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Release – Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science

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Research News and Market Data on UNCY

January 28, 2025 7:00am EST 

Large pill size, high pill burden and palatability were identified as key barriers for phosphate binder adherence

LOS ALTOS, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of a review on patient perspectives regarding phosphate management in the peer-reviewed journal, Journal of Nephrological Science.

The publication, entitled “Patient Perspectives: The Effects of Contemporary Phosphorus Management on Quality of Life,” examines the challenges of phosphate management therapies from patients’ viewpoints, focusing on the limitations of current phosphate binders and their effect on patients’ quality of life. The publication underscores key findings from patient surveys and medical literature, identifying critical barriers to effective phosphorus management and emphasizing the need for patient-centered approaches to improve clinical outcomes and patient satisfaction.

“In therapeutic categories with significant patient non-adherence to standard of care like chronic kidney disease (CKD), it is essential to understand the factors disrupting medical intervention in order to offer physicians and patients innovative solutions,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe products like Oxylanthanum Carbonate (OLC), which is characterized by small pill size, lower pill burden, and easy-to-swallow tablets, have the potential to address many of the inherent challenges in phosphorus management that often lead to nonadherence and poor serum phosphate control. If approved, we look forward to offering OLC to CKD patients on dialysis with hyperphosphatemia.”

Key Findings:

  • Hyperphosphatemia is linked to increased mortality risk.
  • Dialysis patients often face a high daily pill burden, with phosphate binders making up about 50% of the total.
  • Nonadherence to phosphate binders is a significant challenge contributing to elevated phosphate levels. Studies show non-adherence rates range from 22% to 74%, with a mean non-adherence rate of 51%.
  • Factors contributing to non-adherence include large pill size, high pill burden, and unpleasant gastrointestinal side effects. Social factors and timing complexities also impact adherence.
  • Engaging patients in discussions about different phosphate binders and their unique characteristics is key to improving adherence and satisfaction. New therapies that reduce pill size or burden while maintaining efficacy could enhance clinical outcomes, quality of life, and the patient-clinician relationship.

The full publication can be accessed here.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

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

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
[email protected]

Chris Calabrese
LifeSci Advisors
[email protected]

SOURCE: Unicycive Therapeutics, Inc.

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Released January 28, 2025

Release – GeoVax Advanced MVA Manufacturing Process: Aimed to Enhance Vaccine Supply Worldwide

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Research News and Market Data on GOVX

 

  • Last updated: 27 January 2025
  • Created: 27 January 2025
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Process Expected to Increase Production Yield, Flexibility at Lower Cost

Atlanta, GA – January 27, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in vaccines and immunotherapies, has shared updates about its development-stage advanced Modified Vaccinia Ankara (MVA) vaccine manufacturing process. This anticipated process provides the potential to not only address today’s pressing health challenges but also paves the way for more efficient, flexible and lower-cost MVA-vaccine manufacturing.

The Power and Versatility of the MVA Platform

The MVA platform is uniquely designed to incorporate multiple antigens into a single vaccine. This versatility allows GeoVax to develop vaccines targeting multiple aspects of a single pathogen or several pathogens simultaneously. Originally developed as a safer smallpox vaccine, the MVA platform offers distinct advantages, including:

  • Protection against diseases such as Mpox and smallpox.
  • Multi-antigen vaccines like GEO-CM04S1, which targets both the Spike (S) and Nucleocapsid (N) antigens of SARS-CoV-2.
  • Stability under minimal refrigeration and the potential for freeze-drying (lyophilization), simplifying distribution in resource-limited settings.

Advancing MVA Manufacturing

Current vaccine manufacturing methods rely on Chicken Embryo Fibroblast (CEF) cells, requiring pathogen-free eggs. This process is costly, time-consuming, and dependent on limited egg supplies, providing barriers to rapid, real-time MVA manufacturing, as well as hindering the flexibility necessary to establish local MVA manufacturing of critically important vaccines.  GeoVax is addressing these barriers through an advanced MVA Manufacturing process utilizing an avian cell line licensed from ProBioGen AG (Berlin). Key features include:

  • A continuous avian suspension cell line process that eliminates the need for pathogen-free eggs.
  • Compatibility with standard manufacturing equipment, reducing setup time, simplifying the MVA manufacturing process, increasing scalability and lowering manufacturing costs.

This advanced MVA manufacturing process is expected to significantly simplify vaccine production, particularly in middle- and low-income regions where supply chain issues often hinder access to critical vaccines.

Addressing Global Health Needs

“Our advanced MVA manufacturing process represents not only a transformative manufacturing advance but also addresses a public health imperative,” said David Dodd, Chairman and CEO of GeoVax. “By tackling disease protection, logistical hurdles, and manufacturing challenges, we aim to empower regions like Africa with the tools needed to combat current and future health crises.”

GeoVax’s MVA vaccines have demonstrated robust performance in clinical trials, with ongoing Phase 2 studies for GEO-CM04S1, its COVID-19 vaccine candidate, showing broad and durable immune responses. Supported by its BARDA Project NextGen Award and partnerships with leading manufacturing and development organizations, GeoVax is positioned to enhance vaccine access and delivery on a global scale.

Recent Conference Presentations

GeoVax CEO David Dodd recently presented the company’s strategic initiatives and the potential of GEO-MVA at:

  • Biotech Showcase: January 14, 2025
  • Emerging Growth Conference: January 16, 2025

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 to initiate in mid-2025. 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:                         Investor Relations Contact:                     Media Contact:
[email protected] [email protected] [email protected] 
678-384-7220 212-698-8696 202-779-0929

Release – Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to Initiate Phase 1 Clinical Trial Evaluating First-in-Class OCU500 Inhaled Vaccine Candidate for COVID-19

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Research News and Market Data on OCGN

January 27, 2025

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  • OCU500 will be administered via inhalation and as a nasal spray
  • COVID-19 remains a substantial public health threat in the U.S. and around the world
  • Phase 1 clinical trial is anticipated to start in 2Q 2025

MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray.

“We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen,” said Mike Shine, Senior Vice President, Commercial at Ocugen. “COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”

Even though the pandemic has ended, COVID-19 still presents a significant burden in the U.S. The Centers for Disease Control (CDC) estimates that from October 1, 2024 to January 11, 2025, there were 4.4 to 7.9 million COVID infections, resulting in 120,000 to 210,000 hospitalizations and 14,000 to 25,000 deaths.

The Phase 1 trial would enroll 80 adult subjects aged 18 to 64 years. Forty (40) subjects would be assigned to the low-dose group, and 40 subjects would be assigned to the high-dose group. Within each group, 20 subjects would receive the inhalation form of the vaccine, and the other 20 subjects would receive the intranasal form. The primary aim of the study would be to determine safety, while secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.

OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered via inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered intramuscularly. Ocugen intends to expand this mucosal platform to address other serious respiratory threats including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).

The original ChAd36 vector that makes the Ocugen vaccine unique was licensed from Washington University in St. Louis.

“We are delighted to see the progress of the ChAd36 vector encoding a SARS-CoV-2 spike antigen that was originally designed and tested at Washington University in St. Louis,” said Dr. Michael Diamond, Professor of Medicine and Co-Director of the Center for Vaccines and Immunity to Microbial Pathogens at Washington University School of Medicine. “We believe this vector is ideal for mucosal administration and can be designed to carry COVID-19 strains as well as influenza and antigens from other respiratory viruses,” added Dr. David Curiel, Professor of Radiation Oncology, Washington University School of Medicine, co-collaborator on the vector design. 

Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.

“Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern,” said Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. “This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu.”

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 OCU500 to perform in humans in a manner consistent with nonclinical or preclinical 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
Head of Communications
[email protected]

Release – Townsquare Forms Strategic Alliance With Steel City Media

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Research News and Market Data On TSQ

Jan 27, 2025 

Purchase, NY – January 27, 2025 – Townsquare Media, Inc. (NYSE: TSQ), a leader in digital advertising and marketing solutions focused on markets outside of the Top 50 in the United States, announced today a strategic digital advertising partnership with Steel City Media, a multi-media company with market-leading media outlets in Pittsburgh and Kansas City. Townsquare teased this partnership in the pre-release of their estimated 2024 financial results last week.

“We could not be more excited to have the talented team at Steel City Media join our partnership program. They will now be able to leverage Townsquare Ignite’s cutting-edge digital advertising and marketing solutions to their expansive customer base, which importantly exists in markets that do not compete with ours,” said Todd Lawley, President of Townsquare Ignite, the Company’s Digital Advertising division. “Our expertise is coaching and training high performing broadcast sales teams to leverage our proprietary programmatic advertising platform and data-driven insights to deliver exceptional results for their clients. By sharing our proven strategies and dynamic approach, we look forward to helping Steel City strengthen their digital capabilities, driving growth and measurable success for their clients.”

Click here to view the complete press release

About Townsquare Media, Inc.

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 345 local terrestrial radio stations in 74 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com and NJ101.5.com, and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com, and Loudwire.com. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com, and www.townsquareignite.com.

Investor Relations:
Claire Yenicay
(203) 900-5555
[email protected]

Release – P180 Acquires Sun Capital’s Majority Stake in Vince Holding Corp.

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Research News and Market Data on VNCE

01/22/2025

Vince Holding Corp. Significantly Reduces Debt

Brendan Hoffman Expected to Become CEO of Vince Holding Corp.

NEW YORK–(BUSINESS WIRE)– Vince Holding Corp., (NYSE: VNCE) (“VNCE” or the “Company”), a global contemporary retailer, today announced that P180, a new venture focused on accelerating growth and profitability in the luxury apparel sector, acquired a majority stake in VNCE (the “P180 Acquisition”) from affiliates of Sun Capital Partners, Inc. (collectively, “Sun Capital”).

In conjunction with the P180 Acquisition, Brendan Hoffman is expected to assume the role of Chief Executive Officer of VNCE effective on or around February 3, 2025, subject to finalization of his employment terms. With this transition, David Stefko is expected to step down as Interim CEO of VNCE and continue to serve on the VNCE Board of Directors. In addition, Matthew Garff resigned from the VNCE Board of Directors in connection with the P180 Acquisition.

“VNCE is the perfect partner for P180; the brand’s dominance in the luxury contemporary market aligns seamlessly with our acquisition strategy. In addition, as VNCE has evolved its operating model, we believe having access to the technology and team of CaaStle, founded by Christine Hunsicker, my co-founder at P180, will further advance the company’s momentum in driving improved profitability while enhancing its omni-channel experience.” Mr. Hoffman added, “Personally, I have a strong connection to the Vince brand, having served as VNCE CEO for five years. I am excited to lead the team again as we continue to unlock new growth opportunities, drive innovation, enhance the brand’s market position, and focus on monetizing the Company’s inventory to ensure continued long-term success.”

“P180’s acquisition represents a transformative opportunity for VNCE. With this transaction, we will gain the operational expertise and cutting-edge digital capabilities needed to drive the brand’s future success,” commented Michael Mardy, Chairman of VNCE. “On behalf of the Board and the organization, I would also like to thank Dave for stepping into the interim CEO role for the past year. Through his leadership, the company has continued to execute and deliver results by operating a healthier full price model. We are glad to have Dave remain on the Board and are excited to welcome Brendan back to lead the organization into its next chapter.”

This acquisition marks the third strategic deal for P180 since its inception in 2024 and follows its recent investment with the prestigious fashion label Altuzarra and digital partnership with the multi-brand premium retailer elysewalker.

VNCE Significantly Reduces Debt

Simultaneously with the P180 Acquisition, an indirectly wholly owned subsidiary of VNCE, V Opco, LLC (“V Opco”), amended its existing credit agreement (the “ABL Credit Facility”) with Bank of America, N.A. (“BofA”). The amendment consents to, among other things, the change in control in connection with the P180 Acquisition, as well as a partial pay down of the subordinated debt (“Sun Debt Facility”) with SK Financial Services, LLC, an affiliate of Sun Capital, through increased borrowings under the ABL Credit Facility. On the same day, V Opco paid $15 million to SK Financial Services, LLC using proceeds from the ABL Credit Facility, which resulted in a pay-down of $20 million under the Sun Debt Facility (the “Sun Debt Paydown”).

In addition, P-180 acquired and assumed $7 million of the loans (the “P-180 Assumed Loan”) outstanding pursuant to the Sun Debt Facility and immediately thereafter cancelled such $7 million (the “P-180 Debt Forgiveness”).

Following the Sun Debt Paydown and P-180 Debt Forgiveness, the outstanding principal amount of subordinated loans is reduced by approximately $27 million with $7.5 million remaining outstanding under the Sun Debt Facility, which will continue to accrue payment-in-kind interest in accordance with, and otherwise be subject to, the terms and conditions therein.

Immediately following the P-180 Acquisition, P180 beneficially owned approximately 65% of all outstanding shares of common stock of VNCE and affiliates of Sun Capital continue to beneficially own approximately 2% of the Company’s outstanding common stock.

As part of the terms to the transactions described above, P-180 agreed to reimburse the Company for certain fees and expenses incurred in connection with such transactions, including the Company’s legal fees as well as the consent fee to BofA.

About P180:

P180, a new venture co-founded by Christine Hunsicker (founder and CEO of CaaStle, Inc.) and Brendan Hoffman, is dedicated to driving brand and retailer profitability by providing operational expertise and access to leading industry resources, including CaaStle’s innovative monetization platform. P180’s core mission is to invest in or acquire brands and retailers that stand to benefit from digital expertise and inventory monetization.

About VNCE:

Vince Holding Corp. is a global retail company that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 47 full-price retail stores, 14 outlet stores, and its e-commerce site, vince.com and through its subscription service Vince Unfold, www.vinceunfold.com, operated by CaaStle, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.

Forward-Looking Statements: This document contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding, among other things, our planned transformation program and our current expectations about possible or assumed future results of operations of the Company and are indicated by words or phrases such as “may,” “will,” “should,” “believe,” “expect,” “seek,” “anticipate,” “intend,” “estimate,” “plan,” “target,” “project,” “forecast,” “envision” and other similar phrases. Although we believe the assumptions and expectations reflected in these forward-looking statements are reasonable, these assumptions and expectations may not prove to be correct and we may not achieve the results or benefits anticipated. These forward-looking statements are not guarantees of actual results, and our actual results may differ materially from those suggested in the forward-looking statements. These forward-looking statements involve a number of risks and uncertainties, some of which are beyond our control, including, without limitation: our ability to successfully manage the transition of VNCE majority ownership to P180 and to execute P180’s strategies for the Company; our ability to execute and realize the enhanced profitability expectations of our planned transformation program; our ability to maintain the license agreement with ABG Vince, a subsidiary of Authentic Brands Group; ABG Vince’s expansion of the Vince brand into other categories and territories; ABG Vince’s approval rights and other actions; our ability to maintain adequate cash flow from operations or availability under our revolving credit facility to meet our liquidity needs; our ability to realize the benefits of our strategic initiatives; general economic conditions; further impairment of our goodwill; the execution and management of our direct-to-consumer business growth plans; our ability to make lease payments when due; our ability to maintain our larger wholesale partners; our ability to remediate the identified material weakness in our internal control over financial reporting; our ability to comply with domestic and international laws, regulations and orders; our ability to anticipate and/or react to changes in customer demand and attract new customers, including in connection with making inventory commitments; our ability to remain competitive in the areas of merchandise quality, price, breadth of selection and customer service; our ability to attract and retain key personnel; seasonal and quarterly variations in our revenue and income; our ability to mitigate system security risk issues, such as cyber or malware attacks, as well as other major system failures; our ability to optimize our systems, processes and functions; our ability to comply with privacy-related obligations; our ability to ensure the proper operation of the distribution facilities by third-party logistics providers; fluctuations in the price, availability and quality of raw materials; commodity, raw material and other cost increases; the extent of our foreign sourcing; our reliance on independent manufacturers; other tax matters; and other factors as set forth from time to time in our Securities and Exchange Commission filings, including those described under “Item 1A—Risk Factors” in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We intend these forward-looking statements to speak only as of the time of this release and do not undertake to update or revise them as more information becomes available, except as required by law.

This press release is also available on the Vince Holding Corp. website (http://investors.vince.com/).

VNCE Investor Relations Contact:
Caitlin Churchill
ICR, Inc.
[email protected]

P180 Media Contacts:
Jacqueline Renaud
Vice President
Lividini & Co.
[email protected]

Morgan Tanacea
Senior Director
Lividini & Co.
[email protected]

Source: Vince Holding Corp.

Release – Lucky Strike Entertainment to Report Second Quarter 2025 Financial Results on February 5, 2025

Posted on by [email protected]

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01/22/2025

RICHMOND, Va.–(BUSINESS WIRE)– Lucky Strike Entertainment (NYSE: LUCK), one of the world’s premier operators of location-based entertainment, will report financial results for the second quarter of fiscal 2025 on Wednesday, February 5, 2025, before the U.S. stock market opens. Management will discuss the results via webcast at 10:00 AM ET on the same day.

The live webcast, replay, and results presentation will be available in the Events & Presentations section of the Lucky Strike Entertainment Investor Relations website at IR.LuckyStrikeEnt.com.

About Lucky Strike Entertainment

Lucky Strike Entertainment is one of the world’s premier location-based entertainment platforms. With over 360 locations across North America, Lucky Strike Entertainment provides experiential offerings in bowling, amusements, water parks, and family entertainment centers. The company also owns the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Lucky Strike Entertainment, please visit IR.LuckyStrikeEnt.com.

[email protected]

Source: Lucky Strike Entertainment Corporation

Release – Maple Gold Commences 10,000 Metre Phase I Drill Program at Douay and Provides 2025 Outlook for the Douay/Joutel Gold Project

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Drill Now Turning to Expand and Upgrade Current Douay Mineral Resource and Test New Property-Wide Discovery Targets

January 22, 2025 7:00 AM EST | Source: Maple Gold Mines Ltd.

Vancouver, British Columbia–(Newsfile Corp. – January 22, 2025) – Maple Gold Mines Ltd. (TSXV: MGM) (OTCQB: MGMLF) (FSE: M3G) (“Maple Gold” or the “Company“) is pleased to provide an exploration update and 2025 outlook for its 100%-owned Douay Gold Project (“Douay“) and Joutel Gold Project (“Joutel“) (together, “Douay/Joutel” or the “Property“) located along the Casa Berardi-Douay Gold Trend in Québec, Canada (see Figures 1 and 2).

A 10,000-metre (“m“) Phase I diamond drilling program (the “Program“) has now commenced at Douay with an expected duration of three to four months. The location of the Douay mineralized zones and primary targets are shown in Figures 3 and 4. Key objectives of the Program include:

  • Targeting poorly drilled areas within Inferred Resources for conversion to Indicated Resources within the pit-constrained and underground resource domains;
  • Step-out drilling along strike, down-dip, and down-plunge to expand Inferred Resources
  • Step-out drilling from zones of high-grade gold mineralization within the underground Inferred Resources to demonstrate lateral and vertical continuity;
  • Targeting areas between modeled mineralized zones with geological continuity; and
  • Testing new targets developed during the compilation exercise of geological, geochemical and geophysical data.

Concurrent development initiatives are anticipated throughout 2025 to advance and de-risk the Douay deposit, including a review of the current Douay mineral resource estimate (“MRE“) and an evaluation of potential scenarios to optimize higher grade mineral resources that could be accessible via underground mining methods. An additional 3,000 m of diamond drilling is planned at Joutel in H2 2025 to extend the known high-grade gold mineralization along the past-producing Eagle-Telbel mine trend.

“We are excited to be drilling again at Douay with refocused attention on the higher-grade core of the deposit and its possible extensions both within and beyond our current drill pattern up to 500 m vertical depth,” stated Kiran Patankar, President and CEO. “Maple Gold’s technical team has accomplished a monumental task in compiling over 50 years of exploration data to generate new geological/structural/geochemical 3D models that have vastly improved our drill targeting. This work highlights the excellent exploration potential of Douay/Joutel, the importance of its location along the deep-seated Casa Berardi break, and the opportunity for the Property to host multiple gold deposits within a variety of geological settings. Our focus in 2025 will be executing a comprehensive exploration and development program that is aimed at delivering shareholder value through the drill bit and via project de-risking, while maintaining strict cost discipline across the Company.”

A total exploration budget of approximately $6.3 million has been established for 2025, including permitting, drilling, assaying, personnel, camp and site support costs. The 2025 work program will be fully funded from Maple Gold’s existing treasury.

Program Details

The Company is currently planning a minimum of 10,000 m of diamond drilling at Douay in 2025. Phase I drilling has now commenced with an expected duration of approximately three to four months (see Figures 3 and 4). The breakdown of the drilling metreage will be approximately: 70% dedicated to de-risking and expanding the Douay MRE through strategic infill and step-out holes (along strike and at depth); and 30% for the testing of new regional geological and geophysical targets along strike from the Douay MRE and north into the Taibi Group sediments along favourable structural breaks and lithologic contacts. The Company plans to complete infill drilling throughout the Douay MRE to convert Inferred Resources to Indicated Resources, potentially add new Inferred Resources within poorly drilled 100-200 m gaps between modeled mineral domains and target the down-plunge extensions of higher-grade zones outside the Douay MRE.

The Company plans to utilize all available data from its year-long data compilation exercise to initially target the shallow portions of the Douay mineralizing system (<500 m vertical depth) to fully understand the geometry of the known zones and outline key plunge directions (Phase I on Figure 4) before systematically stepping down-plunge and at depth (>500 m vertical depth) during a proposed second drilling phase (Phase II on Figure 4). This will allow the Company to control exploration risk and maximize exploration success.

The initial focus of Phase I drilling will be on the central portions of the Douay MRE targeting higher grade areas within the Porphyry Zone (comprised of West/Central/East portions), which is hosted within the Douay Intrusive Complex and includes some of the highest-grade assays returned on the Property (up to 2,888 grams/tonne (“g/t”) of gold (“Au”) over 0.5 m in historical drill hole DO-05-04). Other targets include: the 531 Zone which is hosted within mafic volcanic and folded interflow sedimentary rocks and includes one of highest-grade gold intersections reported by the Company in drill hole DO-21-310 which returned 8.8 g/t Au over 28.5 m, including 12.7 g/t Au over 10.0 m and 31.1 g/t Au over 0.5 m (see Company news release dated September 9, 2021); and the Main Zone which lies along the northern edge of the Douay Deformation Zone (“DDZ“) with gold mineralization hosted along the sheared graphitic contact between the Taibi Group volcaniclastic and sedimentary rocks to the north and Cartwright Hills Group mafic volcanic rocks to the south. Taibi Group sediments represent a promising new target area for the Company with the potential for sediment-hosted gold deposits along a major lithotectonic boundary similar to the Casa Berardi and Canadian Malartic deposits.

Douay/Joutel Exploration Update

Since the completion of its last drilling campaign in Spring 2023, the Company has focused on streamlining onsite operations, standardizing procedures, enhancing efficiencies, centralizing data management, optimizing workflow, and reducing overhead site costs. This effort has led to increased productivity from a revamped technical team that has reviewed historical drill core, compiled and digitized data, distinguished new geological and structural controls on gold mineralization, and developed vectors for targeting gold mineralization in the next phases of drilling.

Key tasks completed by the Maple Gold technical team include: re-logging of historical diamond drill core (>20,000 m); re-interpretation and preparation of drill hole cross-sections and level plans for all mineralized zones; updating and creating new robust 3D geological and structural models in Leapfrog software; updating of the Property-wide drill hole and geochemical databases with previously unincorporated historical data; layering of geological, structural, geochemical and geophysical data sets to generate new targets; and use of expert geochemical consultants to process multi-element assay data to identify potential pathfinder elements and ‘hot’ spots.

Key findings from the year-long data review and compilation exercise include:

  • The Casa Berardi Deformation Zone (the “CBDZ“) widens around Douay/Joutel resulting in complex zones along the DDZ of brittle and ductile deformation, subsidiary splays, NNE cross-faulting, and potential dextral rotation around the Douay Intrusive Complex resulting in Delta-type pressure shadows and possible structural traps for gold (see Figure 2).
  • A variety of host domains and rock types are favourable for gold mineralization including the Douay Alkaline Intrusion, Taibi Group sediments (including iron formations), Cartwright Hills Group basalts (including Fe-Rich tholeiitic komatiites), Temiskaming-style conglomerates, and structural breaks associated with major lithotectonic (volcanic-sedimentary) contacts.
  • Multiple styles and generations of mineralization are present at Douay/Joutel including Intrusion-Related Gold Systems (“IRGS“), multi-phase breccias, late orogenic gold, and synvolcanic-exhalative gold (Eagle-Telbel).
  • Gold mineralization is commonly associated with broad zones of albitization, Fe-carbonatization, silicification, hematization, fenitization, biotitization, and pyritization and alteration can be used as a key vector for gold mineralization.
  • The twelve (12) main mineralized zones all display a strong plunge geometry to the higher-grade gold mineralization, which varies from shallow to steep, and from southeast to southwest, possibly related to an earlier folding event. There also appears be a periodicity to the mineralized zones within the DDZ spaced 500 m to 1,000 m apart (see Figure 3).
  • There has been very limited drilling below 500 m vertical depth in comparison to other gold deposits in the Abitibi (East Gouldie/Odyssey, LaRonde) (see Figure 4).

Planned Douay Development Initiatives

The Company plans to review the current Douay MRE for the Project which currently contains both pit-constrained and underground Inferred and Indicated mineral resources to optimize higher grade resources that could be accessible via an underground mining scenario. Initial focus would include the Douay West zone which currently hosts Indicated mineral resources totaling 4.2 million tonnes (“Mt“) grading 2.13 g/t Au (containing 286,000 ounces of Au) and Inferred mineral resources totaling 3.7 Mt grading 1.39 g/t Au (containing 169,000 ounces of Au)1. Douay West also includes existing surface infrastructure constructed in 1995 including a headframe and mine hoist.

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Figure 1: Location of the Douay/Joutel (Eagle-Telbel) Property in the Abitibi Sub-Province, Québec

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Figure 2: Plan view map showing generalized geology and mineralized zones at Douay/Joutel

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Figure 3: Plan view map showing location of Douay Mineralized Zones, 2025 Target Area and Drill Collars

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Figure 4: Composite longitudinal section showing location of Douay Mineralized Zones and 2025 Target Areas (in red) (note: comparison to other deposits for reference purposes only)

To view an enhanced version of this graphic, please visit:
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2024 Exploration Work Completed at Joutel and Morris VMS Project

In Q2 2024, the Company completed a 525 line-km airborne drone-magnetic geophysical survey over a detailed grid on the western portion of the Joutel gold project to assist in the development of new drill targets along the western strike extent of the Eagle-Telbel stratigraphy.

In Q3 2024, the Company completed a lithogeochemical sampling program over its Morris volcanogenic massive sulphide (“VMS“) project, located 29 km east of Matagami, Québec. The program focused on the felsic volcanic rocks of the key Watson Lake formation which is present on the Morris project and is known to host the major VMS deposits within the Matagami mining camp. The Summer 2024 sampling program highlighted several areas of highly altered rhyolite, and the Company is developing plans for follow-up work in 2025.

Qualified Person

Ian Cunningham-Dunlop, P.Eng., Vice President, Technical Services of Maple Gold and a qualified person (“QP“) as defined by Canadian National Instrument 43-101, has reviewed and approved the scientific and technical information related to exploration and Mineral Resource matters contained in this news release.

About the Douay/Joutel Gold Project

The Douay/Joutel Gold Project is located adjacent to Highway 109 in the heart of the Abitibi greenstone belt, Canada’s premier gold mining jurisdiction (see Figure 1). This large, 100%-owned land package includes the multi-million ounce2 Douay Gold Project and the past-producing, high-grade Joutel Gold Mine Complex3. The Property contains ~400 km2 of highly prospective geology (see Figure 2) within the influence of the major gold-bearing CDBZ. Gold mines in the immediate region include the Casa Berardi Gold Mine operated by Hecla Mining Company and the Detour Lake Gold Mine operated by Agnico Eagle Mines Ltd. (see Figure 1).

About Maple Gold

Maple Gold Mines Ltd. is a Canadian advanced exploration company focused on advancing its 100%-owned, district-scale Douay and Joutel gold projects located in Québec’s prolific Abitibi Greenstone Gold Belt. The Douay/Joutel projects benefit from exceptional infrastructure access and boast ~400 km2 of highly prospective ground including an established gold mineral resource at Douay with significant expansion potential as well as the past-producing Telbel and Eagle West mines at Joutel. In addition, the Company holds an exclusive option to acquire 100% of the Eagle Mine Property, a key part of the historical Joutel Mining Complex.

Maple Gold’s property package also hosts a significant number of regional exploration targets along a 55-km strike length of the Casa Berardi Deformation Zone that have yet to be tested through drilling, making the property ripe for new gold and polymetallic discoveries. The Company is currently focused on carrying out exploration and drill programs to grow mineral resources and make new discoveries to establish an exciting new gold district in the heart of the Abitibi. For more information, please visit www.maplegoldmines.com.

ON BEHALF OF MAPLE GOLD MINES LTD.

“Kiran Patankar”

Kiran Patankar, President & CEO

For Further Information Please Contact:

Mr. Kiran Patankar
President & CEO
Tel: 604.639.2536
Email: [email protected]

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS RELEASE.

Forward-Looking Statements and Cautionary Notes:

This news release contains “forward-looking information” and “forward-looking statements” (collectively referred to as “forward-looking statements”) within the meaning of applicable Canadian securities legislation in Canada. Forward-looking statements are statements that are not historical facts; they are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “aims,” “potential,” “goal,” “objective,”, “strategy”, “prospective,” and similar expressions, or that events or conditions “will,” “would,” “may,” “can,” “could” or “should” occur, or are those statements, which, by their nature, refer to future events. Forward-looking statements in this news release include, but are not limited to, statements about the resource expansion and discovery potential across the Company’s gold projects, and its intention to pursue such potential, and the Company’s exploration work and results from current and future work programs. Although the Company believes that forward-looking statements in this news release are reasonable, it can give no assurance that such expectations will prove to be correct, as forward-looking statements are based on assumptions, uncertainties and management’s best estimate of future events on the date the statements are made and involve a number of risks and uncertainties. Consequently, actual events or results could differ materially from the Company’s expectations and projections, and readers are cautioned not to place undue reliance on forward-looking statements. For a more detailed discussion of additional risks and other factors that could cause actual results to differ materially from those expressed or implied by forward-looking statements in this news release, please refer to the Company’s filings with Canadian securities regulators available on the System for Electronic Document Analysis and Retrieval Plus (SEDAR+) at www.sedarplus.ca or the Company’s website at www.maplegoldmines.com. Except to the extent required by applicable securities laws and/or the policies of the TSX Venture Exchange, the Company undertakes no obligation to, and expressly disclaims any intention to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

________________________
1 For additional details, see the technical report for the Douay gold project entitled “Technical Report on the Douay and Joutel Projects Northwestern Québec, Canada Report for NI 43-101” prepared by SLR Consulting (Canada) Ltd. with an effective date of March 17, 2022, and dated April 29, 2022.
2 The Douay Project contains Indicated Mineral Resources estimated at 10 million tonnes at a grade of 1.59 g/t Au (containing 511,000 ounces of gold), and Inferred Mineral Resources estimated at 76.7 million tonnes at a grade of 1.02 g/t Au (containing 2,527,000 ounces of gold). See the technical report for the Douay Gold Project entitled “Technical Report on the Douay and Joutel Projects Northwestern Québec, Canada Report for NI 43-101″ prepared by SLR Consulting (Canada) Ltd. with an effective date of March 17, 2022, and dated April 29, 2022.
3 The Eagle, Eagle West and Telbel Gold Mines at Joutel were in production from 1974 to 1993 and produced 1.1 million ounces of gold at an average grade of 6.5 g/t Au (Agnico Eagle Mines Ltd. website)

info

SOURCE: Maple Gold Mines Ltd.

Release – Townsquare Media, Inc. Reports Preliminary Estimated 2024 Results

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January 21, 2025

PURCHASE, N.Y., Jan. 21, 2025 (GLOBE NEWSWIRE) — Townsquare Media, Inc. (NYSE: TSQ) (“Townsquare”, the “Company,” “we,” “us,” or “our”) announced today preliminary estimated financial results for the fourth quarter and full year ended December 31, 2024.

“We are pleased to pre-announce our fourth quarter and full year 2024 estimated results that are directly in-line with the expectations and guidance we had previously outlined on our third quarter earnings call. We expect full year net revenue will be between $450 million and $452 million, within our guidance range of $448 million to $452 million. Therefore, we expect fourth quarter net revenue will be between $117 million and $119 million. In addition, we expect full year 2024 Adjusted EBITDA will be approximately $100 million, within our guidance range of $100 million to $101 million. Therefore, we expect fourth quarter Adjusted EBITDA will be approximately $31 million,” commented Bill Wilson, Chief Executive Officer of Townsquare Media, Inc. “As anticipated, our digital divisions had a very strong fourth quarter, as Townsquare Interactive returned to year-over-year revenue growth, and Digital Advertising net revenue accelerated to year-over-year growth rates in excess of +15%, helped by national digital advertising returning to revenue growth together with ongoing strength in our digital programmatic business. In total, we expect fourth quarter Digital revenue to increase approximately +11% year-over-year, and represent 52% of Townsquare’s net revenue in 2024, a true point of differentiation from others in local media, as we have evolved from a local broadcast radio company that was founded in 2010, to a Digital First Local Media Company with a world class team and a unique and differentiated strategy, assets, platforms and solutions. Further, we could not be more pleased to share that we are continuing to expand our Media Partnerships division, whereby we provide a white-label service that equips other local media companies with the digital advertising solutions that have driven Townsquare’s success. Following our October 2024 announcement that we partnered with SummitMedia, who operates in nine markets that do not overlap with Townsquare’s footprint, we have recently entered an agreement with another local media provider who operates in two additional non-overlapping markets. We expect that partnership to launch this summer.”

Mr. Wilson continued, “Given the cash generative nature of our business and our strong cash position, we were able to repurchase and retire approximately $12 million of our Senior Secured Notes in the fourth quarter (and $36 million in total in 2024), ending the year with $467 million of debt and $33 million of cash on hand. The combination of our healthy balance sheet, ongoing digital strength and momentum, Digital First Local Media strategy, and focus on markets outside of the Top 50 U.S. cities, reinvigorates my confidence in our business model and our path to long-term, sustainable growth and success.”

The information presented herein is based on internally available financial information that has not been audited or subject to regular period end closing procedures. As such, the financial guidance presented above reflects various assumptions and estimates based only upon information available to management as of the date hereof. This information should not be viewed as a substitute for full audited financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). As a result, while this information is presented with ranges and approximations that management considers to be reasonable, it remains in all cases subject to change pending finalization. It is very difficult to predict the impact of known factors and it is impossible for the Company to anticipate all factors that could affect its actual results. Actual results may differ materially from the estimates presented above due to developments or other information that may arise between now and the time the financial results for the fourth quarter and fiscal year are finalized. Therefore, you should not place undue reliance on estimated financial information provided herein, which speaks only as of the date hereof. Estimates of results are inherently uncertain and subject to change, and the Company does not undertake any obligation to update this information. The Company’s independent registered public accounting firm, BDO USA, P.C., has not audited, reviewed, compiled or performed any procedures with respect to any of the estimated financial information. Accordingly, BDO USA, P.C. does not express an opinion or any other form of assurance with respect thereto. The preliminary estimated financial information for the quarter and year ended December 31, 2024 is not necessarily indicative of the results to be achieved in any future period.

About Townsquare Media, Inc.

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for SMBs; a robust digital advertising division, Townsquare Ignite, a powerful combination of a) an owned and operated portfolio of more than 400 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 345 local terrestrial radio stations in 74 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com and NJ101.5.com, and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com, and Loudwire.com. For more information, please visit www.townsquaremedia.com, www.townsquareinteractive.com and www.townsquareignite.com.

Forward-Looking Statements
Except for the historical information contained in this press release, the matters addressed are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “aim,” “anticipate,” “estimate,” “expect,” “forecast,” “outlook,” “potential,” “project,” “projection,” “plan,” “intend,” “seek,” “believe,” “may,” “could,” “would,” “will,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms. Actual events or results may differ materially from the results anticipated in these forward-looking statements as a result of a variety of factors. While it is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by us include the impact of general economic conditions in the United States, or in the specific markets in which we currently do business including supply chain disruptions, inflation, labor shortages and the effect on advertising activity, industry conditions, including existing competition and future competitive technologies, the popularity of radio as a broadcasting and advertising medium, cancellations, disruptions or postponements of advertising schedules in response to national or world events, our ability to develop and maintain digital technologies and hire and retain technical and sales talent, our dependence on key personnel, our capital expenditure requirements, our continued ability to identify suitable acquisition targets, and consummate and integrate any future acquisitions, legislative or regulatory requirements, risks and uncertainties relating to our leverage and changes in interest rates, our ability to obtain financing at times, in amounts and at rates considered appropriate by us, our ability to access the capital markets as and when needed and on terms that we consider favorable to us and other factors discussed in “Risk Factors” and “Forward-Looking Statements” in our 2023 Annual Report on Form 10-K, for the year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2024, as well as other risks discussed from time to time in our filings with the SEC. Many of these factors are beyond our ability to predict or control. In addition, as a result of these and other factors, our past financial performance should not be relied on as an indication of future performance. The cautionary statements referred to in this section also should be considered in connection with any subsequent written or oral forward-looking statements that may be issued by us or persons acting on our behalf. The forward-looking statements included in this press release are made only as of the date hereof or as of the date specified herein. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Non-GAAP Financial Measures and Definitions
In this press release, we refer to Adjusted EBITDA, which is a financial measure that has not been prepared in accordance with GAAP.

We define Adjusted EBITDA as net income before the deduction of income taxes, interest expense, net, gain on repurchases of debt, transaction and business realignment costs, depreciation and amortization, stock-based compensation, impairments, net loss (gain) on sale and retirement of assets and other expense (income) net. This measure does not represent, and should not be considered as an alternative to or superior to, financial results and measures determined or calculated in accordance with GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. You should be aware that in the future we may incur expenses or charges that are the same as or similar to some of the adjustments in the presentation, and we do not infer that our future results will be unaffected by unusual or non-recurring items. In addition, this non-GAAP measure may not be comparable to similarly-named measures reported by other companies. Net income, the most directly comparable GAAP measure to Adjusted EBITDA, and a reconciliation of Adjusted EBITDA to net income are not included herein because we are not able to estimate certain components of these measures without unreasonable effort. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results.

We use Adjusted EBITDA to facilitate company-to-company operating performance comparisons by backing out potential differences caused by variations in capital structures (affecting interest expense), taxation and the age and book depreciation of facilities and equipment (affecting relative depreciation expense), which may vary for different companies for reasons unrelated to operating performance. We believe that this measure, when considered together with our GAAP financial results, provides management and investors with a more complete understanding of our business operating results, including underlying trends, by excluding the effects of transaction costs, net loss (gain) on sale and retirement of assets, business realignment costs and certain impairments. Further, while discretionary bonuses for members of management are not determined with reference to specific targets, our board of directors may consider Adjusted EBITDA when determining discretionary bonuses.

Investor Relations
Claire Yenicay
(203) 900-5555
[email protected]

Release – Century Lithium and Orica Specialty Mining Chemicals Sign MOU for Sodium Hydroxide From Angel Island

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January 21, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium) is pleased to announce it signed a non-binding memorandum of understanding (MOU) with Orica Specialty Mining Chemicals (Orica) on January 16, 2025. The non-binding MOU outlines the intent of Century Lithium and Orica to formalize a multiyear offtake agreement for Orica to purchase sodium hydroxide (NaOH) from Century Lithium’s wholly owned Angel Island project near Silver Peak, Nevada. Orica is one of the world’s leading mining and infrastructure solutions providers, and a major US manufacturer and supplier of specialty mining chemicals to Nevada’s mining industry.

“The non-binding MOU with Orica marks a key milestone for Angel Island,” said Century Lithium President and CEO, Bill Willoughby. “The MOU outlines the first expected agreement of its kind for the project and involves a large portion of the surplus sodium hydroxide anticipated during the early years of operation. We are excited to work with Orica and have their support at this stage of development at Angel Island.”

Orica President Specialty Mining Chemicals Andrew Stewart said: “This collaboration signifies our commitment to strengthening and unlocking Nevada’s manufacturing and mining sectors. By securing a reliable source of sodium hydroxide from Angel Island, we strengthen the local supply chain and reinforce our dedication to innovative US manufacturing solutions for our customers in North America.”

Century Lithium patent-pending process for extracting lithium from the claystone at Angel Island combines chloride leaching with direct lithium extraction and uses salt, in the form of solid sodium chloride or saline brine, to make the reagents for leaching and pH control. In addition to lithium, the process produces surplus sodium hydroxide, the sales of which are anticipated to underpin low operating costs for Angel Island’s primary product, lithium carbonate.

Highlights of MOU

  • Century Lithium to intends to provide Orica membrane-grade sodium hydroxide (NaOH)
  • Initial 5-year term, right of first offer for an additional 5 years
  • Pricing to be determined by definitive agreement
  • Orica – Century Lithium relationship will strengthen the U.S. supply chain, reducing reliance on imports of NaOH to the western U.S. and supporting Nevada’s mining industry

ABOUT ORICA

Orica (ASX: ORI) is one of the world’s leading mining and infrastructure solutions providers. From the production and supply of explosives, blasting systems, specialty mining chemicals and geotechnical monitoring to our cutting-edge digital solutions and comprehensive range of services, we sustainably mobilize the earth’s resources.

 Operating for more than 150 years, today our 14,000+ global workforce supports customers across surface and underground mines, quarry, construction, and oil and gas operations.

With a sodium cyanide manufacturing plants located in Winnemucca, Nevada and Alvin Texas, Orica is now the world’s largest producer of sodium cyanide and supplier to the Nevada mining industry, a leader in U.S. gold production. Find out more about Orica: www.orica.com

ABOUT CENTURY LITHIUM CORP.

Century Lithium Corp. is an advanced stage lithium company, focused on developing its wholly-owned Angel Island project in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with direct lithium extraction to make high purity lithium carbonate product samples from Angel Island lithium-bearing claystone on-site at its Pilot Plant in Amargosa Valley, Nevada.

Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery quality lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan expected to yield an average of 34,000 tonnes per year of lithium carbonate over a 40-year mine-life.

Century Lithium trades on both the TSX Venture Exchange under the symbol “LCE” and the OTCQX under the symbol “CYDVF”; and on the Frankfurt Stock Exchange under the symbol “C1Z”. To learn more, please visit: centurylithium.com 

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
[email protected]
centurylithium.com

Andrew Valler | Head of Communications
Direct: +61 437 829 211
[email protected]  
orica.com

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” 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” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.

Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.

These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update-forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.

Release – Bitcoin Depot Reports Strong Preliminary Fourth Quarter 2024 Results

Posted on by [email protected]

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January 21, 2025 8:00 AM EST Download as PDF

Q4 2024 Results Signal Strength and Momentum for 2025

ATLANTA, Jan. 21, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot Inc. (“Bitcoin Depot” or the “Company”), a U.S.-based Bitcoin ATM operator and leading fintech company, today announced certain preliminary financial results for the fourth quarter ended December 31, 2024.

The Company expects revenue to range between $135 million and $137 million, compared to $135.3 million reported in the third quarter of 2024 and $148.4 million reported in the fourth quarter of 2023. The Company also expects adjusted EBITDA to range between $11 million and $13 million, an increase of 22% to 44% compared to the $9.0 million reported in the fourth quarter of 2023 and an increase of 19% to 41% compared to the $9.2 million reported in the third quarter of 2024.

“We ended 2024 on a strong note, with an anticipated uptick in sequential revenue and significant improvements in adjusted EBITDA on both a sequential and year-over-year basis,” said Brandon Mintz, CEO and Founder of Bitcoin Depot. “This performance reflects the expansion of our BTM network and our progress in improving kiosk profitability. The strength of our fourth quarter positions us well for a rebound in 2025, supported by the overall health of our business and a more favorable cryptocurrency market environment.”

The financial results for the fourth quarter ended December 31, 2024, included in this release are preliminary, have not been reviewed or audited, are based upon the Company’s estimates, and were prepared prior to the completion of the company’s financial statement close process. The preliminary financial results should not be viewed as a substitute for the Company’s full fourth quarter results and do not present all information necessary for an understanding of the Company’s financial performance. Accordingly, undue reliance should not be placed on this preliminary data. Bitcoin Depot plans to release its fully audited fourth-quarter and full-year 2024 financial results in March.

About Bitcoin Depot

Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 48 states and at thousands of name-brand retail locations in 29 states through its BDCheckout product. The Company has the largest market share in North America with approximately 8,400 kiosk locations as of December 31, 2024. Learn more at www.bitcoindepot.com. 

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

Use of non-GAAP Financial Measures

This press release includes preliminary Adjusted EBITDA results for the fourth quarter ended December 31, 2025. Adjusted EBITDA is a non-GAAP. Bitcoin Depot defines Adjusted EBITDA as net income before interest expense, income tax expense, depreciation and amortization, non-recurring expenses, share-based compensation, expenses related to the PIPE financing and miscellaneous cost adjustments. Such items are excluded from Adjusted EBITDA because these items are non-cash in nature, or because the amount and timing of these items is unpredictable, not driven by core results of operations and renders comparisons with prior periods and competitors less meaningful. Bitcoin Depot believes Adjusted EBITDA provides useful information to investors and others in understanding and evaluating Bitcoin Depot’s results of operations, as well as provides a useful measure for period-to-period comparisons of Bitcoin Depot’s business performance. Adjusted EBITDA is a key measurements used internally by management to make operating decisions, including those related to operating expenses, evaluate performance and perform strategic and financial planning. However, you should be aware that Adjusted EBITDA may exclude items that are significant in understanding and assessing Bitcoin Depot’s financial results, and further, that Bitcoin Depot may incur future expenses similar to those excluded when calculating this measures. Bitcoin Depot primarily relies on GAAP results and relies on Adjusted EBITDA and other non-GAAP measures on a supplemental basis. No such measure should be considered in isolation from, or as an alternative to, net income, cash flows from operations or other measures of profitability, liquidity or performance under GAAP and may not be indicative of Bitcoin Depot’s historical or future operating results. Bitcoin Depot’s computation of Adjusted EBITDA may not be comparable to other similarly titled measures computed by other companies because not all companies calculate such measures in the same fashion. As such, undue reliance should not be placed on such measures. Due to some of the information excluded from Adjusted EBITDA calculation being non-ascertainable or non-accessible until the financial close is complete, Bitcoin Depot is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable GAAP measures is included and no reconciliation of the non-GAAP financial measures is included.

Contacts:

Investors 
Cody Slach
Gateway Group, Inc. 
949-574-3860 
[email protected]

Media 
Brenlyn Motlagh, Ryan Deloney 
Gateway Group, Inc.
949-574-3860 
[email protected]

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Source: Bitcoin Depot Inc.

Released January 21, 2025

Release – Alliance Resource Partners, L.P. Announces Fourth Quarter 2024 Earnings Conference Call

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Research News and Market Data on ARLP

January 20, 2025

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TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) will report its fourth quarter 2024 financial results before the market opens on Monday, February 3, 2025. Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.

To participate in the conference call, dial U.S. Toll Free (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13750955.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at [email protected].

Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
[email protected]

Source: Alliance Resource Partners, L.P.

Release – Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200—a Novel Integrin-Targeting Biologic for Diabetic Macular Edema

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Research News and Market Data on OCGN

January 16, 2025

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MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME).

“OCU200 has the potential to change the treatment landscape for DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors that play a crucial role in disease pathogenesis,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “OCU200 holds the promise to benefit all DME patients, including the 30-40% of patients who do not respond to current anti-VEGF therapies.”

The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). All subjects will receive a total of two intravitreal injections of OCU200 six weeks apart. Patient follow-up will take place up to three months after the last injection.

Approximately 12 million people in the United States and 130 million people worldwide are affected by DME, DR or wet AMD. Patients affected by these diseases share common symptoms, such as blurriness in vision and progressive vision loss as the disease progresses. The formation of fragile and leaky new blood vessels leads to fluid accumulation in and around the retina, causing damage to vision.

“I am seeing an increasing rate of vision-threatening diseases associated with diabetes at my clinic and am eager to provide a new therapeutic option to these patients,” said Dr. David Almedia, Vitreoretinal Surgeon and Clinician Scientist, President and CEO of Erie Retina Research, and Founder and President of Case X Global in Erie, Pennsylvania. “There remains a considerable unmet medical need for DME and DR patients with currently available anti-VEGF treatments.”

OCU200 is a recombinant fusion protein that consists of two parts connected by a linker: tumstatin, the active component, acts as an anti-inflammatory, anti-VEGF agent by binding to integrin receptors; and transferrin, which targets the drug to the choroid and retina by binding transferrin receptors on endothelial cells. These features will potentially enable OCU200 to reduce the vascular permeability, inflammation, and neovascularization that drive the pathophysiology of DME, DR, and wet AMD at a significantly lower dose compared to currently approved therapies.

“We are enthusiastic about getting patients started in the OCU200 Phase 1 clinical trial and sharing not only safety but preliminary efficacy data as the study progresses,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “OCU200 brings an innovative biologic candidate to Ocugen’s ophthalmology portfolio targeting blindness diseases.”

The Company intends to pursue approval to use OCU200 as a first-line therapy for DME, DR, and wet AMD.

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 patients’ 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 OCU200 to perform in humans in a manner consistent with nonclinical or preclinical 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
Head of Communications
[email protected]

Release – GeoVax Announces Major Gedeptin® Milestone with Plans of Phase 2 Trial

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Research News and Market Data on GOVX

Represents a Key Step Toward Validating Gedeptin Potential in Solid Tumor Therapy

Atlanta, GA, January 15, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing innovative immunotherapies and vaccines for cancer and infectious diseases, announced significant progress in advancing Gedeptin as a cancer therapy. Gedeptin, based on a Gene-Directed Enzyme Prodrug Therapy (GDEPT) platform, employs a targeted approach to deliver therapeutic agents directly to tumor sites. The result of this approach is the localized production of a potent anti-cancer agent(s) within the tumor microenvironment, while minimizing systemic exposure and the potential for associated side effects. 

Following a review of the data from the completed Phase 1 single-cycle and Phase 1/2 multi-cycle Gedeptin trials among patients with advanced Head & Neck (H&N) tumors, GeoVax has decided to initiate a Phase 2 clinical study, evaluating neoadjuvant Gedeptin therapy in combination with an approved immune check point inhibitor (ICI) in 1st recurrent H&N cancer scheduled for resection with curative intent.

Therapy Potential and Market Opportunity

Gedeptin has been granted Orphan Drug Designation by the U.S. FDA for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, underscoring its potential to address significant unmet medical needs.

“Preclinical data suggest that Gedeptin/fludarabine can enhance the activity of ICIs in treatment of solid tumors.  Our upcoming Phase 2 trial will investigate this approach as a neoadjuvant therapy for patients with first recurrence head and neck cancer. We believe this will lead to increased tumor response and decreased recurrence rates in these patients,” said David Dodd, Chairman and CEO of GeoVax. “Based on the data generated to date, this combination has the potential to address multiple solid tumor indications, and represents a significant medical and commercial opportunity, if approved.”

David Dodd added, “We are entering an exciting phase of clinical development with Gedeptin, and our team remains committed to advancing this innovative therapy to deliver life-changing benefits for cancer patients worldwide.”

Advancing Clinical Development

The upcoming Phase 2 trial will evaluate the efficacy of Gedeptin in combination with ICIs in patients with first-recurrence head and neck cancer. Key endpoints will include pathologic response rates and overall treatment outcomes. GeoVax plans to initiate trial activities mid-year and partner with leading academic oncology centers.

A Transformative Year Ahead

GeoVax projects significant milestones in 2025, with Gedeptin expected to play a key role in delivering transformative cancer therapies. Beyond head and neck cancers, the company plans to explore Gedeptin’s potential applications across other solid tumor types.

GeoVax’s CEO, David Dodd, will present the Company’s 2024 progress and outlook for 2025 at the Emerging Growth Conference: January 16, 2025, at 2:35 PM ET.

For more information on GeoVax’s portfolio and developments, please visit www.geovax.com.

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 to initiate during the first half of 2025. 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:                         Investor Relations Contact:                     Media Contact:
[email protected] [email protected] [email protected] 
678-384-7220 212-698-8696 202-779-0929