Author: aweinsoff@channelchek.com

Release – U.S. District Court Dismisses Class Action Lawsuit Against Direct Digital Holdings

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DRCT

August 13, 2025 8:30 am EDT Download as PDF

HOUSTON, Aug. 13, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), has been granted a motion to dismiss a shareholder class action lawsuit by the U.S. District Court, Southern District of Texas, Houston Division, subject to potential appeal. 

The lawsuit alleged false and misleading disclosures made by the Company in its public filings. After reviewing the statements offered by the plaintiff, the Court ruled “…none of the statements constitute either materially false statements or omissions that would lead a rational investor to rely on them.”  

Keith Smith, President of Direct Digital Holdings, commented, “We appreciate the Court’s thoughtful consideration and ultimate conclusion in the dismissal of this case.”

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws that are subject to certain risks, trends and uncertainties. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Accordingly, any such statements are qualified in their entirety by reference to the information described under the caption “Risk Factors” and elsewhere in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Form 10-K”) and subsequent periodic and or current reports filed with the Securities and Exchange Commission (the “SEC”).

The forward-looking statements contained in this press release are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this press release, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (many of which are beyond our control) and assumptions.

Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements. We believe these factors include, but are not limited to, the following: ability to service debt or dividend payment obligations; the restrictions and covenants imposed upon us by our credit facilities; the substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing; our ability to secure additional financing to meet our capital needs; our ineligibility to file short-form registration statements on Form S-3, which may impair our ability to raise capital; our failure to satisfy applicable listing standards of the Nasdaq Capital Market resulting in a potential delisting of our common stock; costs, risks and uncertainties related to restatement of certain prior period financial statements; any significant fluctuations caused by our high customer concentration; risks related to non-payment by our clients; reputational and other harms caused by our failure to detect advertising fraud; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; the appeals process in any litigation; our failure to manage our growth effectively; the difficulty in identifying and integrating any future acquisitions or strategic investments; any changes or developments in legislative, judicial, regulatory or cultural environments related to information collection, use and processing; challenges related to our buy-side clients that are destination marketing organizations and that operate as public/private partnerships; any strain on our resources or diversion of our management’s attention as a result of being a public company; the intense competition of the digital advertising industry and our ability to effectively compete against current and future competitors; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; as a holding company, we depend on distributions from Direct Digital Holdings, LLC (“DDH LLC”) to pay our taxes, expenses (including payments under the Tax Receivable Agreement) and any amount of any dividends we may pay to the holders of our common stock; the fact that DDH LLC is controlled by DDM, whose interest may differ from those of our public stockholders; any failure by us to maintain or implement effective internal controls or to detect fraud; and other factors and assumptions discussed in our Form 10-K and subsequent periodic and current reports we may file with the SEC.

Should one or more of these risks or uncertainties materialize, or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this press release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. New factors that could cause our business not to develop as we expect emerge from time to time, and it is not possible for us to predict all of them. Further, we cannot assess the impact of each currently known or new factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT) combines cutting-edge sell-side and buy-side advertising solutions, providing data-driven digital media strategies that enhance reach and performance for brands, agencies, and publishers of all sizes. Our sell-side platform, Colossus SSP, offers curated access to premium, growth-oriented media properties throughout the digital ecosystem. On the buy-side, Orange 142 delivers customized, audience-focused digital marketing and advertising solutions that enable mid-market and enterprise companies to achieve measurable results across a range of platforms, including programmatic, search, social, CTV, and influencer marketing. With extensive expertise in high-growth sectors such as Energy, Healthcare, Travel & Tourism, and Financial Services, our teams deliver performance strategies that connect brands with their ideal audiences.

At Direct Digital Holdings, we prioritize personal relationships by humanizing technology, ensuring each client receives dedicated support and tailored digital marketing solutions regardless of company size. This empowers everyone to thrive by generating billions of monthly impressions across display, CTV, in-app, and emerging media channels through advanced targeting, comprehensive data insights, and cross-platform activation. DDH is “Digital advertising built for everyone.”

Contacts:

Investors:
IMS Investor Relations
Walter Frank/Jennifer Belodeau
(203) 972-9200
investors@directdigitalholdings.com

Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

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Released August 13, 2025

Release – Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 13, 2025

PDF Version

MALVERN, Pa., Aug. 13, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).

EMA provided this opinion based on safety and tolerability that OCU410ST demonstrated in the Phase 1 GARDian trial, including 48% slower lesion growth and statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up in evaluable treated eyes compared to untreated eyes. The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The unique adaptive design of this trial includes a masked interim analysis of 24 subjects in the study (16 in treatment group and 8 in control group) at 8 months. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the Company’s planned Biologics License Application (BLA) and MAA in the EU.

“This positive opinion endorses a single trial as the basis for both BLA and MAA submissions and brings us closer to providing a one-time, modifier gene therapy to approximately 100,000 Stargardt patients in the U.S. and Europe combined,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “We are very encouraged about the prospect of addressing the unmet medical need that exists for these patients who currently have no approved treatment options available to them.”

The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU. Alignment with the EMA follows recent important milestones for the OCU410ST program, including Rare Pediatric Disease Designation (RPDD) in May, IND clearance in June, and first patient dosing in July. With enrollment scheduled to be complete in the first quarter of 2026 the Company remains on track for a BLA filing in the first half of 2027, aligned with its goal of three BLAs in the next three years.

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 biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on 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

Release – Comstock Prices $30 Million Upsized and Oversubscribed Public Offering of Common Stock

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

  • With the elimination of all outstanding debt and approximately $45 million in expected cash on hand, Comstock is positioned to fully fund the commercialization of its first industry-scale Comstock Metals facility and advance key development initiatives
  • Offering includes participation from fundamental institutional investors, including a long-only mutual fund, a leading alternative asset manager, several preeminent global investment managers, and existing investors

Virginia City, Nevada, August 12, 2025 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”), today announced that it has priced its previously announced underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $2.25 per share (the “Offering”). All of the shares of common stock in the offering are to be sold by Comstock. The gross proceeds to the Company from this offering are expected to be approximately $30 million before deducting underwriting discounts and commissions and other offering expenses. This Offering positions the Company to fully fund its commercialization for its industry-scale solar panel recycling facilities, each capable of recycling over 3 million panels per year, and to advance site selection and other key development initiatives.

“We are pleased to secure this level of fundamental support from leading institutional investors,” said Corrado De Gasperis, Executive Chairman and CEO of Comstock. “By eliminating all outstanding debt and fortifying our cash position, we have established an incredibly strong foundation for immediate and future growth. We believe our solar panel recycling business is uniquely positioned to accelerate commercialization of our industry-leading technologies and industry-scale recycling facilities.”

The Company intends to use the net proceeds from this offering for capital expenditures associated with commercializing its first industry scale facility for Comstock Metals, development expenses, and general corporate purposes, including the payment of existing indebtedness. The offering is expected to close on August 14, 2025, subject to customary closing conditions.

The Company has granted the underwriter a 30-day option to purchase up to an additional 2,000,000 shares of common stock to cover over-allotments, if any, at the per share public offering price, less underwriting discounts and commissions.

Titan Partners Group, a division of American Capital Partners, is acting as the sole bookrunner for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-285744) (including a base prospectus) previously filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and declared effective on March 24, 2025. The offering is being made only by means of a preliminary prospectus supplement and a final prospectus supplement and the accompanying base prospectus that form a part of the registration statement. These documents, including the preliminary prospectus supplement relating to the offering, are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying base prospectus relating to the offering may be accessed for free on the SEC’s website at www.sec.gov or obtained by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at prospectus@titanpartnersgrp.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 such state or jurisdiction.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that enable, support and sustain clean energy systems across entire industries by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable electrification metals, like silver, aluminum, copper, and other critical minerals from end-of-life photovoltaics. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

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

Contacts

For investor inquiries:
Judd B. Merrill, Chief Financial Officer
Tel (775) 413-6222
ir@comstockinc.com

For media inquiries:
Zach Spencer, Director of External Relations
Tel (775) 847-7573
media@comstockinc.com

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

Release – Comstock Inc. Announces Proposed Public Offering of Common Stock

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

Virginia City, Nevada, August 12, 2025 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”), today announced that it has commenced an underwritten public offering for the sale of its common stock (or pre-funded warrants in lieu thereof). In connection with the offering, Comstock expects to grant the underwriter a 30-day option to purchase additional common stock in an amount up to 15% of the shares of common stock (or pre-funded warrants) offered in the offering, to cover over-allotments, if any. The pre-funded warrants will be immediately exercisable and may be exercised at any time until exercised in full. The Company intends to use the net proceeds from this offering for capital expenditures associated with commercializing its first industry scale facility for Comstock Metals, development expenses, and general corporate purposes, including the payment of existing indebtedness. The offering is subject to market conditions and other factors, 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.

Titan Partners Group, a division of American Capital Partners, is acting as the sole bookrunner for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-285744) (including a base prospectus) previously filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 12, 2025, and declared effective on March 24, 2025. The offering is being made only by means of a preliminary prospectus supplement and a final prospectus supplement and the accompanying base prospectus that form a part of the registration statement. Before investing, prospective investors should read the preliminary prospectus supplement, the accompanying base prospectus and the documents incorporated by reference therein for more complete information about the Company and the offering. These documents, including the preliminary prospectus supplement relating to the offering, are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying base prospectus relating to the offering may be accessed for free on the SEC’s website at www.sec.gov or obtained by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at prospectus@titanpartnersgrp.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 such state or jurisdiction.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that enable, support and sustain clean energy systems across entire industries by efficiently, effectively, and expediently extracting and converting under-utilized natural resources into reusable electrification metals, like silver, aluminum, copper, and other critical minerals from end-of-life photovoltaics. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

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

Contacts

For investor inquiries:
Judd B. Merrill, Chief Financial Officer
Tel (775) 413-6222
ir@comstockinc.com

For media inquiries:
Zach Spencer, Director of External Relations
Tel (775) 847-7573
media@comstockinc.com

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

Release – SKYX Reports Increase of 15% with Record Second Quarter 2025 Revenues of $23.1 Million Compared to $20.1 Million for First Quarter 2025 as it Continues to Grow its Market Penetration in the U.S. and Canadian Markets

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

August 12, 2025 16:05 ET | Source: SKYX Platforms Corp.

Company reports $15.7 million in cash, cash equivalents, and restricted cash, as compared to $12.3 million as of March 31, 2025. SKYX Continues to Leverage its Cash Position Through its E-Commerce Platform of 60 Websites among Other Methods Including Support from Strategic Investors and Insiders

SKYX Revenues Increased for 6 Comparable Quarters from Q1 2024 Through Q2 2025 with $19M in Q1/24, 21.4M in Q2/24, $22.2M in Q3/24, $23.7M in Q4/24, $20.1M in Q1/25, and $23.1M in Q2/25

Gross Profit Improvement by 23% to $7 million in the Second Quarter of 2025 Sequentially from the First Quarter of 2025

Net cash used in Operating Activities for the Second Quarter ending June 30, 2025, Decreased Sequentially by 54% to $2.0 Million Compared to $4.3 Million in the First Quarter of 2025

Major SKYX Collaboration with a Miami $3 Billion Mix-Use Urban, Smart Home City Project; SKYX is Expected to Supply Over 500,000 Units of its Advanced Smart Home Plug & Play Platform Technologies for the Entire Smart City Project

SKYX’s Technologies Provide Additional Opportunities for Future Recurring Revenues Through Interchangeability, Upgrades, Monitoring and Subscriptions, Among Others

SKYX’s Safety Code Standardization Team is Continuing to Progress and is Receiving Significant Support from a New Prominent Leader with its Government Safety Organization Process for Safety Mandatory Standardization in Homes and Buildings of Its Ceiling Outlet/Receptacle Technology

Company Expects Its Products to Be in 40,000 Units/Homes by The End of Q3 2025 in the U.S and Canada Through Retail and Pro Segments

MIAMI, Aug. 12, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive platform technology company with over 100 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the Second quarter ended June 30, 2025.

Second Quarter 2025 Highlights and Recent Events

  • Generated record Second quarter 2025 revenues of $23.1 million compared to $20.1 million for the first quarter of 2025.
  • As of June 30, 2025, Company reported $15.7 million in cash, cash equivalents, and restricted cash, as compared to $12.3 million as of March 31, 2025.
  • As common with companies such as ours when sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, the Company leverages its trades payable to finance its operations, to enhance its cash position and to lower its cost of capital.
  • Management believes it has sufficient cash to achieve its goals including being cash flow positive in 2025.
  • Net cash used in operating activities for the Second quarter ending June 30, 2025, decreased sequentially by 54% to $2.0 million compared to $4.3 million in the First quarter of 2025.
  • The gross profit for the Second quarter ending June 30, 2025, increased sequentially by 23% to $7.0 million, compared to the First quarter ending March 31, 2025.
  • The gross margin for the Second quarter ending June 30, 2025, increased sequentially by 7% to 30.3%, compared to the First quarter ending March 31, 2025.
  • Entered into a major collaboration with a $3 billion mixed-use smart city development in the Little River District in the heart of Miami. SKYX has financial backing from U.S. and Global manufacturers to support its massive product deployment.
  • SKYX is expected to deliver over 500,000 units of its advanced and plug & play smart home technologies addressing the 5,700 residential units, 350,000 square feet of retail and commercial space and a new $35 million Tri-Rail station.
  • Announced demand surge towards the launch of its new disruptive patented all-in-one smart turbo heater and ceiling fan. This highly innovative product – integrating a ceiling fan with a built-in heater – is designed to address a massive market opportunity for all four seasons. The combined ceiling fan and portable heater category is a multi-billion-dollar market, with tens of millions of units sold annually in the U.S. alone.
  • Announced a U.S. and global sales and marketing collaboration agreement with Parrot Uncle, a world leading ceiling fan and home décor manufacturer selling millions of fans globally with SKYX and Parrot Uncle jointly marketing SKYX’s disruptive technologies and products in the U.S. and to global markets including its patented all-in-one smart turbo heater & ceiling fan.
  • Granted 8 newly issued U.S. and global patents with now over 100 patents and pending applications with 45 issued patents. Each of Company’s 100 patents and pending application is based on three major factors: 1. Safety, 2. Massive Addressable Market, and 3. Global Applications.
  • Through the Second quarter of 2025, SKYX has secured additional equity, mainly through preferred stock with no warrants as part of a broader financing round totaling approximately $15 million to date, led by The Shaner Group, owner, and developer of more than 70 hotels worldwide.
  • The $15 million broader round included substantial participation from company insiders, including SKYX President Steve Schmidt and Co-CEOs Lenny Sokolow and John Campi, underscoring their continued confidence in SKYX’s strategic vision and growth trajectory.
  • Net loss per share decreased by $0.01 to $0.08 per share in the Second quarter of 2025 compared to $0.09 in the first quarter of 2025. Adjusted EBITDA loss per share, a non-GAAP measure, decreased to $0.02 per share in the Second quarter of 2025, as compared to $0.04 per share, in the First quarter of 2025.

 Market Acceptance and Recent Events:

  • SKYX is continuing to grow its market penetration in the U.S. and Canada to both retail and pro segments through its e-commerce platform of 60 websites among other channels as described below.
  • Collaborating with Home Depot for its advanced and smart plug & play products for both retail and professional segments. Company is in the process of growing its product assortment in Home Depot to offer a variety of its advanced plug & play smart products including ceiling fans, heater fans, light fixtures, EXIT signs, Emergency lights, ceiling outlet receptacles, recessed lights, downlights indoor and outdoor wall lights, retrofit kits, among others.
  • Collaborating with Wayfair for Its Advanced and Smart Plug & Play Products for both retail and professional segments. SKYX’s product offering will include a variety of its advanced and Smart Plug & Play products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and more.
  • Collaborating with U.S. and world leading lighting companies including Kichler Quoizel, European leading company, EGLO, and world lighting manufacturer Ruee.
  • Collaborating with a new Miami $3 billion smart urban city. Expected to deploy over 500,000 units of its advanced smart plug & play products.
  • Collaborated with Cavco Homes, a leading U.S. prefabricated home manufacturer, for integrating our advanced and smart plug & play technologies into Cavco’s high-end premium homes shown at the builder show. Cavco is a public company that has sold nearly one million homes and continues to deliver close to 20,000 annually.
  • Three luxury developments by Forte Developments, including an 80-story high-rise in Miami’s Brickell District and projects in Clearwater Beach and Jupiter, Florida, will feature SKYX’s technology. More than 12,000 smart plug & play products, including ceiling outlets, lighting, fans, and emergency fixtures, will be supplied across 400+ units. A 1,000-unit mixed-use development by Jeremiah Baron Companies will incorporate smart plug & play technologies, with 140 units receiving initial product supply. This product rollout will include ceiling outlets, lighting, fans, and emergency fixtures, with deliveries continuing throughout construction.
  • A strategic partnership with JIT Electrical Supply, a leading builder supplier, will expand SKYX’s footprint in electrical, lighting, and ceiling fan markets. JIT, which has supplied over 100,000 U.S. homes, will distribute SKYX’s lighting solutions, ceiling fans, recessed lights, emergency lights, exit signs, and indoor/outdoor wall lights beginning early 2025.
  • Huey Long, former Amazon E-Commerce Director and executive at Walmart and Ashley Furniture, has joined as head of SKYX’s e-commerce platform. He will collaborate with the existing team to expand market penetration across 60 lighting and home décor websites and other key e-commerce channels in the U.S. and Canada.
  • SKYX’s technologies provide opportunities for recurring revenues through interchangeability, upgrades, monitoring, and subscriptions. Company is focused on the “Razor & Blades” model and its product range includes its advanced ceiling electrical outlet (Razor) and its advance and smart home plug & play products (Blades) including its advance and smart home plug & play platform products, lighting, recessed lights, down lights, EXIT signs, emergency lights, ceiling fans, chandeliers/pendants, holiday/kids/themes lights, indoor/outdoor wall lights among other. Company’s plug & play technology enables an installation of lighting, fans, and smart home products in high-rise buildings and hotels within days rather than months.

Safety Standardization Mandatory Code / Insurance Specification and Recommendation

  • SKYX’s code team, led by industry veterans Mark Earley, former head of the National Electrical Code (NEC), and Eric Jacobson, former President, and CEO of the American Lighting Association (ALA). Company’s safety Code Standardization team believes it will achieve assistance from additional safety organizations with its code mandatory safety standardization efforts based on the product’s significant safety aspects. Mr. Earley and Mr. Jacobson were instrumental in numerous code and safety changes in both the electrical and lighting industries. Both strongly believe that, considering the Company’s standardization progress including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturers Association) and being voted into 10 segments in the NEC Code Book, it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings.
  • Insurance Companies. Company strongly believes its products can save insurance companies many billions of dollars annually by reducing fires, ladder falls, and electrocutions among other things. Management expects that once it completes an entire range and variations of its safe advanced plug & play products it will start being recommended by insurance companies.
  • SKYX – GE (General Electric) Global licensing agreement. To accommodate SKYX’s its code standardization and licensing strategy the Company has signed a 5-year global licensing agreement with GE to license its advanced and smart home platform technologies.

Select Second Quarter 2025 Financial Results

Revenue in the Second quarter of 2025 increased 15% and 8% to $23.1 million, including E-commerce sales as well as smart and standard plug and play products, as compared to $20.1 million and $21.4 million in the First quarter of 2025 and the Second quarter of 2024, respectively.

Net cash used in operating activities for the Second quarter ending June 30, 2025, decreased sequentially by 54% to $2.0 million compared to $4.3 million in the First quarter of 2025.

The gross profit for the Second quarter ending June 30, 2025, increased sequentially by 23% to $7.0 million, compared to the First quarter ending March 31, 2025.

The gross margin for the Second quarter ending June 30, 2025, increased sequentially by 7% to 30.3%, compared to the First quarter ending March 31, 2025.

Reported $15.7 million in cash, cash equivalents, and restricted cash, as of June 30, 2025, as compared to $12.3 million as of March 31, 2025. As common with companies such as ours when their sales are converted into cash rapidly, often referred to as the “Dell Working Capital Model”, we leverage our trades payable to finance our operations to enhance our cash position and lower our cost of capital.

Through the Second Quarter of 2025, we secured additional equity, mainly through preferred stock investment with no warrants as part of broader financing round totaling approximately $15 million to date, led by The Shaner Group, owner and developer of more than 70 hotels worldwide as well as SKYX’s President Steve Schmidt and Co-CEOs Lenny Sokolow and John Campi, underscoring their continued confidence in SKYX’s strategic vision and growth trajectory.

For the Second quarter of 2025 Adjusted EBITDA loss, which is the loss before interest, taxes, depreciation, and amortization, as adjusted for share-based payments, a non-GAAP measure, decreased to $2.6 million, or $0.02 per share, as compared to $3.6 million, or $0.04 per share, in the First quarter of 2025.

The Company’s financial statements for the quarter ended June 30, 2025, will be filed with the SEC and are available on the Company’s investor relations website. https://ir.skyplug.com/sec-filings/

Management Commentary

Company’s Management, Board members, and Senior Advisors include former CEO’s and executives from Fortune 100 companies including Nielsen, Microsoft, Disney, GE, Home Depot, Office Depot, Chrysler, among others.

The Company generated record Second quarter 2025 revenues of $23.1 million as compared to $21.4 million for the Second quarter of 2024.

We are encouraged by our path to the builder/commercial segments, large online and brick-and-mortar retail partners as well as our future potential to realize incremental licensing, subscription, and AI/data aggregation revenues.

Furthermore, our e-commerce website platform with 60 websites enhances the acceleration of marketing, distribution channels, collaborations, licensing, and sales to both professional and retail segments. Our websites include banners, videos, and educational materials regarding the simplicity, cost savings, timesaving, and lifesaving aspects of the Company’s patented technologies.

We believe we have accelerated our pace of sales with a robust gross margin profile, notably managing the cash burn of SKYX. Our e-commerce platform with over 60 websites is expected to continue providing additional cash flow to the Company.

Video link of SKYX’s Technologies: Link to video

About SKYX Platforms Corp.

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

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with First-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, including recent measures adopted by the federal government, 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.

Non-GAAP Financial Measures

Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business. 

Investor Relations Contact:

Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com

Release – Sky Harbour Announces Q2 Results; Opening of New Campus in Centennial Airport, Denver, CO; Updates on Leasing, Construction and Other Activities; Reiterates Prior Guidance for 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYH

08/12/2025

WEST HARRISON, N.Y.–(BUSINESS WIRE)– Sky Harbour Group Corporation (NYSE: SKYH, SKYH WS) (“SHG” or the “Company”), an aviation infrastructure company building the first nationwide Home Base Operator (HBO) network of campuses for business aircraft, announced the release of its unaudited financial results for the three months ended June 30, 2025 on Form 10-Q. The Company also announced the filing of its unaudited financial results for the three months ended June 30, 2025 for Sky Harbour Capital (Obligated Group) with MSRB/EMMA. Please see the following links to access the filings:

SEC 10-Q:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001823587/000143774925026180/ysac20250630_10q.htm

MSRB/EMMA:

https://emma.msrb.org/P21953654-P21491522-P21943258.pdf

Financial Highlights on a Consolidated Basis include:

  • Constructed assets and construction in progress reached over $295 million at quarter end, an increase of $125 million year-over-year and $18 million as compared to the prior quarter.
  • Q2 2025 consolidated revenues increased 82% as compared to Q2 2024 and 18% as compared to the prior quarter.
  • Net cash used in operating activities was approximately $0.9 million for the quarter, a significant improvement from the $5 million used in prior quarter.
  • Strong liquidity and capital resources as of June 30th, 2025, with consolidated cash and US Treasuries totaling nearly $75 million.
  • Reiterating our guidance of reaching operating cash-flow breakeven on a consolidated run-rate basis by year-end 2025, supported by the commencement of revenues from campuses in Phoenix, Denver, Dallas and Seattle.

Financial Highlights at Sky Harbour Capital (Obligated Group) include:

  • Q2 2025 Obligated Group Revenues increased approximately 20% as compared to the prior quarter.
  • Net cash from operating activities (positive) reached approximately $2.2 million in Q2 2025, a 117% increase from the prior quarter.
  • Cash and US Treasuries at the Obligated Group totaled $37 million as of June 30th, 2025.

Update on Site Acquisition

  • Sky Harbour currently has campuses operating at Houston’s Sugar Land Regional Airport (SGR), Nashville International Airport (BNA), Miami Opa-Locka Executive Airport (OPF), San Jose Mineta International Airport (SJC), Camarillo Airport (CMA), Phoenix Deer Valley Airport (DVT), Dallas’s Addison Airport (ADS), Seattle’s King County International Airport – Boeing Field (BFI); one campus nearing construction completion at Denver’s Centennial Airport (APA); campuses in pre-development at Chicago Executive Airport (PWK), Sky Harbour’s first four New-York-metro area airports – Bradley International Airport (BDL), Hudson Valley Regional Airport (POU), Trenton-Mercer Airport (TTN), and Stewart International Airport (SWF); Orlando Executive Airport (ORL), Dulles International Airport (IAD), Salt Lake City International Airport (SLC), and Portland-Hillsboro Airport (HIO).
  • We reiterate our prior guidance of five additional airport ground leases to be announced by the end of 2025, for a total portfolio of 23 airports by year end.

Update on Construction and Development Activities, Change in Development Leadership

  • As reported on our monthly activity reports filed with MSRB/EMMA, and available on our website, Dallas Addison (ADS) achieved its first Certificates of Occupancy in Q2 and has commenced resident flight operations. Denver Centennial (APA) achieved its first Certificates of Occupancy last month and will commence resident flight operations in the coming weeks. Please see the following link for the last monthly construction report:

https://emma.msrb.org/P21941616-P21483179-P21934207.pdf

  • Miami Opa Locka (OPF) Phase 2 commenced construction in Q2 and is expected to be completed by Q2 2026.
  • Outgoing COO, Will Whitesell, who led the Company’s construction division, has entered an amicable separation agreement with the Company and has assisted in an orderly transfer of his responsibilities. The Company is grateful for Will’s commitment and his contributions and wishes him much success in his future endeavors.
  • Phil Amos, a 40-year veteran of the Pre-Engineered Metal Building (PEMB) industry, and co-founder of A&F Contractors, has joined Sky Harbour as Head of Construction and President of Sky Harbour’s newly-formed, wholly-owned development subsidiary, Ascend Aviation Services (“Ascend”). Ascend brings specialized airport construction-management and in-house General Contracting capabilities to Sky Harbour. Ascend is headquartered in Houston, TX, and staffed by veterans of the airport construction industry around the United States, including legacy members of the Sky Harbour development team. In addition to its construction management and general contracting functions, Ascend oversees the operations of Stratus Building Systems, Sky Harbour’s wholly-owned PEMB manufacturing subsidiary. Ascend and Stratus together constitute a vertically-integrated, specialized airport infrastructure developer. Mr. Amos, while at A&F, served as the general contractor for Sky Harbour’s first hangar campus at Sugar Land Regional Airport, which was delivered on time and under budget.

Update on Leasing Activities

  • Stabilized campuses: The Company continues to enjoy higher-than-forecast revenue per square foot at its stabilized campuses. Revenue per square foot continues to grow as legacy hangar leases turn or are renewed.
  • New campuses: The Company has executed the first six hangar leases at its new Denver, Dallas and Phoenix campuses, and is under LOI for additional leases. The Company expects to meet its revenue run-rate targets at the new campuses within six months.
  • Pre-leasing: The Company has initiated a pilot project at two airports – Bradley International Airport (BDL) and Dulles International Airport (IAD) to pre-lease hangar space prior to construction commencement. The objective is to take advantage of growing awareness of the Sky Harbour HBO value proposition within the US Business Aviation industry to a) reduce lease-up times, b) better curate resident communities, and c) integrate customized resident improvements during construction (as opposed to retrofitting). Hangar leases have been executed at both airports at revenue rates that present an introductory pricing advantage to pre-lease residents while still delivering above-target per-square-foot revenue to the Company. Additional pre-leases are under LOI.

Update on Airport Operations

  • As of Q3, the Company is conducting flight operations at nine airports.
  • Under the leadership of Marty Kretchman, Senior Vice President of Airports, the company has transitioned to a centralized operating model, featuring National Directors of Line Training; Facilities; and Ground Support Equipment (GSE).
  • Surveys of current residents indicate that Sky Harbour’s HBO service offering has become a key differentiating component of the Sky Harbour value proposition. The Company plans to continue to invest in constant improvement in airfield operations, through selective recruiting, rigorous training, detailed and thoughtful operating procedures, and constant innovation in collaboration with Sky Harbour residents.

Update on Capital Formation

  • After several quarters of “dual tracking” the review of various debt funding alternatives and proposals, the Company has decided to pursue a tax-exempt bank debt facility in lieu of a bond issue.
  • We are currently in advanced discussions with a major US financial institution for an expected five (5) year drawdown construction facility of $200 million, with an expected indicative interest rate of 80% of 3-month SOFR plus 200 basis points (~5.47% in the current market).
  • Our debt financing plan is to fund the next 5-6 airport projects using this facility and internal equity. The Company expects to replace this facility with permanent tax-exempt bonds in the next 3-4 years. We expect to close the facility on or about August 28th. However, we can provide no assurance on exact terms or the timing of this facility.

Tal Keinan commented: “As Sky Harbour navigates the transition from a tactical team, emphasizing agility, innovation and flexibility, to a high-growth organization, increasingly embracing process, discipline and specialization, five constants will continue to guide our leadership: 1) Obsessive focus on the Resident, 2) Commitment to building long-term shareholder value, 3) Uncompromising pursuit of professional excellence, 4) Cost-efficiency, and 5) Individual ownership of results. We value the reputation we are building in business aviation and intend to continue building it for years to come.”

About Sky Harbour

Sky Harbour Group Corporation is an aviation infrastructure company developing the first nationwide network of Home-Basing campuses for business aircraft. The company develops, leases, and manages general aviation hangar campuses across the United States. Sky Harbour’s Home-Basing offering aims to provide private and corporate residents with the best physical infrastructure in business aviation, coupled with dedicated service, tailored specifically to based aircraft, offering the shortest time to wheels-up in business aviation. To learn more, visit www.skyharbour.group.

Forward Looking Statements

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements about the financial condition, results of operations, earnings outlook and prospects of SHG, including statements regarding our expectations for future results, our expectations for future ground leases, our expectations on future construction and development activities and lease renewals, and our plans for future financings. When used in this press release, the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on the current expectations of the management of Sky Harbour Group Corporation (the “Company”) as applicable and are inherently subject to uncertainties and changes in circumstances. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. For more information about risks facing the Company, see the Company’s annual report on Form 10-K for the year ended December 31, 2024 and other filings the Company makes with the SEC from time to time. The Company’s statements herein speak only as of the date hereof, 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 law.

Key Performance Indicators

We use a number of metrics, including annualized revenue run rate per leased rentable square foot, to help us evaluate our business, measure our performance, identify trends affecting our business, formulate business plans, and make strategic decisions. Our key performance indicators may be calculated in a manner different than similar key performance indicators used by other issuers. These metrics are estimated operating metrics and not projections, nor actual financial results, and are not indicative of current or future performance.

Sky Harbour Investor Relations: investors@skyharbour.group Attn: Francisco X. Gonzalez

Source: Sky Harbour Group Corporation

Release – Ocugen, Inc. Announces Closing of $20 Million Registered Direct Offering of Common Stock and Warrants

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 12, 2025

PDF Version

MALVERN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the closing of its previously announced registered direct offering pursuant to a securities purchase agreement with Janus Henderson Investors, a global asset management firm, for the purchase and sale of 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share (closing price on August 7, 2025) and accompanying warrant. The warrants have an exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire two years following the date of issuance. The warrants are callable by the Company when the VWAP of the Company’s common stock exceeds $2.50 per share for at least five of a trailing 30 trading day period. 

Noble Capital Markets, Inc. acted as the sole placement agent in connection with the offering. Maxim Group LLC and Titan Partners Group, a division of American Capital Partners, acted as independent financial advisors in connection with the offering.

The gross proceeds to the Company were approximately $20 million before deducting the placement agent fees and other estimated offering expenses, which the Company anticipates will extend the Company’s cash runway into the second quarter of 2026. The Company may receive up to $30 million of additional gross proceeds if the warrants are exercised in full. The Company anticipates that combined offering proceeds of $50 million with warrant exercise will extend the Company’s cash runway into the first quarter of 2027. The offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the U.S. Securities and Exchange Commission (“SEC”), which was declared effective on May 1, 2024. The offering was made only by means of a prospectus forming a part of the effective registration statement relating to the offering. A prospectus supplement relating to the shares of common stock and warrants has been filed by the Company with the SEC. Copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Noble Capital Markets, Inc., 150 East Palmetto Park Rd., Suite 110, Boca Raton, FL 33432.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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 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 on X and LinkedIn.

Cautionary Statement Regarding Forward–Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, 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. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the Company’s expected cash runway, whether the warrants will be exercised and various other factors. 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.

Ocugen Contact:

Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@Ocugen.com

Release – Xcel Brands to Host Second Quarter 2025 Earnings Call on August 14, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on XELB

PDF Version

NEW YORK, Aug. 12, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), today announced that it will report its second quarter 2025 financial results on August 14, 2025. The Company will hold a conference call with the investment community on August 14, 2025, at 9:00 a.m. ET.

A webcast of the conference call will be available live on the Investor Relations section of Xcel’s website at https://xcelbrands.co/pages/events-and-presentations or directly at https://edge.media-server.com/mmc/p/r52mtx59.

Interested parties unable to access the conference call via the webcast may dial 800-715-9871 or 646-307-1963 and use the Conference ID 9043618. A replay of the webcast will be available on Xcel’s website.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the co-branded collaboration brands TowerHill by Christie Brinkley, LB70 by Lloyd Boston, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford, and a brand in development with Coco Rocha and also holds noncontrolling interests or long-term license agreements in the Isaac Mizrahi brand, Orme Live, and Mesa Mia Live by Jenny Martinez. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, and over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 43 million social media followers with broadcast reach into 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.

For further information please contact:
Seth Burroughs
Xcel Brands, Inc.
sburroughs@xcelbrands.com

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Source: Xcel Brands, Inc

Release – Bitcoin Depot Reports Second Quarter 2025 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BTM

August 12, 2025 8:00 AM EDT Download as PDF

Q2 Revenue up 6% Year-Over-Year to $172.1 Million

Q2 Net Income up 183% Year-Over-Year to $12.3 Million

Q2 Gross Profit up 32% Year-Over-Year to $30.9 Million

Q2 Adjusted EBITDA up 46% Year-Over-Year to $18.5 Million

ATLANTA, Aug. 12, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (Nasdaq: BTM) (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today reported financial results for the second quarter ended June 30, 2025. Bitcoin Depot will host a conference call and webcast at 10:00 a.m. ET today. An earnings presentation and link to the webcast will be made available at ir.bitcoindepot.com.

“Bitcoin Depot delivered another strong quarter, with 6% revenue growth and a 46% increase in Adjusted EBITDA to $18.5 million,” said Brandon Mintz, Founder and CEO of Bitcoin Depot. “Our performance demonstrates the operating leverage in our business, driven by kiosk expansion, higher transaction volumes, and disciplined cost management. As a result, we significantly improved profitability, with net income more than tripling year-over-year, and further strengthened our balance sheet. With nearly $60 million in cash and digital assets, we are well-positioned to capitalize on growth opportunities, both in the U.S. and internationally. Looking ahead, we remain focused on scaling efficiently and delivering sustained value for our customers and shareholders.”

“In addition to our financial progress, we’ve taken meaningful steps to further strengthen our operations and enhance shareholder alignment. We eliminated our former UP-C corporate structure to simplify our governance and improve transparency, and continued to strategically add Bitcoin to our treasury. These actions reflect our long-term commitment to responsible growth, prudent capital allocation, and building a stronger, more shareholder-friendly company.”

Second Quarter 2025 Financial Results

Revenue in the second quarter of 2025 increased 6% to $172.1 million compared to $163.1 million in the second quarter of 2024. This increase was driven by increased kiosk deployment and higher median transaction size. 

Total operating expenses declined 9% to $17.0 million for the second quarter of 2025 compared to $18.8 million for the second quarter of 2024 due to lower depreciation, insurance and share-based compensation expenses as the Company continues to optimize its cost structure as a steady-state public company.

Net income for the second quarter of 2025 increased 183% to $12.3 million compared to $4.4 million for the second quarter of 2024. Net income attributable to common shareholders increased to $6.1 million, or $0.16 per share, from a net loss of $2.6 million, or ($0.13) per share, in last year’s second quarter. The increase was due to higher revenue and income from operations in 2025, as well as a $2.3 million mark-to-market gain on the Company’s BTC investment holdings.

Gross profit in the second quarter of 2025 increased 32% to $30.9 million from $23.4 million for the second quarter of 2024. Gross profit margin in the second quarter of 2025 increased approximately 360 basis points to 17.9% compared to 14.3% in the second quarter of 2024.

Adjusted EBITDA, a non-GAAP measure, in the second quarter of 2025 increased 46% to $18.5 million compared to $12.7 million for the second quarter of 2024. The increase was primarily due to the higher revenue and gross profit. Please see “Explanation and Reconciliation of Non-GAAP Financial Measures” below.

Cash, cash equivalents, and cryptocurrencies as of June 30, 2025, were $59.6 million compared to $31.0 million at the end of 2024. The company used $0.6 million in the second quarter of 2025 to acquire 6.00 more Bitcoin, bringing the total held for investment to 100.35 BTC.

Net cash flows provided by operations in the first six months of 2025 were $26.4 million compared to $11.5 million in the first six months of 2024.

Outlook

The Company expects revenue in the third quarter of 2025 to grow high-single digits on a percentage basis from the third quarter of 2024, and Adjusted EBITDA to be 20% to 30% above the prior year quarter. 

Conference Call

Bitcoin Depot will hold a conference call at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) today to discuss its financial results for the second quarter ended June 30, 2025.

Call Date: Tuesday, August 12, 2025 
Time: 10:00 a.m. Eastern time (7:00 a.m. Pacific time) 

Phone Instructions
U.S. and Canada (toll-free): 888-596-4144
U.S. (toll): 646-968-2525
Conference ID: 9071245

Webcast Instructions
Webcast link: https://edge.media-server.com/mmc/p/jfv35c2i

A replay of the call will be available beginning after 2:00 p.m. Eastern time through August 19, 2025.

U.S. & Canada (toll-free) replay number: 800-770-2030
U.S. toll number: 609-800-9909
Conference ID: 9071245

If you have any difficulty connecting with the conference call, please contact Bitcoin Depot’s investor relations team at 1-949-574-3860.

About Bitcoin Depot

Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 47 states and at thousands of name-brand retail locations in 31 states through its BDCheckout product. The Company has the largest market share in North America with over 8,800 kiosk locations as of June 2025. Learn more at www.bitcoindepot.com.
 
Cautionary Statement Regarding Forward-Looking Statements

This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, our ability to strengthen our financial profile, and worldwide growth in the adoption and use of cryptocurrencies. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,“ ”plan,“ ”potential,“ ”priorities,“ ”project,“ ”pursue,“ ”seek,“ ”should,“ ”target,“ ”when,“ ”will,“ ”would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.

These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of our projected financial information; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.

We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

View full release here.

Contacts:

Investors 
Cody Slach,
Gateway Group, Inc. 
949-574-3860 
BTM@gateway-grp.com

Media 
Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
BTM@gateway-grp.com

Primary Logo

Source: Bitcoin Depot Inc.

Released August 12, 2025

Release – Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 11, 2025 4:15pm EDT

Download as PDF

FDA PDUFA goal date of August 15, 2025, for TNX‑102 SL for fibromyalgia: if approved by FDA, TNX‑102 SL would be the first new drug for fibromyalgia in more than 16 years 

In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution

Phase 3 RESILIENT results published in peer-reviewed journal, Pain Medicine, including statistically significant reduction in fibromyalgia pain with once‑nightly TNX‑102 SL; generally well tolerated

Cash and cash equivalents of $125.3 million reported as of June 30, 2025; current cash runway expected to fund operations into the third quarter of 2026

CHATHAM, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended June 30, 2025, and provided an overview of recent operational highlights.

“With the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, we are excited about the potential to make this important new therapy available to patients in the fourth quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “FDA considers fibromyalgia a serious condition and awarded TNX-102 SL Fast Track designation last year. There has been no new treatment for this debilitating condition approved in over 16 years. Additionally, our RESILIENT Phase 3 study results were recently published in the peer-reviewed journal, Pain Medicine.”

Dr. Lederman continued, “Our pipeline momentum remains strong. In the second quarter, we dosed the first patient in the U.S. Department of Defense (DoD)-funded, investigator-initiated, OASIS trial of TNX-102 SL for acute stress reaction. We also presented new data for our live-virus vaccine, TNX-801, which demonstrated durable single-dose protection against mpox and rabbitpox in animal models. We previously reported positive Phase 1 safety and pharmacokinetic data for TNX-1500, advancing this next-generation anti-CD40L antibody toward a Phase 2 kidney-transplant study. We are well-positioned to translate these milestones into meaningful value for patients and shareholders alike.”

Key Investigational Product Candidates
 

Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual tablets 2.8 mg): two tablets (5.6 mg), once-daily at bedtime for fibromyalgia (FM) – a centrally-acting, non-opioid
analgesic.

  • In June 2025, Tonix presented a poster at the European Congress of Rheumatology (EULAR 2025) demonstrating that TNX‑102 SL produced statistically significant, durable (14‑week) pain reduction across two Phase 3 trials.
  • In July 2025, Tonix announced online publication of full results from the confirmatory Phase 3 RESILIENT trial of TNX‑102 SL in the peer-reviewed journal Pain Medicine, showing once‑nightly 5.6 mg achieved a statistically significant reduction in fibromyalgia pain versus placebo and was well tolerated; the data confirm the earlier RELIEF study and support the ongoing New Drug Application (NDA) review with an August 15, 2025 PDUFA goal date.

TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)

  • In May 2025, the first patient was dosed in the Phase 2 investigator initiated OASIS trial evaluating a two week course of TNX102 SL 5.6 mg to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD); the study is sponsored by the University of North Carolina and supported by a $3 million U.S. Department of Defense grant, with topline results expected in the second half of 2026.
Immunology Pipeline
 

TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders

  • In May 2025, Tonix reported positive topline data from a Phase 1 single‑ascending‑dose study in healthy volunteers: TNX‑1500 met all safety, pharmacokinetic and pharmacodynamic goals, blocked primary and secondary antibody responses at 10 mg/kg and 30 mg/kg doses with intravenous (i.v.) administration, and showed a 34–38‑day mean half‑life that supports monthly i.v. dosing—supporting the path for a planned Phase 2 study to evaluate TNX-1500 for prevention of rejection in kidney allogeneic transplant.

TNX-801 (recombinant horsepox virus, minimally replicative live-virus vaccine): potential vaccine to protect against mpox and smallpox.

  • In April 2025, Tonix presented new preclinical data on TNX-801 at the World Vaccine Congress Washington 2025 showing a single subcutaneous (s.c.) dose protected animals from mpox and rabbitpox for at least six months, remained well tolerated even in immunocompromised models, and met key attributes in the WHO’s preferred target product profile for mpox vaccines.
Corporate and Partnerships
 
  • In May 2025, Tonix appointed Joseph Hand, Esq. as General Counsel and Executive Vice President of Operations, adding more than two decades of legal and operational expertise as the Company prepares for potential TNX‑102 SL commercialization.
  • In June 2025, Tonix announced that commercial veteran James Hunter joined its Board of Directors, bringing forty years of go‑to‑market experience to strengthen strategy and governance ahead of the expected TNX‑102 SL launch.
  • In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among institutional investors as Tonix approaches key regulatory milestones.
Financials
 

As of June 30, 2025, Tonix had $125.3 million in cash and cash equivalents, compared with $98.8 million as of December 31, 2024. Net cash used in operations was approximately $31.4 million for the six months ended June 30, 2025, compared to $27.5 million for the same period in 2024.

The Company believes that, based on its current operating plan, its cash on hand at June 30, 2025, together with $51.5 million in net proceeds received from equity offerings during the third quarter 2025, will fund planned operating and capital expenditures into the third quarter of 2026.

Second Quarter 2025 Financial Results

Net product revenue for the three months ended June 30, 2025 was approximately $2.0 million, compared to $2.2 million for the same period in 2024; revenue again reflected combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of sales for the three months ended June 30, 2025 was approximately $3.3 million, compared to $3.4 million for the same period in 2024.

Research and development expenses for the three months ended June 30, 2025 were $10.8 million, compared to $9.7 million for the same period in 2024. The increase was predominately due to increased clinical expenses, nonclinical expenses and manufacturing expenses, reflecting spend on pipeline priorities.

Selling, general and administrative expenses for the three months ended June 30, 2025 were $16.2 million, compared to $7.5 million in 2024. The increase is predominately due to spend on sales and marketing to progress pre-launch activities related to the potential FDA approval of TNX-102 SL for fibromyalgia.

Net loss available to common stockholders was $28.3 million, or $3.86 per share (basic and diluted), for the second quarter 2025, compared to a net loss of $78.8 million, or $1,920.85 per share, for the same period in 2024. The basic and diluted weighted-average common shares outstanding for the second quarter 2025 were 7,327,257 compared to 41,011 for the same period in 2024.

Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for fibromyalgia and for which a PDUFA goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA had also granted Fast Track designation to TNX-102 SL for fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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

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

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

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

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

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

Indication and Usage

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

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

Important Safety Information

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

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

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

Do not use Zembrace or Tosymra if you have:

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

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

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

Zembrace and Tosymra may cause serious side effects including:

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

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

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

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

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released August 11, 2025

Release – V2X Advances National Security Growth with Strategic Acquisition

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

Research News and Market Data on VVX

August 11, 2025

  • Accelerates growth strategy with access to new opportunities in the Intelligence Community
  • Provides specialized data engineering, intel mission support and cyber solutions
  • Brings highly skilled talent supporting critical national security missions
  • Enhances ability to deliver improved mission solutions across all domains

RESTON, Va., Aug. 11, 2025 /PRNewswire/ — V2X Inc. (NYSE: VVX), announced today that it has entered into an agreement to acquire a specialized data engineering, intel mission support and cyber solutions business serving the Intelligence Community. This move brings access to new channels, capabilities, and further strengthens V2X’s position within the national security space, expanding its solutions to support mission-critical operations in the cyber domain.

The acquisition advances V2X’s strategic growth objectives and further extends its reach beyond traditional defense markets, enabling the company to pursue a greater share of the National Intelligence Program budget and related opportunities.

“I am thrilled to welcome approximately 70 highly skilled professionals to the V2X family,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “This acquisition marks an important milestone in V2X’s evolution, adding complementary capabilities, opening doors to new customers, and delivering solutions that accelerate our growth strategy.”

“It also demonstrates how we are transforming V2X into a leader in data-enabled mission solutions. Expanding our presence in the Intelligence Community reinforces our commitment to national security, innovation, and delivering greater value to our customers and shareholders.”

The transaction is valued at approximately $24 million net of estimated tax benefits and will be integrated into V2X’s national security portfolio in the coming months. Macquarie Capital acted as financial advisor to the seller.

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

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SOURCE V2X, Inc.

Release – Gyre Therapeutics Reports Second Quarter 2025 and Year-to-Date Financial Results and Provides Business and Leadership Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GYRE

August 11, 2025

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 Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million

Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role

  • Revenue of $26.8 million and $48.8 million for the three and six months ended June 30, 2025, respectively
  • GAAP basic EPS: $0.00 and $0.04 for the three and six months ended June 30, 2025, respectively
  • Pivotal Phase 3 trial of Hydronidone (F351) in CHB-associated liver fibrosis demonstrated statistically significant fibrosis regression after 52 weeks of treatment; Phase 2 trial in the United States evaluating Hydronidone for the treatment of MASH-associated liver fibrosis expected to initiate in 2H 2025, pending regulatory approval
  • Successfully launched Etorel (nintedanib ethanesulfonate soft capsules) in the PRC for the treatment of SSc-ILD and PF-ILD
  • Announced NMPA approval for clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications with Phase 2/3 trial anticipated in 2H 2025
  • First volunteer dosed in Phase 1 clinical trial of F230 for treatment of PAH

SAN DIEGO, Aug. 11, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the second quarter ended June 30, 2025 and provided a business and leadership update.

Dr. Han Ying has stepped down as Chief Executive Officer and will transition into the role of Senior Vice President, Science and will oversee research and discovery activities to support Gyre’s fibrosis focused pipeline. Ping Zhang, Executive Chairman, has been appointed Interim Chief Executive Officer, and will lead the company’s day-to-day operations and strategic global expansion.

“I want to thank Dr. Ying for his contributions and dedication during his tenure as CEO. His deep background in research and discovery will be invaluable to advance our science and continued innovation,” said Mr. Zhang. “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients.”

“Looking ahead, we are thrilled with the rapid progress we have made towards expanding our commercial footprint and advancing our pipeline of fibrosis-first therapies. Our lead compound, Hydronidone, demonstrated statistically significant fibrosis regression in patients with CHB-associated liver fibrosis in a pivotal Phase 3 trial in the PRC, a critical step that not only underscores the potential of Hydronidone, but also lays the foundation to expand into additional fibrotic indications,” continued Mr. Zhang. “In the second half of 2025 we are well-positioned to grow our footprint in the United States with our planned Phase 2 trial evaluating Hydronidone in MASH-associated liver fibrosis, while continuing to advance our robust pipeline in the PRC, highlighted by a new Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications expected to initiate later this year. In addition, Gyre Pharmaceuticals remains on track to file an NDA for Hydronidone with the NMPA in the third quarter of 2025 to potentially support our growing commercial portfolio.”

Second Quarter Business Highlights and Upcoming Milestones

Commercial Portfolio Expansion

ETUARY® (pirfenidone): Generated $23.5 million in sales of ETUARY® for the quarter ended June 30, 2025, compared to $25.1 million for the same period in 2024.

Etorel (nintedanib ethanesulfonate soft capsules): In June 2025, Gyre launched Etorel in the PRC for the treatment of systemic sclerosis-associated ILD, and progressive fibrosing ILD, and generated sales of $1.6 million in the first partial quarter of launch.

Contiva (avatrombopag maleate tablets): In March 2025, Gyre initiated commercialization of Contiva in the PRC for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, and generated sales for $1.5 million in the second quarter of 2025.

Pipeline Development Updates

Hydronidone:

  • In May 2025, Gyre reported positive results from its pivotal Phase 3 trial of Hydronidone for chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC, which demonstrated statistically significant regression in liver fibrosis after 52 weeks compared to placebo. In addition, Hydronidone met a key secondary endpoint with statistically significant inflammation improvement without fibrosis progression at Week 52 versus the placebo arm. 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. Gyre plans to submit primary results for publication in a peer-reviewed journal and present full trial results at a future medical conference. Based on these results, Gyre intends to file a New Drug Application (“NDA”) with the PRC’s National Medical Products Administration (“NMPA”) in the third quarter of 2025.
  • Gyre previously submitted an investigational new drug application (“IND”) for the treatment of liver fibrosis associated with a broad spectrum of chronic liver diseases with the U.S. Food and Drug Administration and conducted a Phase 1 trial of Hydronidone in healthy volunteers for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis. The Company is currently conducting an internal review to determine whether a new IND will be required for a Phase 2 trial in MASH-associated liver fibrosis. The Phase 2 trial is expected to start in the second half of 2025, subject to regulatory feedback.

ETUARY® (Pirfenidone):

  • Gyre plans to initiate an adaptive Phase 2/3 trial of pirfenidone for radiation-induced lung injury (“RILI”), including cases complicated by immune-related pneumonitis across top oncology centers in the PRC in the second half of 2025.

F573:

  • F573 is a caspase inhibitor and potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 for ALF/ACLF is expected by the end of 2026.

F230:

  • In June 2025, the first volunteer was successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A receptor agonist, for the treatment of pulmonary arterial hypertension (“PAH”) in the PRC.

F528:

  • F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026.

Corporate Updates

  • In August 2025, Ping Zhang was appointed interim CEO as Dr. Han Ying transitions to a scientific leadership role. Mr. Zhang, who was appointed Executive Chairman in March 2025, has served on Gyre’s Board of Directors since January 2025.
  • In May 2025, Gyre completed an underwritten public offering of 2,555,555 shares of its common stock at a public offering price of $9.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $23.0 million.
  • In the third quarter of 2025, BJContinent Pharmaceuticals Limited increased its capital contribution in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.) by $1.28 million in exchange for 9,184,910 additional shares. As a result, the Company’s indirect interest in Gyre Pharmaceuticals increased from 65.2% to 69.7%.

Financial Results

Cash Position

As of June 30, 2025, Gyre held $36.5 million in cash and cash equivalents, $17.9 million in short-term bank deposits, and $21.5 million in long-term certificates of deposit, totaling $75.9 million. The increase of cash and cash equivalents mainly includes net proceeds of approximately $21.3 million received from the May 2025 underwritten public offering.

Financial Results for the Three Months Ended June 30, 2025

  • Revenues: Revenues for the three months ended June 30, 2025 were $26.8 million, compared to $25.2 million for the same period in 2024. The $1.6 million increase was primarily driven by a $1.6 million increase in revenue as a result of Etorel’s commercial launch in June 2025 and a $1.5 million increase in revenue from the sales of Contiva. These increases were offset by a $1.5 million decline in ETUARY® sales.

    Gyre anticipates revenue growth over the remainder of the year, driven by the commercial launch of Etorel in June 2025 and the continued expansion of Contiva.
  • Cost of Revenues: For the three months ended June 30, 2025, cost of revenues was $1.2 million, compared to $0.8 million for the same period in 2024. The $0.4 million increase was primarily driven by a $0.2 million increase in the costs associated with Contiva and Etorel, in line with the corresponding increase in their sales, and a $0.2 million increase in ETUARY®’s cost due to the higher plant, property and equipment depreciation from a plant renovation.
  • Selling and Marketing Expense: For the three months ended June 30, 2025, selling and marketing expense was $15.2 million, compared to $14.4 million for the same period in 2024. The $0.8 million increase was primarily attributable to a $0.9 million increase in payroll costs, driven by higher headcount and increase of sales in the three months ended June 30, 2025, partially offset by $0.1 million decrease in promotion and conference expenses.
  • Research and Development Expense: For the three months ended June 30, 2025, research and development expense was $3.4 million, compared to $3.3 million for the same period in 2024. The $0.1 million increase was primarily attributable to a $0.1 million increase in clinical trial costs, primarily related to data analysis costs for Hydronidone, and a $0.1 million increase in staff costs. These increases were partially offset by a $0.1 million decrease in materials and utilities expenses.
  • General and Administrative Expense: For the three months ended June 30, 2025, general and administrative expense was $4.8 million, compared to $3.4 million for the same period in 2024. The $1.4 million increase was primarily driven a $0.5 million increase in professional fees, and a $0.9 million increase in functional and administrative department’s personnel and stock compensation costs.
  • Income from Operations: For the three months ended June 30, 2025, income from operations was $2.2 million, compared to $3.2 million income from operation for the same period in 2024. The $1.0 million decrease was primarily driven by $2.6 million increase in total operating expenses, partially offset by a $1.6 million increase in revenue.
  • Net Income: For the three months ended June 30, 2025, net income was $1.6 million, compared to $4.5 million net income for the same period in 2024.
  • Non-GAAP Adjusted Net Income: For the three months ended June 30, 2025, non-GAAP adjusted net income was $2.9 million, compared to $3.1 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the increase in operating expenses of $1.7 million, partially offset by an increase in revenue of $1.6 million.

Financial Results for the Six Months Ended June 30, 2025

  • Revenues: Revenues for the six months ended June 30, 2025 were $48.8 million, compared to $52.4 million for the same period in 2024. The $3.6 million decrease was primarily driven by a $6.8 million decline in ETUARY® sales, partially offset by the increase in new product sales of Contiva by $1.8 million and Etorel by $1.6 million. The decrease in ETUARY® sales was mainly due to lower sales volume compared to the first half of 2024, when revenues were elevated by a one-time rural marketing campaign that was not repeated in 2025. Additionally, weaker economic conditions in China and increased competition in the IPF treatment market also contributed to the decline. During the first half of 2025, marketing funds were intentionally shifted to support the launches of Etorel and Contiva.

    Gyre anticipates revenue growth over the remainder of the year, driven by the continued expansion of Contiva in March 2025 and the commercial launch of Etorel in June 2025.
  • Cost of Revenues: For the six months ended June 30, 2025, cost of revenues was $2.0 million, compared to $1.7 million for the same period in 2024. The $0.3 million increase was primarily driven by a $0.1 million increase in stock-based compensation and a $0.2 million increase in the costs of Etorel and Contiva, in line with the corresponding increase in their sales.
  • Selling and Marketing Expense: For the six months ended June 30, 2025, selling and marketing expense was $26.0 million, compared to $26.9 million for the same period in 2024. The $0.9 million decrease was primarily driven by a reduction in commission costs due to the decrease of sales.
  • Research and Development Expense: For the six months ended June 30, 2025, research and development expense was $6.5 million, compared to $5.5 million for the same period in 2024. The $1.0 million increase was primarily attributable to a $1.5 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone. This increase was offset by a $0.3 million decrease in materials and utilities expenses and a $0.1 million decrease in facilities, depreciation and other.
  • General and Administrative Expense: For the six months ended June 30, 2025, general and administrative expense was $9.8 million, compared to $6.8 million for the same period in 2024. The $3.0 million increase was primarily driven a $0.6 million increase in professional fees, a $1.6 million increase in functional and administrative department’s personnel and stock compensation costs, and a $0.8 million increase in miscellaneous expense, mainly due to the increase for the annual meeting expense.
  • Income from Operations: For the six months ended June 30, 2025, income from operations was $4.4 million, compared to $11.3 million income from operation for the same period in 2024. The $6.9 million decrease was primarily driven by a $3.6 million decrease in revenue and $3.3 million increase in total operating expenses.
  • Net Income: For the six months ended June 30, 2025, net income was $5.3 million, compared to $14.5 million net income for the same period in 2024.
  • Non-GAAP Adjusted Net Income: For the six months ended June 30, 2025, non-GAAP adjusted net income was $5.8 million, compared to $11.3 million non-GAAP adjusted net income for the same period in 2024. The decrease was primarily driven by the decline in revenue of $3.6 million and increase in operating expenses of $1.9 million.

Full Year 2025 Financial Guidance

For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of Etorel and Contiva and sales of ETUARY®.

 Guidance Range
Total Revenue$118 to $128 million
  

Please note that total revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021 and NDA filing is expected in the third quarter of 2025. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals. In the third quarter of 2025, this indirect interest was increased from 65.2% to 69.7% through the increased capital contribution from BJContinent Pharmaceuticals Limited to Gyre Pharmaceuticals.

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 United States 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: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of the initiation of Gyre’s Phase 2 trial in the U.S. for Hydronidone for the treatment of MASH-associated liver fibrosis, the initiation of Gyre’s Phase 2/3 trial in the PRC for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA for Hydronidone for the treatment of CHB-related liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, and IND submission of F528 in COPD, the expectations regarding commercial revenues from the sales of Etorel and Contiva maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. 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 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
Gyre Therapeutics
david.zhang@gyretx.com

View full release here.

Release – Xcel Brands and TSC Product Lab Partner to Launch GemmaMade by Gemma Stafford, a New Kitchen Brand for Everyday Bakers and Home Cooks

Posted on by aweinsoff@channelchek.com

Research News and Market Data on XELB

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NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB), a media and consumer products company known for building influential, creator-led brands, today announced a strategic partnership with TSC Product Lab to launch GemmaMade by Gemma Stafford—a new kitchenware brand created in close collaboration with chef and baking expert Gemma Stafford, designed to bring stylish, functional, and approachable tools to everyday bakers and home cooks.

This collaboration blends Xcel’s omnichannel brand-building capabilities with TSC Product Lab’s innovation-driven product development, delivering a thoughtfully designed assortment of kitchen products that reflect Stafford’s personal passion for joyful, stress-free cooking and baking at home. The product line will include bakeware, kitchen tools, food storage solutions, mixing bowls, and more—each created to support everyday needs with ease, charm, and reliability.

“GemmaMade is a celebration of the home kitchen,” said Robert W. D’Loren, Chairman and CEO of Xcel Brands. “We’re thrilled to partner with Gemma and TSC Product Lab to bring her vision to life through products that are as inviting and dependable as the content she shares with her loyal audience.”

With millions of fans and years of experience as a professionally trained chef, Gemma Stafford has built one of the most trusted and beloved baking communities in the world through her digital brand Bigger Bolder Baking. As both the creator and namesake behind GemmaMade, Gemma has worked hands-on with Xcel and TSC to develop a line that reflects her bold baking philosophy, her Irish heritage, and her belief that anyone can create delicious food with the right tools and a little confidence

“At the heart of GemmaMade is a simple promise: to super-serve home bakers and cooks with tools they can trust and love,” said Gemma Stafford. “I created this line for the everyday bakers and cooks who show up for birthdays, holidays, after-school snacks, and Sunday mornings—because they deserve products that are as joyful and reliable as they are. With Xcel and TSC, I’m excited to share the warmth of Irish hospitality through every bowl, pan, and spatula. In my kitchen, everyone’s welcome—because in a way, everyone is Irish.”

Rick Lapine, President of TSC Product Lab, added: “We are proud to be working with Gemma and Xcel to launch a brand that blends tradition and GemmaMade by Gemma Stafford reinforces Xcel Brands’ ongoing mission to build creator-led businesses that resonate with modern consumers and support how people live, cook, and share today.”

For more information, please visit www.xcelbrands.com

About Xcel Brands
Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the co-branded collaboration brands TowerHill by Christie Brinkley, LB70 by Lloyd Boston, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford, and a brand in development with Coco Rocha and also holds noncontrolling interests or long-term license agreements in the Isaac Mizrahi brand, Orme Live and Mesa Mia by Jenny Martinez brands. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone and consisting of over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 43 million social media followers with broadcast reach into 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.

About TSC Lab Products
The Sneaky Chef Product Lab (“TSC”) is a cost-effective product development and sourcing company specializing in innovative solutions for the home. The Company’s mission is to create products and brands for leading retailers. Since 2007, TSC has built a diverse portfolio of owned, private label and exclusively licensed brands and has partnered with such legacy names such as Martha Stewart, Sodastream, GreenPan and Calvin Klein. Its network of retail partners includes HSN, QVC, Walmart, Amazon and TJX Companies among others.

Led by Rick Lapine, an industry veteran with decades of experience, TSC is supported by a full-time team of passionate experts, bringing over 30 years of combined expertise in sourcing and production. This team has helped establish TSC as a trusted partner for efficient product development, manufacturing, and logistics, with the capability to execute projects rapidly and reliably.

About Gemma Stafford

For more than a decade, Irish-born chef Gemma Stafford has been bringing her passion for teaching people how to bake with confidence to her top online baking show and brand, Bigger Bolder Baking. Today, with more than 8 million followers (“Bold Bakers”) and half a billion video views to date, Bigger Bolder Baking has become the leading – and indispensable – multimedia destination for bakers. Gemma’s unique combination of expertise, bold recipes, and approachable techniques have led to appearances as a judge on Netflix’s Nailed It!, Food Network’s Best Baker in America, and Hulu’s Baker’s Dozen, along with appearances on national and local TV nationwide. Gemma is also the co-creator and host of the #1 baking entertainment podcast, Knead To Know, which releases every week in partnership with HRN. In 2025, she will launch the first-ever baking TV network, the Bold Baking Network, on connected television (CTV) and free ad-supported streaming television (FAST) platforms dedicated to educating and entertaining home bakers 24/7.

For further information please contact:
Seth Burroughs
Xcel Brands
sburroughs@xcelbrands.com

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Source: Xcel Brands, Inc