 100% of Treasure Mountain, a high-grade silver mine for which the mill was originally constructed.  The permitting and production of our partners highlights BC’s Ministry of Mining and Critical Minerals active support of smaller projects, for which we believe Nicola will become a hub.

    Bagged Gravity Concentrate and Gravity Concentrate Close Up

    About Nicola Mining

    Nicola Mining Inc. is a junior mining company listed on the Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.

    The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.

    On behalf of the Board of Directors

    “Peter Espig”
    Peter Espig CEO & Director

    For additional information
    Contact: Bill Cawker
    Phone: (604) 649 0080
    Email: info@nicolamining.com

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

    Release – FreightCar America, Inc. Adopts Limited Duration Stockholder Rights Plan

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on RAIL

    09/08/2025

    Protects Long-Term Value for All Stockholders

    CHICAGO, Sept. 08, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (the “Company” or “FreightCar”) announced today that its Board of Directors (the “Board”) has adopted a limited duration stockholder rights plan (the “Rights Plan”) to protect the best interests of all FreightCar America, Inc. stockholders. The Rights Plan is effective immediately and will expire on August 5, 2026, unless terminated earlier by the Board.

    The plan is intended to enable all stockholders to realize the long-term value of their investment and protect against any potential efforts to obtain control of the Company that are inconsistent with the best interests of its stockholders.

    “Over the past several years, we have fully re-engineered our business and are now actively executing on a strategic plan to deliver substantial growth and long-term value creation. Following an analysis of our current position, the Board determined it was appropriate to adopt a rights plan to promote the fair and equal treatment of all the Company’s stockholders,” said Jim Meyer, Chairman of FreightCar America.

    “We believe that there is significant upside ahead as we drive execution across our business, particularly given our leading margin profile and continued growth in market share,” said Nick Randall, President and Chief Executive Officer of FreightCar America. “Our management team is focused on advancing our commercial strategy with the inclusion of tank car conversions and other value-add solutions, while also continuing to support our flexible manufacturing model, which has proved itself to be a key competitive advantage for us and a hallmark of our approach.”

    The Board adopted the Rights Plan following a review of the Company’s current ownership structure. The Rights Plan is intended to reduce the likelihood that any person or group gains control of the Company through open-market accumulation or other tactics without paying an appropriate control premium or providing the Board sufficient time to make informed decisions that are in the best interests of the Company and all FreightCar America stockholders. The Rights Plan is not intended to deter offers or preclude the Board from considering offers that are in the best interest of the stockholders.

    About the Rights Plan
    The Rights Plan is similar to plans adopted by other publicly-traded companies. In connection with the adoption of the Rights Plan, the Board of Directors declared a non-cash dividend distribution of one preferred share purchase right for each share of the Company’s common stock outstanding as of September 2, 2025, the record date. In general terms, the rights will become exercisable only if a person or group acquires 15% or more of the outstanding common stock of the Company without the approval of the Board (or 20% or more in the case of passive investors who are eligible to, and do, report their holdings on Schedule 13G). In the event that the rights become exercisable, each right will entitle stockholders (other than the acquiring person or group) to buy shares of FreightCar’s common stock at a 50% discount. The rights of the acquiring person or group in that event will become void and not exercisable.

    This announcement is a summary only and is qualified by reference to the full text of the Rights Plan. Additional details regarding the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

    About FreightCar America

    FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com. 

    Forward-Looking Statements

    This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse geopolitical, economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials, including steel and aluminum; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion; delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings; potential unexpected changes in laws, rules, and regulatory requirements, including tariffs and trade barriers (including recent United States tariffs imposed or threatened to be imposed on China, Canada, Mexico and other countries and any retaliatory actions taken by such countries); and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

    For more information, please contact:
    RAILIR@Riveron.com

    Primary Logo

    Source: FreightCar America, Inc.

    View all news

    Release – The ONE Group Hospitality, Inc. Appoints Nicole Thaung as Chief Financial Officer

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on STKS

     Download as PDF September 08, 2025

    Seven-Year Benihana CFO to Lead Accounting and Finance Organization

    DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today announced the appointment of Nicole Thaung as Chief Financial Officer effective, September 8, 2025. Ms. Thaung will succeed Tyler Loy, who is departing the Company to pursue other opportunities.

    “Nicole’s extensive financial knowledge and deep understanding of our business make her the ideal leader for our finance organization,” said Emanuel “Manny” Hilario, Chief Executive Officer. “Her leadership has been instrumental in the seamless integration of the Benihana acquisition. Nicole’s expertise will be invaluable as we continue realizing the $20 million in expected synergies from this transformative acquisition, which now represents over 55% of our total revenues. We remain on track to capture the full value of these synergies by the end of 2026.”

    Ms. Thaung has over 15 years of experience with Benihana, where she has served as CFO since August 2018. Prior to her CFO role, Ms. Thaung held progressive leadership positions at Benihana including Vice President of Finance and Controller. Before joining Benihana in 2009, she spent nearly eight years at Ernst & Young LLP, with her last role being that of Audit Manager. Ms. Thaung holds bachelor’s and master’s degrees in accounting from the University of Florida.

    “We thank Tyler for his contributions over the years with The ONE Group,” added Hilario. “We wish him success in his future endeavors.”

    About The ONE Group

    The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:

    • STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe and the Middle East, featuring premium steaks, seafood and specialty cocktails in an energetic upscale atmosphere.
    • Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
    • Benihana Express, a small footprint casual concept showcasing the best of Benihana but without teppanyaki tables or bar.
    • Kona Grill, a polished casual, bar-centric grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
    • RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
    • Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
    • Samurai, an interactive dining experience located in sunny Miami, FL, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki right before your eyes.
    • ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.

    Additional information about The ONE Group can be found at www.togrp.com.

    Cautionary Statement on Forward-Looking Statements

    This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including with respect to the impact of the Benihana Inc. acquisition, restaurant openings and 2025 financial targets. Forward-looking statements may be identified by the use of words such as “target,” “intend,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements, including but not limited to: (1) our ability to integrate the new or acquired restaurants into our operations without disruptions to operations; (2) our ability to capture anticipated synergies; (3) our ability to open new restaurants and food and beverage locations in current and additional markets, grow and manage growth profitably, maintain relationships with suppliers and obtain adequate supply of products and retain employees; (4) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and/or licensing authorities; (5) our ability to successfully improve performance and cost, realize the benefits of our marketing efforts and achieve improved results as we focus on developing new management and license deals; (6) changes in applicable laws or regulations; (7) the possibility that The ONE Group may be adversely affected by other economic, business, and/or competitive factors, including economic downturns; (8) the impact of actual and potential changes in immigration policies, including potential labor shortages; (9) the potential impact of the imposition of tariffs, including increases in food prices and inflation and any resulting negative impacts on the macro-economic environment; and (10) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q.

    Investors are referred to the most recent reports filed with the Securities and Exchange Commission by The ONE Group Hospitality, Inc. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

    Investors:
    ICR
    Michelle Michalski or Raphael Gross
    (646) 277-1224
    Michelle.Michalski@icrinc.com

    Media:
    ICR
    Judy Lee
    (646) 277-1242
    judy.lee@icrinc.com

    Source: The ONE Group Hospitality, Inc.

    Released September 8, 2025

    Gyre Therapeutics, Inc (GYRE) – Positioned To End YE2025 With Strong Products and Pipeline Development

    Posted on by slightbourne@noblecapitalmarkets.com


    Tuesday, September 09, 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.

    Gyre Has Made Strong YTD Progress. Gyre has made significant progress during the first three quarters of FY2025 that we believe positions the company for a strong year-end. These developments include continued sales growth from two products introduced in 1H25, an application for Hydronidone approval in China, and the start of a Phase 2 clinical trial for Hydronidone in the US. The company also announced the appointment of Dr. Han Ying as the new CEO, a member of the Board of Directors since January 2025.

    Hydronidone Data Showed Efficacy and Proof of Concept. The pivotal Phase 3 trial testing Hydronidone in Chronic Hepatitis B-associated fibrosis has met its primary endpoint of fibrosis regression. The study was conducted in China, and an application for approval by the NMPA (the Chinese regulatory authority) is planned for 3Q2025. Hydronidone has received Breakthrough Therapy Designation, allowing for accelerated review. We expect approval in 2H2026, followed by launch in FY2027.


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