Author: aweinsoff@channelchek.com

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

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Research News and Market Data on GYRE

May 22, 2025

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

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

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

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

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

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Forward-Looking Statements

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

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

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

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GYRE

May 22, 2025

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

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

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

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

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

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Forward-Looking Statements

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

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

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

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

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Research News and Market Data on GYRE

May 22, 2025

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

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

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

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

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

Hydronidone Week 52 Results

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

Efficacy Results

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

Primary EndpointHydronidone 270mg
N=123		Placebo
N=124		P-value
≥1-stage fibrosis regression (Ishak)52.85%29.84%P=0.0002
    
Key Secondary Endpoints   
≥1-Grade inflammation improvement (Scheuer score) without progression of fibrosis49.57%34.82%P=0.0246

Safety Results

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

Our Path Forward

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

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

About the Phase 3 Trial

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

Patient Population for CHB-Associated Liver Fibrosis

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

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

About Hydronidone (F351)

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

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

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including timing of a U.S. Phase 2 clinical trial initiation in the second half of 2025 and NDA submission to NMPA for F351. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.

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

For Investors:
David Zhang
david.zhang@gyretx.com

Release – Hemisphere Energy Announces 2025 First Quarter Results, Declares Quarterly Dividend, Renews Credit Facility, and Provides Operations Update

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Research News and Market Data on HMENF

May 22, 2025 8:00 AM EDT

Vancouver, British Columbia–(Newsfile Corp. – May 22, 2025) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) provides its financial and operating results for the first quarter ended March 31, 2025, declares a quarterly dividend payment to shareholders, renews credit facility, and provides operations update.

Q1 2025 Highlights

  • Attained record quarterly production of 3,833 boe/d (99% heavy oil), a 21% increase over the same period of last year.
  • Generated $27.3 million in revenue, a 30% increase over the first quarter of 2024.
  • Achieved total operating and transportation costs of $14.63/boe.
  • Delivered an operating netback1 of $17.0 million, or $49.27/boe.
  • Realized quarterly adjusted funds flow from operations (“AFF”)1 of $12.7 million, or $36.83/boe, a 26% increase over the first quarter of 2024.
  • Generated free funds flow1 of $11.5 million, or $0.12 per share.
  • Distributed $2.4 million, or $0.025 per share, in dividends to shareholders during the quarter.
  • Purchased and cancelled 709,700 shares for $1.3 million under the Company’s Normal Course Issuer Bid (“NCIB”).
  • Exited the first quarter with positive working capital1 of $14.1 million, compared to $4.2 million at the end of March 2024.

(1) Operating netback, adjusted funds flow from operations (AFF), free funds flow, capital expenditure, and working capital are non-IFRS measures, or when expressed on a per share or boe basis, non-IFRS ratio, that do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other entities. Non-IFRS financial measures and ratios are not standardized financial measures under IFRS and may not be comparable to similar financial measures disclosed by other issuers. Refer to the section “Non-IFRS and Other Specified Financial Measures”.

Selected financial and operational highlights should be read in conjunction with Hemisphere’s unaudited condensed interim consolidated financial statements and related notes, and the Management’s Discussion and Analysis for the three months ended March 31, 2025 which are available on SEDAR+ at www.sedarplus.ca and on Hemisphere’s website at www.hemisphereenergy.ca. All amounts are expressed in Canadian dollars unless otherwise noted.

Quarterly Dividend

Hemisphere is pleased to announce that its Board of Directors has approved a quarterly cash dividend of $0.025 per common share in accordance with the Company’s dividend policy. The dividend will be paid on June 30, 2025 to shareholders of record as of the close of business on June 19, 2025. The dividend is designated as an eligible dividend for income tax purposes.

Including Hemisphere’s special dividend of $0.03 per common share paid in April and base quarterly dividends of $0.025 per common share in February and June, Hemisphere will have paid its shareholders $0.08 per common share in dividends during the first half of 2025.

Credit Facility

The Company has completed its annual bank review and renewed its $35.0 million two-year extendible credit facility with the same key terms, and the next annual review date set for May 31, 2026.

Operations Update

With the majority of Hemisphere’s 2025 capital spending scheduled for the latter half of the year, the Company generated $11.5 million in free funds flow during the first quarter. Current second quarter production of approximately 3,800 boe/d (99% heavy oil, field estimates between April 1 – May 15, 2025) is consistent with that of the first quarter, and represents an increase of 13% over fourth quarter production of 3,359 boe/d (99% heavy oil), due both to downtime in November and continued injection support from Hemisphere’s polymer floods at its Atlee Buffalo projects in southeast Alberta.

At Hemisphere’s Marsden pilot polymer flood project, injection continues to repressure the reservoir. Management anticipates that polymer response could take until late 2025, at which time the Company will determine economics of further development.

Management continues to closely monitor the volatility of the oil market and will adjust capital spending accordingly. With over $14 million in working capital and an undrawn credit line, Hemisphere will prioritize shareholder returns, share buybacks, and potential acquisition activity over accelerated capital spending.

Annual General and Special Meeting of Shareholders

Hemisphere’s Annual General and Special Meeting of Shareholders will be held at 10:00 am (Pacific Daylight Time) on June 2, 2025 in the Walker Room of the Terminal City Club located at 837 West Hastings Street, Vancouver, British Columbia.

About Hemisphere Energy Corporation

Hemisphere is a dividend-paying Canadian oil company focused on maximizing value-per-share growth with the sustainable development of its high netback, ultra-low decline conventional heavy oil assets through polymer flood enhanced oil recovery methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.

For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:

Don Simmons, President & Chief Executive Officer
Telephone: (604) 685-9255
Email: info@hemisphereenergy.ca

Website: www.hemisphereenergy.ca

View full release here.

info

SOURCE: Hemisphere Energy Corporation

Release – Comstock Releases Shareholder Letter

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Research News and Market Data on LODE

Closes Initial $20 Million Tranche of Series A Investment and Separation of Fuels

VIRGINIA CITY, NEVADA, MAY 22, 2025 – Comstock Inc. (NYSE American: LODE) (“Comstock” and the “Company”) today announced that its executive chairman and chief executive officer, Corrado De Gasperis, issued the following letter to shareholders announcing major transformative milestones, including the separation of Comstock Fuels.

Dear Shareholders:

On behalf of our Board of Directors, Executive Officers, and the entire Comstock team, thank you for your continued support of our goals and bold strategies for achieving systemic decarbonization, establishing technological leadership in the massive global renewable fuels and renewable metals markets and positioning great value for all of our shareholders.

I am genuinely thrilled to announce the completion of the successful separation of our renewable fuels segment into a new independent entity, Bioleum Corporation (“Bioleum”), and its high-value capitalization, through the closing on the first $20 million in direct Series A equity investment. This investment is the first of $50 million planned this year.

This achievement fulfills the first phase of the plans we outlined earlier this year and positions us with two high-growth companies – one focused on renewable metals and mining here in Nevada, and the other on renewable fuels headquartered in Oklahoma – enabling two extremely different business and capital profiles and providing each the platform to thrive in their own markets. In doing so, we are unleashing unprecedented opportunities for growth and value creation.

Bioleum Separation Completed: A Bold New Chapter

We have officially separated and contributed the assets that formerly comprised Comstock’s fuels segment into Bioleum, a newly formed company dedicated to accelerating and maximizing the production and use of lignocellulosic biomass – or BioleumTM – derived fuels and attracting the necessary capitalization to do so. Bioleum’s formation marks the next chapter in this rapid evolution – one where our renewable fuels platform can accelerate under its own banner with singular focus and clarity with the ultimate objective of also becoming a publicly traded company.

Comstock now owns $65 million of the preferred stock in Bioleum, convertible into 32.5 million common shares, nearly the exact number of total outstanding shares of LODE today. This represents the substantial majority of Bioleum, positioning an exceptional value for our shareholders today and preserving our ability to accelerate the growth of that value and the delivery of that value directly to our shareholders, ultimately through a future public offering and beyond.

This transaction was structured to give Bioleum operational independence, with direct governance from Comstock and the strategic Series A investors, while maintaining and ensuring exceptional alignment with Comstock’s interests. Bioleum now has its own dedicated leadership and resources: Kevin Kreisler has been appointed Chief Executive Officer of Bioleum, and – in addition to my continuing role as Executive Chairman and Chief Executive Officer of Comstock, I will also serve as Bioleum’s Executive Chairman and Chief Financial Officer to both guide and support the new enterprise. I will be the only professional employed directly by both companies. With an independent board and governance, including representatives of the Series A investors and independent board members of Comstock, Bioleum can effectively and efficiently accelerate its mission and critical financing strategy. We believe that this structure, combined with Comstock’s ongoing governance and preferred equity interest, strikes the ideal balance to maximize Bioleum’s potential and unlock the full value of its clean energy portfolio for all of our shareholders.

Critically, the separation and its aligned structure, satisfies key conditions of large, sophisticated investors for new investment in Bioleum. Concurrently with the separation, Bioleum has closed an initial $20 million tranche of its Series A preferred stock financing. This infusion of growth capital validates Bioleum’s strategy and provides the resources to accelerate its next phase of development. These funds will support Bioleum’s continuing development as it completes engineering, financing, and construction of its first planned 400,000 barrel per year commercial demonstration facility in Oklahoma. In short, Bioleum is now equipped, capitalized, and structured to move forward at full speed. This capital also immediately relieves Comstock of a substantial majority of its liquidity and capital resource demands and constraints.

Bioleum’s Path to Full Commercialization

The initial objectives are clear. Bioleum will continue to focus on securing all approvals and agreements, including with top-tier Engineering, Procurement and Construction (“EPC”) and other strategic relationships while engineering is completed to construct its flagship 400,000 barrel per year refinery in Oklahoma. This first facility will deliver over $30 million in annual operating income once up and running, showcasing its commercial viability. Bioleum has already advanced site selection and engineering, and is working on project-level financing, permitting, regulatory approvals, and all other site agreements, fueled by the Series A capital.

Bioleum’s proprietary refining platform can convert underutilized woody biomass into a low-carbon, direct substitute for gasoline, diesel, and sustainable aviation fuel, effectively transforming waste biomass into high-value fuels with a carbon intensity as low as 15. In essence, we have uncovered a new kind of “oil well” – one that never runs dry because it is fed by renewable resources. As we often say, imagine an oil well that never stops producing – that is what Bioleum delivers. With market-leading yields of up to 140 gallons of fuel per ton of feedstock (on a gasoline gallon equivalent basis) and a platform designed to scale 10x beyond the first facility, Bioleum is poised to enlist major oil companies in accelerating and maximizing the production and use of Bioleum derived fuels.

Comstock Metals: Strength in Sustainable Innovation

While Bioleum separates, our Metals business will continue to grow stronger than ever. We are proud to report that Comstock Metals revenues are growing rapidly and achieving the highest levels of industry recognition. Recently, Comstock Metals became the first company in North America to earn the stringent R2v3 and RIOS certifications for zero-waste solar panel recycling. This groundbreaking certification validates that our recycling facility and processes meet the highest global standards for safety, environmental stewardship, and total waste elimination. In fact, under the R2v3/RIOS standard (including the specialized Appendix G), we demonstrated a 100% landfill-free recycling process – every component of an end-of-life solar panel (glass, aluminum, semiconductor fines, and other metals) is fully reclaimed and repurposed into new raw materials. Nothing goes to waste. This achievement is an extraordinary testament to our team’s innovation and diligence. It proves that our proprietary thermal recycling technology can deliver commodity-grade outputs from solar trash, with all parts of the panel fully recycled into valuable products.

Importantly, this certification also provides assurance to our customers, partners, and regulators that Comstock Metals’ operations meet the absolute highest bar for responsible recycling, without any reliance on government incentives. We have essentially built a new kind of mine above ground – one that harvests critical metals from retired solar panels instead of digging ore from the earth. As I’ve described before, it’s like a “world-class silver mine using solar panel waste as ore” that never depletes and just keeps on producing. With this validation in hand, Comstock Metals is aggressively scaling up its services to meet surging demand. We have been ramping up our recycling throughput (a fourfold increase year-over-year in Q1) and expanding our partnerships, including world-class customers and a master services agreement with RWE Clean Energy all while maintaining our zero-landfill promise. We are securing expanded and new permits and are preparing to expand to industry-scale operations at our Nevada facility to process dramatically larger volumes of photovoltaic waste. In short, Comstock Metals is now a proven leader in sustainable metal recycling, with a robust pipeline of business and technology that positions us for exponential growth. We could not be prouder of our teams.

Strategic Rationale: Capital Efficiency, Risk Management, and Value Creation

I want to clearly articulate our thinking behind separating the Bioleum and Comstock entities at this time. This transaction was driven by opportunity – and by necessity. Both our Fuels and Metals businesses have matured to a point where they can attract significant investment and growth on their own. However, they each have very different capital needs, risk profiles, and operational focuses. By separating them, we enable each company to pursue tailored funding and growth strategies with maximum efficiency. Bioleum can now raise capital (such as the Series A financing) directly into its projects and technology, without competing with or being bottlenecked by Comstock’s other needs. At the same time, Comstock Metals can seek its own strategic partnerships and financing faster and more efficiently (for new industry scale recycling facilities, for example) without having to dilute or divert resources to the Fuels business. This clear management, capital and growth focus in each company means more efficient use of funds and faster development cycles for both.

Separation also improves risk management. Renewable fuels and recyclable metals are adjacent in our mission, but they are fundamentally different businesses. Each business faces unique technical and market risks. By structurally isolating them, we ensure that challenges in one domain will not hinder the progress of the other. Investors and partners can now engage with a pure-play renewable metals producer or a pure-play renewable fuels developer, without ambiguity. This clarity reduces the perceived risk for stakeholders and allows each company to be evaluated on its own merits. Moreover, it grants each management team the autonomy to focus exclusively on its core mission – whether that is scaling up recycling operations or building biorefineries – thus sharpening execution and accountability.

Finally, and most importantly, this separation is about unlocking the full value and impact of the businesses we have built. We firmly believe that the combined value of Comstock and Bioleum as separate entities will exponentially exceed what might have been reflected as a single conglomerate. The market can now properly value our Metals business as the first mover in zero-waste solar recycling, and value Bioleum as a high-growth renewable fuels innovator, without one overshadowing the other. Early evidence of this value creation is clear: the separation and Bioleum’s financing were completed at an implied valuation that significantly uplifts the recognized value of our Fuels segment. Comstock retains a substantial majority equity position in Bioleum, so our shareholders keep substantial upside in Bioleum’s future success, while better protecting against downside risks and gaining all the benefits of a more focused parent company. We expect that as Bioleum reaches its milestones and as Comstock Metals rapidly expands, the sum-of-parts value to our shareholders will deliver dramatic and exponential returns.

Moving Forward

I want to emphasize the confidence I have in our bold path forward. We have spent the last four years investing in new technologies, overcoming challenges, and relentlessly driving toward commercialization of two revolutionary platforms. That effort has now culminated in a historic achievement: we launched Bioleum as an independent company and fortified Comstock Metals as a standalone powerhouse. We are now operating with a sharpened focus in each business. Our vision of enabling energy independence and a circular, decarbonized economy is not just alive – it’s accelerating.

Comstock emerges from this separation as a more streamlined enterprise laser-focused on renewable metals, with a healthy balance sheet and a stake in one of the most promising renewable fuel ventures in the world. Bioleum, for its part, is charging ahead to reinvent how we produce fuels, armed with world-class technology, a passionate team of industry veterans, and the funding to realize its plans. Together, though operating separately, Comstock and Bioleum are advancing complementary missions that address two of the world’s most pressing needs: clean energy and resource sustainability. We are leading – setting new standards, forging new partnerships, and capturing new markets.

I have never been more confident in our strategy or more excited looking to the future. We will continue executing with the same determination and ingenuity that brought us to this point. We look forward to creating extraordinary value together as we drive a true revolution in renewable fuels and sustainable materials.

Key Highlights

  • Completed Separation of Comstock Fuels into Bioleum – Successfully separated our renewable fuels business into Bioleum Corporation, an independent entity, satisfying all conditions for the capital needs of the business. Comstock retains a substantial majority in Bioleum to participate in its tremendous growth potential.
  • Comstock’s Stake – $65M Preferred Equity – Comstock received $65 million in preferred equity in Bioleum, convertible into 32.5 million common shares, representing a well-protected and substantial majority ownership of Bioleum. This ensures Comstock shareholders benefit from Bioleum’s future success.
  • Bioleum Funded and Positioned for IPO – Bioleum closed an initial $20 million Series A financing concurrent with the separation. Proceeds will fund critical growth milestones. Bioleum plans an IPO upon completing the construction of its first 400,000 barrel per year refinery and meeting key commercialization milestones.
  • Comstock Metals’ Extraordinary First Mover Advantage – Comstock Metals recycling business is thriving. Comstock Metals achieved the first R2v3/RIOS certification in North America for 100% zero-waste solar panel recycling, validating our world-class, zero-landfill process. Comstock Metals is scaling up with new permits, major customers, and expanding revenues, fulfilling the vision of a “solar waste silver mine” that never depletes.
  • Strategic Benefits of Separation – The separation enhances capital efficiency (each company can raise and allocate capital optimally), improves risk management (distinct businesses are insulated from each other’s risks), and unlocks value (investors can properly value each pure-play business, driving greater aggregate shareholder value). We expect this separation to accelerate growth and maximize shareholder returns for both companies.

I appreciate everyone’s dedication and support in helping us get to this launching point. I am very much looking forward to discussing these achievements, our remarkable progress, and next steps with you during our 2025 Annual Meeting.

Kindest regards, 

Corrado De Gasperis
Executive Chairman and Chief Executive Officer
Comstock Inc. 

Additional information on the Bioleum transactions will be provided in Comstock’s planned Current Report on Form 8-K to be filed online on May 23, 2025.

About Bioleum Corporation

Bioleum Corporation (“Bioleum”) is setting a new standard in oil by developing and commercializing breakthrough refining technologies that convert lignocellulosic biomass into low-carbon transportation fuels at commercial scale, including cellulosic ethanol, gasoline, renewable diesel, synthetic aviation fuel (“SAF”), and other renewable fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 140 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”). Bioleum plans to contribute to domestic energy dominance by directly building, owning, and operating a network of refineries in the U.S., starting with its planned first 400,000 barrel per year commercial demonstration facility in Oklahoma. Bioleum also licenses its advanced feedstock and refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.bioleum.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. 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:
Tracy Saville, Director of Marketing
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 Collaborates with a $3 Billion Mix-Use Urban, Smart Home City Project in the Heart of Miami to Supply its Advanced Plug & Play Smart Home Platform Technologies for the Entire Smart City Project

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

May 21, 2025 09:17 ET | Source: SKYX Platforms Corp.

The 63-Acre Mix-Use Urban Smart Home City in The Miami Little River District will include High- & Mid-Rise Buildings with over 5,700 Condos and Apartments including Workforce and Affordable Living, 350,000 SQF of Retail, 1.5 Million SQF of Green Walkways, Parks, Bike Paths, Shuttle Lanes, a New $35 Million Tri-Rail Station, and More

SKYX is Expected to Deploy Over 500,000 Units of its Advanced and Smart Home Plug & Play Platform Technologies and Products, including an AI Ecosystem. SKYX has Financial Backing from U.S. and Global Manufacturers to Support its Massive Product Deployment

The $3 Billion Project is Led by Prominent Developers SG Holdings, a Joint Venture between Swerdlow Group, SJM Partners, and Alben Duffie

The Architecture and Design of the Project is Led by World-Renowned Architectural Firm Arquitectonica

The Groundbreaking Smart Home Mixed-Use Major Development Will Redefine Miami’s Urban Landscape

MIAMI, May 21, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (“SKYX” or the “Company”), a highly disruptive smart home platform technology company with over 97 issued and pending patents globally and a growing portfolio of over 60 lighting and home décor websites, with a mission to make homes and buildings become smart, safe, and advanced as the new standard today announced 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. SKYX’s platform technologies make homes and buildings safer, smart, and advanced, while saving significant time and cost.

SKYX’s deployed products will include ceiling outlet receptacles, its all-in-one smart home platform technology, an AI ecosystem, and plug & play products including lighting, ceiling fans, recessed lights, EXIT signs, emergency lighting, downlights, and indoor/outdoor wall lighting among others.

Per developers’ commitment to an advanced smart and safe urban community, all homes will be provided with SKYX’s all-in-one smart home platform technology that will include smart and safety features such as WIFI and WIFI repeaters, voice, and app controls, a 911 emergency calling feature, speakers, room to room intercom, emergency light, safety night light, color changing light, smoke and CO detectors, thermostats, among other AI and smart home features. Developers will be providing free internet for all community apartments. The Miami Little River project will be the first of its kind in the State of Florida.

SKYX’s technologies offer long-term recurring revenue opportunities through upgrades, product interchangeability, monitoring services, subscriptions, and platform-wide integrations for future developments.

The groundbreaking 63-acre urban revitalization project will be one of the largest housing and smart home initiatives in Miami’s history and will offer the 2,400 affordable apartments services, technology and amenities usually offered in high-end projects. The project is led by prominent developers SG Holdings, a joint venture comprised of the Swerdlow Group, SJM Partners and Alben Duffie, the team that has just delivered the 1.5 million sq. ft. Sawyer Walk project in Miami’s Overtown area.

The Urban Mixed-Use Smart Home Development will Contain High- & Mid-Rise Buildings and Housing and Will Include:

  • Over 5,700 residential units, including workforce and affordable housing
  • 350,000 square feet of retail and commercial space including major and national retailers, a major supermarket, big box retail, restaurants, offices, convenience stores, food and beverage options, and more
  • 1.5 million square feet of green walkways, parks, bike paths, and shuttle lanes
  • A new $35 million Tri-Rail station
  • 250,000+ square feet of publicly accessible green space
  • Amenities including fitness centers, pools, computer labs, among others
The Groundbreaking Smart Home Mixed-Use Major Development Will Redefine Miami’s Urban Landscape

The Groundbreaking Smart Home Mixed-Use Major Development Will Redefine Miami’s Urban Landscape

Michael Swerdlow, Founder and CEO of Swerdlow Group and lead partner in SG Holdings, said, “Our $3 billion mixed-use development is set to redefine the urban landscape of Miami. To support that vision, we are integrating safe, advanced, and intelligent technologies—like SKYX’s innovative plug-and-play smart home platform—across our buildings and residences. These technologies will deliver meaningful value to our homeowners and the broader community.”

Stephen Garchik, Founder of SJM Partners, and a principal partner in SG Holdings, said, “Our 63-acre mixed-use development is designed to be a model for the future of smart urban living—safe, connected, and forward-thinking. We are looking forward to incorporating SKYX’s game-changing technologies, which will add significant value to our project, while enhancing safety, functionality, and overall experience of our buildings and homes and for the entire community.”

Rani Kohen, Founder, Inventor and Executive Chairman of SKYX Platforms Corp., said, “We are proud to collaborate on a Miami urban mixed-use smart city project of this magnitude in the heart of the city. Our advanced plug & play smart platform was designed to support the next generation of urban developments, and we look forward to the opportunity to contribute to a connected, safer, and more efficient living environment.”

Khadija Mustafa, Global AI and Sales Leader at Microsoft and Senior Technology Advisor to SKYX, added: “This Miami groundbreaking smart city project marks the start of a new era in intelligent living. While phones and cars have leapt ahead, the building socket has been left behind — until now. SKYX is laying the infrastructure to not just connect homes, hotels, and communities, but to unlock a gateway for AI-enabled services that will redefine how we live, work, and connect.”

For SKYX’s Technologies Video Link CLICK HERE

About SKYX Platforms Corp.

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

Forward-Looking Statements

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

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d058044d-f44f-4d13-b4b9-7fb3bb4fd1b9

Release – Nicola Mining to Commence Gold and Silver Production

Posted on by aweinsoff@channelchek.com

Research News and Market Data on HUSIF

May 21, 2025 9:00 AM EDT | Source: Nicola Mining Inc.

Vancouver, British Columbia–(Newsfile Corp. – May 21, 2025) – Nicola Mining Inc. (TSXV: NIM) (FSE: HLIA) (OTCQB: HUSIF) (the “Company” or “Nicola“) is pleased to announce that has started receiving gold / silver ore from Talisker Resources Inc. and is currently undergoing pre-production adjustment. The modern $33.0 million plus milling and processing facility, which is located near Merritt, British Columbia, has undergone numerous upgrades in 2H 20241.

Production at the modern facility, which is constructed on free-hold industrial-zone land owned 100% by the Company, is expected to ramp up and reach full capacity in Q3. The Company has also commenced the process of applying for an amendment to its permit, for the purpose of increasing mill throughput.

Nicola’s Merritt Mill is the only facility in the Province of British Columbia permitted to accept third party gold and silver mill feed from throughout the province.

Talisker Resources Ltd.
Nicola and Talisker have recently entered into a new Milling Agreement and the latter has commenced transportation of high grade gold/silver ore to Nicola’s mill site. Nicola had previously announced that it and Talisker had signed a Milling Agreement2 on July 18, 2024. Nicola and Talisker have commenced working with Ocean Partners UK Limited3 on the sale of gold and silver concentrate.

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Ore from Talisker’s Bralorne Mine

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Nicola Mining’s Merritt Mill

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Blue Lagoon Resources
Nicola continues to work closely with Blue Lagoon Resources (“Blue Lagoon“) and has participated in all tranches of the latter’s recent private placement. In a previous capital round, Blue Lagoon announced that Nicola had subscribed for 7,142,857 shares. The Company will participate in Blue Lagoon’s official opening of the latter’s Dome Mountain Mine on July 9th, 2025, and is completing final preparations to accept Dome’s high-grade gold / silver ore, thereafter.

Dominion Gold / Silver Bulk Sample
Nicola announced on March 12, 2025 that it has received the Final Permit (“Final Permit[1]“) to complete a bulk sample[2] at its Dominion Creek Mineral Project (“Dominion”), a high grade gold and silver project, of which Nicola owns a 75% economic interest. Preparation has been initiated to mobilize equipment and begin mining activities in July of 2025.

The Company will provide separate news releases for each project soon.

In addition to commencing gold and silver production, Nicola is currently preparing to commence copper exploration at its New Craigmont Copper Project. To strengthen its geological team the Company has hired Vicente García as a Senior Geologist. Mr. García is an experienced exploration geologist with a strong technical background from having worked on many deposit types in North and South America, including porphyry copper. The Company will issue a separate geological news release soon.

Mr. Peter Espig, CEO of Nicola Mining Inc., commented, “Unlike previous milling campaigns we are excited to realize that Nicola is morphing into a steady and long term producer. It is rare for junior miners to reach the production pinnacle and to monetize current precious metal prices with our partners. We are also witnessing firsthand augmented efficiencies in British Columbia’s permitting of underground mining operations, which characteristically minimize environmental impact, as well as the strategic significance of our fully permitted mill. In addition to production, we have boosted our geological team and are ramping up activities for what we believe to be an exciting exploration campaign, not only at the New Craigmont Project, but also our fully permitted silver mine, Treasure Mountain.”

Qualified Person
William Whitty, P. Geo., the Company’s VP Exploration, is the Qualified Person as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects and supervised the preparation of, and has reviewed and approved, the technical information in this release.

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

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

On behalf of the Board of Directors

“Peter Espig“

Peter Espig
CEO & Director

For additional information

Contact: Peter Espig
Phone: (778) 385-1213
Email: info@nicolamining.com
URL: www.nicolamining.com

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

1 News Release describing upgrades: Link
2 News Release: April 9, 2024 Link
3 Ocean Partners operates in several countries throughout the world and maintains a strong global network of relationships and contacts in the base metal mining and smelting sector.

info

SOURCE: Nicola Mining Inc.

Release – Tonix Pharmaceuticals Announces First Patient Dosed in Phase 2 OASIS Study of TNX-102 SL for Reduction of Acute Stress Reaction

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

May 21, 2025 7:00am EDT Download as PDF

Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD)

Trial is sponsored by the University of North Carolina (UNC) and supported by a grant from the U.S. Department of Defense

Topline results from the trial are expected in the second half of 2026

CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the first patient has been dosed in the Phase 2, investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD). The trial is sponsored by the University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).

“TNX-102 SL has been shown to improve sleep quality in PTSD, and previous trials of TNX-102 SL suggested activity on sleep and stress-related symptoms in the first several weeks of treatment,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Addressing sleep disturbances is crucial in managing ASR, as poor sleep can exacerbate other symptoms and hinder recovery. There is a significant unmet need for treating ASR after traumatic events, such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. We are encouraged by the support of TNX-102 SL’s prior data improving PTSD symptomatology in the first several weeks of treatment, which may be crucial to reducing ASR symptoms and their sequalae. We look forward to topline results in the second half of 2026.”

The Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision (MVC). The trial plans to enroll approximately 180 MVC-trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.

The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative to improve the understanding, prevention and recovery of individuals who experience a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies, such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service. Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD. Currently, no medication is available in the immediate aftermath of traumatic events to treat the initial reaction and support long term health via a post-trauma clinical trajectory that prevents development or worsening of ASD, thereby also preventing PTSD.

For more information, see ClinicalTrials.gov Identifier: NCT06636786

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biotech company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s 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

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

Media Contact

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

Indication and Usage

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

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

Important Safety Information

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

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

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

Do not use Zembrace or Tosymra if you have:

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

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

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

Zembrace and Tosymra may cause serious side effects including:

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

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

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

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

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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released May 21, 2025

Release – Unicycive Therapeutics Announces Time Change for 2025 Annual Meeting of Stockholders

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

May 21, 2025 7:00am EDT Download as PDF

LOS ALTOS, Calif., May 21, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (NASDAQ: UNCY) (“Unicycive” or the “Company”), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced a change in the time of the 2025 Annual Meeting of Stockholders (the “Annual Meeting”). The previously announced date of the meeting (June 9, 2025) and location of the meeting (4300 El Camino Real, Suite 210, Los Altos, CA 94022) will not change, but the meeting will be held at 7:00 a.m., Pacific Daylight Time, on that date. Stockholders of record as of the close of business on April 30, 2025, the record date, can find additional details regarding participation in the Annual Meeting at https://annualgeneralmeetings.com/uncy2025.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com
SOURCE: Unicycive Therapeutics, Inc.

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released May 21, 2025

Release – GeoVax Reaffirms Urgent Need for Multi-Antigen COVID-19 Vaccines as CDC Shifts Recommendations

Posted on by aweinsoff@channelchek.com

Research news and Market Data on GOVX

    GEO-CM04S1 Demonstrates Superior Protection in Immunocompromised Populations; Fully Aligned with HHS Priorities for Durable, Broad-Spectrum Immunization

    ATLANTA, GA, May 20, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) anticipated changes to COVID-19 vaccine recommendations.

    According to recent reports, HHS is preparing to limit blanket vaccine guidance in favor of a risk-based approach focused on older adults and those with chronic health problems. This pivot away from one-size-fits-all vaccine recommendations underscores the urgent need for next-generation immunization strategies—precisely the role that GeoVax’s multi-antigen COVID-19 vaccine, GEO-CM04S1, is designed to fulfill.

    “As public health strategy shifts toward protecting those most vulnerable, the demand increases for vaccines that work where others fall short,” said David Dodd, Chairman and CEO of GeoVax. “GEO-CM04S1 delivers broad, durable immunity even in immunocompromised patients—a population estimated at over 40 million adults in the U.S. that are inadequately served by the current authorized, single-antigen mRNA vaccines.”

    GEO-CM04S1: Purpose-Built for the New Vaccine Paradigm

    GEO-CM04S1 is based on the Modified Vaccinia Ankara (MVA) platform and expresses both Spike (S) and Nucleocapsid (N) proteins—offering multi-antigen protection against SARS-CoV-2. This broader design induces both antibody and T cell responses, essential for robust, durable protection against continually evolving COVID-19 variants and is especially critical in populations with weakened immune systems.

    Recent interim results from a Phase 2 clinical trial in patients with chronic lymphocytic leukemia (CLL) demonstrated a superior T cell response rate versus a leading mRNA vaccine. The trial’s independent Data Safety Monitoring Board recommended and implemented continuing enrollment in the GEO-CM04S1 arm while halting the underperforming mRNA comparator arm.

    Aligned with the New HHS Biosecurity Vision

    GEO-CM04S1 is fully aligned with the new strategic direction from HHS Secretary Kennedy, who has called for a focus toward multi-antigen vaccine technologies that can deliver durable, variant-adaptive immunity while prioritizing safety and domestic production.

    GeoVax’s MVA vaccines offer:

    • Multi-antigen breadth: Including both S and N antigens for protection across variants.
    • Durability: Sustained antibody and T cell immunity—even in immunocompromised individuals.
    • Safety: MVA is non-replicating and approved for use in vulnerable groups such as transplant patients, pregnant women, and children.
    • Domestic advanced manufacturing: Using an avian continuous cell line platform that eliminates reliance on specialized pathogen-free eggs and a slow vaccine manufacturing process, enabling scalable U.S.-based vaccine production aligned with President Trump’s recent Executive Order on pharmaceutical onshoring.

    “The HHS call for broader, more resilient vaccine solutions is well-founded,” Dodd added. “GEO-CM04S1 is not only scientifically advanced but strategically aligned with our nation’s public health and biosecurity goals.”

    Multiple Trials Support Path to Licensure

    GEO-CM04S1 is currently in three active Phase 2 trials, evaluating its use among:

    1. Immunocompromised blood cancer patients in preparation for stem cell transplantation or CAR-T therapy (in comparison to mRNA-based vaccine),  
    2. Immunocompromised patients with Chronic Lymphocytic Leukemia (in comparison to mRNA vaccine), and
    3. Healthy adults, previously vaccinated with a mRNA vaccine as a more robust, more durable booster following mRNA vaccination.

    About GeoVax

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

    Forward-Looking Statements

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

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

    Company Contact:                 

    info@geovax.com                   

    678-384-7220                          

    Investor Relations Contact:

    geovax@precisionaq.com

    212-698-8696

    Release – Zomedica Unveils Exclusive Fourth Friday at Four Webinar Series to Explore Cutting-Edge Veterinary Innovations

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on ZOMDF

    Engaging Sessions to Highlight Game-Changing Technologies, Expert Insights, and Growth Opportunities in Animal Health Featuring Zomedica Products

    ANN ARBOR, MI / ACCESS Newswire / May 19, 2025 / Zomedica Corp. (OTCQB:ZOMDF) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, today announced the launch of a new monthly webinar series designed to highlight its innovative product portfolio, introduce key personnel, showcase manufacturing capabilities, and educate investors and strategic partners on the company’s long-term growth strategy.

    This exclusive webinar series scheduled for the fourth Friday of every month beginning May 23rd, offers a front-row seat to Zomedica’s game-changing technologies and strategic vision, providing veterinarians, investors, and industry leaders with an unparalleled opportunity to stay ahead of the curve in animal healthcare. Attendees will gain first-hand insights into cutting-edge advancements that are shaping the future of veterinary medicine while discovering how Zomedica is driving innovation, expanding its market presence, and delivering solutions that improve patient outcomes.

    Each engaging session will dive deep into Zomedica’s groundbreaking technologies, including the:

    • PulseVet® Shock Wave system – A revolutionary, non-invasive therapy accelerating healing in musculoskeletal conditions, setting new standards in veterinary therapeutics.
    • Assisi Loop® and Calmer Canine products – Advanced tPEMF™ (Targeted Pulsed Electromagnetic Field) therapy devices that provide drug-free, highly effective pain and inflammation management, as well as the Calmer Canine therapy for behavioral separation anxiety.
    • TRUFORMA® Diagnostic Platform – A next-generation in-clinic system offering unique, precise, rapid diagnostic testing to support complex veterinary cases with unparalleled accuracy at the point of care.
    • TRUVIEW® Digital Cytology System: Best-in-class imaging and the only fully automated slide prep solution-ensuring consistent quality, telepathology-backed confidence, and a streamlined workflow for faster, more accurate diagnoses in veterinary medicine.
    • VETGuardian® No-Touch Monitoring System – A state-of-the-art, contact-free monitoring solution ensuring continuous remote tracking of vital signs for enhanced patient care.
    • VETIGEL® – An innovative, plant-based hemostatic gel designed for rapid and effective bleeding control, revolutionizing wound management in veterinary medicine.

    “Zomedica’s monthly webinar series isn’t just about showcasing our products-it’s about building a community of forward-thinking professionals and investors dedicated to advancing animal healthcare,” said Larry Heaton, CEO of Zomedica. “Through these interactive sessions, we are offering an exclusive look at our industry-leading technologies, expert-driven discussions, and our commitment to driving growth and innovation in veterinary medicine.”

    Designed to be interactive and insightful, each webinar will feature product demonstrations, in-depth discussions with industry experts, and Q&A opportunities with Zomedica’s leadership team. Investors and strategic partners will gain a deeper understanding of the company’s expanding market influence, robust R&D pipeline, and vision for sustainable revenue growth and shareholder value.

    Webinar Registration & Details

    Don’t miss this opportunity to connect with industry experts, discover groundbreaking technologies, and explore new possibilities in veterinary healthcare. The series is open to veterinary professionals, industry partners, investors, and all who are interested in improving the lives of our family pets.

    To secure your spot in the upcoming sessions, click on the link below https://us02web.zoom.us/webinar/register/WN_lUpmJTicRliHUCVyz6JEbg or visit www.investors.zomedica.com.

    About Zomedica

    Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. Zomedica grew revenue 8% in 2024 to $27 million and maintains a strong balance sheet with approximately $65 million in liquidity as of March 31, 2025. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

    Follow Zomedica

    Cautionary Note Regarding Forward-Looking Statements

    Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

    Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements and our ability to realize upon our business plans and cost control efforts.

    Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, including international efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to realize the anticipated growth opportunities from our acquisitions; uncertainty as to our ability to supply products in response to customer demand; supply chain risks associated with tariff changes;; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products and purchase of consumables following adoption of our capital equipment; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

    The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

    Investor Relations Contact:

    Zomedica Investor Relations
    investors@zomedica.com
    1-734-369-2555

    SOURCE: Zomedica Corp.

    Release – Codere Online Reports Financial Results for the First Quarter 2025

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on CDRO

    05/16/2025

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    • Total revenue was €54.3 mm in Q1 2025, while net gaming revenue1 was €57.0 mm in the period, 8% above Q1 2024 (17% in constant currency terms).
    • Mexico revenue was €27.6 mm in Q1 2025, while net gaming revenue was €30.5 mm in the period, 15% above Q1 2024 (34% in constant currency terms).
    • Net loss was €0.7 mm in Q1 2025 versus a net income of €3.4 mm in Q1 2024.
    • Total cash position of €41.8 mm as of March 31, 2025.
    • Reiterating 2025 net gaming revenue outlook of €220-230 million and Adj. EBITDA2 outlook of €10-15 million.
    • Repurchased $0.5 million of the Company’s shares under the Company’s $5.0 million share buyback plan through May 15, 2025.

    Madrid, Spain and Tel Aviv, Israel, May 16, 2025 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, has released its preliminary unaudited3 financial results for the quarter ended March 31, 2025.

    Below are the main financial and operating metrics of the period.

     Quarter ended March 31
     20242025Chg. %
        
    Net Gaming Revenue (EUR mm)1   
    Spain22.321.9(2%)
    Mexico26.630.515%
    Other4.14.510%
    Total53.057.08%
        
    Avg. Monthly Active Players (000s)4   
    Spain50.052.04%
    Mexico62.582.031%
    Other30.627.2(11%)
    Total143.2161.313%

    Aviv Sher, CEO of Codere Online, stated, “We are off to a good start in 2025, with net gaming revenue reaching €57.0 million in the first quarter, an 8% increase compared to the same period last year. In Mexico, net gaming revenue grew 15% to €30.5 million, despite the 16% devaluation of the Mexican peso. Meanwhile, net gaming revenue in Spain was slightly below last year’s at €21.9 million.”

    Oscar Iglesias, CFO of Codere Online, commented, “We are very pleased with our performance in Mexico and the underlying trends in local currency. Also, our portfolio of active customers grew by an impressive 31% versus the prior year quarter which is quite encouraging”.

    Mr. Iglesias added, “Based on these results, we believe that we are on track to meet our net gaming revenue outlook of €220-230 million and Adj. EBITDA outlook of €10-15 million that we provided to investors earlier this year.”

    Recent Events

    Compliance with Nasdaq Listing Requirements

    • On May 1, 2025, the Company filed its 2023 annual report (ahead of the May 12th deadline) and on May 15th, Nasdaq informed the Company that it had regained compliance with applicable listing requirements.
    • The Company is actively working to complete the audit of its 2024 financial accounts and expects to file the 2024 annual report by the end of this month. However, as we did not file by May 15th (i.e. within the 15-day grace period provided for), we expect that a delisting notice from Nasdaq is forthcoming.
    • Upon receipt of said delisting notice, the Company will promptly request a hearing with the Nasdaq Hearings Panel and seek a stay of any trading suspension; however, the Company expects to file the 2024 annual report and regain compliance with Nasdaq requirements ahead of any hearing.

    Repurchases under the Share Buyback Plan

    • At a general meeting held on March 3, 2025, Codere Online shareholders authorized the repurchase of up to 1 million of the Company’s ordinary shares over a one-year period (for a total investment of up to $5.0 million, as approved by the Company’s Board of Directors).
    • The Company repurchased 68,384 shares at an average price of $6.63 under the authorized share buyback plan through May 15, 2025.


    Conference Call Information

    Codere Online’s management will host a conference call to discuss the results and provide a business update at 8:30 am US Eastern Time today, May 16, 2025. Dial-in details as well as the audio webcast and presentation will be accessible on Codere Online’s website at www.codereonline.com. A recording of the webcast will also be available following the conference call.

    Reconciliation of Revenue (IFRS) to Net Gaming Revenue (non-IFRS)

     Quarter ended March 31
    Figures in EUR mm20242025Chg. %
        
    Total   
        
    Revenue50.454.34%
    (+) Accounting Adjustments52.62.669%
    Net Gaming Revenue53.057.08%
        
    Spain   
        
    Revenue22.321.9(2%)
    (+) Accounting Adjustments5––n.m.
    Net Gaming Revenue22.321.9(2%)
        
    Mexico   
        
    Revenue23.827.616%
    (+) Accounting Adjustments52.72.97%
    Net Gaming Revenue26.630.515%
        
    Other   
        
    Revenue4.34.8(30%)
    (+) Accounting Adjustments5(0.2)(0.3)n.m.
    Net Gaming Revenue4.14.510%

    Reconciliation of Net Income (IFRS) to Adj. EBITDA (non-IFRS)6

     Quarter ended March 31
    Figures in EUR mm20242025Chg.
        
    Net Income (Loss)3.4(0.7)(3.4)
    (+/-) Provision for Corporate Income Tax0.50.2(0.1)
    (+/-) Interest Expense / (Income)(4.8)1.15.8
    (+/-) Var. In Fair Value of Public Warrants1.90.5(1.4)
    (+) D&A0.00.20.2
    EBITDA0.91.31.1
    (+) Employee LTIP Expense0.60.5(0.6)
    (+/-) Other Accounting Adjustments0.20.0(0.4)
    Adj. EBITDA (Pre Non-Recurring Items)1.71.80.1
    (+) Non-Recurring Items0.00.00.0
    Adj. EBITDA1.71.80.1

    About Codere Online

    Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online, launched in 2014 as part of the renowned casino operator Codere Group, offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere Online currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina; this online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.

    About Codere Group
    Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).

    Note on Rounding. Due to decimal rounding, numbers presented throughout this report may not add up precisely to the totals and subtotals provided, and percentages may not precisely reflect the absolute figures.

    Forward-Looking Statements
    Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans as well as he Company’s expectations about the timing of completion and filing of the Form 20-F for the year ended December 31, 2024 (the “2024 Annual Report”), and statements related to the Company’s plan, timing and actions taken to regain compliance with the Listing Rule 5250(c)(1).

    These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

    As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, (xii) the risk that Codere Online’s securities may be delisted from Nasdaq and (xiii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.

    Financial Information and Non-GAAP Financial Measures
    Codere Online’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), which can differ in certain significant respects from generally accepted accounting principles in the United States of America (“U.S. GAAP”).

    This document includes certain financial measures not presented in accordance with U.S. GAAP or IFRS (“non-GAAP”), such as, without limitation, net gaming revenue, Adjusted EBITDA and constant currency information. These non-GAAP financial measures are not measures of financial performance in accordance with U.S. GAAP or IFRS and may exclude items that are significant in understanding and assessing Codere Online’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to revenue, net income, cash flows from operations or other measures of profitability, liquidity or performance under U.S. GAAP or IFRS. You should be aware that Codere Online’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. In addition, the audit of Codere Online’s financial statements in accordance with PCAOB standards, may impact how Codere Online currently calculates its non-GAAP financial measures, and we cannot assure you that there would not be differences, and such differences could be material.

    Codere Online believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing Codere Online’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. These non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Reconciliations of non-GAAP financial measures to their most directly comparable measure under IFRS are included herein.

    This document may include certain projections of non-GAAP financial measures. Codere Online is unable to quantify certain amounts that would be required to be included in the most directly comparable U.S. GAAP or IFRS financial measures without unreasonable effort, due to the inherent difficulty and variability of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such comparable measures or such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, ascertained or assessed, which could have a material impact on its future IFRS financial results. Consequently, no disclosure of estimated comparable U.S. GAAP or IFRS measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.

    Use of Projections
    This document contains financial forecasts with respect to Codere Online’s business and projected financial results, including net gaming revenue and adjusted EBITDA. Codere Online’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this document, and accordingly, they did not express an opinion or provide any other form of assurance with respect thereto for the purpose of this document. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information. See “Forward-Looking Statements” above. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of Codere Online or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this document should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.

    For further information on the limitations and assumptions underlying these projections, please refer to Codere Online’s filings with the SEC.

    Preliminary Information
    This document contains figures, financial metrics, statistics and other information that is preliminary and subject to change (the “Preliminary Information”). The Preliminary Information has not been audited, reviewed, or compiled by any independent registered public accounting firm. This Preliminary Information is subject to ongoing review including, where applicable, by Codere Online’s independent auditors. Accordingly, no independent registered public accounting firm has expressed an opinion or any other form of assurance with respect to the Preliminary Information. During the course of finalizing such Preliminary Information, adjustments to such Preliminary Information presented herein may be identified, which may be material. Codere Online undertakes no obligation to update or revise the Preliminary Information set forth in this document as a result of new information, future events or otherwise, except as otherwise required by law. The Preliminary Information may differ from actual results. Therefore, you should not place undue reliance upon this Preliminary Information. The Preliminary Information is not a comprehensive statement of financial results, and should not be viewed as a substitute for full financial statements prepared in accordance with IFRS. In addition, the Preliminary Information is not necessarily indicative of the results to be achieved in any future period.

    No Offer or Solicitation
    This document does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

    Trademarks
    This document may contain trademarks, service marks, trade names and copyrights of Codere Online or other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this document may be listed without the TM, SM, © or ® symbols, but Codere Online will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.

    Industry and Market Data
    In this document, Codere Online relies on and refers to certain information and statistics obtained from publicly available information and third-party sources, which it believes to be reliable. Codere Online has not independently verified the accuracy or completeness of any such publicly-available and third-party information, does not make any representation as to the accuracy or completeness of such data and does not undertake any obligation to update such data after the date of this document. You are cautioned not to give undue weight to such industry and market data.

    Contacts:

    Investors and Media
    Guillermo Lancha
    Director, Investor Relations and Communications
    Guillermo.Lancha@codere.com
    (+34) 628.928.152

    1 Net Gaming Revenue is a non-IFRS measure; please see reconciliation of Net Gaming Revenue to Revenue at the end of the report.

    2 Adjusted EBITDA is a non-IFRS measure; please see reconciliation of Adjusted EBITDA to Net Income at the end of the report. Net gaming revenue and Adjusted EBITDA outlooks are forward-looking non-IFRS measures; please see important disclaimers at the end of the report.
    3 See “Preliminary Information” below.        

    4 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives.

    5 Figures primarily reflect differences in recognition of revenue related to certain partner and affiliate agreements in place in Colombia, VAT impact from entry fees in Mexico and the impact from the application of inflation accounting (IAS 29) in Argentina.

    6 Please refer to page 26 of our Q1 2025 Earnings Presentation for further details regarding this reconciliation.

    Source: Codere Online Luxembourg, S.A.

    Release – Comstock Announces Appointment of Chief Financial Officer

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on LODE

    VIRGINIA CITY, NEVADA, May 15, 2025 – Comstock Inc. (the “Company”) today announced that the Board of Directors has approved the appointment of Mr. Judd B. Merrill, as Chief Financial Officer of the Company and President of the Company’s wholly-owned mining subsidiary, Comstock Mining LLC, that, together with the Company’s other affiliated mining activities, controls all of the Company’s mineral exploration and mining assets. Mr. Merrill will assume his new role starting May 19, 2025.

    Mr. Merrill brings extensive public company mining and clean mineral technology industry experience to Comstock. Mr. Merrill, age 54, most recently served as Chief Financial Officer of Aqua Metals, Inc., (NASDAQ: AQMS), a Nevada-based metal recycling company, from November 2018 to May 2025.  Prior to joining Aqua Metals, Mr. Merrill was the Chief Financial Officer and the Director of Finance & Accounting at Klondex Mines Ltd., a North American based, publicly traded gold and silver mining company, listed on both the Toronto and New York Stock Exchanges. Mr. Merrill previously held financial management positions at Fronteer Gold Inc. and Newmont Mining Corporation and started his career as an auditor, working for the independent accounting firm of Deloitte and Touche LLP.

    Mr. Corrado De Gasperis, Executive Chairman and CEO, said, “We are thrilled to welcome Judd back to the Comstock. Judd is the ultimate systems-based, team-oriented professional, whose extensive Nevada-based mining, both explorational and transactional, with innovative clean technology, metal recycling and public company financial experience makes him an ideal member of our executive team.  His inclusion is especially significant as we capitalize, accelerate and expand our metal recycling business and prepare our teams to separate our renewable fuels business into a stand-alone, independent company.”

    Mr. Merrill was previously employed by the Company (then known as, Comstock Mining Inc.) for over six years, in positions of increasing responsibility, including Chief Financial Officer and Corporate Secretary and subsequently, as a director of our board.

    Mr. Merrill holds a Bachelor of Science in Accounting from Central Washington University and he received an M.B.A. from the University of Nevada, Reno and is a licensed Certified Public Accountant (“CPA”).

    Mr. Walter “Del” Marting, Chairman of the Audit Committee, commented, “Judd adds strong capacity and competency to every salient aspect of our financial organization, including liquidity and capital resource management, public company financial accounting and reporting, internal financial controls and regulatory compliance and his experience in metal-based business development makes a strong addition to the business teams.”

    About Comstock Inc.

    Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. 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:
    William McCarthy, Chief Operating Officer
    Tel (775) 413-6222
    ir@comstockinc.com

    For media inquiries:
    Tracy Saville, Director of Marketing
    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.