Page 46 – Channelchek

Release – CORRECTING and REPLACING MAIA Biotechnology Announces Private Placement of Approximately $695,000

Posted on May 27, 2025May 28, 2025 by aweinsoff@channelchek.com

May 27, 2025 4:30pm EDT Download as PDF

CHICAGO–(BUSINESS WIRE)– This is a correction of the announcement. The number of shares and expected proceeds from the private placement have been corrected to 463,332 shares and approximately $695,000. All other aspects of the announcement remain the same.

The updated release reads:

MAIA BIOTECHNOLOGY ANNOUNCES PRIVATE PLACEMENT OF APPROXIMATELY $695,000

MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 463,332 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.71 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of five years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about May 29, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $695,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250527845229/en/

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

Source: MAIA Biotechnology, Inc.

Released May 27, 2025

Release – GeoVax Commends FDA’s Shift to Risk-Based COVID-19 Vaccination Guidance

Posted on May 27, 2025May 28, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Highlights Critical Role of Multi-Antigen GEO-CM04S1 in Protecting Vulnerable Populations

ATLANTA, GA, May 27, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced its strong support for the U.S. Food and Drug Administration (FDA) advisory panel’s updated COVID-19 vaccine recommendations. The new guidance prioritizes protection for older adults and individuals with chronic health conditions, moving away from a universal vaccination strategy and signaling a more focused public health approach – one that GeoVax believes that it is well equipped to support through its multi-antigen COVID-19 vaccine, GEO-CM04S1. The advisory panel’s recommendations follow details on how the FDA is changing the type of evidence it will accept from vaccine manufacturers to approve updated COVID-19 vaccines as outlined in an editorial published last week in the New England Journal of Medicine.

GeoVax’s COVID-19 candidate, GEO-CM04S1, is designed to address the precise needs of high-risk populations, including those identified in the new FDA guidance. Developed on the Modified Vaccinia Ankara (MVA) platform, GEO-CM04S1 delivers multiple antigens—specifically, both the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2—to induce broad, durable immune responses, including both antibody and T-cell immunity. This approach is believed to enhance protection, especially in individuals with compromised immune systems, such as those undergoing cancer treatment, organ transplant recipients, and others whose response to current mRNA vaccines may be suboptimal.

“GEO-CM04S1 embodies the next generation of COVID-19 vaccines—vaccines that offer layered immune protection and are purpose-built for the most vulnerable individuals,” said David Dodd, Chairman and CEO of GeoVax. “The FDA’s new guidance underscores the urgency of advancing vaccine solutions tailored for those at greatest risk. Our clinical data thus far appear to demonstrate that GEO-CM04S1 delivers a more comprehensive immune response, and we believe it is uniquely suited to fulfill the mission articulated by the FDA and the U.S. Department of Health and Human Services (HHS).”

The FDA’s updated recommendations mirror recent priorities set forth by HHS and the National Science and Technology Council (NSTC), which have called for a pivot toward vaccine technologies that provide durable, variant-resistant protection. This policy evolution reflects growing concerns about waning immunity, limited breadth of response, and manufacturing vulnerabilities associated with single-antigen platforms.

GeoVax’s alignment with these priorities is reflected not only in its COVID-19 vaccine design but also in its commitment to domestic manufacturing and pandemic preparedness. GEO-CM04S1 is currently being evaluated in multiple Phase 2 clinical trials. Interim results from a Phase 2 trial in patients with chronic lymphocytic leukemia (CLL) demonstrated superior T-cell responses relative to an FDA-approved mRNA vaccine, prompting the study’s independent Data Safety Monitoring Board to halt the comparator arm and continue enrollment exclusively with GEO-CM04S1.

“The future of pandemic response lies in broad, durable, and accessible solutions that meet the needs of real-world patients—not just the healthy and immunocompetent,” added Dodd. “We’re building a vaccine portfolio that we believe will meet this challenge, and we are encouraged by the FDA’s and HHS’s recognition of the need for more sophisticated vaccine approaches.”

With over 40 million immunocompromised adults in the U.S. and an annual global need estimated to be in excess of 400 million, GeoVax believes GEO-CM04S1, with an estimated market potential exceeding $30 billion, is uniquely positioned to potentially capture a significant market opportunity while advancing the public health mission. Its MVA-based COVID-19 approach enables expression of multiple antigens with a well-established safety profile, making it especially well-suited for vulnerable and immunocompromised populations.

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Release – SKYX to Be Added to Russell 2000® and Russell 3000® Indexes

Posted on May 27, 2025May 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on SKYX

May 27, 2025 10:39 ET

MIAMI, May 27, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (“SKYX” or the “Company”), a highly disruptive smart home platform technology company with over 97 issued and pending patents globally and a growing portfolio of over 60 lighting and home décor websites, with a mission to make homes and buildings become smart, safe, and advanced as the new standard, today announced that it is set to be added to the Russell 2000® and the broad-market Russell 3000® Index following the 2025 annual reconstitution of the Russell indexes, according to a preliminary list of additions posted by FTSE Russell on May 23, 2025. SKYX’s inclusion will become effective after the U.S. market opens on June 27, 2025.

Annual Russell index reconstitution ranks the Russell 2000® Index and the 3,000 largest U.S. public companies by total market capitalization. Inclusion in the all-cap Russell 3000® Index results in automatic membership in either the large-cap Russell 1000® Index or the small-cap Russell 2000® Index, as well as in relevant growth and value style indexes. FTSE Russell determines index membership primarily based on market-cap rankings and style attributes.

“This is an exciting milestone that reflects the strong progress SKYX has made in scaling our business and executing our strategic vision,” said Lenny Sokolow, Co-CEO of SKYX. “We believe that inclusion in the Russell indexes will help broaden investor awareness of our technology platform and increase institutional ownership as we continue to grow and advance our mission to make homes and buildings safer and smarter.”

Russell indexes are widely used by investment managers and institutional investors for index-based funds and benchmarking purposes. According to FTSE Russell, approximately $10.6 trillion in assets are benchmarked to Russell U.S. indexes. Russell indexes are maintained by FTSE Russell, a global leader in index analytics and solutions.

For more information on the Russell 3000® Index and the annual reconstitution process, please visit the “Russell Reconstitution” section on the FTSE Russell website.

For SKYX’s Technologies Video Link CLICK HERE

About SKYX Platforms Corp.

As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 97 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.

Forward-Looking Statements

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

Investor Relations Contact:
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Release – Graham Corporation Wins Follow-On Contract Award to Support U.S. Navy’s Virginia Class Submarine Program

Posted on May 27, 2025May 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GHM

May 27, 2025 8:00am EDT Download as PDF

Secures $136.5 million contract to support the Virginia class submarine program
Strengthens Graham’s position as a critical supplier to U.S. Navy’s submarine programs

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“Graham” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer, and vacuum technologies for the defense, space, energy, and process industries, today announced that its wholly-owned subsidiary Barber-Nichols, LLC (“Barber-Nichols”) has been awarded a $136.5 million follow-on contract to support the U.S. Navy’s Virginia Class Submarine program.

The period of performance extends from April 2025 through February 2034. The Company recognized approximately $50 million in backlog¹ from this contract award during the fourth quarter of its fiscal year ending March 31, 2025 to procure long-lead time materials.

Michael E. Dixon, General Manager of Barber-Nichols, commented, “This substantial contract award reinforces our position as a trusted supplier of critical naval components and builds upon our successful execution of previous contracts for Virginia Class Submarines.”

This contract provides an opportunity to showcase the Company’s advanced engineering and manufacturing capabilities. Graham’s long-standing partnership with HII’s Newport News Shipbuilding division (NNS) has led to significant investments in machinery and facilities, ensuring optimal performance in delivering mission-critical systems for the U.S. Navy.

About Graham Corporation

Graham is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries. Graham Corporation and its family of global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps, and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

__________________________

¹ Backlog is a key performance metric. See “Key Performance Indicator” below for important disclosures regarding Graham’s use of this metric.

Safe Harbor Regarding Forward Looking Statements

This news release contains 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.

Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “opportunity” and other similar words. All statements addressing operating performance, events, or developments that Graham Corporation expects or anticipates will occur in the future, including but not limited to, profitability of future projects and the business, its ability to deliver to plan, its ability to meet customers’ shipment and delivery expectations, its ability to continue to strengthen relationships with customers in the defense industry, and the timing of conversion of backlog to sales, are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission (the “SEC”), included under the heading entitled “Risk Factors”, and in other reports filed with the SEC.

Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

Key Performance Indicator

Management uses the backlog to analyze and measure the Company’s financial performance and results of operations. Management uses backlog as measure of current and future business and financial performance, and it may not be comparable with measures provided by other companies. Backlog is defined as the total dollar value of net orders received for which revenue has not yet been recognized. Management believes tracking backlog is useful as it often times is a leading indicator of future performance. In accordance with industry practice, contracts may include provisions for cancellation, termination, or suspension at the discretion of the customer.

Given that backlog is an operational measure and that the Company’s methodology for calculating backlog does not meet the definition of a non-GAAP measure, as that term is defined by the U.S. Securities and Exchange Commission, a quantitative reconciliation for it is not required or provided.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250527540167/en/

For more information, contact:
Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Tom Cook
Investor Relations
Phone: (203) 682-8250
tom.cook@icrinc.com

Source: Graham Corporation

Released May 27, 2025

Release – Ocugen Announces Rare Pediatric Disease Designation Granted for OCU410ST—Modifier Gene Therapy for the Treatment of Stargardt Disease

Posted on May 27, 2025May 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 27, 2025

PDF Version

MALVERN, Pa., May 27, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the United States Food and Drug Administration (U.S. FDA) has granted Rare Pediatric Disease Designation (RPDD) for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3. Previously, OCU410ST received Orphan Drug designations for the treatment of ABCA4-associated retinopathies from the FDA and European Medicines Agency.

“This latest designation for OCU410ST reaffirms the urgency of providing a therapeutic option to Stargardt patients who have no FDA-approved treatment available,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This inherited retinal disease presents itself most often in childhood—making Stargardt disease a diagnosis that not only affects the patient but impacts the entire family.”

The FDA grants RPDD for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. There are approximately 100,000 people in the U.S. and Europe combined living with Stargardt disease.

With this designation for OCU410ST, Ocugen may be awarded a Priority Review Voucher (PRV), if the PRV program is reauthorized by the U.S. Congress. The PRV program is designed to incentivize drug development for serious rare pediatric diseases. If awarded, a PRV can be redeemed to receive priority review for a different product or sold to another sponsor and typically sells for about $100 million.

Ocugen is committed to advancing the OCU410ST program through clinical development and plans to initiate the Phase 2/3 pivotal confirmatory trial in the next few weeks with a target Biologics License Application (BLA) filing in 2027.

About OCU410ST
OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

About Stargardt Disease
Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us X and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Nippon Steel Set to Finalize $55/Share Acquisition of U.S. Steel in Landmark U.S.-Japan Deal

Posted on May 27, 2025May 27, 2025 by slightbourne@noblecapitalmarkets.com

Key Points:
– Nippon Steel to acquire U.S. Steel for $55/share in a U.S.-approved strategic deal.
– The agreement secures American leadership, board control, and a $14B investment.
– Labor concerns persist over Nippon’s trade history and potential job risks

Japan’s Nippon Steel is expected to finalize its acquisition of U.S. Steel at $55 per share, marking a significant shift in the global steel industry and setting the stage for a tightly regulated, cross-national partnership. The $14 billion deal, which had previously been blocked under the Biden administration over national security concerns, was cleared on Friday by President Donald Trump, who framed the acquisition as a “strategic investment partnership.”

U.S. Steel, a historic symbol of American industrial might, will maintain its headquarters in Pittsburgh under the agreement. The deal ensures U.S. control in several key areas, aiming to strike a balance between foreign investment and national economic security.

President Trump emphasized that Nippon’s investment would not only protect American manufacturing but enhance it, noting that the $14 billion capital injection includes $2.4 billion earmarked for modernizing the Mon Valley plant outside Pittsburgh. “It’s not a buyout—it’s a commitment to American steel,” Trump said. He also announced plans to hold a rally at the Pittsburgh facility on May 30.

Critically, the agreement includes provisions designed to address concerns from both lawmakers and organized labor. Pennsylvania Senator Dave McCormick described the arrangement as a “win-win,” highlighting that U.S. Steel will be led by an American CEO, and that a majority of its board members will be U.S.-based. In addition, a “golden share” mechanism gives the U.S. government veto power over key board decisions, further safeguarding American interests.

The deal is poised to save 10,000 steel jobs in Pennsylvania and generate an additional 10,000 building trade jobs through new infrastructure investments, including plans to construct another arc furnace—an initiative that could help revitalize domestic production capabilities.

Despite these assurances, skepticism remains. The United Steelworkers (USW) union continues to express concern over Nippon’s track record regarding trade practices. USW President David McCall said the union is awaiting more details before determining whether the deal adequately protects American workers. “Nippon has a long and proven history of violating our trade laws,” McCall stated. “We’re worried this could further erode our steelmaking capacity and union jobs.”

For Nippon Steel, the acquisition represents a major strategic gain—providing access to the U.S. market and strengthening its position in a globally competitive industry. Senator McCormick acknowledged that the Japanese firm will have board representation and will integrate the U.S. Steel unit into its larger corporate structure. “This was their proposal. They see economic opportunity in strengthening ties with the American industrial base,” he said.

While the full impact of the deal will unfold over time, one thing is clear: this acquisition represents more than a business transaction. It’s a litmus test for how the U.S. navigates foreign investment in critical sectors, balancing economic opportunity with sovereignty and security.

Take a moment to take a look at more emerging growth industrials and basic industries companies by taking a look at Noble Capital Markets’ Research Analyst Mark Reichman’s coverage list.

Comstock (LODE) – Comstock Achieves a Transformative Milestone

Posted on May 27, 2025May 27, 2025 by slightbourne@noblecapitalmarkets.com

Tuesday, May 27, 2025

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Annual general meeting. Comstock Inc. recently hosted its virtual annual general meeting. Shareholders voted to: 1) elect seven named nominees to the Board of Directors for the ensuing year or, if earlier, until their successors are duly elected and qualified, 2) to ratify the appointment of Assure CPA, LLC as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2025, and 3) to approve a non-binding advisory resolution for the compensation of named executive officers.

Separation of Comstock Fuels. Comstock Inc. officially separated and contributed the assets that formerly comprised Comstock’s fuels segment into Bioleum Corporation, a newly formed company that will operate independently with the objective of becoming a publicly traded company.

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Circle Targets Nearly $6 Billion Valuation in Landmark Stablecoin IPO

Posted on May 27, 2025May 27, 2025 by slightbourne@noblecapitalmarkets.com

Key Points:
– Circle launches IPO to raise $624M, targeting a $5.65B valuation amid stablecoin growth.
– USDC’s market cap has surged 40% in 2025, driven by rising demand and pending U.S. regulation.
– Cathie Wood’s ARK and Coinbase stand to benefit as Circle eyes wider institutional adoption.

Circle, the fintech firm behind the widely-used USDC stablecoin, has officially launched its long-anticipated initial public offering (IPO), aiming to raise approximately $624 million. The move would value the company at around $5.65 billion — and closer to $6.7 billion when including outstanding shares and options — marking a pivotal moment for both Circle and the broader digital asset space.

The offering includes 24 million shares of Class A common stock, priced between $24 and $26 per share. Of those, Circle itself will sell 9.6 million, while existing shareholders are offloading the remaining 14.4 million. The shares will trade under the ticker CRCL on the New York Stock Exchange, giving traditional investors direct exposure to one of the most influential players in the crypto ecosystem.

Founded in 2018, Circle’s signature product, USD Coin (USDC), is now the second-largest stablecoin in the world, with around $62 billion in circulation — roughly 27% of the total stablecoin market. It trails only Tether (USDT), which holds a 67% share. However, USDC has outpaced its rival in growth this year, boasting a 40% increase in market cap compared to Tether’s 10%, according to CryptoQuant.

The IPO comes at a strategic inflection point for the crypto industry, as U.S. lawmakers move closer to passing the first major federal legislation aimed at stablecoins. Last week, the Senate advanced a regulatory bill that would establish clear guidelines for their issuance and oversight. Former President Donald Trump, now back in office, has voiced strong support for crypto regulation and stated his desire to sign a stablecoin-focused bill before the August recess.

A significant backer of Circle’s IPO is ARK Investment Management, led by Cathie Wood, which has signaled interest in purchasing up to $150 million worth of shares — a vote of confidence in Circle’s future and stablecoin utility.

The IPO is also expected to have notable ripple effects for Coinbase, a co-founder of USDC and one of its primary distribution channels. Coinbase and Circle maintain a 50/50 revenue-sharing agreement on USDC, and the crypto exchange earns 100% of the interest income generated by USDC-based products on its platform. Coinbase CEO Brian Armstrong has called making USDC the world’s top stablecoin a “stretch goal” for the company.

Beyond trading and DeFi use cases, USDC and other stablecoins have increasingly been recognized for their ability to move U.S. dollars quickly and inexpensively across borders. This functionality is attracting attention from fintech firms, traditional banks, and policymakers alike — especially as global conversations around preserving U.S. dollar dominance intensify.

With its IPO, Circle isn’t just going public — it’s stepping into the spotlight as a central player in the next era of global finance.

Oil Prices Rise Slightly as U.S.-Iran Nuclear Talks Stall and Geopolitical Tensions Mount

Posted on May 27, 2025May 27, 2025 by slightbourne@noblecapitalmarkets.com

Key Points:
– Oil inches up as U.S.-Iran nuclear talks stall without resolution.
– Geopolitical risks and strong U.S. data support prices amid market fears.
– Bearish sentiment persists due to OPEC+ supply hikes and rising U.S. stockpiles.

Oil prices edged higher this week as U.S.-Iran nuclear negotiations failed to deliver significant progress, deepening market uncertainty and raising concerns over potential disruptions in global supply. West Texas Intermediate (WTI) crude hovered near $61 a barrel following a fifth round of talks in Rome, where both sides reported “some but not conclusive progress.”

Iranian Foreign Minister Abbas Araghchi acknowledged that while talks had moved forward, critical issues remain unresolved. The lack of a breakthrough is fueling doubts about whether Iranian crude will re-enter the market anytime soon. Traders are watching closely, as failed negotiations could restrict supply from the OPEC member and tighten global markets.

Geopolitical tension is further intensifying sentiment. Reports from U.S. intelligence suggesting that Israel may be preparing to strike Iranian nuclear facilities have added to anxiety in the energy sector. While Iranian officials indicated that a deal limiting nuclear weapons development might be possible, Tehran remains firm on continuing uranium enrichment—an issue that could derail diplomacy.

Meanwhile, strong U.S. economic data helped buoy prices after a brief dip triggered by fresh tariff threats from former President Donald Trump. In a social media post, Trump criticized the European Union as “very difficult to deal with” and suggested a sweeping 50% tariff on EU imports starting June 1. The rhetoric briefly shook markets, but solid U.S. consumer and industrial data helped counterbalance demand fears.

Despite the recent uptick, oil’s broader outlook remains bearish. Crude prices are down about 14% year-to-date, recently touching lows not seen since 2021. A faster-than-anticipated easing of production limits by OPEC+ and rising U.S. commercial oil stockpiles have both added to concerns about oversupply.

Energy strategist Jens Naervig Pedersen from Danske Bank emphasized that bearish sentiment persists. He cited ongoing output hikes by OPEC+, lackluster progress in both trade and nuclear talks, and the possibility of sanctions relief for Iran as factors undermining oil prices.

Looking ahead, a virtual meeting of key OPEC+ producers, including Saudi Arabia, is set for June 1 to decide on output levels for July. Most analysts surveyed by Bloomberg anticipate a continued rise in production, which could further pressure prices.

Adding another wrinkle, the European Commission is proposing to lower the price cap on Russian oil to $50 a barrel. Currently set at $60, the cap was designed to punish Russia for its war in Ukraine while keeping oil flowing. With prices already low, the existing ceiling is seen as ineffective.

In summary, oil is caught in a tug-of-war between geopolitical risk and structural oversupply. Unless a clear resolution emerges in U.S.-Iran talks or OPEC+ shifts its stance on production, the market may remain volatile with a downward bias.

Release – Gyre Therapeutics Announces Pricing of $20.0 Million Public Offering of Common Stock

Posted on May 23, 2025May 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GYRE

May 22, 2025

PDF Version

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced the pricing of its previously announced underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share. In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 333,333 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds of the offering to Gyre, before deducting the underwriting discounts and commissions and other offering expenses payable by Gyre, are expected to be approximately $20.0 million. The offering is expected to close on or about May 27, 2025, subject to the satisfaction of customary closing conditions.

Jefferies is acting as lead book-running manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering.

Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes.

The shares of common stock described above are being offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission (“SEC”) that was declared effective by the SEC on November 22, 2024. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov and may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for 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: Gyre’s expectations regarding the consummation of the offering and the satisfaction of customary closing conditions with respect to the offering; and the expected use of net proceeds from the offering. 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: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the offering; 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 Gyre may make with the SEC.

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.

Investor Contact:
David Zhang
Gyre Therapeutics
david.zhang@gyretx.com

Release – Gyre Therapeutics Announces Proposed Underwritten Public Offering of Common Stock

Posted on May 23, 2025May 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GYRE

May 22, 2025

PDF Version

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares of common stock to be sold in the offering are being offered by Gyre.

Jefferies is acting as lead book-running manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering.

The shares of common stock described above are being offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission (“SEC”) that was declared effective by the SEC on November 22, 2024. The offering will be made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement and the accompanying prospectus and other documents Gyre has filed with the SEC for more complete information about Gyre and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com.

About Gyre Therapeutics

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: Gyre’s expectations regarding the offering, including the timing, size, structure and completion of the proposed offering on the anticipated terms; the grant to the underwriters of the option to purchase additional shares; and the expected use of net proceeds from the offering. 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: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the offering; 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 Gyre may make with the SEC.

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.

Investor Contact:
David Zhang
Gyre Therapeutics
david.zhang@gyretx.com

Release – Gyre Therapeutics’ Hydronidone Met the Primary Endpoint and Demonstrated Statistically Significant Fibrosis Regression in Pivotal Phase 3 Trial for the Treatment of CHB-associated Liver Fibrosis in China

Posted on May 23, 2025May 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GYRE

May 22, 2025

PDF Version

Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002).
Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events.
Breakthrough Therapy Designation granted by China’s National Medical Products Administration (“NMPA”) in 2021 supports potential first-in-class approval in CHB-associated liver fibrosis (“CHB fibrosis”).
Gyre intends to seek accelerated approval for Hydronidone in CHB fibrosis, with a New Drug Application (“NDA”) submission to the NMPA expected in Q3 2025.
U.S. Phase 2 trial in MASH-associated liver fibrosis expected to begin in 2H2025.

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that its lead compound, Hydronidone (F351), met the primary endpoint in a pivotal Phase 3 trial evaluating its efficacy and safety for the treatment of liver fibrosis in patients with chronic hepatitis B (“CHB”) in China.

The 52-week, multicenter, double-blind, placebo-controlled trial enrolled 248 patients with CHB fibrosis across 39 hospitals in China. Patients were randomized 1:1 to receive either Hydronidone (270 mg/day, orally) or placebo, in addition to background entecavir antiviral therapy. The trial met its primary endpoint, with a statistically significant proportion of patients receiving Hydronidone achieving a ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002). These results are consistent with the efficacy and safety outcomes observed in Gyre’s prior Phase 2 trial.

“These landmark Phase 3 results represent a major step forward for Gyre and for the millions of Chinese patients living with CHB fibrosis,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “Pending regulatory approval in China, Hydronidone may become the first therapy specifically indicated for reversing liver fibrosis in CHB patients and the foundation for broader expansion into metabolic dysfunction-associated steatohepatitis (“MASH”)-related fibrosis in the United States. We are deeply grateful to the patients and investigators who participated in this pivotal trial and made this important milestone possible.”

“The fibrosis regression in our trial marks a breakthrough in the treatment of CHB fibrosis,” said Prof. Lungen Lu, M.D., Dean of the Department of Gastroenterology at Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, and lead principal investigator. “With no approved anti-fibrotic therapies for this liver disease currently available, Hydronidone has the potential to transform the treatment landscape and offer new hope to patients facing the serious risks of cirrhosis, liver failure, and hepatocellular carcinoma.”

Hydronidone Week 52 Results

The efficacy analysis followed the intent-to-treat (“ITT”) principle. The ITT population comprised all randomized subjects who received at least one dose of study drug. One randomized subject who did not receive any treatment was excluded. All biopsies were independently reviewed by three blinded central pathologists to ensure consistency and objectivity of fibrosis and inflammation assessments.

Efficacy Results

In the ITT population, Hydronidone demonstrated statistically significant regression in liver fibrosis compared to placebo.

Primary Endpoint	Hydronidone 270mg N=123	Placebo N=124	P-value
≥1-stage fibrosis regression (Ishak)	52.85%	29.84%	P=0.0002

Key Secondary Endpoints
≥1-Grade inflammation improvement (Scheuer score) without progression of fibrosis	49.57%	34.82%	P=0.0246

Safety Results

Hydronidone was well tolerated, with a comparable incidence of serious adverse events (4.88% vs. 6.45% in the placebo group) and no discontinuations due to adverse events in either group. Most adverse events were mild or moderate and unrelated to Hydronidone, while a small number of severe adverse events occurred, none of which were considered related to the trial drug.

Our Path Forward

Gyre plans to submit primary results for publication in a peer-reviewed journal and present full trial results at a future medical congress.

Based on these positive results, Gyre plans to file an NDA with China’s NMPA in the third quarter of 2025. In parallel, the Company is actively preparing to file an investigational new drug (“IND”) application in the third quarter of 2025 and, subject to IND clearance, plans to initiate a Phase 2 trial in the U.S. evaluating Hydronidone for the treatment of MASH-associated fibrosis in the second half of 2025. A prior U.S. Phase 1 trial in healthy volunteers confirmed Hydronidone’s tolerability and demonstrated a pharmacokinetic profile consistent with the Chinese population.

About the Phase 3 Trial

The randomized, double-blind, placebo-controlled multicenter Phase 3 trial (NCT05115942) enrolled 248 patients with CHB fibrosis (Ishak fibrosis stage ≥3) across 39 hospitals in China. Patients were randomized 1:1 to receive either 270 mg Hydronidone or placebo daily, in combination with entecavir. The primary endpoint of the trial was the efficacy of fibrosis regression, defined as a decrease in the Ishak stage score of liver fibrosis ≥ 1 after 52 weeks of treatment compared to baseline. A key secondary endpoint was a ≥1-grade reduction in liver inflammation, as assessed by the Scheuer scoring system, after 52 weeks of treatment compared to baseline, without progression of fibrosis.

Patient Population for CHB-Associated Liver Fibrosis

According to national serological surveys, approximately 75 million people in China are chronically infected with hepatitis B virus. A significant subset develops CHB with progressive fibrosis. Based on internal modeling of epidemiologic and staging data, Gyre estimates that approximately 2.6 million patients in China have been diagnosed with compensated F2-F4 CHB fibrosis, representing the initial addressable market for Hydronidone. CHB remains the leading cause of liver fibrosis in China, and currently no approved anti-fibrotic therapies exist for this population.

Hydronidone is uniquely positioned to address this significant and urgent unmet medical need. Gyre was granted Breakthrough Therapy Designation in 2021 by the NMPA.

About Hydronidone (F351)

Hydronidone (F351) is a structural analogue of Pirfenidone, for which Gyre received first-in-class approval in China in 2011 for the treatment of idiopathic pulmonary fibrosis (IPF). Hydronidone exhibits enhanced potency in inhibiting p38γ kinase activity and TGF-β1-induced collagen synthesis in hepatic stellate cells (HSCs), key drivers of liver fibrosis. It also demonstrates anti-proliferative activity in HSCs through upregulation of Smad7, which downregulates TGF-βRI, thereby suppressing both the p38γ and Smad2/3 fibrogenic pathways.

Hydronidone has shown robust anti-fibrotic activity in multiple preclinical models, including the CCl₄-induced mouse model, DMN- and HSA-induced rat models, and a MASH model combining CCl₄ with a Western high-fat diet. In a randomized, double-blind, placebo-controlled Phase 3 trial, Hydronidone 270 mg/day significantly reduced liver fibrosis in CHB patients after 52 weeks of treatment. Compared to Pirfenidone, Hydronidone’s unique Phase II conjugation metabolism may contribute to an improved hepatic safety profile.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for 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 trials, including timing of a U.S. Phase 2 clinical trial initiation in the second half of 2025 and NDA submission to NMPA for F351. 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:
David Zhang
david.zhang@gyretx.com

QuoteMedia Inc. (QMCI) – Delivers Encouraging Q1 Results

Posted on May 23, 2025May 23, 2025 by slightbourne@noblecapitalmarkets.com

Friday, May 23, 2025

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.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.

Solid Q1 Results. The company reported Q1 revenue of $4.8 million, which increased 3% over the prior year period, and was in line with our estimate of $4.8 million. Notably, revenue in Q1 was highest amount of quarterly revenue in the company’s history. Moreover, the company recorded adj. EBITDA of $0.4 million in Q1, which was moderately lower than our estimate of $0.5 million, as illustrated in Figure #1 Q1 Results.

Q1 adj. EBITDA impact. Notably, adj. EBITDA in Q1 was impacted by the company capitalizing less development costs than in prior quarters, leading to more development costs expensed in Q1. Importantly, the increase in development costs that were expensed did not have an impact on cashflow. Furthermore, the company highlighted that it will be expensing development costs at a similar rate to Q1, which was higher than in previous quarters, moving forward.

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