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Oil Prices Climb Amid Geopolitical Uncertainty and Sanction Risks

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Oil rises on U.S.-Iran tensions and Russia sanctions threat.
– OPEC+ holds steady but may boost output in July.
– Prices stay volatile amid supply risks and demand concerns

Oil prices edged higher Wednesday as traders reacted to a flurry of geopolitical developments that could disrupt supplies from two of the world’s key producers: Russia and Iran.

West Texas Intermediate (WTI) crude rose by 1.6%, settling just below $62 a barrel. The gains came as U.S. President Donald Trump warned that Russian President Vladimir Putin was “playing with fire” following a recent escalation of attacks in Ukraine. The remarks have fueled speculation that Washington could impose fresh sanctions on Russia’s energy sector — a move that would likely reduce Russian oil exports and tighten global supply.

Earlier this year, similar sanctions helped push crude prices above $80 per barrel before prices retreated amid growing fears of oversupply and global economic uncertainty. Although talks between Russia and Ukraine are scheduled to resume in Istanbul on June 2, markets remain on edge over the potential fallout of continued conflict.

Adding to the market tension is mounting uncertainty over Iran’s nuclear program. According to The New York Times, Israeli Prime Minister Benjamin Netanyahu has threatened military action that could target Tehran’s nuclear infrastructure, potentially derailing ongoing negotiations between Iran and the United States. A breakdown in talks could further hinder Iran’s ability to export oil, tightening the global supply picture.

Still, market optimism is tempered by bearish pressures, particularly around the role of the OPEC+ alliance. On Wednesday, the group ratified its existing production quotas through the end of next year, even as eight key member countries prepare for another round of discussions this weekend. Insiders say some members are pushing for a third consecutive monthly production hike starting in July.

“The early confirmation of quotas puts added pressure on this weekend’s decision,” said Robert Yawger, director of energy futures at Mizuho Securities USA. “The market is essentially at the mercy of OPEC on Saturday.”

Rising output from OPEC+ — particularly from members reviving previously idled capacity — has stoked concerns about oversupply. Some segments of the Brent futures curve have flipped into contango, a market condition where future prices are higher than current prices, signaling a supply glut.

Despite the recent uptick, oil prices have trended downward since mid-January, weighed down by global trade tensions, including sweeping tariffs introduced by the Trump administration and retaliatory measures from affected countries. These trade frictions have stoked fears of slower economic growth and weaker demand for fuel.

However, with tentative signs of easing trade disputes and renewed geopolitical risk in oil-producing regions, analysts say the next few weeks will be crucial in determining the market’s direction.

“Oil is being pulled in opposite directions,” said one market strategist. “If sanctions tighten and diplomacy falters, prices could surge. But if OPEC turns on the taps and global growth stalls, we could be looking at a very different scenario.”

Release – XCEL BRANDS, INC. Receives NASDAQ notice regarding delinquent Form 10-K and Form 10-Q filing

Posted on by aweinsoff@channelchek.com

Research News and Market Data on XELB

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NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), today announced that on May 22, 2025, it received a delinquency notification letter from the Nasdaq Stock Market LLC (“Nasdaq”) indicating that since Nasdaq has not received the Company’s Form 10-Q for the period ended March 31, 2025 indicating that, and because the Company remains delinquent in filing its Form 10-K for the year ended December 31, 2024, does not comply with Nasdaq’s Listing Rules for internal listing. The Nasdaq notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.

Nasdaq has informed the Company that in accordance with its April 29, 2025 letter to the Company that the Company has until June 30, 2025 to submit a plan (the “Plan”) to regain compliance with respect to the delinquent reports and that any exception to allow the Company to regain compliance, if granted, will be limited to October 13, 2025. The Company filed the delinquent Form 10-K on May 28, 2025 and intends to file the delinquent Form 10-Q as soon as practicable and, in any event, on or prior to June 30, 2025 and thereby regain compliance with the Nasdaq continued listing requirements and eliminate the need for the Company to submit a Plan.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the Tower Hill by Christie Brinkley co-branded collaboration, and holds noncontrolling interests in the Isaac Mizrahi brand and Orme Live. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, and over 20,000 hours of live-stream and social commerce. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. www.xcelbrands.com

For further information please contact:

Seth Burroughs
Marketing and Public Relations, Xcel Band, Inc..
347 532 5894
sburroughs@xcelbrands.com

Release – Graham Corporation Announces Fourth Quarter Fiscal Year 2025 Financial Results Conference Call and Webcast

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GHM

May 28, 2025 8:00am EDT Download as PDF

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM), a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries, announced that it will release its fourth quarter and fiscal year 2025 financial results before financial markets open on Monday, June 9, 2025.

The Company will host a conference call and webcast to review its financial and operating results, strategy, and outlook. A question-and-answer session will follow.

Fourth Quarter Fiscal Year 2025 Financial Results Conference Call

Monday, June 9, 2025
11:00 a.m. Eastern Time
Phone: (201) 689-8560
Internet webcast link and accompanying slide presentation: ir.grahamcorp.com

A telephonic replay will be available from 3:00 p.m. ET on the day of the teleconference through Monday, June 16, 2025. To listen to the archived call, dial (412) 317-6671 and enter conference ID number 13753289 or access the webcast replay via the Company’s website at ir.grahamcorp.com, where a transcript will also be posted once available.

ABOUT GRAHAM CORPORATION
Graham is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy and process industries. Graham Corporation and its family of global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems.

Graham routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

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

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

Source: Graham Corporation

Released May 28, 2025

Release – Xcel Brands, Inc. Announces Fourth Quarter and Year-End 2024 Financial Results, Shows Improvements as a Result of Its “Project Fundamentals” Restructuring Program

Posted on by aweinsoff@channelchek.com

Research News and Market Data on XELB

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  • Fourth quarter 2024 net loss of $7.1 million, compared with a net loss of $6.8 million for the prior year quarter.
  • Net loss on a non-GAAP basis was $1.6 million for the fourth quarter 2024, representing a 53% improvement from the fourth quarter of 2023 non-GAAP net loss of $3.5 million.
  • Net loss on a non-GAAP basis was $5.1 million for the full year 2024, representing a 58% improvement from 2023 non-GAAP net loss of $12.2 million.
  • Adjusted EBITDA for the fourth quarter 2024 was negative $0.8 million, compared with Adjusted EBITDA of negative $1.2 million for the fourth quarter 2023, representing a 31% improvement.
  • Adjusted EBITDA for the full year 2024 was negative $3.5 million, compared with Adjusted EBITDA of negative $5.7 million for 2023, representing a 40% improvement.

NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company with significant expertise in livestream shopping and social commerce, today announced its financial results for the quarter ended March 31, 2025, and the quarter and fiscal year ended December 31, 2024.

Robert W. D’Loren, Chairman and Chief Executive Officer of Xcel commented, “Despite headwinds in the industry from tariffs and other external forces, I am extremely pleased with where we are headed given our recent new brand launches. The social media following of our brand portfolio has grown from 5 million to 45 million followers over the past five months. We believe this positions us well to drive new business growth and is a significant step toward our goal of reaching 100 million followers across our brands”.

Fourth Quarter 2024 Financial Results

Total revenue for the fourth quarter of 2024 was $1.2 million, representing a decrease of approximately $1.1 million (-47%) from the fourth quarter of 2023. This decrease was predominantly driven by a decline in net licensing revenue – specifically, the June 30, 2024 divestiture of the Lori Goldstein brand, partially offset by increased licensing revenues generated by the Company’s other brands.

Net loss attributable to Xcel Brands stockholders for the quarter was approximately $7.1 million, or $(3.00) per share, compared with a net loss of $6.8 million, or $(3.43) per share, for the prior year quarter.

After adjusting for certain cash and non-cash items, results on a non-GAAP basis were a net loss of approximately $1.6 million, or $(0.69) per share for the current quarter and a net loss of approximately $3.5 million, or $(1.76) per share, for the prior year quarter.

Adjusted EBITDA also improved on a year-over-year basis, from negative $1.2 million in the prior year quarter to negative $0.8 million for the current quarter – an improvement of 31%.  

Full Year 2024 Financial Results

Total revenue for the fiscal year was $8.3 million, representing a decrease of approximately $9.5 million (-53%) from fiscal year 2023. This decline was predominantly driven by the decrease in net product sales due to the Company’s discontinuance of its wholesale businesses as part of its Project Fundamentals plan in 2023.

Net loss attributable to Xcel Brands stockholders for the year ended December 31, 2024, was approximately $22.4 million, or $(9.84) per share, compared with a net loss of $21.1 million, or ($10.68) per diluted share, for the prior year. The fiscal year 2024 period includes significant one-off non-cash items, including a $3.8 million gain on the divestiture of the Lori Goldstein brand, a $3.5 million charge related to the exit and sublease of the Company’s prior office space, and $10.0 million of charges stemming from the valuation of and contractual contingent obligations related IM Topco, LLC.

After adjusting for certain cash and non-cash items, results on a non-GAAP basis were a net loss of approximately $5.1 million, or ($2.23) per share for the current year and a net loss of approximately $12.2 million, or ($6.17) per share, for the prior year.

Adjusted EBITDA improved significantly on a year-over-year basis, from negative $5.7 million in fiscal year 2023 to negative $3.5 million for fiscal year 2024; this 40% improvement was attributable to the restructuring of the business and entry into the new long-term license agreements in 2023 for the Halston, Judith Ripka, C Wonder, and Longaberger brands.

Balance Sheet

The Company’s balance sheet at December 31, 2024, reflected stockholders’ equity of approximately $28 million, unrestricted cash and cash equivalents of approximately $1.3 million, and a working capital (exclusive of the current portion of lease obligations, deferred revenue, and contingent obligations payable in shares or via other non-cash means) of approximately $1.0 million. The Company’s balance sheet at December 31, 2024, also reflected $6.6 million of long-term debt.

In April 2025, the Company refinanced its term loan debt, resulting in a net increase of approximately $3.0 million in the Company’s liquidity.

Conference Call and Webcast

The Company will host a conference call with members of the executive management team to discuss these results and together with the first quarter of 2025 results. Details of the date and time of this call will be released shortly

About Xcel Brands

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

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including statements regarding future events, our future financial performance, business strategy and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “ongoing,” “could,” “estimates,” “expects,” “intends,” “may,” “appears,” “suggests,” “future,” “likely,” “goal,” “plans,” “potential,” “projects,” “predicts,” “seeks,” “should,” “would,” “guidance,” “confident” or “will” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding our anticipated revenue, expenses, profitability, strategic plans and capital needs. These statements are based on information available to us on the date hereof and our current expectations, estimates and projections and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors, including, without limitation, the risks discussed in the “Risk Factors” section and elsewhere in the Company’s Annual Report on form 10-K for the year ended December 31, 2023 and its other filings with the SEC, which may cause our or our industry’s actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws, we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.

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

View full release here.

Seanergy Maritime (SHIP) – Better-than-Expected First Quarter Results

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, May 28, 2025

Seanergy Maritime Holdings Corp. is a prominent pure-play Capesize shipping company listed in the U.S. capital markets. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 18 vessels (1 Newcastlemax and 17 Capesize) with an average age of approximately 13.4 years and an aggregate cargo carrying capacity of approximately 3,236,212 dwt. Upon completion of the delivery of the previously announced Capesize vessel acquisition, the Company’s operating fleet will consist of 19 vessels (1 Newcastlemax and 18 Capesize) with an aggregate cargo carrying capacity of approximately 3,417,608 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP”.

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

Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.

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

First quarter results. Seanergy reported first-quarter net revenues of $24.2 million, slightly ahead of our estimate of $23.5 million, due to a higher-than-expected time charter equivalent (TCE) rate. Adjusted EBITDA and earnings per share (EPS) were $8.0 million and a loss of $0.27, respectively, compared to our estimates of $6.1 million and a loss of $0.38. The better-than-anticipated results are reflective of higher revenues as well as lower costs due to savings in general and administrative expenses.

Updating estimates. We are increasing our 2025 revenue estimates to $142.9 million from $142.5 million. Additionally, we are raising our adjusted EBITDA and EPS estimates to $70.5 million and $0.74, respectively, up from $68.1 million and $0.59. These revisions are reflective of management’s guidance of better-than-expected TCE rates and fewer dry-docking days, resulting in higher operating days and lower expenses.


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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. 

Graham (GHM) – Awarded Large Follow-on Contract

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, May 28, 2025

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

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

Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.

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

New Award. Yesterday, Graham announced that its Barber-Nichols subsidiary was awarded a $136.5 million follow-on contract to support the U.S. Navy’s Virginia Class Submarine program. This new award strengthens Graham’s position as a critical supplier to the U.S. Navy’s undersea programs.

Details. The contract period of performance extends from April 2025 through February 2034. Graham recognized approximately $50 million in backlog from the contract during the fourth quarter of the fiscal year ended March 31, 2025 to procure long-lead-time materials. As a reminder, the backlog at the end of the fiscal third quarter totaled $384.7 million, just below a record high.


Get the Full Report

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

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

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

SunCoke Energy Expands Steel Industry Footprint with $325M Acquisition of Phoenix Global

Posted on by slightbourne@noblecapitalmarkets.com

SunCoke Energy, Inc. (NYSE: SXC), a leading U.S. producer of high-quality metallurgical coke and logistics services, has announced a definitive agreement to acquire Phoenix Global for $325 million. The all-cash deal will significantly expand SunCoke’s presence in the steel value chain, diversify its customer base, and accelerate international growth.

Phoenix Global, a privately held company operating under Flame Aggregator, LLC, is a mission-critical service provider to top global steel producers. The company operates across 19 mill sites in North America, Brazil, Europe, and South Africa, offering services such as molten slag handling, scrap metal processing, and logistics for steelmaking inputs and outputs.

The acquisition marks a strategic shift for SunCoke, as it moves beyond traditional blast furnace-focused services into supporting electric arc furnace (EAF) operators, including both carbon and stainless steel producers. With the global steel industry increasingly transitioning toward more energy-efficient EAF technology, this move positions SunCoke at the forefront of evolving demand.

The purchase price implies a 5.4x multiple on Phoenix’s last twelve months (LTM) adjusted EBITDA of $61 million, as of March 31, 2025. SunCoke will finance the transaction using a mix of existing cash and availability under its undrawn revolving credit facility. The deal is expected to be immediately accretive to SunCoke’s earnings and to deliver annual synergies of $5 million to $10 million.

“This acquisition is a powerful step forward for SunCoke,” said Katherine T. Gates, President and CEO of SunCoke Energy. “Phoenix brings an impressive asset base, a global footprint, and long-term customer contracts that complement our current operations. This merger strengthens our role as a critical partner in the steel industry while expanding our reach into new markets and technologies.”

Phoenix has invested approximately $72 million in capital improvements since 2023, ensuring the durability and efficiency of its operations. Its revenue model, based on long-term contracts with fixed components, adds predictable earnings for SunCoke and reduces exposure to commodity price volatility.

The deal has been unanimously approved by the boards of directors of both companies and is backed by a majority of Phoenix’s unitholders. Completion is expected in the second half of 2025, pending customary regulatory approvals, including antitrust clearance under the Hart-Scott-Rodino Act.

Analysts see the acquisition as a strategic masterstroke for SunCoke, enabling the company to leverage its technical expertise, strong financial profile, and sustainable infrastructure into adjacent industrial services. Moreover, SunCoke’s expansion into global markets and EAF-related services could open new avenues for organic growth and customer engagement.

With this acquisition, SunCoke not only solidifies its position in the North American steel supply chain but also extends its reach as a global service provider committed to innovation, sustainability, and long-term value creation.

Release – MustGrow Announces Record Q1-2025 Results:$3.8 Million Revenue, 14.3% Gross Profit Margin,$4.4 Million in Cash and Inventory

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

Investor Webcast: Wednesday, May 28th at 4:00pm ET / 1:00pm PT

Register/View Here: https://us02web.zoom.us/webinar/register/6217478678603/WN_h8uMVWINQsmS3HWF8K59Wg

Please join/register at least 5 minutes prior to the call.

Questions emailed to info@mustgrow.ca will be addressed during the Q&A portion of the webcast.

SASKATOON, Saskatchewan, Canada, May 27, 2025 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”), a leading provider of biological and regenerative agriculture solutions, is pleased to announce its operating and financial results for the three months ended March 31, 2025. For complete details, please refer to the Q1-2025 Condensed Interim Financial Statements and associated Management’s Discussion and Analysis, available on SEDAR+: www.sedarplus.ca or on the Company’s website: www.mustgrow.ca.

Key Financial Highlights:

  • Sales revenue of $3.8 million was recorded in Q1-2025 vs. zero in Q1-2024
  • Gross profit of $541,221 (14.3% gross profit margin) in Q1-2025(1)
  • Cash and equivalents on hand as at March 31, 2025 was $2.0 million with Inventory of $2.4 million
  • Net loss for the three-month period ended March 31, 2025 was $1.6 million and the net loss per share was $0.03 (basic) for the same period

“Our 2025 first quarter marked a pivotal milestone for MustGrow, reflecting the first full quarter of revenue since the acquisition of the NexusBioAg sales and distribution business on December 31, 2024,” stated Corey Giasson, President and CEO of MustGrow. “$3.8 million is a meaningful revenue figure for us, and with additional products already secured for the NexusBioAg distribution platform and increasing commercial farmer interest in our TerraSanteTM U.S. biofertility product, we are accelerating our mission to improve the global food system through sustainable production solutions.”

The Company continues to focus on capital allocation that generates revenue and revenue growth of both its NexusBioAg Canadian sales and distribution business and TerraSanteTM biofertility sales in the United States.

In the first quarter, MustGrow secured access to several additional agriculture products through its NexusBioAg sales and distribution platform in Canada, including a five-year exclusive distribution agreement with Adjuvants Plus Inc. (a Canadian regenerative agriculture company) and the addition of three new biological solutions to its product lines designed to enhance crop health, boost yield potential, and improve environmental resilience: EZ-Gro Max, EZ-Gro Cyto, and Rootella® mycorrhizal inoculants. MustGrow is continually working on securing new and meaningful products for Canadian farmers. More information is available on the NexusBioAg website: nexusbioag.com.

Notes:

  1. Gross margin is a non-IFRS financial measure. This ratio expresses gross profit as a percentage of revenue for a given period. It assists in explaining the Company’s results from period to period and measuring profitability. This ratio is calculated by dividing gross profit for a period by the corresponding revenue for the period. There is no directly comparable IFRS measure.

About MustGrow

MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 112 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 52.4 million common shares issued and outstanding and 59.4 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

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

MustGrow Forward-Looking Statements

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

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

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

© 2025 MustGrow Biologics Corp. All rights reserved.

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

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

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

The updated release reads:

MAIA BIOTECHNOLOGY ANNOUNCES PRIVATE PLACEMENT OF APPROXIMATELY $695,000

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

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

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

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

Source: MAIA Biotechnology, Inc.

Released May 27, 2025

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

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

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

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

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

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

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

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

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

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

May 27, 2025 10:39 ET 

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

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

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

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

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

For SKYX’s Technologies Video Link CLICK HERE

About SKYX Platforms Corp.

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

Forward-Looking Statements

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

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

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GHM

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

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

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

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

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

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

About Graham Corporation

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

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

Safe Harbor Regarding Forward Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

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

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

Key Performance Indicator

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

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

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

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

Source: Graham Corporation

Released May 27, 2025

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

May 27, 2025

PDF Version

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

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

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

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

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

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

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

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

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

Cautionary Note on Forward-Looking Statements

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

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