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Unicycive Therapeutics (UNCY) – CRL Letter Received As Second Manufacturer Generates Data

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, July 01, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Approval Delay Is Not A Surprise. Unicycive announced that it has received a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). This was expected following the announcement earlier this month stating that the FDA manufacturing inspection had found deficiencies with one of the OLC contract manufacturers. The company has switched to one of its other manufacturers, which we believe can resolve the issues quickly. We see approval possible around 4Q25 to 1Q26.

Plans To Address The Issues. Unicycive plans to hold a Type A meeting with the FDA to determine its requirements for resolution of the issues cited in the CRL. The company’s second manufacturer already produces OLC and has been generating data for FDA certification. This should allow Unicycive to submit any additional data requested quickly to resolve the issue.


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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Kratos Defense & Security (KTOS) – Completes $575 Million Capital Raise

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, July 01, 2025

Kratos Defense & Security Solutions, Inc. (NASDAQ:KTOS) develops and fields transformative, affordable technology, platforms, and systems for United States National Security related customers, allies, and commercial enterprises. Kratos is changing the way breakthrough technologies for these industries are rapidly brought to market through proven commercial and venture capital backed approaches, including proactive research, and streamlined development processes. At Kratos, affordability is a technology, and we specialize in unmanned systems, satellite communications, cyber security/warfare, microwave electronics, missile defense, hypersonic systems, training and combat systems and next generation turbo jet and turbo fan engine development. For more information go to www.kratosdefense.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

Capital Raise. Kratos completed its previously announced offering of Kratos common stock, raising  $575 million in gross proceeds, at a public offering price of  $38.50 per share, for a total of 14,935,065 shares of common stock, which includes the exercise of the underwriter’s option to purchase additional shares. Net proceeds from the offering were approximately  $556 million. Noble Capital participated as a co-manager of the offering.

Use of Proceeds. Kratos expects to use the net proceeds of the offering to (i) fund investments and capital expenditures to scale and successfully execute on large, mission critical National Security priorities related to existing programs, recent program awards and significant high-probability pipeline opportunities; (ii) to finance important customer and program targeted acquisitions; (iii) and for general corporate purposes.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Great Lakes Dredge & Dock (GLDD) – Some Award Updates

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, July 01, 2025

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

Awards. Yesterday, Great Lakes provided an update on some recent awards. Each of the awards adds to the Company’s significant backlog, which stood at approximately $1 billion with an additional $265 million in low bids and options pending award at the end of the first quarter. The large backlog, with a majority being higher margin capital projects, provides strong visibility for 2025 and into 2026.

Woodside LNG. The Company received Notice to Proceed from Bechtel Energy for dredging work on the Woodside Louisiana LNG project. The first phase of work, which was awarded in the second quarter of 2025, includes the construction of a ship berthing basin for use by large LNG carriers, with potential for award of two options to expand the scope of construction for additional ship berths. Dredging operations are expected to commence in early 2026.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Labor Market Shows Unexpected Strength as Job Openings Surge in May

Posted on by slightbourne@noblecapitalmarkets.com

The American labor market delivered a surprise in May, with job openings climbing to their highest point in over six months, according to fresh government data that has caught economists and Federal Reserve watchers off guard.

The Bureau of Labor Statistics reported Tuesday that available positions reached 7.76 million at the end of May, representing a substantial jump from April’s 7.39 million openings. This figure significantly exceeded analyst predictions, which had anticipated job openings would remain relatively flat at approximately 7.3 million positions.

The unexpected surge in available positions marks the strongest showing for job openings since November 2024, suggesting that despite broader economic uncertainties, employers continue to maintain robust demand for workers across various sectors.

While the job opening data painted an optimistic picture, other components of the Job Openings and Labor Turnover Survey revealed a more nuanced employment landscape. Hiring activity actually declined during the month, with companies bringing on 5.5 million new employees compared to 5.61 million in April. This translated to a hiring rate of 3.4%, down from the previous month’s 3.5%.

The data reveals what labor economists have characterized as a market in equilibrium, where demand for workers remains strong but actual hiring activity has moderated from the rapid pace seen in recent years. Both hiring and voluntary quit rates are currently operating near decade-low levels, indicating a more measured approach to job market transitions.

Interestingly, the quit rate—often viewed as a barometer of worker confidence—edged upward to 2.1% from April’s 2.0%. This modest increase suggests that while employees remain cautious about making career moves, some are beginning to show renewed confidence in finding alternative employment opportunities.

The labor market data arrives at a critical juncture for monetary policy discussions. Financial markets are closely monitoring employment trends as the Federal Reserve weighs potential interest rate adjustments in response to evolving economic conditions.

Current market expectations indicate approximately a 23% probability of a rate cut at the Fed’s July meeting, with odds rising to 96% for at least one reduction by the September meeting. The stronger-than-expected job opening figures could influence these calculations, as robust labor demand typically supports arguments against immediate monetary easing.

The employment picture becomes more complex when considering recent policy developments, including the implementation of new trade measures under the Trump administration. Economists are watching for any signs that tariff policies might be affecting hiring patterns or business confidence across different industries.

Market participants will receive additional labor market insights Thursday when the Bureau of Labor Statistics releases the comprehensive June employment report. Economists are forecasting a continued moderation in hiring activity, with projections calling for 110,000 new nonfarm payroll additions—a notable decline from recent months.

The unemployment rate is expected to tick slightly higher to 4.3%, which would represent a modest increase from the current 4.2% level. If these projections prove accurate, they would reinforce the narrative of a labor market that remains fundamentally healthy but is operating at a more sustainable pace than the breakneck hiring seen in the post-pandemic recovery period.

As one economist noted, while hiring activity remains below historical norms, the combination of low layoff rates and steady job creation suggests the labor market has achieved a state of relative stability rather than deterioration. This balance could prove beneficial for both workers and employers as the economy navigates ongoing policy transitions and global economic uncertainties.

Release – GoHealth Secures Amended Credit Agreement Highlighting Broad Based Support from Stakeholders

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Jun 30, 2025 at 4:30 PM EDT

CHICAGO, June 30, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO), a leading health insurance marketplace, today announced it has entered into an amendment with its lenders under the Company’s existing credit agreement in order to, among other things, provide covenant adjustments as well as extend the maturity of the Company’s revolving credit facility through September 30, 2025. The amendment also provides consent for the Company to pursue a receivables financing (such consent also covering a securitization transaction) as the parties continue to work toward a comprehensive financing plan intended to alleviate the Company’s recent going concern position, strengthen the Company’s financial foundation, provide flexibility and position GoHealth for future sustainable and cash generating growth.

“This amendment highlights broad-based support from stakeholders across the capital structure and allows the Company to focus on longer-term strategic priorities,” said Vijay Kotte, Chief Executive Officer of GoHealth. “For nearly a decade, GoHealth has been a leader in supporting Medicare consumers as they assess their benefit options and enroll in Medicare Advantage plans. These actions, announced today, and the expected subsequent transactions are intended to reinforce this leadership while positioning us well for the future.”

Additional terms of the amendment are set forth in GoHealth’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission on June 30, 2025.

About GoHealth

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com/.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding GoHealth’s future liquidity, going concern and related plans, the negotiation of a comprehensive financing plan, subsequent transactions and the pursuit of a receivables financing, results of operations and financial position, business strategy and plans and objectives of management for future operations are forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “aims,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although GoHealth believes that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements speak only as of the date of this press release and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the Company’s inability to alleviate the going concern, failure to obtain the benefits from the announced amendment, failure to pursue and secure a comprehensive financing plan, subsequent transaction or a receivables facility, failure to improve operational performance, the factors described in the sections titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in GoHealth’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Annual Report on Form 10-K”), Quarterly Report on Form 10-Q for the first quarter ended March 31, 2025 (“Q1 2025 Quarterly Report on Form 10-Q”) and in its other filings with the Securities and Exchange Commission. The factors described in GoHealth’s 2024 Annual Report on Form 10-K and the Q1 2025 Quarterly Report on Form 10-Q should not be construed as exhaustive and should be read together with the other cautionary statements included in this press release, as well as the cautionary statements and other risk factors set forth in our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that GoHealth references in this press release completely and with the understanding that its actual future results may be materially different from what it expects. GoHealth qualifies all of its forward-looking statements by these cautionary statements. Except as required by applicable law, GoHealth does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Release – CVG Announces Successful Completion of Debt Refinancing Transactions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVGI

June 30, 2025

Refinancing extends maturity to 2030 and increases flexibility

NEW ALBANY, OHIO, June 30, 2025 (GLOBE NEWSWIRE) — Commercial Vehicle Group (together with its subsidiaries, the “Company” or “CVG”) (NASDAQ: CVGI), a diversified industrial products and services company, today announced that on June 27, 2025 it had closed on $210 million in senior secured credit facilities, consisting of (i) a $95 million senior secured term loan facility (the “Term Loan”) with TCW Asset Management Company LLC (together with certain of its affiliates, the “TCW Group”), as agent, and (ii) a $115 million senior secured asset-based revolving credit facility (the “ABL Facility” and together with the Term Loan, the “Senior Secured Credit Facilities”) with Bank of America, N.A., as agent. The ABL Facility amended and restated the Company’s existing senior secured revolving credit facility with Bank of America, N.A., as agent (the “Existing Facility”), and a portion of the proceeds of the Senior Secured Credit Facilities was used to refinance outstanding obligations under the Existing Facility in an aggregate principal amount of $120,100,000.

Andy Cheung, Chief Financial Officer, said, “We are pleased to announce the successful refinancing of our debt facilities maturing in 2027, which marks an important milestone as we continue to advance our strategic operational initiatives. The new facilities provide a long runway of funding certainty and increased financial flexibility as we look to drive further cost reductions, margin improvement, and overall operational efficiency. Moving forward, we remain committed to deleveraging the balance sheet through free cash generation and disciplined debt paydown.”

Term Loan of $95 million

Obligations under the Term Loan will mature on June 27, 2030.

The Term Loan will have tiered interest costs based on the consolidated total leverage ratio ranging from SOFR plus 8.75% with a leverage ratio < 3.50x to SOFR plus 10.75% with a leverage ratio > 6.25x. The SOFR floor is 2.00%. The initial interest rate payable under the Term Loan is SOFR plus 9.75%.

Until June 28, 2028, voluntary prepayments of the Term Loan are subject to a premium, calculated as a percentage of the obligations so prepaid under the Term Loan, equal to (x) from June 27, 2025 until June 27, 2027, 4.00%, (y) from June 28, 2026 until June 27, 2028, 2.00% and (z) thereafter, none. The Term Loan is also subject to an excess cash flow sweep and certain other customary mandatory prepayment requirements.

The Term Loan will be subject to certain financial covenants:

  • a consolidated total leverage ratio covenant, tested quarterly, which will be initially set at 7.25x, with step-downs to 6.50x at December 31, 2025, 6.00x at March 31, 2026, 5.25x at June 30, 2026, and additional quarterly 0.25x step-downs until a ratio of 4.00x applicable from and after September 30, 2027.
  • a maximum consolidated capital expenditure covenant, capped at $20 million in any fiscal year, and a sublimit of $10 million for foreign capital expenditures.
  • a 30-day rolling minimum average liquidity requirement of $15 million.

ABL Facility of $115 million

Obligations under the ABL Facility will mature on June 27, 2030, springing to the date that is 91 days prior to the maturity of the Term Loan.

The initial principal amount of the ABL Facility is $115 million, subject to availability under a borrowing base based on the Company’s US and UK inventory and receivables. The ABL Facility comprises of a US subfacility in an initial principal amount of $100 million (the “US Subfacility”) and a UK subfacility in an initial principal amount of $15 million (the “UK Subfacility”), in each case subject to availability under their respective borrowing bases. The US Subfacility further has a FILO tranche in a principal amount of $12.5 million, subject to availability under its borrowing base.

The ABL Facility will be available in US Dollars, Pounds Sterling and Euros, and borrowings will accrue interest at SOFR, SONIA or EURIBOR, with margins based on average daily availability ranging from 1.50% if average daily availability > $50 million to 2.00% if average daily availability < $30 million. The FILO tranche will accrue interest at a 1% higher rate. The Company is also required to pay an unused line fee of 0.25% on any unutilized commitments under the ABL Facility.

The Company will be required to comply with a maximum fixed charge coverage ratio of 1.00x, tested quarterly, during any trigger period. Such period shall be triggered upon availability dropping below the greater of 10% of the line cap and $10 million, and such period shall end upon availability exceeding this threshold for 30 consecutive days.

Warrants

In connection with the financing, TCW Group affiliates received five-year warrants for the purchase of up to 3,934,776 shares of the company’s common stock, issued in two equal tranches. The tranches have an exercise price of $1.58 and $2.07, respectively. Until the fourth anniversary after issuance, the Company has the right to repurchase up to 50% of each tranche of warrants at a price equal to $1.40 or $1.00, respectively, above the applicable exercise price. Upon a refinancing of the new credit agreement, the holders can require the Company to repurchase up to 50% of each tranche at a price equal to the stock price of the common stock at the time of repurchase less the exercise price. The warrants contain customary anti-dilution adjustments. The Company has provided the holders with certain information and registration rights, including agreeing to file a registration statement within 45 days to register the resale of the shares underlying the warrants.

The Company will file a Current Report on Form 8-K with the United States Securities Exchange Commission that will contain further details regarding the terms of the of the transactions.

Company Contact
Andy Cheung
Chief Financial Officer
CVG
IR@cvgrp.com

Investor Relations Contact
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

About CVG

CVG is a global provider of systems, assemblies and components to the global commercial vehicle market and the electric vehicle market. We deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. These statements often include words such as “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions. In particular, this press release may contain forward-looking statements about the Company’s expectations for future periods with respect to its plans to improve financial results, the future of the Company’s end markets, changes in the Class 8 and Class 5-7 North America truck build rates, performance of the global construction and agricultural equipment business, the Company’s prospects in the wire harness, and electric vehicle markets, the Company’s initiatives to address customer needs, organic growth, the Company’s strategic plans and plans to focus on certain segments, competition faced by the Company, volatility in and disruption to the global economic environment and the Company’s financial position or other financial information. These statements are based on certain assumptions that the Company has made in light of its experience as well as its perspective on historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from the anticipated results because of certain risks and uncertainties, including those included in the Company’s filings with the SEC. There can be no assurance that statements made in this press release relating to future events will be achieved. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on behalf of the Company are expressly qualified in their entirety by such cautionary statements.

Primary Logo

Source: Commercial Vehicle Group, Inc.

The Strategic Imperative: Why European Healthcare and Life Sciences Companies Should Look To The U.S. Now

Posted on by slightbourne@noblecapitalmarkets.com

In a global economy reshaped by innovation and evolving policy, European Healthcare and Life Sciences companies have a unique opportunity to accelerate growth by investing in the U.S. middle market. Our new thought leadership series—developed by leading M&A professionals from CNM LLP, Cozen O’Connor, NOBLE Capital Markets, and Pathfinder Advisors LLC—dives into the strategic, operational, and financial reasons why the time to act is now.

🔹 Compressed U.S. valuations + innovation-rich sectors
🔹 Favorable budgetary, regulatory, and M&A conditions
🔹 Cross-border synergies driving sustainable global health outcomes

This first installment lays out the business case, key advantages, and regulatory shifts creating ripe conditions for transatlantic healthcare deals. Don’t miss these insights—and get ready for the July 24 webinar that takes the conversation further.

📘 Read the full article

🎙️ Save the Date: July 24 – Expert Webinar

Comstock Set to Join Russell Microcap® Index

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

Virginia City, NV (June 30, 2025) — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) announced today that it is set to join the Russell Microcap® Index at the conclusion of the 2025 Russell Microcap Index’s annual reconstitution, effective after the U.S. market opens on June 30, 2025. Membership in the Russell Microcap Index means automatic inclusion in the appropriate growth and value indexes. FTSE Russell determines membership for its indices primarily by objective, market-capitalization rankings and style attributes.

“Our representation in the Russell Microcap Index independently recognizes our progress and growing value and positions our already appreciating capital base for the next phase of our growth,” stated Corrado De Gasperis, Comstock’s Executive Chairman and CEO. “Our innovations and leadership in creating truly sustainable supply chains, across industries, is just getting realized, and we are truly grateful for this meaningful recognition.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $18.1 trillion in assets are benchmarked against Russell’s U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell Microcap® Index, go to the “Russell Reconstitution” section on the FTSE Russell website.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries and contribute to energy abundance by efficiently extracting and converting under-utilized natural resources into reusable electrification metals, like aluminum, copper and silver, from end-of-life photovoltaics,.

To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

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

Contacts

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

For media inquiries:
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 – Great Lakes Announces Receipt of Four Dredging Awards including Woodside Louisiana LNG

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GLDD

Jun 30, 2025

PDF Version

HOUSTON, June 30, 2025 (GLOBE NEWSWIRE) — Great Lakes Dredge & Dock Corporation (“Great Lakes” or the “Company”) (NASDAQ: GLDD), the largest provider of dredging services in the United States, announced today the receipt of four work awards.

The awarded work includes:

  • Woodside Louisiana LNG (Capital, Louisiana, amount undisclosed)
  • Galveston Entrance Channel and Houston Ship Channel from Bolivar to Redfish (Maintenance, Texas, $36.2 million)
  • Mississippi River Hopper Dredge Contract No. 3 (Rental, Louisiana, $17.6 million)
  • Charleston Entrance Channel (Maintenance, South Carolina, $10.8 million)

GLDD has received Notice to Proceed from Bechtel Energy for dredging work on the Woodside Louisiana LNG project, in the vicinity of Lake Charles, LA, along the Calcasieu River ship channel. The first phase of work, which was awarded in the second quarter of 2025, includes construction of a ship berthing basin for use by large LNG carriers, with potential for award of two options to expand the scope for construction of additional ship berths. All dredged materials will be placed into designated Beneficial Use of Dredged Material (BUDM) areas for marshlands restoration, providing ecological benefit and storm surge protection for the surrounding area. Dredging operations are expected to commence early 2026.

The Galveston Entrance Channel and Houston Ship Channel from Bolivar to Redfish maintenance project, which was awarded in the second quarter of 2025, involves dredging to maintain operating depths for the channel area. Suitable maintenance material dredged from specific sections of the channel will be disposed of on Galveston Island Beach for beneficial use. The client on this project is the U.S. Army Corps of Engineers, Galveston District. The project is funded by both the Federal Government and the City of Galveston, in partnership with the General Land Office (GLO). Work is expected to start in the third quarter of 2025 with estimated completion in the fourth quarter of 2025.

The Mississippi River Hopper Dredge Contract No. 3, which was won and awarded in the second quarter of 2025, involves rental of a trailing suction hopper dredge for maintenance dredging on the Mississippi River from Baton Rouge to Gulf of Mexico Southwest Pass. The client on this project is the U.S. Army Corps of Engineers, New Orleans District and is federally funded. Work started in May of 2025.

The Charleston Entrance Channel project, which was included in the fourth quarter 2024 low bids pending award and awarded in the first quarter, involved dredging to maintain operating depths for the channel. The client on this project was the U.S. Army Corps of Engineers and was federally funded. Work started in the first quarter of 2025 and was completed in the second quarter of 2025.

Lasse Petterson, President and Chief Executive Officer commented, “These projects enable Great Lakes to play a vital role in enhancing the resilience and sustainability of the nation’s environment, coastlines, and critical infrastructure. We have also strengthened our presence in the LNG and broader energy sector with our award of Woodside Louisiana LNG. These initiatives are essential to advancing U.S. energy infrastructure, supporting increased export capacity, and aligning with national energy security priorities. These four awards contribute to the growth of our 2025 dredging backlog, further solidifying our revenue visibility for the remainder of the year and into 2026.”

The Company
Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States, which is complemented with a long history of performing significant international projects. In addition, Great Lakes is fully engaged in expanding its core business into the offshore energy industry. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 135-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking” statements as defined in Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), the Private Securities Litigation Reform Act of 1995 (the “PSLRA”) or in releases made by the Securities and Exchange Commission (the “SEC”), all as may be amended from time to time. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of Great Lakes and its subsidiaries, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements that are not historical fact are forward-looking statements. These cautionary statements are being made pursuant to the Exchange Act and the PSLRA with the intention of obtaining the benefits of the “safe harbor” provisions of such laws. Great Lakes cautions investors that any forward-looking statements made by Great Lakes are not guarantees or indicative of future events.

Although Great Lakes believes that its plans, intentions and expectations reflected in this press release are reasonable, actual events could differ materially. The forward-looking statements contained in this press release are made only as of the date hereof and Great Lakes does not have or undertake any obligation to update or revise any forward-looking statements whether as a result of new information, subsequent events or otherwise, unless otherwise required by law.

For further information contact:
Eric Birge
Vice President of Investor Relations
313-220-3053

Release – Codere Online Reports Favorable AGM Results and Changes to its Compliance Committee

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CDRO

06/30/2025

Luxembourg, Grand Duchy of Luxembourg, June 30, 2025 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, today announced the favorable resolution of all 24 agenda items at the Annual General Meeting (“AGM”) held today at the registered office of the Company, including the confirmation and renewal of all currently serving Board members, thereby maintaining the existing composition of the Board.

For detailed biographies of the members of our Board of Directors please visit our website.

Appointment of A.G. Burnett as Chairman of the Compliance Committee

In the Board of Directors meeting held earlier this month ahead of the AGM, A.G. Burnett was appointed as Chairman of the Compliance Committee, effective July 1, 2025. Rafael Catalá and Yaiza Rodríguez will continue to serve as members.

Mr. Burnett brings over 20 years of experience in gaming regulation and law, including his service as Chairman and Executive Director of the Nevada Gaming Control Board (“GCB”) from 2012 to 2017. Prior to that, he served as a Board Member and Deputy Chief of the GCB’s Corporate Securities Division, as well as Senior Deputy Attorney General representing the GCB and the Nevada Gaming Commission.

Mr. Burnett is a recognized professional in gaming law, regulatory compliance, enforcement, legislative affairs, AML, and sports betting law and regulation. He currently serves as a Partner at McDonald Carano, where he advises gaming clients on a wide range of regulatory and compliance matters. A graduate of Gonzaga University School of Law, Mr. Burnett holds leadership and advisory roles with several industry groups, including the International Association of Gaming Advisors, the International Masters of Gaming Law, and the UNLV’s Boyd School of Law Gaming Law Advisory Board.

Mr. Burnett succeeds Mark Dunn as chairman of the Compliance Committee. We extend our sincere thanks to Mr. Dunn for his outstanding contribution as member and Chair of the Compliance Committee. From his appointment as member of the Compliance Committee in 2022, his dedication and integrity have been instrumental in shaping a strong compliance culture across the Company, and we are very grateful for his service.

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. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina. Codere Online’s 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).

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.

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, and (xii) 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.

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.

Contacts:

Investors and Media
Guillermo Lancha
Director, Investor Relations and Communications
Guillermo.Lancha@codere.com
(+34) 628 928 152

Release – Kratos Defense & Security Solutions, Inc. Announces Completion of Public Offering of $575 Million of Common Stock at $38.50 Per Share

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KTOS

June 30, 2025 at 8:00 AM EDT

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SAN DIEGO, June 30, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (“Kratos”) (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Commercial Markets, today announced that it has completed its previously announced offering of Kratos common stock, raising $575,000,000 in gross proceeds, at a public offering price of $38.50 per share, for a total of 14,935,065 shares of common stock, which includes the exercise of the underwriters option to purchase additional shares. Net proceeds from the offering, after deducting underwriting discounts and commissions and related fees, are approximately $556 million.

Kratos expects to use the net proceeds of the offering to (i) fund investments and capital expenditures to scale and successfully execute on large, mission critical National Security priorities related to existing programs, recent program awards and significant high-probability pipeline opportunities; (ii) to finance important customer and program targeted acquisitions; (iii) and for general corporate purposes, including pay-down of debt and to pay fees and expenses in connection with the offering.

Eric DeMarco, Kratos’ President and CEO, said, “There is a generational, global recapitalization of technologically advanced strategic weapon systems underway, which Kratos is uniquely positioned to successfully execute on. We raised this capital to ensure that Kratos has the capability to move quickly, scale and successfully execute on large mission critical, National Security priorities. We have a significant number of new, substantial opportunities we expect to be successful on over the next 12 months, we expect our opportunity pipeline to continue to grow – and we must be ready.”

The securities described above were offered by Kratos pursuant to an effective registration statement previously filed with the U.S. Securities and Exchange Commission. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements relate to a variety of matters including, without limitation, Kratos’ expectations regarding the use of the proceeds from the public offering, the pipeline for opportunities, and Kratos’ success with respect to such opportunities, as well as other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements including, but not limited to: risks and uncertainties related to market conditions as well as general economic factors. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Burghoff
claire.burghoff@kratosdefense.com

Investor Information:
877-934-4687
investor@kratosdefense.com

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Source: Kratos Defense & Security Solutions, Inc.

Release – V2X Awarded New Foreign Military Sales Contract Supporting Iraq’s F-16 Program

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

Research News and Market Data on VVX

June 30, 2025

RESTON, Va., June 30, 2025 /PRNewswire/ — V2X Inc., (NYSE: VVX) has been awarded a new cost-plus-fixed-fee undefinitized contract to provide support services for the Iraq F-16 program.

The initial contract value is $118 million to support an immediate start with full definitization of the contract before the end of 2025. The full period of performance of the contract is expected to be five years. 

The contract, awarded under the Foreign Military Sales program, includes comprehensive base operations, life support services, and other operations. Work will be performed at Martyr BG Ali Flaih Air Base in Iraq.

“This award is a testament to the strength of V2X’s full-spectrum capabilities,” said Ken Shreves, Senior Vice President of Mission Support at V2X. “We are honored to have been selected to deliver this critical strategic capability to the Iraqi Air Force in this high-stakes environment.”  

Jeremy C. Wensinger, President and Chief Executive Officer of V2X added, “This award reflects our ability to leverage a broad portfolio of capabilities and our global footprint into larger and more strategic opportunities. Foreign military sales and international markets represent a significant and growing area of opportunity for V2X.”  

V2X brings decades of experience enabling complex missions from start to finish in global theaters across air, land, sea, space, and cyber domains. 

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

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

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-awarded-new-foreign-military-sales-contract-supporting-iraqs-f-16-program-302494078.html

SOURCE V2X, Inc.

Release – Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

June 30, 2025 7:05am EDT Download as PDF

–Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC)

–No other concerns stated, including pre-clinical, clinical, or safety data

–The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL

–The Company plans to immediately request a Type A meeting with the FDA to align on next steps

–Unicycive currently has an unaudited cash balance of approximately $20.7 million, with cash runway currently expected into the second half of 2026

LOS ALTOS, Calif., June 30, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.”

After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection. This citation is unrelated to OLC. Unicycive also notes that as part of the NDA review, the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself.

As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. The second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.

About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

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, please visit Unicycive.com and follow us on LinkedIn and X.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.

Investor Contact:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:
Rachel Visi
Real Chemistry
redery@realchemistry.com

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Source: Unicycive Therapeutics, Inc.

Released June 30, 2025