Author: aweinsoff@channelchek.com

Release – Former Amazon E-Commerce Director Huey Long Joins SKYX to Lead Its E-Commerce Platform, Expanding SKYX’s Market Penetration Across Its 60 Lighting and Home Décor Websites Among Other E-Commerce Leading Channels

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SKYX

March 03, 2025 09:20 ET 

Mr. Long’s Proven Track Record in Driving E-Commerce Growth and Innovation Includes Leadership Roles at Walmart, Ashley Furniture, and Amazon

Mr. Long will Collaborate with the Existing E-commerce Management Team and Founders to Expand SKYX ‘s Sales and Market Penetration of Its Disruptive Advance and Smart Home Plug & Play Technologies in the U.S. and Canadian Markets

MIAMI, March 03, 2025 (GLOBE NEWSWIRE) — SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive advanced and smart home platform technology company for homes and buildings, with more than 97 issued and pending patents globally and a portfolio of over 60 lighting and home décor websites, announces today that Huey Long, former Director of Amazon E-Commerce, Senior Vice President of Walmart, and Executive Vice President at Ashley Furniture, has joined SKYX to lead its e-commerce platform.

Mr. Long will work together with the existing e-commerce management team and founders to drive innovation and expand sales and market penetration of SKYX’s advanced and smart home plug & play technologies across the U.S. and Canadian markets.

Long is renowned for his strategic vision and operational excellence across advanced business ecosystems. With over 28 years of experience in e-commerce, omnichannel retail, and global sourcing, he brings a wealth of expertise and leadership to SKYX. His career includes pivotal roles at industry-leading companies, including as Director at Amazon.com, where he spearheaded the development of Amazon Basics, the company’s first private brand initiative. Additionally, he has served as Senior Vice President at Walmart Stores Inc., General Merchandise Manager at Sam’s Club, and Executive Vice President at Ashley Furniture.

Commenting on his appointment, Huey Long said, “I am honored to join SKYX and work with its e-commerce management team and founders at such an exciting time. The company’s commitment to innovation with its game-changing plug & play technologies aligns perfectly with my passion for driving value through innovation, strategic transformation, and operational excellence. I look forward to driving growth and further expanding the market penetration of SKYX’s technologies in the U.S. and Canadian markets. SKYX’s disruptive and smart platform technologies present a unique opportunity for recurring revenues.”

Rani Kohen, Founder/Inventor and Executive Chairman, of SKYX Platforms, said, “Huey’s extensive experience in e-commerce and omnichannel retail makes him uniquely positioned to drive the next phase of growth of our advanced and smart home plug & play platform technologies. We are excited to have Huey on board and look forward to his leadership as we continue to grow our market penetration.”

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 – GeoVax Highlights the Critical Role of MVA-Based Vaccines in U.S. Biodefense Strategy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

GeoVax’s GEO-MVA: Strengthening U.S. Biodefense

ATLANTA, GA – March 3, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, underscores the strategic importance of its Modified Vaccinia Ankara (MVA) vaccine platform in helping to bolster U.S. biodefense capabilities. Efforts in MVA vaccine design and manufacturing improvements align with key recommendations from the recent “Bolstering U.S. Biodefense: Recommendations For The New Administration” report, published by the Janne E. Nolan Center on Strategic Weapons at the Council on Strategic Risks, a respected think tank specializing in national security and biodefense policy. The report emphasizes the need for robust, diversified medical countermeasures to protect national and global security.

Addressing Biodefense Gaps with MVA-Based Solutions

The “Bolstering U.S. Biodefense” report highlights the urgency of strengthening U.S. preparedness against biological threats, including deliberate attacks, emerging infectious diseases, and supply chain vulnerabilities. GeoVax’s efforts towards the development of MVA-based vaccines, including GEO-MVA for vaccination against Mpox and smallpox, and efforts to transition to a next-generation manufacturing platform utilizing a continuous avian cell line, directly align with these national security objectives:

  • Vaccine Supply Chain Resilience: Current reliance on a single non-U.S. manufacturer for critical vaccines, such as MVA, poses a national security risk. GeoVax’s efforts to transition to a next generation manufacturing platform should allow for the use of existing domestic manufacturing facilities, leading to a reduced dependence on foreign suppliers and enhancing supply chain security.
  • Advanced Biomanufacturing for Scalability: The biodefense report calls for investment in next-generation biomanufacturing. GeoVax is developing a continuous cell line-based MVA manufacturing platform that it expects will result in rapid, high-volume vaccine production, which is currently not feasible utilizing existing MVA directed manufacturing platforms
  • Diverse Medical Countermeasures for Threat Readiness: The Department of Defense’s Biodefense Posture Review and National Biodefense Strategy emphasize the need for multiple vaccine approaches. GeoVax’s MVA platform complements mRNA and protein-based vaccines, ensuring a broader and more resilient national preparedness framework.
  • Strategic National Stockpile Shortfalls: The 2022 Mpox epidemic revealed significant vaccine shortages in the National Strategic Stockpile, leaving public health officials unable to meet urgent demand. The reliance on a single foreign supplier for any vaccine can further exacerbate these challenges, reinforcing the need for a diversified, U.S.-based vaccine supply.

Relevance to the New HHS Administration

The transition of leadership at the U.S. Department of Health and Human Services (HHS) presents a pivotal moment for vaccine policy and national preparedness. The Administration has emphasized transparency, safety, and domestic vaccine manufacturing, aligning closely with GeoVax’s mission.

  • Alignment with National Health Security Goals: GeoVax’s focus on U.S.-based vaccine production supports HHS’s priority of reducing dependency on foreign pharmaceutical supply chains, ensuring America’s self-sufficiency in pandemic preparedness.
  • Advancing a Diversified Vaccine Portfolio: With a growing consensus that a single vaccine platform is unable to address the breadth of infectious disease concerns, there is a clear recognition of the benefits of having multiple alternative vaccine platforms available. GeoVax’s MVA-based approach provides a proven, durable, and safe alternative, reinforcing a well-rounded immunization strategy.
  • Public Trust and Transparency: Given the call for increased scrutiny of vaccine development, GeoVax is committed to transparency, publishing full clinical trial results and working collaboratively with HHS to foster public confidence.

Policy Action to Strengthen U.S. Biodefense

GeoVax urges policymakers to act swiftly in supporting domestic vaccine production and biodefense innovation. Key recommendations include:

  1. Expanding Federal Investment in MVA-Based Vaccines: Increased funding from BARDA, the Department of Defense, and the NIH to accelerate the development, next-generation manufacturing scale up and deployment of GEO-MVA.
  2. Accelerating Regulatory Approvals: Streamlined pathways for emergency use authorization and priority review of MVA-based vaccines to strengthen national preparedness.
  3. Public-Private Partnerships: Enhanced collaboration between government agencies, biotechnology firms, and global health organizations to integrate MVA-based solutions into pandemic and biodefense planning.

A Call for Action

“The ‘Bolstering U.S. Biodefense’ report clearly articulates the vulnerabilities in our national health security framework. GeoVax is committed to helping address these gaps with our MVA-based vaccines and next-generation manufacturing capabilities,” said David Dodd, Chairman & CEO of GeoVax. “With a new HHS administration, there is a timely opportunity to strengthen domestic vaccine infrastructure and ensure greater national resilience against emerging threats.”

GeoVax remains dedicated to advancing innovative, scalable, and accessible vaccine solutions to safeguard public health and national security.

References:
Council on Strategic Risks. (2025). Bolstering U.S. Biodefense: Strengthening the Nation’s Response to Biological Threats. Janne E. Nolan Center on Strategic Weapons. Retrieved from https://www.councilonstrategicrisks.org.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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                          

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – ODP Business Solutions Partners with Hunter Amenities to Expand Product Offerings and Enhance Presence in the Hospitality Industry

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ODP

PDF Version

New partnership reaffirms ODP Business Solutions’ commitment to the hospitality industry and adjacent categories, fostering a refined guest experience

BOCA RATON, Fla.–(BUSINESS WIRE)–Mar. 3, 2025– ODP Business Solutions, a leading supplier of workplace solutions and services and a division of The ODP Corporation (NASDAQ: ODP), announced today a strategic distribution partnership with Hunter Amenities. ODP Business Solutions will distribute Hunter’s wide range of hotel and guest amenities to hospitality partners, including liquid beauty products, soaps, dry goods and more, all uniquely bundled to accommodate the needs of every client and guest.

“Our partnership with Hunter Amenities demonstrates our commitment to continuing to expand our presence and product offerings in the hospitality industry and other adjacent sectors,” said David Centrella, EVP and president of ODP Business Solutions. “Distributing Hunter Amenities’ premium products further positions ODP Business Solutions to serve as a key-supplier for in-room needs.”

Hunter Amenities is an award-winning global manufacturing company that has been a pioneer in the personal care and hospitality industry for more than four decades. Renowned for its world-class manufacturing facilities that combine artisanal traditions with cutting-edge innovation, the company partners with some of the world’s most prestigious hospitality and retail brands. Hunter Amenities now provides its rich portfolio of high-end personal care products through ODP Business Solutions’ vast network of solutions and service, advancing how the hospitality industry can bring a luxurious, elevated experience to their guests.

“Partnering with ODP Business Solutions as a distribution partner is a natural fit for our company. Their best-in-class distribution capabilities and remarkably agile team give us complete confidence, which is why we’ve gone all in—rolling out our full portfolio within their expansive customer network. This collaboration is a true win-win for both organizations and a game-changer for the entire hospitality industry,” said John Hunter, founder of Hunter Amenities.

Hunter’s extensive product portfolio includes curated shampoo, conditioner, body wash, lotion, and hand wash, along with VIP indulgences such as lip balm, hand cream, eye cream, sleep balm, facial mist, and pillow mist—crafted for discerning travelers who expect nothing but the best.

“Introducing Hunter Amenities to our hospitality distribution services will provide our customers the opportunity to enhance each guest’s stay with custom, high-end offerings that pair seamlessly with ODP Business Solutions’ unparalleled service,” said Nisha Brown, vice president of marketing & product management at ODP Business Solutions. “Hunter is a globally recognized luxury brand that aligns perfectly with our commitment to quality and innovation. We look forward to continuing our growth in the hospitality market and beyond, offering tailored solutions that meet the evolving needs of our clients.”

ODP Business Solutions also delivers high-quality solutions in categories that include technology, professional cleaning and furniture, while expanding into new verticals to better serve the needs of its customers. This partnership announcement follows ODP Business Solutions recent milestone contract with a leading hospitality management company.

To learn more about ODP Business Solutions, visit odpbusiness.com.

About ODP Business Solutions:

ODP Business Solutions is a trusted partner with more than 30 years of experience working with businesses to adapt to the ever-changing world of work. From technology transformation, sustainability, innovative workspace design, cleaning and breakroom, and everything in between, ODP Business Solutions has the integrated products and services businesses need. Powered by a collaborative team of experienced business consultants, world-class logistics and trusted brand names, ODP Business Solutions advances how the working world gets work done. For more information on ODP Business Solutions, visit odpbusiness.com.

ODP Business Solutions is a division of The ODP Corporation (NASDAQ: ODP). ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Any other product or company names mentioned herein are the trademarks of their respective owners.

About Hunter Amenities:

Since 1981, Hunter Amenities has become one of the world’s largest manufacturers and leading formulators of superior personal care guest amenities, servicing hospitality customers in over 100 countries. Our products range from a prominent selection of licensed, internationally recognized designer and cosmetic brands to distinctive luxurious spa hotel amenities and retail collections.

Learn more at hunteramenities.com.

About The ODP Corporation

The ODP Corporation (NASDAQ:ODP) is a leading provider of products and services through an integrated business-to-business (B2B) distribution platform and omnichannel presence, which includes world-class supply chain and distribution operations, dedicated sales professionals, online presence and a network of Office Depot and OfficeMax retail stores. Through its operating companies Office Depot, LLC; ODP Business Solutions, LLC; and Veyer, LLC, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.

ODP and ODP Business Solutions are trademarks of ODP Business Solutions, LLC. Office Depot is a trademark of The Office Club, LLC. OfficeMax is a trademark of OMX, Inc. Veyer is a trademark of Veyer, LLC. ©2025 Office Depot, LLC. All rights reserved. Any other product or company names mentioned herein are the trademarks of their respective owners.

FORWARD LOOKING STATEMENTS – THE ODP CORPORATION

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements or disclosures may discuss goals, intentions and expectations as to future trends, plans, events, results of operations, cash flow or financial condition, or state other information relating to, among other things, The ODP Corporation (“the Company”), based on current beliefs and assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “expectations”, “outlook,” “intend,” “may,” “possible,” “potential,” “predict,” “project,” “propose” “aim” or other similar words, phrases or expressions, or other variations of such words. These forward-looking statements are subject to various risks and uncertainties, many of which are outside of the Company’s control. There can be no assurances that the Company will realize these expectations or that these beliefs will prove correct, and therefore investors and stakeholders should not place undue reliance on such statements.

Investors and shareholders should carefully consider the foregoing factors and the other risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. The Company does not assume any obligation to update or revise any forward-looking statements.

Press Contact:
Katee Schalau
6600 North Military Trail
Boca Raton, FL 33496
mediarelations@odpbusiness.com

Source: ODP Business Solutions

Release – Ocugen Announces Positive Opinion of EMA’s Committee for Advanced Therapies for ATMP Classification for Novel Modifier Gene Therapy Candidate OCU410 for Geographic Atrophy and OCU410ST for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 3, 2025

MALVERN, Pa., March 03, 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 European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced Therapy Medicinal Product (ATMP) classification. OCU410 is a novel, multifunctional modifier gene therapy candidate being developed for the treatment of patients with vision loss due to geographic atrophy (GA)—an advanced stage of dry age-related macular degeneration (dAMD)—and OCU410ST is being developed for Stargardt disease due to ABCA4-related retinopathies.

GA affects 2-3 million people in the United States (U.S.) and Europe combined. There are two approved therapies in the U.S. that require frequent dosing (every month or every other month), however neither therapy has been approved in Europe. Stargardt disease affects 100,000 people in the U.S. and Europe combined, and there are no approved treatments available globally.

“Receiving ATMP classification for OCU410 and OCU410ST is a critical step to potentially address these severely unmet medical needs in the very near future,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Dosing of Phase 2 in the ongoing OCU410 ArMaDa clinical trial is complete, and we are on track to initiate the Phase 3 clinical trial next year to pursue potential Marketing Authorization Application (MAA) and Biologics License Application (BLA) filings in 2028. Last week, the U.S. Food and Drug Administration (FDA) endorsed Ocugen’s plan to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST, which can be the basis of BLA and potential MAA submissions in 2027.”

ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance.

Preliminary 9-month data of OCU410 in GA patients demonstrated considerably slower lesion growth (44%) from baseline and clinically meaningful 2-line (10-letter) improvement in visual function (LLVA) in treated eyes compared to untreated eyes in the Phase 1 portion of the trial. Furthermore, a single subretinal OCU410 treatment preserves more retinal tissue around GA lesions of treated eyes at 9 months compared to published data on currently available GA therapies.

6-month data from Phase 1 of the OCU410ST GARDian clinical trial demonstrated considerably slower lesion growth (52%) from baseline in treated eyes versus untreated fellow eyes and clinically meaningful 2-line (10-letter) improvement in visual function (BCVA), which is statistically significant (p=0.02) in treated eyes. The Company plans to initiate the Phase 2/3 pivotal confirmatory clinical trial for OCU410ST by mid-2025.

“The novel modifier gene in OCU410 and OCU410ST targets all four pathways linked with dAMD and Stargardt and is delivered through a single subretinal injection as a one-and-done treatment,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “We are very pleased with the structural and functional outcomes demonstrated by both of these candidates, along with a stellar safety profile.”

OCU410 and OCU410ST utilize an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410 and OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

Release – InPlay Oil Corp. Confirms Monthly Dividend for March 2025

Posted on by aweinsoff@channelchek.com
InPlay Oil Logo (CNW Group/InPlay Oil Corp.)

Research News and Market Data on IPOOF

Mar 03, 2025, 07:30 ET

CALGARY AB, March. 3, 2025 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.015 per common share payable on March 31, 2025, to shareholders of record at the close of business on March 14, 2025. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.

About InPlay Oil Corp.

InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

www.inplayoil.com

SOURCE InPlay Oil Corp.

For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634

Release – AZZ Inc. Announces Successful Repricing of its Senior Secured Revolving Line of Credit

Posted on by aweinsoff@channelchek.com
AZZ Inc is the leading independent provider of hot-dip galvanizing and coil coating solutions in North America. (PRNewsfoto/AZZ, INC.)

Research News and Market Data on AZZ

Mar 03, 2025, 06:30 ET

FORT WORTH, Texas, March 3, 2025 /PRNewswire/ — AZZ Inc. (NYSE: AZZ), the leading independent provider of hot-dip galvanizing and coil coating solutions in North America, today announced the completion of repricing its $400 million Senior Secured Revolving Line of Credit. The repricing decreased the interest rate margin applicable to the Revolving Credit Loans from margins ranging from 275 basis points to 350 basis points (subject to leverage ratio step-downs) to margins ranging from 175 basis points to 275 basis points (subject to leverage ratio step-downs); (b) reduced the Commitment Fee applicable to the Revolving Credit Loans from fees ranging from 25 basis points to 37.5 basis points (subject to leverage ratio step-downs) to fees ranging from 20 basis points to 30 basis points (subject to leverage ratio step-downs); and (c) reduced the Letter of Credit Fees from 425 basis points to fees ranging from 175 basis points to 275 basis points (subject to leverage ratio step-downs).

Jason Crawford, Chief Financial Officer commented, “We are pleased to announce the successful completion of our revolver repricing. The repricing will result in significantly lower interest costs through the maturity of the facility and demonstrates our ongoing commitment to interest expense reduction.”

About AZZ Inc.
AZZ Inc. is the leading independent provider of hot-dip galvanizing and coil coating solutions to a broad range of end-markets. Collectively, our business segments provide sustainable, unmatched metal coating solutions that enhance the longevity and appearance of buildings, products and infrastructure that are essential to everyday life.

Safe Harbor Statement
Certain statements herein about our expectations of future events or results constitute forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by terminology such as “may,” “could,” “should,” “expects,” “plans,” “will,” “might,” “would,” “projects,” “currently,” “intends,” “outlook,” “forecasts,” “targets,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Such forward-looking statements are based on currently available competitive, financial, and economic data and management’s views and assumptions regarding future events. Such forward-looking statements are inherently uncertain, and investors must recognize that actual results may differ from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date they are made and are subject to risks that could cause them to differ materially from actual results. Certain factors could affect the outcome of the matters described herein. This press release may contain forward-looking statements that involve risks and uncertainties including, but not limited to, changes in customer demand for our products and solutions, including demand by the construction markets, the industrial markets, and the metal coatings markets. We could also experience additional increases in labor costs, components and raw materials including zinc and natural gas, which are used in our hot-dip galvanizing process; supply-chain vendor delays; customer requested delays of our products or solutions; delays in additional acquisition opportunities; an increase in our debt leverage and/or interest rates on our debt, of which a significant portion is tied to variable interest rates; availability of experienced management and employees to implement AZZ’s growth strategy; a downturn in market conditions in any industry relating to the products we inventory or sell or the solutions that we provide; economic volatility, including a prolonged economic downturn or macroeconomic conditions such as inflation or changes in the political stability in the United States and other foreign markets in which we operate; acts of war or terrorism inside the United States or abroad; and other changes in economic and financial conditions. AZZ has provided additional information regarding risks associated with the business, including in Part I, Item 1A. Risk Factors, in AZZ’s Annual Report on Form 10-K for the fiscal year ended February 29, 2024, and other filings with the SEC, available for viewing on AZZ’s website at www.azz.com and on the SEC’s website at www.sec.gov. You are urged to consider these factors carefully when evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. These statements are based on information as of the date hereof and AZZ assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Relations and Company Contact:
David Nark, Senior Vice President of Marketing, Communications, and Investor Relations
AZZ Inc.
(817) 810-0095
www.azz.com

Investor Contact:
Sandy Martin / Phillip Kupper
Three Part Advisors
(214) 616-2207
www.threepa.com

SOURCE AZZ, Inc.

Release – Comstock Fuels Completes Financing with Marathon Petroleum

Posted on by aweinsoff@channelchek.com

Research News and Market Data on LODE

OKLAHOMA CITY, OKLAHOMA – FEBRUARY 28, 2025 – Comstock Inc. (NYSE: LODE) today announced a new investment and strategic collaboration with Marathon Petroleum Corporation (NYSE: MPC) to advance its lignocellulosic biomass refining solutions to commercial maturity. Comstock Fuels Corporation (“Comstock Fuels”), a subsidiary of Comstock Inc., has entered into a series of definitive agreements with subsidiaries of Marathon Petroleum Corporation (“Marathon”), involving the purchase of $14,000,000 in Comstock Fuels equity (“Investment”).

The Investment includes $1,000,000 in cash and $13,000,000 in payment-in-kind assets (“Payment-In-Kind Assets”) by Marathon, comprised of equipment, related intellectual properties, and other materials located at a Marathon renewable fuel demonstration facility in Madison, Wisconsin (“Madison Facility”). Comstock Fuels will use the Madison Facility to increase Comstock Fuels’ current pilot production capabilities in Wausau, Wisconsin.

Comstock Fuels’ advanced lignocellulosic biomass refining solutions are designed to align with oil producers by converting massive supplies of historically inaccessible biomass feedstock into “drop-in” hydrocarbon fuels for use in existing petroleum-based infrastructure.

Most current forms of renewable fuel draw from the same pool of conventional feedstocks, including corn, soy and various vegetable oils in the U.S., and the entire universe of those feedstocks only represents a tiny fraction of the domestic fuel demand. In contrast, the U.S. Department of Energy has previously estimated that America can produce upwards of one billion tons per year of biomass for conversion into fuel. That’s enough untapped feedstock to produce more than 3 billion barrels of fuel per year with Comstock Fuels’ refining solutions.

“We’re excited to collaborate with Marathon’s team as we work to integrate the Madison Facility and advance our unique renewable fuels technology to commercial maturity,” said Kevin Kreisler, Comstock Fuels’ chief technology officer.

The transaction documents included Comstock Fuels’ board observation rights for Marathon and reiterated the parties’ commitment to finalize an offtake agreement, joint development agreement, and warrant agreement on or before May 31, 2025.

Additional information on the transaction documents is available online in Comstock’s February 28, 2025, Current Report on Form 8-K.

About Comstock Fuels Corporation

Comstock Fuels Corporation (“Comstock Fuels”) delivers advanced lignocellulosic biomass refining solutions that set industry benchmarks for production of cellulosic ethanol, gasoline, renewable diesel, sustainable aviation fuel (“SAF”), and other renewable Bioleum™ fuels, with extremely low carbon intensity scores of 15 and market-leading yields of up to 140 gallons per dry metric ton of feedstock (on a gasoline gallon equivalent basis, or “GGE”), depending on feedstock, site conditions, and other process parameters. Comstock Fuels additionally holds the exclusive rights to intellectual properties developed by Hexas Biomass Inc. (“Hexas”) for production of purpose grown energy crops in liquid fuels applications with proven yields exceeding 25 to 30 dry metric tons per acre per year. The combination of Comstock Fuels’ high yield Bioleum refining platform and Hexas’ high yield energy crops allows for the production of enough feedstock to produce upwards of 100 barrels of fuel per acre per year, effectively transforming marginal agricultural lands with regenerative practices into perpetual “drop-in sedimentary oilfields” with the potential to dramatically boost regional energy security and rural economies.

Comstock Fuels plans to contribute to domestic energy dominance by directly building, owning, and operating a network of Bioleum Refineries in the U.S. to produce about 200 million barrels of renewable fuel per year by 2035, starting with its planned first 400,000 barrel per year commercial demonstration facility in Oklahoma. Comstock Fuels also licenses its advanced feedstock and refining solutions to third parties for additional production in the U.S. and global markets, including several recently announced and other pending projects. To learn more, please visit www.comstockfuels.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) innovates and commercializes technologies that are deployable across entire industries to contribute to energy abundance by efficiently extracting and converting under-utilized natural resources, such as waste and other forms of woody biomass into renewable fuels, and end-of-life electronics into recovered electrification metals. Comstock’s innovations group is also developing and using artificial intelligence technologies for advanced materials development and mineral discovery for sustainable mining. 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:
RB Milestone Group LLC
Tel (203) 487-2759
ir@comstockinc.com 

For media inquiries or questions:
Colby Korsun
Comstock Fuels Corporation
fuels@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; 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, 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, 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 – Direct Digital Holdings Introduces Guide to High-Quality AI Data Management for Businesses

Posted on by aweinsoff@channelchek.com
Direct Digital Holdings Logo (PRNewsfoto/Direct Digital Holdings)

Research News and Market Data on DRCT

February 27, 2025 9:00 am EST Download as PDF

New resource provides a structured framework to help organizations assess, prepare, and govern data for high-quality AI inputs

HOUSTON, Feb. 27, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the release of The Role of Data in AI Quality, a comprehensive guide developed by Direct Digital Holdings’ AI Council to help organizations enhance the quality and integrity of data used in AI systems.

As artificial intelligence drives innovation across industries, organizations face a fundamental challenge: ensuring they have high-quality data to achieve consistently reliable AI outcomes. Businesses risk inaccurate predictions, biased models, and security vulnerabilities without structured, well-defined instructions and high-integrity data. The Role of Data in AI Quality equips business leaders with the insights needed to establish effective data management practices, ensuring AI solutions produce meaningful and trustworthy results. Additionally, it helps organizations make informed decisions about resource allocation, timelines, and investment in data preparation—critical first steps before embarking on any AI initiative.

Setting a Standard for AI Data Readiness

“AI systems are only as good as the data that powers them,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings. “Businesses investing in AI must first prioritize data quality, ensuring that information is accurate, complete, and ethically sourced. Our guide provides a practical approach for organizations looking to refine their data management strategies, identify gaps that can affect AI performance, and set a strong foundation for AI success.”

The “The Role of Data in AI Quality” guide offers key insights into:

  • Understanding the impact of data quality on AI performance
  • Best practices for data assessment, preparation, and governance
  • Managing compliance and privacy risks in AI-driven environments
  • Strategies for eliminating bias and enhancing data integrity
  • Leveraging data enrichment techniques to optimize AI outputs

“Many organizations are eager to adopt AI but struggle with the foundational step of data readiness,” added Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings. “This guide goes beyond theory and provides actionable steps to help businesses effectively clean, structure, and manage their data. By following these best practices, companies can ensure their AI systems deliver accurate and meaningful insights.”

By addressing the complete data lifecycle and establishing rigorous controls for accuracy and security, the comprehensive resource enables organizations to build the strong data foundation essential for successful AI implementation.

To download “The Role of Data in AI Quality,” please visit our AI Council resource center.

About Direct Digital Holdings

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

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-introduces-guide-to-high-quality-ai-data-management-for-businesses-302387470.html

SOURCE Direct Digital Holdings

Released February 27, 2025

Release – MAIA Biotechnology to Initiate Phase 3 Pivotal Trial of THIO Sequenced with Checkpoint Inhibitor Compared with Chemotherapy Treatment in Advanced Non-Small Cell Lung Cancer Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 27, 2025 8:51am EST Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant to checkpoint inhibitors and chemotherapy. The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients.

“THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment,” said Vlad Vitoc, M.D., CEO of MAIA. “We expect that the results from this study will further illuminate THIO’s unmatched benefits for advanced stage NSCLC patients.

“Our initiation of THIO-104 will mark an important milestone along our goal for THIO’s FDA commercial approval,” Dr. Vitoc added.

MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in Asia, Europe and in the U.S.

The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.

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 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) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) 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 February 27, 2025

Release – Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 27, 2025

PDF Version

MALVERN, Pa., Feb. 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 alignment has been reached with the U.S. Food and Drug Administration (FDA) to move forward with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST which, if positive, can be the basis of a biologics license application (BLA) submission.

The GARDian trial for OCU410ST demonstrated:

  • A favorable safety and tolerability profile with no serious adverse events related to OCU410ST, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization and no adverse events of special interest
  • Considerably slower lesion growth (52%) from baseline in treated eyes versus untreated fellow eyes at 6-month follow-up from the Phase 1 study
  • Clinically meaningful 2-line (10-letter) improvement in visual function (BCVA) at 6-month follow-up from the Phase 1 study, which is statistically significant (p=0.02) in treated eyes

“I am very pleased that the FDA has recognized the promise of Ocugen’s modifier gene therapy for Stargardt disease and accelerated the regulatory pathway for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This new development allows us to initiate a pivotal confirmatory trial for this game-changing, one-time treatment for life in the next few months and prepare for a potential BLA filing by 2027. Now patients suffering from Stargardt disease have a new hope where previously none existed. This achievement furthers our mission to cure blindness diseases.”

Stargardt disease affects 100,000 people in the U.S. and Europe combined, and there is no treatment. OCU410ST received orphan drug designations from the FDA and the European Medicines Agency (EMA) in 2023 and 2024, respectively.

“Getting approval for a Phase 2/3 trial is a pivotal milestone, as this approach has never been explored in clinical trials for Stargardt disease. The FDA’s decision underscores the potential of OCU410ST to meet a critical unmet medical need for the approximately 44,000 Stargardt patients in the U.S.,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Professor of Ophthalmology, Pediatrics and Biomedical Engineering with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Retina Scientific Advisory Board Chair of Ocugen.

The Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, 200-μL injection of OCU410ST at a concentration of 1.5 x 1011 vector genomes (vg)/mL in the eye with worse visual acuity, and 17 of whom will serve as untreated controls. The primary endpoint in the clinical trial is change in atrophic lesion size. Secondary endpoints include visual acuity as measured by best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) compared to untreated controls. One-year data will be utilized for the BLA filing.

“This approval pathway, established in collaboration with the FDA, has made it possible to expedite the clinical development of OCU410ST by two to three years and has aided in bringing an innovative gene therapy to patients desperate for a treatment option,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “Recent data from the OCU410ST clinical trial have shown significant improvements in both structural and functional outcomes. Additionally, OCU410ST has consistently demonstrated a very favorable safety and tolerability profile.”

Accelerating the clinical timeline of OCU410ST will save significant costs in addressing disease burden even sooner than anticipated.

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

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

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

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

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

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

Release – CoreCivic Announces Four New Contract Modifications to Add Capacity for U.S. Immigration and Customs Enforcement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CXW

February 27, 2025

PDF Version

BRENTWOOD, Tenn., Feb. 27, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today that it has entered into contract modifications to add capacity for up to a total of 784 detainees from U.S. Immigration and Customs Enforcement (“ICE”) at its 2,016-bed Northeast Ohio Correctional Center, its 1072-bed Nevada Southern Detention Center, and its 1,600-bed Cimarron Correctional Facility in Oklahoma. In addition, CoreCivic has obtained a contract modification to specify that ICE may use up to 252 beds at its 2,672-bed Tallahatchie County Correctional Facility in Mississippi.

CoreCivic currently cares for approximately 650 residents under a contract with the U.S. Marshals Service (“USMS”), as well as 925 residents under a contract with the Ohio Department of Rehabilitation and Correction at the Northeast Ohio Correctional Center. CoreCivic currently cares for approximately 800 residents under a contract with the USMS at the Nevada Southern Detention Center, and approximately 1,100 residents under a contract with the USMS at the Cimarron Correctional Facility. CoreCivic currently cares for approximately 1,400 residents at the Tallahatchie County Correctional Facility under contracts with eight different customers.

Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “We are pleased to provide U.S. Immigration and Customs Enforcement with this additional capacity. We have an extensive supply of available beds that provides our government partners the flexibility to satisfy their immediate and long-term needs in a cost-effective manner. I am particularly proud of our dedicated team of professionals at each of these three facilities who are capable of managing these diverse customer requirements. We are entering a period where our government partners, particularly our federal government partners, are expected to have increased demand. We anticipate additional contracting activity that will help satisfy their growing needs.”

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements as to our beliefs and expectations of the outcome of future events including increasing demand from our government partners, particularly our federal government partners, and the prospects of growth in CoreCivic’s business. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.

Contact:Investors: Michael Grant – Managing Director, Investor Relations – (615) 263-6957
Media: Steve Owen – Vice President, Communications – (615) 263-3107

Release – GoHealth Reports Strong Fourth Quarter and Fiscal Year 2024 Results, Driven by a Successful Annual Enrollment Period

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Feb 27, 2025 at 7:01 AM EST

CHICAGO, Feb. 27, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three and twelve months ended December 31, 2024.

Fourth Quarter Highlights

  • Achieved net revenues of $389.1 million, a substantial 41% increase compared to the prior year period.
  • Submissions grew to 481,445, representing a 67% increase compared to the prior year period.
  • Net income of $58.0 million, a substantial improvement of $60.3 million compared to the prior year period.
  • Adjusted EBITDA1 surged to $117.8 million, a significant 107% increase compared to the prior year period.
  • Compared to the prior year period, Direct Operating Cost per Submission2 improved 27%, to an industry leading $501.
  • The integration and transformation of e-TeleQuote Insurance, Inc. (“e-TeleQuote”) has driven growth and efficiency gains, delivering significant performance improvements in the 2024 Annual Enrollment Period.

Full-Year 2024 Highlights

  • Full-year net revenues reached $798.9 million, reflecting 9% growth compared to the prior year.
  • Submissions were 1,016,182, a 23% increase compared to the prior year.
  • Net loss of $7.3 million, an improvement of $144.0 million compared to the prior year.
  • Adjusted EBITDA1 of $120.3 million, a 60% increase compared to the prior year.
  • Successfully refinanced our credit facility with new five-year term and lender group.
  • Supported nearly 3 million Medicare consumers in assessing benefit options in 2024.
  • Implemented the PlanFit Save initiative and began receiving health plan compensation for membership retention.
  • Remained top partner to health plans based on Submission volume.

“GoHealth’s strong 2024 performance highlights our market-leading, technology-driven approach in the digital Medicare marketplace. While we predicted favorable market dynamics, we were even more pleased by the velocity of our efficiency improvements and the immediate impact of our technology initiatives on profitability. We are energized by the opportunities ahead and are already executing on them,” said Vijay Kotte, CEO of GoHealth. “The successful onboarding and optimization of e-TeleQuote, expansion of our health plan partnerships, and continued investment in artificial intelligence and advanced analytics have further strengthened GoHealth’s position as a leading digital Medicare marketplace. As we move into 2025, we continue to focus on driving sustainable, profitable growth, enhancing the consumer experience, and reinforcing our market leadership through continued innovation and operational excellence.”

“Our 2024 financial results demonstrate GoHealth’s capacity to achieve exceptional performance through disciplined execution and strategic investment,” said Brendan Shanahan, CFO of GoHealth. “The substantial year-over-year growth in net income and the 107% year-over-year growth in Adjusted EBITDA1 during Q4, coupled with significant gains in operating efficiency, reinforces the strength of our strategy. As we begin 2025, we are optimistic that the favorable market dynamics we experienced will persist through at least the first three quarters with cautious optimism for similar favorable dynamics for the fourth quarter, enabling us to build on this solid financial foundation.”

(1)Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.
(2)Direct Operating Cost per Submission is an operating metric. For a definition of Direct Operating Cost per Submission and an explanation of its calculation, please see below.
  

Conference Call Details

The Company will host a conference call today, Thursday, February 27, 2025 at 8:00 a.m. (ET) to discuss its financial results. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

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 our future results of operations and financial position, business strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, future capital expenditures, debt service obligations, adoption and use of artificial intelligence technologies, the impact on our business from the acquisition of e-TeleQuote and our ability to successfully integrate e-TeleQuote’s operations, technologies and employees into our business, 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 we believe 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 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (“2023 Annual Report on Form 10-K”) and our forthcoming Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Annual Report on Form 10-K”), as well as our other filings with the Securities and Exchange Commission. The factors described in our 2023 Annual Report on Form 10-K and our forthcoming 2024 Annual Report on Form 10-K 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 the Quarterly Report on Form 10-Q for the first fiscal quarter ended March 31, 2024, the Quarterly Report on Form 10-Q for the second fiscal quarter ended June 30, 2024, the Quarterly Report on Form 10-Q for the third quarter ended September 30, 2024 and in our other filings with the Securities and Exchange Commission.

You should read this press release and the documents that we reference in this press release completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do 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.

View Full Release Here.

Release – The GEO Group Awarded 15-Year Contract by U.S. Immigration and Customs Enforcement for Company-Owned, 1,000-Bed Delaney Hall Facility in New Jersey

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GEO

February 27, 2025

PDF Version

BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 27, 2025– The GEO Group, Inc. (NYSE: GEO) (“GEO” or the “Company”) announced today that it has been awarded a 15-year, fixed-price contract by U.S. Immigration and Customs Enforcement (“ICE”) to provide support services for the establishment of a federal immigration processing center at the company-owned, 1,000-bed Delaney Hall Facility (the “Facility”) in Newark, New Jersey. GEO’s support services include the exclusive use of the Facility by ICE, along with security, maintenance, and food services, as well as access to recreational amenities, medical care, and legal counsel.

The new support services contract is expected to generate in excess of $60 million in annualized revenues for GEO in the first full year of operations, with margins consistent with GEO’s company-owned Secure Services facilities. GEO estimates the 15-year value of the contract with normal cost of living adjustments to be approximately $1 billion. GEO expects to reactivate the Facility in the second quarter of 2025 with revenues and earnings from the new contract normalizing during the second half of 2025.

George C. Zoley, Executive Chairman of GEO, said, “Our company-owned Delaney Hall Facility will play an important role in providing needed detention bedspace and support services for ICE in the Northeast. We are continuing to prepare for what we believe is an unprecedented opportunity to help the federal government meet its expanded immigration enforcement priorities. We are taking several important steps to meet this opportunity, including making a previously announced $70 million investment in capital expenditures to strengthen our capabilities to deliver expanded detention capacity, secure transportation, and electronic monitoring and related services to ICE and the federal government.”

About The GEO Group
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 99 facilities totaling approximately 79,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.

Use of forward-looking statements
This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission including its Form 10-K, 10-Q and 8-K reports. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Readers are strongly encouraged to read the full cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including those referenced above. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.

Pablo E. Paez (866) 301 4436
Executive Vice President, Corporate Relations

Source: The GEO Group, Inc.